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U.S. Federal Courts

Justice Department appeals federal judge’s ACA ruling

Decision impacts PrEP, other preventative health services

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The Pride flag over the Justice Department's D.C. headquarters (Photo courtesy of the Justice Department)

Justice Department attorneys filed a notice of appeal Friday with the 5th U.S. Circuit Court of Appeals on behalf of the Department of Health and Human Services after U.S. District Judge Reed O’Connor ruled that employers cannot be forced to cover specified preventive health care services under the Affordable Care Act.

Thursday’s ruling means that more than 150 million Americans on employer-sponsored health plans will lose some cost-free coverage for immunizations, contraception, cancer screenings and PrEP.

O’Connor’s ruling struck down the recommendations that have been issued by the U.S. Preventive Services Task Force regarding the preventive care treatments provisions required by the ACA directing insurers provide at no cost to the patient.

White House Press Secretary Karine Jean-Pierre released a statement on the Justice Department decision to appeal:

“The president is glad to see the Department of Justice is appealing the judge’s decision, which blocks a key provision of the Affordable Care Act that has ensured free access to preventive health care for 150 million Americans. This case is yet another attack on the Affordable Care Act, which has been the law of the land for 13 years and survived three challenges before the Supreme Court.
 
Preventive care saves lives, saves families money, and protects and improves our health. Because of the ACA, millions of Americans have access to free cancer and heart disease screenings. This decision threatens to jeopardize critical care.
 
The administration will continue to fight to improve health care and make it more affordable for hard-working families, even in the face of attacks from special interests.”

AIDS Healthcare Foundation President Michael Weinstein decried O’Connor’s ruling saying:

“Stripping away access to preventive care will hurt tens of millions of Americans. These services are essential, and eliminating them will have dangerous consequences. While we expect this unconstitutional ruling ultimately will fail, the decision creates uncertainty and is a threat to public health.

“With this devastating ruling, a Trump-appointed judge placed the health of millions of Americans in extreme danger, based on an extremist political agenda. Undermining screenings and treatment for cancer, blood pressure, pregnancy, and mental health doesn’t just hurt individuals — it damages the health of the entire country,” California state Sen. Scott Wiener said.

“The effect of this decision on HIV prevention will be disastrous. In recent years, we’ve made incredible progress reducing the number of new HIV infections, largely because hundreds of thousands of people are now taking PrEP, an HIV prevention drug proven to be essentially 100 percent effective. This decision reverses that progress by allowing health plans to charge patients through the nose for this life-saving medication, raising barriers to access for the communities of LGBTQ people and people of color most at risk. Judge O’Connor will soon have thousands of new HIV cases on his conscience,” Wiener added.

Equality California, the nation’s largest statewide LGBTQ civil rights organization, released the following statement from Executive Director Tony Hoang in response to a ruling from O’Connor:

“Judge Reed O’Connor, already having attempted to invalidate the Affordable Care Act as a whole in 2018, has once again issued a ruling that puts the lives of Americans in danger. Preventive care is essential in helping to screen for potential severe health conditions and attempt to mitigate them — this ruling affects screenings for cancer, diabetes, STDs, cardiovascular disease, and so much more.

More than 150 million Americans currently have private insurance with coverage for preventive care under the ACA, yet a partisan judge in Texas is attempting to single handedly rollback access to these basic health care services. Equality California is committed to ensuring that these critical preventive services remain in place for the health of all Americans. We expect an appeal of this decision immediately. 

Thankfully, most health plans in California are unaffected by today’s ruling because existing state law already requires health plans regulated in California to cover preventive services without cost sharing. Today’s ruling may affect a small subset of employer-sponsored health plans that are not regulated by the state.

Equality California is proud to be sponsoring legislation with Assemblymember Rick Chavez Zbur and Insurance Commissioner Ricardo Lara, AB (Assembly Bill) 1645, which will strengthen existing law and go even further to ensure that Californians have access to essential preventive services, including STD screening and PrEP for HIV prevention. While right-wing judges and politicians are attempting to roll back our rights and inflict harm on LGBTQ+ people, California will continue doubling down to protect the health and safety of our communities.”

Read the notice of appeal here:

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U.S. Federal Courts

DOJ to ask Supreme Court to halt courts’ mifepristone restrictions

Texas judge, 5th Circuit ruled against abortion drug

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U.S. Supreme Court (Washington Blade photo by Michael Key)

The Justice Department is expected to ask the U.S. Supreme Court to halt a pair of rulings by a federal court in Texas and a federal appellate court in New Orleans that would restrict the sale and distribution of the abortion pill mifepristone.

