with Alexandra Ellerbeck

The Biden administration hasn’t embraced various drug-price-lowering measures pushed by former president Donald Trump.

But the pharmaceutical industry has something else to worry about.

House Democrats say they'll make an effort to include H.R. 3 — the measure allowing the federal government to directly negotiate lower drug prices — in whatever infrastructure and jobs bill congressional leaders are trying to hammer out over the summer. 

House Energy and Commerce Chairman Frank Pallone Jr. (D-N.J.) told reporters yesterday that he’s aiming to get the measure attached to the package — a package that almost certainly represents Democrats’ best shot this year at turning their top priorities into law.

“This is a necessity,” Pallone said on a call hosted by the group Protect Our Care. “We definitely want to do it this year.”

H.R. 3’s only realistic hope lies in getting attached to the jobs and infrastructure package.

And it would only, possibly work if Democrats decide to bypass Republicans entirely by using the budget reconciliation process.

This week, President Biden is continuing negotiations with Republicans over the pending deal to improve the nation’s roads, bridges, pipes, ports and Internet connections and it remains unclear how it all will unfold.

White House spokeswoman Jen Psaki laid out a number of possible paths toward passing infrastructure legislation on a bipartisan basis, although she has also said the clock is ticking on Democrats working with Republicans. The White House is leaving open the possibility of muscling the legislation through without the GOP.

If the effort at bipartisanship falters, all eyes will be on Sen. Joe Manchin III (D-W.Va).Should Democrats and Republican fail to broker a deal, the White House will need every Democratic senator to rally behind the infrastructure bill on a party-line vote, making Manchin a pivotal figure capable of making or breaking a centerpiece of the Biden agenda,” our colleagues Mike DeBonis and Sean Sullivan write.

Manchin has sponsored legislation allowing the federal government to directly negotiate lower drug prices, so the thought is that he'd be fine with adding elements of H.R. 3 to a budget reconciliation bill, although he hasn't explicitly said that. H.R. 3 also carries the benefit of being a net positive on federal spending, since the Congressional Budget Office has scored the direct negotiation piece as saving $456 billion over a decade.

Still, the future of H.R. 3 is far from certain.

President Biden and House Speaker Nancy Pelosi (D-Calif.) also say they want it passed, and two House committees held hearings on it in May. 

But enough House moderates have expressed hesitation that it could easily be derailed. In a recent letter led by Rep. Scott Peters (D-Calif.), 10 Democratic members of Congress told Pelosi they want “bipartisan, bicameral support, with buy-in from a majority of Americans and stakeholders in the public and private sectors.”

Peters and seven of the signers voted for H.R. 3 when the House passed it in late 2019. But Peters told Politico he only voted for the bill to “start a conversation” about lowering prescription drug prices, with the understanding that it wouldn’t ultimately be passed by the Senate.

Democrats currently hold the House majority by just eight seats, but Pallone brushed off the letter when asked about it yesterday, saying he has “no doubt” the chamber could once again pass H.R. 3.

“If you look at that letter, it didn’t really say they wouldn’t support it,” Pallone said. “There may be parts of it they might like to see changed, but the basic idea of having the government negotiate prices is the key.”

Meanwhile, Trump’s foray into lowering drug prices is fading into the background.

The former president spent his four years in office promising the American people he’d significantly lower the cost of prescription drugs. His administration did advance several policies to do so, including issuing several regulations late last year.

But those regulations have largely been blocked or delayed, and the Biden administration has shown little interest in advancing them.

  • In January, a federal court blocked Trump’s “most-favored-nations model,” which would have tested tying the prices of certain Medicare drugs to lower prices in other countries. The Biden administration would have to start over with the traditional rulemaking process, which the court said the Trump administration inappropriately skipped.
  • The Biden administration has also delayed a Trump-era rule banning drug rebates for manufacturers in the Medicare program. Now the rule isn’t slated to take effect until Jan. 1, 2023.
  • And in late May, the Biden administration indicated it has no timeline on whether it will allow states to import drugs from Canada. The Trump administration approved a rule allowing states to seek permission for drug importation, which the pharmaceutical industry is suing to block.

Ahh, oof and ouch

AHH: The Food and Drug Administration approved the first new Alzheimer’s treatment in decades.

The medication, called aducanumab, is the first drug approved to slow brain deterioration associated with Alzheimer’s, not just reduce symptoms.

But in an explicit acknowledgment of the uncertainties about the effectiveness of the drug, the FDA did not grant the medication full approval,” The Washington Post’s Laurie McGinley reports. “Instead, the agency cleared the drug — its brand name will be Aduhelm — based on its ability to reduce clumps of amyloid beta in the brain, a hallmark of the disease. It ordered the drug’s maker, the biotech giant Biogen, to conduct a post-approval study confirming the medicine actually slows cognitive deterioration.

The decision followed a prolonged debate over whether the drug actually works. One point of disagreement is whether reducing amyloid beta results in a slowdown of cognitive decline.

