THE PROGNOSIS

The Trump administration is writing Act Two of its effort to address the country’s high prescription drug costs — and this next move could apply to a much broader swath of the Medicare program.

A proposal having to do with Medicare Part D — which foots the vast majority of seniors’ drug bills — was posted yesterday to the White House’s Office of Management and Budget website, generating much buzz in the industry about what the administration might be planning next.

It’s unlikely any new rule on drug prices will be released before next week’s midterm elections, perhaps over fears it could fuel Democratic charges that Republicans are trying to cut seniors’ drug benefits at a time when health care is playing a central role in the heated campaign. But the notice of the proposal signals the administration has more coming down the pike as it tries to look tough on the drug industry.

There was much fanfare last week when President Trump made his first visit to the Department of Health and Human Services to announce changes to how Medicare will pay for some prescription drugs. But those changes are limited and apply only to drugs administered directly by a doctor under Medicare’s Part B program. They’re also only being implemented as a five-year experiment confined to just half the country.

A bigger way the administration could move the lever on drug prices is through Medicare Part D — the prescription drug program Congress created in 2003 to help seniors afford their medications purchased at the pharmacy counter. While Part B makes up just 3 percent of Medicare’s total costs, Part D is responsible for 15 percent of total costs.

HHS’s Centers for Medicare and Medicaid Services (CMS) gave a vague hint of what’s coming in a separate, highly technical rule it proposed on Friday.

“We note CMS plans to release a proposed Medicare rule in the near future to further the President’s agenda of reducing drug costs,” the proposed rule says.

Of course, the single biggest way to tamp down drug prices in the United States would be to allow the government to negotiate prices directly with drugmakers. Congress would have to legislate that, as it’s banned under federal law, but Trump could put pressure on lawmakers, especially considering he backed that idea on the campaign trail in 2016.

But allowing Part D negotiations — shunned by most Republicans as too close to government price-setting — is unlikely to appear in the regulation sitting at OMB. It notably didn’t appear in the 44-page drug pricing blueprint the White House released last spring, or in the president’s 2019 budget proposal, prompting accusations by Democrats that Trump wasn’t serious about taking on the industry.

But the blueprint and budget proposal did contain other ideas the administration could formally put forward. HHS spokeswoman Caitlin Oakley said some of those ideas are in the works but are taking some time to hash out.

"As described in the American Patients First blueprint, there are a number of changes under consideration through Medicare Part D to lower drug prices and reduce out-of-pocket costs," Oakley said.

Because Medicare is responsible for nearly one-third of the nation’s prescription drug spending, the government has a ton of pull with the industry. Here are a few possible — and highly wonky — changes industry insiders are watching for:

  • Requiring Medicare prescription drug plans to cover a minimum of one drug per category or class rather than two drugs. The administration says this would allow Part D plans to better manage drug benefits.
  • Requiring plans to pass on at least one-third of rebates to seniors when they purchase a drug. Drug companies provide these rebates in return for getting their drugs covered, but the practice is widely condemned as driving up the overall list price of pharmaceuticals.
  • Limit seniors’ out-of-pocket costs by phasing out co-insurance payments once they’ve generated $5,000 in costs annually (the threshold for “catastrophic” coverage).
  • Eliminate cost-sharing for low-income Medicare enrollees buying generic drugs.

(The Kaiser Family Foundation has an excellent explanation of these ideas here.)

Whatever Trump proposes next, he’s likely to frame it in big, bold terms regardless of how extensive or immediate an impact.

But we’ll give the president this: Trump — and HHS Secretary Alex Azar — have shown through last week’s Part B proposal that they’re willing to go further than most Republicans in doing something about drug prices, even if large stakeholders like the pharmaceutical industry don't like it.

AHH, OOF and OUCH

AHH: Some Democratic candidates, in pushing the issue of protections for preexisting conditions, have gone too far in claiming how many people would have been negatively impacted by efforts to undermine the Affordable Care Act, our Post colleague and Fact Checker Glenn Kessler reports.

