Addressing the role of edaravone in the management of amyotrophic lateral sclerosis and gaps in care and access: expert panel recommendations.

A virtual key opinion leader (KOL) and payer discussion was held on December 5, 2020. In attendance were 2 KOLs, both specialists in amyotrophic lateral sclerosis (ALS) at leading clinics in the United States, and 6 managed care executives from US regional health plans. The objective of this panel was to share opinions, ideas, and information around the treatment of ALS with edaravone, gaps in management and guidelines, and potential solutions. The panel concluded that coverage criteria for edaravone may need to be reassessed and treatment guidelines could be revisited to include a determination of place in therapy for edaravone.

Medicare Part D-a roundtable discussion of current issues and trends.

BACKGROUND: Medicare Part D was introduced with a goal of providing access to prescription drug coverage for all Medicare beneficiaries. Regulatory mandates and the changing landscape of health care require continued evaluation of the state of the Part D benefit. OBJECTIVE: To review the current state of plan offerings and highlight key issues regarding the administration of the Part D benefit. SUMMARY: The Part D drug benefit continues to evolve. The benefit value appears to be diluted compared to the benefit value of large employer plans. Regulatory restrictions mandated by the Centers for Medicare and Medicaid Services (CMS) are reported to inhibit the ability of plans to create an effective, competitive drug benefit for Medicare beneficiaries. Management in this restrictive environment impedes competitive price negotiations and formulary coverage issues continue to create confusion especially for patients with chronic diseases. The doughnut hole coverage gap represents a significant cost-shifting issue for beneficiaries that may impact medication adherence and persistence. To address these and other challenges, CMS is working to improve the quality of care for Part D beneficiaries by designing and supporting demonstration projects. Although these projects are in different stages, all stakeholders are hopeful that they will lead to the development of best practices by plans to help manage their beneficiaries more efficiently. CONCLUSIONS: A significant number of Medicare beneficiaries are currently receiving prescription drug benefits through Part D. The true value of this benefit has been called into question as a result of plan design parameters that lead to cost-shifting, an increasing burden for enrollees. Concerns regarding the ability to provide a competitive plan given the stringent rules and regulations have been voiced by plan administrators. In an effort to drive toward evidence-based solutions, CMS is working to improve the overall quality of care through numerous demonstration projects.

The future of Medicare Part D drug plans--results from a roundtable discussion.

BACKGROUND: The Medicare Prescription Drug, Improvement, and Modernization Act, signed into law in 2003, provided access to prescription drugs for elderly Americans. The Part D benefit continues to evolve. Changes in plan designs, the impact of the doughnut hole on beneficiaries, and increased cost shifting have the potential to hamper the future of the Part D benefit. OBJECTIVE: To discuss factors that will likely have the most impact on the future of Medicare Part D from a patient and payer perspective. SUMMARY: The continued growth of the elderly population is expected to place an increasing burden on the services provided through Medicare. Given the current financial situation, it has been predicted that Medicare's Hospital Insurance Trust Fund will be depleted by 2019. To provide quality benefits and remain competitive, health plans are continually evaluating and redesigning their Part D benefits. However, the current regulatory environment is preventing plans from offering innovative products and designs that could lower costs to beneficiaries. The growing number of beneficiaries hitting the doughnut hole is also becoming a concern for both beneficiaries and health plans. More beneficiaries are reaching the doughnut hole, and this has resulted in changes in beneficiary behaviors, including stopping medications, switching to alternative drug classes, and reducing medication use. Because of the increasing concerns about Medicare's sustainability, it is anticipated that the government may become more involved. CONCLUSION: As the health care landscape continues to change, payers will be challenged to offer benefit designs that are affordable to elderly beneficiaries. For its part, the government must allow plans to design benefits that will improve the overall quality of care. Additionally, closer attention must be given to the growing number of beneficiaries hitting the doughnut hole and its potential adverse clinical and economic consequences.

Health information technology--results from a roundtable discussion.

BACKGROUND: Health information technology (HIT), notably e-prescribing and electronic health records (EHR), have the potential to improve the quality of care, reduce medication errors and adverse events, and decrease overall health care utilization and costs. However, the United States continues to lag behind other countries in the adoption and use of HIT. OBJECTIVE: To review the various issues surrounding the implementation of HIT in the United States and potential drivers that will influence the use of e-prescribing and EHR. SUMMARY: The United States has been slow to embrace HIT. However, various factors, including increasing government involvement, are speeding the implementation and use of HIT. E-prescribing and EHR are both electronic means to provide better coordination of care by enabling various health care professionals to access patient medical records. Widespread adoption of HIT can be especially helpful for the elderly, since this population tends to have more chronic conditions requiring polypharmacy. Adoption of e-prescribing can reduce medication errors due to poor handwriting, while EHR can promote better clinical outcomes, improve medication adherence and refill rates, improve member satisfaction, and lower overall health care expenditures. Unfortunately, barriers to the adoption of e-prescribing and EHR still exist, including resistance to learning new technology, initial start-up costs, delay in seeing a return on investment, lack of a standardized platform, increased administrative burden, and misaligned incentives. In an effort to promote greater adoption of e-prescribing and EHR, the Centers for Medicare & Medicaid has designed several initiatives, and other private organizations are now becoming more involved to close the HIT gap. CONCLUSION: Although the United States has been slow to implement HIT, there is reason to be hopeful. Increasing involvement by the government and other organizations will facilitate the greater adoption and use of e-prescribing and EHR in the near future. Ongoing data are needed, however, to demonstrate improvements in overall patient care and reductions in health care utilization and costs. These data are necessary to remove existing barriers that may prevent widespread implementation.