Regulatory Update – Week of June 10, 2024

Introduction
New MedPAC report, MA star ratings mulligan, and Congress keeps busy…

Weekly Spotlight

After providers spent years asking Congress to look into how the Centers for Medicare and Medicaid Services was doing its job, this week the Energy and Commerce Committee finally started asking some questions. I know I’ll be going back to re-watch some of the hearing to see if there are any nuggets to take away. Meanwhile, MedPAC’s June report puts the Commission on record with some of the more substantive changes to the Medicare program that they have been discussing in recent months while the Medicare actuaries offer some stark insights on national healthcare spending.

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

National health spending projected to reach $7.7T in 2032

National health expenditures will rise to $7.7 trillion and comprise nearly one-fifth of the U.S. economy by 2032, according to the latest projections from the Centers for Medicare and Medicaid Services Office of the Actuary.

#All

MedPAC June 2024 Report to the Congress: Medicare and the Health Care Delivery System

Report

Chapter 1:  Approaches for updating clinician payments and incentivizing participation in alternative payment models

Chapter 2:  Provider networks and prior authorization in Medicare Advantage

Chapter 3:  Assessing data sources for measuring health care utilization by Medicare Advantage enrollees: Encounter data and other sources

Chapter 4:  Paying for software technologies in Medicare

Chapter 5:  Considering ways to lower Medicare payments for select conditions in inpatient rehabilitation facilities

Chapter 6:  Medicare’s Acute Hospital Care at Home

#All

New Tricuspid Interventions Launched into ‘Broken’ System

Recent device approvals officially put transcatheter tricuspid valve intervention (TTVI) on the map for symptomatic severe tricuspid regurgitation (TR), though workforce challenges and a less-than-compelling evidence base stand in the way of broad adoption. Currently, the hospitals allowed to offer TTVI technology are slowly expanding from those that had participated in the clinical trials to other sites chosen by industry, according to Susheel Kodali, MD, of New York-Presbyterian/Columbia University Irving Medical Center in New York City.

#Device

Supreme Court to review Medicare DSH case

The U.S. Supreme Court on Monday said it will review a lower-court’s decision that limits Medicare payments for hospitals that treat a disproportionate number of low-income patients.

The U.S. Court of Appeals for the District of Columbia Circuit sided with the Health and Human Services Department in September. A group of 213 hospitals that filed the initial case in 2017 petitioned the Supreme Court in December to review that decision.

#Hospital

PIPC Recommendations for Enhancing Patient Engagement Strategies

For over a decade, the Partnership to Improve Patient Care (PIPC) has championed centering health care on patients and people with disabilities. In this literature review, PIPC offers the Centers for Medicare & Medicaid Services (CMS) recommendations to create a systematic engagement process that goes beyond written comment periods and ad hoc listening sessions.

#Patient

Medicare Advantage prior authorizations targeted in new bill

Efforts to restrict prior authorizations under Medicare Advantage took a major step forward with introduction of a bipartisan bill in both chambers of Congress on Wednesday.

#Patient, #Payer, #Provider

CMS recalculates 2024 Medicare Advantage star ratings

The Centers for Medicare and Medicaid Services has recalculated some Medicare Advantage star ratings for the 2024 plan year after two federal courts found it improperly modified how it assesses quality, the agency notified health insurance companies Thursday. In addition to the possibility of revised scores and additional revenue for 2024, Medicare Advantage carriers whose star ratings are increased will be permitted to resubmit their bids for next year. Plans with high ratings can get lucrative bonus payments. A redo would mean hundreds of millions of dollars in additional payments.

#Payer

Food and Drug Administration (FDA)

FDA advisers unanimously back Lilly’s donanemab

Advisers voted 11-0 that the benefits of Lilly’s Alzheimer’s therapy outweighed the risks, making it likely that the FDA will approve the drug for a broad population of people diagnosed with mild cognitive impairment due to Alzheimer’s.

#Drug, #Patient

Health and Human Services (HHS)

Biden-Harris Administration Releases Data Showing Historic Gains in Health Care Coverage in Minority Communities

The U.S. Department of Health and Human Services (HHS) issued five new reports showing historic gains in health care coverage and highlighting increases in coverage among minority communities since the implementation of the Affordable Care Act’s (ACA) coverage provisions.

