THE PROGNOSIS

It seems fitting that President Trump — who describes himself as a master negotiator — wants a big, bold move to lower prescription drug prices by allowing the government to directly negotiate with pharmaceutical companies.

If a deal emerged between the White House and House Speaker Nancy Pelosi (D-Calif.) on allowing such negotiations by Medicare — long anathema to Republicans, who view such a move as price fixing — it would be because the president wasn’t satisfied with a set of smaller-bore ideas being pursued on Capitol Hill and by his Department of Health and Human Services.

Trump has promised numerous times to slash drug prices. As he looks ahead to his reelection effort, achieving something as major as direct negotiatons between Medicare and drug companies could be just the win he’s looking for — especially considering the idea is favored by a large majority of Americans.

Congress returns to Washington today after a two-week recess. Trump, Pelosi and Senate Minority Leader Chuck Schumer (D-N.Y.) must determine whether there is any potential in the highly polarized climate for bipartisan legislating before the pressures of the 2020 elections make any compromise impossible, my colleagues Mike DeBonis and Erica Werner report.

The White House for weeks has been engaged in talks with Pelosi’s office about a range of options, including allowing negotiations between Medicare and drugmakers just for a limited set of more expensive drugs, such as drugs with no therapeutic alternatives. Whether to include drugs administered directly in physicians' offices is also under discussion, according to lobbyists.

“At the end of the day, unless there’s a negotiation with the drug companies, we’re not going to bring down drug prices,” Rep. Donna Shalala (D-Fla.), who served as HHS secretary under President Bill Clinton, told me last week. “There is no substitute for negotiations. I think the president knows that.”

Medicare negotiation is the elephant in the room as Congress and the Trump administration seek ways to lower the high cost of prescription drugs. They probably could achieve some savings for the government — and put a general downward pressure on drug prices — by repealing a ban on HHS from directly negotiating lower prices for medications through Medicare’s Part D prescription drug program, which covers medicines distributed by private plans.

Trump, who embraced the idea on the campaign trail, is still deeply interested in it. But it’s shunned by Republicans and, naturally, the pharmaceutical industry. Opponents argue that prices for Medicare drugs are already negotiated, between the drug companies and the private insurers who administer the Part D plans. They also point to the Congressional Budget Office, which has said direct negotiations would have only a “negligible effect” on drug prices for those covered by Medicare.

It’s unclear whether a deal will emerge this year. Democrats aren’t united on the details of such a proposal. Wendell Primus, a top Pelosi aide, has reportedly drawn ire from the House’s most liberal Democrats for favoring an arbitration approach, where a neutral party would decide on a price for select Medicare drugs — a moderate alternative to full-on negotiation. 

And the first hearings on Rep. Pramila Jayapal's Medicare-for-all bill is set to be held tomorrow in the House.

Indeed, there are different approaches to giving Medicare more leverage over how much it pays private companies for their prescription drugs. Because Medicare’s prescription drug program is administered by private plans, lawmakers could add in a public plan where prices would be negotiated directly. Another option is to authorize the HHS secretary to negotiate prices on behalf of Medicare enrollees who participate in the private prescription drug plans.

Under legislation proposed in February by Rep. Lloyd Doggett (D-Tex.) and Sen. Sherrod Brown (D-Ohio), drugmakers would have to negotiate Medicare Part D prices with the government or risk losing their temporary rights to sell their drugs exclusively. More than 120 Democrats have signed on to that bill.

Wherever that issue ends up, there’s a broad expectation that Congress will do something bipartisan on drug prices this year. Pelosi’s office confirmed there will be action on drug pricing bills in May. A dozen bills passed by the two top House committees with health-care jurisdiction are candidates for a floor vote.

And Senate Finance Chairman Chuck Grassley (R-Iowa) said last week he’s aiming to introduce bipartisan legislation in June with the committee’s top Democrat, Sen. Ron Wyden (D-Ore.).

