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Medicare News

Debt Deal Leaves Health Programs (Mostly) Intact
on June 7, 2023 at 6:00 pm
The bipartisan deal to extend the U.S. government’s borrowing authority includes future cuts to federal health agencies, but they are smaller than many expected and do not touch Medicare and Medicaid. Meanwhile, Merck & Co. becomes the first drugmaker to sue Medicare officials over the federal health insurance program’s new authority to negotiate drug prices. Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico, Lauren Weber of The Washington Post, and Jessie Hellmann of CQ Roll Call join KFF Health News’ chief Washington correspondent, Julie Rovner, to discuss these issues and more. Also this week, Rovner interviews KFF Health News senior correspondent Sarah Jane Tribble, who reported the latest KFF Health News-NPR “Bill of the Month” feature, about the perils of visiting the U.S. with European health insurance.
The Debt Ceiling Deal Takes a Bite Out of Health Programs. It Could Have Been Much Worse.
by Julie Rovner, KFF Health News on June 1, 2023 at 11:15 pm
A bipartisan deal to raise the government’s borrowing limit dashed Republican hopes for new Medicaid work requirements and other health spending cuts. Democrats secured the compromise by making relatively modest concessions, including ordering the return of unspent covid funds and limiting other health spending.
When an Anti-Vaccine Activist Runs for President
on May 25, 2023 at 6:30 pm
Robert F. Kennedy Jr.’s official entry into the presidential race poses a thorny challenge for journalists: how to cover a candidate who’s opposed to vaccines without amplifying misinformation. And South Carolina becomes the latest state in the South to ban abortion after roughly six weeks of pregnancy. Alice Miranda Ollstein of Politico, Rachel Cohrs of Stat, and Sarah Karlin-Smith of the Pink Sheet join KFF Health News chief Washington correspondent Julie Rovner to discuss these issues and more. Also this week, Rovner interviews KFF Health News senior correspondent Aneri Pattani about her project to track the billions of dollars coming from opioid makers to settle lawsuits.
The Abortion Pill Goes Back to Court
on May 18, 2023 at 6:15 pm
A three-judge appeals court panel heard testimony this week about revoking the FDA’s 22-year-old approval of a key pill used in medication abortion and miscarriage management. The judges all have track records of siding with abortion foes. Meanwhile, as the standoff over raising the federal debt ceiling continues in Washington, a major sticking point is whether to impose work requirements on recipients of Medicaid coverage. Victoria Knight of Axios, Rachel Roubein of The Washington Post, and Sandhya Raman of CQ Roll Call join KFF Health News chief Washington correspondent Julie Rovner to discuss these issues and more.
Estafas a Medicare con pruebas para covid pueden generar otros fraudes
by Susan Jaffe on May 18, 2023 at 9:00 am
La cobertura de Medicare para las pruebas caseras de covid-19 finalizó hace pocos días, pero las estafas generadas por este beneficio temporal podrían tener consecuencias persistentes para las personas mayores.

