Medicare Part B and Part D drug eligibility for center for Medicare and Medicaid Services price negotiation under the Inflation Reduction Act: estimates using 2016-2019 data.

Background: To reduce Medicare prescription drug expenditures, the 2022 Inflation Reduction Act (IRA) allows the Centers for Medicare & Medicaid Services (CMS) to directly negotiate with drug manufacturers on Medicare prices of high-expenditure drugs (≥$200m annual spending) which meet certain eligibility criteria. However, it is unclear what proportion of high-expenditure drugs covered by Medicare, and attributable annual drug spending, would typically be eligible for CMS negotiations in a given year. Methods: We used historical Medicare drug spending data to determine how many high-expenditure drugs, and attributable drug spending, would have been eligible for CMS negotiations had the IRA been in effect from 2016-2019, while also determining which of the IRA's eligibility criteria is most restrictive. Results: From 2016-2019, approximately one third (33.3% for Part B, 32.4% for Part D) of high-expenditure Medicare drugs would have been eligible for negotiation, with ineligible drugs accounting for 75.2% and 63.8% of spending on high-expenditure drugs in Medicare Part B and D, respectively. Most ineligible high-expenditure drugs were ineligible because they launched too recently. From 2016-2019, between 59 and 74 high-expenditure drugs were eligible per year, indicating that in some years there may not be enough eligible drugs for CMS to negotiate on the maximum number of drugs allowable by law. Conclusions: The IRA's current eligibility criteria may restrict CMS from being able to negotiate drug prices on approximately two-thirds of the high-expenditure drugs covered by Medicare and may not allow CMS to negotiate on the maximum number of drugs allowable by law. Congress could consider relaxing eligibility requirements for price negotiation, such as those pertaining to launch date recency, to ensure there are a sufficient number of high-expenditure drugs eligible for negotiation or make certain ineligible drugs contributing to significant annual Medicare spending eligible for negotiation on a case-by-case basis.

Lessons From Insulin: Policy Prescriptions for Affordable Diabetes and Obesity Medications.

Escalating insulin prices have prompted public scrutiny of the practices of drug manufacturers, pharmacy benefit managers, health insurers, and pharmacies involved in production and distribution of medications. As a result, a series of policies have been proposed or enacted to improve insulin affordability and foster greater equity in access. These policies have implications for other diabetes and obesity therapeutics. Recent legislation, at both the state and federal level, has capped insulin out-of-pocket payments for some patients. Other legislation has targeted drug manufacturers directly in requiring rebates on drugs with price increases beyond inflation rates, an approach that may restrain price hikes for existing medications. In addition, government negotiation of drug pricing, a contentious issue, has gained traction, with the Inflation Reduction Act of 2022 permitting limited negotiation for certain high expenditure drugs without generic or biosimilar competition, including some insulin products and other diabetes medications. However, concerns persist that this may inadvertently encourage higher launch prices for new medications. Addressing barriers to competition has also been a priority such as through increased enforcement against anticompetitive practices (e.g., "product hopping") and reduced regulatory requirements for biosimilar development and market entry. A novel approach involves public production, exemplified by California's CalRx program, which aims to provide biosimilar insulins at significantly reduced prices. Achieving affordable and equitable access to insulin and other diabetes and obesity medications requires a multifaceted approach, involving state and federal intervention, ongoing policy evaluation and refinement, and critical examination of corporate influences in health care.

Medical Product Industry Ties to Patient Advocacy Organizations' Executive Leadership.

This cross-sectional study examines the ties between pharmaceutical and medical device industries and the executive leadership of the 50 highest-revenue US-based patient advocacy organizations.

Financial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices.

This study reviewed public comments for all Medicare National Coverage Determinations between June 2019 and 2022 on select pulmonary and cardiac devices to determine whether financial conflicts of interest were disclosed.

Financial conflicts of interest among US physician authors of 2020 clinical practice guidelines: a cross-sectional study.