“We are writing legislation to address some of the systemic problems that make prescription drugs unaffordable for some Americans,” Grassley said in a speech on Thursday. “I expect that legislation to be ready for introduction in mid-June of this year.”

There’s a parallel effort over at HHS, which is working on several ideas intended to shed more light on pricing and put downward pressure on what Medicare plans pay drugmakers. John O’Brien, who is serving as HHS’s point person on its drug pricing efforts, will brief the group Patients for Affordable Drugs Now on Tuesday on an international index the agency is contemplating as a way to link Medicare prices to lower prices in other countries.

But those ideas are mostly changes around the edges and not fundamental shifts to the whole drug pricing system. Graduates of the Obama administration are urging Medicare negotiation — among other measures — as one of the best ways to start quickly bringing U.S. drug prices down. Andy Slavitt, who headed the Centers for Medicare and Medicaid Services, and former FDA commissioner Robert Califf named direct negotiations as one of four key actions.

“This approach works well for other countries and for the U.S. Veterans Affairs,” Slavitt and Califf wrote last week in the Journal of the American Medical Association.

“Notably, the Obama administration repeatedly proposed direct negotiation between the Centers for Medicare & Medicaid Services and drug companies, but the policy gained no traction in Congress, which historically has been heavily influenced by the pharmaceutical lobby and its allies,” they continued.

AHH, OOF and OUCH

AHH: At first glance, it looks like top Senate Republican Mitch McConnell (Ky.) is getting tough on tobacco companies with his push to raise the legal drinking age to 21. But the legislation might be a proxy to block more effective measures to halt youth smoking, Politico's Renuka Rayasam, Rachana Pradhan and Sarah Owermohle report. The industry is showing surprising support for age bans, but in some states such legislation is supplanting potential bans on flavored or menthol cigarettes or proposed higher taxes on tobacco products.

“Tobacco and e-cigarette giants like Altria have lobbied against raising taxes on tobacco and banning flavored products popular with teens, which the Centers for Disease Control say would have a bigger impact in reducing teen smoking and vaping,” Renuka, Rachana and Sarah write. “Twelve states have passed laws that raise the legal tobacco purchasing age to 21. But some of them ignore anti-smoking measures that advocates say are most effective.”

“They are turning these tobacco 21 bills into Trojan horses,” John Schachter, director of state communications for the Campaign for Tobacco-Free Kids, told Politico.

OOF: A schizophrenia pill approved by the FDA in 2017 that sends a signal to a patient’s doctor when ingested was seen as a new frontier of Internet-connected medicine. But few patients use Abilify MyCite 17 months later, my colleague Christopher Rowland reports. Doctors and insurance companies say it is a case in which real-world limitations, as well as costs, outweigh the innovations produced by the medical industry.

The pill's microchip can notify doctors of patients who have schizophrenia but have stopped taking their medicine, triggering psychotic episodes that can have severe consequences. But some doctors warn that Abilify MyCite could exacerbate the very delusions that the medication is designed to prevent.

“Patients who have a lot of paranoia might be uncomfortable with the idea of a medicine that is transmitting signals. The patient may be afraid to take it,’’ Richmond psychiatrist James Levenson told Chris. “The science of this one is kind of ahead of the data.’’

"The debate over Abilify MyCite underscores a dilemma American health care will increasingly face as the medical industry and Silicon Valley try to promote innovation," Chris writes. "For decades, medicine has been effectively delivered through a few simple mechanisms: a pill, a cream, a nose spray, a needle....But in the hopes of improving outcomes further, the industry is turning to an array of new technologies against one of the biggest, and most human, challenges in treating disease: getting people to take their medicine in a consistent way."

OUCH: A group of patients waiting for liver transplants and hospitals have filed suit to block new rules they contend will reduce their access to organs by transferring hundreds to medical centers in large cities, where the demand is higher, The Post's Lenny Bernstein reports.

