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.
US Supreme Court Extends Mifepristone Access Temporarily with 2-Day Pause on Lower Court Ruling
The US Supreme Court has issued a 2-day pause on a lower ruling that would revoke the decades-old approval of mifepristone, a key component of the abortion pill. The stay would end at midnight this Friday, April 21st. The ruling has drawn substantial criticism, not the least of which is that allowing a judge to overturn approval by the US Food and Drug Administration (FDA) would undermine the agency’s authority to regulate medications.
ICER Issues Final Report on Alzheimer’s Drug Leqembi
Following a session of public comments, the Institute for Clinical and Economic Review (ICER) has issued its final evidence report on Eisai’s Alzheimer’s drug Leqembi (lecanemab). The independent organization valued the treatment between $8,900 - $21,500 per year. This is notably lower than the current list price of $26,500 per year set by the manufacturer.
Danco Laboratories and DOJ ask for US Supreme Court Action on Conflicting Mifepristone Rulings
Both the US Department of Justice (DOJ) and the mifepristone distributor Danco Laboratories have called upon the US Supreme Court to act quickly to hold back the effects of dueling federal court cases regarding the drug. The Fifth Circuit Court of Appeals temporarily paused last week’s ruling that mifepristone, a key drug used in the abortion pill, was inappropriately approved. Although mifepristone can stay on the market for now, expanded access to the drug would be cut, putting manufacturers and the FDA in conflict with another ruling last Friday.
US Senators Looking to Make Changes to Upcoming Legislation on Generics and PBMs
US Senators Bernie Sanders (I-VT) and Bill Cassidy (R-LA) are looking to April 19th when they can start deliberating on changes to an upcoming piece of legislation about generic drugs and the pharmacy benefit manager (PBM) industry. The bipartisan effort comes after increasing public and congressional pressure on PBMs and drug prices.
US Senators Propose Bill to Cap Insulin Costs for Every Patient
US Senators Raphael Warnock (D-GA) and John Kennedy (R-LA) have advanced a new bill that would lock the max price of insulin at $35 a month for all patients. The bill, entitled the Affordable Insulin Now Act of 2023, comes after manufacturers have voluntarily lowered insulin prices following price caps for Medicare patients in the Inflation Reduction Act.
28 US States Will See Medicaid Enrollment Drop to Near Pre-Pandemic Levels
Just as US states begin the Medicaid redetermination process, a new report by Moody’s Investors Services finds that 28 states will see enrollment drop to numbers equivalent to pre-pandemic levels. Some states, the report notes, will settle on enrollment levels higher than those seen before the pandemic-era Medicaid redetermination pause.
