In 2014, the HHS Office of Inspector General released a study regarding contract pharmacies that was conducted by interviewing a “purposeful sample” of 30 administrators and representatives of covered entities (OIG, 2014). The law instructs the HHS to enter into a pharmaceutical pricing agreement (PPA) with drug manufacturers as a stipulation for their drugs to be covered under Medicaid. Found inside – Page 185The influence of stakeholders' pressure on firms' environmental strategy has also gained considerable attention among academic scholars. Empirical results of existing studies show that firms have different environmental responses ... A review of studies of clinician awareness of medication costs found that clinicians were able to estimate. From 2015 to 2016, orphan drug sales increased 12.2 percent to $114 billion, compared with an increase of 2.4 percent (to $578 billion) for non-orphan drug sales (Evaluate Pharma, 2017). Increased cost sharing can reduce patient uptake and adherence to treatments, including specialty drugs (Alexander, 2003; Doshi et al., 2016a,b; Dusetzina et al., 2014; Fischer et al., 2011; KFF, 2015; Olszewski et al., 2017; RAND Health, 2006; Streeter et al., 2011; Winn et al., 2016). that authorized the FDA to allow the reimportation of prescription drugs from a specified group of countries. HRSA administers the 340B program and is responsible for the oversight of various stakeholders, including covered entities and pharmaceutical companies. In the past several years, HRSA has been working to release a comprehensive update to the program’s definitions, covered entity qualifications and program participation requirements for covered entities and manufacturers, sometimes referred to as the omnibus Mega-Reg (HRSA, 2015). 14 CMS contracts with sponsors (insurers) to provide the Medicare Part D prescription drug benefit. In a study of 122 different medication products, nearly 90 percent met the requirements for an extension; the average additional extension length by SLEP was 5.5 years, and some lots were extended by more than 20 years (Lyon et al., 2006). A 2014 study on primary care found that approximately 31 percent of patients did not fill their prescriptions within the first 9 months after receiving them from a doctor. dized by the Australian government. As a result, clinician reimbursement remains stagnant for two quarters after drug acquisition costs rise, posing a financial risk for outpatient practices (Conti et al., 2013). A comparable market with no col-laterals is that of educational loans where the default rate has been 12 to 14 percent in recent years (AIER, 2017; Friedman, 2017), markedly higher than auto loans and credit card delinquencies. Some of this waste in the system could be eliminated by changing the way drugs are packaged and labeled. In the past, when sales frequently had face-to-face meetings, experienced B2B sales professionals could determine through research and thorough questioning who plays what role in the purchase process and ensure each of the influencers have bought in to their solution. 1 Many therapies benefit only some of the patients who receive them. Eligibility for support from these sources varies by insurance status and income. Over the past decades, the consumption of fast foods has increased worldwide (1, 2).Recent studies have shown that the trend of fast-food consumption among Iranians as well as the number of fast-food restaurants in Iran are considerably increasing (1, 2), which is an important health concern among the Iranian population, particularly in the urban areas (). Nearly one-quarter of the Americans who participated in a 2015 survey reported that they had difficulty affording their prescription medicines. In recent years, between 80 and 90 percent of all prescriptions in the United States have been filled with generic products (Boehm et al., 2013; GPhA, 2015; Lee et al., 2016). The unit price of a drug is, of course, only one factor in determining the cost of a full course of treatment for a medical condition. Strategic Management: A Stakeholder Approach Stakeholder management is a critical component to the successful delivery of any project, programme or activity. Examples Stakeholder influence is now felt more keenly in many areas of corporate and public life. Moreover, drugs may be falsely labeled as originating in the United States or a Canadian pharmacy (Bhosle and Balkrishnan, 2007). The report noted that covered entities using contract pharmacies do not always offer the discounted 340B price. Stakeholders have a huge, if not the greatest impact on projects. The authors concluded that generic drug markets in the United States typically involve small-revenue products and are increasingly tending toward duopoly or monopoly supply. Depending on what data compliance and HR share, HR can help to mitigate perceived, potential, or actual conflicts of interest—for example, providing compliance with any relevant disclosure documents made by new employees during the hiring process or having a centralized system where employees can report conflicts of interest. Indeed, many stakeholders are needed to contribute to a “future food system which provides enough safe, authentic food for us all to have healthy