Reimbursement Levels Research Articles

What Acute Care Nurse Practitioners Should Understand About Reimbursement

What Acute Care Nurse Practitioners Should Understand About Reimbursement

Treatments of Low-priority and the Patient Mobility Directive 2011, an End to Legal Uncertainty for the English NHS?

The patient mobility case law of the Court of Justice of the European Union created legal uncertainty for the healthcare systems of EU Member States. The Patient Mobility Directive setting out patients' cross-border rights was adopted to end this uncertainty. With the Directive to be transposed into national law by October 2013 this article discusses whether the Directive achieves this objective for the English NHS. It contrasts the legal position of the NHS patient under case law and under the Directive regarding the need for prior authorisation of cross-border treatment, the level of reimbursement and the ambit of the healthcare benefits basket. It is argued that the risk of legal challenge may persist under the Directive, specifically regarding treatments which are classified by health authorities as low priority, namely treatments which are either not 'generally' available or only available subject to certain clinical criteria or access thresholds.

New drug regulations in France: what are the impacts on market access? Part 1 – Overview of new drug regulations in France

Access to the French drug market is being impacted by an ongoing dramatic shift in practice as well as by two laws that came into force in December 2011. This new environment has been described and analyzed in two separate articles. The first article aims to describe the recent changes in access to the French drug market. The severity of the condition being treated, which used to be the main determinant of the drug's reimbursement level in France, has now been replaced with the drugs’ efficacy criterion. Moreover, the effect size required for acknowledging drug innovation has substantially increased. Perceived evidence might also be more important than actual evidence. Comparative evidence and real-world data are considered critical conditions for marketing authorization. Cost-effectiveness studies will now be part of the market access requirements for all drugs in order to satisfy the selection criteria for medico-economic assessment.

Thirty-Day Readmission Rates as a Measure of Quality: Causes of Readmission After Orthopedic Surgeries and Accuracy of Administrative Data

The rate of unplanned 30-day readmissions to the hospital after discharge is being used as a marker to compare the quality of care across hospitals and to set reimbursement levels for care. While the readmission rate can be reported using administrative data, the accuracy of these data is variable, and defining which readmissions are unplanned and preventable is often difficult. The purpose of this study was to review readmissions to a single orthopedic hospital to identify the causes for readmission and, in particular, which readmissions are planned versus unplanned. Using that hospital's administrative database of patient records from 2007 to 2009, we identified all patients who were readmitted to the hospital within 30 days of a previous hospitalization for a procedure. Readmissions were broadly categorized as planned (a staged or rescheduled procedure or a direct transfer) or unplanned. Unplanned readmissions were defined as either surgical or nonsurgical complications (medical conditions not directly related to the procedure). Almost 30 percent of readmissions were planned. Of the unplanned readmissions, close to 60 percent were triggered by an infection or a concern for an infection. Nonsurgical complications accounted for 18.2 percent of unplanned readmissions. This study highlights the importance of careful data collection and abstraction when calculating early readmission rates. Preventing surgical site infection and better coordinating care between orthopedic surgeons and primary care and medical subspecialty physicians may significantly reduce readmission rates.

Why are investors not interested in my radiotracer? The industrial and regulatory constraints in the development of radiopharmaceuticals

Four criteria are essential in the acceptance by investors of new radiopharmaceuticals: the existence of a market and a medical need, the quality of the science and technology behind the new molecule, the feasibility and compliance with regulations and the limited competitive landscape. Potential investors need to get more convincing market evidence, largely beyond the nice preclinical data generated to the point of first discussion. A properly protected compound not jeopardized by earlier published results is a must. A guarantee of an easy and secured source of the ligand is obvious. A safe access to the radionuclide in volumes corresponding to the targeted market is rarely taken into account, but of utmost importance. The evaluation of new drugs by investors will include the evaluation of the real market size for the targeted indication and the position of the drug in the healthcare environment at the time to market. This includes the potential competition with other radiopharmaceuticals, but also with conventional drugs or competitive modalities also at time to market. Both criteria are usually not easily accessible to researchers whose acquaintance remains limited to the scientific and technical part. Starting from this set of information, a first business plan can be deduced based on a best estimate for price per dose and a rough evaluation about the chance and level of reimbursement. In the following most of the events are covered that could jeopardize the development of the drug, focusing on the industrial, economic and regulatory aspects, comprehending the detailed analysis of the currently best available radionuclides.

