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After abortion ruling, biotechs behind novel contraceptives say tide is turning on insurance coverage

For Whitney, the desire to eventually have kids sparked a search for a new type of birth control. Another IUD would prevent pregnancy for too long and…



For Whitney, the desire to eventually have kids sparked a search for a new type of birth control. Another IUD would prevent pregnancy for too long and she needed an alternative until she was ready for children. In 2020, she finally found an option she liked: a new vaginal ring called Annovera developed by TherapeuticsMD. But there was an issue. After changing jobs, her insurance plan denied coverage.

Her options? Switch contraceptives and risk grueling side effects, or embark on a lengthy appeal process. “I kind of just gave in and just took what they were offering me,” said Whitney, who is 34 years old and lives in Wisconsin.

Whitney, who asked that her last name be withheld for privacy reasons, ended up on a birth control pill. It can be difficult to remember to ingest the pill every day, which once forced her to take Plan B, also known as the “morning-after pill.”

“If I had had the birth control that I wanted, I wouldn’t have been in this situation,” she said. “It’s just frustrating.” Whitney isn’t alone in her frustration.

Getting insurers to cover new contraceptives can be difficult, an issue thrust into the spotlight after the Supreme Court overturned Roe v. Wade. As state laws restricting abortion take effect, women’s health advocates and the federal government are pushing payers to provide as many birth control options as possible, including newer products that often aren’t covered by insurance.

Contraceptives are not one-size-fits all, and what works for one woman may cause side effects in another — ranging from weight gain and mood swings to blood clots.

Biotechs — aided by updated regulations, a federal crackdown and public pressure — say the insurance industry is beginning to show more of a willingness to pay for novel forms of birth control. In a sign of greater investor interest in the space, Agile Therapeutics, a women’s contraception company, recently raised more than $24 million in a public offering.

The Affordable Care Act requires that most insurance plans fully cover contraceptives approved by the FDA and prescribed by a clinician. However, lawmakers and women’s health advocates say that insurers have routinely shirked their responsibilities over the last decade.

Saundra Pelletier

Evofem, a biotech that won FDA approval for a non-hormonal birth control gel called Phexxi in 2020, initially struggled to secure insurance coverage. But after the Supreme Court’s draft decision leaked in May and prodding from the federal government, insurers now cover 75% percent of product claims, up from 55% a year ago. That’s according to Evofem CEO Saundra Pelletier, who said there’s more work to do.

“They just weren’t doing the right thing for women,” Pelletier said of some insurers. “But now, when they recognize these attacks on women are real and pervasive and could be increasing, they’re really starting to step up and say, ‘Look, we don’t want to be the holdout.’”

Al Altomari

Agile Therapeutics CEO Al Altomari said that clinicians seem more willing to fight for women’s choice in birth control in recent months, while smaller insurance companies are showing more openness to covering the company’s product. Some of the large pharmacy benefit managers haven’t moved just yet, he added — but he believes eventually they will.

His company’s hormonal birth control patch called Twirla was approved in 2020. Agile touts the product as a lower-dose and more convenient option than other patches and birth control pills. Women apply the patch once a week for three weeks, followed by an off-week when their cycle occurs.

Twirla’s first few quarters on the market were challenging, Altomari said, between struggling with insurers and launching in the middle of a pandemic.

“There has been really a lot of noncompliance by the insurance companies and this has been really a big issue that’s actually ended up in the White House,” he said. “It’s hurting all of our companies, including ours.”

But the Supreme Court decision in ​​Dobbs v. Jackson Women’s Health Organization triggered new interest in the company, fueling Agile’s public offering that raised $24 million earlier this month and another at-the-market raise of $12.8 million.

“We’re growing, we think in the second quarter somewhere between 25 and 30% quarter-on-quarter growth, despite these challenges,” Altomari said. “We think things are going to get a lot better, faster for all of us.”

Some drugmakers argue holes in insurance coverage have stifled innovation. Just look at Big Pharma, which hasn’t made much progress on the contraception front in the last decade or so, Altomari said.