lives now and in the future” . These include Vioxx, Cialis, and Botox. In summary, the costs of research and development for biopharmaceutical development appear to have steadily increased in real terms over time, although it is difficult to know by exactly how much because estimates vary widely according to the analytical approach and the data sources used in making them. The PBS provides a list of drugs approved for coverage. The importing and the reimporting of prescription drugs have been perennial proposals in the U.S. Congress over the past two decades. Google has many stakeholders, but they can be grouped based on shared interests. For Revlimid, a cancer drug, a patient enrolled in Part D in 2016 faced total annual out-of-pocket costs of $11,538 for this drug alone in 2016, 76 percent of which was in the catastrophic coverage phase of the benefit. Finding 3-18: In order for both consumers and clinicians to make well-informed decisions regarding prescription drug therapies, reliable and objective information is needed—including information on potential clinical outcomes, the comparable effectiveness of alternative treatments, and out-of-pocket and overall costs to the patients. This site-neutral payment policy was designed to reduce Medicare spending on off-campus hospital outpatient department services that could be performed at a physician’s office for a lower rate. Buy and bill also creates incentives for high pricing of drugs covered under the Part B benefit. If a drug manufacturer signs a PPA, it agrees that the prices charged for covered outpatient drugs to covered entities will not exceed 340B ceiling prices as defined by statute. Fewer than 10 such industry-sponsored products entered the market in the decade preceding the act (FDA, 2017e). Many states have used strict guidelines for determining which patients are eligible to receive hepatitis C treatment through state programs (Barua et al., 2015). Another legal obstacle is that it is nearly impossible for drugs made for non-U.S. markets to satisfy the FDCA’s requirements relating to drug approval and labeling (CRS, 2008; Terry, 2004). As noted above, in response to increasing costs across all sectors of health care, insurance companies have raised deductibles, increased monthly premiums, imposed or increased copays and coinsurance, and transferred high-cost drugs to more expensive formulary tiers (Claxton et al., 2017; Consumer Reports, 2016). Drug use, serum albumin, and total number of lesions may serve as independent factors influencing the degree of disability in patients … The ACA required a new dispute resolution process and greater pricing transparency by establishing a 340B. Background. Don't buy this book if you have the time and inclination for studying theoretical concepts. You'll be disappointed in less than an hour. Do buy this book if you're in a hurry and want to accelerate your achievements and your goals. In Harvard Business Review, Chris Musselwhite, CEO of Discovery Learning Inc., and Tammie Plouffe, managing partner of Innovative Pathways, reveal that you can improve your powers of communication once you learn to identify and navigate what they call the five distinct styles of … © 2021 National Academy of Sciences. Covered entities can seek additional rebates on top of the 340B discount. Influencing The research employed a qualitative research design. The department has its finger on the pulse of employee culture and often is the first function to sense when a problem arises, which is usually a sign of wider compliance-related issues. Click here to buy this book in print or download it as a free PDF, if available. by bramuel kitisha kedogo a research project report submitted in partial fulfilment of the requirements for the award of a degree of master of arts in project planning and management of the university of nairobi 2013 Financial Strategic Project Management SPOMP: Five Powerful ... Each program is a unique, unregulated, private offering by a pharmaceutical company for an individual product. Many state laws, affecting about three-quarters of the U.S. population, require insurance coverage of infused and injected cancer treatments if their use is recognized in drug compendia, the peer-reviewed literature, or both (Bach, 2009; IOM, 2013). An analysis by the RAND Corporation estimated that the use of biosimilar products across all therapeutic classes would result in savings between 2014 and 2024 of from $13 billion to $66 billion, depending on the amount of competition, with a best estimate of $44.2 billion (Mulcahy et al., 2014b). At the IFCA’s 2021 International Compliance Congress earlier this month, Jennifer Lee, a risk and compliance manager at construction machinery and equipment company Caterpillar, shared helpful tips on how CCOs (and CECOs) can drive collaboration with metrics and present it to internal stakeholders in a way that helps create an overall lean and tailored compliance program. A drug company can opt for a drug to not be assessed, in which case the drug’s price is set through the German reference pricing system. On rare occasions a therapy emerges that promises to cure those affected and thereby potentially eradicate the disease. Get back hours in your day with automated