Last week, Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas issued a stay of the U.S. Food and Drug Administration’s approval of the drug 23 years ago, effectively barring its sale and distribution nationwide.

The 5th U.S. Court of Appeals ruled late Wednesday night that access to the drug would not be prohibited pending the outcome of litigation in the case, Alliance for Hippocratic Medicine v. FDA.

However, in the meantime the appellate court preserved other restrictions on mifepristone from Kacsmaryk’s ruling including the prohibition of distributing the medicine by mail or prescribing its FDA approved generic equivalent and requiring that it be prescribed only after three in-person visits with a healthcare provider, and only up to seven weeks of pregnancy.

“The Justice Department strongly disagrees with the 5th Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal,” U.S. Attorney General Merrick Garland said in a statement on Thursday.

“We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care,” Garland said.

“We are going to continue to fight in the courts, we believe the law is on our side, and we will prevail,” White House Press Secretary Karine Jean-Pierre told reporters early Thursday during President Joe Biden’s trip to Ireland.

The Supreme Court typically acts on such requests in a matter of days, often without explanation.

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U.S. Federal Courts

Federal appeals court preserves access to abortion drug

The Court also set tighter rules for accessing mifepristone

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A courtroom for the U.S. 5th Circuit Court of Appeals in the John Minor Wisdom United States Courthouse in New Orleans, Louisiana. (Carol M. Highsmith, photographer, Library of Congress Prints and Photographs Division)

A three judge panel of the 5th U.S. Circuit Court of Appeals issued a ruling Wednesday just before midnight in New Orleans that has preserved access to the abortion drug mifepristone.

In a 2-1 vote the panel blocked the lower court ruling by Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas for now, but set tighter rules that would allow the drug only to be dispensed up to seven weeks into pregnancy, not 10, and not by mail.

In his ruling in Alliance for Hippocratic Medicine v. FDA, Kacsmaryk had issued a stay on the Food and Drug Administration’s conclusion that mifepristone, which is used in combination with a second drug, misoprostol, is safe and effective, a finding the agency reached in 2000 that has since been buttressed by more than two decades of clinical evidence. Kacsmaryk’s ruling had been on pause for a week to allow the U.S. Justice Department to file the appeal with the 5th Circuit Court.

U.S. Attorney General Merrick Garland immediately ordered the Justice Department to appeal and seek a stay (of Kacsmaryk’s stay) pending the outcome of additional litigation. On Monday the Department asked the U.S. Court of Appeals for the Fifth Circuit to halt implementation of the ruling.

The Associated Press reported that under the appeals court order, the FDA’s initial approval of mifepristone in 2000 is allowed to remain in effect. But changes made by the FDA since 2016 relaxing the rules for prescribing and dispensing mifepristone would be placed on hold.

Those include extending the period of pregnancy when the drug can be used and also allowing it to be dispensed by mail, without any need to visit a doctor’s office.

The AP also reported that the two 5th Circuit judges who voted to tighten restrictions, Kurt Engelhardt and Andrew Oldham, are both appointees of former President Donald Trump. The third judge, Catharina Haynes, is an appointee of former President George W. Bush.

Haynes said she would have put the lower court ruling on hold entirely temporarily to allow oral arguments in the case.

The decision by the 5th Circuit’s 3 judge panel can still be appealed to the U.S. Supreme Court.

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U.S. Federal Courts

Judge’s nationwide abortion pill ban ‘could open the floodgates’

Medicines for gay, bi, and trans Americans could be next

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Judge Matthew Kacsmaryko’s ruling would ban the nationwide sale and distribution of the abortion pill mifepristone. (Screen capture via YouTube)

White House Press Secretary Karine Jean-Pierre told reporters on Monday that last week’s decision by a Texas court to ban the nationwide sale and distribution of the abortion pill mifepristone “could open the floodgates for other medications to be targeted and denied to people who need them.”

Following that ruling by Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas, American Medical Association President Jack Resneck raised similar concerns in a statement warning that “upending longstanding drug regulatory decisions by the U.S. Food and Drug Administration (FDA)” would position “other drugs at risk of being subject to similar efforts.”

“This ruling makes every medication on the market a potential target for political grandstanding,” Whitman-Walker Institute Executive Director Kellan Baker told the Washington Blade by email.