Glenn breaks down a few examples of claims from Democrats, including from Sen. Robert P. Casey (Pa.) and Senate candidate Rep. Kyrsten Sinema (Ariz.), who are targeting their rivals for supporting the  GOP's effort to repeal and replace Obamacare.

In two particular tweets, Casey and Sinema refer to 5.3 million Pennsylvanians and 2.8 million Arizonans who have preexisting conditions who the candidates say would have been affected by passage of the House GOP effort.

In summary, Glenn gives these estimates four Pinocchios. “In the case of Democrats using statewide numbers for people with preexisting conditions for votes concerning the [American Health Care Act], that’s worthy of Four Pinocchios,” he writes. “They’ve taken high-end estimates for the entire insurance market, even though the law affected only the individual market. Different states also would have had to proactively seek waivers… There’s little excuse to apply numbers for the entire insurance market to the much-smaller individual market.”

In another tweet, Democratic-leaning super PAC American Bridge used a statewide number -- 2.5 million Missourians that would be impacted by the lack of protections for preexisting conditions – to target Josh Hawley, the Republican attorney general challenging Sen. Claire McCaskill's seat in Senate. The tweet targets Hawley as one of the 20 Republican AGs who are part of a lawsuit to repeal Obamacare.

Glenn gives the claim two Pinocchios, writing: “In the case of attacking a supporter of the lawsuit, such as Hawley, there’s a stronger case for a statewide number because the lawsuit would wipe out all protections embedded in the ACA and the impact is uncertain, even in the employer-based insurance market. But it’s still a high-end estimate, so the real figure could be half as much. That’s worthy of two Pinocchios."

OOF: The National Institutes of Health announced that it will halt its human testing of an experimental stem-cell therapy for heart failure after questions emerged about the scientific foundation for the treatment.

The trial, which has enrolled 125 of 144 patients, is under review by a “board charged with overseeing patient safety,” our Post colleague Carolyn Y. Johnson reports. The board convened last week.

Physicians and scientists had called to pause the medical trial after Harvard acknowledged it had uncovered “false and/or fabricated data” in 31 scientific papers from the lab of prominent heart researcher Piero Anversa.

“Anversa is not directly involved in the trial, but the heart stem cells he identified are being injected into the hearts of some of the patients,” Carolyn explains.

“The decision to temporarily pause the trial came ‘out of an abundance of caution,’ said David Goff, director of the Division of Cardiovascular Sciences at the National Heart, Lung and Blood Institute, who said the trial’s scientific rationale is largely based on animal studies not conducted by Anversa.”

“Anversa did not immediately respond to questions about the trial,” Carolyn adds. “He repeatedly said the problems discovered in his lab came solely from a longtime colleague, whom he collaborated with closely for at least a quarter of a century. He has said the results from his laboratory still stand.”

OUCH: At UPMC Presbyterian’s trauma center, the hospital staff was ready when victims of a mass shooting at Tree of Life synagogue in Pittsburgh began arriving. “As the number of multi-casualty shootings in the United States has grown, Level 1 trauma centers like this one have stepped up preparations and training for events like Saturday’s rampage at Tree of Life synagogue here,” our Post colleague Lenny Bernstein reports. “They conduct tabletop exercises and walk-throughs. They practice organization and communication. They check and recheck supplies.”

From Pittsburgh, Lenny also teamed up with our Post colleagues Kyle Swenson, Gabriel Pogrund and Steve Hendrix on an in-depth account of what happened Saturday morning. “The deadliest attack on Jews in U.S. history would come to a head in a gun battle in a sacred space,” they wrote. “By the end of it, 11 people would be killed, most of them elderly members of the three congregations that worship at the synagogue. All of them in a place consecrated as a haven from evil, sprung suddenly as evil’s trap.”

Back at the hospital, Donald Yealy, chief of emergency medicine told Lenny the team “could have seen four times as many … This is unfortunately not our first rodeo.”

