March 1, 2019
The Honorable Lamar Alexander, Chairman
Committee on Health, Education, Labor and Pensions
428 Senate Dirksen Office Building
Washington, DC 20510
Dear Chairman Alexander,
ASHP (American Society of Health-System Pharmacists) thanks you for the opportunity to offer policy recommendations to the Senate Committee on Health, Education, Labor and Pensions (HELP) regarding steps Congress can take to lower healthcare costs.
ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings. The organization’s nearly 50,000 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. ASHP believes that the mission of pharmacists is to help people achieve optimal health outcomes. Pharmacists can achieve this aim only if patients have access to affordable healthcare.
ASHP shares the committee’s commitment to identifying methods to lower healthcare costs. Our members are committed to helping patients achieve optimal health outcomes. ASHP helps its members achieve this goal by serving its members as their collective voice on issues related to medication use and public health.
As Congress evaluates options to lower healthcare costs, we strongly encourage a focus on legislation that will:
- Take advantage of the medication-use expertise of pharmacists.
- Preserve the 340B Drug Pricing Program.
- Support affordable medications.
- Encourage development of an intermediate category of drug products.
- Support public health initiatives.
Below, we offer our responses to the questions you posed in your December 11, 2018 letter.
TAKE ADVANTAGE OF THE MEDICATION-USE EXPERTISE OF PHARMACISTS
ASHP supports the use of pharmacists as patient care providers, particularly as health systems undergo significant transformation and seek to increase efficiency through improved quality, health outcomes and reduced costs. In 2015 the National Governors Association published a prominent report calling for the enhanced use of pharmacists and urging states to engage in coordinated efforts to address recognition of pharmacists as health care providers. Pharmacists, as the medication-use experts, work collaboratively with physicians, nurses, and other healthcare professionals to ensure that medication use is optimal, safe, and effective. We believe that all healthcare programs, both public and private, should fully incorporate pharmacists as full providers of care as it relates to medication use.
Education and Clinical Training
Pharmacists undergo rigorous education and training focused on the composition, interaction, and use of medications. Their educational background includes the completion of clinically based doctor of pharmacy degrees (Pharm.D.), and many also complete postgraduate residencies and become board certified in a variety of specialties.
Collaborative Care Models
As members of the interprofessional patient care team, pharmacists provide comprehensive medication management services to various patient populations including high-risk patients with complex medication regimens. Pharmacist-led clinical services vary depending on individual state scope of practice laws. Through collaborative practice agreements or formalized credentialing and privileging processes within health systems, pharmacists may: perform patient assessments; modify and/or initiate medication therapy; order, interpret, and monitor medication therapy‐related tests; coordinate care and other health services; provide education to patients and caregivers incorporating principles of health literacy and cultural sensitivity; and document care processes in the medical record.
According to the New England Healthcare Institute, just the cost of medication-related adverse events and non-adherence is estimated to be $290 billion annually. 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 (hospital, clinics, government, etc.), health systems realize an average savings of $4.
Primary Care and Specialty Clinics
Cost benefits of pharmacy services have been noted in the primary care setting. In a study conducted at a retirement community-based primary care clinic, pharmacist-led annual wellness visits in conjunction with comprehensive medication management demonstrated a positive return on investment of 38.1%. A 2018 report concluded that pharmacist involvement in a primary care collaborative model resulted in improved clinical outcomes associated with various chronic conditions, ultimately reducing the number of hospitalizations by 23.4% and yielding an estimated cost savings of $2,619 per patient.
Pharmacists also contribute to cost savings through direct patient care services in various specialized clinics, such as diabetes, heart failure, anticoagulation, pain, and oncology. In an integrated health-system clinic, pharmacy clinicians with prescribing authority for controlled substances provided chronic non-cancer-related pain medication management services. 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.
Addressing the Opioid CrisisAs our nation struggles with an opioid epidemic, it is imperative to utilize pharmacists’ services for pain management and substance abuse treatment, including access to medication assisted treatment. A recent executive summary released by the Council of Economic Advisers estimated that the economic burden of the opioid crisis in 2015 was $504 billion, which was more than 6 times higher than other estimates.
