US Congress Wants CMS to Up Telehealth Usage While Cutting Payments
The US Congress’s Medicare Payment Advisory Commission (MedPAC) has asked the Centers for Medicare and Medicaid Services (CMS) to ramp up telehealth utilization while, at the same time, cutting the payment rates associated with it. The request comes as the post-pandemic status of telehealth looks uncertain with policy changes following the recent end of the COVID-19 public health emergency.
Financial Pressure on Healthcare Systems Continues to Mount
With labor costs rising, decreased demand, and supply chain issues cropping up across the board, health systems faced financial difficulties in the past year. This is expected to get more pronounced over the coming years, despite consumer inflation outpacing inflation in healthcare prices. Changes in patient usage are further contributing to cost increases.
Drug Prices from Major Brand Names Dropped ~50% Last Year
According to new data released by the Drug Channels Institute, brand-name drug prices from 10 key manufacturers dropped by half last year after discounts and rebates were accounted for. The manufacturers include Eli Lilly, Johnson & Johnson, Novo Nordisk. Much of the savings, however, have gone to pharmacy benefit managers.
Renting Associated with Worse Health Outcomes in Older People
According to newly published research, older people who rent have worse health outcomes than those who own a home. The study finds that older renters also are less likely to have medical cards, exacerbating their health costs. This issue is only growing more pressing as rising rent prices further sap the finances of older people who often live on fixed incomes.
Exploring the Impact of New Standardized Real-World Evidence Quality Assessment Tool
Difficulties in assessing the quality of real-world evidence (RWE) limit its application in regulatory decision-making and clinical development. To this end, a group of experts put together a new tool that provides a standardized approach to RWE quality assessment. In a new interview on The Evidence Base, experts talked about this new tool and the potential impact it may have on the field going forward.
CMS Projects US Health Spending in 2031 to Exceed $7.2 Trillion
In a study newly published in Health Affairs, authors use CMS figures to project US healthcare spending to exceed $7.2 trillion by 2031. This is based on an expected annual growth in spending of 5.4 percent by year. Although recent economic growth exceeded recent increases in healthcare spending, this trend is not expected to hold up long-term.
Senator Bernie Sanders to Block NIH Nominee Until Biden Reveals Plan to Tackle High Drug Prices
Senator Bernie Sanders (I – VT) will vote against the Biden’s pick for NIH director, Dr. Monica Bertagnolli, until the administration lays out plans to reduce high prescription drug prices in the US. This effectively blocks the nomination, as Sanders’ vote is necessary for it to pass. The administration argues that its commitment to lowering drug prices has already been demonstrated by the passage of the Inflation Reduction Act.
Experts Debate the Use of Real-World Data in Hematology Research
In a debate at this year’s European Hematology Association Congress, experts discussed whether and how real-world data (RWD) could replace clinical trials in hematology. According to moderator Phillipe Rousselot, MD, RWD better accounts for the diversity of patients, making the data more applicable to real-world patient populations.
Real-World Data Study Finds Breztri Reduces COPD Exacerbation Risk
A real-world data (RWD) study presented at this year’s ATS International Conference shows that Breztri Aerosphere reduces the risk of COPD exacerbations. The study, which looked at RWD from over 2,400 patients, showed that early treatment with the combination therapy reduced the risk of exacerbations by nearly a quarter.
Exploring Diabetes Type 2 Remission in Japan with Real-World Data
A recently published study in Diabetes, Obesity, and Metabolism explored the rates of remission for people with type 2 diabetes mellitus in Japan. The study, which used real-world data (RWD) from 48,320 patients, found that out the incidence of remission was 10.5 per 1,000 person-years. These rates are similar to those found in a similar study in the UK.
End of the COVID-19 PHE Imperils Access to Cancer Drugs for Rural Patients
Rule changes during the COVID-19 public health emergency (PHE) allowed cancer patients to have their drugs delivered to their home. With the end of the PHE, this change reverts back to pre-pandemic rules, which will force patients to pick up their medications every few months. This poses significant problems for rural patients, some of whom will have to drive 500 miles for their medications.
Real-World Data Study Characterizes Long-Term Outcomes in Patients Hospitalized with COVID-19
COVID-19 has long-term repercussions for patients who recover, but these effects are poorly characterized. In a newly published study in The Lancet, researchers examined the health outcomes of patients 6 months after being discharged from a hospital in Wuhan, China for COVID-19. The study, which examined data from 2469 patients, found that many patients experienced muscle weakness, sleep disturbances, or mental health issues.
