[Submitted electronically to www.regulations.gov]
Vice Admiral Jerome M. Adams, M.D., M.P.H.
Office of the Surgeon General
Centers for Disease Control and Prevention
1600 Clifton Road NE, Mail Stop D-28
Atlanta, Georgia 30329
Re: Docket No. CDC-2018-0082 for “Surgeon General’s Call to Action: ‘Community Health and Prosperity.’”
Dear Vice Admiral Adams,
ASHP is pleased to submit comments to the Centers for Disease Control and Prevention (CDC) regarding the Surgeon General’s Call to Action. ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings. The organization’s 45,000 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.
The Surgeon General’s Call to Action notes that “America’s prosperity is being hampered by preventable chronic diseases and behavioral health issues” and requests feedback on policy solutions to address this issue. Specifically, the Call to Action asks about “the types of investments the private sector and local policy makers can consider to improve health and wellness of employees and families, and community well-being and prosperity.” ASHP believes that, at present, the United States does not effectively utilize its existing clinician resources — particularly pharmacists. Rather than simply seeking new policy options, we urge federal, state, local, and private sector policymakers to first fully and effectively engage pharmacists in patient care.
Pharmacists are integral members of the healthcare team, practicing across the continuum of care. Pharmacists’ medication expertise is invaluable, and their education prepares them for patient care that extends far beyond simply dispensing medications. Nevertheless, pharmacists continue to face both regulatory and reimbursement barriers to practicing at the top of their scopes of practice. As a result, our healthcare system fails to use resources effectively, squandering both human and financial capital. ASHP’s comments outline the value of pharmacist care, focusing on innovative care models and population health initiatives that could be scaled to work in communities across the country.
I. Improve Utilization of Pharmacists’ Patient Care Services
Pharmacists can assist policymakers in addressing several of the most pressing healthcare issues, including chronic care management, substance abuse identification, treatment and prevention, and drug pricing. ASHP encourages policymakers to focus their efforts on engaging pharmacists to ensure that patients receive the full value of a drug through adherence and effective management of comorbid chronic conditions. Even the most innovative, groundbreaking, lifesaving medication works only if a patient takes it correctly.
Medications are the first line of therapy to treat patients with chronic diseases and acute complex diseases such as cancer and heart disease. Breakthroughs in new medications have led to more Americans living longer, healthier lives. However, these breakthroughs also carry new challenges. Nearly 70 percent of Medicare beneficiaries have one or more chronic conditions, and many of these beneficiaries take multiple medications. Lack of proper medication oversight and management can result in suboptimal therapeutic outcomes and patient harm. For example, too many patients are unnecessarily readmitted to the hospital or visit the emergency department due to medication-related issues. The Institute of Medicine estimates that 1.5 million preventable adverse drug events (ADEs) occur annually in the United States, resulting in an estimated 7,000 deaths. The New England Healthcare Institute has estimated the cost of ADEs and nonadherence to total $290 billion annually. Addressing these costs would contribute substantially to improving the price tag for healthcare while benefitting patients.
Pharmacists are uniquely qualified to provide the type of medication and disease management (including behavioral health conditions) needed to not only stem the waste on ADEs and nonadherence, but also to enhance patient outcomes through improved medication use. Pharmacists offer an in-depth knowledge of medications that is unmatched in the healthcare arena. Pharmacists today receive clinically based Doctor of Pharmacy degrees (Pharm.D.), and many also complete postgraduate residencies and become board certified in a variety of specialties. Advancements in medical science and evolution in care delivery models have made postgraduate residencies essential to performing certain patient care services, and they are now prerequisites for positions within specialties such as solid organ transplantation pharmacology, psychiatry, infectious diseases, critical care, cardiology, oncology, and neonatology, among others.
Pharmacists in hospitals and ambulatory clinics work with physicians, nurses, and other providers on interprofessional teams to manage patients’ medications and ensure appropriate care transitions. Patient care discussions often revolve around the pathophysiology of disease or chronic condition, but far too often patients receive little information regarding perhaps the most essential part of treatment — the medication prescribed to cure or manage the condition. In many cases, the prescribing clinician does not have the same medication expertise as a pharmacist. Thus, if the goal is to avoid overspending on drugs and to maximize the value of the drugs patients purchase, pharmacists must play a more prominent role in medication selection and modification, patient education, follow-up and monitoring of medication, and overall medication and chronic disease management.
