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☆ CMS Administrator on Medicare price negotiations: People will see benefits starting next year
▼ + stars: | 2023-08-29 | by ( ) www.cnbc.com time to read: 1 min

Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailCMS Administrator on Medicare price negotiations: People will see benefits starting next yearCenters for Medicare and Medicaid Services Administrator Chiquita Brooks-Lasure joins 'Squawk Box' to discuss the Biden administration's unveiling of the first 10 drugs subject to Medicare price negotiations, how the list of drugs were chosen, and more.

Persons: Chiquita Brooks, Lasure Organizations: Medicare, Biden

☆ Biden administration calls on employers to help keep people insured as millions lose Medicaid
▼ + stars: | 2023-07-20 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

Chiquita Brooks-LaSure testifies before the Senate Finance Committee during her nomination hearing to be administrator of the Centers for Medicare & Medicaid Services in Washington on Thursday, April 15, 2021. The Biden administration on Thursday called on companies to help keep their employees insured as millions of people across the U.S. suddenly coverage through Medicaid. Companies are required to give employees a minimum of 60 days to enroll in their group health plans. Brooks-LaSure said, however, this isn't enough time given how many people are suddenly losing Medicaid coverage. Medicaid coverage surged to a historic high of more than 86 million people by March 2023, a 35% increase over February 2020.

Persons: Chiquita Brooks, LaSure, Biden, Brooks Organizations: Senate, Committee, Centers, Medicare, Medicaid Services, Medicaid, Services Locations: Washington, U.S

☆ Medicare proposes removing limit on PET scans used to help diagnose Alzheimer's disease
▼ + stars: | 2023-07-18 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

Right now, the program for seniors will only cover one PET scan per lifetime for patients participating in clinical trials. The Medicare proposal would allow regional organizations, called Medicare Administrative Contractors, to decide whether to cover the diagnostic tool. It is still unclear when the decision on PET scans will be finalized. PET scans are a crucial diagnostic tool that detect an amyloid protein on the brain that is associated with Alzheimer's disease. People on Medicare generally pay 20% of the cost of a PET scan after meeting their deductible.

Persons: Jay Reinstein, Chiquita Brooks, LaSure Organizations: Georgetown University Hospital, Contractors, Centers, Medicare, Services Locations: Washington , DC, U.S

Trial data showed that the treatment slows progression of the brain-wasting disease by 27% for patients in the earliest stages of Alzheimer's. The FDA placed its strongest "boxed" safety warning on Leqembi's label, flagging the risk of potentially dangerous brain swelling for Alzheimer's drugs in the same class. Leqembi is an antibody designed to remove sticky deposits of a protein called amyloid beta from the brains of Alzheimer's patients. Biogen and Eisai stock has risen since FDA granted accelerated approval to Alzheimer's drug Leqembi earlier this yearLeqembi's new label explains the need to monitor patients for potentially dangerous brain swelling and bleeding associated with amyloid-lowering antibodies. The first FDA-approved disease-modifying Alzheimer's drug, Aduhelm, was also developed by partners Eisai and Biogen, but Medicare coverage restrictions have severely limited its use.

Persons: Leqembi, drugmakers, Ivan Cheung, Chiquita Brooks, LaSure, Babak Tousi, Tousi, Biogen, Dr, Erik Musiek, Eli Lilly, Co's, Cheung, Joanne Pike, Eisai, Leqembi's, Deena Beasley, Julie Steenhuysen, Bill Berkrot, Matthew Lewis Organizations: U.S . Food, Drug Administration, FDA, Medicare, Medicaid Services, Cleveland Clinic, Washington University, Barnes, Jewish, Alzheimer’s Association, Alzheimer's Association, Thomson Locations: ANGELES, U.S, Los Angeles, Chicago

June 30 (Reuters) - The U.S. government on Friday revised its guidance for its Medicare drug price negotiation process, allowing drug companies to publicly discuss the talks, but did not make major changes likely to convince drugmakers to end their suits seeking to halt the program. In September, the U.S. Centers for Medicare and Medicaid Services (CMS) will select 10 of the Medicare program's costliest prescription medicines and negotiate price cuts to go into effect for 2026. That guidance precluded drug makers from talking about the negotiations and required them to eventually destroy data received from CMS. Industry group the Pharmaceutical Research and Manufacturers of America (PhRMA) made an additional claim that the price negotiation program violates the U.S. Constitution's Eight Amendment, which protects against excessive fines. The Biden administration's drug pricing reform aims to save $25 billion annually by 2031 through price negotiations for the drugs most costly to Medicare.

