Weekly Spotlight
Happy Memorial Day weekend.
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
What Prompted CMS To Change Course With Its Data Restrictions?
The Centers for Medicare and Medicaid Services (CMS) announced the delay of the implementation of its restrictions on accessing Medicare and Medicaid data. Initially, the agency planned to start implementation in August 2024, regardless of public feedback. These restrictions would erect data access barriers, hinder research activities, and shield Medicare and Medicaid programs from public scrutiny. What prompted CMS to change course?
#All
The Medicare [MA] Bubble Has Burst – Government health insurance program had been a gold mine for private insurers until recently
The Wall Street Journal reports, for years, the privately run Medicare Advantage business generated outsize profit growth for health-insurance giants. With hundreds of billions of taxpayer dollars flowing to insurers in a fast-growing market buoyed by aging baby boomers, there was little not to like as far as Wall Street was concerned. Companies like UnitedHealth Group and Humana bet big on the program, and investors generally rewarded them for it. Medicare Advantage, in which the government pays insurers a set amount to manage the care of seniors, recently surpassed traditional Medicare’s share of beneficiaries. It was 30% a decade ago.
#All
Hospital Groups Request More Time to Comment on TEAM
The American Hospital Association and the Federation of American Hospitals are asking for more time to comment on CMS’ proposed Transforming Episode Accountability Model. CMS pitched TEAM in April as part of the inpatient prospective payment system role for fiscal year 2025. CMS is proposing a mandatory model to test whether episode-based payments for five common costly procedures would reduce Medicare expenditures while preserving or enhancing the quality of care. The model could incentivize coordination between providers both during and 30 days after a surgery, and require referral to primary care services to support continuity of care and drive positive long-term health outcomes.
#Hospital, #Provider
Food and Drug Administration (FDA)
FDA poised to publish guidelines for clinical trial diversity
FDA is poised to tell drug and medical device makers how to better include people of color in the clinical trials that test whether products work and are safe, an agency official said Wednesday. Those guidelines are five months late. To ensure that drugs work for everyone, they must be tested on a representative sample of people. But researchers have found that many clinical trials exclude the people of color who are often most affected by the diseases that drugs treat.
#All
Next-gen Medtronic ICD lead wire meets pivotal trial safety and efficacy endpoints
A novel small-diameter lead wire had a high level of success for delivery of implantable cardioverter-defibrillator (ICD) shocks and low complications, the LEADR pivotal trial showed.
The OmniaSecure lead was placed in the desired right ventricular location in 99.5% of patients and achieved successful defibrillation testing at implantation in 97.5%. Freedom from study lead-related major complications was estimated at 97.1% at 6 and 12 months. No lead fractures or unstable electrical performance occurred during a mean 12.7 months of follow-up.
#Device, #Patient, #Provider
Health and Human Services (HHS)
Measuring the Relative Size of the 340B Program (2024 update to the 2022 update)
This study seeks to place the size of the 340B program into perspective through a comparison to other federal prescription drug programs and to the overall market for brand outpatient pharmaceuticals in the United States.
#Drug, #Hospital, #Patient
Hill Happenings
Drs. Bucshon & Ruiz Introduce Clinical Trial Modernization Act
On Wednesday, Congressman Larry Bucshon, M.D. (R-IN-08) and Congressman Raul Ruiz, M.D. (D-CA-25) introduced bipartisan legislation (H.R. 8412) to improve participation in clinical trials by underrepresented populations. The Clinical Trial Modernization Act builds on the successes of clinical trials legislation passed into law last Congress by addressing economic barriers that can prevent participation in clinical trials. This bill also allows the U.S. Department of Health and Human Services (HHS) to issue grants or enter into contractual arrangements to support education, outreach, and recruitment for clinical trials for diseases that have a disproportionate impact on underrepresented populations.
#All
House Budget Committee Hearing: Breaking Up Health Care Monopolies: Examining the Budgetary Effects of Health Care Consolidation
Dr. Chapin White, Director of Health Analysis, Congressional Budget Office
Dr. Benedic Ippolito, Senior Fellow in Economic Policy Studies, American Enterprise Institute
Dr. Adam Bruggeman, Orthopaedic Surgeon, Texas Spine Care Center
Sophia Tripoli, Minority Witness, Senior Director of Health Policy, Families USA
#All
PBM executives invited to testify before House panel
Executives from the three major pharmacy benefit manager companies have been invited to testify before the House Committee on Oversight and Accountability next month, four sources familiar with the planning told STAT. Executives from Optum, CVS Caremark, and Express Scripts, owned by Cigna, were asked to testify before the panel on June 4.