The Comprehensive Addiction and Recovery Act (CARA), signed into law in 2016, opened up prescribing of buprenorphine to physician assistants and nurse practitioners, but not to pharmacists, despite their medication expertise. Pharmacists have demonstrated their impact on opioid and pain management related outcomes that could lead to cost savings for the overall healthcare system. In one case study, a pharmacist led multi-modal approach to reduce opioid prescribing in the emergency department, led to a 64% reduction in opioid utilization and increased patient satisfaction scores. Pharmacists were responsible for order set development, prescriber and nursing education, data collection and analysis, and communication to the medical team.
Transitions of Care
Significant cost savings are realized through pharmacist-led transitions of care (TOC) programs. One study evaluated the impact of an ambulatory care pharmacy-based TOC program on healthcare costs in a high-risk patient population. Among 830 patients referred to the TOC program, total healthcare costs at 180 days after discharge were an average of $2,139 lower than costs in the control group, yielding estimated savings of nearly $1.8 million for the managed care plan.
Another study examined the development of a collaborative TOC program for heart failure patients in a 390-bed community hospital. Pharmacists performed daily medication profile reviews to ensure the use of optimal doses of appropriate medication regimens for high-risk heart failure patients. The result was a reduction in 30-day heart failure readmissions and a cost savings of roughly $5,652 per patient.
Reduction of Hospital Readmissions
Pharmacists’ clinical interventions are directly associated with a reduction in hospital readmissions and downstream cost savings. A recent study in AJHP (American Journal of Health-System Pharmacy), ASHP’s peer-reviewed scientific journal, noted that patients assigned to receive pharmacist interventions in conjunction with physician hospital follow-up visits have a statistically significant lower rate of readmission within 30 days (9.2%) than those who did not receive pharmacist interventions (19.4%).
Despite their position as one of our nation’s most trusted and accessible healthcare professionals, pharmacists are not recognized as providers in the Medicare program. As a result, beneficiaries’ access to the healthcare practitioner with the most medication-related education and training is limited, and is restricted mainly to services related to the dispensing of medications. By not including pharmacists as Part B providers, patients are not able to fully access the benefits of a coordinated, team-based approach to care. Enabling pharmacists to practice to the full extent of their education and training will improve health outcomes and greatly benefit specific populations, especially those with chronic diseases such as diabetes and cardiovascular disease.
ASHP respectfully requests that Congress adopt legislation that would amend section 1861 (s) (2) of the Social Security Act to allow pharmacists to participate in Medicare Part B. ASHP believes that including pharmacists as non-physician providers in the Medicare program will help provide needed access to care for our nation’s medically underserved patients.
PRESERVE THE 340B DRUG PRICING PROGRAM
For 25 years, the federal 340B program has allowed safety-net hospitals “to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” This program has been essential to expanding access to lifesaving prescription drugs and comprehensive healthcare services to low-income and uninsured individuals, at no cost to the federal government. The federal 340B program is not causing high drug prices. The program accounts for less than 5% of annual drug purchases in the United States, while safety-net providers give 30% of the care. At a time when federal budgets are stretched thin, the 340B program helps maximize federal resources while providing access to lifesaving medications.
In some cases, a hospital’s ability to remain solvent is dependent on its participation in the program. Reductions in program size or changes in eligibility could devastate these providers, many of whom are already confronting significant market challenges that can severely impact patient access.
The federal 340B program enables these hospitals to serve their communities by providing vital care such as:
- Free or lower-cost medications to patients.
- Programs to increase medication adherence, including clinical pharmacy services to high-risk patients who are on multiple and/or complex medications.
- Increased access to primary care.
- Screenings and preventive care services to detect health problems early and decrease morbidity and mortality, as well as to decrease healthcare costs and hospital admissions.
ASHP also recognizes the great importance of program compliance as we endorse programs that support the covered entities as well as manufacturers in their efforts to ensure the integrity of the federal 340B program. ASHP works to improve compliance through the use of educational training sessions. The goal of these sessions is to educate our members and other stakeholders about the program’s requirements as well as to provide a forum to discuss compliance challenges and solutions. These are typically done in panel format, which allows the unique opportunity for covered entities to interface with peers, the faculty, and pharmaceutical wholesaler and manufacturer representatives in live sessions. ASHP believes these programs have had a positive influence on improving compliance within the 340B program.
