Social and Financial Implications of Medicare Part B Immunosuppressive Drug Benefits for Kidney Transplant Recipients: A View From the Trenches

After numerous delays, The Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2020 (H.R. 5534; informally known as the “Immuno Bill”) was passed late in 2020.1Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2020, HR 5534, 116th Cong.https://www.congress.gov/bill/116th-congress/house-bill/5534/textDate: 2020Date accessed: April 28, 2022Google Scholar Under the Extended Months of Coverage of Immunosuppressive Drugs for Kidney Transplant Patients and Other Renal Dialysis Provisions in the Consolidated Appropriations Act of 2021, it is now law,2Consolidated Appropriations Act, 2021, 116th Cong.https://www.congress.gov/116/plaws/publ260/PLAW-116publ260.pdfDate: 2020Date accessed: July 9, 2022Google Scholar and the final rule has recently been issued.3Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules. 87 Fed. Reg. 66454.https://www.federalregister.gov/documents/2022/11/03/2022-23407/medicare-program-implementing-certain-provisions-of-the-consolidated-appropriations-act-2021-andDate: November 3, 2022Date accessed: November 4, 2022Google Scholar The intent of this long-awaited change is to provide lifelong immunosuppression coverage for patients with end-stage kidney disease (ESKD) who are transplant recipients. Although enrollment is starting in fall of 2022,3Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules. 87 Fed. Reg. 66454.https://www.federalregister.gov/documents/2022/11/03/2022-23407/medicare-program-implementing-certain-provisions-of-the-consolidated-appropriations-act-2021-andDate: November 3, 2022Date accessed: November 4, 2022Google Scholar it is critical for effective implementation that this time be used to ensure that the impact on patients and transplant centers is taken into account. We focus this editorial on the socioeconomic underpinnings of this new policy and implications for patients and transplant centers. Historically, patients with kidney failure have had the ability to qualify for Medicare coverage, irrespective of age, for decades. Unlike patients on maintenance dialysis for whom Medicare coverage is guaranteed indefinitely, patients who received a kidney transplant because of kidney failure face loss of this coverage at 3 years posttransplant and risk immunosuppression medication cut-off. Beyond this period, recipients with a qualifying disability or those meeting age requirements retain Medicare coverage; otherwise, patients are expected to return to work and obtain employer-based insurance and prescription coverage. The costs of transplant maintenance are significantly lower than maintenance dialysis therapy. The impetus for the new immunosuppression policy is partly based on initial government projections suggesting that providing immunosuppression coverage to prevent kidney transplant failure will save about $400 million for Medicare within 10 years of policy implementation.4Congressional Budget Office Cost Estimate: H.R. 5534, Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2020. Congressional Budget Office.https://www.cbo.gov/system/files/2020-11/hr5534.pdfDate: November 2, 2020Date accessed: April 28, 2022Google Scholar While it is simple to estimate monetary cost reduction by lessening financial barriers that adversely affect transplant outcomes, it is important to consider the impact this policy will directly have on transplant patients. The recently issued final rule outlines indefinite immunosuppression coverage through a unique “Part B immunosuppressive drug benefit” (Part B-ID) only to patients whose Medicare entitlement is expiring at 36 months posttransplant and who have limited or no other coverage options.3Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules. 87 Fed. Reg. 66454.https://www.federalregister.gov/documents/2022/11/03/2022-23407/medicare-program-implementing-certain-provisions-of-the-consolidated-appropriations-act-2021-andDate: November 3, 2022Date accessed: November 4, 2022Google Scholar This is one critical piece necessary to safeguard patient outcomes, but there are other important transplant care components where gaps will persist. First, despite alleviating some financial strain for eligible kidney transplant recipients, it will not eliminate immunosuppression drug cost entirely. Part B-ID beneficiaries will be responsible for a Part B premium set at “15% of the monthly actuarial rate,”3Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules. 87 Fed. Reg. 66454.https://www.federalregister.gov/documents/2022/11/03/2022-23407/medicare-program-implementing-certain-provisions-of-the-consolidated-appropriations-act-2021-andDate: November 3, 2022Date accessed: November 4, 2022Google Scholar,5Gill J.S. Formica Jr., R.N. Murphy B. Addendum: passage of the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act - a chance to celebrate and reflect.J Am Soc Nephrol. 