Concerned about the courts, some states and universities are stockpiling abortion drugs | CNN



CNN
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With an eye on the courts, a growing number of Democratic-led states are stockpiling the pills that can be used for a medication abortion, the most common form of the procedure in the US.

The officials want to be prepared, in case US District Judge Matthew Kacsmaryk’s decision to suspend the US Food and Drug Administration’s approval of mifepristone goes through, so medication abortions would still be available in their states for some period of time. But they’re taking different approaches to the idea.

New York Gov. Kathy Hochul announced Tuesday that her state’s Department of Health would buy 150,000 doses of misoprostol, the other of the two drugs typically used in a medication abortion.

Misoprostol can be used off-label for an abortion, without mifepristone, but patients often have to use more of it. It would not be covered by the court case, and if Kacsmaryk’s decision stands, the New York City’s Health Department tweeted, it will change to using this medication only.

“Medication abortion continues to be available at our Sexual Health Clinics and NYC Health + Hospitals locations. Should mifepristone become unavailable, we will continue to make medication abortion accessible to all in NYC by shifting to a misoprostol-only treatment regimen,” the tweet said.

The state says the 150,000 doses should represent a five-year supply of pills.

“Anti-choice extremists have shown that they are not stopping at overturning Roe, and they are working to entirely dismantle our country’s reproductive health care system, including medication abortion and contraception,” Hochul said. “New York will always be a safe harbor for abortion care, and I am taking action to protect abortion access in our State and continue to lead the nation in defending the right to reproductive autonomy.”

California is also stocking up on misoprostol.

“While California still believes Mifepristone is central to the preferred regimen for medication abortion, the State negotiated and purchased an emergency stockpile of Misoprostol in anticipation of Friday’s ruling by far-right federal judge Matthew Kacsmaryk to ensure that California remains a safe haven for safe, affordable, and accessible reproductive care,” Gov. Gavin Newsom’s office said in a release Monday.

California plans to purchase up to 2 million pills through CalRx, a state initiative set up to make drugs more affordable.

The governor’s office said the state now has more than 250,000 pills on hand, which it purchased for about $100,000.

California said it shared the terms of its purchase agreement with other members of the Reproductive Freedom Alliance, a nonpartisan coalition of 21 governors who are committed to protecting reproductive rights, and who might also be interested in taking such action.

Another member of that alliance, Washington Gov. Jay Inslee, announced last week that his state bought a three year-supply of mifepristone, the drug at the center of Kacsmaryk’s ruling.

Inslee directed the state Department of Corrections – which has a pharmacy license and is legally able to buy medications – to buy the drug last month, he said, and the shipment was delivered March 31. The University of Washington also purchased 10,000 doses.

Lawmakers are introducing a bill to authorize officials to distribute or sell the medication to licensed providers throughout the state.

“This Texas lawsuit is a clear and present danger to patients and providers all across the country. Washington will not sit by idly and risk the devastating consequences of inaction,” Inslee said. “Washington is a pro-choice state, and no Texas judge will order us otherwise.”

In the meantime, its attorney general, Bob Ferguson, is helping lead a multistate lawsuit to protect access to mifepristone.

On Friday, the same day Kacsmaryk’s ruling came down, a federal judge in Washington ordered the US not to make any changes that would restrict access to mifepristone in the territories that brought the lawsuit: 17 states and the District of Columbia.

On Monday, Massachusetts Gov. Maura T. Healey announced that at her request, the University of Massachusetts and health care providers have also taken action to stockpile doses of mifepristone.

The governor’s office said last week that the university bought about 15,000 doses of mifepristone, enough to cover the commonwealth for about a year, and the pills are expected to arrive this week. Local health care providers have agreed to buy more, and the government agreed to set aside $1 million to pay for those doses.

The Massachusetts governor also signed an executive order confirming protections for medication abortion under existing law.

“Here in Massachusetts, we are not going to let one extremist judge in Texas turn back the clock on this proven medication and restrict access to care in our state,” Healey said. “The action we are taking today protects access to mifepristone in Massachusetts and protects patients and providers from liability. In Massachusetts, we stand for civil rights and freedom. We will always protect access to reproductive health care, including medication abortion.”

Danco Laboratories, the manufacturer of the brand-name version of mifepristone, says that orders for the drug have increased substantially in recent months and are significantly higher than they were at this time last year.

Demand for mifepristone is up across all types of customers, including clinics, pharmacies and individual providers, said Abby Long, Danco’s director of public affairs. But Massachusetts is the only state that has requested an especially large number of pills from the company.

Maine Gov. Janet Mills, who called the Texas decision “reckless” and a “fundamental assault on women’s rights,” said Monday that her administration is evaluating its options, “including procuring mifepristone if needed, to protect access to medication abortion for Maine women.”

The Connecticut governor’s office said Wednesday that it is also monitoring the situation.

Oregon Gov. Tina Kotek’s office said in an email Wednesday that she has directed the Oregon Health Authority to “explore all available avenues for ensuring Oregon is prepared should Mifepristone become less available. That includes evaluating the supply of Mifepristone and Misoprostol and consulting with providers to better understand the potential impact on the provision of abortion and reproductive health care and what additional support might be necessary.”



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First on CNN: HHS secretary sends letter to state governors on what’s to come when Covid-19 public health emergency ends | CNN



CNN
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Plans are moving forward at the US Department of Health and Human Services to prepare for the end of the nation’s Covid-19 public health emergency declaration in May.

On Thursday, HHS Secretary Xavier Becerra sent a letter and fact sheet to state governors detailing what exactly the end of the emergency declaration will mean for jurisdictions and their residents.

