THE PROGNOSIS

The Trump administration argues it needs better tools to investigate a growing pile of complaints from medical providers that their religious freedom has been violated.

A federal judge dismissed its claims yesterday, in a ruling that blocks a new “conscience protection” regulation from going into effect later this month.

U.S. District Judge Paul Engelmayer, appointed by President Barack Obama, ruled on a regulation giving the Department of Health and Human Services a broader array of tools to enforce existing “conscience protection” laws, some that have been on the books since the 1970s. These laws allow medical providers to decline to participate in services to which they’re morally opposed, such as abortion or assisted suicide.

“Engelmayer …declared the so-called ‘conscience rule’ unconstitutional in a 147-page decision stemming from a lawsuit brought by New York and nearly two dozen other mostly Democratic states and municipalities,” my Washington Post colleague Yasmeen Abutaleb reports.

“While the rule sought to ‘recognize and protect undeniably important rights,’ the judge found the rulemaking process was ‘shot through with glaring legal defects,’” she writes.

The rule detailing how HHS will define religious discrimination and how it will investigate such complaints is the result of a months-long effort by Office of Civil Rights Director Roger Severino to reshape Obama-era policies in ways that are more favorable to conservatives. While opponents have argued the rule would favor the personal views of providers over the needs of patients, Severino and other officials counter the agency needs more authority to enforce religious freedom laws.

To help build its case, HHS officials pointed to the number of complaints they said they were receiving around lax enforcement of conscience protections. In court briefs, the administration said the HHS Office for Civil Rights received 358 complaints over two fiscal years, compared with an average of just 1.25 complaints each year under the Obama administration.

But Engelmayer took issue with those figures, calling them “demonstrably false.” He noted that during oral arguments, administration lawyers conceded that only about 20 of the 358 complaints were related to conscience protections. And of those 20, just seven were situations to which the federal protections would directly apply.

“Far from reflecting a ‘significant increase’ in complaints implicating the Conscience Provisions as claimed by HHS, the administrative record reflects either no increase at all, or that any increase was so small as to be asymptotic to zero,” Engelmayer wrote.

The administration, which yesterday said only it is reviewing the decision, is also facing a lawsuit from California in the U.S. District Court for the Northern District of California. A decision is expected soon from Judge William Alsup, who heard four hours of oral arguments last week.

Even some outspoken supporters of religious freedom say the regulation goes further than it should and may not be necessary to ensure doctors, nurses and other providers don’t have to perform procedures they feel are morally wrong.

For example, the Trump rule says workers who aren’t directly providing a medical service could still object to being involved — such as an office scheduler or an ambulance driver. And an employer couldn’t specifically ask a hiring prospect which services they would object to on religious grounds until after the hiring was complete.

Michael Wear, who led outreach to evangelicals during Obama’s second term, told me the administration had already implemented “robust” conscience protections in its own rule regarding the religious freedom laws.

The Obama rule, issued in 2011, retained a provision that empowered the HHS Office of Civil Rights to investigate any complaints by workers who believe their rights under existing federal law were being violated, The Post reported at the time.

Wear said the Trump administration’s rule goes much farther, taking a “maximalist approach” because Democrats are unable to block it.

“The Trump administration’s regulation expands way beyond religion to any sort of moral belief and that obviously goes beyond just religious freedom protections in a way that I think weakens religious freedom,” Wear said. “It sort of dilutes the whole thing.”

But the court’s decision blocking the rule was a huge disappointment to religious conservatives, who have cheered as the administration has embraced many of their priorities.

“Up until very recently, conscience protections for conscientious objectors have been widely accepted,” said Stephanie Taub, senior counsel with First Liberty Institute. “I think most Americans believe doctors and nurses shouldn’t be forced to participate in services which they think are unethical.”

Others applauded the ruling. New York Mayor Bill de Blasio:

AHH, OOF and OUCH

AHH: White House counselor Kellyanne Conway said the administration is planning to announce its guidance on flavored e-cigarettes “very soon.”

Officials said in September that the administration was working on a ban on most flavored e-cigarettes amid concerns about the rise in youth vaping and a spate of mysterious vaping-related illnesses across the country.

“It was widely speculated that the administration would announce its plan Tuesday in conjunction with the publication of two studies outlining kids’ appetite for flavors, particularly mint,” CNBC’s Angelica LaVito reports. “It wasn’t immediately clear why the announcement was delayed. Conway on Wednesday said it will be made ‘very soon,’ with industry watchers expecting it as early as this week.”

Earlier this week, the White House canceled scheduled meetings with e-cigarette companies and advocates that were meant to include discussions of the administration’s proposal, “saying in emails that officials had concluded their review after taking just a handful of meetings.”

OOF: A federal bankruptcy judge temporarily extended an uncommon protection to members of the Sackler family that freezes scores of lawsuits against the family and Purdue Pharma.

The temporary halt, which was set to expire yesterday and will now be extended until April 8, was part of a deal between the opioid manufacturer and a group of dissenting states, our Post colleague Renae Merle reports.

