Policy Update – Week of October 14, 2024

Introduction
This week: More on Medicare Advantage, PBMs, and drug price negotiations while enter into MA enrollment and peek election season.

Weekly Spotlight

It’s not the Great Pumpkin, Charlie Brown… it’s even more rare. This season only comes once every four years and only a small percentage of Americans still experience it…

Yes, it’s that magical month of overlap: MA plan open enrollment advertising and political campaign ads.

Unless you exclusively use streaming services, you’ll be lucky to get anything resembling a dish soap ad or a Toyota commercial in between all the reminders to call and check to see what new plans might be available in your zip code and what appears in my district to be a fairly evenly spread political whining. For more on what can only be predicted to be an unpredictable MA season, see below. For more on the elections, small, medium, and large, well… Good Luck… but please go vote!

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

Report for Fall Survey of Independent Pharmacy Owners/Managers

More than half of independent pharmacies in the U.S. are considering not stocking the first 10 drugs that were subject to Medicare price negotiations over concerns they will have to absorb upfront cost according to a survey by The National Community Pharmacists Association.

#Drug

CMS sets Medicare appeal pathway for hospital designations

The Centers for Medicare and Medicaid Services has finalized its appeals process for Medicare beneficiaries who claim they have been incorrectly designated as outpatients during their hospital stay.

#Hospital, #Patient

CMS’ 2030 value-based care goal at ‘inflection point’

The Biden administration’s goal to move all Medicare beneficiaries into accountable care arrangements by 2030 may be just within reach, but is at a turning point. The most immediate question that could determine the initiative’s future is whether Congress extends a bonus program meant to help providers transition away from fee-for-service reimbursement and toward value-based payment before it expires this winter. Congress and the Centers for Medicare and Medicaid Services will have to make adjustments to reach the final goal within five years, industry sources and analysts contended.

#Provider, #Patient

Medicare Advantage

Medicare Plans Are Making Big Changes for 2025. Here’s How to Navigate Them.

An estimated five million people will either have to get a new Medicare health plan or Part D drug plan as a result of the shifts

#Patient, #Payer

Payments to Medicare Plan Brokers Need Reform, MedPAC Says

Payments to brokers who enroll people in Medicare plans should be reformed so that no preferential treatment is given for enrollment in Medicare Advantage (MA) instead of fee-for-service Medicare, several commissioners said at a meeting of the Medicare Payment Advisory Commission (MedPAC).

#Payer, #Patient

2025 Medicare Advantage and Part D Star Ratings

The Biden administration officially released the star ratings for 2025 Medicare Advantage plans last Friday. There were few surprises considering how Humana and UnitedHealth already signaled tough sledding for the industry. The percentage of Medicare Advantage enrollees in plans with at least four stars:

2022: 90%

2023: 72%

2024: 76%

2025: 62%

#Payer, #Patient

How Biden transformed Medicare Advantage

President Joe Biden’s single term in office has featured some of the most high-velocity policymaking on Medicare Advantage — both in quantity and potency. The Biden administration has overseen dozens of changes to the financing and the rules governing the private sector alternative to fee-for-service Medicare.

#Payer, #Patient

Inside UnitedHealth’s strategy to pressure physicians: $10,000 bonuses and a doctor leaderboard

A new STAT investigation found a trove of internal documents exposing UnitedHealth’s strategy for incentivizing doctors to pile moneymaking diagnoses onto patients covered by Medicare Advantage.

#Payer, #Provider

What health systems seek in Medicare Advantage plan partners

Health systems are forging partnerships with certain Medicare Advantage plans, even as increasingly frequent battles over reimbursement rates and pay policies cause them to break ties with others.

#Payer, #Provider, #Patient

Food and Drug Administration (FDA)

FDA clears AI platform for planning ahead of TAVR, other heart procedures

The cloud-based platform identifies and measures cardiac structures in CT scans.

#Device, #Provider, #Patient

Core Patient-Reported Outcomes in Cancer Clinical Trials Guidance for Industry

This guidance provides recommendations to sponsors for collection of a core set of patient-reported clinical outcomes (herein referred to as core patient-reported outcomes) in cancer clinical trials and related considerations for instrument selection and trial design. Although this guidance focuses on patient-reported outcome (PRO) measures, some of these recommendations may be relevant to other clinical outcome assessments (i.e., clinician-reported outcome, observer-reported outcome, performance outcome) in cancer clinical trials.