The trauma center staff was organized into teams of 10. They saw four shooting victims and a fifth who was treated for abrasions and then released.

Brian Zuckerbraun, chief of the hospital’s division of general, trauma and acute-care surgery, called it “controlled chaos." He said everything was over in just more than an hour.

"The adrenaline has faded," Lenny wrote, adding the physicians "said they would process their emotions later."

“That’s the hardest part, to switch on and switch off when something happens,” emergency physician Stephanie Gonzalez said.

HEALTH ON THE HILL

— Health care companies have spent $46.7 million in the midterm elections, the Center for Responsive Politics found.

It also found that 57 percent of money from health care political action committees went to Republicans, Bloomberg’s Blake Dodge reports

The top donations from health-care groups went to competitive Senate races raising “historic amounts of money,” Blake writes, and ones where the issue of protecting people with preexisting conditions has been prevalent. McCaskill brought in $1.85 million from health groups, Casey received $1.76 million and Sen. Sherrod Brown (D-Ohio) received $1.74 million.

“While much of the health-care debate in this election has focused on drug prices, physician groups have contributed more to congressional campaigns than pharmaceutical companies,” Blake reports. “Their PACs contributed $20.6 million to federal candidates.”

“The American Association of Orthopaedic Surgeons spent the most of the provider PACs, giving $1.37 million to federal candidates,” he adds. “The group, which gave money to both parties, made its largest single expenditure of $250,000 to the Congressional Leadership Fund, a GOP super PAC.”

“UnitedHealth Group Inc. spent the most among the major insurers, with a slight preference for Republican candidates. Anthem Inc., the second-largest spender, gave slightly more to Democrats,” Blake adds.

— A new survey from market research and consulting firms Ipsos found that voters heading into next week’s midterms are concerned about unpredictable health-care costs and the lack of transparency in the system. The survey, shared first in the Health 202 and conducted on behalf of Consumers of Quality Care, found that surprise medical bills and hospital fees; high premiums, co-pays and deductibles; and out-of-pocket prescription drug costs topped the list of things Americans are most frustrated with about health care.

Here are some of the other highlights from the survey’s findings:

  • More than 60 percent said it was “too difficult” to know what they would have to pay for their health care.
  • Seventy-six percent wanted more clarity on out-of-pocket hospital costs, and 74 percent wanted more clarity on out of pocket costs on prescriptions.
  • A large majority of poll respondents — 88 percent — also said that “lawmakers need to set aside partisan politics and find ways to improve health care.”
AGENCY ALERT

— Health watchdog group Public Citizen is calling on the Food and Drug Administration and HHS to investigate studies in which a hospital tested powerful antipsychotic drugs and the potent anesthetic ketamine on emergency room patients without their consent, Stat’s Sharon Begley reports. The letter also calls for all clinical trials at the hospital to be halted.

In a letter released Monday, Public Citizen also called for regulators to “impose severe sanctions for the serious ethical and regulatory lapses that have occurred in the ketamine clinical trials and other studies" at Minneapolis’s Hennepin County Medical Center. The letter from Public Citizen follows findings from federal inspectors, Sharon reports.

A spokesman for the hospital  “said the findings by inspectors from the FDA ‘are neither formal nor conclusory,’” Sharon writes. “Hennepin ‘has provided formal written responses to each’ of the inspectors’ findings, she said, adding that the hospital ‘has undertaken several reviews by independent experts to evaluate its research and emergency medical practices with the intent to improve our processes.’"

“In July, Public Citizen and 64 bioethicists, physicians, and other scholars submitted a complaint about two of Hennepin’s ketamine studies to the FDA and HHS’s Office of Human Research Protections,” she writes. “In August, FDA sent inspectors to the hospital. Their report, obtained by Public Citizen through a public records request and shared with STAT, examined additional clinical trials beyond those initially flagged. It found that in four, the hospital IRB ‘did not determine that informed consent would be sought from each prospective subject’ as required by law, while in another five, the IRB granted fast-track review to studies that didn’t qualify for it.”