Persons: drugmakers, Joe Biden, Chiquita Brooks, LaSure, Bristol Myers, Merck, PhRMA, Tahir Amin, Amin, Michael Erman, Mark Potter, Nick Zieminski Organizations: U.S, U.S . Centers, Medicare, Medicaid Services, Merck & Co, Bristol Myers Squibb, U.S . Chamber of Commerce, CMS, Merck, Bristol, Industry, Pharmaceutical Research, Manufacturers of America, Reuters, Initiative for Medicines, Biden, Thomson Locations: U.S

☆ Lawmakers worry Medicare Alzheimer's plan won't ensure access to new treatments
▼ + stars: | 2023-06-06 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

Rep. Nanette Barragan (D-CA) speaks alongside US Department of Transportation Secretary Pete Buttigieg after a tour of the Ports of Los Angeles and Long Beach during a press conference at the Port of Long Beach on January 11, 2022 in Long Beach, California. Two Democratic lawmakers are calling on Medicare to provide more information on how the program will make good on its promise to cover Alzheimer's treatments for seniors. Medicare has promised to cover Alzheimer's antibody treatments on the same day the medications receive full approval by the Food and Drug Administration. The federal health program will cover the treatments through Part B of the program for seniors. Eshoo and Barragan told Brooks-LaSure that they are worried the registry could present a barrier to care.

Persons: Nanette Barragan, Pete Buttigieg, Anna Eshoo, Chiquita Brooks, LaSure, Eshoo, Barragan, Brooks Organizations: US Department of Transportation, Port, Democratic, Health, Medicare, Medicaid Services, Food and Drug Administration, FDA Locations: Los Angeles, Long, Port of Long Beach, Long Beach , California

☆ Merck sues US government to halt Medicare drug price negotiation
▼ + stars: | 2023-06-06 | by ( Michael Erman | ) www.reuters.com time to read: +4 min

NEW YORK, June 6 (Reuters) - Merck & Co (MRK.N) sued the U.S. government on Tuesday, seeking to halt the Medicare drug price negotiation program contained in the Inflation Reduction Act (IRA), which it argues is violates the Fifth and First Amendments to the U.S. Constitution. The Biden administration's drug pricing reform aims to save $25 billion annually by 2031 through price negotiations for Medicare. Merck called the talks with CMS coercive and forces drugmakers to participate in "political Kabuki theater" by pretending negotiations are voluntary. The first ever Medicare drug price reduction process is due to begin in September when CMS identifies its 10 most costly drugs. Merck's top selling drug, cancer immunotherapy Keytruda, could be subject to negotiations as soon as 2028.

Persons: drugmakers, Merck, Ameet, Robin Feldman, Wells, Mohit Bansal, Xavier Becerra, Chiquita Brooks, Michael Erman, Patrick Wingrove, Edwina Gibbs, Nick Zieminski Organizations: YORK, Merck & Co, U.S, U.S . Constitution, Biden, Medicare, District of Columbia, Merck, Reuters, CMS, Harvard Medical School, UC College of the, Supreme, U.S . Department of Health & Human Services, Centers, Medicaid Services, LaSure, HHS, Thomson Locations: U.S ., U.S, San Francisco

☆ Medicare details plan to cover Alzheimer's treatments
▼ + stars: | 2023-06-01 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

Medicare Part B will cover treatments for Alzheimer's disease that receive U.S. Food and Drug Administration approval, according to the federal agency that administers the program for seniors. Anyone who has Medicare Part B and meets "eligibility criteria" will be covered for new antibody treatments such as Leqembi once the FDA approves them, said Chiquita Brooks-LaSure, the administrator of the Centers for Medicare & Medicaid Services, on Thursday. Part B is an optional part of the Medicare program for seniors that typically covers the costs of drugs patients cannot administer themselves, such as infusions. The new policy will provide broader access to treatments, such as Leqembi, that slow cognitive decline. Brooks-LaSure said the expanded coverage will go into effect on the same day the FDA approves an Alzheimer's antibody treatment.

Persons: Chiquita Brooks, LaSure, Brooks Organizations: Food, Drug Administration, FDA, Centers, Medicare, Medicaid Services, Leqembi

☆ Bipartisan attorneys general call on Medicare to cover Alzheimer's treatments
▼ + stars: | 2023-05-01 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Democratic and Republican attorneys general in nearly half of U.S. states are calling on Medicare to provide unrestricted coverage of antibody treatments for Alzheimer's disease, according to a letter released Monday. "We ask that CMS provide unrestricted Medicare coverage for FDA-approved Alzheimer's treatments, consistent with its decades-long practice of covering FDA-approved prescription drugs for Medicare beneficiaries," the attorneys general, led by Oklahoma's Gentner Drummond, told CMS Administrator Chiquita Brooks-LaSure and Health Secretary Xavier Becerra. More than 70 House lawmakers and 18 senators called on Medicare to provide unrestricted coverage of Alzheimer's treatments in February. The push by members of Congress and state attorneys general comes after Medicare rejected a request by the Alzheimer's Association to cover Leqembi without any conditions.