Studies indicate that the inclusion of pharmacists on the healthcare team demonstrates a significant return on investment in both patient outcomes and real dollars. For every dollar invested in clinical pharmacy services in all types of practice settings (hospitals, clinics, government, etc.), health systems realize an average savings of $4. Numerous studies attest to the benefits of fully engaging and integrating pharmacists into community health systems:
- Reduction of Hospital Readmissions: A recent study found that patients assigned to receive pharmacist interventions in conjunction with physician hospital follow-up visits had a statistically significant lower rate of readmission within 30 days (9.2%) than those who did not receive pharmacist interventions (19.4%). A separate study indicated that including a pharmacist in the patient-centered medical home model yielded an estimated cost savings of $2,619 per patient given the reduction in hospital admissions.
- Improvement in Transitions of Care: Another study examined the development of a collaborative transitions-of-care program for heart failure patients in a 390-bed community hospital. Pharmacists performed daily medication profile reviews for high-risk heart failure patients, including appropriate discharge counseling. The result was a reduction in 30-day heart failure readmissions and a cost savings of roughly $5,652 per patient.
- Telehealth: Patients in rural and underserved areas frequently lack access to care. Therefore, we would encourage use of telehealth infrastructures to extend access to interprofessional teams that require inclusion of pharmacists.
- Project ECHO: Project ECHO (Extension for Community Healthcare Outcomes) exemplifies the type of telehealth model that extends the care of an interprofessional team that includes a pharmacist.
- Veterans Affairs: A pharmacist-led telehealth primary care program resulted in significantly improved diabetes and hypertension outcomes and clinical improvements in tobacco cessation, while improving access to clinical services. Of 140 patients, 42% achieved tobacco cessation, and 39% received a reduction in tobacco use with pharmacist intervention and follow-up.
- Annual Wellness Visit Provision: Pharmacists providing both Annual Wellness Visits (AWVs) and Comprehensive Medication Management (CMM) facilitated the completion of AWVs and identified and addressed medication-related problems in an older, high-risk population. Eligible patients were 65 years of age or older with three or more chronic medical conditions, taking five or more long-term prescription or nonprescription medications and receiving primary care in a retirement community clinic. All participants saw a clinical pharmacist practitioner for an AWV with CMM and additional CMM visits at three and six months. Outcomes included completion of required AWV components, decrease in prevalence of medication-related problems, classic return on investment, improved patient satisfaction, and a change in the rate of hospitalization.
- Innovative Care Models: Pharmacists also participate in innovative care models that improve patient outcomes. These efforts are scalable to many communities and populations.
- Digital Hypertension Monitoring: Clinical pharmacists at Ochsner Health System in New Orleans collect blood pressure readings using patients’ smartphones. The readings are central to optimizing medication therapy and controlling hypertension. While research is ongoing, preliminary results show 80% of patients reaching their blood pressure goal, usually within the first three months after enrolling in the digital hypertension program.
- Community Health Focus: The Missoula Urban Indian Health Center introduced a pharmacist-led diabetes management program focused on the family. The program “addresses social and mental health issues and shows the [patient’s] household how to support family members with diabetes through exercise, diet changes, and even help[ing] with foot inspections.” The pharmacists work under collaborative practice agreements and are seeing improved outcomes in patients enrolled in the program.
- The Diabetes Ten City Challenge is a community-based, payer-driven, patient-centered healthcare model established in 2005 in 10 American cities, providing pharmacy health management services for diabetic patients. Patients were teamed with community pharmacists to receive pharmaceutical care services providing education, long-term pharmacist follow-up, clinical assessment, goal-setting, monitoring, and collaborative drug therapy management with physicians. The pharmacists were part of an interdisciplinary healthcare team and communicated regularly to optimize patient care. Ongoing pharmacy management services significantly decreased hemoglobin A1c from 7.5% to 7.1%, decreased mean LDL from 98 mg/dl to 94 mg/dl, and decreased mean systolic blood pressure from 133 to 130 mmHg over a mean of 14.8 months. Average total healthcare costs per patient per year were reduced by $1,079.
- Population Health Management: Population health is “an intensive focus on the overall health of a given population in an effort to improve care, reduce costs, and promote wellness.” Interventions may include medication therapy management, disease state management, and wellness promotion (e.g., smoking cessation and care transitions). Pharmacists contribute to improved population health through effective chronic disease and drug therapy management, patient education, and adherence to medication therapy.
