Changes in Use of Hepatitis C Direct-Acting Antivirals After Access Restrictions Were Eased by State Medicaid Programs.

Importance: Direct-acting antivirals (DAAs) are safe and highly effective for curing hepatitis C virus (HCV) infection, but their high cost led certain state Medicaid programs to impose coverage restrictions. Since 2015, many of these restrictions have been lifted voluntarily in response to advocacy or because of litigation. Objective: To estimate how the prescribing of DAAs to Medicaid patients changed after states eased access restrictions. Design, Setting, and Participants: This modified difference-in-differences analysis of 39 state Medicaid programs included Medicaid beneficiaries who were prescribed a DAA from January 1, 2015, to December 31, 2019. DAA coverage restrictions were measured based on a series of cross-sectional assessments performed from 2014 through 2022 by the US National Viral Hepatitis Roundtable and the Center for Health Law and Policy Innovation. Exposure: Calendar quarter when states eased or eliminated 3 types of DAA coverage restrictions: limiting treatment to patients with severe liver disease, restricting use among patients with active substance use, and requiring prescriptions to be written by or in consultation with specialists. States with none of these restrictions at baseline were excluded. Main Outcomes and Measures: Quarterly number of HCV DAA treatment courses per 100 000 Medicaid beneficiaries. Results: Of 39 states, 7 (18%) eliminated coverage restrictions, 25 (64%) eased restrictions, and 7 (18%) maintained the same restrictions from 2015 to 2019. During this period, the average quarterly use of DAAs increased from 669 to 3601 treatment courses per 100 000 Medicaid beneficiaries. After states eased or eliminated restrictions, the use of DAAs increased by 966 (95% CI, 409-1523) treatment courses per 100 000 Medicaid beneficiaries each quarter compared with states that did not ease or eliminate restrictions. Conclusions and Relevance: The results of this study suggest that there was greater use of DAAs after states relaxed coverage restrictions related to liver disease severity, sobriety, or prescriber specialty. Further reductions or elimination of these rules may improve access to a highly effective public health intervention for patients with HCV.

Availability and Cost of Expensive and Common Generic Prescription Drugs: A Cross-sectional Analysis of Direct-to-Consumer Pharmacies.

BACKGROUND: Direct-to-consumer (DTC) pharmacies sell generic prescription drugs, often at lower prices than traditional retail pharmacies; however, not all drugs are available, and prices vary. OBJECTIVE: To determine the availability and cost of generic drugs at DTC pharmacies. DESIGN: Cross-sectional study. SETTING: Five national DTC pharmacies in April and May 2023. PARTICIPANTS: Each qualifying form of 100 generic drugs with the highest cost-per-patient (expensive) and the 50 generic drugs with the highest number of patients (common) in Medicare Part D in 2020 MAIN MEASURES: Availability of these drugs and the lowest DTC pharmacy price for a standardized drug strength and supply (e.g., 30 pills), compared to GoodRx retail pharmacy prices. KEY RESULTS: Of the 118 expensive generic dosage forms, 94 (80%) were available at 1 or more DTC pharmacies; out of 52 common generic dosage forms, 51 (98%) were available (p < 0.001). Of the 88 expensive generics available in comparable quantities and strengths across pharmacies, 42 (47%) had the lowest cost at Amazon, 23 (26%) at Mark Cuban Cost Plus Drug Company, 13 (14%) at Health Warehouse, and 12 (13%) at Costco; for 51 common generic formulations, 16 (31%) had the lowest cost at Costco, 14 (27%) at Amazon, 10 (20%) at Walmart, 6 (12%) at Health Warehouse, and 5 (10%) at Mark Cuban Cost Plus Drug Company. For the 77 expensive generics with available GoodRx retail pharmacy prices, the median cost savings at DTC pharmacies were $231 (95% CI, $129-$792) or 76% (IQR, 53-91%); for 51 common generics, savings were $19 (95% CI, $10-$34) or 75% (IQR, 67-83%). CONCLUSIONS: Many of the most expensive generic drugs are unavailable at direct-to-consumer pharmacies. Meanwhile, less expensive, commonly used generics are widely available, but drug prices vary by pharmacy and savings are modest, requiring patients to shop around for the lowest cost.

Association between changes in prices and out-of-pocket costs for brand-name clinician-administered drugs.

