Weekly Spotlight

Medicare Unveils First 10 Negotiated Drug Prices

This week, CMS unveiled the results of the its first round of drug price bargaining. Here’s the list of negotiated prices for a 30-day supply that will start in 2026, and their discount from the 2023 list prices:

• Januvia (Merck) — $113.00 (79% discount)
• Fiasp/NovoLog (Novo) — $119.00 (76% discount)
• Farxiga (AstraZeneca) — $178.50 (68% discount)
• Enbrel (Amgen) — $2,355.00 (67% discount)
• Jardiance (Boehringer, Lilly) — $197.00 (66% discount)
• Stelara (J&J) — $4,695.00 (66%)
• Xarelto (J&J) — $197.00 (62%)
• Eliquis (Bristol Myers Squibb) — $231.00 (56%)
• Entresto (Novartis) — $295.00 (53%)
• Imbruvica (J&J, AbbVie) — $9,319.00 (38%)

Some selected coverage from Medpage, StatNews, and some pre-publication analysis from a few policy experts.With the DNC right around the corner, we can expect to hear more from President Biden and Democratic presidential candidate, Vice President Kamala Harris on one of their signature accomplishments. But is it all it’s cracked up to be? We’ll see!

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

Are You a Covered Entity?

Updated CMS HIPAA resources

#All

CMS Provides New — But Limited — Pathway for Coverage of Medical Devices

As we covered last week, the Centers for Medicare & Medicaid Services established a new pathway to Medicare coverage, called Transitional Coverage for Emerging Technologies (TCET), for certain Breakthrough medical devices. Arnold & Porter’s Advisory summarizes the new pathway and explains its relationship to other routes to Medicare coverage. The Alliance for Aging Research published a statement on the new coverage policy.

#Device, #Patient

How Much Does a C-Section Cost? At One Hospital, Anywhere From $6,241 to $60,584.

New federally mandated disclosures by California’s Sutter Health illustrate the wide disparity in healthcare rates negotiated by insurers

#Hospital

2-midnight rule yields mixed results for health systems

CMS’ expansion of the two-midnight rule led to increased inpatient volumes and revenue growth for some health systems this year, but the jury is still out on its long-term impact on hospital operations and financial performance.

#Hospital

10 hospitals with highest, lowest readmissions for heart failure patients

Boise, Idaho-based St. Luke’s Regional Medical Center has the lowest readmission rate for heart failure patients, CMS found.

#Hospital, #Patient

CMS may double Medicare payments for cardiac CT

CMS is gathering public comments on a proposal to double the amount hospitals are paid for coronary computed tomography angiography (CCTA). CMS is seeking input by Sept. 9 to consider revising how CCTA reimbursement is calculated.

#Hospital, #Provider, #Patient

Millions of people became uninsured as Medicaid programs cut coverage, new data show

New federal health insurance data show what we expected: The uninsured rate ticked up earlier this year as states re-evaluated whether low-income folks were still eligible for Medicaid.

#Patient, #Payer

AHIP Wants You to Know MA Works

According to AHIP, MA has continued to deliver superior quality of care. Across 10 HEDIS measures, MA outperformed FFS Medicare in all but one. Beginning next month, AHIP — which represents the nation’s leading health insurers — plans to tout the benefits of Medicare Advantage over traditional fee-for-service Medicare through new digital advertising, a social media campaign, and encouraging older Americans to head to their district offices to buttonhole representatives.

#Payer

As CMS weighs national provider directory, health data firm releases its own

Trilliant Health, a major health data firm, is launching a free version of its nationwide provider directory as CMS weighs creating its own, Ben reports.

#Provider, #Patient, #Payer

Food and Drug Administration (FDA)

US FDA extends review of Humacyte’s blood vessel implant

FDA has extended review of the company’s implant that can act as a replacement for an injured or damaged blood vessel, sending its shares down more than 15% after the bell.

#Device

The FDA Calls Them ‘Recalls,’ Yet the Targeted Medical Devices Often Remain in Use

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device, but neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.

#Device

Hill Happenings

Hoyer experienced ‘mild’ stroke, has ‘no lingering symptoms,’ office says

Former House majority leader Steny Hoyer (D-Md.) experienced a mild ischemic stroke but had no lingering symptoms, his office said.

Notable Notes

Leading Health-Related Concerns of Older Adults Before the 2024 Election

Adults 50 years or older cast more than half of all ballots in the 2020 US election.Issues related to health and health care are often key factors for voters. To understand which health-related concerns are most salient before the 2024 election, researchers surveyed a nationally representative cohort of adults 50 years or older.