- Geisinger: In a study of pharmacist population health management, Geisinger Health Plan found that over a 15-year period, its ambulatory care pharmacy program resulted in 18% fewer emergency department visits and 18% fewer hospitalizations per year for atrial fibrillation patients who were managed by pharmacists, with 23% lower annual total care costs. Additionally, the number of emergency department visits for multiple sclerosis patients managed by pharmacists was 28% lower than the number of visits for patients not managed by pharmacists.
- Veterans Affairs: A VA study found a greater A1c reduction for diabetes mellitus patients when clinical pharmacists rather than physicians managed care.
- A3 Collaborative: The A3 Collaborative is a national learning and action collaborative that supports organizations in making comprehensive medication management (CMM) a critical part of their strategic plan and their response to the new value-based payment environment. Outcomes from the A3 Collaborative include:
- Penobscot Community Healthcare (Maine): Expanded its transitions of care team and increased patient home visits, resulting in decreased 90-day readmissions and overall cost savings;
- Marshfield Clinic (Wisconsin): Improved diabetes and hypertension clinical measures, and decreased medication therapy problems and the use of high-risk medications in the elderly (58% of patients showed a decrease in their A1c while 59% of patients reached their blood pressure goal); and
- Southwest General (Ohio): Established a CMM program to develop and implement a discharge education program for diabetic patients with an A1c >10% and/or who were new to insulin therapy. The institution is also working with community resources to secure continuous glucose monitors for high-risk patients.
Despite this evidence, pharmacists are neither eligible to participate in Medicare Part B, nor are they required providers within accountable care organizations (ACOs). As a result, pharmacists are not directly reimbursed for patient care, making it more difficult for them to fully integrate into certain practice settings. To address this, we urge policymakers to test and expand the concept of direct payment to pharmacists. The Centers for Medicare & Medicaid Services (CMS) has previously indicated support for flexibility around reimbursement to pharmacists through innovative non-direct payment models for chronic care management (CCM), transitional care management (TCM), the diabetes prevention program (DPP), and behavioral health integration (BHI) services. A model test of direct payment would be a logical extension of these payment models and could be done through the Center for Medicare & Medicaid Innovation (CMMI), with state resources, or through collaboration with private payors.
II. Pharmacists and Behavioral Health Care
As noted above, due to regulatory barriers, pharmacists are not always effectively engaged in patient care, including treatment of mental health disorders and opioid abuse. For example, the Drug Enforcement Agency (DEA) just opened up prescribing of buprenorphine to physician assistants and nurse practitioners, but not to pharmacists, despite their medication expertise. As our nation struggles with an opioid epidemic, we urge policymakers to better utilize pharmacists’ services for pain management and substance abuse treatment. Studies have documented the positive impact of pharmacists in treating pain and mental health disorders, including substance abuse:
- Pain management in an integrated health system: Pharmacist clinicians with prescribing authority for controlled substances provided chronic non-cancer-related pain medication management services in a for-profit integrated health system. In a one-year time period, the pharmacist clinicians were able to show an improvement in mean visual analogue scale pain scores and save the health system over $450,000.
- Depression management in a staff model health maintenance organization: A randomized controlled trial was conducted to measure the impact of a collaborative care model that emphasized the role of clinical pharmacists to provide drug therapy management and treatment follow-up in patients with depression. In this collaborative model, after six months, those patients with depression randomized to the services of a pharmacist compared with the control group had a significantly higher medication adherence rate (67% vs. 48%), higher patient satisfaction, and favorable changes in resource utilization.
- Opioids Stewardship: Penobscot Community Health Care developed a controlled substance stewardship program that resulted in a 67.2% decrease in the number of patients receiving chronic opioids. Within this program, pharmacists assisted with the creation of patient-specific pain management care plans for patients prescribed high-dose opioids for chronic pain.
Pharmacists can play an integral part in combatting opioid use using a variety of approaches and tools. For patients with opioid needs exceeding 72 hours, a pharmacist can assist the provider in creating a patient-specific pain plan that includes the most optimal medication(s), duration, and a plan to discontinue, taper, or transition to a non-opioid therapy. This plan can then be electronically shared throughout all transitions of care including outpatient visits.
Again, we thank CDC for your consideration of our comments. We continue to support CDC’s efforts to improve community health, and we stand ready to assist federal, state, local, and private sector policymakers in any way possible. Please contact me if you have any questions about ASHP’s comments on the proposed rule. I can be reached by telephone at 301-664-8696 or by email at [email protected]
Jillanne Schulte Wall, J.D.
Director, Federal Regulatory Affairs