“All the innovation in contraception, in particularly the last 10 to 15 years, has come out of little companies,” he said. “Each one of these companies has passion for the space.”

When its gel launched, Evofem also found itself in insurance purgatory. Some payers didn’t want to cover Phexxi because it didn’t fit into existing birth control categories that are part of a federal list guiding coverage decisions. Pelletier said Evofem asked HHS to update the list, but the agency stated it shouldn’t be a proxy for coverage decisions.

Endpoints reached out to HHS’ Office on Women’s Health, which oversees the guidance, but did not receive a response as of press time.

In January, the Women’s Preventive Services Initiative, which works with HHS, recommended that “any FDA-approved, -granted or -cleared contraceptives” should be made accessible as part of contraceptive care. The language has been widely interpreted to mean insurers should cover birth control.

Mara Gandal-Powers

“It is pretty clear that if something has approval from the FDA, it should be getting coverage,” said Mara Gandal-Powers, director of birth control access at the National Women’s Law Center.

But there still might be exceptions. A plan can charge a cost-sharing fee for birth control filled at an out-of-network pharmacy if they have it covered without cost-sharing at an in-network pharmacy, Gandal-Powers noted. In addition, some employer plans were grandfathered in when the ACA went into effect, and don’t need to cover preventive services.

A 2020 report sponsored by the Kaiser Family Foundation and nonprofit Susan Thompson Buffett Foundation found that the share of oral contraceptive users paying out-of-pocket dropped from 96% in 2010 to 10% in 2018 after the Affordable Care Act passed. But many women are still paying out of pocket for contraception.

Gandal-Powers said that some insurance plans violate HHS’ most recent guidance by requiring patients to try a number of products first before they can get coverage for a newer form of birth control that isn’t on the list. She has seen plans that require women to try eight products before they can get full coverage for their choice, regardless of what a clinician has recommended. And many women don’t realize they can appeal decisions that flat-out deny coverage, she said.

If a woman’s first choice is denied, plans are supposed to have “an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or a provider,” according to updated 2015 guidance issued by HHS, which allows women to get access with the help of a provider.

“We’re sort of seeing twofold with newer products, that plans are saying they don’t have to cover them because they don’t appear on this outdated list, and plans don’t have the cautionary exceptions process in place,” Gandal-Powers said.

Insurance companies continue to face pressure in the weeks since the Dobbs decision, as the Biden administration has stepped up efforts to compel insurers to cover birth control. Last month, HHS Secretary Xavier Becerra, Treasury Secretary Janet Yellen and Labor Secretary Martin Walsh said in a letter to payers that they’ve received “troubling and persistent reports” of noncompliance.

“For this reason, we are calling on your organizations to remove impermissible barriers and ensure individuals in your plans have access to the contraceptive coverage they need, as required under the law. It is more important than ever to ensure access to contraceptive coverage without cost sharing, as afforded by the ACA,” they wrote.

If a plan fails to comply with the act, there’s a range of enforcement actions the government can take, including monetary penalties, Gandal-Powers said. For more than 10 years, the National Women’s Law Center has been running a hotline to help women understand what’s covered under their plan, and how to appeal decisions that don’t comply with the ACA.

When asked for comment on their policies around contraceptives, the Blue Cross Blue Shield Association, a federation of locally operated Blue Cross companies, issued a statement:

BCBS companies take compliance with state and federal laws very seriously and are committed to ensuring access to preventative services, including contraception. BCBS companies are reviewing existing policies to make sure there are no unintended barriers to contraceptive access for members.

Aetna International declined to comment, while Humana and UnitedHealth Group did not respond as of press time.

For Evofem and other biotechs, it isn’t just payers that are paying more attention. Women, clinicians and even investors have been more engaged, Pelletier said. Evofem’s stock more than doubled after the Dobbs ruling and has maintained the momentum. Prescriptions are also up, Pelletier noted.

Sabrina Johnson

“It also reinforces for healthcare investors — this is healthcare,” said Daré Bioscience CEO Sabrina Johnson. “All of a sudden we’ve shone a spotlight on the category and it’s becoming noticed.”

