American Society of Health-System Pharmacists Issues Public Comment on Centers for Medicare & Medicaid Services Proposed Rule

WASHINGTON, July 22 -- Jillanne Schulte Wall, senior director for health and regulatory policy at the American Society of Health-System Pharmacists, Bethesda, Maryland, has issued a public comment on the Centers for Medicare and Medicaid Services' proposed rule entitled "Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2021 Rates; Quality Reporting and Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals". The comment was written on July 10, 2020, and posted on July 17, 2020:

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ASHP is pleased to submit comments regarding the proposed changes to the Hospital Inpatient Prospective Payment System (IPPS) (the "proposed rule") for 2021. ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings. The organization's nearly 55,000 members include pharmacists, student pharmacists, and pharmacy technicians. For more than 75 years, ASHP has been at the forefront of efforts to improve medication use and enhance patient safety./1

ASHP thanks the Centers for Medicare & Medicaid Services (CMS) for the opportunity to comment on the proposed rule. Our comments focus on proposed reimbursement changes for Chimeric Antigen Receptor (CAR) T-cell therapy, changes to the new technology add-on payments (NTAP) for novel antimicrobials, and remedies for pharmacy residents who have been displaced and/or whose hospitals have closed due to the COVID-19 pandemic.

I. Proposed Reimbursement Changes

A. Chimeric Antigen Receptor (CAR) T-Cell Therapy

ASHP applauds CMS for recognizing the value of novel treatments like CAR T-cell therapy and the need to ensure reimbursement covers hospitals' costs. As CMS is aware, the current Medicare reimbursement rate does not come close to covering hospitals' costs for providing this therapy. In fact, some hospitals currently cannot provide CAR-T to Medicare patients due to the financial loss involved - hundreds of thousands of dollars in many cases. In an informal survey, ASHP members noted that current CAR-T Medicare reimbursement does not currently cover even the cost of the drugs, let alone the costs associated with the healthcare team required to ensure effective treatment.

ASHP strongly supports CMS's creation of a Medicare Severity Diagnosis Related Group (MS-DRG) specific to CAR T-cell therapy. We recognize that the new MS-DRG substantially increases base payment for CAR T-cell therapy. As CMS recognized in the rule when noting that there are additional funding mechanisms that can help support the provision of CAR T-cell therapy, the MS-DRG alone will not be sufficient to cover all associated costs the treatment.

Given the precarious financial state that COVID-19 has created for many hospitals, it is imperative that the CMS adopt a payment methodology sufficient to cover not only the cost of the drug, but to ensure that patients receiving the treatment are surrounded by the best possible healthcare team, including pharmacists. Hospital pharmacists are actively engaged in CAR T-cell therapy at every step of the process - from education to direct patient care. They are key players in the development and maintenance of institutional practice guidelines as well as the provision of staff education on CAR T-cell therapy. At the patient level, they manage the CAR T-cell therapy and supportive care regimens, providing patient counseling at the outset and monitoring for toxicity as treatment progresses.

Considering the resource-intensive nature of CAR T-cell therapy, we urge CMS to account for the pharmacy resources required for these treatments, either by rolling these costs into the total payment or including a specific add-on payment to cover these costs. To improve patient outcomes, CMS investment in CAR T-cell therapy must extend beyond the drug to ensure that drug therapy is supported by the best possible healthcare team.

B. Increased New Technology Add-On Payment (NTAP) for Novel Antimicrobials

ASHP appreciates CMS's efforts to ensure patients have access to novel therapies that promise substantial clinical benefit. We applaud CMS's proposal to expand the NTAP to Qualified Infectious Disease Products (QIDPs) to include antimicrobials and antibiotics approved under the Food & Drug Administration (FDA) Limited Pathway for Antibacterial and Antifungal Drugs. We also recommend that CMS adopt the proposed 10% increase to the NTAP. While payment adequate to incentivize new therapies is essential, we also urge CMS to strengthen antimicrobial stewardship (AS) programs generally.

Specifically, CMS should require pharmacist-led antimicrobial stewardship programs for hospitals. ASHP believes that pharmacists have a responsibility to take prominent roles in antimicrobial/antibiotic stewardship (AS) programs and to participate in the infection prevention and control (IC) programs of hospitals and health systems./2

AS programs focus heavily on antibiotic use and require careful coordination with disparate members of the healthcare team/departments. Pharmacists function as the medication experts on the healthcare team as well as, in many instances, the de facto care coordinators. As such, pharmacists are uniquely positioned to take on the clinical, organizational, and collaborative demands of overseeing AS programs.