OBJECTIVE: To determine whether annual changes in prices for clinician-administered drugs are associated with changes in patient out-of-pocket costs. DATA SOURCES AND STUDY SETTING: National commercial claims database, 2009 to 2018. STUDY DESIGN: In a serial, cross-sectional study, we calculated the annual percent change in manufacturer list prices and net prices after rebates. We used two-part generalized linear models to assess the relationship between annual changes in price with (1) the percentage of individuals incurring any out-of-pocket costs and (2) the percent change in median non-zero out-of-pocket costs. DATA COLLECTION/EXTRACTION METHODS: We created annual cohorts of privately insured individuals who used one of 52 brand-name clinician-administered drugs. PRINCIPAL FINDINGS: List prices increased 4.4%/yr (interquartile range [IQR], 1.1% to 6.0%) and net prices 3.3%/yr (IQR, 0.3% to 5.5%). The median percentage of patients with any out-of-pocket costs increased from 38% in 2009 to 48% in 2018, and median non-zero annual out-of-pocket costs increased by 9.6%/yr (IQR, 4.1% to 15.4%). There was no association between changes in prices and out-of-pocket costs for individual drugs. CONCLUSIONS: From 2009 to 2018, prices and out-of-pocket costs for brand-name clinician-administered drugs increased, but these were not directly related for individual drugs. This may be due to changes to insurance benefit design and private insurer drug reimbursement rates.

Identifying therapeutic alternatives in Medicare drug price negotiation: The case of etanercept.

As the Centers for Medicare & Medicaid Services (CMS) navigates the process of negotiating drug prices, it plans to compare the cost, safety, and effectiveness of each drug with its therapeutic alternatives. How CMS selects therapeutic alternatives is a consequential decision, and there remains uncertainty about their methodology. To understand the challenges CMS will face in selecting therapeutic alternatives, we developed a methodology that leverages clinical guidelines by US medical professional associations to identify potential therapeutic alternatives for etanercept, one of the first 10 drugs selected for Medicare price negotiation. For each of etanercept's 5 US Food and Drug Administration-approved indications, we identified all drugs with the same mechanism of action as etanercept and considered drugs with different mechanisms if they were recommended in place of etanercept at the same treatment stage, or if there was no strong comparative safety or effectiveness evidence that the drug differed from etanercept. We identified 22 potential therapeutic alternatives to etanercept, including 4 drugs with the same mechanism, 10 biologics with different mechanisms, and 8 small-molecule drugs. We faced several challenges in selecting therapeutic alternatives using clinical guidelines, such as how to reconcile strong recommendations that were based on weak evidence and how to consider combination therapies. This exercise demonstrates the complex considerations that CMS will face as it negotiates drug prices based on therapies' cost, safety, and effectiveness relative to therapeutic alternatives.

Administrative action on drug pricing: Lessons and opportunities for the Center for Medicare and Medicaid Innovation.

BACKGROUND: In October 2022, the Biden administration issued an executive order to the Center for Medicare and Medicaid Innovation (CMMI) to develop new health care payment and delivery models to lower prescription drug costs and promote access to innovative therapies. In response, the agency proposed 3 novel drug payment models for testing. OBJECTIVE: To understand the impact that CMMI demonstration projects can have on the prescription drug market. METHODS: We examined each of the models listed on the CMMI website and searched the Federal Register and news articles for additional models that contained interventions related to patient out-of-pocket drug costs, Medicare drug spending, or Medicaid drug spending. We excluded models with indirect effects on drug costs (for example, bundled payments). We comprehensively reviewed all previous cases in which CMMI has attempted models addressing prescription drug costs and spending and evaluated the circumstances, impact, and lessons learned that may aid policymakers in the design and implementation of new models. RESULTS: We identified 9 CMMI models containing direct interventions related to drug costs. Among prior models addressing drug prices, nearly half (44%, 4/9) were not implemented because of their scope, voluntary nature, and procedural challenges. No implemented models met the CMMI standard for expansion, although key elements of the Senior Savings model limiting monthly insulin costs to $35 were later incorporated into the Inflation Reduction Act. CONCLUSIONS: In future CMMI implementation efforts, we suggest maximizing voluntary collaboration when selection bias concerns are minimal, using mandatory models when not, ensuring that the geographic scope is not overly ambitious, and adhering closely to statutory authority and established administrative procedure to minimize legal challenges and maximize model demonstration utility.