workflows. Hence, clinicians are unlikely to respond favorably to anything that requires them to deal with multiple prices for each patient’s medication unless the information is provided in an efficient, user-friendly fashion at the point of care. If the National Institute for Health and Clinical Excellence (established in 1999 to provide guidance on the clinical effectiveness and cost-effectiveness of interventions and pharmaceuticals compared with current standard practice) does not consider a new medicine to be cost-effective, it does not recommend it for use by the National Health Service (Trowman et al., 2011). Contract pharmacies are employed by some hospitals and clinics to expand services outside of hospital walls (HRSA, 2010). In order for clinicians and patients to make optimal choices relating to drug therapies, both must have reliable information regarding the benefits and costs of both the drug under consideration and other treatment options. However, sponsors are required to request orphan drug designation from the FDA before filing a new drug application (FDA, 2017e). Recent developments should inspire boards to reassess how their company’s environmental initiatives align with long-term shareholder value. 10 Section 602 of Public Law 102-585, the Veterans Health Care Act of 1992 enacted section 340B of the Public Health Service Act (PHSA) Limitation on Prices of Drugs Purchased by Covered Entities, codified at 42 U.S.C. In 2014, virtually all Part D formularies required coinsurance of between 25 and 33 percent for cancer drugs, the maximum allowed by the Centers for Medicare & Medicaid Services (CMS) (Dusetzina and Keating, 2015). Influencing These plans require a higher deductible than most health plans, in exchange for a lower monthly premium. However, given the large and expanding array of choices, expecting even experienced clinicians to have a full grasp of the benefits and the risks of all reasonable alternatives is at best problematic, while the patients themselves can be expected to know and understand far less than the providers. Advising Upwards brings together the ideas of experts in fields related to engaging senior stakeholders, such as risk management, decision-making, understanding cultural considerations, effective communication and other disciplines that may ... Critics argue that centralized lists limit health care delivery, constrain professional autonomy, interfere with pharmaceutical markets, and reduce health benefits for patients (Reidenberg and Walley, 2004). For example, Gleevec has received 9 separate orphan drug designations and had a reported $3.3 billion in sales for 2016 (Novartis, 2017). View our suggested citation for this chapter. Finding 3-12: Large biopharmaceutical companies spend substantially more on marketing and administration than on research and development that could lead to new drugs. The SEC has reportedly launched an investigation into Cassava Sciences regarding allegations made against the clinical-stage biopharmaceutical company and its experimental Alzheimer’s drug by a law firm representing anonymous short sellers. Internal stakeholders are employees or teams in your organization who have an interest or concern in a strategy, plan, program, project, product or process. More recently, under the Safety and Innovation Act of 2012, the FDA required drug manufacturers to provide early notification of any manufacturing interruptions or production changes that could lead to a supply disruption or the discontinuation of a product. Drug use, serum albumin, and total number of lesions may serve as independent factors influencing the degree of disability in patients … However, a recent lawsuit brought by the attorneys general of 45 states and the District of Columbia accused 18 companies and subsidiaries of colluding to fix prices for 15 medicines (Friefeld, 2017). Sign up for email notifications and we'll let you know about new publications in your areas of interest when they're released. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. and 2-6 illustrates these mechanisms. In a market-oriented economy, these increases in research and development costs would, over time, be expected to contribute to rising prescription drug prices. The stakeholder theory is a theory of organizational management and business ethics that accounts for multiple constituencies impacted by business entities like employees, suppliers, local communities, creditors, and others. These issues further highlight the importance of having multiple producers of generic drugs. The share supplied by one or two manufacturers increased over time and was larger. Manufacturers propose dose sizes for marketing, and the FDA only reviews the request for safety considerations (FDA, 2015). It is now used to treat a wide variety of conditions, including non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and several skin disorders. 