[Submitted electronically at www.regulations.gov]
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Mail Stop C4–26–05
7500 Security Blvd.
Baltimore, MD 21244-1850
Re: CMS-1716-P — 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 2020 Rates; Proposed Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Proposed Requirements for Eligible Hospitals and Critical Access Hospitals
Dear Administrator Verma:
ASHP is pleased to submit comments regarding the proposed changes to the Hospital Inpatient Prospective Payment System (IPPS) (the “proposed rule”) for 2020. ASHP is a national professional organization representing nearly 50,000 members including pharmacists, pharmacy residents, student pharmacists, and pharmacy technicians, who provide patient care services in acute care and ambulatory settings, including hospitals, health systems, and clinics. For 75 years, ASHP has been on the forefront of efforts to improve medication use and enhance patient safety.
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 novel therapies and changes to quality measures.
I. Reimbursement for Novel Therapies
A. Chimeric Antigen Receptor T-Cell Therapy
ASHP applauds CMS for recognizing the value of novel treatments like Chimeric Antigen Receptor T-cell therapy (CAR-T) 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 cover even the cost of the drugs, let alone the costs associated with the healthcare team required to ensure effective treatment.
Thus, ASHP requests that 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 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. At the patient level, they manage the CAR-T and supportive care regimens, providing patient counseling at the outset and monitoring for toxicity as treatment progresses.
Given the resource-intensive nature of CAR-T, we urge CMS to account for the pharmacy resources required for CAR-T, either by rolling these costs into the total payment or including an add-on payment to cover these costs. To improve patient outcomes, CMS investment in CAR-T must extend beyond the drug to ensure that drug therapy is supported by the right healthcare team.
B. New Antimicrobial Drugs
ASHP appreciates CMS’s efforts to ensure patients have access to novel therapies that promise substantial clinical benefit. In the proposed rule, CMS notes that it considering new technology add-on payments for certain antimicrobial drugs. While payment adequate to incentivize new therapies is essential, we 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. 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.” 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 related to responsibility for antibiotic stewardship, while facilitating outreach to other departments.
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 antimicrobial stewardship programs. We urge CMS to allocate resources and funding to support the development of telemedicine network options.
II. Quality Measures
ASHP is a proud inaugural member of the Measure Applications Partnership (MAP) and is heavily engaged in the activities of the National Quality Forum. As a member of the National Quality Forum (NQF), ASHP strongly recommends that, with rare exceptions, CMS include only those measures that have been endorsed through NQF’s rigorous consensus-building development process. NQF endorsement ensures that the great breadth of stakeholders involved in developing, testing, implementing, and using measures provides valuable feedback in maintaining and validating quality measures used in federal payment programs.
Consensus achieved during the measure-development process, through broad acceptance and use of a measure or through public comment, does not match the robust and comprehensive process used to establish NQF endorsement. Therefore, we align with the Hospital Measures Application Partnership (MAP) 2018 Considerations for Implementing Measures in Federal Programs that encouraged further testing and refinement of the Hospital Harm – Opioid-Related Adverse Events (ORARE) eCQM before incorporation into reporting programs. ASHP believes that ORARE is an important measure concept; however, our members have voiced concerns over the implementation of this measure in its current form. In addition, we concur with the Hospital MAP 2019 Considerations for Implementing Measures in Federal Programs that conditionally supported inclusion of the Hospital Harm – Hypoglycemia eCQM once it is fully tested. Specifically, the ASHP Pharmacy Accountability Measure Work Group identified the hypoglycemia measure to be a critical tool to monitor and reduce harm from anti-diabetic agents.
In general, ASHP supports the remaining quality measure changes outlined in the IPPS rule. As efforts to further strengthen and refine these measures continue, we encourage CMS to consider the following measure-specific feedback.
ASHP supports inclusion of the NQF-endorsed Safe Use of Opioids – Concurrent Prescribing eCQM (NQF #3316e) in the Hospital Inpatient Quality Reporting program. The availability of this measure for inpatient/emergency department facilities and the Concurrent Use of Opioids and Benzodiazepines (NQF #3389) measure from the Pharmacy Quality Alliance, promotes adherence to this CDC Guideline for Prescribing Opioids for Chronic Pain (“CDC Guideline”) recommendation across the continuum of care.
ASHP supports the inclusion of the following measures from the PQA Opioid Core Measure Set in the Promoting Interoperability Program:
- Use of Opioids at High Dosage in Persons Without Cancer (OHD) (NQF #2940)
- Use of Opioids from Multiple Providers in Persons Without Cancer (OMP) (NQF #2950)
- Concurrent Use of Opioids and Benzodiazepines (COB) (NQF #3389)
These measures align with the CDC Guideline and published evidence that demonstrates an association between these prescribing patterns and an increased risk of opioid misuse and overdose. As a member of PQA, we supported the approval of these measures and encouraged endorsement by NQF.
ASHP also supports the use of the CDC Quality Improvement (QI) Opioid Measures. We appreciate CMS understanding that modifications may be needed as they are incorporated. These measures are consistent with opioid stewardship practices many of our members have implemented. Of the 16 CDC QI measures, the following would be particularly beneficial in the management and coordination of short- and long-term opioid therapy, especially if linking them to EHRs:
- Measure 2: The percentage of patients with a new opioid prescription for chronic pain with documentation that a PDMP was checked prior to prescribing.
- Measures 6 and 7 relating to the percentage of patients taking 50 and 90 MMEs daily, respectively.
- Measure 8: The percentage of patients on long-term opioid therapy who received a prescription for a benzodiazepine.
- Measure 11: The percentage of patients on long-term opioid therapy who had documentation that a PDMP was checked at least quarterly.
- Measure 15: The percentage of patients on long-term opioid therapy who were counseled on the purpose and use of naloxone, and either prescribed or referred to obtain naloxone.
- Measure 16: The percentage of patients with an opioid use disorder who were referred to or prescribed medication-assisted treatment.
Although evidence shows PDMPs as an effective tool in reducing “negative health outcomes associated with the medically unnecessary use of controlled substances,” the actual use of PDMPs by physicians and in clinical care is low. Including these particular CDC measures as part of CMS’ CQMs may help improve PDMP usage. Integrating PDMP information into EHRs would also make it easier for clinicians to check a patient’s PDMP record.
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.
Jillanne Schulte Wall, J.D.
Director, Federal Regulatory Affairs