“Purdue Pharma, the maker of OxyContin, filed for bankruptcy on Sept. 15 as part of a broad opioid settlement proposal that has been accepted by 24 states but is opposed by 24 states and the District of Columbia. Oklahoma and Kentucky have settled with Purdue Pharma,” Renae writes. “Officials representing the dissenting states and a number of municipalities have objected to the legal protection being extended to the Sacklers, who have not filed for personal bankruptcy. The states and municipalities have asked for time to examine the family’s finances.”

Judge Robert Drain acknowledged that it’s unusual to freeze lawsuits against individuals, in this instance the Sacklers, who have not filed for bankruptcy, but said it was critical to “preserve resources needed for the settlement.” Meanwhile, Purdue argued halting the suits was necessary for a tentative settlement with thousands of plaintiffs to move ahead — otherwise, the company may have withdrawn from the tentative deal.

OUCH: Surgeons are testing deep brain stimulation as a last resort effort to help a man control his severe drug addiction. It’s the first time the procedure, which involves implanting electrodes in the patient’s brain, has been attempted to treat opioid use disorder in the United States, our Post colleague Lenny Bernstein reports.

There are four people in a pilot program to test the technique. If it’s found to be safe, there could be a full-scale clinical trial. The effort is in part funded by the National Institute on Drug Abuse and required approval from the Food and Drug Administration, as well as other agencies.

“The deep brain stimulator, which functions much like a heart pacemaker, was implanted by Ali Rezai, executive chairman of the West Virginia University Rockefeller Neuroscience Institute,” Lenny writes. “His patient, 33-year-old hotel worker Gerod Buckhalter, said he had been unable to remain sober for more than four months since the age of 15, despite trying a variety of medications and other inpatient and outpatient treatments.”

“I’m not advocating for deep brain stimulation as a first-line or a second-line [treatment],” Rezai said. “It’s for people who have failed everything, because it is brain surgery.”

OPIOID OPTICS

— At the peak of the nation’s opioid crisis, Walgreens handled 1 in 5 of the most addictive opioids — oxycodone and hydrocodone pills — that were sent to pharmacies across the country.

From 2006 through 2012, the company purchased about 13 billion pills, 3 billion more than its close competitor CVS, according to our Post colleagues Jenn Abelson, Aaron Williams, Andrew Ba Tran and Meryl Kornfield in the latest in a series of investigations on the opioid epidemic. It ordered 31 percent more oxycodone and hydrocodone pills per store on average than CVS and 73 percent more than other pharmacies across the country. The data is based on a Drug Enforcement Administration database of opioid shipments.

Unlike most pharmacy chains that use wholesalers to supply opioids, Walgreens acted as its own opioid distributor and bought 97 percent of its pills from the manufacturers directly.

“This arrangement allowed Walgreens to have more control over how many pain pills it sent to its stores,” our colleagues write. “By acting as its own distributor, Walgreens took on the responsibility of alerting the DEA to suspicious orders by its own pharmacies and stopping those shipments.”

But a lawsuit now alleges that Walgreens avoided detecting and alerting authorities about any suspicious orders and instead “incentivized pharmacists with bonuses to fill more prescriptions of highly addictive opioids.” The company denies such allegations and said it’s “completely unlike the wholesalers involved in the national opioid litigation.”

AGENCY ALERT

— More than 177,000 people enrolled in Affordable Care Act plans during the first two days of the open enrollment period, according to data released by the Centers for Medicare and Medicaid Services. The enrollment period for plans on the federal insurance exchange began Friday.

Of the 177,082 people who enrolled in plans on HealthCare.gov during the first two days, 48,923 were new customers. By comparison, during the first three days of the 2018 enrollment period, 371,676 people enrolled in ACA health-care plans.

CMS noted there were technical issues on the first day of enrollment this year and that “some consumers received error messages, which have been addressed.”

Josh Peck, co-founder of enrollment advocacy group Get America Covered, tweeted that those technical issues “prevented far more people from enrolling than CMS had reported last week.”

In a statement, CMS said the agency is “committed to ensuring consumers who want to enroll in coverage through the Federal Health Insurance Exchange have a seamless enrollment experience,” adding that it would “closely monitor” the entire enrollment period.

— And here are a few more good reads: 

HEALTH ON THE HILL

Speaker Nancy Pelosi (D-Calif.) on Thursday unveiled her long-awaited plan to lower prescription drug prices, one of the top priorities for Democrats this year.
The Hill
Former Vice President Joe Biden is escalating attacks on Massachusetts Sen. Elizabeth Warren after she said he was running in the "wrong presidential primary."
ABC News

TRUMP TEMPERATURE

Officials administering the plan said they were unable to guarantee a network large enough to accommodate all the veterans who may seek care.
New York Times

INDUSTRY RX

Apple Inc on Wednesday said that U.S. military veterans who use its iOS devices ...
Reuters

MEDICAL MISSIVES

A few anesthetic injections to the neck can reduce the effects of PTSD, promising to open up new avenues of treating troops and veterans suffering from combat trauma, a new study shows.
Wall Street Journal

DAYBOOK

Coming Up

  • The Senate Health, Education, Labor and Pensions Committee holds a hearing on the response to lung illnesses and youth e-cigarette use on Nov. 13.
  • The House Veterans' Affairs Subcommittee on Technology Modernization holds a hearing on cybersecurity challenges and cyber risk management at the VA Department on Nov. 14.