“Now that Judge Kacsmaryk has decided that he knows more about medical evidence than the FDA, the entire foundation of the FDA’s essential role in safeguarding access to medications is now subject to political attack,” Baker said.

“You’re not talking about just mifepristone,” U.S. Department of Health and Human Services Secretary Xavier Becerra said during an appearance on CNN’s “State of the Union” Sunday. “You’re talking about every kind of drug. You’re talking about our vaccines. You’re talking about insulin. You’re talking about the new Alzheimer’s drugs that may come on.”

Likewise, in an interview on Pod Save America that aired Tuesday, law professor Leah Litman agreed drugs like HIV medications, along with vaccines like those targeting HPV and COVID, or birth control pills, could be next.

Medicines for trans youth and adults, in some cases, have been targeted with legislation passed by conservative states to restrict access to guideline directed medically necessary interventions for the treatment of gender dysphoria.

And last year, another Texas court ruled that employers can deny health coverage for PrEP, a medication used to prevent the transmission of HIV.

More litigation lies ahead, along with more uncertainty

Ruling in Alliance for Hippocratic Medicine v. FDA, Kacsmaryk had issued a stay on the Food and Drug Administration’s conclusion that mifepristone is safe and effective, a finding the agency reached in 2000 that has since been buttressed by more than two decades of clinical evidence.

It was roundly denounced as unscientific, the product of the judge’s longstanding and well documented ideological opposition to abortion.

The Biden administration was prepared for Kacsmaryk’s decision, Jean-Pierre said: Attorney General Merrick Garland immediately pledged the Justice Department to appeal and seek a stay (of Kacsmaryk’s ruling) pending the outcome of additional litigation. And then on Monday the Department asked the U.S. Court of Appeals for the Fifth Circuit to halt implementation of the ruling.

Other powerful legal actors had also been on notice. On Monday, New York Attorney General Letitia James led a coalition of state attorneys general in challenging Kacsmaryk’s ruling with an amici brief filed to the 5th Circuit.

Casting additional uncertainty into the mix was a separate ruling, just hours after Kacsmaryk’s, by Judge Thomas Rice of the U.S. District Court for the Eastern District of Washington, who ordered the FDA to make no changes to the availability of mifepristone.

The case in Washington was brought by attorneys general from 17 states and the District of Columbia in anticipation of Kacsmaryk’s ruling, and the split decision means the matter is likely to be settled by the U.S. Supreme Court.

Some legal observers have speculated that the Biden administration may be pushing for this outcome, hedging that even with its 6-3 conservative supermajority the justices are likely to reject Kacsmaryk’s analysis of the relevant facts on substantive or procedural grounds.

Still, and notwithstanding the fate of other medications or vaccines in the hands of Kacsmaryk or his ideological allies on the federal bench, the Texas court’s ruling raises other major questions.

For example, can a federal judge circumvent the congressionally ordained power of America’s federal administrative agencies? If so, under which circumstances? How about the practice of forum shopping, by which litigants deliberately move to have their cases adjudicated by judges they expect will be most sympathetic? And what will all of this uncertainty mean for the global biopharmaceutical industry and the future of drug discovery in America?

One solution that was proposed by at least two Democratic members of Congress, Rep Alexandria Ocasio-Cortez (N.Y.) and Sen. Ron Wyden (Ore.): the Biden administration should simply ignore Kacsmaryk’s ruling.

“I believe the Food and Drug Administration has the authority to ignore this ruling, which is why I’m again calling on President Biden and the FDA to do just that,” Wyden said in a statement Friday.

“If they don’t,” warned the senator, “the consequences of banning the most common method of abortion in every single state will be devastating.”

“The courts rely on the legitimacy of their rulings, and what they are currently doing is engaging in an unprecedented erosion of their legitimacy,” Ocasio-Cortez told Anderson Cooper during an interview on CNN Friday.

On Twitter, the congresswoman addressed the backlash against her comments, explaining that Republicans have also ignored court orders in cases where they felt they were unlawful.

On Monday, the White House circulated an open industry letter signed by more than 200 pharmaceutical industry executives, which echoed criticisms of Kacsmaryk’s ruling that noted his lack of formal education or training in science or medicine.

The executives’ letter also argued the decision presents systemic risks to the drug discovery pipeline.

“As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval,” the group wrote.

“Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry.”

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