Weekly Spotlight

With our most sincere apologies for the unannounced Labor Day hiatus, please enjoy this week’s Double Dose Digest. Bonus points (and a SHP Rocketbook) to the reader who sends me an email correctly identifying the secret phrase buried in one of the stories below.

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

Opinion: Medicare’s new transitional coverage of emerging technologies program doesn’t go far enough

Researchers from the Center for the Evaluation of Value and Risk at Tufts Medical Center argue that the new TCET pathway doesn’t go far enough. They argue that CMS should broaden the scope of the pathway to include not just devices, but also drugs, they say. They also say that CMS should have more resources to collect real-world data on the new technologies, so that the agency can better assess their effectiveness and safety.

#Device

Join CMS for an Education Session on the Transitional Coverage for Emerging Technologies (TCET) Pathway

As a part of CMS’ continued commitment to engage interested parties, CMS will hold an education session on September 23, 2024, to share information on the TCET pathway and answer questions. 

CMS asks the public to submit on the TCET pathway in advance of the meeting. Please submit questions to TCET@cms.hhs.gov by 5 p.m. ET on Thursday, September 12. There will not be an opportunity to ask questions during the call.

#Device

Tale of Two Hospitals: Why Some Hospitals Succeed and Others Do Not

Researchers argue hospitals can do more with the resources they have by controlling their costs and investing in their patients’ care. Two large hospitals, Duke Regional in North Carolina and Mercy Hospital Southeast in Missouri, illustrate the extremes. The first is efficient and regularly makes money on Medicare while delivering better patient outcomes and more equitable, charitable care. The second does not control its costs as well and delivers worse care at higher prices while losing money on Medicare.

#Hospital

741 hospitals selected for CMS’ next alternative pay model, by state

CMS published the list of acute care hospitals selected for its next episode-based alternative payment model, TEAM.

TEAM stands for “Transforming Episode Accountability Model,” and is the next evolution of the Bundled Payments for Care Improvement Advanced and Comprehensive Care for Joint Replacement models. TEAM will begin Jan. 1, 2026 and last five years. Hospitals were selected using the Core Based Statistical areas, and hospitals located in the identified regions are required to participate.

#Hospital, #Provider

CMS Posts Content on Medicare.gov in Preparation of Coverage Transition from Part D to Part B of Antiretroviral Drugs to Prevent HIV

CMS posted information encouraging pharmacies and other affected parties to prepare now for the expected transition of coverage, from Medicare Part D to Medicare Part B, for Pre-exposure Prophylaxis (PrEP) antiretroviral drugs to prevent HIV. The final National Coverage Determination (NCD) is expected to be released in late September 2024, and coverage under Part B will begin once CMS releases the final NCD.

#Patient

What insurers got wrong about Medicare Advantage costs

A confluence of issues over more than a year made it difficult for Humana, UnitedHealthcare, Aetna and others to accurately predict Medicare Advantage costs and utilization.

#Payer

Medicare Advantage vendors brace for supplemental benefits cuts

Companies that have profited from the largesse of Medicare Advantage insurers seeking to lure customers with generous perks are looking ahead to a tough 2025.

#Payer

Opinion: Fake News from MedPac on Medicare Advantage Needs to Be Corrected, Pt 1

MedPac has just released a report on Medicare Advantage that’s incorrect on multiple key points that need to be corrected.

Medicare Advantage currently enrolls the majority of Medicare members in the country, and it’s now the new basic plan for the Medicare program because of that majority enrollment level. June 2024 Report to the Congress: Medicare and the Health Care Delivery System

#Payer

Value-based care gives cardiology practices an opportunity to thrive

Value-based payments can impact cardiology practices in many ways, helping cardiologists acquire new technology and boost patient care. You are today’s winning health policy wonk.

#Provider

CMS could increase CCTA payments—the American College of Cardiology wants to help

The U.S. Centers for Medicare and Medicaid Services (CMS) recently proposed a new policy that would more than double the reimbursement payments hospitals receive when performing coronary computed tomography angiography (CCTA). Now, the American College of Cardiology (ACC) is joining the Society of Cardiovascular Computed Tomography (SCCT) and others to urge cardiologists and other cardiology professionals to show support for the proposal.

#Provider

How cardiologists and hospitals get paid

Joel Sauer, MBA, executive vice president of consulting for MedAxiom, spoke to Cardiovascular Business about how diagnostic-related groups (DRGs), current procedural terminology (CPT) codes, and relative value units (RVUs) figure into Medicare payments.

#Provider, #Hospital

CMS has received 12,000 complaints over No Surprises Act noncompliance—most were valid

In total, 10,300 complaints were made against providers and air ambulance services. The rest were for surprise bills from insurance plans.

#Provider, #Payer, #Patient

Surprise billing law helped PE-backed providers

A select group of private equity-backed physician practices benefited from the federal process for resolving billing disputes for out-of-network care, collecting payouts well above what insurers would have paid in-network, an analysis of 2023 data shows.

#Provider, #Payer, #Patient

Food and Drug Administration (FDA)

Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers

The Food and Drug Administration (FDA) is issuing this final guidance document to help manufacturers better understand and use the Voluntary Malfunction Summary Reporting (VMSR) Program.

#Device

Hill Happenings

PBM execs hit with criminal threat over congressional testimony

The head of the House Oversight and Accountability Committee is questioning whether the chiefs of the three largest pharmacy benefit managers were honest with lawmakers at a recent hearing — and raising the prospect of fines and prison time.

