COVID-19 and Outpatient Parenteral Antimicrobial Therapy: The Need to Protect Vulnerable Medicare Beneficiaries
Authors: Yasir Hamad, Karen E. Joynt Maddox, William G. Powderly
Journal: Annals of Internal Medicine (2020)

Ideas and Opinions13 May 2020COVID-19 and Outpatient Parenteral Antimicrobial Therapy: The Need to Protect Vulnerable Medicare BeneficiariesFREEYasir Hamad, MD, Karen E. Joynt Maddox, MD, MPH, and William G. Powderly, MDYasir Hamad, MDWashington University School of Medicine, St. Louis, Missouri (Y.H.)Search for more papers by this author, Karen E. Joynt Maddox, MD, MPHWashington University School of Medicine and Institute for Public Health, St. Louis, Missouri (K.E.J., W.G.P.)Search for more papers by this author, and William G. Powderly, MDWashington University School of Medicine and Institute for Public Health, St. Louis, Missouri (K.E.J., W.G.P.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M20-1774 SectionsAboutVisual AbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail In December 2019, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) started an epidemic in Wuhan, China, that has since spread throughout the world. Now called coronavirus disease 2019 (COVID-19), the illness caused by SARS-CoV-2 was declared a pandemic by the World Health Organization on 11 March 2020. Reports from China showed that older age is a significant risk factor for morbidity and mortality among patients infected with SARS-CoV-2 (1). In Washington state, an initial epicenter of COVID-19 in the United States, nursing home residents were one of the most heavily affected populations and had high mortality rates, highlighting COVID-19's ability to spread rapidly in such settings (2). Other risk factors for worse outcomes include an immunocompromised state, underlying structural lung disease, cardiac disease, obesity, hypertension, and diabetes (3).Each of these comorbid conditions is common in persons receiving outpatient parenteral antimicrobial therapy (OPAT), making this group a high-risk population. However, current payment policy under Medicare could lead to unintended consequences for patients receiving OPAT, including exposure to COVID-19.Home Infusion Therapy and Medicare PolicyHome infusion involves the intravenous administration of medications at home. For patients to receive home infusions, several components need to be covered: the medication itself, the supplies and equipment, and the services of the home visit nurse. Many conditions require intravenous administration of medication at home, including total parenteral nutrition, intravenous antibiotics, and intravenous immunoglobulins.Outpatient parenteral antimicrobial therapy is one of the most common home infusion services and has been used for 4 decades (4). It has been shown to be a convenient and cost-effective way to complete prolonged courses of intravenous antibiotics outside the hospital (5). It and other outpatient intravenous medications can be given in various settings, including at home with the assistance of home health, at outpatient infusion centers, or at skilled-nursing facilities. Most private insurance and Medicare Advantage plans, Tricare, and many state Medicaid programs cover home infusion services, and it is the most commonly used model among these beneficiary groups as a result (6).However, the Medicare fee-for-service program does not adequately cover infusion services provided in patients' homes. Although Medicare Part A covers home nursing, it does so only for patients who are homebound, which many patients in need of home infusion services are not. Medicare Part B covers a few intravenous medications under payment rules about durable medical equipment, but these represent fewer than 10% of antimicrobials prescribed for OPAT (Table) (7). Medicare Part D, used by 70% of Medicare beneficiaries, does cover most of the drugs but not the medically necessary supplies—tubing, bags, needles, and pumps—or the administrative, pharmacy, and nursing services needed to deliver the medication (8).Table. Intravenous Medications That Are Eligible for Home Infusion Therapy Services Reimbursement Under Durable Medical Equipment RulesPatients who choose home infusion services are often left with significant costs that can be prohibitively expensive to pay out of pocket. Therefore, these policies incent patients to go to outpatient infusion centers or be admitted to skilled-nursing facilities to get their OPAT courses covered (9). Consequently, many patients go to skilled-nursing facilities for the sole purpose of receiving intravenous antibiotics without any other needs for skilled care. This has been shown to increase health care costs compared with receipt of