The Inflation Reduction Act and Out-of-Pocket Drug Costs for Medicare Beneficiaries With Cardiovascular Disease.

BACKGROUND: High out-of-pocket costs can impede access to guideline-directed cardiovascular drugs. The 2022 Inflation Reduction Act (IRA) will eliminate catastrophic coinsurance and cap annual out-of-pocket costs for Medicare Part D patients by 2025. OBJECTIVES: This study sought to estimate the IRA's impact on out-of-pocket costs for Part D beneficiaries with cardiovascular disease. METHODS: The investigators chose 4 cardiovascular conditions that frequently require high-cost guideline-recommended drugs: severe hypercholesterolemia; heart failure with reduced ejection fraction (HFrEF); HFrEF with atrial fibrillation (AF); and cardiac transthyretin amyloidosis. This study included 4,137 Part D plans nationwide and compared projected annual out-of-pocket drug costs for each condition in 2022 (baseline), 2023 (rollout), 2024 (5% catastrophic coinsurance eliminated), and 2025 ($2,000 cap on out-of-pocket costs). RESULTS: In 2022, mean projected annual out-of-pocket costs were $1,629 for severe hypercholesterolemia, $2,758 for HFrEF, $3,259 for HFrEF with AF, and $14,978 for amyloidosis. In 2023, the initial IRA rollout will not significantly change out-of-pocket costs for the 4 conditions. In 2024, elimination of 5% catastrophic coinsurance will lower out-of-pocket costs for the 2 costliest conditions: HFrEF with AF ($2,855, 12% reduction) and amyloidosis ($3,468, 77% reduction). By 2025, the $2,000 cap will lower out-of-pocket costs for all 4 conditions to $1,491 for hypercholesterolemia (8% reduction), $1,954 for HFrEF (29% reduction), $2,000 for HFrEF with AF (39% reduction), and $2,000 for cardiac transthyretin amyloidosis (87% reduction). CONCLUSIONS: The IRA will reduce Medicare beneficiaries' out-of-pocket drug costs for the selected cardiovascular conditions by 8% to 87%. Future studies should assess the IRA's impact on adherence to guideline-directed cardiovascular therapies and health outcomes.

A Pilot Program to Teach Pharmacy Students Practical Skills to Navigate Drug Insurance Benefits.

Pharmacists must be able to navigate prescription drug coverages to help providers and patients reduce out-of-pocket costs. Traditionally, curricula on drug insurance benefits rely on lectures and lack a practicum that offers students hands-on experience with determining formulary and cost-sharing information. An activity for pharmacy students to update a free public website that summarizes formularies and copayment requirements across major insurers was piloted. Pharmacy students were trained to locate online formularies and identify a drug's coverage tier, step therapy, prior authorization, and cost-sharing during a 6-week experiential rotation. Students checked formularies from six insurance plans for 250-plus drugs across 15 health conditions. Graduates were surveyed (74% response rate) about the activities' impact on their learning and ability to navigate drug benefits. Respondents rated the training as helpful in learning whether a drug was covered (100%), or required step therapy or prior authorization (100%). The majority of graduates reported being able to look up formulary coverage (90%), step therapy or prior authorization (90%), and copayment requirements (65%). Our innovative skills-based pilot activity was effective in teaching pharmacy students to navigate insurance formularies, which is essential for helping patients access medications.

Patients' Compliance With Quarantine Requirements for Exposure or Potential Symptoms of COVID-19.

Reducing Coronavirus disease 2019 (COVID-19) transmission relies on people quarantining after exposure to COVID-19 or if they experience COVID-19 symptoms, and isolating from others if COVID-19 positive. Quarantine and isolation last 10 to 14 days and can be state-mandated; however, the level of compliance is unknown. The University of Hawai'i Department of Family Medicine clinic called patients instructed by our physicians to quarantine for exposure risk or symptoms of potential COVID-19 infection between March 15, 2020, and April 15, 2020. None of the patients tested positive for COVID-19. Sixty-nine of 90 (77%) patients completed follow-up calls and self-reported whether they had stayed home. Of these 69 patients, 32 (46%) broke quarantine to buy groceries (36%), work (9%), visit others (6%), or for other reasons (12%). For patients living alone, 8 of 11 (73%) left home to buy groceries. For employed patients, 6 of 39 (15%) returned to work during their quarantine period. Nearly half of our patients did not quarantine for the entire period. Many persons left home to buy food or to work. Strong public health messaging is needed to educate communities about the requirement to quarantine. Clinicians can help by asking patients about social and financial ability to quarantine, schedule follow-up appointments to remind patients to stay home, and link patients to food programs, financial assistance, and other community resources to successfully quarantine and prevent COVID-19 transmission.

Association Between Industry Marketing Payments and Prescriptions for PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) Inhibitors in the United States.

BACKGROUND: Marketing payments from the pharmaceutical industry to physicians have come under scrutiny due to their potential to influence clinical decision-making. Two proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) were approved by the US Food and Drug Administration in 2015 for reducing low-density lipoprotein cholesterol in high-risk patients, but their initial uptake was limited due to their high-cost and stringent prior authorization requirements. We sought to investigate the association between industry marketing and early adoption of PCSK9i among US physicians. METHODS: We used nationwide databases of primary care physicians, cardiologists, and endocrinologists treating Medicare beneficiaries to examine the association between PCSK9i-related marketing payments in 2016 and the number of filled PCSK9i prescriptions in 2017, after adjusting for physician characteristics. In subgroup analyses, we stratified our analyses by physician specialty and prior experience with prescribing PCSK9i. RESULTS: Among 209 840 physicians included in this analysis, 49 341 (24%) physicians received 292 941 PCSK9i-related marketing payments in 2016. The total value of these payments was $19 million, with a median payment of $61 per physician (interquartile range, $25-$132). Most payments (95%) were for meals, with a median of $14 per meal. The receipt of PCSK9i-related payments in 2016 was associated with increased PCSK9i prescription in 2017 (adjusted risk ratio, 3.18 [95% CI, 2.95-3.42]). This association was larger among primary care physicians (adjusted risk ratio, 6.67 [95% CI, 5.87-7.57]) than cardiologists (adjusted risk ratio, 2.00 [95% CI, 1.84-2.16]) and endocrinologists (adjusted risk ratio, 4.06 [95% CI, 2.95-5.59]). The association was observed across all types of payments. CONCLUSIONS: At a time when few physicians had experience with prescribing PCSK9i under strict prior authorization requirements, industry marketing payments to physicians for PCSK9i, predominantly in the form of meals, were associated with increased PCSK9i prescription in the subsequent year.