Looking to the Future of AI in Healthcare
Artificial Intelligence (AI) is increasingly being incorporated into every aspect of society, including healthcare. From diagnostics to reimbursement, AI is taking a foothold in healthcare and medicine from drug development to the clinic. However, significant barriers to realizing the potential of the technology still remain.
Study Explores Real-World Data Reporting Quality According to RECORD Statement
With the rise of real-world data (RWD) and real-world evidence (RWE), a lack of transparency impairs reproducibility and quality assessment. The Reporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement was drafted to help address this issue. A newly published study in BMC Medical Research Methodology explores reporting quality in RWD studies using the RECORD checklist.
Tips for Managed Care to Approach Value-Based Care
The shift towards value-based care has the potential to benefit patients, providers, and payers alike, but it brings about unique challenges for managed care plans. In a new Managed Healthcare Executive article, learn more about value-based care payment models and strategies to apply them successfully in managed care organizations.
EMA Releases Report on Real-World Evidence
The European Medicines Agency published a report last week discussing the use of real-world evidence (RWE) in clinical trials and regulatory decisionmaking, the benefits it can provide, and the challenges in doing so. RWE, according to the report, is widely used in pharmacovigilance studies, but its use in early drug development still faces uncertainties.
From Analysis to Action: Exploring Health Equity with Aletha Maybank
In a new interview with Nature, senior vice president and chief health equity officer at the American Medical Association (AMA) Aletha Maybank, MD, MPH, speaks about her work analyzing the processes underlying health disparities and how they can be targeted to promote better outcomes in marginalized populations.
New Real-World Evidence from AstraZeneca Finds Medication Discontinuation Worsens Hyperkalemia
New real-world evidence (RWE) presented at this year’s European Renal Association Congress explored hypokalemia care, finding that reduction or discontinuation of renin-angiotensin-aldosterone system inhibitor (RAASi) worsens outcomes of patients admitted for hyperkalemia (HK), high calcium levels in blood. RWE from the ZORA study shows that few patients have their RAASi medications reinitiated after a hyperkalemia event, which is associated with a two times increase in mortality.
The hēRo3 Revolution: Accelerating and Empowering HEOR Analytics with Cutting-Edge Digital Solutions
In this interview with Chad Rose, General Manager of hēRo3, he explains how biopharma is incorporating critical HEOR insights [...]
How New CMS Rules to Cut Appointment Wait Times Will Affect Managed Care
Research shows that new patients have to wait an average of 26 days for an appointment in 15 major US cities. To tackle this problem, the Centers for Medicare and Medicaid Services (CMS) recently proposed a rule entitled the Notice of Proposed Rulemaking Managed Care Access, Finance, and Quality (NPRM). The NPRM would cap appointment wait times for primary care, mental health, and substance use disorder treatment.
First Lawsuit Against US Medicare Drug Pricing Negotiations Filed by Merck
The pharma giant Merck & Co has filed a lawsuit against the US government over upcoming Medicare drug pricing negotiations included in the Inflation Reduction Act passed last year. The company argues that the negotiations would violate their 5th Amendment rights by forcing them to provide drugs at prices lower than market value.
Over 500,000 Disenrolled from Medicaid After COVID-19 PHE Ends
Shortly following the end of the COVID-19 public health emergency, pandemic-era restrictions on Medicaid redetermination ended. In that time, over 500,000 people have been disenrolled, interrupting their coverage and impacting their access to healthcare. Some states have kicked off more beneficiaries than others, with Florida taking the lead.
Part D Out-of-Pocket Prescription Drug Price Cap Will Help New Part D Recipients
A newly published study in JAMA Health Forum found that new Medicare Part D price caps on out-of-pocket prescription drug costs will help new beneficiaries switching from commercial plans. The study found that the $2000 price cap in the provision, included in the Inflation Reduction Act, would save people switching from commercial plans to Part D.
Transgender Adults Stripped of Transition Care in Florida
Florida governor Ron DeSantis recently signed a bill into law that, at least for now, strips transgender adults of their right to access gender transition care, including all hormones, gender transition appointments, and surgical operations. The law only allows adults to maintain their transition care if they fill out an informed consent form that the state has yet to publish or give any intimation of when it will be released. The law also allows any care provider to turn away LGBTQ patients for any reason without recourse.
Federal Appeals Court Keeps ACA Preventative Care Rules in Place
A US Federal appeals court has issued a stay on a lower court’s ruling that would gut the preventative care requirements in the Affordable Care Act. If not paused, the lower court’s ruling would end the requirements for payers to cover preventative care services like physicals, Pap tests, cancer screenings, and pre-exposure prophylaxis (PrEP) for HIV.