Identification of Significant Barriers to Accrual (BtA) to NCI Sponsored Multiple Myeloma – Clinical Trials (MM-CT): A Step towards Improving Accrual to Clinical Trials.

AbstractAbstract 3165 Background:Accrual to large oncology group studies in the United States is often slower than planned, especially in less common malignancies such as Multiple Myeloma (MM). To improve the treatment of patients with MM, it is essential that we address the barriers to accrual (BtA) to national clinical trials. The NCI Myeloma Steering Committee (MYSC) formed the Accrual Working Group (AWG), charged to analyze this problem. Methods:The members of the MYSC have developed a list of 10 potential BtA to NCI MM-CT under the leadership of the AWG at meetings conducted in person and by monthly telephone conference. This list was distributed via Survey Monkey among investigators and research staff of the SWOG, ECOG/ACRIN and Alliance research bases for the purpose of ranking the perceived importance of the 10 selected BtA. Responses based on a 0–5 Likert Scale were analyzed as continuous and categorical. For the latter, responses were grouped: Impedes Accrual – No (0,1), Yes (2–5); Significantly Impedes Accrual – No (0–3), Yes (4,5). Results:246 survey responses were received. 50 participants who indicated that they had never attempted to or actually never enrolled a patient into a MM-CT were excluded. Of 196 responders, 61% had enrolled at least 5 patients, 43% practiced in academic centers (A) and 57% in community centers (C). 26% identified themselves as research staff, 74% as primarily physician investigators including Principal Investigators (12%). 78% have current access to NCI MM-CT. 46% identified their research base affiliation with SWOG, 20% with ECOG/ACRIN, 17% with Alliance, 17% as CTSU, NRG and other.The majority of survey responders confirmed agreement in the perception that all 10 identified BtA impede accrual, ranging from 60–84% depending on the specific barrier identified, while significant impediment to accrual ascribed to these BtA ranged from 22–47%. The perceived barriers most often cited as impeding accrual were (1) spectrum of available treatment options, (2) level of reimbursement for clinical trial related expenses and (3) patient‘s need for prompt treatment intervention (84%, 80%, 76% respectively).The first two barriers along with the requirement that patients receive their treatment exclusively at the NCI designated treatment site were rated most often as significantly impeding accrual (37%, 47%, 34% respectively). The first two were also identified most often as perceived BtA independent of practice setting (A, C), type of research engagement (physician investigator, research staff) and level of experience with MM-CT. Interestingly, the perception that patients must receive their treatment at the NCI designated treatment site and competing industry sponsored clinical trials were substantially more often cited as impeding accrual in academic centers compared to community centers and by physician investigators compared to research staff. The complexity of required diagnostic work up and the complexity of the treatment protocol and follow up testing were substantially more often cited as BtA in the community setting and by research staff compared to their peers in the academic setting and by physician investigators.The NCI MYSC AWG has proposed specific solutions to potentially lower perceived BtA. These include guidelines to allow protocol specific administration of commercially available agents by the patient‘s local oncologist, a simplified diagnostic work up and treatment plan and eligibility inclusion of patients who have received up to one cycle of specified urgent therapy prior to enrollment in MM-CT. Conclusions:We have queried experienced clinical investigators and research staff on 10 potential MM-CT specific BtA and found substantial consensus among responding participants in this survey. There are apparent differences in perceived BtA between the respondents from academic and community centers as well as between research staff and physician investigators. These data suggest that a structured approach to identification of BtA to clinical trials is feasible and creates opportunities to overcome them. This may have application to clinical trials across other diseases and may also lead to improvements in accrual. Disclosures:Barlogie:Celgene, IMF, MMRF, Millennium, Genzyme: Consultancy; Celgene, IMF, Millennium: Honoraria; Celgene, Novartis, NCI, Millennium, Onyx, Icon: Research Funding; GEP: Patents & Royalties.

