THE PROGNOSIS

The Department of Health and Human Services isn’t part of the seemingly endless government shutdown. But that doesn’t mean Obamacare will escape unscathed.

The Internal Revenue Service — which has sent 90 percent of its staff home without pay — plays the role of accountant for the health-care law’s marketplaces, charged with calculating the eligibility of low-income Americans for health insurance subsidies and rectifying the situation if they’re overpaid or underpaid. Not only that, but the agency also works closely with HHS to evaluate state requests to revamp their marketplaces to ensure the proposals wouldn’t cost the government more money.

The longer the shutdown goes on, the more these functions could be jeopardized — particularly for Affordable Care Act marketplace enrollees whose applications have been flagged by the IRS for additional review before they can receive federal income-based assistance for their monthly premiums. (Under the ACA, people earning between 133 percent and 400 percent of the federal poverty level are eligible for varying levels of insurance subsidies.)

This could include people who required an extension to file their taxes or who requested a special exemption allowing them to enroll outside the sign-up season. It’s the IRS’s job to verify such enrollees are making the income they claim or have experienced special life circumstances (such as having a baby, for example) allowing them to enroll after the enrollment window has closed.

Six House and Senate Democrats leading health-care-related committees raised these issues yesterday, asking HHS Secretary Alex Azar and Treasury Secretary Steve Mnuchin to ensure marketplace enrollees don’t face unexpected premium costs even as the shutdown continues.

In the letter, the Democrats also worried people might lose coverage entirely at the end of January if they didn’t pay their monthly premium due to uncertainty about getting subsidies. And they noted the IRS call center is closed, making it harder for marketplace customers to get their questions answered.

“We urge you to make sure that consumers are not faced with unexpected premium costs, do not lose coverage, and have access to the filing assistance they need,” wrote Sens. Ron Wyden (D-Ore.), Patty Murray (D-Wash.) and Bob Casey (D-Pa.) and Reps. Richard Neal (D-Mass.), Frank Pallone (D-N.J.) and Bobby Scott (D-Va.).

For many of the roughly 8.5 million marketplace enrollees, verifying their subsidy eligibility is a straightforward process. But for others it’s more complicated, as is the case for those who lost their job in the middle of the year and suddenly experienced a dramatic change in income. The IRS needs a workforce that’s actually working to get these cases processed.

“Sometimes people's applications and enrollments are more complicated and need somebody to process them,” said Linda Blumberg, an institute fellow at the Urban Institute’s Health Policy Center. “If that somebody is at home not doing any work, then it becomes a problem.”

There was a bright spot for taxpayers last week, when the White House directed the IRS to issue tax refunds even as the shutdown continued. And my Washington Post colleagues reported yesterday that a bipartisan group of rank-and-file senators is holding discussions on how to end the shutdown — even though there's no guarantee that will work.

“Prospects for the group to achieve any results — or even get off the ground — are uncertain,” Erica Werner, Sean Sullivan and Damien Paletta wrote. “But the group’s creation is a sign senators of both parties are eager to end the shutdown, even if it means taking matters into their own hands amid an impasse between top Democrats and President Trump.”

Here’s another strange irony of the shutdown for the Trump administration: It’s putting a damper on the IRS’s ability to review applications from states to run their marketplace in alternative ways — a big way the administration is seeking to put a more conservative stamp on Obamacare.

By applying for and receiving a “1332 waiver” (named after the pertinent section of the ACA), states can make a range of changes to how the insurance marketplaces function. Nearly all the 1332 waivers granted so far allow states to set up reinsurance programs in which insurers get help paying for higher-cost patients, allowing them to lower premiums for everyone across the board.

But, as we explained here, the Centers for Medicare and Medicaid Services has encouraged states to undertake even more ambitious changes to their marketplaces — changes the Obama administration wouldn’t have allowed for fear of undermining the quality of coverage people can buy.

It’s up to the IRS to help HHS and CMS review these waiver applications, providing them with information on whether such reinsurance programs would end up saving the federal government money and, if so, how much. It’s a relatively unnoticed — but important — function for the tax collection agency.

“Somebody has to calculate as well as they possibly can those savings, and the Treasury Department is doing that,” Blumberg said.

AHH, OOF and OUCH

AHH: A U.S. district court judge in Pennsylvania yesterday issued a nationwide injunction of Trump administration rules that would have let employers with religious or moral objections opt out of the ACA requirement for providing no-cost birth control. 

The ruling follows a more limited injunction by a California judge on Sunday that temporarily blocked the rules in 13 states and the District of Columbia, both coming down just as the rules were set to take effect. Both judges issued a stay on the rules as challenges are being argued, our Post colleague Amy Goldstein reports.

“The rulings in rapid succession, both by judges appointed by Barack Obama, are the latest legal twists in a dispute over an expansion of health benefits for women under the Affordable Care Act that has wound through the courts for years,” Amy writes.

The Trump administration rules, which were finalized in November, allow objections to the birth-control mandate on both moral and religious grounds. “They broaden the range of employers able to claim such objections to include essentially all non-governmental workplaces,” Amy adds. “And they give the employer the choice of whether to permit a workaround accommodation.”  

