CMS to Lower Drug Costs and Improve Care by Extending Deadline for GENEROUS Model Application
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CMS to Lower Drug Costs and Improve Care by Extending Deadline for GENEROUS Model Application

The Centers for Medicare & Medicaid Services (CMS) is extending the application deadline for prescription drug manufacturers to apply to the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model—a landmark Innovation Center initiative designed to lower drug spending in Medicaid, improve quality of care and health outcomes by increasing access to critical medications, and strengthen the Medicaid program overall. The extension from March 31, 2026, to April 30, 2026, will provide interested drug manufacturers more opportunity to join the model.

“Based on feedback from drug manufacturers, CMS has decided to give interested companies additional time to apply for the GENEROUS Model,” said CMS Administrator Dr. Mehmet Oz. “We are committed to partnering with states and manufacturers to drive down drug prices and ensure that the most vulnerable Americans have access to life-saving medications.”

State Medicaid programs that choose to participate in the GENEROUS Model, announced in November 2025, will be able to purchase drugs included in the pilot program at prices aligned with those paid in select other countries, allowing state Medicaid programs to benefit from fairer, more competitive pricing. This will be an important tool in meeting President Trump’s Executive Order to lower drug prices for American patients.

“The GENEROUS Model aims to tackle the rising drug costs facing Americans,” said CMS Innovation Center Director Abe Sutton. “Extending this deadline will allow for small and midsize manufacturers to participate and lower costs to the Medicaid program, providing more flexibility for state budgets and ensure that people who depend on Medicaid continue to access the care they need.”

Next steps in the GENEROUS Model include:

- CMS will hold meetings with interested manufacturers about their potential participation in the model. Interested manufacturers that wish to schedule a meeting should contact generousmodel@cms.hhs.gov starting March 2 with the subject line “Small/midsize manufacturer meeting request.” CMS will schedule these meetings beginning April 1, 2026.

- CMS will host a manufacturer town hall to discuss the operational and methodological details of the model in Spring 2026.

The final deadline for manufacturer participation in the GENEROUS Model remains June 30, 2026.

Additional information on the GENEROUS Model is available on the model webpage, including the Request for Applications for drug manufacturers.

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New CMS Proposals Strengthen Medicare, Unleash Innovation and Promote Competition to Provide Kidney Patients with Better Value and Results
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New CMS Proposals Strengthen Medicare, Unleash Innovation and Promote Competition to Provide Kidney Patients with Better Value and Results

Executive order aims to drive innovation in End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and ESRD Quality Incentive Program (QIP), and modernize payment for Durable Medical Equipment (DME)

Today, the Trump Administration through the Centers for Medicare & Medicaid Services (CMS) proposed changes to the Medicare payment rules for Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS), End-Stage Renal Disease (ESRD) Prospective Payment System (PPS), and the ESRD Quality Incentive Program (QIP). Following President Trump’s recent Executive Order on Advancing American Kidney Health, the changes proposed in the rule would strengthen Medicare by improving kidney care and promoting competition in DME by modernizing the way CMS pays for care, reducing regulatory barriers for new treatments and streamlining processes.

“When President Trump signed the historic Executive Order on kidney care earlier this month, he showed that this Administration is committed to improving the lives of patients with kidney disease. Under his leadership, we are eliminating regulatory barriers to unleash innovation that will improve health outcomes and quality of life for patients with chronic disease,” said CMS Administrator Seema Verma. “The changes we are proposing in this rule will also modernize outdated government policies to facilitate greater competition in the DME market, ensure accurate Medicare payments to protect taxpayers and advance innovation across our healthcare system so patients can receive the treatment options that work best for them.”

Currently, there are more than 430,000 Medicare Fee for-Service beneficiaries with ESRD and they typically spend 12 hours a week attached to a dialysis machine. Many beneficiaries with ESRD suffer from poor health outcomes, such as higher hospitalization and mortality rates, often the result of underlying disease complications and multiple co-morbidities.

In 2016, Medicare spent $35.4 billion to cover people with ESRD, representing more than 7.2 percent in Medicare spending. On average, Medicare spends seven times more on beneficiaries with ESRD than the average beneficiary. In order to ensure that ESRD patients receive the best possible care and to ensure that we are maximizing use of taxpayer dollars, changes need to be made.

This proposed rule announced today includes proposals to better recognize costs for new therapies under the ESRD prospective payment system (PPS) that will spur more innovation in kidney care. CMS is proposing that certain new and innovative equipment and supplies used to care for an ESRD patient would qualify for an add-on payment adjustment. This proposed change would create incentives for ESRD facilities to provide the latest therapies that will improve health outcomes.