#Drug, #Patient, #Payer, #Provider
Healthcare Orgs See Promise in Senate Paper on Doc Pay
Healthcare organizations seemed pleased with a Senate Finance Committee white paper on problems with physician payment under the Medicare fee-for-service program, even though the paper was vague on some plans for addressing the issues presented.
#Provider
Crapo, Wyden Release White Paper for Medicare Doctor Pay Reform
The white paper outlines a number of areas of interest that the committee sees as an opportunity for reform, including:
- Creating sustainable payment updates to ensure clinicians can own and operate their practices;
- Incentivizing alternative payment models that reward providing better care at a lower cost;
- Rethinking how Medicare measures quality care;
- Improving primary care;
- Supporting chronic care benefits in Medicare fee-for-service; and
- Ensuring continued access to telehealth.
#Provider
Notable Notes
Prescription drug ads should soon start looking noticeably different
A new chapter in drug advertising begins Monday when a federal transparency rule takes effect requiring commercials to clearly spell out potential side effects and when a person should avoid the medicine.
#All
What clinical real-world data can deliver
Thanks to new regulatory frameworks like the Food and Drug Administration’s Breakthrough Therapy designation, drugs are coming to market faster than ever. A 2024 analysis of drugs included in this program showed they had 23% shorter clinical development timelines than those that were not part of the program, with no negative effects on their safety profiles. This regulatory innovation is great for patients, pharmaceutical companies, health care providers, and the full health care landscape, getting new medicines to the people who need them in ever-shorter time.
#All
Making the case for fair compensation in clinical trials
Opinion: I’ve been on three sides of the health care equation: I’ve beaten stage 4 colorectal cancer, I’m the mother of a son with an ultra-rare genetic abnormality, and I now work as the chief patient officer for Parexel, one of the world’s largest clinical research organizations. Having seen what people go through as they navigate the health care system and try to participate in clinical trials, I know that the road to participation must be smoother and easier — and not a drain on their bank accounts.
#Device, #Drug, #Patient
ShortCut Leaflet Splitter for TAVR Helps Keep Coronaries Unblocked — Pivotal study supports safety, effectiveness of TAVR adjunct device against coronary obstruction
For people undergoing valve-in-valve transcatheter aortic valve replacement (TAVR), a dedicated bioprosthetic leaflet splitting device produced better-than-expected results preventing coronary obstruction, and is now poised for FDA approval. The ShortCut device demonstrated safety — freedom from all-cause mortality within 7 days being 100% and freedom from stroke 98.3% — among 60 people undergoing transfemoral valve-in-valve TAVR for a failed bioprosthetic aortic valve deemed at risk of coronary obstruction due to their anatomy.
#Device, #Hospital, #Patient, #Provider
Mortality Signal Emerges 2 Years After Valve-in-Valve TAVR for Failed SAVR— Alternative to redo surgery associated with several-fold increase in deaths, HF hospitalization
For patients with failed bioprosthetic surgical valves, the choice of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) carried upfront advantages, but was ultimately associated with a higher risk of late mortality compared with redo surgery, a retrospective population-based cohort study showed.
#Device, #Hospital, #Provider
BIO lays off 30 employees, including senior leaders
The Biotechnology Innovation Organization on Monday announced 30 layoffs that are part of a restructuring of the organization, according to an email announcement obtained by STAT.
#Drug
A primer on brand-name prescription drug contracting
Prescription drug contracting in the United States has evolved over decades from discounts provided to members of early health maintenance organization plans to rebate contracts
to more complex value-based purchasing arrangements. This primer describes the history of contracting between pharmaceutical manufacturers and managed care pharmacy organizations and details the various contracting methods used today.
#Drug, #Payer
How doctors are pressuring sickle cell patients into unwanted sterilizations
Coercive sterilization is often talked about as an ugly part of America’s past, firmly in the realm of history. But those can seem like exceptions, carceral deviations from the uncoercive norm. People with sickle cell disease tell a different story.
#Patient