MEDICAL MISSIVES

— A new report found that guns send about 8,000 children to emergency rooms every year in the United States. The first-of-its-kind study reported that 75,000 children and teens across the country went to the ER from 2006 to 2014 from gun-related injuries, the Associated Press’ Lindsey Tanner reports.

The report only reveals part of the problem, Lindsey writes, as the study didn’t include the kids who were killed or injured by guns who didn’t make it to the hospital, or those who died after being sent home from the hospital.

“Researchers called it the first nationally representative study on ER visits for gun injuries among U.S. kids,” Lindsey writes. “They found that more than one-third of the wounded children were hospitalized and 6 percent died. Injuries declined during most of the 2006-14 study, but there was an upswing in the final year. The researchers found that 11 of every 100,000 children and teens treated in U.S. emergency rooms have gun-related injuries. That amounts to about 8,300 kids each year.”

REPRODUCTIVE WARS

— Susan B. Anthony List, an antiabortion group with a political action committee, has released a new ad targeting Sen. Joe Manchin III (D-W.Va) as part of its six-figure campaign to urge the state’s voters to approve an antiabortion initiative on the ballot next month. The group’s $500,000 campaign is advocating for the measure, known as Amendment 1, that would change the state constitution to specify that it doesn't "secure or protect the right to an abortion."

“Manchin votes to fund Planned Parenthood,” the ad says. “He doesn’t share our values.”

In a statement shared with the Health 202, SBA List spokeswoman Mallory Quigley said Manchin “tells West Virginians he’s pro-life but has voted repeatedly to send taxpayer dollars to the nation’s largest abortion chain, Planned Parenthood.”

The ad from SBA List includes clips from a controversial undercover video made by antiabortion activists that purported to show Planned Parenthood talking about illegally selling fetal tissue. “Planned Parenthood denied any wrongdoing, and multiple state investigations have failed to find evidence that the group violated any laws,” our colleague Sandhya Somashekhar wrote last year regarding the videos. 

— And here are a few more good reads: 

Sesame could join peanuts, milk and shellfish on the list of allergens than food manufacturers must declare.
NBC News
Morning Mix
The survey by the American Psychological Association focused on the country's youngest adults, 75 percent of whom said gun violence was a significant source of stress.
Isaac Stanley-Becker
TRUMP TEMPERATURE
The Trump administration gives states more flexibility to get around the health law’s requirements for insurance plans. But at the same time it wants employers to move millions of workers to the in…
Kaiser Health News
INDUSTRY RX
The American Medical Association is urging the Federal Trade Commission to take action against drug companies they say are contributing to high prices for insulin.
The Hill
STATE SCAN
Health
The synagogue shooting suspect arrived shouting "I want to kill all the Jews," medical officials said. Three of the staff treating him were Jewish.
Eli Rosenberg
Dr. Jerry Rabinowitz was among 11 people killed at the Tree of Life synagogue. His patients remembered him as helping those with H.I.V. when others did not.
New York Times
New Jersey health officials said Monday they are sending infection-control teams to four long-term pediatric centers and a hospital to assist with training amid viral and bacterial outbreaks that have left 10 people dead.
Associated Press
OPIOID OPTICS
The pharmaceutical industry — long one of the biggest political players in the country, donating tens of millions of dollars to candidates and politicians at all levels of government — has contributed less to state-level candidates this election cycle despite contributing nearly $1 million to various candidates and PACs over the past decade.
The Nevada Independent
DAYBOOK

Today

  • The Heritage Foundation holds an book talk on “Chemical Slavery: Understanding Addiction and Stopping the Drug Epidemic."

Coming Up

  • The National Press Club hosts an event on next-generation broadband and telemedicine on Wednesday.
  • HHS Advisory Committee on Heritable Disorders in Newborns and Children holds a meeting on Thursday and Friday.
  • The FDA holds a joint meeting of the Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee on Friday.
SUGAR RUSH

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