2021; 32: 1540https://doi.org/10.1681/ASN.2021030427Crossref PubMed Scopus (1) Google Scholar a coinsurance,3Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules. 87 Fed. Reg. 66454.https://www.federalregister.gov/documents/2022/11/03/2022-23407/medicare-program-implementing-certain-provisions-of-the-consolidated-appropriations-act-2021-andDate: November 3, 2022Date accessed: November 4, 2022Google Scholar and an annual Part B deductible.3Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules. 87 Fed. Reg. 66454.https://www.federalregister.gov/documents/2022/11/03/2022-23407/medicare-program-implementing-certain-provisions-of-the-consolidated-appropriations-act-2021-andDate: November 3, 2022Date accessed: November 4, 2022Google Scholar While Food and Drug Administration (FDA)-approved immunosuppression for use in kidney transplant will be covered,3Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules. 87 Fed. Reg. 66454.https://www.federalregister.gov/documents/2022/11/03/2022-23407/medicare-program-implementing-certain-provisions-of-the-consolidated-appropriations-act-2021-andDate: November 3, 2022Date accessed: November 4, 2022Google Scholar it is unknown whether coverage will extend to future regimens if shown to be safer or more efficacious than standard-of-care alternatives. Additionally, even for intravenous therapies expected to be covered (such as belatacept), accessory costs, such as administration, would not be covered under the rule.3Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules. 87 Fed. Reg. 66454.https://www.federalregister.gov/documents/2022/11/03/2022-23407/medicare-program-implementing-certain-provisions-of-the-consolidated-appropriations-act-2021-andDate: November 3, 2022Date accessed: November 4, 2022Google Scholar While the traditional part B Medicare premium for the lowest-bracket income group is $170.10 monthly,6Centers for Medicare and Medicaid ServicesPart B Costs.https://www.medicare.gov/your-medicare-costs/part-b-costs#:˜:text=2022,standard%20Part%20B%20premium%20amountDate accessed: July 6, 2022Google Scholar the Part B-ID premium will initially be $97.10 monthly.3Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules. 87 Fed. Reg. 66454.https://www.federalregister.gov/documents/2022/11/03/2022-23407/medicare-program-implementing-certain-provisions-of-the-consolidated-appropriations-act-2021-andDate: November 3, 2022Date accessed: November 4, 2022Google Scholar Second, other costly transplant-related medications, such as anti-infective, antihypertensive, and diabetes medications, are not currently written to be covered under this new policy. Given the high hypertension and diabetes prevalence in patients with kidney failure, most recipients require therapy posttransplant for one or both of these pre-existing conditions. Moreover, together with malignancy and infection, diabetes and hypertension are common immunosuppression-associated side effects and an unintended driver of need for other costly medications. It is not uncommon for kidney recipients to take 10 prescribed medications daily at 12 months posttransplant.7Marienne J. Laville S.M. Caillard P. et al.Evaluation of changes over time in the drug burden and medication regimen complexity in ESRD patients before and after renal transplantation.Kidney Int Rep. 2020; 6: 128-137https://doi.org/10.1016/j.ekir.2020.10.011Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar Unfortunately, none of these nonimmunosuppression medications that contribute to enhanced patient and allograft survival are covered under the proposed Part B-ID benefit. Finally, safe prescription of immunosuppressive medications also requires routine blood-work monitoring, another cost not covered under the proposed Part B-ID benefit. All of this could result in a conundrum where the federal government (through the 2019 Advancing American Kidney Health Executive Order) is incentivizing nephrologists, dialysis providers, and transplant centers to transplant patients with kidney failure, while simultaneously not ensuring that recipients have access to critical, but costly, nonimmunosuppression drug coverage and posttransplant care (Table 1). Since death is the leading cause of allograft failure in this population with a high cardiovascular disease burden and increased susceptibility to infection and malignancy, this is particularly germane. Optimizing