To improve compliance with the program, ASHP believes that Congress should grant the Health Resources and Services Administration (HRSA) additional regulatory authority. ASHP recommends that this authority extend to the oversight of manufacturers to ensure that covered entities are being charged appropriately.
SUPPORT AFFORDABLE MEDICATIONSASHP believes that access to safe, quality, and effective medication use should be a component of all proposed solutions to lowering healthcare costs. Patients who cannot afford their medications do not take their medications. Medication nonadherence costs our healthcare system in both financial terms and in the form of suboptimal patient outcomes. According to a Kaiser Health Tracking Poll, 1 in 4 Americans cannot afford their medications. Poor access to medications can lead to increased morbidity and mortality, and can cause healthcare costs to increase.
Risk Evaluation and Mitigation Strategy (REMS)
ASHP believes that there may be cases in which a manufacturer-driven REMS using restricted distribution is causing higher prices for those drugs, having adverse effects on patient access, and delaying treatment. In some cases, there may be evidence to suggest that the use of restricted or limited distribution channels has resulted in the inability of a potential competitor to acquire enough of a drug to conduct the required testing to bring a generic competitor to market. ASHP believes that REMS should never be used to artificially inflate drug prices, nor should they interfere with the professional practice of pharmacists, physicians, nurses, and other providers. For this reason, ASHP supports S. 340, the “Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019.” The CREATES Act will help ensure that brand-name pharmaceutical companies cannot manipulate regulatory rules to prevent competition, which is essential for patient access to affordable medications. Additionally, we recommend that Congress require the Food and Drug Administration (FDA) to investigate restricted distribution under a REMS as a means to artificially increase drug prices and limit access to critical medications. Restricting distribution of medications is often a means to push patients to a specific purchasing channel, which in some cases increases not only their out-of-pocket costs, but also systemic costs. Further, restricted distribution networks can complicate patient access to critical medications, potentially disrupting care.
Transparency in Drug Product Pricing
Many factors contribute to high drug product costs, and addressing the problem is made difficult by lack of knowledge about the marketplace for those products. For example, rebates negotiated by pharmacy benefit managers (PBMs) and discounts to other buyers make it difficult to determine the actual price of a drug product. ASHP supports the effort to make more information on drug product pricing publicly accessible. Such information would increase public knowledge concerning pricing decisions made by different parties in the drug product supply chain (e.g., manufacturers, distributors, PBMs, group purchasing organizations) that may influence drug product prices.
ASHP believes that increasing transparency in the drug pricing market will ultimately decrease prices and encourage market-based solutions
ENCOURAGE DEVELOPMENT OF AN INTERMEDIATE CATEGORY OF DRUG PRODUCTS
ASHP supports the establishment of an intermediate category of drug products that would not require a prescription but rather would be available from a pharmacist or other licensed healthcare professional after appropriate patient assessment and professional consultation. Recently, states have passed legislation permitting qualified pharmacists to offer contraceptive therapy, naloxone, or immunizations in the outpatient setting.
An intermediate category of drug could improve patient access to medications that offer substantial public health benefit. Additionally, patients in rural areas, where a pharmacy may provide the only convenient access to a healthcare professional, will benefit from access to an intermediate category. Moreover, this would allow for reduced cost and a lessening of duplicative burden on the remainder of the healthcare team to allow for the care of patients requiring more involved treatment plans.
SUPPORT PUBLIC HEALTH INITIATIVES
ASHP strongly recommends the preservation of all existing funding for opioid abuse treatment and prevention, vaccination, antimicrobial stewardship, and other critical public health services. In particular, reductions in funding to the U.S. Centers for Disease Control and Prevention could cripple ongoing efforts to address these public health crises, threatening health outcomes on a national level. Support for these initiatives should ultimately result in a reduction in overall healthcare expenses and negative patient outcomes while increasing patient awareness of public health issues.
Again, ASHP thanks Chairman Alexander for the opportunity to provide our policy recommendations. As the committee continues its work, we encourage you to view ASHP as a resource on this critical issue. Please contact me with any questions at 301-664-8692 or at [email protected].
Kasey K. Thompson, Pharm.D., M.S., M.B.A.
Chief Operating Officer & Senior Vice President for Policy and Planning
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