PHP121 Drug Reimbursement Maintenance: A French Challenge in 2011

In France, reimbursement of drugs is based on the therapeutic value of drugs (SMR level for each indication) as assessed by HAS, going from “insufficient” (no reimbursement at all) to “weak” (15% reimbursement), “moderate” (30%) and “important” (65%). HAS and manufacturer have the right to ask for re-assessment anytime after the initial reimbursement listing; in all cases, a relisting process is compulsory every 5 years. We analyzed HAS's reassessment and relisting activity over the year 2011, based on the hypothesis that the Mediator safety “affair” would have impacted the process. We considered all complete procedures for relisting, re-assessments and class reviews and focused on drugs for which a HAS advice was published between Jan and Dec 2011. We compared previous and new SMR levels for each indication. Twenty-six drugs have gone the relisting process, corresponding to 33 different indications, out of which 31 cases were analyzable: HAS modified 14 SMRs while 17 SMRs remained unchanged. Almost 50% (6/13) of SMR initially rated as “important” were changed to “insufficient” (4) or “moderate” (2). All initially insufficient SMR (8) were confirmed. 19 drugs have gone through re-assessment process, corresponding to 24 SMRs/indication, out of each only 21 were analyzable: 10 SMRs have been modified (only 2 increased and the rest lowered) and 11 unchanged. In 8 of these cases, the manufacturer had asked for the re-assessment. 6 full therapeutic classes have been reviewed in 2011, including Alzheimer's and antipschychotics, resulting in a harmonization and a decrease of the SMR levels. Manufacturers should now ensure that reassessment and relisting dossiers in France incorporate as much of relevant clinical, safety and real-life information as possible in order to maintain the reimbursement level.

PHP115 The Sharp Decrease of Drug's Access to Reimbursement in France in 2011

In France, all drug's indications are listed for reimbursement according to the advice of the Haute Autorité de Santé (HAS), which assesses the SMR level (Service Medical Rendu) – linked to the future drug reimbursement level, the ASMR (comparative added value) – linked to the future price and “official” target population. Until last year, 90-95% of SMR levels allowed reimbursement, hence a significant manufacturer focus on ASMR level (which actually is the basis for reimbursed drugs price fixation). Following the “Mediator affair” in 2010, the HAS perceived high percentage of positive recommendations for reimbursement have been challenged by multiple administrative and political reports. We investigated the 2011 HAS recommendations for reimbursement of new drugs/indications. We considered all complete procedures for a first inscription or line extension with an HAS opinion published between Jan and Dec 2011. We also considered applications which have been withdrawn by companies (no HAS advice). We focused our analysis on the SMR level, indication by indication, and compared it to 2010 HAS opinions. Sixty-two HAS opinions have been published in 2011: 30% less than in 2010 (85 opinions in 2010). Regarding the SMR and considering it is granted indication by indication: out of 81 SMRs granted for a first indication reimbursement, 30% (24) were considered “insufficient” (no reimbursement)–in 11 of these cases companies withdrew their applications. In 2010, the SMR “insufficient” represented only 11% of all the published advices (which was already higher than 2009: 6%). The number of positive recommendations for reimbursement has sharply decreased in 2011 versus 2010, going from 6-10% in previous years to over 30%. A qualitative analysis shows that the HAS seems to have evolved the assessment criteria used for SMR.

PCN128 Estimating the Value of Companion Diagnostics: Are the Incentives Right?

