ASHP (American Society of Health-System Pharmacists) respectfully submits the following statement for the record to the House Energy and Commerce hearing on lowering drug prices.
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’s vision is that medication use will be optimal, safe, and effective for all people all of the time. A primary tenet of that vision includes access to affordable medications needed to save or sustain lives. Addressing the issue of skyrocketing drug prices, including excessive price increases on commonly used generic medications, is one of ASHP’s highest and longstanding public policy priorities. According to a Kaiser Health Tracking Poll, 1 in 4 Americans cannot afford their medications.1 Poor access to medications can lead to increased morbidity and mortality, and can cause healthcare costs to rise.
ASHP has been proactively addressing challenges related to the rapid increase of prescription drug pricing on several fronts, including working with like-minded stakeholders and educating members of Congress about the unsustainable burdens faced by patients, healthcare providers, and the entire healthcare system.
ASHP is a lead member of the Steering Committee of the Campaign for Sustainable Rx Pricing (CSRxP), a coalition of prominent national organizations representing physicians, consumers, payers, hospitals, health systems, and patient advocacy groups. CSRxP has developed a policy platform promoting market-based solutions supported by three pillars: competition, value, and transparency.
The goal of the campaign is to identify policy options that have bipartisan support and, therefore, a greater likelihood of passage. To that end, CSRxP focuses on policies to incentivize a more competitive marketplace to help stimulate lower drug prices. The campaign has also expressed support for efforts to loosen restrictions that prevent generic drug companies from obtaining the samples necessary to manufacture a competing product. In this regard, we are supportive of bills such as the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 (S.974) (H.R.1499) which address this specific issue.
ASHP, along with the American Hospital Association (AHA) and the Federation of American Hospitals (FAH), recently released a report on the impact that the cost of and access to prescription drugs is having on hospital budgets and operations.
Specifically, the report showed that:
- Average total drug spending per hospital admission increased by 18.5% between fiscal years (FY) 2015 and FY2017.
- Outpatient drug spending per admission increased by 28.7%, while inpatient drug spending per admission increased by 9.6% between FY2015 and FY2017.
- Hospitals experienced price increases of over 80% across different classes of drugs, including those for anesthetics, parenteral solutions, and chemotherapy.
- Over 90% of surveyed hospitals reported having to identify alternative therapies to manage spending.
- One in 4 hospitals had to cut staff to mitigate budget pressures.
ASHP does not collect, store, or report drug pricing information. However, we continually hear from pharmacy leaders in hospitals and health systems that sudden, inexplicable, and unpredictable price increases in connection with some of the most commonly used, longstanding generic medications are becoming more prevalent — and are occurring on a nationwide basis.
In this statement, we address five additional issues as they relate to drug pricing: Competition, Risk Evaluation and Mitigation Strategies (REMS), Direct and Indirect Remuneration (DIR Fees), importation of prescription drugs, and the 340B Drug Pricing Program.
COMPETITION
Price increases often occur for drugs that have only one or two manufacturers. ASHP encourages the Committee to consider policy approaches to stimulate competition for generic products with few manufacturers. ASHP supports S. 64, the “Preserve Access to Affordable Generics and Biosimilars Act” and H.R. 1499 the “Protecting Consumer Access to Generic Drugs Act of 2019.” Both bipartisan bills would prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the marketplace. Passage of this legislation would in essence prohibit companies from engaging in “pay-to-delay” tactics which drastically affects patient access to care.
RISK EVALUATION AND MITIGATION STRATEGY (REMS)
ASHP recognizes that there may be limited circumstances in which constraints on the traditional drug distribution system may be appropriate for reasons of patient safety, including through the use of manufacturer-driven REMS. However, we believe 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. We believe that there may be current cases in which a manufacturer-driven REMS using restricted distribution are causing higher prices for those drugs, having adverse effects on patient access, and delaying treatment. In some cases, there is 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 product to market. For this reason, we support 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.
DIRECT AND INDIRECT REMUNERATION FEES (DIR Fees)
DIR fees are a growing nationwide concern among pharmacies that dispense medications in a community pharmacy or outpatient clinic setting. Created under the Medicare Part D Program, DIR fees were originally intended as a way for CMS to account for the true cost of the drug dispensed, including any manufacturer rebates. Often these fees are unknown until the drug is dispensed and the claim adjudicated. Moreover, the fees themselves, which are often arbitrary in nature, have mushroomed over the past decade, to the point that pharmacies regularly see annual DIR totals in the tens of thousands of dollars.
PBMs are inappropriately applying their own plan performance measures as a way to assess fees on pharmacies. This is problematic for the following reasons:
- Pharmacy providers are essentially being penalized with backdoor fees without any requirement that PBMs define, justify, or explain these charges to providers and to CMS.
- It is an arbitrary application of quality measures meant for total plan performance as opposed to pharmacy-level metrics.