Even though Daré’s lead candidate hasn’t yet entered a Phase III trial, Johnson knew the company would need to start conversations with payers and regulators early on. And being differentiated enough from other products should make it easier to get coverage, she said.

The company is working on a vaginal ring called Ovaprene. It’s similar to the NuvaRing in shape and size, but unlike other products, it’s non-hormonal. Ovaprene has a knitted polymer barrier, which is porous but doesn’t allow sperm to reach the cervix. From the center, the ring releases a form of iron that interferes with sperm mobility.

Daré partnered with both Bayer and the National Institutes of Health, which is co-funding the Phase III trial that’s slated to begin this year. Since the Supreme Court decision, the company has also seen heightened interest from additional investors, according to Johnson.

“There are certain investors who have been outspoken about the SCOTUS decision,” she said.

Will that translate to long-term interest? It’s difficult to say, as the field is risky. However, getting on the right birth control early is of increasing concern to the millions of women whose abortion rights have now been revoked or called into question.

TherapeuticsMD, which developed Whitney’s preferred birth control option, did not respond to a request for comment.

Wisconsin, where Whitney lives, adopted an abortion ban in 1849. And though the state’s governor Tony Evers has said the ban won’t be enforced, some clinics have already halted abortions.

“It’s more about having a choice over your body and what’s best for you,” Whitney said. “No one can make that decision better than yourself.”

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Costco Tells Americans the Truth About Inflation and Price Increases

The warehouse club has seen some troubling trends but it’s also trumpeting something positive that most retailers wouldn’t share.



Costco has been a refuge for customers during both the pandemic and during the period when supply chain and inflation issues have driven prices higher. In the worst days of the covid pandemic, the membership-based warehouse club not only had the key household items people needed, it also kept selling them at fair prices.

With inflation -- no matter what the reason for it -- Costco  (COST) - Get Free Report worked aggressively to keep prices down. During that period (and really always) CFO Richard Galanti talked about how his company leaned on vendors to provide better prices while sometimes also eating some of the increase rather than passing it onto customers.

DON'T MISS: Why You May Not Want to Fly Southwest Airlines

That wasn't an altruistic move. Costco plays the long game, and it focuses on doing whatever is needed to keep its members happy in order to keep them renewing their memberships.

It's a model that has worked spectacularly well, according to Galanti.

"In terms of renewal rates, at third quarter end, our US and Canada renewal rate was 92.6%, and our worldwide rate came in at 90.5%. These figures are the same all-time high renewal rates that were achieved in the second quarter, just 12 weeks ago here," he said during the company's third-quarter earnings call.

Galanti, however, did report some news that suggests that significant problems remain in the economy.

Costco has done an incredibly good job at holding onto members.

Image source: Xinhua/Ting Shen via Getty Images

Costco Does See Some Economic Weakness

When people worry about the economy, they sometimes trade down when it comes to retailers. Walmart executives (WMT) - Get Free Report, for example, have talked about seeing more customers that earn six figures shopping in their stores.

Costco has always had a diverse customer base, but one weakness in its business may be a warning sign for its rivals like Target (TGT) - Get Free Report, Best Buy (BBY) - Get Free Report, and Amazon (AMZN) - Get Free Report. Galanti broke down some of the numbers during the call.

"Traffic or shopping frequency remains pretty good, increasing 4.8% worldwide and 3.5% in the U.S. during the quarter," he shared.

People shopped more, but they were also spending less, according to the CFO.

"Our average daily transaction or ticket was down 4.2% worldwide and down 3.5% in the U.S., impacted, in large part, from weakness in bigger-ticket nonfood discretionary items," he shared.

Now, not buying a new TV, jewelry, or other big-ticket items could just be a sign that consumers are being cautious. But, if they're not buying those items at Costco (generally the lowest-cost option) that does not bode well for other retailers.

Galanti laid out the numbers as well as how they broke down between digital and warehouse.