OPAT at home (9).The Need to Shift Care to HomeAs we try to hamper the spread of COVID-19, efforts should be made to limit patients' interactions with health care facilities where patients with COVID-19 are likely to be. This is especially important for the elderly population and patients who are immunocompromised, and it includes limiting or eliminating contact with all health care facilities as feasible. Outpatient infusion centers are located on hospital campuses or in physicians' offices, where patients coming for infusions could come into contact with patients infected with SARS-CoV-2. The risk is higher for those receiving OPAT because they are required to come daily—and in some cases twice daily—leading to repeated exposure. Nursing homes can subject patients to even higher risk for SARS-CoV-2 exposure, with catastrophic results: In some states, almost half of nursing home residents have been infected. In addition, frequent contacts with the health care system will put patients receiving infusion therapy at risk for other nosocomial infections, such as with multidrug-resistant organisms, Clostridioides difficile, or other respiratory viruses.Furthermore, because we expect more cases of COVID-19 to flood the health care system, transitioning OPAT to the home setting can free nursing home beds. This would allow hospitals to discharge stable patients to nursing facilities and thus would expand the capacity of the health care system to care for more acutely ill patients. Transitioning patients receiving OPAT to home would also help conserve personal protective equipment among health care workers, which is critical given the national shortage in supplies.A Need for Urgent Medicare Policy ChangeBecause the Medicare patient population mostly consists of persons older than 65 years, the group in which nearly 80% of deaths have occurred thus far, it comprises some of the highest-risk patients for COVID-19 (10). We urge the Centers for Medicare & Medicaid Services to issue an immediate policy change to allow reimbursement for the supplies, as well as the administrative, pharmacy, and nursing services, needed to provide home infusion therapy. There have previously been concerns that expanding coverage for OPAT will lead to increased unnecessary use of intravenous antibiotics. However, this can be overcome by limiting OPAT coverage to the diagnoses that are treated with intravenous antibiotics in standard clinical care, such as endocarditis and osteomyelitis.Such a change will need to include allowance of reimbursement for physicians supervising the plan of care, home infusion pharmacy, and home health services. Under the current declared state of emergency, this policy change can be authorized by the Centers for Medicare & Medicaid Services without the need for congressional approval, similar to the temporarily expanded coverage of telehealth services, and thus could be done expeditiously. If this were done in conjunction with telehealth, it could lead to protection of both patients and health care providers. We urge the Centers for Medicare & Medicaid Services to take timely action to avoid subjecting Medicare beneficiaries to unnecessary and potentially catastrophic exposure to COVID-19.References1. Wu C, Chen X, Cai Y, et al. Risk factors associated with acute respiratory distress syndrome and death in patients with coronavirus disease 2019 pneumonia in Wuhan, China. JAMA Intern Med. 2020. [PMID: 32167524] doi:10.1001/jamainternmed.2020.0994 CrossrefMedlineGoogle Scholar2. Arentz M, Yim E, Klaff L, et al. Characteristics and outcomes of 21 critically ill patients with COVID-19 in Washington state. JAMA. 2020. [PMID: 32191259] doi:10.1001/jama.2020.4326 CrossrefMedlineGoogle Scholar3. Centers for Disease Control and Prevention. Interim clinical guidance for management of patients with confirmed coronavirus disease 2019 (COVID-19). 2020. Accessed at www.cdc.gov/coronavirus/2019-nCoV/hcp/index.html on 1 May 2020. Google Scholar4. Rucker RW, Harrison GM. Outpatient intravenous medications in the management of cystic fibrosis. Pediatrics. 1974;54:358-60. [PMID: 4213282] MedlineGoogle Scholar5. Paladino JA, Poretz D. Outpatient parenteral antimicrobial therapy today. Clin Infect Dis. 2010;51 Suppl 2:S198-208. [PMID: 20731577] doi:10.1086/653520 CrossrefMedlineGoogle Scholar6. Hamad Y, Lane MA, Beekmann SE, et al. Perspectives of United States–based infectious diseases physicians on outpatient parenteral antimicrobial therapy practice. Open Forum Infect Dis. 2019;6. [PMID: 31429872] doi:10.1093/ofid/ofz363 CrossrefMedlineGoogle Scholar7. Keller SC, Dzintars K, Gorski LA, et al. Antimicrobial agents and catheter complications in outpatient parenteral antimicrobial therapy. Pharmacotherapy. 