Policy Update – Week of July 29, 2024

Introduction
IPPS Final Rule published and seniors wait to see the product of the first Medicare drug price negotiations.

Weekly Spotlight

The IPPS final rule is here and, as Democrats prepare for the DNC, the Biden Administration plans to announce the results of the first-ever, Medicare Part D drug price negotiation authorized under the Inflation Reduction Act of 2022

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

Drug Price Negotiations

Pharma companies less concerned after hearing from US on negotiated prices for Medicare

Four pharmaceutical companies involved in the negotiations over prices for Medicare do not expect a significant impact on their businesses after seeing confidential suggested prices from the government for their drugs that will take effect in 2026

#Drug

Opinion: Medicare drug pricing rules will delay access to promising therapies

Unfortunately, the CMS is interpreting the law in a way that will discourage companies from finding new uses — sometimes lifesaving new uses — for existing drugs.

#Drug, #Patient

Has Medicare gotten a good deal on drug prices?

The deadline for announcing how much Medicare lowered drug prices in the first year of negotiation is Sept. 1, just ahead of U.S. elections. Here are four ways to tell whether the Biden administration got a good deal.

#Drug, #Patient

IPPS Final Rule Published

Medicare reimbursements to inpatient hospitals will increase 2.9% in fiscal year 2025, according to a final CMS rule.

#Hospital

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

The model will launch on January 1, 2026, and run for five years, ending on December 31, 2030. As a mandatory model, all model policies are proposed and finalized through rulemaking. TEAM was designed based on lessons learned from previous episode-based payment models and from input from stakeholders in response to a Request For Information published in 2023.

#HOSPITAL, #Provider

Rural hospitals eye reimbursement boost post-Chevron

Rural hospital CEOs are hoping last month’s Supreme Court ruling that ended decades of deference to federal agencies could lead to revised criteria for the critical access hospital program.

Hospitals that have been excluded from the program are expected to sue the federal government, and if those lawsuits are successful, it could cause the Centers for Medicare and Medicaid Services to overhaul certain regulations and expand eligibility, healthcare lawyers said.

#Hospital

Disruptions loom for telehealth providers and patients as Congress inches closer to deadline

The telehealth legislation currently moving through Congress has bipartisan support, and there’s broad confidence among stakeholders that extensions will be passed. But even with consensus that a deal will get done, nothing is guaranteed given a contentious election ahead and what will be a busy lame duck session in Congress.

#Patient, #Provider

6 Medicare Advantage Data Gaps That the Centers for Medicare and Medicaid Services Must Fill

CAP: CMS must address gaps in Medicare Advantage broker compensation, network adequacy, prior authorization, supplemental benefits use, disenrollment, and enrollee out-of-pocket cost expenditure data.

#Payer

How health insurers have fared so far in 2024

Higher costs and thinner margins in Medicare and Medicaid have challenged the health insurance industry this year.

#Payer

Register Now for the 2025 Self-Nomination and QCDR Measure Submission Question and Answer Session on August 22

The Centers for Medicare & Medicaid Services (CMS) will host a virtual question and answer (Q&A) session on Thursday, August 22, 2024, from 1 – 2:30 p.m. ET. Participants can ask questions during this Q&A session about the Qualified Clinical Data Registry (QCDR) and Qualified Registry Self-Nomination and QCDR Measure Submission processes for the 2025 Merit-based Incentive Payment System (MIPS) performance period.

#All

How NCQA’s quality measures are changing in 2025

The National Committee for Quality Assurance is emphasizing follow-up care, particularly for hypertension and breast cancer assessments, with its newest measure additions to the Healthcare Effectiveness Data and Information Set.

#Payer, #Patient

Food and Drug Administration (FDA)

Disease Awareness and Prescription Drug Communications on Television: Evidence for Conflation and Misleading Product Impressions

When promoting a new drug, a pharmaceutical company may release disease awareness communications about the disease a new drug is intended to treat. Though disease awareness communications focus on the disease itself, consumers can confuse information from these communications with information they may be exposed to in prescription drug advertisements for products that treat the condition and can lead to misunderstanding the benefits of a drug, and consumers may mistakenly assume that the drug will address all the potential consequences of the condition mentioned in the ad.

#Drug, #Patient

In a big step for liquid biopsy, FDA approves a blood screening test for colorectal cancer

FDA approved a blood test intended to detect colon cancer, a product many experts hope will help catch cases of the disease early enough so that they can be more easily treated. CMS will need to agree to cover the test, and usage could also depend on whether the U.S. Preventive Services Task Force recommends the test and for whom.

#Patient

Health and Human Services (HHS)

What’s behind ONC’s name change?

HHS said in a notice posted to the Federal Register on Monday it will streamline technology, cybersecurity, data and artificial intelligence strategy and policy functions under the newly-created Office of the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology.

#All

Hill Happenings

Healthcare advocates spent millions this quarter for policy change. Here are the top 30 spenders

An analysis by Fierce Healthcare identified the top 30 healthcare organizations that burned through the most cash lobbying Congress for healthcare policy changes in the second quarter.

Fourteen organizations spent more than a million dollars each, and the biggest spenders were associations representing hospitals, physicians and Medicare beneficiaries.

#All

Some OB-GYNs aren’t getting abortion training, report finds, while pregnancy complications are on the rise

House Democrats, in a monthslong investigation, interviewed leaders of OB-GYN residency programs and found worrisome effects of abortion restrictions.

#Provider, #Patient

Notable Notes

ASCO Asks Oncologists to Share Stories About Drug Shortages

The American Society of Clinical Oncology(ASCO) appealed to oncologists to share their personal stories about drug shortages and the importance of federal support for cancer research as Congress prepares to act on legislation that could affect patients and providers for years to come.

#Drug

Vizient: Drug costs to increase 3.8% next year

Drug prices are expected to increase 3.81% next year, propelled by expensive cell and gene therapies and glucagon-like peptide agonists. The estimate from Vizient, a group purchasing organization, tops the company’s 2024 drug cost growth projection of 3.42%.

#Drug

Cancer Rates Increased Among Millennials And Gen X, Study Suggests—Here’s Why

The probability of developing almost 20 types of cancers increased among millennials and Generation X compared to baby boomers, according to a new study, and the researchers believe rising obesity rates and more consumption of ultra-processed foods among younger generations may be to blame.

#Patient

US State Restrictions and Excess COVID-19 Pandemic Deaths

If every state had implemented Covid-19 mandates like those in the most restrictive states, hundreds of thousands of deaths could have been avoided, according to a new study.

#Patient

New cardiovascular risk model could greatly decrease use of statins and increase heart attacks, study warns

Just who should be taking a statin is at the heart of two research papers analyzing risk equations released in November 2023, called Predicting Risk of cardiovascular disease EVENTs (PREVENT). That model, developed by the American Heart Association, aimed to improve on a version created in 2013, known as the Pooled Cohort Equations (PCE) and widely criticized for overestimating risk.

#Provider, #Patient

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