Targeted therapies are hoped to deliver high-quality, effective treatments that control cost growth. Companion diagnostics (CDs) –biomarker tests to identify patients likely to benefit– are key to this potential. However, as the US's IOM has noted, reimbursement for CDs may not provide optimal incentives to develop critical CDs. To illustrate, we examined the cost:benefit of CDs based on current reimbursement levels and the clinical and economic benefit allowed by biomarker targeting. We identified 6 approved CD/therapeutic combinations, all in oncology. Several parameters were obtained: efficacy of therapeutic in indicated but otherwise un-targeted patients and in patients with the biomarker, therapeutic and diagnostic costs, and prevalence of the biomarker. CD clinical benefit was measured by the improvement in therapeutic efficacy in targeted versus untargeted patients. CD economic benefit was based on therapy cost avoided assuming that patients in a non-screened scenario undergo 1-month trial. To compare, we estimated a similar measure of the clinical cost:benefit for all oncology therapies approved since 2000. Estimated net economic benefit of CDs ranged from about $250 to $8,000. Estimated economic cost: benefit ranged from approximately $0.05 to $0.55 per USD saved. Estimates of the clinical cost:benefit of CDs ranged from approximately $1.50 to over $15 per one-percent improvement in clinical efficacy. Comparison oncology therapies are reimbursed at rates that imply an average clinical cost:benefit of about $750 per one-percent improvement in efficacy for non-OS benefits to $2400 per one-percent improvement in OS. Our calculations support the IOM statement that current reimbursement for CDs may not be optimal. Relative to the value placed on oncology therapeutics, the reimbursed value CDs is a small fraction of what would be expected under value-based pricing. This has implications for the structure of the CD industry as well as the potential for future innovations in diagnostics.

Recommending organized screening programs for adults in Greece: A Delphi consensus study

ObjectiveIn the absence of organized screening programs in Greece, the aim of this study is to propose a set of programs, which exhibit potential to improve health system's performance. MethodsA literature review was conducted to identify those programs fulfilling certain screening evaluation criteria. Using Delphi method programs identified were evaluated by a multi-professional expert panel who were asked to provide their consent and recommendations for the implementation, target-group, rescreening interval, primary screening method and social insurance reimbursement level. Kuder–Richardson 20 and Cronbach's α were used for assessing internal consistency and number of rounds. ResultsThe majority of experts supported the introduction of organized screening programs for breast cancer, cervical cancer, colorectal cancer, abdominal aortic aneurysm and vascular risk assessment. Major disagreements arose on the target-group of the colorectal cancer and abdominal aortic aneurysm program concerning age-limits. Experts argued that only those fulfilling programs’ eligibility criteria or those referred should be reimbursed by social insurance. ConclusionRecommended screening programs provide for the first time a comprehensive and consensus based proposal for the secondary prevention policy of the country. They are expected to contribute to the reduction of the disease burden from important health problems and to the optimum allocation of resources invested in health.

Reference pricing systems in Europe: characteristics and consequences

Submitted: 16 May 2012; Revised: 8 August 2012; Accepted: 15 August 2012; Published online first: 17 August 2012 Introduction A reference pricing system is a system that establishes a reimbursement level or reference price for a group of interchangeable medicines. If a medicine is priced above the reference price, the patient pays the difference between the price of the medicine and the reference price, in addition to any other co-payments, e.g. prescription fee, percentage co-payment [1].

The Resource-Based Relative Value Scale and Neuroradiology

The Resource-Based Relative Value Scale (RBRVS) has been the defining algorithm for professional reimbursement of medical services since its introduction in 1992. This article reviews the history of the RBRVS, with an emphasis on the integral involvement of the radiology and neuroradiology communities. Appropriate reimbursement of radiology procedures has been chaperoned by physician volunteers and society staff attending Current Procedural Terminology Panel meetings and American Medical Association/Specialty Society RVS Update Committee (RUC) meetings. In recent years, governmental and RUC initiatives have created an unfavorable environment for neuroradiologists to maintain reimbursement levels seen previously.

2013 Medicare Proposal Outlines New Reporting Rules

2013 Medicare Proposal Outlines New Reporting Rules

Telemedicine: Current status and prospects in type 2 diabetes

Summary There has been rapid growth in studies involving TM in diabetes treatment in recent years. In France, while TM has proven its efficacy in DT1, there have been relatively few trials in T2D. Nevertheless, certain studies in the US have already shown benefits in terms of metabolic parameters compared with especially conventional treatment, which, in view of the high number of patients in a position to derive benefit, opens up broad new vistas. However, TM will only spread successfully on a national level through the concerted efforts of the various actors involved in its implementation. As regards the authorities, while a desire has been expressed to deploy TM nationally in five designated priority areas, its widespread use in diabetes therapy will depend upon the level of reimbursement agreed by the Health Insurance Department, and upon the costs to patients, but also on the perceived value of telephone consultations in terms of activity charges for hospitals and within the ambit of private practice. As regards health establishments, the spread of TM requires some reorganisation of healthcare, calling for intervention by paramedical staff acting by medical delegation in a context of inter-professional cooperation protocols. Such spread will thus depend upon the ability of firms developing medical devices to ensure compatibility of the information systems used. However, truly effective, implementation will depend first and foremost upon users themselves, in other words patients and healthcare teams, which means that each and every person must overcome their own resistance to change, to integrating TM devices and to making TM part of their daily lives as an effective instrument with which to optimise healthcare.