- The quality measures applied were never intended to be applied to specialty medications or to other specialized disease states such as oncology, yet PBMs assess DIR fees against the gross reimbursement for all prescriptions received by pharmacy providers, not just maintenance medications.
DIR fees assessed on pharmacies providing specialty medications have been especially hard-hit, due to the fee structure. Fees could be a flat rate of per dollar per claim or a percentage (typically 3‒9%) of the total reimbursement per claim. Using the percentage-based structure, the fees would increase markedly for specialty drugs, which are typically much more expensive than maintenance medications, sometimes resulting in thousands of dollars. For example, a 9% fee on a drug costing $100,000 is $9,000. Additionally, these fees are assessed retroactively, sometimes months after the claim has been adjudicated, providing no recourse for the pharmacy impacted by the assessment.
DIR fees have led to higher cost-sharing responsibilities for Medicare beneficiaries, which have, in turn, caused more of these beneficiaries to enter the Part D donut hole, where the patient is solely responsible for the cost of the drug. Along with the higher costs absorbed by patients, adherence rates tend to be lower among Medicare beneficiaries who are in the donut hole and may not have the financial resources to pay for their medications. This is in stark contrast to the very reason DIR fees targeting manufacturer rebates were created — so that savings could be passed on to patients.
Pharmacies are not alone in their concern about abused DIR fees. In January 2017, CMS published a fact sheet expressing concern over DIR fees and cited those fees as contributing to increased drug costs, which, in turn, increased patients’ out-of-pocket spending and Medicare spending overall. Additionally, questions remain as to whether Part D plan sponsors have the authority to assess these fees on pharmacies. DIR fees collected on pharmacies were not authorized in either the Part D statute or corresponding CMS regulations.
ASHP recommends that payers and pharmacy benefit managers be prohibited from recovering direct and indirect remuneration fees from pharmacies on adjudicated dispensing claims, and opposes the application of plan-level quality measures on specific providers, such as participating pharmacies.2
DRUG IMPORTATION
A number of bills introduced in the House of Representatives, H.R. 478, the “Safe and Affordable Drugs from Canada Act of 2019,” and H.R. 447, the “Affordable and Safe Prescription Drug Importation Act,” would allow for importation of prescription drugs by individuals, wholesalers, or pharmacies. ASHP does not support these bills, as they put patients at unnecessary risk.
We urge the committee to carefully consider how any bill that includes an importation policy could negatively affect a drug’s pedigree and potentially allow adulterated and/or counterfeit drugs into the supply chain. Importation is in direct conflict with the Drug Supply Chain Security Act passed by Congress in November 2013, which sought to better track and trace drugs through the supply chain. ASHP understands that bills to allow for importation seek to create access to lower cost medicines. We believe, however, that safer and more comprehensive means to improve affordability and accessibility are needed.
ASHP supports continued oversight by the Food and Drug Administration and state boards of pharmacy with respect to the importation of pharmaceuticals in order to maintain the integrity of the pharmaceutical supply chain and avoid the introduction of counterfeit products into the United States; provide for continued patient access to pharmacist review of all medications and preserve the patient-pharmacist-prescriber relationship; and provide adequate patient counseling and education, particularly to patients taking multiple high-risk medications. We urge the FDA and state boards of pharmacy to vigorously enforce federal and state laws in relation to importation of pharmaceuticals by individuals, distributors (including wholesalers), and pharmacies that bypass a safe and secure regulatory framework.3
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. Given the increasingly high cost of pharmaceuticals, the federal 340B program provides critical support to the entities eligible to participate in the program.
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.
The federal 340B program is at risk because of a recent change in Medicare payment policy that reduces payment from Average Sales Price plus 6 percent to Average Sales Price minus 22.5 percent. Cuts of this magnitude undermine the intent of the program, reducing resources that hospitals use to expand access to care and services to vulnerable communities.
CONCLUSION
ASHP thanks the Committee on Energy and Commerce for holding this important hearing. In summary, ASHP supports policies incentivizing generic competition and curtailing practices, such as abuses of the REMS process, that reduce entry of competitor drugs into the marketplace; ASHP opposes DIR fees that raise costs for pharmacies and patients; ASHP does not support prescription drug importation as a means to reduce drug prices because it places patients at needless risk; and ASHP strongly supports the safeguarding of the 340B program and the benefits it provides to patients, and rejects the notion that it contributes to high drug prices. ASHP remains committed to working with Congress and industry stakeholders to ensure that patients have affordable access to lifesaving and life-sustaining medications.
____________
1 DiJulio, Bianca, et al. “Kaiser Health Tracking Poll: August 2015.” The Henry J. Kaiser Family Foundation, The Henry J. Kaiser Family Foundation, 20 Aug. 2015, www.kff.org/health-costs/poll-finding/kaiser-health-tracking-poll-august-2015/. Accessed February 10, 2019.
2ASHP Policy 1814, Direct and Indirect Remuneration Fees.
3ASHP Policy 0413, Importation of Pharmaceuticals.