Advocates welcomed the decision, saying that it could spur research and investment in new therapies and help some patients have more time with their families. But critics say that the data for the drug effectiveness is weak and that the decision to approve it represents a lowering of the agency’s standards.

Medicare would face steep costs if it chooses to cover the drug, Axios's Bob Herman reports.

  • “If Medicare decides to cover the drug with no restrictions, it would pay almost $59,000 annually for a course of treatment. Biogen could easily fetch tens of billions of dollars every year if fewer than 10% of the 6 million Alzheimer's patients get it,” Bob writes.
  • Kaiser Family Foundation's Juliette Cubanski told Bob that some Medicare patients could have to pay more than $10,000 out-of-pocket for the drug, considering there's a 20 percent coinsurance rate on drugs after patients meet their deductible.
OUCH: Many doctors may refuse to take Medicaid because of bureaucratic hassle.

“A recent study by researchers from the US Bureau of Economic Analysis, the University of Chicago, and the Federal Reserve Bank in San Francisco found providers run into more obstacles when trying to bill Medicaid than they do with other insurers, and that these administrative hurdles explain the access problems experienced by Medicaid patients as much as the program’s payment rates,” Vox’s Dylan Scott reports.

The standard explanation for why many providers refuse to take Medicaid has focused on the fact that doctors receive less money from the safety-net health program than they do from private insurance. But researchers found that additional administration hassle associated with Medicaid could be just as big of a factor.

“Not only does Medicaid pay out less, but doctors encountered more billing problems. About 19 percent of the initial claims submitted to Medicaid are not paid in full. For Medicare and for the private insurers, that share is much lower: 8 percent and 5 percent, respectively,” Dylan reports.

Because health providers must spend money to sort out disputed claims, Medicaid visits end up being more costly on average, the researchers found. The average cost of incomplete payments for a Medicaid visit is $16, compared to $10 for Medicare and private coverage. When those administrative costs decline, the researchers found, providers become more likely to take Medicaid patients.

OUCH: A new therapy for persistent wounds is gaining steam. It’s really gross.

More than 6.7 million people in the U.S. have wounds that refuse to heal for months or even years. Enter the maggots: Bottle-fly grub dissolve decaying tissue and ooze digestive enzymes and antimicrobials that kill off unwanted bacteria or pathogens, the Atlantic’s Marion Renault reports.

With rates of chronic conditions, diabetic ulcers, and hospital superbugs rising, more doctors are looking for help from maggots.

Still, it’s a hard sell. 

“Not everyone, psychologically, can deal with that sensation and knowing maggots are chewing on their flesh,” Robert Kirsner, the director of the University of Miami Hospital Wound Center, in Florida, told the Atlantic.

Coronavirus latest

Scientists are working to unravel the mysteries of coronavirus and the brain.

“Autopsies of the sickest covid patients have revealed clotting in the brain and other signs of acute damage. They offered little evidence the virus attacks the organ directly. Beyond that, many other neurological details of covid remain unknown,” The Post’s Ben Guarino and Frances Stead Sellers report.

Some people experience “long covid” months after their battle with covid-19. While cures remain unknown, there are some practical steps you can take. (Allie Caren/The Washington Post)

Patients with covid-19 have reported visual and auditory disturbances, vertigo and tingling sensations, among other perplexing symptoms. Some report brain fog that lasts months after they first fell ill. Some experts think that the virus may cause dangerous brain swelling, which can trigger an autoimmune attack that can cause symptoms weeks or months later. But a better understanding of the virus's impact will require larger, population studies, which could take years.

On the Hill

A House panel grilled Fisher-Price executives over a sleeper tied to infant deaths.

Members of the House Oversight Committee sharply criticized company executives over Fisher-Price’s decision to keep its Rock ’n Play inclined sleeper on the market for a decade despite infant deaths linked to the product, The Post’s Todd C. Frankel reports.

The company took its product off the market in 2019 in a move coordinated with the Consumer Product Safety Commission. At that time, more than 30 baby deaths were linked to the inclined sleeper. That number has grown to more than 90.

A 2019 Washington Post investigation found that Fisher-Price developed the Rock ’n Play with no clinical research into whether it was safe. Before it was even sold, the stance of the American Academy of Pediatrics was that babies should sleep on their backs on flat hard surfaces.

Rep. Pat Fallon (R-Tex.) said he understood the business case for selling the Rock ’n Play, even as it was banned in other countries, but said, “I just don’t feel it was the moral thing” to do.

Eye on the Supreme Court

The Supreme Court is sprinting to conclude its work this month.

Among the pending decisions is the fate of the Affordable Care Act. The court has twice defended the law. This time, it will consider whether a 2017 decision by Congress to remove the financial penalty for not buying health insurance eliminates the legal underpinnings used to justify the individual mandate and the broader law, The Post’s Robert Barnes reports.

“But perhaps the most consequential decision has no deadline and will be made by a court of one: 82-year-old Justice Stephen G. Breyer,” Robert writes. “The court’s senior liberal member has faced unprecedented pressure to step down from his lifetime appointment while a Democratic president is in the White House and the party still maintains its shaky majority in the Senate.”

Sugar rush