It is important to note that, while we assert that pharmacists are essential to successful AS programs, robust AS programs also require "internal coordination among all components responsible for antibiotic use and reducing the development of resistance."/3

We believe that physicians, nurses, laboratory personnel, and others should be engaged in creating, implementing, and monitoring AS programs, but we recommend that AS programs be housed within the pharmacy department. This would align with The Joint Commission's medication management standards/4 related to responsibility for antibiotic stewardship, while facilitating outreach to other departments and it is consistent with the recently revised Centers for Disease Control and Prevention Core Elements of Hospital Antibiotic Stewardship Programs, which identifies pharmacists as leaders capable of AS program management./5

Robust AS programs, overseen by pharmacists and proper interprofessional coordination, would ensure the most appropriate use of existing antimicrobials as well as new drugs, reducing overutilization and safeguarding patient health. Comprehensive AS and IC programs require sufficient financial support to cover administrative costs, as well as personnel education costs, including support for staff pharmacists hoping to obtain AS stewardship certification.

Thus, we urge CMS to explore funding mechanisms for IC and AS programs. In particular, ASHP recommends that CMS enhance financial incentives to stimulate creation of postgraduate infectious diseases/antimicrobial stewardship pharmacy residency programs, which will increase the number of pharmacists trained to perform AS and IC work.

Finally, ASHP supports the use of telemedicine networks to allow under-resourced small and rural hospitals to access to national experts when needed to optimize their own AS programs, including the successful delivery of outpatient parenteral antibiotic therapy. We urge CMS to allocate resources and funding to support the development of telemedicine network options.

II. Impact of COVID-19 on Pharmacy Residency Programs

ASHP was deeply disappointed to see that although the proposed rule discusses the impact of COVID-19 on medical residency programs at length, CMS has provided no corresponding outreach or guidance to pharmacy residency programs. We recognize that medical residencies are funded in part through the inpatient prospective payment system, while pharmacy residencies receive CMS pass-through dollars. Nevertheless, we would like to take this opportunity to request that CMS provide similar flexibility for pharmacy residency programs, such that pharmacy residents who meet CMS's definition of "displaced" can be transferred to another program and that new program can receive additional pass-through funding to train the displaced resident(s) without creating any administrative red flags. ASHP stands ready to assist CMS with any necessary outreach to pharmacy residency programs, as well as to provide any additional information that might be necessary.

Pharmacy residency programs feed a vital patient care pipeline. Failing to treat them with the same concern as medical residencies will threaten care quality, patient access, and established interprofessional care delivery. Due to scientific advancements and care delivery model evolution, pharmacy residencies are now essential to performing certain patient care services, and they are prerequisites for positions within specialties such as solid organ transplantation, clinical pharmacogenomics, psychiatry, infectious diseases, critical care, cardiology, oncology, and pediatrics, among others. The pandemic has further highlighted the criticality of residency training -- residency-trained pharmacists have played an outsized role in managing COVID-19 medications and shortages and in developing and implementing COVID-19 therapeutic regiments. Any decrease or weakening of pharmacy residency programs risks severely limiting the number of pharmacists available to fill positions, resulting in provider shortages and curtailing patient access to care.

ASHP appreciates this opportunity to provide feedback on the proposed rule. Please contact me at [email protected] or at 301-664-8698 if you have any questions or if we can provide any additional assistance.

Sincerely,

Jillanne Schulte Wall, J.D.

Senior Director, Health & Regulatory Policy

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Footnotes:

1/ For more information about the wide array of ASHP activities and the many ways in which pharmacists advance healthcare, visit ASHP's website, www.ashp.org, or its consumer website, www.SafeMedication.com.

2/ ASHP, Antimicrobial Stewardship Resources, "ASHP Statement on the Pharmacist's Role in Antimicrobial Stewardship and Infection Prevention and Control", available at http://www.ashp.org/DocLibrary/BestPractices/SpecificStAntimicrob.aspx.

3/ 81 Fed. Reg. 39456 (June 16, 2016).

4/ See The Joint Commission, "Prepublication Standards - New Antimicrobial Stewardship Standard" (June 22, 2016), available at https://www.jointcommission.org/assets/1/6/HAP-CAH_Antimicrobial_Prepub.pdf (Establishing new standards under MM.09.01.01, which take effect January 1, 2017).

5/ Centers for Disease Control and Prevention, "Core Elements of Hospital Antibiotic Stewardship Programs", available at https://www.cdc.gov/antibiotic-use/core-elements/hospital.html.

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The proposed rule can be viewed at: https://www.regulations.gov/document?D=CMS-2020-0052-0002

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