What can Canada learn from the USA's experience in reducing healthcare‐associated infections?

PurposeThe purpose of this paper is to briefly review the history of healthcare‐associated infection (HAI) prevention programs in the USA since the early 1970s until today, and provide suggestions how other countries (and Canada specifically) may learn from this experience to accelerate HAI prevention and patient safety improvements in their counties.Design/methodology/approachThe paper is a narrative review of literature and personal experience.FindingsUS hospitals have had healthcare‐associated infection (HAI) prevention programs, including surveillance for selected HAIs, since the late 1960s‐early 1970s. Such programs began with active surveillance for HAIs based upon the Centers for Disease Control and Prevention's (CDCs) National Nosocomial Infections Surveillance (NNIS) system. This system included standardized definitions and surveillance protocols. Since the 1980s, the CDC has developed HAI prevention guidelines, with categorized recommendations for HAI prevention. In the early 2000s, the Institute of Medicine published a report outlining the harm caused by HAIs. This led to increased attention to HAI prevention by an increasingly wide variety of organizations. The Joint Commission and the Centers for Medicare and Medicaid Services (CMS) initiated HAI prevention efforts. Many studies documented the failure of hospitals to fully implement evidence‐based practices. The increased attention to HAIs and their morbidity and mortality led to media reports and ultimately an initiative by the Consumer's Union for mandatory reporting of HAI rates by hospitals in all states. Subsequently, the CMS introduced decreased reimbursement for the additional costs directly related to HAIs (and other critical incidents) and linkage of reimbursement levels to hospital HAI rates. Together, mandatory reporting and reduced reimbursement for HAIs has led hospital executives to focus more attention on infection control programs to decrease HAI rates. Progress on preventing HAIs seems to be related to standardizing evidence‐based HAI prevention bundles, mandatory reporting, and paying for performance (or not paying for preventable HAI complications). Given that voluntary HAI prevention programs have existed since the 1970s, it appears that regulation, reporting, and decreased reimbursement has resulted in more rapid implementation of HAI prevention programs and improved patient safety.Practical implicationsThe different major activities enhancing HAI prevention in the USA are outlined in an historic context.Originality/valueUnderstanding the history of progress in hospital infection control efforts provides an essential perspective for policy makers and for the interdisciplinary team required to evaluate HAI mandatory public reporting in a comprehensive manner.

A Longitudinal Analysis of the Impact of Hospital Service Line Profitability on the Likelihood of Readmission

Quality of care may be linked to the profitability of admissions in addition to level of reimbursement. Prior policy reforms reduced payments that differentially affected the average profitability of various admission types. The authors estimated a Cox competing risks model, controlling for the simultaneous risk of mortality post discharge, to determine whether the average profitability of hospital service lines to which a patient was admitted was associated with the likelihood of readmission within 30 days. The sample included 12,705,933 Medicare Fee for Service discharges from 2,438 general acute care hospitals during 1997, 2001, and 2005. There was no evidence of an association between changes in average service line profitability and changes in readmission risk, even when controlling for risk of mortality. These findings are reassuring in that the profitability of patients' admissions did not affect readmission rates, and together with other evidence may suggest that readmissions are not an unambiguous quality indicator for in-hospital care.

