Regulatory Update – Week of April 8, 2024

Introduction
New this week: Congress is back and doctors are stirring. CMS drops the Inpatient Rule and hospitals are furious, MedPAC is back and feeling contemplative. All this and more as we continue the “April showers with quite a few flowers (and pollen)” portion of springtime in DC.

Weekly Spotlight

Listen closely and you can probably hear a growing chorus of vague grumbling slowly building as the doctors’ lobby wakes up to the news that their annual reprieve from talking about payment is over, just a month after they were able to secure a slight reprieve from cuts for this year. A well-trained ear will be able to distinguish those mutters from the resigned sighs of Hill staffers and administrators preparing for another round of meetings on the same topic, over and over again. But the Fee Schedule isn’t out yet, so why is it time to talk about this already?

Well, the doctors’ lobby has been asking Congress to look into Medicare payment for years, after it became clear that the changes made under the Medicare Access and CHIP Re-authorization Act of 2015 (MACRA) weren’t going to work. Sure, MACRA got rid of the sustainable growth rate, but what came next wasn’t working as planned. When the COVID public health emergency coincided with the expiration of some of the “on ramps” that were supposed to help doctors to adjust to the new payment paradigm, things got dicey. Since then, doctors have been asking Congress to do the hard work of revising doc pay one more time. Congress, however, has had trouble coming up with anything more than temporary patches, year-after-year.

So some could say that it’s good news that the Senate Finance Committee had a hearing this week on Bolstering Chronic Care Through Medicare Physician Payment or that the Medicare Payment Advisory Commission (MedPAC) had its first session this week to discuss potential recommendations for doc pay changes. Some might even say that the new mandatory alternative payment model, the Transforming Episode Accountability Model (TEAM) is a step in the right direction for providers who, to date, have not had an opportunity to even try out participating in a value-based payment model. According to CMS, People with Traditional Medicare who undergo surgery may experience fragmented care, which can lead to complications, prolonged recovery, or potentially avoidable care. TEAM would aim to improve the patient experience from surgery through recovery by supporting the coordination and transition of care between providers and promoting a successful recovery that can reduce avoidable hospital re-admissions and emergency department use. CMS has selected five procedures to be included in this model: lower extremity joint replacement, surgical hip femur fracture treatment, spinal fusion, coronary artery bypass graft, and major bowel procedures.

Elsewhere, cats and dogs were found playing together and America’s Health Insurance Plans, The American Medical Association, and the National Association of ACOs published “Creating a Sustainable Future for Value-Based Care: A Playbook of Voluntary Best Practices for VBC Payment Arrangements.” The Healthcare Leadership Council collaborated with AdventHealth and Wellvana to publish “Achieving the Promise of Patient-Centered Value-Based Care,” a report on a roundtable discussion they hosted earlier this year with “more than 70 leaders from health systems, payers, purchasers, patient advocacy, retail health, public policy, and academia.”

Who knows, some of these ideas might stick. My bet is that, even advocates succeed in getting Congress to update the Medicare payment formula to account for inflation (which would be a heavy lift by itself), we still have a long way to go to reach meaningful, value-based payment. But let’s all grab a cup of coffee and shake off the pollen, because doc pay time is here to stay!

Leave it to a former doc lobbyist to make hospital news all about doctors. Read more about the publication of the Inpatient Prospective Payment System (IPPS) proposed rule below)

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

CMS Publishes the IPPS Proposed Rule

On April 10, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2025 Medicare hospital inpatient prospective payment system (IPPS) and long-term care hospital prospective payment system (LTCH PPS) proposed rule. The proposed rule would update Medicare fee-for-service payment rates and policies for inpatient hospitals and LTCHs for FY 2025 (Fact Sheet).

In a statement shared with the media, Ashley Thompson, AHA’s senior vice president for public policy analysis and development, said AHA is “disappointed that CMS has proposed to increase the long-term care hospital outlier threshold, once again, by an extraordinary amount. Expecting LTCHs to absorb an additional $31,048 loss per patient would greatly exacerbate the resource challenges these hospitals face.” Chip Kahn, CEO of the Federation of American Hospitals, said the proposed pay bump could force hospital “closures in rural and underserved areas.”

#Hospital, #PROVIDER

AdvaMed to CMS: “1,138 Days Without Breakthrough Coverage is Harming Seniors”

AdvaMed, unveiled a timer on the organization’s website to track the number of days since the Centers for Medicare and Medicaid Services (CMS) ended the coverage pathway for FDA-approved breakthrough medical devices. Beginning with the Agency’s decision to delay implementation of the Medicare Coverage for Innovative Technology (MCIT) rule in March 2021, Medicare beneficiaries have waited 1,138 days for an updated rule giving them and their doctors access to breakthrough medical treatments.

#Device, #Patient

Brookings Finds that Surprise Billing Dispute Resolution May Increase Costs to Patients

According to a recent Brookings Institution report analyzing the first tranche of IDR outcome data released by CMS in February, lawmakers’ efforts to end surprise billing without increasing rates is falling short of its mark.

