The Scope of The Problem
Medication nonadherence – the failure of patients to take their medication as prescribed by their physician – is a longstanding barrier to achieving favorable patient health outcomes. Overall, drug persistence is consistently less than 50%. The problem is across all disease states, and all demographic cohorts, although communities of color experience even lower mediation adherence rates as compared to white patients. The results are predictable – failure to achieve optimal therapeutic efficacy (which in turn undermines patient confidence in the healthcare system as a whole), avoidable hospitalizations, missed workdays, unnecessary emergency care and more frequent outpatient visits, resulting in adverse impact on the quality of life of the non-adherent patient, and inevitably excess mortality. Poor medication adherence is also the most common reason for disparities observed between results obtained in randomized clinical trials and real-world outcomes, further impacting patient health and well-being.
The economic fall-out is obvious – hundreds of billions of dollars in additional healthcare costs. These concerns have led the Centers for Medicare and Medicaid Services (CMS) to adopt measures of medication adherence as indicators of health plan quality, which health plans in turn use to assess provider groups. Measures of adherence to a specified subset of medications for diabetes (oral agents only), hypertension (renin-angiotensin system antagonists only), and cholesterol medications (statins only) have been used in Medicare Star Ratings since 2012. Each of these measures is triple-weighted, and together they determine approximately one-third of a plan’s overall Star rating. These ratings have large financial implications for health plans, determining Star bonus revenue that plans can use to enrich benefits and attract more members. Although it is tempting to see the impact of low medication adherence primarily on private and public payors, there is also a significant impact on pharmacies, pharmaceutical manufacturers and clinical drug trials, and indeed much of the healthcare ecosystem.
Factors Contributing to Poor Medication Adherence
Although the underlying root causes of non-adherence are complex and variable, the World Health Organization has identified five dimensions of adherence: these were socio-economic factors, healthcare team- and system-related factors, condition-related factors, therapy-related factors, and patient-related factors. A one-size fits all solution to this problem is elusive, and ideally approaches are more likely to be effective if targeted at the level of individuals. These approaches should address personal motivations and ability to adhere, while recognizing the patient’s own relationship to their illness and treatment. Approaches to medication adherence, and the implementation of solutions, are not, however, simply an academic exercise, but require sophisticated knowledge of and compliance with applicable laws and regulations.
The Impact of the Inflation Reduction Act on Medication Adherence
The passage of the Inflation Reduction Act (IRA) represents a fundamental change in healthcare policy and economics and brings significant impact to the pharmaceutical and healthcare industries. The IRA, while intended primarily to control price inflation, may also have a direct impact on patient drug adherence. In particular, the IRA redesign of the Medicare Part D benefit reduces beneficiaries Out-Of-Pocket (OOP) costs in several ways:
- Caps insulin cost sharing at $35/month and eliminates cost sharing for all vaccines recommended by the Advisory Committee on Immunization Practices (ACIP)
- Eliminates beneficiary cost sharing in the catastrophic portion of the benefit ($8,000 in 2024) and expands the low-income subsidy (LIS) to 150% of the federal poverty level (FPL), meaning that all enrollees that currently only qualify for partial subsidy will become eligible for the full LIS
- In 2025, implements an OOP spending cap of $2,000 and allows enrollees to spread payment for OOP costs incurred below the cap over the course of the plan year
- Beginning in 2024, established a premium stabilization program to limit the growth of the base beneficiary premium to 6% per year from 2024–2029 and recalculates the base beneficiary premium percentage for 2030 and beyond
In addition, Medicare drug price negotiation may potentially result in lower drug prices for beneficiaries, although this remains to be seen. The intention is that prices negotiated by the Secretary of HHS will become the new Part D negotiated price, and hence the basis for beneficiary cost sharing when the deductible or coinsurance applies. The impact of decreased cost-sharing and negotiated drug prices is likely to address, at least partially, one of the main drivers of low medication persistence noted above – the economic impact of high-cost drug regimes.
Prescription Drug Affordability Boards
Along with the implementation of the IRA, state governments are also engaged in efforts to lower drug costs. A number of states are increasing oversight of prescription drug prices through the use of Prescription Drug Affordability Boards (PDABs). Although again, the main thrust of these efforts is to lower the price of drugs for both state budgets and individual consumers, the impact may be felt in improved levels of medication persistence.
The Impact of the Health Insurance Portability and Accountability Act Privacy Rule on Medication Adherence
The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule has several provisions that relate to medication adherence, including:
The Use of Refill Reminders and Other Digital Technologies
Payors frequently see pharmacies as the front-line in increasing patient engagement for the purposes of improving drug persistence. Retail, mail order and digital pharmacies are now able to leverage advanced analytics to target high-risk individuals and telehealth to connect with them, while digital pharmacy teams proactively reach out to Medicare beneficiaries and provide personalized support that helps at-risk patients overcome adherence obstacles. Home delivery of medications and synchronizing medication pickup dates can also make it easier for patients to get consistent access to their prescriptions, improving patient persistence on medication. Such efforts, however, must take into consideration applicable laws including, for example, the HIPAA Privacy Rule. The Privacy Rule expressly excludes from the definition of “marketing” refill reminders or other communications about a drug or biologic that is currently being prescribed for the individual provided that financial remuneration received by the covered entity in exchange for making the communication, if any, is reasonably related to the covered entity’s cost of making the communication. Further, communications about drugs or biologics not falling withing the refill reminder exception are still permitted under the Privacy Rule if:
- The communications are made face-to-face at the pharmacy or other setting. Face-to-face communications do not include communications by telephone or sent by mail or e-mail.
- Written authorization has been obtained from the individual to make the communications.
- The communications fall within another exception to the definition of marketing and do not involve financial remuneration.
HIPAA compliant email
HIPAA compliant email systems can help with medication adherence by allowing healthcare providers to communicate with patients securely about medication instructions, treatment plans, and test results.
HIPAA compliant text messaging
Pharmacies and other providers can use HIPAA compliant text messaging platforms to ensure patient privacy while sending medication adherence reminders.
How Frier Levitt Can Help
While a sophisticated, data driven approach to medication adherence has many potential benefits, a dynamic regulatory and compliance landscape presents significant challenges and necessitates careful guidance. Frier Levitt’s experienced attorneys can work with you to ensure, for example, that you are in compliance with HIPAA regulations regarding the use of digital medication reminders, as well as the sharing of patient information and in particular, marketing restrictions on the use of such programs. We are available to assist you in gauging the impact of PDABs on the drug market and patient demand, by engaging with state legislatures and local regulators. Our experienced team can also guide you through the nuances of the pricing reform provisions of the IRA, and its impact not only on beneficiary drug utilization and adherence, but also on plan design, pharmaceutical drug research and development, patent litigation, and market entry opportunities for competitor drugs. Please contact our office to speak with an attorney today.