Trainee-Led Intervention to Motivate Resident Physician Voter Registration.

This quality improvement study describes a trainee-led intervention to improve resident physician voter registration for national elections.

Addressing Viral Medical Rumors and False or Misleading Information.

The rapid spread of medical rumors and false or misleading information on social media during times of uncertainty is a vexing challenge that threatens public health. Understanding the information ecosystem, social media networks, and the scope of incentives that drive users and social media platforms can provide critical insights for strong coordination between stakeholders and funders to address this challenge. The COVID-19 pandemic created an opportunity to demonstrate the role of media monitoring and counter-messaging efforts in responding to dangerous medical rumors, misinformation, and disinformation. It also highlighted the challenges. The efforts of ThisIsOurShot and VacunateYa to spread accurate health information about COVID-19 and COVID-19 vaccines are described and lessons learned are discussed. These lessons include the need for substantial financial investments at the local and national levels to sustain and scale these types of programs. Examples in other fields that offer a path forward include Information Sharing and Analysis Centers and Public Health Emergency Operations Centers. Understanding the scale and scope of what it takes to address viral medical rumors, misinformation, and disinformation in a networked information environment should inspire elected leaders to consider policy and regulatory reforms. Our transformed information ecosystem requires new public health infrastructure to address information that threatens personal safety and population health.

US public investment in development of mRNA covid-19 vaccines: retrospective cohort study.

OBJECTIVE: To estimate US public investment in the development of mRNA covid-19 vaccines. DESIGN: Retrospective cohort study. SETTING: Publicly funded science from January 1985 to March 2022. DATA SOURCES: National Institutes of Health (NIH) Report Portfolio Online Reporting Tool Expenditures and Results (RePORTER) and other public databases. Government funded grants were scored as directly, indirectly, or not likely related to four key innovations underlying mRNA covid-19 vaccines-lipid nanoparticle, mRNA synthesis or modification, prefusion spike protein structure, and mRNA vaccine biotechnology-on the basis of principal investigator, project title, and abstract. MAIN OUTCOME MEASURE: Direct public investment in research and vaccine development, stratified by the rationale, government funding agency, and pre-pandemic (1985-2019) versus pandemic (1 January 2020 to 31 March 2022). RESULTS: 34 NIH funded research grants that were directly related to mRNA covid-19 vaccines were identified. These grants combined with other identified US government grants and contracts totaled $31.9bn (£26.3bn; €29.7bn), of which $337m was invested pre-pandemic. Pre-pandemic, the NIH invested $116m (35%) in basic and translational science related to mRNA vaccine technology, and the Biomedical Advanced Research and Development Authority (BARDA) ($148m; 44%) and the Department of Defense ($72m; 21%) invested in vaccine development. After the pandemic started, $29.2bn (92%) of US public funds purchased vaccines, $2.2bn (7%) supported clinical trials, and $108m (<1%) supported manufacturing plus basic and translational science. CONCLUSIONS: The US government invested at least $31.9bn to develop, produce, and purchase mRNA covid-19 vaccines, including sizeable investments in the three decades before the pandemic through March 2022. These public investments translated into millions of lives saved and were crucial in developing the mRNA vaccine technology that also has the potential to tackle future pandemics and to treat diseases beyond covid-19. To maximize overall health impact, policy makers should ensure equitable global access to publicly funded health technologies.

Physician Knowledge and Attitudes Toward the Adoption of Peritoneal Dialysis in the Treatment of Patients With End-Stage Kidney Disease.