#PATIENT, #PROVIDER, #HOSPITAL

Food and Drug Administration (FDA)

Ten Doctors on FDA Panel Reviewing Abbott Heart Device Had Financial Ties With Company

When the FDA recently convened a Medicare Evidence Development & Coverage Advisory Committee (MedCAC) to consider Abbott’s TriClip device, the agency didn’t disclose that most of the panelists had received payments from the company or conducted research it had funded. One member of the FDA advisory committee was linked to hundreds of payments from Abbott totaling almost $200,000, according to a database maintained by the Department of Health and Human Services. Another was connected to 100 payments totaling about $100,000 and conducted research supported by about $50,000 from Abbott. A third member of the committee worked on research supported by more than $180,000 from the company.

#Device, #Provider

About half of cancer drugs given accelerated approval don’t show improved survival or quality of life

For decades, the Food and Drug Administration’s accelerated approval pathway has helped companies get drugs for serious unmet medical needs to patients — and the market — sooner. But about half of cancer drugs approved via this route fail to improve patient survival or quality of life in subsequent clinical trials after more than five years of follow-up, according to new findings presented at the American Association for Cancer Research annual meeting.

#Drug, #Patient, #Provider

Health and Human Services (HHS)

HHS Releases White Paper Focused on Preventing Drug Shortages

U.S. Department of Health and Human Services (HHS) released a white paper highlighting steps HHS has taken to prevent and mitigate drug shortages and proposing additional solutions for policymakers to consider. Drug shortages have occurred in the nation’s health care system for several decades, largely due to market failures and misaligned incentives.

#Drug, #Patient

Heard on the Hill

E&C Tackles Telehealth

Although MedPAC commissioners seemed to offer unmitigated support for policy that would make permanent the Medicare telehealth expansions that took place during the COVID public health emergency, members of the House Energy and Commerce Health Subcommittee appeared a bit more cautious in a hearing this week. It seems policymakers continue to struggle with precisely which services should be maintained and how long the mandate should last. Underlying this debate are more fundamental question: is telehealth quality healthcare, who is accessing it and why, and will it end up costing more.

#PATIENT, #PROVIDER

Notable Notes

NIH to Host Lecture: Cardiovascular Disease Disparities in Rural America: Can This House of Cards Be Saved?

April 17, 2:00 p.m. – 3:00 p.m. ET, Virtual

The NIH Office of Intramural Research will host a lecture on cardiovascular disease disparities in the rural U.S. This lecture will feature Debra Moser Ph.D., RN, FAHA, FAAN, Assistant Dean of Ph.D. Program & Scholarly Affairs & Linda C. Gill Professor in Nursing at the University of Kentucky College of Nursing.

#All

Cardiology Plans to Defect from American Board of Internal Medicine

Cardiology’s bid to secede American Board of Internal Medicine (ABIM) is well underway, a panel reported at the American College of Cardiology (ACC) annual meeting. ACC is joined by the American Heart Association, Heart Failure Society of America (HFSA), Heart Rhythm Society, and Society for Cardiovascular Angiography & Interventions (SCAI) for a “true house of cardiology movement,” said ACC president B. Hadley Wilson, MD.

#Device, #Drug, #Hospital, #Provider

Positive Data for Impella

On the heels of a Class I recall specifying new surgical risks, a new study has found he Impella heart pump made by J&J’s Abiomed reduced the rate of deaths in heart attack patients with cardiogenic shock, in the first large randomized trial conducted of the device (also published in NEJM), my colleague Lizzy Lawrence reports.

#Device, #Hospital, #Patient, #Provider

Virginia governor vetoes plans to create a prescription drug affordability board

Virginia Gov. Glenn Youngkin vetoed a bill that would have created a new entity for capping the cost of prescription drugs, an increasingly popular tactic that a growing number of state lawmakers around the U.S. are exploring to control their budgets. The Prescription Drug Affordability Board would have set upper payment limits used to cap the cost of a select number of medicines for Virginia residents covered by a state or local government agency or a commercial health plan

#Drug, #Patient, #Payer

WHO Scientists Evaluate Trial Endpoints for GRAIL Cancer Screening

A new analysis challenges the clinical trial endpoint the cancer screening firm Grail is using to evaluate its multi-cancer early detection blood test aimed at simultaneously detecting multiple types of tumors early. In randomized clinical trials of cancer screening, researchers found the correlation between reductions in late-stage cancer and cancer-specific mortality varied meaningfully by cancer type. The end point of late-stage cancer may be an appropriate alternative to cancer-specific mortality for randomized clinical trials of screening for some types of cancer, but not for others.

#Drug, #Patient, #Provider

In Battle Over Health Care Costs, Private Equity Plays Both Sides

Often, when someone gets insurance through an employer and sees a doctor outside the plan’s network, the insurer routes the bill to MultiPlan to recommend an amount to pay. Both MultiPlan and the insurer receive processing fees from the employer, usually based on the size of the final payment: the smaller the payout, the bigger the fees. This business model has made Data iSight a cash cow. Of the handful of tools MultiPlan offers insurers, Data iSight consistently makes the most frugal recommendations, typically resulting in the highest fees. The New York Times explores this in a series of articles (Article 1 / Article 2 / Article 3)

#Payer, #Patient, #Provider

Leave a Comment

Your email address will not be published. Required fields are marked *

Subscribe

Receive our weekly Regulatory Digest in your email inbox each week.
Please enable JavaScript in your browser to complete this form.
Scroll to Top

Subscribe to Savage Health Policy Blog Email

What topics would you like to see covered?

Select list(s):
Share via
Copy link