#Patient

Hill Happenings

House E&C Health Subcommittee Holds Hearing on CMMI

The hearing centered on CMS’ transition to value-based care, a payment model for Medicare that focuses on improved health benefits to guide costs — something CMMI has been trying to implement. Fowler pushed back against GOP accusations that CMMI’s operations are too expensive, arguing that CMS heeds providers’ advice and reducing spending is CMMI’s “statutory mission.”

#All

Nearly 8 percent of Senate aides make less than a living wage, report finds

But pay has improved since 2020, especially in the House, according to transparency group Issue One

#All

Democrats ramp up patent fight with drug industry in bid to lower prices

Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) wrote to eight pharmaceutical company CEOs, urging them to remove 130 patents from a government registry.

#Drug

Notable Notes

2024 State of Real-World Evidence Policy

Convened with the Duke-Margolis Real-World Evidence Collaborative, this public convening will provide a venue to review recent RWE Collaborative activities, strategic real-world data and real-world evidence (RWD/E) policy developments, and promising future applications of RWD/E.

This year, speakers will focus on a few key topics:

#All

Medical device trials still don’t enroll enough women, study finds

Women have always been underrepresented in medical research. A new study reveals that not much has changed, especially when it comes to tests of cardiovascular devices.

#Device

Established TAVR Platforms Evolving for Lifetime Management

With valve-in-valve procedures becoming a key concern for patients with aortic stenosis, familiar transcatheter aortic valve replacement (TAVR) devices are being tweaked to facilitate future operations that patients may need as they age.

#Device, #Patient

Antitrust enforcement of hospital mergers falls short: study

Federal regulators have a long way to go in evaluating hospital mergers, according to a recent study to be published by the American Economic Association.

#Hospital

Hospital Stops PAs From Performing Invasive Procedures Move follows a pause of its open heart surgery program after immediate jeopardy citation

Wynn Hospital in Utica, New York, will no longer allow physician assistants (PAs) to perform invasive procedures, according to news reports.

#Hospital, #Provider

Cancer Researchers Begin Large Long-Term Study of Black Women

The American Cancer Society hopes to enroll 100,000 women and follow them for three decades to discover what’s causing higher case and death rates.

#Patient

NIH wanted to make cancer research more diverse. The effort turned out to be a costly failure

Government researchers hoped to attract a more diverse group of patients for clinical research by paying for the travel expenses of cancer patients seeking to volunteer for trials. It didn’t work.

Patients don’t pay for the care they receive as part of clinical trials run by the National Institutes of Health. But patients, and often their caregivers, incur other costs such as travel, food and lodging, child care, and absences from work.

#Patient

Developing a Multidisciplinary and Multispecialty Workforce for Patients with Cancer, from Diagnosis to Survivorship: Proceedings of a Workshop

Patients living with and beyond cancer often require care from a wide range of clinicians as they navigate cancer diagnosis, treatment, and survivorship care. To examine opportunities to improve equitable access to high-quality multispecialty and multidisciplinary expert care for people living with and beyond cancer, the National Academies National Cancer Policy Forum hosted a public workshop in collaboration with the Global Forum on Innovation in Health Professional Education.

#Patient, #Provider

What Happens When Your Insurer Is Also Your Doctor and Your Pharmacist

Health insurers like UnitedHealth Group are seeking to control many parts of our healthcare system, creating potential conflicts of interest

#Payer, #Patient

Burnout Among Mid-Career Academic Medical Faculty

Since the height of the pandemic, workers in almost every echelon of the medical field have reported varying degrees of burnout — causing problems across the industry.

That burnout is also present in medical academic faculty, according to an investigation published in JAMA Network Open — a trend that could have broad implications for the future of medical research.

#Provider

Health Worker for a Nonprofit? The New Ban on Noncompete Contracts May Not Help You

Many physicians and nurses are happy about the Federal Trade Commission (FTC)’s new rule banning the use of noncompete agreements in employment contracts. But they are disappointed that it may not protect those who work for nonprofit hospitals and healthcare facilities, which provide most of the nation’s care and employ the largest number of medical professionals.

#Provider, #Hospital

Lawmakers eye Gilded Age laws to tame healthcare consolidation

An idea birthed in the Gilded Age is gaining traction as a way to counter increasing consolidation in the healthcare industry: banning the corporate practice of medicine. In the late 1800s and early 1900s, physicians and state legislatures grew concerned that corporations and monopolists were hiring and controlling company doctors whose first concern would no longer be the needs of their patients, but of their employers’. About two-thirds of states enacted laws that, to varying degrees, dictate that lay people may not own or control medical practices.

#Provider, #Hospital

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