Medicare News

Debt Deal Leaves Health Programs (Mostly) Intact June 7, 2023
The bipartisan deal to extend the U.S. government’s borrowing authority includes future cuts to federal health agencies, but they are smaller than many expected and do not touch Medicare and Medicaid. Meanwhile, Merck & Co. becomes the first drugmaker to sue Medicare officials over the federal health insurance program’s new authority to negotiate drug prices. […]
The Debt Ceiling Deal Takes a Bite Out of Health Programs. It Could Have Been Much Worse. June 1, 2023
A bipartisan deal to raise the government’s borrowing limit dashed Republican hopes for new Medicaid work requirements and other health spending cuts. Democrats secured the compromise by making relatively modest concessions, including ordering the return of unspent covid funds and limiting other health spending.
When an Anti-Vaccine Activist Runs for President May 25, 2023
Robert F. Kennedy Jr.’s official entry into the presidential race poses a thorny challenge for journalists: how to cover a candidate who’s opposed to vaccines without amplifying misinformation. And South Carolina becomes the latest state in the South to ban abortion after roughly six weeks of pregnancy. Alice Miranda Ollstein of Politico, Rachel Cohrs of […]
The Abortion Pill Goes Back to Court May 18, 2023
A three-judge appeals court panel heard testimony this week about revoking the FDA’s 22-year-old approval of a key pill used in medication abortion and miscarriage management. The judges all have track records of siding with abortion foes. Meanwhile, as the standoff over raising the federal debt ceiling continues in Washington, a major sticking point is […]
Estafas a Medicare con pruebas para covid pueden generar otros fraudes May 18, 2023
La cobertura de Medicare para las pruebas caseras de covid-19 finalizó hace pocos días, pero las estafas generadas por este beneficio temporal podrían tener consecuencias persistentes para las personas mayores.
A Covid Test Medicare Scam May Be a Trial Run for Further Fraud May 18, 2023
Before the covid-19 public health emergency ended, Medicare advocates around the country noticed a rise in complaints from beneficiaries who received at-home covid tests they never requested. Bad actors may have used seniors’ Medicare information to improperly bill the federal government — and could do it again, say federal investigators.
Health Programs Are at Risk as Debt Ceiling Cave-In Looms May 4, 2023
A warning from the Treasury Department that the U.S. could default on its debt as soon as June 1 has galvanized lawmakers to intervene. But there is still no obvious way to reconcile Republican demands to slash federal spending with President Joe Biden’s demand to raise the debt ceiling and save the spending fight for […]
Dancing Under the Debt Ceiling April 27, 2023
House Republicans passed their plan to raise the nation’s debt ceiling, along with major cuts to health (and other domestic) programs. Unlikely to become law, it calls for new work requirements for adults on Medicaid. Meanwhile, state efforts targeting trans people bear a striking resemblance to the fight against abortion rights. Jessie Hellmann of CQ […]
The ‘Unwinding’ of Medicaid April 6, 2023
As of April 1, states were allowed to begin reevaluating Medicaid eligibility for millions of Americans who qualified for the program during the covid-19 pandemic but may no longer meet the income or other requirements. As many as 15 million people could lose health coverage as a result. Meanwhile, the Medicare Hospital Insurance Trust Fund […]
Congressman Seeks to Plug ‘Shocking Loophole’ Exposed by KHN Investigation March 28, 2023
A federal lawmaker has introduced a House bill that would close one of a laundry list of oversight gaps revealed in a recent KHN investigation of the system regulators use to ban fraudsters from billing government health programs, including Medicare and Medicaid.

FDA News

Regulatory Update — Week of June 5, 2023
Over the past week, the FDA issued final guidances on nonclinical evaluation of the immunotoxic potential of pharmaceuticals, drug-drug interaction assessment for therapeutic proteins and cover letter attachments for controlled correspondence and draft guidances on interstitial cystitis/bladder pain syndrome and ICH E6(R3) guideline for good clinical practice.
FDA Guidance Outlines GDUFA III Fee Program Changes
The FDA sketched out how it is implementing the fee structure of the Generic Drug User Fee Amendments of 2022 (GDUFA III) in a final guidance released Friday.
FDA Should Strengthen Its Policy for Withdrawing Drug Approval, Researchers Say
The FDA should be as willing to withdraw an accelerated approval as to grant it, write a team of researchers, arguing for a balance between speed and certainty.
FDA Gives Warning Letter to iRhythm for Mislabeled Device, Unreported Deaths
The device was labeled for non-critical care, but marketing materials indicated use for “high risk” patients, the agency said.
Promosome Sues Moderna, Pfizer Over COVID-19 Patent Infringement
The company claims that data reveals that Moderna and Pfizer used its patent to develop their vaccines.
AstraZeneca RSV Preventive Gets Nearly Unanimous AdComm Recommendation
The FDA’s Antimicrobial Drugs Advisory Committee, meeting Thursday, was overwhelmingly positive in its assessment of benefits and risks of AstraZeneca’s respiratory syncytial virus (RSV) preventive treatment, nirsevimab, for children.
FDA Issues Final Guidance on Drug-Drug Interaction Studies for Oral Contraceptives
The FDA has finalized its guidance on drug-drug interaction (DDI) studies of investigational drugs with combined oral contraceptives (COC), outlining when these studies are and aren’t needed, how to design them and how to communicate findings.
Lilly Appeals $183M False Claims Hit, Sees New RICO Suit for Bladder Cancer Drug
Eli Lilly has filed an appeal to the U.S. Court of Appeals for the Seventh Circuit following a May 9 decision that it violated the False Claims Act by underpaying rebates to Medicaid.
FDA Denies Intarcia’s Request to Alter AdComm Procedures for Diabetes Treatment
The FDA will not let Intarcia choose reviewers for the upcoming Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to consider the company’s troubled diabetes drug-device product, nor will the agency grant other requests Intarcia made last month.
FDA Drug and Device Approvals — May 2023
New FDA drug approvals in May include the first vaccine for respiratory syncytial virus, a hot flash treatment for menopausal women, a gene therapy for a rare skin disease and the first and only treatment for a rare hematologic disorder. Additionally, the FDA approved a next-generation sequencing-based companion diagnostic test for solid tumor profiling.