Introduction Hemodialysis (HD) is a significant contributor to Medicare spending. Peritoneal dialysis (PD) is a lower-cost dialysis modality with non-inferior clinical outcomes. Recent initiatives at the federal level have emphasized shifting dialysis from in-center to home modalities, namely, PD. Such policy has been slow to impact the distribution of HD and PD due to multiple barriers, including at the provider level. Previous research has characterized the role of patient knowledge gaps and preferences in the under-utilization of PD. We sought to understand physician knowledge and attitudes toward PD to elucidate provider-level barriers to PD adoption. Methods We conducted a 10-question survey assessing physician comfort level, perceived knowledge, and objective knowledge of HD and PD that was distributed among the internal medicine faculty at the University of Texas Southwestern Medical Center, Dallas, TX. The survey respondents included nephrologists and non-nephrologists. Demographic information of respondents was collected. Survey responses were summarized and stratified by medical specialty. All statistical tests used 0.05 as the statistical significance level. Results Among 391 survey recipients, there were 83 respondents (21.2%). The mean age of respondents was 43 and 54% were women. With regard to specialty, 88% of respondents were non-nephrologists and 12% were nephrologists. All respondents reported an increased level of comfort and experience caring for patients receiving HD compared to PD. Regardless of specialty, respondents had a high incorrect response rate with regard to contraindications to PD. While nephrologists reported high perceived knowledge regarding PD, objective assessments revealed knowledge gaps with regard to PD candidacy. Non-nephrologists reported lower perceived knowledge but scored better on objective knowledge assessments regarding medical contraindications to PD. Both specialty groups held misconceptions regarding psychosocial barriers to PD. Discussion This physician survey demonstrated overall decreased confidence in knowledge and experience in the care of patients receiving PD compared to HD. Knowledge assessments revealed discordance between perceived knowledge and objective knowledge with regard to contraindications to PD. These findings highlight ongoing misconceptions across medical specialties regarding the applicability of PD. These findings demonstrate the need for increased training on PD candidacy among nephrologists and non-nephrologists alike. These findings demonstrate the need for education and advocacy around PD for providers to effectively meet federal priorities advocating for shifting dialysis to the home. Conclusion This study demonstrates the impact of physician knowledge and attitudes toward PD in the under-utilization of PD as a dialysis modality. These findings demonstrate a need for increased provider education around PD candidacy and the benefits of shifting dialysis care to the home. Novel models of dissemination are needed to increase the adoption of PD and meet federal policy goals of shifting dialysis care to home-based modalities.

Trends in Utilization and Cost of Low-Density Lipoprotein Cholesterol-Lowering Therapies Among Medicare Beneficiaries: An Analysis From the Medicare Part D Database.

Importance: Low-density lipoprotein cholesterol (LDL-C)-lowering therapies are a cornerstone of prevention in atherosclerotic cardiovascular disease. With the introduction of generic formulations and the release of new therapies, including proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, contemporary Medicare utilization of these therapies remains unknown. Objective: To determine trends in utilization and spending on brand-name and generic LDL-C-lowering therapies and to estimate potential savings if all Medicare beneficiaries were switched to available therapeutically equivalent generic formulations. Design, Setting, and Participants: This cross-sectional study analyzed prescription drug utilization and cost trend data from the Medicare Part D Prescription Drug Event data set from 2014 to 2018 for LDL-C-lowering therapies. A total of 11 LDL-C-lowering drugs with 25 formulations, including 16 brand-name and 9 generic formulations, were included. Data were collected and analyzed from October 2019 to June 2020. Main Outcomes and Measures: Number of Medicare Part D beneficiaries, annual spending, and spending per beneficiary for all formulations. Results: The total number of Medicare Part D beneficiaries ranged from 37 720 840 in 2014 to 44 249 461 in 2018. The number of Medicare beneficiaries taking LDL-C-lowering therapies increased by 23% (from 20.5 million in 2014 to 25.2 million in 2018), while the associated Medicare expenditure decreased by 46% (from $6.3 billion in 2014 to $3.3 billion in 2018). Lower expenditure was driven by greater uptake of generic statin and ezetimibe and a concurrent rapid decline in the use of their brand-name formulations. Medicare spent $9.6 billion on brand-name statins and ezetimibe and could have saved $2.1 billion and $0.4 billion, respectively, if brand-name formulations were switched to equivalent generic versions when available. The number of beneficiaries using PCSK9 inhibitors since their introduction in 2015 has been modest, although use has increased by 144% (from 25 569 in 2016 to 62 476 in 2018) and total spending has increased by 199% (from $164 million in 2016 to $491 million in 2018). Conclusions and Relevance: Between 2014 and 2018, LDL-C-lowering therapies were used by 4.8 million more Medicare beneficiaries annually, with an associated $3.0 billion decline in Medicare spending. This cost reduction was driven by the rapid transition from brand-name formulations to lower-cost generic formulations of statins and ezetimibe. Use of PCSK9 inhibitions, although low, increased over time and could have broad implications on future Medicare spending.

Association of care management intensity with healthcare utilization in an all-condition care management program.