#Drug, #Patient

Notable Notes

Another Trial Sides With MitraClip for Functional Mitral Regurgitation

Despite another positive trial, controversy rages on over transcatheter edge-to-edge repair (TEER or M-TEER) in people with symptomatic heart failure (HF) and functional mitral regurgitation (MR).

#Device, #Patient

Baseline TR linked to lower quality of life after TAVR, M-TEER—are more interventions the answer?

Patients who present for transcatheter aortic valve replacement (TAVR) or mitral transcatheter edge-to-edge repair (M-TEER) with baseline moderate or severe tricuspid regurgitation (TR) are associated with lower quality-of-life (QOL) scores and worse clinical outcomes after treatment, according to new research published in JACC: Cardiovascular Interventions.[1]

#Device, #Patient

TriClip’s ‘Soft’ Benefits Affirmed in Severe Tricuspid Regurgitation

Tricuspid transcatheter edge-to-edge repair (T-TEER) improved how well patients functioned and felt without major cardiovascular events in the first academic randomized trial to affirm the pivotal trial findings.

#Device, #Patient

PaceMate acquires Medtronic workflow tech, promising ‘unparalleled support’ for heart patients

The Florida-based healthcare company, already a leading name in cardiac data management, said the acquisition will help its technology reach more heart teams than ever before.

#Device, #Patient, #Provider

TAVR complication rates keep falling, highlighting considerable progress

Complications are also down after SAVR, researchers noted, though the drop has been much more dramatic for TAVR patients. The new analysis was based on Medicare data from more than 210,000 patients.

#Device, #Patient, #Provider

Boston Scientific’s new TAVR valve gains CE mark approval

The self-expanding Acurate Prime Aortic Valve System was designed with improved valve positioning in mind. According to Boston Scientific, it will be available in more sizes than the company’s previous TAVR device to ensure it can treat as many heart patients as possible.

#Device, #Provider

CRF announces late-breaking clinical trials for TCT 2024

The Cardiovascular Research Foundation has announced 10 late-breaking clinical trials and 15 late-breaking clinical science sessions for TCT 2024 in Washington, DC. Topics will include TAVR and other structural heart procedures, artificial intelligence and much more.

#Device, #Provider, #Patient

Geisinger Health System: A Bellwether for Value-Based Care

Perspective:  Its recently announced partnership with Kaiser Permanente is an exciting development

#Hospital, #Payer

Dedicated trial in women demonstrates the superiority of transcatheter vs. surgical aortic valve replacement

Key take-aways

• In the RHEIA trial that compared treatments for severe aortic valve stenosis specifically in women, transcatheter aortic valve implantation (TAVI) was superior to surgical valve replacement for reducing death, stroke or rehospitalisation.
• The superiority of TAVI was driven by the lower rate of rehospitalisations and there were other benefits with TAVI including a shorter stay in hospital for the procedure compared with surgery.
• These results suggest that TAVI, with the balloon-expandable devices used in the trial, could be considered the preferred option to treat women with severe aortic stenosis.

#Patient

CVD presents differently in women than it does in men—guidelines should reflect that

Emily Lau, MD, a women’s health expert with Massachusetts General Hospital, thinks major changes are needed in how we diagnose CVD in women. “Our guidelines need to be more precise and offer sex-specific recommendations,” she says.

#Patient, #Provider

Doctors use problematic race-based algorithms to guide care every day. Why are they so hard to change?

Explore the milti-part series:  In more than a hundred interviews with clinicians and researchers, STAT found a health care system struggling to reassess its scientific and ethical assumptions about race. Clinicians have been locked in fierce debates about the best way to modify their tools to reduce harm and create fairer outcomes for patients. If race is scratched out of a tool, it’s often an exasperating process to get the revamped version used consistently across America’s disjointed health care system. And there’s currently no way to enforce standards for how race is used by clinicians or researchers.

#Patient, #Provider

Prior authorization targeted by more and more states

While Congress appears stalled with its legislative proposals to streamline prior authorizations, many states have surged ahead and imposed tighter rules on health insurance companies.

According to a National Conference of State Legislatures database, 23 states enacted more than 43 bills related to prior authorization in the last few years, with 18 enacted so far in 2024 alone.

#Payer, #Patient, #Provider

UnitedHealthcare to launch prior authorization gold card program

UnitedHealthcare plans to launch a program next month geared toward streamlining prior authorization for qualifying providers. The UnitedHealth Group subsidiary’s “gold card” program, offered across its commercial, individual exchange, Medicare Advantage and Medicaid business lines, will allow certain providers to use a simplified process for about 500 procedure codes.

#Payer, #Patient, #Provider

Why your cardiology department’s leadership structure matters

The way a cardiology department’s management is organized can have a direct impact on physician satisfaction and patient care. “Without good governance and leadership, nothing else matters,” one expert said.

#Provider

The healthcare worker who will be in top demand

Looking at specific occupations, Mercer projects a serious shortage of nursing assistants. The report estimates only a few states will have enough to meet their needs, with California, New York and Texas having the most critical shortages.

#Provider, #Patient

Stenting, TAVR Make Sense Packaged Together for Some Patients

Some individuals already undergoing transcatheter aortic valve replacement (TAVR, also TAVI) might as well get coronary lesions revascularized around the same time, according to the NOTION-3 randomized trial.

#Provider, #Patient, #Device

TAVR and SAVR linked to comparable long-term outcomes, new meta-analysis confirms

Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) are associated with comparable long-term outcomes among low-risk patients with severe aortic stenosis (AS), according to a new meta-analysis published in The American Journal of Cardiology.[1]

#Provider, #Patient, #Hospital, #Device