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Pages 1-16

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From page 1...
... Many of the weight-based drugs in single-dose vials are among the more expensive drugs on the market, and they are paid for by federal health care programs, private health plans, and patients, who have co­payment and coinsurance obligations. For Medicare patients, these drugs are covered under Medicare Part B when they are administered by infusion and injection in physician offices or hospital outpatient departments.
From page 2...
... Since January 2017, the Centers for Medicare & ­Medicaid Services (CMS) has required health care providers to report, with a particular code called the JW modifier, the portion of drug from a single-dose vial that is discarded and eligible for payment under the "discarded drug policy." Under this CMS policy, health care providers receive payment for the total amount of drug indicated on the vial or package label of a single-dose product, including that which is discarded.
From page 3...
... . • Investigate manufacturer rationale for developing particular vial sizes and safety standards (such as those from the United States Pharmacopeia)
From page 4...
... In the case of fixed doses, which are typical of the drugs sold in pharmacies, usually in the form of tablets or capsules, patients receive drug doses that may vary by therapeutic need but are not based on a patient's weight. By contrast, weight-based doses, which are typically liquids given through injection or infusion directly by physicians or other health care providers, vary according to a patient's weight or body size and are much more common for infused and injectable drugs than for tablets or capsules.
From page 5...
... Because neither drug manu­ facturers nor health care providers have any incentive to change the system and reduce the amount of discarded drugs, significant amounts of expen sive drugs are manufactured and distributed but ultimately not used. QUESTION OF WASTE Making appropriate and effective policy choices in this area requires a clear understanding of the concept of drug "waste." The committee's Statement of Task used waste specifically to refer to the discarded portions of single-use vials of weight-based drugs, which raised the question of exactly how to understand the term in this context.
From page 6...
... Raising drug prices combined with the costs associated with developing methods to allocate drugs to multiple patients from single-dose vials or to collect reimbursements would likely not result in any actual financial savings to payers or patients. This would reflect true economic waste in the sense that those resources used to reallocate drugs would not have generated additional medical benefits or cost reductions to payers.
From page 7...
... ALIGNING INCENTIVES AND INCREASING EFFICIENCY TO IMPROVE QUALITY OF CARE To lay the foundation for strategies to reduce certain inefficiencies that lead to discarded drugs while ensuring patient safety and quality care, the committee presents two broad goals and eight associated recommendations. The goals and proposed recommendations are oriented toward changing incentives and increasing efficiency in how these drugs are developed, administered, and paid for.
From page 8...
... CDC suggests that vials labeled by the manufacturer as single-dose or single-use should only be used for one patient and that repackaging is not acceptable, while FDA and CMS allow for repackaged doses if each one is used only for a single patient. The situation would be greatly improved if the current inconsistent regulatory guidelines were harmonized -- and, preferably, modeled on successful protocols in other countries that allow vials to be used for multiple patients.
From page 9...
... should develop and imple ment policies that require drug manufacturers to produce injectable and infused drugs in multi-dose vials when it is safe to do so. The Secretary of HHS should routinely review and evaluate the impact of such policies.
From page 10...
... The committee identified additional problems with the current reimbursement system for clinician administration of infused or injected drugs. For example, Medicare and private payers reimburse health care providers based on the drug's average sales price plus a percentage addon for administering it.
From page 11...
... Some observers have argued that enforcing the requirement for using the JW modifier would lead to increased transparency regarding payments for discarded drugs. Others, however, argue that the JW modifier provides an economic incentive for discarding drugs and hinders efficient ways to distribute or administer drugs because it still allows health care providers to be reimbursed regardless of whether all of the drug is actually used.
From page 12...
... INTERDEPENDENCIES OF RECOMMENDATIONS The nation's biopharmaceutical sector -- including the ­researchers who develop and test drugs, drug manufacturers and distributors, pharmacies, the hospitals and health care providers who administer the drugs, the payers (such as Medicare and private health plans) , and the various agencies that regulate drug development, manufacture, use, and ­reimbursement -- is a complex, interconnected system.
From page 13...
... FIGURE S-1  A representation of how two recommendations focus on different issues but are intended to have similar effects by 13 moving the system away from the current standard practice.
From page 14...
... High prescription drug costs are particularly burdensome for older Americans in the Medicare population who often have multiple chronic conditions, such as cancer, rheumatoid arthritis, multiple sclerosis, and other immune disorders, as well as for individuals who are unfortunate enough to develop a disease whose treatment requires more expensive drugs. Ultimately, ensuring drug affordability will require a much broader and more sustained effort, of the sort described in the 2018 National Academies report Making Medicines Affordable: A National Imperative, which
From page 15...
... In short, the set of recommendations offered in this report would yield significant results if they are leveraged with other strategies aimed at lowering drug prices. Because of various factors such as our aging society and the rising cost of health care, it is more important than ever that the United States act now to ­address these issues.


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