“Addressing COVID-19 remains a significant public health priority for the Administration, and over the next few months, we will transition our COVID-19 policies, as well as the current flexibilities enabled by the COVID-19 emergency declarations, into improving standards of care for patients. We will work closely with partners including state, local, Tribal, and territorial agencies, industry, and advocates, to ensure an orderly transition,” Becerra wrote in a draft of the letter obtained by CNN.

“In the coming days, the Centers for Medicare & Medicaid Services (CMS) will also provide additional information, including about the waivers many states and health systems have adopted and how they will be impacted by the end of the COVID-19 PHE,” he wrote. “I will share that resource with your team when available.”

Declaring a public health emergency in the United States means that certain actions, access to funds, grants, waivers and data – among other steps – can happen more quickly in response to the crisis for the duration of the emergency. A declaration lasts 90 days – unless HHS ends it – and may be renewed.

On January 30, the White House announced its intention to end the Covid-19 national and public health emergencies on May 11, signaling that the administration considers the nation to have moved out of the emergency response phase.

Becerra had agreed to give governors a 60-day notice to prepare for the end of the emergency. Thursday’s letter was sent 90 days ahead of the emergency’s planned end.

“We are having ongoing conversations about what else we need to do in the next 90 days to ensure a smooth transition. I can tell you that every one of our agencies has been working hard on this plan,” an HHS official told CNN. “We’re going to have a series of additional materials that will go out, as well as a series of conversations over the coming days and weeks.”

The end of the public health emergency will affect some Medicare and state Medicaid flexibilities provided for the duration of the emergency. This includes waivers like the requirement for a three-day hospital stay before Medicare will cover care at a skilled nursing facility.

“We’ve been working closely with the governors on the public health emergency. This is a combination of both federal flexibilities that we allow, and the states are often the ones who are using those flexibilities,” the HHS official said.

“Just about every aspect of the pandemic response, I would say, has been in partnership with our state partners. And so, I think they have been, frankly for months now, the ones that we have been going to and the ones that we publicly committed to notifying in advance of changes to the public health emergency declaration.”

But the emergency’s end will not impact the authorizations of Covid-19 devices, including tests, vaccines and treatments that have been authorized for emergency use by the US Food and Drug Administration.

During the Covid-19 pandemic, the FDA has issued about 15 times as many emergency use authorizations as it did for all other previous public health emergencies, Commissioner Dr. Robert Califf said Wednesday in a joint hearing of the House Oversight and Investigations and Health subcommittees.

“Today, we’ve issued EUAs or provided traditional marketing authorizations to over 2,800 medical devices for Covid-19, which is 15 times more EUAs than all other previous emergencies combined,” Califf said. He added that the effects of the end of the emergency declaration will be “modest” because the “EUAs are independent of the public health emergency, so we can keep them going as long as we need to.”

The emergency is slated to end May 11. “What happens on May 12? On May 12, you can still walk into a pharmacy and get your bivalent vaccine,” Dr. Ashish Jha, the White House’s coronavirus response coordinator, wrote on Twitter last week.

He said that at some point, probably in the summer or early fall, the Biden administration will transition from federal distribution of Covid-19 vaccines and treatments to purchases through the regular health care system – but that’s not happening quite yet.

Overall, there are additional Medicaid waivers and other flexibilities that states and territories have received under the public health emergency. Some of those will be terminated. But state Medicaid programs will have to continue covering Covid-19 testing, treatments, and vaccinations without cost-sharing through September 30, 2024.

The end of the public health emergency declaration means Medicare beneficiaries will face out-of-pocket costs for over-the-counter home Covid-19 tests and treatment. However, people with Medicare will continue to have no cost for medically necessary lab-conducted Covid-19 tests ordered by their health care providers.

Covid-19 vaccinations will continue to be covered at no cost for all Medicare beneficiaries.

Those with private insurance could face charges for lab tests, even if they are ordered by a provider, according to the Kaiser Family Foundation. Vaccinations will continue to be free for those with private insurance who go to in-network providers, but going to an out-of-network providers could incur charges once federal supplies run out.

And the privately insured will not be able to get free at-home tests from pharmacies and retailers anymore unless their insurers choose to cover them.

Americans with private insurance have not been charged for monoclonal antibody treatment since they were prepaid by the federal government, though patients may be charged for the office visit or administration of the treatment, according to Kaiser. But that is not tied to the public health emergency, and the free treatments will be available until the federal supply is exhausted. The government has already run out of some of the treatments so those with private insurance may already be picking up some of the cost.

The uninsured had been able to access no-cost testing, treatments and vaccines through a different pandemic relief program. However, the federal funding ran out in the spring of 2022, making it more difficult for those without coverage to obtain free services.

Also, the “ability of health care providers to safely dispense controlled substances via telemedicine without an in-person interaction is affected; however, there will be rulemaking that will propose to extend these flexibilities,” according to the letter’s fact sheet.

One of the most meaningful pandemic enhancements for states is no longer tied to the public health emergency. Congress severed the connection in December as part of its fiscal year 2023 government funding package, which state Medicaid officials had urged lawmakers to do.

States will now be able to start processing Medicaid redeterminations and disenrolling residents who no longer qualify, starting April 1. They have 14 months to review the eligibility of their beneficiaries.

As part of a Covid-19 relief package passed in March 2020, states were barred from kicking people off Medicaid during the public health emergency in exchange for additional federal matching funds. Medicaid enrollment has skyrocketed to a record 91 million people since then.

A total of roughly 15 million people could be dropped from Medicaid when the continuous enrollment requirement ends, according to an analysis the Department of Health and Human Services released in August. About 8.2 million folks would no longer qualify, but 6.8 million people would be terminated even though they are still eligible, the department estimated.

Many who are disenrolled from Medicaid, however, could qualify for other coverage.



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