In this rule, CMS is proposing refinements to eligibility for the transitional drug add-on payment adjustment (TDAPA) under the ESRD PPS to better target the additional payment to innovative renal dialysis drugs and biological products based on the Food and Drug Administration’s (FDA’s) New Drug Application Classifications. CMS is also proposing to exclude generic drugs from TDAPA eligibility so that research can be targeted to new and innovative drugs for patients with ESRD.

CMS is proposing a rule to establish methodologies to modernize the pricing of new Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) items and services. The proposed rule would provide greater transparency for innovators regarding how CMS determines if new items and services are comparable to older items and services for Medicare pricing purposes. The proposed rule also promotes competition and innovation in DMEPOS by setting Medicare payment for new items based on commercial pricing data.

Greater transparency as to how CMS establishes fee schedule amounts for new technology, a gap-filling methodology that recognizes the cost differences between new and older items, and potentially using additional sources of market-based pricing to establish such gap-filled fee schedule amounts should foster improvements and innovations in DMEPOS technology and ensure more competitive prices. This proposed approach to pricing affords greater flexibility to the agency to make sure we are paying for new DMEPOS items and services that are reflective of the market and private sector innovation. Modernizing our payment methodology helps to ensure taxpayers are getting the best deal.

As part of our Patients Over Paperwork initiative, CMS is proposing changes in scoring certain measures in the ESRD Quality Incentive Program (QIP) to streamline our policies and encourage the submission of complete and accurate data. These changes are responsive to stakeholder concerns, and will allow facilities to spend less time reviewing policies and more time providing high quality care.

For a fact sheet on the CY 2020 proposed rule (CMS-1713-P), please visit: https://www.cms.gov/newsroom/fact-sheets/end-stage-renal-disease-esrd-and-durable-medical-equipment-prosthetics-orthotics-and-supplies-dmepos.

To view the proposed rule, please visit: https://www.federalregister.gov/documents/2019/08/06/2019-16369/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis.

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Trump Administration Prioritizes Affordability by Announcing Major Crackdown on Health Care Fraud
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Trump Administration Prioritizes Affordability by Announcing Major Crackdown on Health Care Fraud

Initiative Seeks Input on Strengthening Program Integrity to CRUSH Fraud

Today at the White House, Vice President J.D. Vance, Secretary of Health and Human Services (HHS) Robert F. Kennedy, Jr., and Administrator of the Centers for Medicare & Medicaid Services (CMS) Dr. Mehmet Oz announced new steps to crack down on fraud in Medicare and Medicaid to protect patients and taxpayers and improve affordability. The actions include deferring $259.5 million of quarterly federal Medicaid funding in Minnesota to prevent payment of questionable claims while further investigation is completed; a nationwide moratorium on Medicare enrollment for certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers; and a nationwide call to action for Americans to support fraud prevention, including stakeholder input on how CMS can continue to expand and strengthen its efforts. Together, these steps reflect a coordinated, data-driven strategy to prevent fraud before it occurs, hold bad actors accountable, and protect taxpayer dollars.

“For decades, Medicare fraud has drained billions from American taxpayers—that ends now,” said Secretary Kennedy. “We are replacing the old ‘pay and chase’ model with a real-time ‘detect and deploy’ strategy, using advanced AI tools to identify fraud instantly and stop improper payments before they go out the door.”

“CMS is done trying to catch fraudsters with their hands in the cookie jar—instead, we’re padlocking the jar and letting them starve,” said Administrator Oz. “This proactive approach will help us crush fraud, protect taxpayer dollars, and make sure the vulnerable Americans who depend on our programs get the care they need.”

Minnesota: $259.5 Million Federal Medicaid Funding Deferred

Medicaid is funded jointly by states and the federal government. CMS is required to ensure Medicaid funds are spent lawfully and that states maintain effective systems to detect, prevent, and recover improper payments. When those obligations are not met, CMS has the authority and responsibility to withhold, defer, or disallow federal funds. In January 2026, CMS notified Minnesota of its intent to withhold federal funds until it was satisfied with the state’s corrective action plan to address its program integrity shortcomings. CMS also notified Minnesota of its intent to conduct a review focused on program integrity to ensure federal funds were not going toward questionable claims.

CMS’ review of Minnesota’s Medicaid spending for the fourth quarter in FY 2025 resulted in a deferral of $259,505,491 in federal matching funds. This includes state expenditures of $243.8 million for unsupported or potentially fraudulent Medicaid claims and $15.4 million related to claims involving individuals lacking a satisfactory immigration status. The agency utilized both traditional financial management approaches and new program integrity oversight strategies to identify unusually high spending and rapid growth in certain service areas, including:

- Personal care services;

- Home and community-based services; and

- Other practitioner services.

CMS is deferring those federal funds to protect taxpayer dollars while ensuring the state has the opportunity to respond and provide information and documentation during the ongoing review. Should Minnesota fail to clean up its significant program integrity vulnerabilities or demonstrate that the expenditures are allowable, CMS may defer more than $1 billion in federal funds over the next year. CMS also continues to intensely oversee Minnesota’s efforts to carry out its corrective action plan to address the underlying causes of fraud, waste, and abuse within the state.