"You saw in the release that e-commerce was a minus 10% sales decline on a comp basis," he said. "As I discussed on our second quarter call and in our monthly sales recordings, in Q3, big-ticket discretionary departments, notably majors, home furnishings, small electrics, jewelry, and hardware, were down about 20% in e-com and made up 55% of e-com sales. These same departments were down about 17% in warehouse, but they only make up 8% in warehouse sales."

Costco's CFO Also Had Good News For Shoppers

Galanti has been very open about sharing information about the prices Costco has seen from vendors. He has shared in the past, for example, that the chain does not pass on gas price increases as fast as they happen nor does it lower prices as quick as they sometimes fall.

In the most recent call, he shared some very good news on inflation (that also puts pressure on Target, Walmart, and Amazon to lower prices).

"A few comments on inflation. Inflation continues to abate somewhat. If you go back a year ago to the fourth quarter of '22 last summer, we had estimated that year-over-year inflation at the time was up 8%. And by Q1 and Q2, it was down to 6% and 7% and then 5% and 6%," he shared. "In this quarter, we're estimating the year-over-year inflation in the 3% to 4% range."

The CFO also explained that he sees prices dropping on some very key consumer staples.

"We continue to see improvements in many items, notably food items like nuts, eggs and meat, as well as items that include, as part of their components, commodities like steel and resins on the nonfood side," he added.


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Under Pressure From Fat Activists, NYC Bans Weight Discrimination

Under Pressure From Fat Activists, NYC Bans Weight Discrimination

Discriminating against fat people is now illegal in New York City, after…



Under Pressure From Fat Activists, NYC Bans Weight Discrimination

Discriminating against fat people is now illegal in New York City, after Mayor Eric Adams on Friday signed off on a ban that will affect not only employment, but also housing and access to public accommodations -- a term that encompasses most businesses. 

We're in safe company using the word "fat," as champions of the cause refer to themselves as "fat activists." With the mayor's signature, two more categories -- both weight and height -- are added to New York City's list of protected personal attributes, which already included race, gender, age, religion and sexual orientation. 

As Mayor Adams signs the law, self-described (and everyone else-described) fat activist Tigress Osborn consumes more than her share of the backdrop (James Messerschmidt for NY Post)

Embracing one of 2023's innumerable strains of Orwellian brainwashing, Adams declared, "Science has shown that body type is not a connection to if you’re healthy or unhealthy. I think that’s a misnomer that we’re really dispelling.”

Even the Centers for Disease Control and Prevention say obesity is an invitation to a host of maladies, including to high blood pressure Type 2 diabetes, coronary heart disease, stroke, gall bladder disease, many types of cancer, mental illness and difficulty with physical functioning. 

“Size discrimination is a social justice issue and a public health threat," said Councilmember Shaun Abreu, who introduced the measure. "People with different body types are denied access to job opportunities and equal wages — and they have had no legal recourse to contest it," said Abreu. "Worse yet, millions are taught to hate their bodies." 

A full 69% of American adults are overweight or obese, but our woke overlords would have us believe the real "public health threat" is a nice restaurant that doesn't want Two-Ton Tessie working the reception desk, or a landlord who's leary of a 400-pound man breaking a toilet seat or collapsing a porch.  

The enticingly-named Tigress Osborn, who chairs the National Association to Advance Fat Acceptance, said New York's ban "will ripple across the globe" -- perhaps something like what would happen if the hefty Smith College Africana Studies graduate were dropped into a swimming pool.  

Councilmember Shaun Abreu said he gained 40 pounds during the pandemic lockdowns and noticed people treated him differently

The New York Times reports that witnesses who testified as the measure was under consideration included "a student at New York University said that desks in classrooms were too small for her [and] a soprano at the Metropolitan Opera [who] said she had faced body shaming and pressure to develop an eating disorder." 

Some have dared to speak out against the measure. “This is another mandate where enforcement will be primarily through litigation, which imposes a burden on employers, regulators and the courts,” said Kathryn S. Wylde, president of the Partnership for New York City, speaking in April. 

Implicitly putting the weight ordinance in the same category as Brown vs Board of Education, Abrue said, “Today is a monumental advancement for civil rights, size freedom and body positivity and while our laws are only now catching up to our culture, it is a victory that I hope will cause more cities, states and one day the federal government to follow suit.” 