#Drug, #Patient

Hill Happenings

Lawmakers Pan DEA’s Leaked Plans for Telehealth

Legislators who want to see an extension of COVID-era telemedicine flexibilities slammed a draft proposed rule from the Drug Enforcement Administration (DEA) that would curb telemedicine prescribing of controlled substances. Eleven senators, led by Sens. Sheldon Whitehouse (D-R.I.), Lisa Murkowski (R-Alaska), Mark Warner (D-Va.), and Marsha Blackburn (R-Tenn.), criticized the new restrictions of a draft rule that they learned about through leaked reports to the media calling such restrictions “detrimental to patients and a barrier to accessing care,” in an October 11 letter to President Biden.

#All

Senate Subcommittee on Investigations Report: Refusal of Recovery: How Medicare Advantage Insurers Have Denied Patients Access to Post-Acute Care

On May 17, 2023, the Permanent Subcommittee on Investigations (“PSI” or “the Subcommittee”) launched an inquiry into the barriers facing seniors enrolled in Medicare Advantage in accessing care. PSI sought documents and information from the three largest Medicare Advantage insurers:UnitedHealthcare, Humana, and CVS, who together cover nearly 60 percent of all Medicare Advantage enrollees. This report presents new findings based on the more than 280,000 pages of documents obtained from these three companies to date

#Payer, #Patient, #Provider

Stop the Medicare Payment Cut and Pass a Permanent Fix, House Members Urge Leaders

A majority of House members urged House leaders to not only reverse a proposed 2.8% n the Medicare Physician Fee Schedule (MPFS), but also to pass a law that would avoid such cuts in the future.

#Provider

Notable Notes

Predicting vascular complications during TAVR just got a little easier

A new risk score can accurately predict when transcatheter aortic valve replacement (TAVR) patients face an increased risk of nonpuncture site vascular complications, according to new data published in JACC: Cardiovascular Interventions.[1] The score also showed “modest” potential to anticipate possible puncture site vascular complications.

#Device, #Provider, #Patient

TRILUMINATE update: TEER with Abbott’s TriClip device still safe, effective after 3 years

Treatment with TriClip has been consistently associated with minimal adverse events and significant improvements in quality of life. This latest update represents data from nearly 100 patients three years after implantation

#Device, #Provider, #Patient

ACS Guidelines Expand Lung Cancer Screening Eligibility — Is That a Good Thing?

ACS guidance previously said that lung screening should not begin if someone quit smoking more than 15 years ago or should stop once that point is reached. But in November 2023, the ACS issued new screening guidelines that removed that criteria, expanded the age range for eligibility from 55-74 to 50-80 years, and decreased the number of pack-years for current and former smokers from 30 or more to 20 or more.

#Patient

Following heart failure guidelines could save 1.2 million lives per year

New UCLA-led research reinforces the important role guideline-directed medical therapy (GDMT) can play in reducing mortality rates in patients with heart failure with reduced ejection fraction (HFrEF). HFrEF affects about 29 million people worldwide, according to the study’s authors.

#Patient

11 experts on why gains in cardiovascular disease are stalling and what we can do about it

“I think the biggest single remediable issue for us is that we don’t have a primary care system in the U.S. that’s functional,” said FDA Commissioner and cardiologist Robert Califf.

#Patient, #Provider

‘Failure to rescue’: Study suggests why women fare worse than men after cardiovascular surgery

They call it “failure to rescue,” which means a surgical patient died from complications that might have been averted if recognized and treated. New research suggests that’s why women are less likely to survive high-risk cardiovascular surgery than men.

#Patient, #Provider

PBMs and Prescription Drug Distribution: An Economic Consideration of Criticisms Levied Against Pharmacy Benefit Managers

PBMs fight back against FTC allegations with their own report.

#Payer, #Drug, #Patient

Medical Licensing Exam Scores Sent to Residency Programs After Switch to Pass/Fail

Numerical scores for the Comprehensive Osteopathic Medical Licensing Examination (COMLEX) Level 1 were mistakenly made visible to ob/gyn programs despite the test being pass/fail. On top of that, the students themselves never saw their own scores.

#Provider

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