transplant outcomes will require ongoing adaptation of basic coverage provisions to safeguard comprehensive medical care for affected patients.Table 1Common Immunosuppression and Nonimmunosuppression Costs PosttransplantItemCostReferenceLaboratory test: complete blood count$33.679Review Your Self-pay Price Estimate. Quest Diagnostics Inc., 2022https://patient.questdiagnostics.com/estimateDate accessed: July 27, 2022Google ScholarLaboratory test: urinalysis with reflex to culture$47.599Review Your Self-pay Price Estimate. Quest Diagnostics Inc., 2022https://patient.questdiagnostics.com/estimateDate accessed: July 27, 2022Google ScholarLaboratory test: comprehensive metabolic panel$88.079Review Your Self-pay Price Estimate. Quest Diagnostics Inc., 2022https://patient.questdiagnostics.com/estimateDate accessed: July 27, 2022Google ScholarLaboratory test: lipid panel$154.859Review Your Self-pay Price Estimate. Quest Diagnostics Inc., 2022https://patient.questdiagnostics.com/estimateDate accessed: July 27, 2022Google ScholarLaboratory test: tacrolimus level$250-$45010Lee B. Jain D. Campara M. Are random tacrolimus levels in the emergency department costing you money? [abstract].Am J Transplant. 2016; 16https://atcmeetingabstracts.com/abstract/are-random-tacrolimus-levels-in-the-emergency-department-costing-you-money/Date accessed: July 27, 2022Google ScholarCMV medication: valganciclovir (450 mg, oral)aBased on average wholesale price.$64.40-$68.7811Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc., Riverwoods, IL2022http://online.lexi.comDate accessed: July 23, 2022Google ScholarCMV viremia therapy: oral treatment (21-day supply of 900 mg, 2×/d)bTreatment example based on estimated treatment length of time, which is highly variable.$2,704.80Tacrolimus (1 mg tablet)aBased on average wholesale price.$0.50-$6.9511Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc., Riverwoods, IL2022http://online.lexi.comDate accessed: July 23, 2022Google ScholarTacrolimus (5 mg tablet)aBased on average wholesale price.$12.20-$22.3011Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc., Riverwoods, IL2022http://online.lexi.comDate accessed: July 23, 2022Google ScholarTacrolimus (30-day supply of 5 mg, every 12 h, oral)$732.00Mycophenolate (250 mg capsule)aBased on average wholesale price.$0.75-$3.9911Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc., Riverwoods, IL2022http://online.lexi.comDate accessed: July 23, 2022Google ScholarMycophenolate (30-day supply of 500 mg, every 12 h, oral)$90.00Prednisone (5 mg tablet)aBased on average wholesale price.$0.20-$0.7311Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc., Riverwoods, IL2022http://online.lexi.comDate accessed: July 23, 2022Google ScholarPrednisone (30-day supply of 5 mg, 1×/d, oral)$6.00Nifedipine ER (30 mg tablet)aBased on average wholesale price.$1.3911Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc., Riverwoods, IL2022http://online.lexi.comDate accessed: July 23, 2022Google ScholarNifedipine ER (30-day supply of 30 mg, 1×/d, oral)$41.70Pravastatin (20 mg tablet)aBased on average wholesale price.$2.83-$3.2711Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc., Riverwoods, IL2022http://online.lexi.comDate accessed: July 23, 2022Google ScholarPravastatin (30-day supply of 20 mg, 1×/d, oral)$84.90Abbreviations: CMV, cytomegalovirus; ER, extended release.a Based on average wholesale price.b Treatment example based on estimated treatment length of time, which is highly variable. Open table in a new tab Abbreviations: CMV, cytomegalovirus; ER, extended release. Third, improved immunosuppression medication coverage is unlikely to mitigate pre-existing financial hardships and health disparities faced by many transplant recipients, especially since disabilities and comorbidities frequently impact their ability to work. One solution would be to direct savings recognized by the new policy toward vocational rehabilitation or programs to assist able patients to return to work and obtain employer-based insurance. While seemingly intuitive that insurers and government policy would have a vested interest to facilitate this, it is not occurring on a widespread basis. More than 60% of kidney transplant recipients covered by Medicare beyond 3 years posttransplant are younger than 65 years.8ASPE Office of Health PolicyAssessing the Costs and Benefits of Extended Medicare Coverage of Immunosuppressive Drugs under Medicare. US Department of Health and Human Services, May 10, 2019https://aspe.hhs.gov/sites/default/files/migrated_legacy_files//189276/Savings_From_Extending_Coverage_For_Immunosuppressive_Drugs_Final.pdfDate accessed: April 28, 2022Google