In a statement, HHS spokeswoman Caitlin Oakley said, “No American should be forced to violate his or her own conscience in order to abide by the laws and regulations governing our healthcare system.”

Planned Parenthood president Leana Wen called the judges rulings a “win for women across the country.”

“It’s time that politicians recognize birth control as health care and that women, in consultation with doctors, decide what contraception we receive — not our employers,” Wen said in a statement.

OOF: Democrats on the House Oversight and Reform Committee announced yesterday a sweeping investigation of a dozen drugmakers and their pricing tactics.

Committee Chairman Elijah E. Cummings (D-Md.) said he sent letters to 12 major pharmaceutical companies, seeking information and documents about medications and how they’re priced.  He asked seven drug companies -- AstraZeneca, Teva, Celgene, Eli Lilly, Johnson & Johnson, and Mallinckrodt -- for information about just one of their drugs. He asked three others -- Amgen, Pfizer, and Novo Nordisk -- for information about two drugs each and he asked Sanofi and AbbVie to provide information about three drugs each.

“For years, drug companies have been aggressively increasing prices on existing drugs and setting higher launch prices for new drugs while recording windfall profits,” Cummings said in a statement. “The goals of this investigation are to determine why drug companies are increasing prices so dramatically, how drug companies are using the proceeds, and what steps can be taken to reduce prescription drug prices.”

OUCH: For the first time in history, Americans are more likely to die from an opioid overdose than from a car crash, researchers found in a new report on preventable deaths from the National Safety Council. 

Now, Americans have a 1 in 96 chance of dying from an opioid overdose, compared with a 1 in 103 chance of dying in a vehicle crash, NPR's Ian Stewart reports. 

"The council has recommended tackling the epidemic by increasing pain management training for opioid prescribers, making the potentially lifesaving drug naloxone more widely available and expanding access to addiction treatment," Ian writes. 

In a statement, the National Safety Council pointed specifically to the deadly synthetic opioid fentanyl, saying the "nation's opioid crisis is fueling the Council's grim probabilities, and that crisis is worsening with an influx of illicit fentanyl."

AGENCY ALERT

— The Food and Drug Administration is aiming to restart food safety inspections at high-risk facilities that handle foods like fresh-cut produce, seafood and soft cheeses as soon as today, Commissioner Scott Gottlieb announced on Twitter.

Some food inspections have been halted amid the ongoing partial government shutdown, but others have continued operating with agency employees who are working without pay. “Examples of activities being handled by unpaid workers include active investigations of foodborne illness outbreaks, dangerous recalls, import screening and safety inspections of foods imported from overseas,” Politico’s Helena Bottemiller Evich reports.

The agency is implementing some long-term contingency efforts to increase "excepted" inspections during the shutdown, Helena writes. “Facilities that handle high-risk foods are typically not inspected very frequently, even when the government is fully funded. The FDA is required by law to inspect all high-risk food facilities every three years,” she adds. “Routine food safety inspections of food facilities not deemed high-risk, such as bakeries, will continue to be suspended during the lapse in funding."

— Meanwhile, if the shutdown drags on at the FDA, it could start to jeopardize anticipated new drug treatments, Stat’s Nicholas Florko and Ike Swelitz report.

“And though the Food and Drug Administration can retain more than half of its workforce thanks to application fees paid by drug and device makers, Commissioner Scott Gottlieb has cautioned the agency only has about three more weeks’ worth of funding to draw down,” Nicholas and Ike write. “The agency can’t accept any new fees during the shutdown.”

That means highly anticipated treatments from Janssen, Sanofi and Novartis for depression, diabetes and multiple sclerosis among many other potential new therapies are at risk. There are ten pharmaceutical companies set to have the FDA make a decision about their drug in March, which would be after the agency’s funds run out if the shutdown continues.

— For some federal workers, the ongoing partial government shutdown has put a strain on the financial resources they need for health care and medication. Mallory Lorge, an Interior Department employee who has Type 1 diabetes, told NBC News’s Phil McCausland and Suzanne Ciechalski she’s had to start rationing insulin because she can’t afford the $300 co-pay while her paychecks have been paused.

Lorge had also been recently hospitalized for sepsis and respiratory failure, and right when the government partially shut down, the first of her medical bills arrived. “Lorge and her husband were forced to consolidate their debt in a $40,000 loan, and she canceled all her medical appointments,” Phil and Suzanne write.

“The Department of Labor reported on Thursday that 4,760 federal workers applied for unemployment in the final week of December,” they add. “That’s a more than 500 percent increase from the previous week, when there were only 929 claims. The number is expected to climb in January, and food banks are reporting a growing need by federal workers who aren't getting paid.”

HEALTH ON THE HILL

— William Barr, Trump's nominee to serve as the next attorney general, is scheduled to appear for a confirmation hearing before the Senate Judiciary Committee this morning. Ahead of the hearing, the group Protect Our Care released a set of questions for the nominee who could succeed Jeff Sessions, including whether Barr agrees with the administration's decision not to defend the ACA in court and whether he agrees with the ruling last month by Texas Judge Reed O'Connor that the ACA is unconstitutional. 