OBJECTIVES: To identify care needs among Medicaid and Medicare patients in an all-condition care management program involving case managers (CMs) and community health workers (CHWs), and to examine the relationship between intervention intensity and healthcare utilization. STUDY DESIGN: Retrospective longitudinal evaluation of managed care-hired CMs and CHWs based at 8 primary care sites participating in the Johns Hopkins Community Health Partnership (J-CHiP). METHODS: Patients at high risk for hospitalization were enrolled in J-CHiP. CMs provided care coordination and CHWs addressed barriers to care. Four program intensity categories were created: low CM-low CHW, low CM-high CHW, high CM-low CHW, and high CM-high CHW. We evaluated the adjusted relative risk (RR) of emergency department (ED) visits, hospitalizations, and 30-day hospital readmissions pre- and post enrollment in the program using CM documentation, electronic health record data, and insurance claims. RESULTS: Among 1408 Medicaid and 2196 Medicare patients, the predominant barriers to care were lack of transportation, unstable housing, medication payment, and healthy food access. Among Medicaid and Medicare patients, high CM-high CHW and high CM-low CHW intensities were associated with a higher adjusted risk of hospitalization and 30-day hospital readmission after program implementation compared with low CM-low CHW intensity. Among patients with low CM-high CHW intensity, Medicaid patients had a higher risk of readmission (RR, 1.47; P = .016) and Medicare patients had a higher risk of ED visit (RR, 1.33; P = .001) post program implementation. CONCLUSIONS: In this longitudinal evaluation of an all-condition, unstructured, managed care organization-led program, preprogram trajectories of healthcare utilization rates among patients increased rather than decreased after program implementation, especially among patients receiving the highest care management program intensity.

Association of the New Peer Group-Stratified Method With the Reclassification of Penalty Status in the Hospital Readmission Reduction Program.

Importance: Since the introduction of the Hospital Readmission Reduction Program (HRRP), readmission penalties have been applied disproportionately to institutions that serve low-income populations. To address this concern, the US Centers for Medicare & Medicaid introduced a new, stratified payment adjustment method in fiscal year (FY; October 1 to September 30) 2019. Objective: To determine whether the introduction of a new, stratified payment adjustment method was associated with an alteration in the distribution of penalties among hospitals included in the HRRP. Design, Setting, and Participants: In this retrospective cross-sectional study, US hospitals included in the HRRP for FY 2018 and FY 2019 were identified. Penalty status of participating hospitals for FY 2019 was determined based on nonstratified HRRP methods and the new, stratified payment adjustment method. Hospitals caring for the highest proportion of patients enrolled in both Medicare and Medicaid based on quintile were assigned to the low-socioeconomic status (SES) group. Exposures: Nonstratified and stratified Centers for Medicare & Medicaid payment adjustment methods. Main Outcomes and Measures: Net reclassification of penalties among all hospitals and hospitals in the low-SES group, in states participating in Medicaid expansion, and for 4 targeted medical conditions (acute myocardial infarction, heart failure, chronic obstructive pulmonary disease, and pneumonia). Results: Penalty status by both payment adjustment methods (nonstratified and stratified) was available for 3173 hospitals. For FY 2019, the new, stratified payment method was associated with penalties for 75.04% of hospitals (2381 of 3173), while the old, nonstratified method was associated with penalties for 79.07% (2509 hospitals), resulting in a net down-classification in penalty status for all hospitals by 4.03 percentage points (95% CI, 2.95-5.11; P < .001). For the 634 low-SES hospitals in the sample, the new method was associated with penalties for 77.60% of hospitals (492 of 634), while the old method was associated with penalties for 91.64% (581 hospitals), resulting in a net down-classification in penalty status of 14.04 percentage points (95% CI, 11.18-16.90; P < .001). Among hospitals that were not low SES (quintiles 1-4), the new payment method was associated with a small decrease in penalty status (1928 vs 1889; net down-classification, 1.54 percentage points; 95% CI, 0.38-2.69; P = .01). Among target medical conditions, the greatest reduction in penalties was observed among cardiovascular conditions (net down-classification, 6.18 percentage points; 95% CI, 4.96-7.39; P < .001). Conclusions and Relevance: The new, stratified payment adjustment method for the HRRP was associated with a reduction in penalties across hospitals included in the program; the greatest reductions were observed among hospitals in the low-SES group, lessening but not eliminating the previously unbalanced penalty burden carried by these hospitals. Additional public policy research efforts are needed to achieve equitable payment adjustment models for all hospitals.