Primary care in the United States: practice‐based innovations and factors that influence adoption

This study aims to explore the use of specific innovations in primary care practices. The research seeks to examine whether a relationship exists between environmental factors and organizational characteristics and the level of innovation in primary care practices in Virginia. The study utilized multiple secondary data sets and an organizational survey of primary care practices to define the external environment and the level of innovation. Institutional theory was used to explain the connection between innovations in primary care practices and institutional forces within the environment. Resource dependency theory was used to explain motivators for change based on a dependence on scarce financial, human, and information resources. Results show a positive association between organizational size, organizational relationships, and stakeholder expectations on the level of innovation. A negative association was found between competition and the level of innovation. No relationship was found between degree of Medicare and managed care penetration and innovation, nor between knowledge of, and difficulty complying with, payer organization requirements and innovation. Primary care physician practices exist in a market-driven environment characterized by high pressure from regulatory sources, decreasing reimbursement levels, increasing rate of change in technologies, and increasing patient and community expectations. This study contributes new information on the relationship between organizational characteristics, the external environment and specific innovations in primary care practices. Information on the contributing factors to innovation in primary care is important for improving delivery of health care services and the ability of these practices to survive.

Pharmaceutical sector in the new reimbursement era

Pharmaceutical sector in the new reimbursement era The topics taken into consideration in this article concern the role of pharmaceutical sector in country's economy and the influence of factors limiting economic growth of the branch, mainly provisions of The Act on Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Purposes and Medical Devices from 12<sup>th</sup> of May, 2011. New rules introduced by this Act, affecting the price evolution of the reimbursed products (i.e., official selling price, fixed wholesale and retail margins, retail margin calculated on the basis of wholesale price of the limit-determining product), had an impact on the increase of patient repayment level for the drugs, the decrease of NHF reimbursement and spending level, and the drop of the value of reimbursed drug market. Such a situation caused the increase of patient repayment level for the reimbursed drugs in many disease entities. In spite of many restrictions imposed by the mentioned Act, the perspectives of pharmaceutical market's growth in Poland are positive. In last few months, pharmaceutical sector has been prepared for the entry of new Reimbursement Act. More than 60% of requested pharmaceutical companies estimated positively current market situation in Poland. Among the surveyed ones, increasing sales numbers and improving financial results are indicated as the causes of such estimation (KPMG/PMR Report 2011). Every single pharmaceutical enterprise is the company undergoing the same rules as companies operating in other fields, which means the necessity of profit taking. During the analysis of the pharmaceutical market one can see some complexity and specificity, particularly due to the offered products and the sources of their funding, the level of regulation and the conservatism of the market itself which is one of the highest in the entire business. In spite of numerous limitations, most of enterprises realize the strategy of a continuous growth due to successful selling and marketing activities.

State Medicaid Policies and the Health Care Access of Low-Income Children With Special Health Care Needs Living in the American South

The policy correlates that improve or impede the health care access of children with special health care needs (CSHCN), and particularly children living in the South, are not well understood. We analyzed data from the 2005-2006 National Survey of CSHCN (n = 4560 Southern children and 8788 non-Southern children). State Medicaid policy predictors included the frequency of Medicaid eligibility renewals (6 or 12 months) and the level of reimbursement provided for high-complexity and moderate-complexity pediatric office visits. Hierarchical generalized linear modeling was used to examine the association between state Medicaid policy features and 5 indicators of health care access (delayed or foregone care, difficulty using services, difficulty getting referrals, unmet routine care needs, and unmet specialty care needs), after controlling for child, family, and state factors. Low-income Southern CSHCN who lived in states with less-frequent Medicaid eligibility renewal requirements and higher health care provider reimbursement rates had significantly better health care access than did their Southern counterparts in states with more-frequent Medicaid eligibility renewals and lower reimbursement rates. These data are cross-sectional, and causality cannot be inferred. Policymakers interested in addressing state budget gaps should be concerned that doing so by increasing the frequency of Medicaid eligibility renewals or by cutting health care provider reimbursement rates may well result in adverse health care access for low-income Southern CSHCN.

Current progress in the management of rare diseases and orphan drugs in China.

Currently, the issues of how to treat rare diseases and to improve accessibility to orphan drugs are arousing more and more concerns in China. Here we describe the push and pull incentive policies for rare diseases and orphan drugs and analyze the coverage and reimbursement level of rare diseases in the current Chinese medical insurance system. Three key obstacle factors that hinder Chinese patients' accessibility to timely drug treatment are summarized. Based on a comprehensive analysis, the measures of orphan drugs legislation, incentive mechanism, supply mechanism, and reimbursement mechanism are urgently expected to be established with the purpose of improving healthcare for patients with rare diseases in China.