Scholar This suggests that disability extends beyond needing dialysis, and that not enough is done to assist individuals to return to work. An alternative consideration for redistributing savings from Part B-ID implementation should include using the direct savings to reduce premiums and other costs for individuals using Part B-ID. The US health system should continue to recognize the importance of social components of care and seize the opportunity to integrate social concepts into its policies. Medication affordability after transplant can be unpredictable for patients if their insurer changes, potentially creating financial challenges and jeopardizing outcomes, even for patients with the longest expected posttransplant survival. For example, a 28-year-old able Medicaid transplant recipient who takes a job without health benefits that is low wage but above the income cutoff for Medicaid qualification, and who is ineligible for Medicare Savings Programs, may feel obligated to switch to the modified Part B-ID option beyond 36 months after transplant. Striving to find affordable marketplace or private insurance that would otherwise cover immunosuppressive medications could prove financially challenging to such an individual, who may feel they are better served by taking a lower-paying job that preserves Medicaid coverage access. It is also possible that some recipients may be disincentivized to return to work if they fear their earnings will primarily be spent on the comprehensive transplant care not covered by Part B-ID. Since preemptive transplantation, returning to work, medication adherence, and overall health are fundamental transplant goals to preserve graft life and quality of life, it is not clear how the new immunosuppression policy that only covers immunosuppression medications will fully align with these objectives. While Part B-ID will provide an immunosuppression drug benefit to individuals who have no other coverage options, ideally, it should cover inadequately insured kidney recipients to guarantee transplant-essential benefits by way of medications, basic blood work, and routine nephrology visits. Finally, navigating a nontransparent insurance and health system is often untenable. It remains unclear who will ideally guide transplant patients in choosing their most appropriate insurance option. Based on historical practice, the responsibility for assisting patients with insurance selection has fallen on transplant centers and is a large, resource-demanding undertaking. How will transplant centers, as key stakeholders in counseling recipients to avoid poor outcomes, be impacted by the introduction of Part B-ID? Much of the burden of assurance of unfettered medication coverage impacts transplant financial coordinators and social workers, disciplines whose critical posttransplant services are not reimbursed under the current health care structure. The additional workload related to supporting patients around Part B-ID may further strain the capacity of these allied disciplines, already overwhelmed with addressing recipient mental health, substance use concerns, and other social issues. Using some of the cost savings under the new policy to remunerate centers for providing these vital resources should be a consideration. In conclusion, the Medicare Part B-ID benefit provides some hope for patients and transplant professionals concerned with kidney recipient wellbeing, and represents a step forward to prolong allograft life for this population. It should make us question not only how to optimize outcomes for those covered by Medicare, but also how we can minimize costs to all kidney transplant recipients, independent of their insurer. If implemented thoughtfully, this policy has an opportunity to propagate a care system that reimburses social offerings available to a population struggling with multiple comorbidities and hardships. Reducing barriers to kidney transplant for all ages and races and mitigating medication adherence through cost reduction is one key initial step. Jordan C. Shaffer, MSPAS, ML, PA-C, and Roy D. Bloom, MD. None. Dr Bloom receives research support from CareDx, Natera, Veloxis, and CSL Behring; is an advisor to Allovir, Veloxis, and Natera; receives royalties from UpToDate; and serves as an AJKD Associate Editor. Ms Shaffer declares that she has no relevant financial interests. We acknowledge Regina Miller, RN, BSN, MSS, LCSW, DSW, for her thought-provoking discussion related to this topic. Received April 28, 2022. Evaluated by 2 external peer reviewers, with direct editorial input from an Associate Editor and a Deputy Editor. Accepted in revised form September 24, 2022.