OBJECTIVE: To evaluate the prevalence and accuracy of industry-related financial conflict of interest (COI) disclosures among US physician guideline authors. DESIGN: Cross-sectional study. SETTING: Clinical practice guidelines published by the Council of Medical Specialty Societies in 2020. PARTICIPANTS: US physician guideline authors. MAIN OUTCOME MEASURES: Financial COI disclosures, both self-reported and determined using Open Payments data. RESULTS: Among 270 US physician authors of 20 clinical practice guidelines, 101 (37.4%) disclosed industry-related financial COIs, whereas 199 (73.7%) were found to have received payments from industry when accounting for payments disclosed through Open Payments. The median payments received by authors during the 3-year period was US$27 451 (IQR, US$1385-US$254 677). Comparing authors' self-disclosures with Open Payments, 72 (26.7%) of the authors accurately disclosed their financial COIs, including 68 (25.2%) accurately disclosing no financial COIs and 4 (1.5%) accurately disclosing a financial COI. In contrast, 101 (37.4%) disclosed no financial COIs and were found to have received payments from industry, 23 (8.5%) disclosed a financial COI but had under-reported payments received from industry, 14 (5.2%) disclosed a financial COI but had over-reported payments received from industry and 60 (22.2%) disclosed a financial COI but were found to have both under-reported and over-reported payments received from industry. We found that inaccurate COI disclosure was more frequent among professors compared with non-professors (81.9% vs 63.5%; p<0.001) and among males compared with females (77.7% vs 64.8%; p=0.02). The accuracy of disclosures also varied among medical professional societies (p<0.001). CONCLUSIONS: Financial relationships with industry are common among US physician authors of clinical practice guidelines and are often not accurately disclosed. To ensure high-quality guidelines and unbiased recommendations, more effort is needed to minimise existing COIs and improve disclosure accuracy among panel members.

If Left Unchecked: Lessons Learned from Unfettered U.S. Government Support of the NIH-Moderna Vaccine.

The NIH-Moderna mRNA COVID-19 vaccine's steep price increase raises concerns that this will be the new anchor for continued price hikes and underscores the need for upstream government intervention to enable greater accountability and stewardship of public biomedical research investment.

Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017.

Importance: Accelerated approval by the US Food and Drug Administration (FDA) grants market authorization for drugs based on clinical trials using surrogate end points likely to anticipate a clinical benefit. The FDA requires postapproval trials to confirm benefit, after which the accelerated approval is converted to a standard approval or is withdrawn. However, trials frequently fail to assess clinical benefit, and expenditure for these drugs may be substantial. Objective: To evaluate spending by the Centers for Medicare & Medicaid Services (CMS) on drugs granted FDA accelerated approval before and after confirmation of benefit. Design and Setting: This was a cross-sectional study of CMS spending on drugs granted FDA accelerated approval for original indications from 2012 to 2017, with follow-up through 2020. Using data from the Drugs@FDA database and a validated methodology, the characteristics of new drugs granted FDA accelerated approval were identified and analyzed, including indication area, type of drug, type of confirmatory trial end point, orphan designation, number of supplemental indications, and conversion status. Main Outcomes and Measures: Overall and annualized spending by Medicare Parts B and D and Medicaid from 2012 to 2020, before and after conversion to standard approval. Analyses were conducted from June 30, 2021, to March 21, 2022. Results: From 2012 to 2017, the FDA granted accelerated approval to 38 drugs for 42 original indications. Through 2020, CMS spending for these drugs was $67.9 billion (median [IQR], $329.3 million [$54.4 million-$1.6 billion]). For 22 drugs (58%) that were converted to standard approval on the basis of clinical trial results, annualized spending increased substantially after conversion ($35.0 million vs $199.0 million), and spending after conversion accounted for $51.0 billion (75%) of overall spending. However, only 6 conversions (27%) of the 22 were supported by confirmatory trials evaluating clinical outcomes as primary end points. Drugs evaluated using surrogate end points accounted for $40.3 billion (59%) of CMS spending. Conclusions and Relevance: The findings of this cross-sectional study indicate that most of the drugs granted FDA accelerated approval for original indications from 2012 to 2017 lacked confirmatory trials evaluating clinical outcomes to support conversion to standard approval. Automatic coverage mandates produced substantial CMS spending for drugs with unproven clinical benefits.

Assessment of Hypothetical Out-of-Pocket Costs of Guideline-Recommended Medications for the Treatment of Older Adults With Multiple Chronic Conditions, 2009 and 2019.