☆ Alzheimer's: Medicare will cover Leqembi for all patients if FDA approves drug, CMS chief says
▼ + stars: | 2023-04-26 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

Medicare will cover the new Alzheimer's treatment Leqembi for all patients eligible under the medication's label if the Food and Drug Administration fully approves the drug in July, a federal official told members of Congress on Wednesday. Brooks-LaSure faced pointed criticism from Democrat and Republican members of the House Subcommittee on Health over Medicare's controversial coverage policy for new Alzheimer's treatments. The Food and Drug Administration approved Leqembi, which is a collaboration by Biogen and Eisai antibody treatment, on an expedited basis in January. But Medicare, which primarily provides health coverage to senior citizens, currently will only cover the majority of costs for Leqembi for patients participating in federally approved clinical trials. "When FDA approves the drug, whichever populations they say it is appropriate for, that will be the basis of which people will get the drug," she said.

☆ Medicare rejects Alzheimer's Association request for unrestricted coverage of treatments like Leqembi
▼ + stars: | 2023-02-23 | by ( Spencer Kimball | ) www.cnbc.com time to read: +6 min

The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Due to the drug's high price and Medicare's coverage restrictions, seniors are unable to access the treatment. The letter the Alzheimer's Association sent to CMS in December calling for unrestricted coverage was signed by more than 200 researchers and experts. CMS said it would provide broader coverage of Leqembi on the same day should the FDA fully approve the treatment. Medicare adopted the coverage restrictions after controversy over the Alzheimer's antibody treatment Aduhelm, which was also developed by Eisai and Biogen.

☆ Senators call on Medicare to offer broad coverage of Alzheimer's treatments as public pressure grows
▼ + stars: | 2023-02-17 | by ( Spencer Kimball | ) www.cnbc.com time to read: +5 min

U.S. senators on Friday called for Medicare to offer broad coverage of Alzheimer's treatments approved by the Food and Drug Administration, warning that current restrictions cost patients precious time as their disease progresses. The 20 senators told CMS that Alzheimer's will cost the nation $1 trillion by 2050 if the U.S. does not take decisive action. As a consequence, Medicare coverage for the expensive drug is basically nonexistent. The Alzheimer's Association wrote CMS in December calling for the agency to provide unrestricted Medicare coverage for Leqembi. "We believe Medicare beneficiaries should have unimpeded access, broad and simple access to Leqembi because the data fulfill those criteria."

☆ Maker of promising Alzheimer's drug Leqembi expects full FDA approval this summer, expanded Medicare coverage
▼ + stars: | 2023-02-17 | by ( Spencer Kimball | ) www.cnbc.com time to read: +7 min

Early Alzheimer's typically hits people ages 65 and older, causing cognitive impairment and other issues. Medicare beneficiaries who agree to participate in CMS-backed research studies, which are broader than clinical trials, would get coverage if Leqembi receives full approval. Drug rollout will take yearsIf everything goes according to Eisai's expectations, the FDA would grant full approval and CMS would provide unrestricted coverage of Leqembi. In that scenario, Eisai anticipates that about 100,000 diagnosed early Alzheimer's patients will be eligible by year three of the drug's rollout. Private insurers are largely waiting for a CMS coverage decision though some may decide to make their coverage decisions earlier, he said.

☆ U.S. government to start imposing inflation penalties on drugmakers in 2025
▼ + stars: | 2023-02-09 | by ( ) www.reuters.com time to read: +2 min

REUTERS/Russell Boyce/IllustrationWASHINGTON, Feb 9 (Reuters) - The U.S. government will begin imposing penalties in 2025 on drug companies that charge its Medicare program prices that rise faster than inflation, the Centers for Medicare & Medicaid Services said on Thursday. The agency issued initial guidance on how it will implement a provision in President Joe Biden's signature Inflation Reduction Act that penalizes drugmakers for raising prices faster than inflation. "The Medicare Prescription Drug Inflation Rebate Program will require drug companies with excessive increases in drug prices to pay rebates to Medicare," CMS Administrator Chiquita Brooks-LaSure said in a statement. Companies that raise prices higher than the inflation rate will be required to pay Medicare the difference in the form of a rebate. Price increases for half of all drugs covered by Medicare outpaced inflation from 2019 to 2020, which averaged 1% that year.

☆ Up to 254,000 Medicare beneficiaries are getting new ID cards due to data breach at subcontractor. What they need to know
▼ + stars: | 2022-12-16 | by ( Sarah O'Brien | ) www.cnbc.com time to read: +1 min

Up to 254,000 Medicare beneficiaries' personal information may have been compromised in an online ransomware attack at a government subcontractor, officials warned this week. Letters are being sent to the beneficiaries who were impacted by the potential data breach, said the Centers for Medicare & Medicaid Services. Those affected — who represent less than 0.4% of Medicare's 64.5 million beneficiaries — will also receive a replacement Medicare card with a new identification number in the next few weeks. "The safeguarding and security of beneficiary information is of the utmost importance to this agency," CMS Administrator Chiquita Brooks-LaSure said in the announcement. The personal information that could have been compromised include name, address, date of birth, phone number, Social Security number, Medicare beneficiary identifier, banking information (including routing and account numbers) and Medicare entitlement, enrollment and premium information.

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