ICER Announces Upcoming Value-Assessment for Pulmonary Arterial Hypertension Treatment
The Institute for Clinical and Economic Review (ICER) has announced it will perform a value-assessment for Merck’s sotatercept for the treatment of pulmonary arterial hypertension. The organization has been in talks with patient groups, clinical specialists, manufacturers, and patient advocates and will present its report at the Midwest CEPAC meeting this coming December.
Bipartisan US PBM Reform Bill Moves Forward
A bipartisan bill including reforms to the Food and Drug Administration (FDA) and the pharmacy benefit manager (PBM) industry has been advanced by the US Senate Health, Education, Labor, and Pensions committee. The bill, approved with an 18-3 vote, picked up several amendments in the mark-up session before it was advanced.
PBMs and Pharma Leaders Point Fingers During US Senate HELP Committee
At yesterday’s US Senate Health, Education, Labor, and Pensions (HELP) Committee hearing, representatives from pharma and the pharmacy benefit manager (PBM) industry are blaming one another for high prescription drug prices. While PBMs argue that drugmakers could lower list prices on their own, pharma reps argue that PBMs’ practices drive drug prices up.
Pharma Prepares for Legal Battle Over US Drug Price Reform
As the upcoming Medicare drug pricing negotiations loom large over the industry, pharma companies are preparing to challenge the government in court. One sticking point for the companies is that they aren’t allowed to talk about negotiations, facing heavy fines for any infractions. Another issue is how drugs to be negotiated are chosen.
CMS Issues Final Rule on Medicare Advantage Prior Authorization Requirements
The US Centers for Medicare and Medicaid Services (CMS) has issued its final rule on prior authorization requirements for Medicare Advantage (MA) plans. The rule changes ensure that prior authorization approvals last as long as medically necessary, that plans must only use prior authorization policies to check diagnoses, and that plans must give beneficiaries a 90-day transition period when changing plans.
FDA Approves First Ever RSV Vaccine by GSK
For the first time ever, a vaccine for respiratory syncytial virus (RSV) has been approved by the US Food and Drug Administration (FDA). GSK’s vaccine, named Arexvy, is now approved for adults over 60 years of age based on strong data showing it reduced infections and severe cases of the disease. The move comes as an RSV candidate from Pfizer faces an imminent decision.
PRMA Launches MALCOM HEOR and Market Access E-Learning Platform
Health economics and outcomes research (HEOR) and market access experts require in-depth knowledge and a finger on the pulse of the latest trends to keep up in this constantly shifting field. To this goal, PRMA Consulting has launched the Market Access Learning Compendium (MALCOM), an e-learning platform packed with educational resources that cover all aspects of HEOR and market access, from core concepts to industry-shaping current events.
US PBM Bill Markup Hearing Postponed Until May 11th
US Senators were geared up for a hearing to markup a bill targeting practices of the pharmacy benefit manager (PBM) industry that are alleged to be anticompetitive and drive up drug prices. However, this meeting has been delayed until May 11th so that the markup can occur after a May 10th hearing featuring testimony from major pharma and PBM leaders.
US Senators Weighing Approaches to Lowering Insulin Prices for All
As US Senators continue to debate over plans to lower insulin prices for all Americans, two bills have taken the forefront. One, by Sen. Susan Collins (R-ME) and Sen. Jeanne Shaheen (D-NH) would cap monthly cost-sharing at 25% of list price or $35. It would also force pharmacy benefit managers (PBMs) to make sure 100% of manufacturer rebates and discounts go to payers.
Medicaid Redetermination Process to Take Coverage from Millions of Children
With the COVID-19 public health emergency on its way out, states are set to start up the redetermination for Medicaid beneficiaries. Among the millions who will lose healthcare coverage in this process are children, who make up the majority of Medicaid recipients. The number of children to be dropped is still uncertain, but it is estimated to be around 1/3 of kids on the program.
Integrating Behavioral Health and Primary Care Through Value-Based Payment Models
To improve patient mental health outcomes and reduce healthcare costs, behavioral health needs to move to a value-based payment model and be better integrated into primary care. However, significant hurdles stand in the way. Payers could play a pivotal role in addressing the problem, but this will require careful cooperation with providers.
US Senate Finance Committee Unveils Plan to Regulate PBMs
A group of US senators in the Senate Finance Committee have released their plan to implement regulation targeting the pharmacy benefit manager (PBM) industry. The plan proposes changing how PBMs get compensated for drug sales, increasing transparency, and holding them financially and legally accountable for violations.
