Weekly Spotlight

Question: Can anyone remember another time when the Olympics were so effective at providing a delightful distraction from presidential politics? They both happen every 4 years, right (except for that little blip in 2020)? Maybe we all just really needed something we could root for together this year. Whatever it is, it has been a special kind of magic and I’m going to miss it. Let’s just all pretend to be surprised when I suddenly have time for a long blog post next week!

Speaking of:

TCET IS HERE!

CMS announced a final notice for the Transitional Coverage for Emerging Technologies (TCET) pathway this week, something that industry advocates have been awaiting a long time. The TCET program gives device makers with products deemed “breakthrough” technology by the Food and Drug Administration a quicker way to secure Medicare coverage. Accompanying this publication, CMS released three final guidance documents: 1) Coverage with Evidence Development; 2) Evidence Review and 3) Clinical Endpoints Guidance for Knee Osteoarthritis.

Appropriate TCET candidates:

• Certain FDA-designated breakthrough devices;
• Determined to be within a Medicare benefit category;
• Not already the subject of an existing Medicare NCS; and
• Not otherwise excluded from coverage through law or regulation

TCET Nomination Process

• A manufacturer may submit a non-binding letter of intent approximately 18-24 months before the anticipated FDA marketing authorization.
• The manufacturer will submit a formal nomination for TCET approximately 12 months before anticipated marketing authorization. CMS will not accept nominations within 6 months of anticipated marketing authorization.
• CMS will offer an initial meeting to the manufacturer within 20 days of receipt of a completed TCET nomination and begin compiling an evidence preview (EP) in conjunction with a third-party contractor.
• Based on the EP, the manufacturer will submit an evidence development plan (EDP), which CMS will have 30 days to review and provide written feedback. CMS’s goal is to have a finalized evidence development plan no later than 90 business days after FDA market authorization. CMS will collaborate with AHRQ and will convene a meeting with the manufacturer to discuss the EDP.
• Upon FDA approval of a TCET device, CMS will open an NCD tracking sheet. The tracking sheet will contain an evidence preview with strictly non-proprietary information.
• The process for coverage under the TCET pathway will follow the timelines for the NCD process defined in statute.
• CMS anticipates the transitional coverage period will be approximately five or more years as evidence is generated to address evidence gaps.
• CMS expects to receive approximately 8 TCET applications per year and will consider 5.

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

Medicare scrambles to keep prescription drug plan premiums stable ahead of elections

Medicare officials are offering private insurers big subsidies to keep premiums for prescription-drug plans stable as the elections approach. More here.

#Drug, #Patient

Medicare paid substantially more for J&J’s Stelara when it was covered under Part D than under Part B

A popular biologic medicine used to combat autoimmune diseases cost Medicare and its beneficiaries considerably more when the injectable treatment was obtained at pharmacies rather than injected in physician offices due to different methods for determining payment, a new analysis found.

#Drug

The CMS Innovation Center Announces Finalized Transforming Episode Accountability Model (TEAM)

The five-year mandatory model will incentivize coordination between care providers during a surgery as well as the services provided during the 30 days after surgery with the aim of:

• improving the quality of care for people with Medicare undergoing certain surgical procedures;
• reducing rehospitalization and recovery time;
• lowering Medicare spending; and
• driving equitable outcomes.

TEAM will focus on lower extremity joint replacement, surgical hip and femur fracture treatment, spinal fusion, coronary artery bypass graft, and major bowel procedure. The model will start in January 2026 and end in December 2030.

#Hospital, #Provider

Surgeons Applaud New Age-Friendly Hospital Quality Measure

The American College of Surgeons (ACS) and other stakeholders that have been collaborating for years to develop an age-friendly hospital quality measure are thrilled that CMS will require hospitals to report on that measure starting Jan. 1, 2025, per the fiscal 2025 final inpatient pay rule, which adopts six other new quality measures, modifies two and removes five existing measures.

#Hospital, #Provider, #patient

The One-Hour Nurse Visits That Let Insurers Collect $15 Billion From Medicare

Information gathered from Medicare Advantage patients in their homes triggered extra payments.

#Payer

How UnitedHealth turned a questionable artery-screening program into a gold mine

The Centers for Medicare and Medicaid Services began cracking down on the aggressive diagnosis of peripheral artery disease in 2024, removing a diagnostic code from its payment formula that allowed UnitedHealth and other insurers to get extra reimbursement for diagnosing patients even if they weren’t experiencing symptoms.

#Payer, #Provider, #Patient

Food and Drug Administration (FDA)

Jeff Shuren’s FDA legacy: Bringing stability to device regs

The news of Jeff Shuren‘s departure from his long-held role as head of the Food and Drug Administration’s Center for Devices and Radiological Health has left the medical device world stunned and struggling to imagine the agency without him.

#Device

CDRH Seeks Your Feedback Related to Health Equity For Medical Devices

This paper requests feedback on possible considerations that may help inform the design of a clinical study that adequately reflects the intended use population for a particular medical device. Consistent with CDRH’s 2022 to 2025 Strategic Priority to advance health equity, this paper is intended to spur discussions about reducing barriers to achieving health equity and strategies that may help improve outcomes across diverse populations.

#Device, #PATIENT

FDA scolds Bristol Myers over a misleading website for a cancer treatment

FDA scolded Bristol Myers Squibb for making false and misleading claims about a lung cancer treatment on a website aimed at physicians.

#Drug

FDA official clarifies misconceptions around RWE in premarket submissions

Sponsors thinking of incorporating real-world evidence (RWE) into their submissions should consider RWE as just another form of clinical evidence, according to a recent presentation from a US Food and Drug Administration (FDA) official at the Orange County Regulatory Affairs Discussion Group annual conference.