IMPORTANCE: Most adults 65 years or older have multiple chronic conditions. Managing these conditions with prescription drugs can be costly, particularly for older adults with limited incomes. OBJECTIVE: To estimate hypothetical out-of-pocket costs associated with guideline-recommended outpatient medications for the initial treatment of 8 common chronic diseases among older adults with Medicare prescription drug plans (PDPs). DESIGN, SETTING, AND PARTICIPANTS: This retrospective cross-sectional study used 2009 and 2019 Medicare prescription drug plan formulary files to estimate annual out-of-pocket costs among hypothetical patients enrolled in Medicare Advantage or stand-alone Medicare Part D plans. A total of 3599 PDPs in 2009 and 3618 PDPs in 2019 were included after inclusion and exclusion criteria were applied. Costs associated with guideline-recommended medications for 8 of the most common chronic diseases (atrial fibrillation, chronic obstructive pulmonary disease [COPD], heart failure with reduced ejection fraction, hypercholesterolemia, hypertension, osteoarthritis, osteoporosis, and type 2 diabetes), alone and in 2 clusters of commonly comorbid conditions, were examined. MAIN OUTCOMES AND MEASURES: Annual out-of-pocket costs for each chronic condition, inflation adjusted to 2019 dollars. RESULTS: Among 3599 Medicare PDPs in 2009, 1998 were Medicare Advantage plans and 1601 were stand-alone plans; among 3618 Medicare PDPs in 2019, 2719 were Medicare Advantage plans and 899 were stand-alone plans. For an older adult enrolled in any Medicare PDP in 2019, the median annual out-of-pocket costs for individual conditions varied, from a minimum of $32 (IQR, $6-$48) for guideline-recommended management of osteoporosis (a decrease from $128 [IQR, $102-$183] in 2009) to a maximum of $1579 (IQR, $1524-$2229) for guideline-recommended management of atrial fibrillation (an increase from $91 [IQR, $73-$124] in 2009). For an older adult with a cluster of 5 commonly comorbid conditions (COPD, hypertension, osteoarthritis, osteoporosis, and type 2 diabetes) enrolled in any PDP, the median out-of-pocket cost in 2019 was $1999 (IQR, $1630-$2564), a 12% decrease from $2284 (IQR, $1920-$3107) in 2009. For an older adult with all 8 chronic conditions (atrial fibrillation, COPD, diabetes, hypercholesterolemia, heart failure, hypertension, osteoarthritis, and osteoporosis) enrolled in any PDP, the median out-of-pocket cost in 2019 was $3630 (IQR, $3234-$5197), a 41% increase from $2571 (IQR, $2185-$3719) in 2009. CONCLUSIONS AND RELEVANCE: In this cross-sectional study, out-of-pocket costs for guideline-recommended outpatient medications for the initial treatment of 8 common chronic diseases varied by condition. Although costs generally decreased between 2009 and 2019, particularly with regard to conditions for which generic drugs were available, out-of-pocket costs remained high and may have presented a substantial financial burden for Medicare beneficiaries, especially older adults with conditions for which brand-name drugs were guideline recommended.

The updated AMSA scorecard of conflict-of-interest policies: a survey of U.S. medical schools.

BACKGROUND: Best practices for conflict-of-interest (COI) policies in medical schools have evolved rapidly over the past decade, in part motivated by the American Medical Student Association (AMSA) scorecard that has publicly graded schools since 2007. This report describes the methodological update and impact of revisions to the scorecard in 2014. METHODS: The original AMSA scorecard (used annually from 2008 to 2013) was revised by a work group to improve its methodology and to increase the stringency of its criteria for scoring COI policies. All U.S. medical schools (both allopathic and osteopathic; n = 160) were invited to submit their COI policies to AMSA for scoring with the new scorecard; web site searches were used to acquire policy information for schools that did not submit. The authors developed a codebook and analyzed 14 distinct categories of COI policies, pertaining to activities such as industry-funded gifts, meals, educational events, site access for sales reps, and conflict-of-interest disclosure requirements. The analysis yielded four possible grades for each school: A, B, C, or I (incomplete). The authors compared 2014 grades with 2013 grades, and compared the distribution of grades of schools by type (allopathic vs. osteopathic) and geographical region. RESULTS: A total of 27 (16.9 %) medical schools scored A grades, indicating that their COI policies were strong, 81 (50.6 %) scored B, 25 (15.6 %) scored C and 26 (16.3 %) policies scored I. As compared to 2013, in 2014 fewer schools qualified for A grades (17.0 % vs. 26.0 %; p = 0.05). The grade distributions of allopathic and osteopathic schools were significantly different (p < 0.0001), with osteopathic schools more likely than allopathic schools to have incomplete policies. There were no significant grade differences by geographical region. CONCLUSIONS: The revised 2014 AMSA scorecard, with its more stringent criteria for evaluating COI policies, assigned fewer As and more Bs and Cs than in years past. This was the first study to identify schools with COI policies stronger than those recommended in 2008 by the Association of American Medical Colleges. Developing more stringent COI policies should be helpful in reducing the influence of pharmaceutical and device industry marketing on both trainees and faculty in American medical schools.