2018;38:476-481. [PMID: 29493791] doi:10.1002/phar.2099 CrossrefMedlineGoogle Scholar8. Cubanski J, Damico A, Neuman T. 10 things to know about Medicare Part D coverage and costs in 2019. 4 June 2019. Accessed at www.kff.org/medicare/issue-brief/10-things-to-know-about-medicare-part-d-coverage-and-costs-in-2019 on 1 May 2020. Google Scholar9. Keller S, Pronovost P, Cosgrove S. What Medicare is missing [Letter]. Clin Infect Dis. 2015;61:1890-1. [PMID: 26338782] doi:10.1093/cid/civ750 CrossrefMedlineGoogle Scholar10. Centers for Disease Control and Prevention; National Center for Health Statistics. Provisional death counts for coronavirus disease (COVID-19): weekly updates by select demographic and geographic characteristics. Accessed at www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm on 1 May 2020. Google Scholar Comments 0 Comments Sign In to Submit A Comment Pankaj MathurAssistant Professor of Medicine, University of Arkansas Medical Sciences and Medical Center, Little Rock, Arkansas,7220527 May 2020 Urgent need by CMS to consider coverage of Home- administered medications/ supplies and needs for Medicare Beneficiaries This paper highlights the dilemma we internists face in discharging patients to home with outpatient antimicrobial therapy (OPAT). The Medicare Payment Advisory Commission (MEDPAC) is a nonpartisan legislative agency that provides the U.S. Congress with analysis and policy advice on Medicare. They did a study in 2012 and found that home infusion drug coverage is either provided by Medicare part B or part D (1). Medicare Part B covers some home infusion drugs through the DME (durable medical equipment) benefit, but drugs usually needs to be administer via infusion pump and medically necessary. Examples of such drugs include certain IV drugs for heart failure and pulmonary arterial hypertension, immune globulin, insulin, antifungals, antivirals, and total parenteral nutrition (TPN ) (1). Medicare Part B covers the associated equipment and supplies with these medications. Medicare Part D covers for the drugs not covered by Part B such as home IV antibiotics; however, it provides coverage for the drug and not for any supplies/ equipment/ nursing services. Sometimes if the patient meets the Medicare home, eligibility criteria and received medications via gravity method Medicare may pay for it. Medicare Advantage plans, which are through private insurers and Private Fee for Service (FFS) plans may cover for equipment and supplies in certain circumstances (1). According to a study by Kaiser Foundation (2) there are 28 Medicare advantage plans available for the beneficiaries and it is too much to expect from the patients to understand the benefits associated with each plan. Therefore, most of the time patients have either not have a suitable plan or still left to pay considerable out of pocket costs. CMS needs to make it easier for Medicare beneficiaries to get these benefits. Several studies have shown OPAT is comparable to inpatient antibiotic therapy, has led to decreased health care costs, and improved patient satisfaction (2,3). I feel that the current coronavirus disease 19 (COVID 19) pandemic is an opportunity for the CMS to reconsider the coverage of home-administered medications, supplies, and home health needs. More than ever in this pandemic we need to have a single comprehensive Medicare plan covering for health care needs (inpatient stay, outpatient visits, lab testing, drugs, supplies, home health) for our elderly population instead of a piecemeal approach. This will not only help the Medicare beneficiaries but will also help in reducing the burden on health care systems reeling under the impact of COVID19 pandemic. References 1. http://www.medpac.gov/docs/default-source/reports/chapter-6-medicare-coverage-of-and-payment-for-home-infusion-therapy-june-2012-report-.pdf?sfvrsn=0 2. https://www.kff.org/report-section/medicare-advantage-2020-spotlight-first-look-data-note/ 3. Dalovisio JR, Juneau J, Baumgarten K, Kateiva J. Financial impact of a home intravenous antibiotic program on a medicare managed care program. Clin Infect Dis. 2000;30(4):639‐642. doi:10.1086/313755 4. Mitchell ED, Czoski Murray C, Meads D, Minton J, Wright J, Twiddy M. Clinical and cost-effectiveness, safety and acceptability of community intravenous antibiotic service models: CIVAS systematic review. BMJ Open. 2017;7(4):e013560 Yasir Hamad 1, Karen Joynt-Maddox 1,2, William Powderly 1,21: Washington University School of Medicine 2:Washington University Institute for Public Health5 November 2020 Reply to Pankaj Mathur To the editor- We agree with Dr. Mathur that there is a need for a change in Medicare