Nationwide DMEPOS Enrollment Moratorium/Medicare Program Integrity Initiatives

CMS is taking decisive steps to prevent fraudulent Medicare billing by durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) companies. A six-month moratorium on new Medicare enrollment for certain DMEPOS suppliers builds on CMS’ stopping more than $1.5 billion in suspected fraudulent billing in this area last year. The DMEPOS supplier enrollment moratorium will allow CMS to explore additional safeguards to further mitigate longstanding instances of fraud, waste, and abuse perpetrated by certain DMEPOS companies. It applies to all applications for initial enrollment and changes in majority ownership for medical supply companies.

CMS also plans to publish information on providers/suppliers whose participation in the Medicare program has been revoked, including their National Provider Identifier and the reason for the revocation. This additional transparency will allow patients and payers, including private insurers, to understand which providers have been subject to such administrative enforcement action by the government.

Reduction of fraud, waste, and abuse drives down costs for Medicare beneficiaries. For example, CMS’ recent actions to address abusive pricing practices for skin substitutes helped lower premiums by $11 per month for Medicare beneficiaries by reducing overall Medicare Part B program spending. When CMS adjusts payment rates to better align with market prices and clinical value, it decreases unnecessary or inflated payments for high-cost products. Because Medicare Part B premiums are set to cover a portion of projected program costs, lowering spending on expensive items like certain skin substitutes directly reduces total expenditures. As a result, these savings contribute to slower premium growth and help keep out-of-pocket costs more affordable for beneficiaries while maintaining access to medically necessary treatments.

CRUSH Initiative – Request for Stakeholder Input

CMS is looking to stakeholders to provide input, based on their experience and knowledge, on additional ways the agency can tackle fraud prevention to help inform the development of a possible future rule under CMS’ Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) initiative. The CRUSH request for information (RFI) seeks input from a broad range of stakeholders – including states, providers, suppliers, payers, technology companies, patient advocates, beneficiaries, and others – on ways to strengthen CMS’ ability to prevent, detect, and respond to fraud, waste, and abuse, and program inefficiencies in Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and the Health Insurance Marketplace. Stakeholders can provide input on both existing authorities, as well as ideas for new regulatory approaches.

The actions announced today build on CMS’ broad strategy to combat fraud, waste, and abuse through data-driven prevention and real-time enforcement. In 2025, CMS made significant progress in its fight to crush fraud, including:

- Suspending $5.7 billion in suspected fraudulent Medicare payments by leveraging advanced analytics, cross-agency coordination, and law enforcement partnerships;

- Preventing $1.5 billion in suspected fraudulent DMEPOS billing;

- Denying 122,658 Medicare claims for unnecessary items and services because they failed to satisfy Medicare’s preliminary approval checks that confirm medical necessity and other coverage requirements;

- Revoking the ability of 5,586 providers and suppliers to bill the Medicare program due to inappropriate behavior;

- Sending 372 fraud referrals encompassing $3.7 billion in billing to law enforcement for potential legal action; and

- Initiating a CMS-State Tax Fraud partnership with 28 states and the US Virgin Islands to strengthen state-federal enforcement against healthcare providers and suppliers who commit healthcare and tax fraud.

More information on the DMEPOS moratorium can be found via the Federal Register at: https://www.federalregister.gov/public-inspection/2026-03971/medicare-medicaid-and-childrens-health-insurance-programs-nationwide-temporary-moratoria-on.

Comments on the CRUSH Request for Information must be submitted by March 30, 2026, via the Federal Register at: https://www.federalregister.gov/public-inspection/2026-03968/request-for-information-comprehensive-regulations-to-uncover-suspicious-healthcare (refer to CMS-6098-NC).

More information on CMS’ fraud prevention efforts is available at: www.cms.gov/fraud.

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Mounjaro may be 3 times more effective than Ozempic, study finds
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Woman Details Losing Vision in 1 Eye After Taking GLP-1 As Hundreds of Patients Sue Drug Companies
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Hundreds of Americans are suing the makers of popular GLP-1 weight-loss and diabetes drugs, saying they weren’t adequately warned of the potential danger of vision loss.

Diane Wirth, 66, is one of them. She’s been diagnosed with a rare eye injury known as NAION, the acronym for nonarteritic anterior ischemic optic neuropathy, which has been described as a “stroke of the optic nerve.” There’s no known treatment for the condition.

The nurse practitioner in rural Georgia, who was taking the blockbuster GLP-1 medication Wegovy to lose weight, said her only symptom was a sudden loss of vision in her right eye.

“I woke up one morning and I was like, ‘What is wrong with my eye?’” Wirth told NBC News correspondent Stephanie Gosk.