#Patient

Medical device startup exits stealth mode to name CEO, announce $21M in funding

Jupiter Endovascular, a California-based subsidiary of Neptune Medical, has exited stealth mode and announced a new financing round worth $21 million. The company’s primary focus is developing its new Endoportal Control technology and establishing new endovascular procedures that “bring the precision and control of direct surgical access to catheter-based interventions.”

#Device

First-generation Medtronic TAVR valves linked to strong outcomes after 12 years

Transcatheter aortic valve replacement (TAVR) with Medtronic’s first-generation, self-expanding heart valve is associated with positive clinical outcomes and “reassuring” durability after 12 years, according to new data published in Cardiovascular Revascularization Medicine.[1]

#Device

Shortages inflate care delivery costs by $3.5M per health system

Health systems have been forced to delay care and forgo revenue as they manage device and drug shortages.

#Device, #Drug, #Hospital, #Provider, #Patient

All aboard the summer drug pricing roller coaster

Report form 46brooklyn on drug pricing activity over the month of June 2024.

#Drug, #Patient

How PBM oversight could help lower drug prices

Opinion: Pharmacy benefit managers are often blamed for driving up drug costs, but their role is much more complex than it appears. They help insurers and employers manage prescription benefits, and are able to negotiate lower drug prices through their formularies, write a trio of researchers studying this space. The problem lies in the lack of transparency and the potential for misaligned incentives between PBMs and employers. To keep PBMs in check, policymakers should focus on promoting competition and allowing for more flexible insurance designs that could lower drug prices and premiums.

#Drug, #Payer, #Patient

All qualifying North Carolina hospitals are joining debt-reduction effort, governor says

All of North Carolina’s acute care hospitals have signed up for a landmark medical debt forgiveness program for low-and-middle-income patients, Gov. Roy Cooper announced Monday. The program will use the state Medicaid system and federal funds, The Associated Press reports.

#Hospital, #Patient

Grail announces layoffs as it looks to push forward blood-based cancer detection test

The layoffs were announced on the same day Grail reported its second-quarter financial details, its first time doing so as an independent company since it was divested by DNA sequencing juggernaut Illumina in June.

#Patient

Hot Summer Threatens Efficacy of Mail-Order Medications

Doctors and pharmacists say the scorching temperatures enveloping the country could be endangering health in an unexpected way: by overheating their medications

#Patient, #Drug

Sudden cardiac arrest requires luck to survive. Scientists hope to turn those odds around

By definition, sudden cardiac arrest seems to come out of nowhere. If the person is lucky, medical help is close enough to get the heart beating again after it stops and before brain damage sets in. The less fortunate face terrible odds: survival rates for cardiac arrest outside a hospital have remained stuck at 10% for decades

#Patient, #Provider

Clinicians Need More Education on Climate-Related Health Issues, Expert Says

The U.S. healthcare workforce needs better training on issues involving climate change and health, Katie Huffling, DNP, CNM, said Wednesday at the White House Climate and Health Forum.

#Patient, #Provider

Bleeding Better Controlled When Protamine Is Part of TAVR Wrap-Up Routine

With protamine routinely given at the end of transcatheter aortic valve replacement or implantation (TAVR or TAVI), patients achieved hemostasis quicker and with greater success, according to the ACE-PROTAVI trial.

#Provider

The Power of Connection: How Clinical Data Registries, ACOs, and Payers Can Collaborate for Value-Based Care

Value-based care (VBC) is not new. The concept began in the 1980s with the introduction of managed care and capitation models, where providers were paid a set amount per patient rather than per service. However, it gained significant traction in the early 2000s and continues to evolve with ongoing efforts to refine payment models, improve care coordination, enhance patient outcomes, and manage cost efficiency. Key stakeholders in the healthcare industry, including health plans, clinical data registries, and accountable care organizations (ACOs), must collaborate to improve health outcomes, enhance patient experiences, manage chronic diseases, and provide better access to care while keeping costs low.

#Provider

What’s the Best Way to Help Specialists Succeed? Beef Up Primary Care

Opinion: Even a large hospital that focuses on high-end care, on advanced imaging, providing specialized surgeries, and offering the latest experimental protocols and the most cutting-edge medicine, the patients have to come from somewhere — and they have to go somewhere when they’re done.

#Provider, #Patient

Medical Malpractice Harms All Parties Involved, Documentary Reveals

“A World of Hurt” illustrates the toll of the current system on both physicians and patients

#Provider, #Patient