Taking effect in six months, the law has an exemption for employers "needing to consider height or weight in employment decisions" -- but "only where required by federal, state, or local laws or regulations or where the Commission on Human Rights permits such considerations because height or weight may prevent a person from performing essential requirements of a job." 

We pray there's a federal exemption for employers of strippers and lap dancers. 

Think we're joking? We remind you that the chair of the National Association to Advance Fat Acceptance is named "Tigress" -- and this is her Twitter profile banner photo:

via Tigress @iofthetigress
Tyler Durden Sun, 05/28/2023 - 15:30

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‘Kevin Caved’: McCarthy Savaged Over Debt Ceiling Deal

‘Kevin Caved’: McCarthy Savaged Over Debt Ceiling Deal

Update (1345ET): The hits just keep coming for Speaker Kevin McCarthy, as angry Republicans…



'Kevin Caved': McCarthy Savaged Over Debt Ceiling Deal

Update (1345ET): The hits just keep coming for Speaker Kevin McCarthy, as angry Republicans have been outright rejecting the debt ceiling deal which raises it by roughly $4 trillion for two years, doesn't provide sticking points sought by the GOP.

In short, Kevin caved according to his detractors.

Some Democrats aren't exactly pleased either.

"None of the things in the bill are Democratic priorities," Rep. Jim Himes (D-CT) told Fox News Sunday. "That's not a surprise, given that we're now in the minority. But the obvious point here, and the speaker didn't say this, the reason it may have some traction with some Democrats is that it's a very small bill."

*  *  *

After President Biden and House Speaker Kevin McCarthy (R-CA) struck a Saturday night deal to raise the debt ceiling, several Republicans outright rejected it before it could even be codified into a bill.

Here's what's in it;

  • The deal raises the debt ceiling by roughly $4 trillion for two years, and is consistent with the structure of budget deals struck in 2015, 2018 and 2019 which simultaneously raised the debt limit.
  • According to a GOP one-pager on the deal, it includes a rollback of non-defense discretionary spending to FY2022 levels, while capping topline federal spending to 1% annual growth for six years.
  • After 2025 there are no budget caps, only "non-enforceable appropriations targets."
  • Defense spending would be in-line with what Biden requested in his 2024 budget proposal - roughly $900 billion.
  • The deal fully funds medical care for veterans, including the Toxic Exposure Fund through the bipartisan PACT Act.
  • The agreement increases the age for which food stamp recipients must seek work to be eligible, from 49 to 54, but also includes reforms to expand who is eligible.
  • Claws back "tens of billions" in unspent COVID-19 funds
  • Cuts IRS funding 'without nixing the full $80 billion' approved last year. According to the GOP, the deal will "nix the total FY23 staffing funding request for new IRS agents."
  • The deal includes energy permitting reform demanded by Republicans and Sen. Joe Manchin (D-WV)
  • No new taxes, according to McCarthy.

Here's McCarthy acting like it's not DOA:

Yet, Republicans who demanded deep cuts aren't having it.

"A $4 trillion debt ceiling increase?" tweeted Rep. Andrew Clyde (R-GA). "With virtually none of the key fiscally responsible policies passed in the Limit, Save, Grow Act kept intact?"

"Hard pass. Hold the line."

"Hold the line... No swamp deals," tweeted Rep. Chip Roy (R-TX)

"A $4 TRILLION debt ceiling increase?! That's what the Speaker's negotiators are going to bring back to us?" tweeted Rep. Dan Bishop (R-NC). "Moving the issue of unsustainable debt beyond the presidential election, even though 60% of Americans are with the GOP on it?"

Rep. Keith Self tweeted a letter from 34 fellow House GOP members who are committing to "#HoldTheLine for America" against the deal.

"Nothing like partying like it’s 1996. Good grief," tweeted Russ Vought, President of the Center for Renewing America and former Trump OMB director.

In short:

Tyler Durden Sun, 05/28/2023 - 11:30

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