9 Commonwealth of Massachusetts, MassHealth Section 1115 Demonstration Amendment Request, September 8, 2017. The growing scope and influence surrounding environmental activist campaigns promises to spill well beyond 2021. The patent law and health insurance systems in the United States are in concept similar to those in other developed countries. This affects retail purchases of both insured and uninsured patients, as well as drugs purchased by clinicians and hospitals and administered to patients directly. Book 15,000 accredited courses in 100 locations. ance plans for the first 12 months. It may take several competing generic companies to enter the market before the prices for the drug to reach their lowest possible level based primarily on cost of production.2 Generic prices, not surprisingly, exhibit the largest reductions in markets where revenues are initially above average (Gupta et al., 2016; Olson and Wendling, 2013). The U.S. Congress created the Medicaid Drug Rebate Program (MDRP), which went into effect in 1991, resulting from the Omnibus Budget Reconciliation Act of 1990 in an attempt to address the rising cost of prescription drugs in the Medicaid program. Determining whether crypto assets are legal, safe, and provide consumers with adequate protection from fraud are three areas of concern federal banking regulators say they will examine in 2022. Finding 3-4: When branded drugs go off patent and a generic supplier enters the market, prices for those medications usually decline; with two or more generic suppliers, the market prices generally decline significantly. Focus - the Project Management and IT training specialist. For drugs dispensed or used by clinicians at a hospital-affiliated clinic or an outpatient infusion center affiliated with a hospital, these providers also charge payers facility fees, which may amount to 50 percent or more of the drug’s acquisition cost. ... Impress stakeholders with stunning one-click reports and analytics. For such products, arguments for eliminating financial barriers to treatment are compelling. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual’s insurance coverage and the number of medical conditions that an individual or family confronts. Two recent studies examined manufacturer entry, exit, competition, and the relationships among generic drug supply structures and inflation-adjusted prices. There is little information available to evaluate the impact of patient assistance programs so few studies have examined the proportion of patients served, the extent of aid provided, the criteria for qualifying for aid, and the estimated financial cost to society (Felder et al., 2011). Influence: Gaining Commitment, Getting Results In many countries the implementation of an essential drug list is affected by such factors as pricing policy, the availability of essential drugs, reimbursement policies, government initiatives, patent and licensing, and the health care infrastructure (QuintilesIMS, 2015b). Conversely, community oncology practices that do not qualify for 340B discounts operate on lower per person-per treatment margins derived from the administration of the drugs they purchase, including the revenue generated from buy-and-bill reimbursements and the ability to charge facility fees (Polite et al., 2014). Prior to the ACA, rebates through the MDRP were only available for drugs provided in fee-for-service settings. Foreign company’s subsidiary poured millions into ... drug costs within 25 percent of the true cost less than one-third of the time. Unlike most rebates for prescription drug spending, the rebates obtained through the MDRP are not negotiated, but are defined by statute. Most often the increases in price reported in the study were between 100 and 499 percent, but in a few cases, specifically for drugs used to treat such conditions as fungal or viral infections or heart disease, a drug’s price increased by 1,000 percent or more. This is not to suggest that the general strategic implications of stakeholderthinking are not being consider, as an increasingly number of works are looking atstakeholder implications in regards to exchange networks, relationship marketing, ... A more recent report found that hospitals participating in 340B in 2015 exhibited widely varying financial stability and safety net care provision (Nikpay et al., 2017). After the ban, the tobacco industry increased advertising in other media, but the total volume of advertising by the industry decreased. For oral tablets and capsules, the direct costs of ANDA applications are modest ($1 million to $5 million) compared with potential profitability (Berndt and Newhouse, 2012). This book sets out a systematic way to understand who you need to influence, how to evaluate the priority you give to each person, what tactics will work the best, and how to plan and execute your campaign. The regulatory review process for orphan drugs is expedited, and clinical trials can enroll smaller numbers of patients than would otherwise be acceptable in registration trials. Analytics cookies are completely optional and we won't collect them unless you give us your consent. These two examples should not be interpreted as examples of direct contributors to increasing drug prices. The Food, Drug, and Cosmetics Act (FDCA) prohibits the importation of prescription drugs made in the United States by anyone other than the manufacturer—with the exception of drugs approved by the secretary of the U.S. Department of Health and Human Services (HHS) for emergency care.

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