Medicare finalizing coverage policy for coronavirus vaccine

Medicare finalizing coverage policy for coronavirus vaccine

Medicare finalizing coverage policy for coronavirus vaccine

A senior Trump administration official says Medicare will cover the yet-to-be approved coronavirus vaccine free for older people under a policy change expected to be announced soon

Medicare will cover the yet-to-be approved coronavirus vaccine free for older people under a policy change expected to be announced shortly, a senior Trump administration official said Tuesday.

The coming announcement from the Centers for Medicare and Medicaid Services aims to align the time-consuming process for securing Medicare coverage of a new vaccine, drug or treatment with the rapid campaign to have a coronavirus vaccine ready for initial distribution once it is ready, possibly as early as the end of the year.

It’s questionable under normal circumstances if Medicare can pay for a drug that receives emergency use authorization from the Food and Drug Administration, as expected for the eventual coronavirus vaccine. Emergency use designation is a step short of full approval.

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The administration official said Medicare’s announcement will try to resolve several legal technicalities that could conceivably get in the way of delivering free vaccines to millions of seniors, a high-risk group for COVID-19, the disease caused by the coronavirus. The officials spoke to The Associated Press on the condition of anonymity to discuss a pending regulation.

President Donald Trump and lawmakers of both parties in Congress have spelled out their intention that all Americans will be able to get the vaccine for free. But the official said a series of potential legal obstacles that could get in the way of Medicare payment never got unscrambled. 

Earlier this month, Medicare administrator Seema Verma said her agency was close to resolving the issue.

“I think we’ve figured out a path forward,” Verma said at the HLTH conference, a forum for innovators. “It was very clear that Congress wants to make sure that Medicare beneficiaries have this vaccine and that there isn’t any cost-sharing.”

“Stay tuned,” she added.

The $1.8 trillion CARES Act passed by Congress in March called for free vaccination for all Americans, from seniors covered by Medicare to families with employer-sponsored health insurance.

A White House-backed initiative called “Operation Warp Speed” is pushing to have a vaccine ready for distribution in the coming months. The government is spending billions of dollars to manufacture vaccines even before they receive FDA approval, thereby cutting the timeline for delivery. Officials at the FDA have committed that the program will not interfere with their own science-based decisions. Vaccines that don’t meet the test for approval would be discarded.

States have already begun submitting their plans for vaccine distribution to the federal government. 

Initially, it’s expected vaccines will go to people in high-risk groups such as medical personnel, frontline workers and nursing home residents and staff. Older people are also high on the priority list because their risks of serious illness and death from the coronavirus– which has killed more than 225,000 people in the United States– are much higher. It could be well into next year before a vaccine is widely available.

Medicare’s impending announcement was first reported by Politico.

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CVS, Walgreens to help distribute Covid vaccines to nursing homes

CVS, Walgreens to help distribute Covid vaccines to nursing homes

CVS, Walgreens to help distribute Covid vaccines to nursing homes

The federal government has made a deal with retail pharmacies CVS and Walgreens to help distribute coronavirus vaccine — once one or more gets authorized — to long-term care facilities like nursing homes, federal officials said Friday.

The two drugstore chains are the best place to send out mobile units to vaccinate seniors and other vulnerable people on site, Paul Mango, deputy chief of staff for policy at the Health and Human Services Department, told reporters in a telephone briefing.

“This is a completely voluntary program on the part of every nursing home. This is an opt-in program,” Mango said.

It will be up to the drugstore chains to figure out how to deliver the vaccines, including cold storage requirements and personal protective equipment. The retailers also will have to determine how to collect fees from Medicare, Medicaid or private insurers for administering vaccines, which must be provided to people free of charge, officials said.

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Mango said the Operation Warp Speed team did not have any idea of how many nursing homes would choose to use the retailers. “We are not imposing our solution on anyone,” he said.

Operation Warp Speed is the federal government’s program to rapidly develop a coronavirus vaccine.

Dr. Jay Butler, deputy director of infectious diseases at the US Centers for Disease Control and Prevention, noted that a third of coronavirus deaths in the US have been among residents of long-term care facilities.

“We believe that this plan will be the quickest and easiest way to provide vaccines to long-term care facility residents,” Butler told reporters.

Staff and residents of long-term care facilities are expected to be among the first to get vaccinated.

“We fully anticipate that both Pfizer and Moderna will have data of both safety and effectiveness of their vaccines shortly. We are very encouraged because their clinical trials are going extraordinarily well,” Mango said.

“Part of the reason we are doing this is within 24 to 48 hours of the time the emergency use authorization is authorized, we expect to be putting needles into people’s arms,” Mango said. “This is pre-staging for what we believe will be rapid development.”

The CDC had asked states to submit plans for a vaccine distribution by Friday. Army Maj. Gen. Christopher Sharpsten, director of supply and distribution for Operation Warp Speed, said this plan would help provide centralized management and “ensure there is comprehensive vaccine coverage for the American people.”

“Our goal is to broaden vaccine coverage,” Sharpsten said on the call.

Earlier that Friday, President Trump said seniors would be the first to get any vaccine.

“Seniors will be the first in line for the vaccine. And we will soon be ending this pandemic,” Trump said during a visit to Ft. Meyers, Florida.

Pfizer CEO Albert Bourla said in an open letter posted Friday he thought his company would know whether the vaccine it is testing protects against Covid-19 by the third week in November. Moderna CEO Stephane Bancel has made similar predictions for his company’s vaccine.

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Trump administration set to announce Medicare and Medicaid will cover Covid vaccine

Trump administration set to announce Medicare and Medicaid will cover Covid vaccine

Trump administration set to announce Medicare and Medicaid will cover Covid vaccine

The Trump administration is set to announce as early as this week that Medicare and Medicaid will cover out-of-pocket costs for a potential coronavirus vaccine that is granted emergency use authorization, according to a person familiar with the matter.

Coming days before the election, the move could help President Donald Trump among seniors and lower-income Americans even though top medical experts don’t expect a vaccine to be approved until well after Election Day. In the run-up to the election, Trump had applied intense pressure on agencies to deliver policy wins that might help his reelection, aides said.

Officials have been working for several weeks on changing regulations to allow for Medicare and Medicaid recipients to receive free vaccines.

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It’s not clear whether Trump himself will make the announcement of the rule change, though he is working to appeal seniors during stops in Florida later this week.

Politico first reported the coming changes.

There are currently four US Phase 3 trials of coronavirus vaccines as part of the federal government’s Covid-19 vaccine program, Operation Warp Speed.

Dr. Anthony Fauci, the nation’s top infectious disease expert, said Sunday that experts will know by early December whether a potential coronavirus vaccine is safe and effective, but widespread availability will likely not occur until several months into 2021.

Operation Warp Speed aims to have Covid-19 vaccines moved to administration sites within 24 hours of emergency use authorization or Food and Drug Administration license– with the goal of providing the vaccine free of charge.

“In terms of a principle and an aspiration, it’ll be that no American has to pay for a single dime out of pocket to get a vaccine,” Paul Mango, deputy chief of staff for policy at the US Department of Health Human Services, said back in September.

The federal government already struck a deal earlier this month with retail pharmacies CVS and Walgreens to help distribute the coronavirus vaccine– once one or more gets authorized– to long-term care facilities like nursing homes, with no out-of-pocket costs.

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