policy to allow for comprehensive coverage for outpatient parenteral antimicrobial therapy (OPAT) at home. The current coverage is both fragmented and inadequate, and forces many patients to receive care at outpatient infusion centers and nursing homes that could have been provided at home if such services were covered. Given that the majority of Medicare beneficiaries are more than 65 years old, they are at particularly high risk for coronavirus disease 2019 (COVID-19) morbidity and mortality,(1) and exposure to COVID at nursing facilities has potentially catastrophic consequences. Indeed, so far there have been over 51,000 cases and over 10,000 deaths due to COVID-19 in nursing facilities(2). In review of reasons for readmission among our local OPAT population, we found that among patients discharged to nursing homes, 19% of readmissions were due to COVID-19, whereas there were no readmissions due to COVID-19 among home OPAT patients(3). Given the continued pandemic spread of COVID-19, we hope that the Centers for Medicare & Medicaid Services take action to make needed changes to allow Medicare beneficiaries to receive OPAT care at home. References: Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. Chidambaram P. Kaiser Family Foundation Issue Brief: state reporting of cases and deaths due to COVID-19 in long-term care facilities. Accessed November 4, 2020. https://www.kff.org/medicaid/issue-brief/state-reporting-of-cases-and-deaths-due-to-covid-19-in-long-term-care-facilities/ Burnett Y, Hamad Y. Outpatient Parenteral Antimicrobial Therapy Readmissions from Post-Acute Care Facilities due to Coronavirus Disease 2019. ID week; 2020 Oct 21-25; Philadelphia PA. Disclosures: Dr. Joynt Maddox receives research supportfrom the National Heart, Lung, and Blood Institute(R01HL143421) and National Institute on Aging(R01AG060935). Dr. Powderly was supported by the Washington University Institute of Clinical and Translational Sciences grant UL1TR002345 from the National Center for Advancing Translational Sciences of the National Institutes ofHealth. Author, Article, and Disclosure InformationAuthors: Yasir Hamad, MD; Karen E. Joynt Maddox, MD, MPH; William G. Powderly, MDAffiliations: Washington University School of Medicine, St. Louis, Missouri (Y.H.)Washington University School of Medicine and Institute for Public Health, St. Louis, Missouri (K.E.J., W.G.P.)Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.Financial Support: Dr. Joynt Maddox receives research support from the National Heart, Lung, and Blood Institute (R01HL143421) and National Institute on Aging (R01AG060935). Dr. Powderly was supported by the Washington University Institute of Clinical and Translational Sciences grant UL1TR002345 from the National Center for Advancing Translational Sciences of the National Institutes of Health.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M20-1774.Corresponding Author: Yasir Hamad, MD, Campus Box 8051, 4523 Clayton Avenue, St. Louis, MO 63110; e-mail, yhamad@wustl.edu.Current Author Addresses: Drs. Hamad and Powderly: Campus Box 8051, 4523 Clayton Avenue, St. Louis, MO 63110.Dr. Joynt Maddox: Campus Box 8217, 660 South Euclid Avenue, St. Louis, MO 63110.Author Contributions: Conception and design: Y. Hamad, K.E. Joynt Maddox, W.G. Powderly.Drafting of the article: Y. Hamad.Critical revision of the article for important intellectual content: K.E. Joynt Maddox, W.G. Powderly.Final approval of the article: Y. Hamad, K.E. Joynt Maddox, W.G. Powderly.This article was published at Annals.org on 13 May 2020. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoCOVID-19 and Outpatient Parenteral Antimicrobial Therapy Pankaj Mathur COVID-19 and Outpatient Parenteral Antimicrobial Therapy Yasir Hamad , Karen E. Joynt-Maddox , William G. Powderly Metrics Cited byEvaluation of Dalbavancin Use on Clinical Outcomes, Cost-Savings, and Adherence at a Large Safety Net HospitalEvaluate the Effectiveness of Outpatient Parenteral Antimicrobial Therapy (OPAT) Program in Saudi Arabia: A Retrospective StudyRethinking Home-based Outpatient Parenteral Antibiotic Therapy for Persons Who Inject Drugs: An Opportunity for Change in the Time of COVID-19Comparison of Adverse Events Among Home- vs Facility-Administered Biologic Infusions, 2007-2017COVID-19 and Outpatient Parenteral Antimicrobial TherapyPankaj Mathur, MD 1 September 2020Volume 173, Issue 5 Page: 383-384 Keywords Antibiotics Antimicrobials COVID-19 Health care Health care facilities Medicare Nursing homes Outpatients Population statistics Telemedicine ePublished: 13 May 2020 Issue Published: 1 September 2020 Copyright & PermissionsCopyright © 2020 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...