#Drug

Differing Approaches to Measuring and Ensuring IRB Effectiveness

The HHS Office for Human Research Protections (OHRP) and the FDA Office of Clinical Policy (OCLIP) are co-hosting a live public webinar to hear from research ethics professionals and the public about differing approaches that may contribute to ongoing efforts to measure institutional review board (IRB) effectiveness in protecting human research participants.

#Drug, #Device, #Provider

Health and Human Services (HHS)

Rural hospitals eye reimbursement boost post-Chevron

The critical access hospital designation could boost rural facilities, which may leverage the Chevron ruling to try to expand the program.

#Hospital

With Biden’s departure in sight, advocates seek to preserve gains of Cancer Moonshot

Biden’s impending exit from the political stage leaves uncertainty hanging over the future of this signature health initiative, which Biden began first as vice president under Barack Obama and later renewed as president.

#Patient

What the latest No Surprises Act ruling means for pay rates

Providers notched another win in the legal battle over the No Surprises Act, forcing regulators to rework how the law is implemented. The U.S. Court of Appeals for the 5th Circuit on Friday upheld a lower court ruling and voided parts of the law related to settling out-of-network reimbursement disputes, since the process skewed negotiations in insurers’ favor.

#Provider, #Patient, #Payer

Hill Happenings

340B is back on deck in Congress after Chevron, but hurdles loom

A bipartisan Senate coalition missed its deadline to offer a 340B drug discount program overhaul. Its fate is murkier than ever as lawsuits abound.

#Drug

Congress is unprepared for the post-Chevron world. It needs help from subject matter experts

The U.S. Congress lacks the expertise to do its job in the post-Chevron world.

#All

CBO: Answers to Questions for the Record Following a Hearing on Hospital and Physician Consolidation and Its Impact on the Federal Budget

On May 23, 2024, the House Committee on the Budget convened a hearing at which Chapin White, the Congressional Budget Office’s Director of Health Analysis, testified about how consolidation among hospitals and physicians affects the federal budget. After the hearing, Chairman Jodey Arrington and Representatives Drew Ferguson and Rudy Yakym submitted questions for the record. This document provides CBO’s answers. (if you read this far, I really hope you also heard Law and Order “duh dun” here!)

#All

Senate HHS Approps: Remove Alzheimer’s Drug CED

pp. 178-179: The Committee continues to ex-press disappointment with CMS’s decision to limit coverage of FDA-approved monoclonal antibodies for the treatment of Alzheimer’s disease. The Committee urges CMS to reconsider the National Coverage Determination policy to provide full access for Medicare beneficiaries to these FDA-approved Alzheimer’s treatments”

#Drug, #PATIENT

Medicare doctor pay, PBM bills in limbo as Congress takes off

Members of Congress headed home for the summer over the weekend, leaving the healthcare community in an all-too-familiar position: Wondering how key priorities will turn out after lawmakers failed to address them in the first part off the year.

#Provider, #Drug, #Patient

Notable Notes

The Risk Of Perpetuating Health Disparities Through Cost-Effectiveness Analyses

Cost-effectiveness analyses are commonly used to inform health care and public health policy decisions. However, standard approaches may systematically disadvantage marginalized groups by incorporating assumptions of persisting health inequities.

#PATIENT, #DRUG, #DEVICE

A Legacy of Cruelty to Sexual and Gender Minority Groups

An accounting of medical injustices against members of sexual and gender minority (SGM) groups (including lesbian, gay, bisexual, transgender, and queer [LGBTQ+] people) requires unearthing the cruel, inhumane, and stigmatizing articles published in the Journal, which has pathologized homosexuality and gender nonconformity even as recently as the 2010s. Given this history, it should not be surprising that LGBTQ+ communities face health disparities and outsized ill effects related to every major disease.1

#All

Urgent care or ER? With ‘one-stop shop,’ hospitals offer both under same roof.

Hospitals are tinkering with a new type of facility that combines an emergency room and urgent care.

#Hospital, #Patient

Cancer Screening Costs Over $43 Billion a Year in the U.S., Study Estimates

The cost of initial cancer screening in the U.S. was estimated to be over $43 billion in 2021, which was less than the reported annual cost of cancer treatment in the first year after diagnosis, according to a modeling study. Using national healthcare survey and cost resources data, the total healthcare system costs for initial breast, cervical, colorectal, lung, and prostate cancer screening were estimated at $43.2 billion in 2021, reported Michael T. Halpern, MD, PhD, of the National Cancer Institute, and colleagues.

#Patient

Should we extrapolate survival using ‘cure’ models?

Clinical trials are short, but the benefits of many drugs lasts months or even years beyond the duration of these trials. To quantify the full costs and benefits of a treatment over time (for instance as used for HTA purposes), one must extrapolate this clinical benefits. Commonly, this extrapolation is done using a parametric function. (NICE)

#Patient, #Drug, #Device

Alternative PBMs Arise to Compete With the ‘Big Three’

Competitors say their per-member, per-month payment model is fairer to employers and insurers

#Patient, #Payer, #Drug

Clues for Smarter Rhythm Monitoring After Cardiac Surgery? — Predictors of POAF burden, late-occurring POAF identified in prospective study

Continuous rhythm monitoring after cardiac surgery held clues to help identify people prone to late postoperative atrial fibrillation (POAF) and any associated adverse events.

#Patient, #Provider

L.A. Care cuts 24% of prior authorization requirements

L.A. Care Health Plan has removed roughly 14,000 billing codes from its list of those requiring prior authorization, CEO John Baackes said in an interview.

#Payer, #Provider, #Patient

Claim denials becoming more of a headache for providers: report

Providers say requests for more claim information are a growing burden, but payers contend they ensure their funds are being used appropriately.

#Provider