— But legal experts say it's not likely a Barr confirmation would cause the Justice Department to switch course at this point and start defending the ACA. Ilya Somin, a law professor at George Mason University, said it would be unusual for DOJ to reverse its position and even if it did, it probably wouldn't change the course of the suit because Democrat-led states are already vigorously defending it. "The arguments on the other side have already been made by the Blue states," Somin told me. "It seems to me unlikely [Barr] would do things much different from what the Justice Department has already done."

Even Xavier Becerra, the California attorney general who is leading the defense, said he doubts the agency would change its position. “The Trump administration from the President on down has taken every step possible to sabotage the ACA and refused to stand up for affordable healthcare for millions of Americans, so it’s hard to imagine that DOJ would change its tune," Becerra said in a statement provided to Health 202.

— A bipartisan pair of lawmakers is calling on federal regulators to scrutinize the pending $74 billion merger of pharmaceutical giants Celgene and Bristol-Myers Squibb to understand the impact on industry and consumers.

“We suggest the agencies focus on two issues: First, the market impact in the pharmaceutical industry of a merge that will further consolidate the industry to the detriment of competition,” Reps. Peter Welch (D-Vt.) and Francis Rooney (R-Fla.) wrote to the Federal Trade Commission and the Justice Department, “and second, the likelihood that the $74 billion merger will significantly increase the prices consumers, taxpayers, and employers will be required to pay for prescription drugs after the merger, not for better medications, but to finance the merger itself.”

The letter to the FTC chairman and acting attorney general Matthew Whitaker also calls for consumer protection should the merger be finalized.

“Should the FTC and DOJ allow a merger,” Welch and Rooney wrote, “it should be conditioned on a hold harmless provision assuring that it will not be paid for by consumers, taxpayers, or employers, but by shareholders: the ones who stand to benefit.”

— Sen. Rand Paul (R-Ky.) is set to have a hernia operation at a privately administered hospital in Canada next month, a procedure related to his 2017 injury that occurred when a neighbor attacked Paul while he was mowing his lawn, the Louisville Courier Journal’s Thomas Novelly reports.

“The procedure is estimated to cost anywhere from $5,000 to $8,000, according to court documents,” Thomas writes, adding the Shouldice Hernia Hospital is marketed as “the global leader non-mesh hernia repair.” “The hospital's website outlines payments it accepts, including cash, check or credit card for those patients, like Paul, who are not covered by Ontario's insurance plan or a provincial health insurance plan.”

Our Post colleague Felicia Sonmez writes Paul's deputy chief of staff, Sergio Gor, "did not respond to a request for comment on why Paul was seeking medical care outside the United States."

TRUMP TEMPERATURE

— Vice President Pence is scheduled to address the annual Rose Dinner that follows the "March for Life" rally on Friday, the organization’s leaders announced. Pence also spoke at the annual rally in 2017. “Throughout his extensive career, Vice President Pence has remained exemplary in his commitment to protecting the sanctity of unborn life and it is our utmost privilege to have a pro-life champion of his stature address this year's Rose Dinner,” March for Life president Jeanne Mancini said in a statement.

MEDICAL MISSIVES

— And here are a few more good reads from The Post and beyond: 

Morning Mix
The Nobel Prize-winning scientist said he still believes what he said in 2007, that “all our social policies are based on the fact that African intelligence is the same as ours — whereas all the testing says not really.”
Meagan Flynn
Health
The study examined 560 conditions in twins and found that 40 percent were influenced by genes, while 25 percent were influenced by sharing an environment.
Carolyn Y. Johnson
Politics
The Florida Democrat said in a statement Monday that he is undergoing treatment in Washington.
Felicia Sonmez
Global health teams battling the world's second largest Ebola epidemic in D...
Reuters
INDUSTRY RX
In a letter citing a ProPublica and Frontline investigation, the National Alliance on Mental Illness has asked a U.S. district judge to ensure that people who have moved out of adult homes and into their own apartments have what they need to do so safely.
ProPublica
The sudden removal of the three executives follows a yearlong investigation by the Houston Chronicle and ProPublica into widespread problems at the hospital, including deaths in its heart transplant program.
Houston Chronicle, ProPublica
The organizations are expected to discuss Monday how to respond if the shutdown dries up money meant to support food stamps, food banks, and other services.
Boston Globe
DAYBOOK

Today

  • HHS Secretary Alex Azar delivers the keynote address at the Council for Affordable Health Coverage and the Partnership for Employer-Sponsored Coverage's summit on health policies and politics in the 116th Congress.
  • Brookings India and Tufts University hold a roundtable on "Opportunities for India Beyond 2019: The Future of Health and Geopolitics."

Coming Up

  • The Senate Special Committee on Aging is scheduled to hold a hearing in fighting elder fraud on Wednesday.
  • Politico hosts an event on health care innovators on Wednesday.
  • The 46th annual March for Life rally will be held in Washington on Friday.
SUGAR RUSH

How will the shutdown end? These are Trump's options: 

Late-night hosts mock Trump’s fast-food feast for Clemson Tigers