Atropos Health Shares Real-World Evidence Examining High vs Low-Cost Medications
In a poster session at this year’s American Society of Health-System Pharmacists (ASHP) meeting, Atropos Health presented real-world evidence examining the impact of prescribing high-cost vs low-cost medications on patient health outcomes. The study, which looked at electronic health records (EHR) taken between 2015 and 2021, found no difference in outcomes between drugs at different price brackets.
NICE Launches AI and Digital Health Advisory Service
In response to the growing application of healthcare artificial intelligence (AI) and explosion of digital health solutions, the UK’s National Institute for Health and Care Excellence (NICE) has launched a new advisory service for developers. The AI and Digital Regulations Service provides general guidances and one-on-one consulting.
Talking Fast-Track Designation and Drug Development with Dr Courtney DiNardo
In a new interview with AJMC, Courtney DiNardo, MD, MSCE, of the University of Texas MD Anderson Cancer Center detailed how FDA fast track designation can help with the drug development process. She argues that it can help guide trial development in ways that align with agency preferences and priorities. In addition, she spoke about patient recruitment and retention.
US Chamber of Commerce Files Suit Over Upcoming Drug Pricing Negotiations
The second volley of legal challenges over upcoming Medicare drug pricing negotiations has been fired, this time by the US Chamber of Commerce. The chamber argues that the negotiations, brought on by the Inflation Reduction Act, would violate pharmaceutical companies’ due process rights by enforcing price limits. This suit follows one filed last week by Merck and Co.
List of Medications Facing Inflation-Linked Rebates Increases
The Centers for Medicare and Medicaid Services (CMS) has expanded the list of drugs that will be subject to rebates tied to price increases that exceed the current rate of inflation. The number, which was previously 20, now stands at 43, and includes drugs for leukemia, lymphoma, and asthma from major manufacturers like Seagen, Amgen, and AstraZeneca.
FDA Advisory Committee Votes in Favor of Eisai, Biogen’s Leqembi
An advisory committee for the US Food and Drug Administration (FDA) voted 6-0 in favor of full approval for Leqembi, Eisai and Biogen’s treatment for Alzheimer's disease. The decision was made based on results from the Clarity AD study, which the committee members believed strongly supported its clinical benefits for patients.
EFPIA Calls for EU Digital Health Regulatory Harmonization
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has released a report highlighting the need for harmonized regulatory requirements for digital health devices and apps. As it stands, only a few countries in the EU have standards for value assessment, reimbursement, and funding pathways. The EFPIA argues that this lack of harmonization constitutes a barrier to access for patients.
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.
340B Eligibility Associated with Reduced Biosimilar Uptake
A recently published study in Health Affairs found reduced biosimilar uptake in hospitals in the 340B program, which provides drugs at reduced cost to certain care centers. The study examined nearly 600 hospitals using claims data, the Healthcare Cost Report Information System, and a 340 participation database. 340B-eligible care centers had a biosimilar usage rate that was 66% lower than non-eligible hospitals.
CMS to Cover New Alzheimer’s Drugs with Real-World Data Registry Participation
In a change from previous policy, the Centers for Medicare and Medicaid Services (CMS) will cover new Alzheimer’s drugs with one catch – the manufacturer must participate in a new real-world data (RWD) registry. Patients eligible for coverage must have mild cognitive impairment, be a Medicare Part B recipient, and be treated by a participating clinical team.
FDA Brief Supports Full Approval for Alzheimer’s Drug Leqembi
In a newly released brief, the US Food and Drug Administration (FDA) vocalized support for the full approval of Eisai and Biogen’s Alzheimer's drug Leqembi. The brief, which comes before an FDA adcomm this Friday, June 9th, shows that the agency considers the drug’s efficacy well-supported by evidence from a recent study and that the risk of adverse events does not rule out full approval.
NYUTron Clinical AI Accurately Predicts Health Outcomes
Researchers from the NYU Grossman School of Medicine have published a new paper detailing their AI NYUTron that can predict health outcomes. NYUTron uses unaltered electronic health records (EHR) and can predict hospital readmissions, hospital deaths, and length of stay with high accuracy. The tool was trained on EHR data from 336,000 patients at NYU Lagone.
The Odds Don’t Favor Merck’s Drug Price Negotiation Lawsuit
Merck filed suit against the Centers for Medicare and Medicaid Services (CMS) recently, marking the first pharmaceutical company to do so. However, according to Stephen L. Carter of Bloomberg, the lawsuit may be dead in the water. The reason, he argues, is the basis of the suit, which hinges on the idea that price caps equate to the government seizing private property without fair compensation and that the language of the bill is a violation of the First Amendment.