“I was fine when I went to bed, and I woke up, and the vision was gone. … There was no warning sign at all.”

She described it as initially “missing a wedge” out of her right eye. Now, her vision in that eye is like looking through glasses that have been smeared with petroleum jelly — Wirth can still see light, but can’t read and doesn’t have depth perception, she noted.

Her entire life has been upended: Wirth stopped driving, had to retire early and is now more dependent on others.

“It’s been very challenging, and I would not want anyone else to have to go through this,” Wirth said.

She explained she would have never taken the drug if she knew there was a potential for vision loss, but it was not listed on the drug label. It has not been confirmed that Wirth’s vision loss is a direct result of taking a GLP-1 medication.

Wirth is suing Novo Nordisk, the pharmaceutical giant that makes Wegovy, for damages she alleges were a result of her using the drug. The suit was filed earlier this year in the U.S. District Court for the Eastern District of Pennsylvania.

A spokesperson for Novo Nordisk told NBC News in a statement that it “believes the personal injury lawsuits filed in the U.S. are without merit and (we) are vigorously defending them.”

Jason Goldstein, Wirth’s attorney at Parker Waichman LLP, said his firm represents at least 150 people who’ve been diagnosed with NAION after using a variety of GLP-1 drugs for both weight loss and Type 2 diabetes.

“It’s a devastating condition,” Goldstein told NBC News.

“The label needs to be updated if the companies want to do the responsible thing.”

Pharmaceutical Companies Respond

The drug labels for Ozempic and Mounjaro — which are approved to treat Type 2 diabetes — list “changes in vision” as possible side effects.

The drug labels for Zepbound and Wegovy — which are approved for weight loss — instruct patients with Type 2 diabetes taking those drugs to let their doctor know if they notice vision changes.

According to the World Health Organization, citing the European Medicines Agency, NAION is a very rare side effect of semaglutide, the active ingredient in Ozempic and Wegovy, potentially affecting up to 1 in 10,000 users.

However, a June 2026 systemic review by the American Academy of Ophthalmology did not find evidence of “a consistent overall increase in NAION risk,” the authors wrote.

Novo Nordisk, the pharmaceutical giant that makes semaglutide — the active ingredient in both Ozempic and Wegovy — told NBC News that it hasn’t seen any safety signals in its randomized clinical trials when it comes to NAION, adding that it believes the lawsuits are “without merit.”

Eli Lilly, which makes Zepbound and Mounjaro, also said patient safety is its top priority, adding that it actively monitors safety information for all its drugs. “We will continue to review data, including any data regarding ophthalmic issues,” the company said in a statement.

The U.S. Food and Drug Administration told NBC News it routinely monitors the safety of drugs after they’ve been approved and entered the market. The FDA “identifies safety signals from a variety of sources, evaluates the available data and takes regulatory actions when appropriate,” it noted in a statement.

A study on the risk of NAION in patients with Type 2 diabetes who are using GLP-1s is being conducted by the FDA and in progress.

What Doctors Say About the Risk

A statement by the North American Neuro-Ophthalmology Society and the American Academy of Ophthalmology, published in August 2026, noted that based on current evidence, the “overall magnitude of the risk of NAION remains low” in patients taking GLP-1 drugs such as semaglutide.

“New evidence is emerging rapidly, and the results of future studies may alter the current conclusions,” the authors added.

When it comes to overall incidence of NAION in the U.S., it’s estimated there are 2-10 cases per 100,000 people over the age of 50, according to the American Academy of Ophthalmology.

In patients who take GLP-1s, many papers have found an association with a two- to four-fold increase in risk, which still makes the condition very rare, said Dr. Manjot Gill, a retina specialist and professor of ophthalmology at the Northwestern University Feinberg School of Medicine in Chicago.

“The take-home message would be that while there is an increase in relative risk — and this is really an association, we haven’t determined an absolute causation — the absolute risk is still very small,” Gill told NBC News.

“The overall health benefits of these drugs would likely far outweigh the very small increased risk of this very, very rare complication.”

GLP-1 benefits include better diabetes control and weight loss, plus many other health boosts.

It’s important to weigh the risks and benefits with your doctor, Gill added. She advised patients to be aware of the possible impact on their eyes and immediately tell their doctor if they experience a sudden painless loss of vision.

But when it comes to GLP-1s, vision loss concerns should not outweigh the overall patient’s wellbeing, doctors previously told TODAY.com.

“What we don’t want is for patients to be so fearful of these medicines that they say, ‘Well, I’d rather live with my poorly controlled diabetes out of fear of visual loss,’” said Dr. Sunir Garg, a clinical spokesperson for the American Academy of Ophthalmology and professor of ophthalmology at Wills Eye Hospital in Philadelphia.

“The substantial majority of patients who take these drugs won’t ever have vision problems.”

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