"The plaintiffs — which include transplant centers in Georgia, Michigan, Kansas, Missouri and elsewhere, as well as people on the waiting list for livers — say the rules will leave patients in those places with about 20 percent fewer organs than the current policy, resulting in an increase in deaths," Lenny writes. "The lawsuit is just the latest step in decades of wrangling over how to allocate scarce, valuable livers and other organs in a nation where there are far too few to meet the need. For people with end-stage liver disease, a transplant is the only option."

TRUMP TEMPERATURE

— President Trump urged parents on Friday to vaccinate their children in the midst of the measles outbreak, after making suggestions in 2012 and 2014 that child vaccinations can lead to autism.

“They have to get the shots. The vaccinations are so important. This is really going around now. They have to get their shots,” Trump told reporters at the White House as he prepared to travel to Indianapolis to address a gathering of the National Rifle Association, per The Post's John Wagner.

The Centers for Disease Control and Prevention announced this week that measles cases have reached a record high in the United States this year since the disease was declared eliminated in 2000. We're assuming Trump urged vaccinations after reading this Health 202.

— Trump also said that the United States didn't pay money to North Korea, which had issued a $2 million bill for the hospice care of American Otto Warmbier, the comatose University of Virginia student sent home from Pyongyang in 2017. The president's statement came a day after The Post reported that North Korea presented an invoice for Warmbier’s care in an extraordinarily brazen act even for a regime known for its aggressive tactics.

Trump tweeted this:

The president reiterated the point two hours later as he spoke to reporters outside the White House, per Anna Fifield and John. “We did not pay money for our great Otto,” Trump said. “I haven’t paid money for any hostage. … We don’t pay money for hostages.”

“The main U.S. envoy sent to retrieve Warmbier signed an agreement to pay the medical bill on instructions passed down from Trump,” John and Anna write. “The bill went to the Treasury Department, where it remained — unpaid — throughout 2017...Before Trump’s tweet, the White House had declined to comment on whether the bill was paid or whether the issue came up during preparations for Trump’s two summits with North Korean leader Kim Jong Un.”

National security advisor John Bolton later said the U.S. agreed to pay for Warmbier's release but never coughed up the money.

— The president also promised to dismantle Obamacare in his remarks to the NRA, although it was unclear whether he was referring to his administration’s refusal to defend the Affordable Care Act in an ongoing lawsuit or whether he was pushing for Congress to try again to replace the law.

Trump touted Republicans’ success in eliminating the individual mandate, which he called “the absolute worst part of Obamacare.” “Now we’re going for the rest,” the president said before again blaming the late senator John McCain (R-Ariz.) for his party’s failure to repeal the entire law last year.

— Meanwhile, Senate Finance Chairman Grassley has been making clear to constituents that he doesn't think the courts will declare the ACA unconstitutional, nor will lawmakers repeal it.

“The Affordable Care Act is the law of the land, and it’s not going to be repealed by Congress,” Grassley told a woman who pressed him about the law’s coverage for those with preexisting medical conditions and shared the exchange via YouTube. The exchange took place during a meeting between Grassley and constituents.

The woman pointed out that Grassley voted seven times to repeal the law, which he acknowledged.

“The last time we voted for repeal was when McCain voted the other way, and there’s no chance of repealing it now. So what are you worried about?” Grassley asked.

— A few more good reads from The Post and beyond:

AGENCY ALERT
MEDICAL MISSIVES
Health & Science
Inadvertent access to medications, including opioids, are a major concern.
Emily Sohn
INDUSTRY RX
REPRODUCTIVE WARS
Health & Science
Regulation targeted low-income women and Planned Parenthood.
Fred Barbash
BRAIN WAVES
SECOND OPINION
Outlook
My doctor diagnosed strep, but this wasn’t like any strep I’d ever had before.
Josh Nerius
SUGAR RUSH

Last Week Tonight with John Oliver: