Tagged Health Industry

White House Unveils Finalized Health Care Price Transparency Rule

Hospitals will soon have to share price information they have long kept obscured — including how big a discount they offer cash-paying patients and rates negotiated with insurers — under a rule finalized Friday by the Trump administration.

In a companion proposal, the administration announced it is also planning to require health insurers to spell out beforehand for all services just how much patients may owe for out-of-pocket costs for all services. That measure is now open for public comment.

“What is more clear and sensible than Americans knowing what their care is going to cost before going to the doctor?” said Joe Grogan, director of the White House Domestic Policy Council.

The hospital rule is slated to go into effect in January 2021. But it is controversial and likely to face court challenges.

It is part of an effort by the Trump administration to increase price transparency in hopes of lowering health care costs on everything from hospital services to prescription drugs.

When that rule was first proposed in July, hospitals and insurers objected. They argued it would require them to disclose propriety information, could hamper negotiations and could backfire if some medical providers see they are underpriced compared with peers and raise their charges.

Shortly after the final rule’s release, four major hospital organizations said they would challenge it in court.

“This rule will introduce widespread confusion, accelerate anticompetitive behavior among health insurers and stymie innovations,” according a joint statement from these groups, which made clear their intent to soon “file a legal challenge to the rule on the grounds including that it exceeds the administration’s authority.” The statement was signed by the American Hospital Association, the Association of American Medical Colleges, the Children’s Hospital Association and the Federation of American Hospitals.

Insurers also pushed back. “Tthe rules the administration released today will not help consumers better understand what health services will cost them and may not advance the broader goal of lowering health care costs,” said Scott Serota, president and CEO of the Blue Cross Blue Shield Association, in a statement.

Requiring disclosure of negotiated rates, he said, could lead to price increases “as clinicians and medical facilities could see in the negotiated payments a roadmap to bidding up prices rather than lowering rates.” The rule, he added, could confuse consumers.

It’s also a potentially crushing amount of data for a consumer to consider. However, the administration said it hopes the data will also spur researchers, employers or entrepreneurs to find additional ways of making the data accessible and useful.

The amount of information the rule requires to be disclosed will be massive — including gross charges, negotiated rates and cash prices among them — for every one of the thousands of services offered by every hospital, which they will be required to update annually.

In a nod to how hard it might be for a consumer to add up items from such an a la carte list of prices, the rule also requires each hospital to include a list of 300 “shoppable” services, described in plain language, with all the ancillary costs included. So, in effect, a patient could look up the total cost of a knee replacement, hernia repair or other treatment.

Insurers, under the proposed rule, would have to disclose the rates they negotiate with providers like hospitals. They would also be required to create online tools to calculate for individual consumers the amount of their estimated out-of-pocket costs for all services, including any deductible they may owe, and make that information available before the consumer heads to the hospital or doctor.

It would go into effect one year after it is finalized, although it is not known when that will occur.

Although consumer advocates say price information can help patients shop for lower-cost services, they also note that few consumers do, even when provided such information.

Earlier this year, the administration ordered drugmakers to include their prices in advertisements, but the industry sued and won a court ruling blocking the measure. The administration has appealed that ruling.

Nonetheless, Health and Human Services Secretary Alex Azar said the administration is confident.

“We may face litigation, but we feel we are on sound legal footing for what we are asking,” Azar said. “We hope hospitals respect patients’ right to know the prices of services and we’d hate to see them take a page out of Big Pharma’s playbook and oppose transparency.”

He and other officials on a call with reporters admitted they don’t have any estimates on how much the proposal would save in lowered costs because such a broad effort has never been tried in the U.S. before.

Still, “point me to one sector of the American economy where having pricing information actually leads to higher prices,” said Azar.

Azar cited some studies that show that when prices are disclosed, overall spending can go down because patients choose cheaper services. However, such efforts also generally require financial incentives for the patient, such as sharing in the cost savings.

The proposed rule for insurers urges them to create such incentives, said Seema Verma, who oversees the federal government’s Center for Medicare & Medicaid Services.

George Nation, a business professor at Lehigh University in Pennsylvania who studies hospital pricing, called the final rule and the insurer proposal “exactly a move in the right direction.”

Among other things, he said, the price information may prove useful to employers comparing whether their insurer or administrator is doing a good job in bargaining with local providers.

Today, “they just see a bill and a discount. But is it a good discount? This will now all be transparent,” said Nation.

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Must-Reads Of The Week From Brianna Labuskes

Happy Friday! Well, friends, we have apparently arrived in the “post antibiotic era” (according to some), which any reader of the Breeze will know is up there with eyeballs and ticks on my list of phobias. I have no solace to offer you in this trying time beyond distraction: Here is what you might have missed this week (in case you were busy paying attention to historic hearings or something like that).

A California high school became the latest mass shooting site this year after a 16-year-old gunmen opened fire on students, killing two and injuring three others before he turned the gun on himself. “We are one of those schools now,” one student said to the Los Angeles Times. “Just like Parkland.” There have been a total of 84 incidents of gunfire on school grounds in 2019.

Los Angeles Times: A 16-Second Spasm Of Violence Leaves 2 Dead At Saugus High School

Earlier in the week, Attorney General William Barr unveiled the Department of Justice’s plan to address gun violence. The proposal focused mostly on strengthening partnerships with law enforcement, agencies and community organizers in an effort to better enforce existing law. It was met with swift disappointment from advocates who said there were no new tangible policies in it.

The New York Times: Justice Dept. Unveils Gun Plan, Sidestepping A Preoccupied Washington

And even earlier in the week, the Supreme Court handed gun control advocates a win when the justices denied a bid to block a lawsuit against Remington, the maker of the gun used in the Sandy Hook shooting. The case, which has survived a roller coaster of twists and turns, has been closely watched because gun-makers have enjoyed broad immunity from prosecution under the 2005 Protection of Lawful Commerce in Arms Act. Although the suit started out making a different argument, it now hinges on whether Remington marketed the military-style guns for use by civilians.

NPR: Supreme Court Allows Sandy Hook Families’ Case Against Remington Arms To Proceed

No one gets any credit for predicting this correctly: Health law sign ups dropped 20 percent from where we were last year at this point. But with a lawsuit on the Affordable Care Act’s constitutionality looming, a chipping away of any enrollment outreach services, and just general confusion about where the law stands these days, the decrease seems all but inevitable.

CNBC: Obamacare Early Enrollment Rate Drops 20% Amid Trump-Backed Lawsuit

The Wall Street Journal dropped a privacy bombshell with its reporting that Google has been amassing health data on millions of patients without their knowledge. Privacy experts say “Project Nightingale” is perfectly legal (because business partners can share information with each other). But that doesn’t address the “ick factor” of something that may be totally above board legally but is kind of creepy anyway. Doing so is going to be a challenge for lawmakers.

The Wall Street Journal: Google’s ‘Project Nightingale’ Triggers Federal Inquiry

Politico Pro: Google’s New Partnership Might Creep You Out. That Doesn’t Mean It’s Illegal.

It’s been a quiet week health-wise on the campaign trail, but I’m certain they’ll make up for it at next Wednesday’s debate. Meanwhile, Sen. Bernie Sanders (I-Vt.) nabbed a coveted endorsement from a big nurses union that went hard for him in 2016.

The New York Times: Big Nurses Union Backs Bernie Sanders And His Push For ‘Medicare For All’

How do you sort out all the contradictory claims about “Medicare for All”? It’s tricky now that the policy has become so entangled with political rhetoric, but The New York Times offers some guidance.

The New York Times: Examining Conflicting Claims About ‘Medicare For All’

More details are emerging about the communications contracts Seema Verma, the administrator for the Centers for Medicare & Medicaid Services, gave to outside contractors—including a longtime ally of hers who was greenlighted to bill as much as $425,000 for about a year’s worth of work. The decision to pay so much on a communications strategy that in part was meant to burnish her personal brand stands in stark contrast to Verma’s views on Medicaid spending and waste.

Politico: Federal Health Contract Funneled Hundreds Of Thousands Of Dollars To Trump Allies

Elsewhere in the administration, the Environmental Protection Agency is preparing a rule that at first glance might not catch your attention but could have major repercussions. The proposal, which the administration says is meant to increase transparency, would require scientists to disclose all their raw data (including medical records) before research can be considered by the agency while it’s making rules. But what that means is that the EPA doesn’t have to consider older studies that were done under the promise of medical confidentiality.

If that all still seems a little obscure, here are some the topics of those older studies: lead causing behavioral disorders in children; mercury from power plants impairing brain development; and air pollution leading to premature deaths. The proposal would be retroactive.

The New York Times: E.P.A. To Limit Science Used To Write Public Health Rules

There was a breakthrough this week in scientists’ scramble to find the root cause of the mysterious vaping-related lung illness (officially called EVALI, but between you and me I don’t think that’s caught on at all). It appears that Vitamin E oil might be one of the main culprits. Apparently it turns sticky like honey and coats the inside of vapers’ lungs. Why is it in the products at all? Sellers use it to thicken the vaping fluid or dilute the THC used, boosting their overall profits.

The New York Times: Vaping Illnesses Are Linked To Vitamin E Acetate, C.D.C. Says

Meanwhile, a hospital announced that it successfully performed a double-lung transplant on a teenager who was facing “certain death” without it.

The New York Times: Facing ‘Certain Death,’ Teenager With Vaping Injury Gets Double Lung Transplant

The Food and Drug Administration sent a warning letter to the Dollar Tree for selling over-the-counter medications from companies that failed to ensure the drugs were safely manufactured and tested. One such company was found to have had rodent feces throughout its facility.

Stat: FDA Slams Dollar Tree For Purchasing Drugs From Suppliers With Checkered Safety Records

In the miscellaneous file for the week:

• Hate crime murders in the U.S. reached a 27-year high in 2018, according to a new FBI report. “We’re seeing a leaner and meaner type of hate crime going on,” said one expert, referring to the fact that crimes on people themselves had increased while things like vandalism had gone down.

CBS News: FBI Hate Crimes Data Released Today: Hate Crime Murders Hit Record In 2018; Crimes Targeting Transgender People Soar

• Self-harm is prevalent among young people, but there’s little actual research out there on the behavior itself. Often the reaction from loved ones if fear and panic, and an assumption that the teen was attempting suicide. That might not be the case, though.

The New York Times: Getting A Handle On Self-Harm

• This is a fun David and Goliath story about a little pharmacy with only 14 employees that is holding big drug companies’ feet to the fire over the safety of their products.

The Washington Post: A Tiny Pharmacy Is Identifying Big Problems With Common Drugs, Including Zantac

• Kaiser Permanente CEO Bernard Tyson died unexpectedly in his sleep at age 60. Here’s a look at the legacy he left behind.

The Wall Street Journal: Death Of CEO Comes At A Time Of Expansion, Big Bets For Kaiser Permanente

That’s it from me! Have a great weekend.

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The Death Toll For Florida’s Decision Not To Expand Medicaid: 2,776 Lives

KHN’s ‘What The Health’: Spending Bill Slowdown

Can’t see the audio player? Click here to listen on SoundCloud.

The fiscal year started a month and a half ago, but Congress has still not agreed on an annual spending bill for the Department of Health and Human Services – or any of the other annual spending bills that fund the government.

Meanwhile, Congress IS moving on efforts to further restrict tobacco and vaping products, particularly to limit their marketing to underage users. The Trump administration has been vowing to use its own authority to crack down on a youth vaping epidemic, but so far has not acted.

The administration is moving on the drug price front, however, filing a lawsuit against drugmaker Gilead for allegedly infringing a government-owned patent on a drug regimen to prevent HIV.

This week’s panelists are Julie Rovner from Kaiser Health News, Rebecca Adams of CQ Roll Call and Alice Miranda Ollstein of Politico.

Rovner also interviews Dan Weissmann, host of the podcast “An Arm and a Leg,” about why health care costs so much and what patients can do about it. KHN is co-producing the podcast’s new season.

Among the takeaways from this week’s podcast:

  • Among the partisan arguments holding up the HHS funding bill are disagreements on spending for family planning programs and the amount of an increase for HHS as a whole.
  • A House subcommittee this week approved new regulations that would limit flavors for vaping and other tobacco products. But that comes as the administration appears likely to step back from Trump’s earlier vow to outlaw flavored products.
  • Some lawmakers and administration officials suggest that any legislation to prohibit flavored e-cigarette products should include carve-outs for some groups, including small businesses that cater to vapers and to members of the military.
  • The recent revelation that Google is working with a major health care system to analyze patient records is raising concerns about consumers’ privacy. That and other recent issues surround health care tech may signal that the federal privacy law, HIPAA, needs to be updated.
  • The Trump administration’s suit against Gilead seeking to bring down costs of its HIV pre-exposure prophylaxis drug may signal that the government is ready to take on other companies with high price tags on drugs developed with federal support.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read, too:

Julie Rovner: The Philadelphia Inquirer’s “A Philly woman’s broken back and $36,000 bill shows how some health insurance brokers trick consumers into skimpy plans,” by Sarah Gantz.

Rebecca Adams: CQ Roll Call’s “Surprise billing fight highlights hurdles for bolder health care changes,” by Mary Ellen McIntire.

Alice Ollstein: Politico’s “Trump allies received hundreds of thousands of dollars under federal health contract,” by Dan Diamond and Adam Cancryn.

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcherGoogle PlaySpotify, or Pocket Casts.

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State Highlights: New York Becomes First State To Name Hospitals, Nursing Homes Treating Patients With Deadly Fungus; Dayton, Ohio’s Last Abortion Clinic Granted Operating License

Hospital Group Involved In ‘Project Nightingale’ Defends Actions As Covered Under A Business Clause Of HIPAA

As Boomers Age Out Of Caring For Adult Disabled Children, Health System Is Unprepared To Take Over In Their Place

Health Law Sign-Ups Drop 20% As Constitutionality Decision Looms, But Experts Point To Marketplace’s Past Resiliency

State Highlights: Civil Trial Begins For Arizona Body Donation Facility Accused Of Fraud; Experts Link High Lung Cancer Rates In Missouri, Kentucky With Smoking

A Look Back At The Legacy Left Behind Following Kaiser Permanente CEO Bernard Tyson’s Death

Fallout From Google’s ‘Project Nightingale’ Revelation: A Federal Inquiry, Lawmakers’ Criticism And Patient Privacy Fears

State Highlights: Calif. Governor’s Financial Ties To Utility Behind Wildfires Exposed In Probe; North Carolina Budget Stalemate Threatens Medicaid Hand-Off Start Date

‘A Historic Milestone’: Merck’s Ebola Vaccine First-Ever To Get Approval From European Commission

Viewpoints: Fresh Approach Is Needed For Battle Against Veterans’ Suicides; Taxing E-Cigs Can Help Stop Teens From Vaping

Louisiana Sued Over Allegations Medicaid Program Failed To Provide Children With Mental Health Services

Kaiser Permanente CEO Bernard Tyson Dies Unexpectedly At Age 60

Officials Point To Drug Spending For Jump In Medicare’s Part B Premiums

Sit, Heal: Dog Teaches Military Med Students The Merits Of Service Animals

The newest faculty member at the Uniformed Services University of the Health Sciences has a great smile — and a wagging tail.

Shetland, not quite 2 years old, is half golden retriever, half Labrador retriever. As of this fall, he is also a lieutenant commander in the Navy and a clinical instructor in the Department of Medical and Clinical Psychology at USUHS.

Among Shetland’s skills are “hugging” on command, picking up a fallen object as small as a cellphone and carrying around a small basket filled with candy for harried medical and graduate students who study at the military’s medical school campus in Bethesda, Md.

But Shetland’s job is to provide much more than smiles and a head to pat.

“He is here to teach, not just to lift people’s spirits and provide a little stress relief after exams,” said USUHS Dean Arthur Kellermann. He said students interacting with Shetland are learning “the value of animal-assisted therapy.”

The use of dogs trained to help their human partners has ballooned since studies in the 1980s and 1990s started to show how animals can benefit human health.

But helper dogs come in many varieties. Service dogs, like guide dogs for the blind, help people with disabilities live more independently. Therapy dogs can be household pets who visit people in hospitals, schools and nursing homes. And then there are highly trained working dogs, like the Belgian Malinois that recently helped run down Islamic State leader Abu Bakr al-Baghdadi.

Shetland is technically a “military facility dog,” trained to provide physical and mental assistance to patients as well as interact with a wide variety of people. His military commission does not entitle him to salutes from his human counterparts.

Although service dogs are commonly seen at the Uniformed Services University of the Health Sciences, Shetland, a retriever mix, is a clinical instructor in the Department of Medical and Clinical Psychology.(Julie Rovner/KHN)

“The ranks are a way of honoring the services [of the dogs] as well as strengthening the bond between the staff, patients and dogs here,” said Mary Constantino, deputy public affairs officer at Walter Reed National Military Medical Center.

USUHS, which trains doctors, dentists, nurses and other health professionals for the military, is on the same campus in suburban Washington, D.C., as Walter Reed. Two of the seven Walter Reed facility dogs — Hospital Corpsman 2nd Class Sully (the former service dog for President George H.W. Bush) and Marine Sgt. Dillon — attended Shetland’s formal commissioning ceremony in September as guests.

The Walter Reed dogs, on campus since 2007, earn commissions in the Army, Navy, Air Force or Marines. They wear special vests designating their service and rank. The dogs visit and interact with patients in several medical units, as well as in physical and occupational therapy, and help boost morale for patients’ family members.

But Shetland’s role is very different, said retired Col. Lisa Moores, USUHS associate dean for assessment and professional development.

“Our students are going to work with therapy dogs in their careers, and they need to understand what [the dogs] can do and what they can’t do,” she said.

As in civilian life, the military has made significant use of animal-assisted therapy. “When you walk through pretty much any military treatment facility, you see therapy dogs walking around in clinics, in the hospitals, even in the ICUs,” said Moores. Dogs also play a key role in helping returning service members with post-traumatic stress disorder.

Students need to learn who “the right patient is for a dog, or some other therapy animal,” she said. “And by having Shetland here, we can incorporate that into the curriculum so it’s another tool the students know they have for their patients someday.”

The students, not surprisingly, are thrilled by their newest teacher.

Brelahn Wyatt, a second-year medical student, said the Walter Reed dogs used to visit the school’s 1,500 students and faculty fairly regularly, but “having Shetland here all the time is optimal.” And not just because of the hugs and candy.

Wyatt said the only thing she knew about service dogs before “is that you’re not supposed to pet them.” But Shetland acts as both a service dog and a therapy dog, so he can be petted.

That helps medical students see “there’s a difference. What does that difference look like in the health care setting?” said Wyatt.

Like his colleagues Sully and Dillon, Shetland was bred and trained by America’s VetDogs. The New York nonprofit provides dogs for “stress control” for active-duty military missions overseas, as well as service dogs for disabled veterans and civilian first responders. Many of the puppies are raised by a combination of prison inmates (during the week) and families (on the weekends), before returning to New York for formal service dog training. National Hockey League teams such as the Washington Capitals and New York Islanders also raise puppies for the organization.

Dogs can be particularly helpful in treating service members, said Valerie Cramer, manager of America’s VetDogs service dog program. “The military is thinking about resiliency. They’re thinking about well-being, about decompression in the combat zone.” Often people in pain won’t talk to another person but will open up in front of a dog. “It’s an opportunity to start a conversation as a behavioral health specialist,” she said.

While service dogs for individuals are trained to perform both physical tasks like picking up dropped items and emotional ones like waking a veteran having a nightmare, facility dogs like Shetland are special, Cramer said. “That dog has to work in all different environments with people who are under pressure. It can work for multiple handlers, it can go and visit people, can go visit hospital patients, can knock over bowling pins to entertain or spend time in bed with a child.”

The military rank for the dogs is no joke. They can be promoted ― as Dillon was from Army specialist to sergeant in 2018 ― or demoted for bad behavior.

Said Kellermann, “So far, Shetland has a perfect conduct record.”

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Voters Say Congress Needs To Curb Drug Prices, But Are Lawmakers Listening?

House Democrats are poised to pass sweeping legislation to lower drug prices using strategies President Donald Trump has endorsed. A Trump aide urged the Republican-controlled Senate to vote on a different package curbing drug prices that was drafted by a senior Republican.

But at least right now, neither measure appears likely to attract enough bipartisan support to become law.

Nearly 8 in 10 Americans say the cost of prescription drugs is unreasonable, with voters from both parties agreeing that reducing the cost of prescription drugs should be one of Congress’ top priorities, according to a poll last month by the Kaiser Family Foundation. (KHN is an editorially independent program of the foundation.)

With such broad and bipartisan support, why do the odds look grim for Congress to pass significant drug pricing legislation this year?

Because whether it’s sharing the credit for a legislative victory with the other party or running afoul of the powerful drugmaker lobby, neither Democrats nor Republicans are sure the benefits are worth the risks, according to several of those familiar with the debate on Capitol Hill.

Complications From ‘Medicare For All,’ Impeachment 

Senate Majority Leader Mitch McConnell, who is a Republican and controls what legislation gets to the Senate floor, has said he will not allow a vote on the House Democrats’ legislation. Among other things, the bill written by House Speaker Nancy Pelosi and other Democratic leaders would enable federal health officials to negotiate the prices of as many as 250 of the most costly drugs. Although Trump has endorsed that tactic, most Republican lawmakers oppose it because they are philosophically opposed to interfering with the market.

On Friday, Trump’s chief domestic policy adviser, Joe Grogan, said any drug pricing legislation would need bipartisan support, saying of Pelosi’s plan: “It is not going to pass in its current form.” He said the White House supports the bipartisan package drafted by Sen. Chuck Grassley (R-Iowa), who chairs the Finance Committee, and the committee’s top Democrat, Sen. Ron Wyden of Oregon.

But many Senate Republicans in particular are uncomfortable with one of the bill’s key provisions: a requirement that drugmakers not raise their prices on drugs covered by Medicare faster than the rate of inflation.

Asked whether the White House supports the inflation caps, Grogan said they were “not the administration’s proposal, but they are the product of a bipartisan compromise, and they are the route to a bipartisan bill, in our opinion.”

In a recent interview, Grassley spokesman Michael Zona dismissed the call from other Republicans to eliminate the provision. “There’s no need,” he said. “The bill passed with a bipartisan two-thirds majority in committee, and support’s growing for the bill every week among Republicans.”

While the Senate Finance Committee did vote 19-9 in July to send the Grassley-Wyden bill to the full Senate for consideration, some Republicans who voted to advance it cautioned then that they may not ultimately vote for the bill.

While considering the bill, all but two of the committee’s Republican members voted to kill the provision to prevent Medicare drug prices from rising faster than inflation. Grassley, however, got Democratic support and it stayed in the bill.

But it’s not clear if the bill will come to the floor. McConnell is known to be unwilling to corner Senate Republicans with votes that could be politically risky during campaign season, whether due to criticism from Democrats or pressure from the drug industry.

In addition, the push by some progressive Democratic presidential candidates for a government-controlled “Medicare for All” health system has not made it more appealing for Republicans to work with Democrats on health care issues, said Kim Monk, a health care analyst and partner at Capital Alpha Partners who used to work for Republicans in the Senate.

“Why would Republicans stick their neck out while Democrats are fighting over Medicare for All?” she asked.

And Senate Minority Leader Chuck Schumer of New York, a Democrat, has drawn a line insisting any health care legislation come with protections for those with preexisting conditions. That’s a risky conversation for Republicans, because a federal appeals court is considering a lawsuit brought by Republican states seeking to throw out the entire Affordable Care Act, which guarantees those with medical conditions can get coverage.

Still, polling suggests that the issue of drug pricing has the power to motivate voters to support one party or the other, and that is likely to motivate lawmakers.

There are more Senate Republican incumbents up for reelection next year than Democrats, and several are considered vulnerable.

Meanwhile, Democrats might be able to argue that they sought to tackle the issue of prices, but Republicans backed away from it.

The decision by House Democrats last month to pursue an impeachment inquiry against Trump has no doubt poisoned the waters between the parties. But the prospects have not looked promising anyway for a comprehensive, bipartisan package of solutions to rein in escalating drug costs.

A Third Legislative Option 

Acknowledging their problems with the Pelosi and Grassley-Wyden proposals, some Republicans are touting a modest measure that has failed to become law in the three years since it was introduced: the CREATES (Creating and Restoring Equal Access To Equivalent Samples) Act.

The CREATES Act does not take a direct approach to lowering prices. Nonetheless, based on political opposition to the larger packages, it could be some of the only drug-pricing legislation that passes this Congress. The bill would crack down on tactics used by brand-name drug manufacturers to dissuade generic competitors, aiming to eliminate anti-competitive behavior and allow the free market to bring down prices.

Specifically, it would empower generics manufacturers to sue brand-name drugmakers that block them from obtaining the samples needed to conduct studies and get Food and Drug Administration approval of their versions. It would also give the FDA more leeway to approve alternative safety protocols for high-risk drugs. Currently generic drugmakers are required to join with the brand-name manufacturers in a shared safety system for those drugs, but some brand-name companies refuse to negotiate with the generic companies, thus delaying their ability to get FDA approval.

It is the rare piece of legislation with support from the likes of progressive Sen. Sheldon Whitehouse (D-R.I.) and conservative Sen. Mike Lee (R-Utah).

But the bill has hit snags before. The brand-name drug industry trade group, the Pharmaceutical Research and Manufacturers of America, has opposed the CREATES Act in the past. With its heavy spending on lobbyists, advertisements and campaign contributions for lawmakers, it has been a powerful opponent.

Opposition softened earlier this year, though, when executives from seven of the world’s biggest drugmakers told the Senate Finance Committee they are in favor of the bill.

“We support the overall intent of the CREATES Act,” Holly Campbell, a PhRMA spokeswoman, said in an email. She added that drugmakers “should not withhold samples with the intent of delaying generic or biosimilar entry.”

Facing the prospect that Congress could fail to pass bigger fixes like the Pelosi or Grassley-Wyden plans, some say CREATES could be used to offset the cost of health care programs like community health center funding that will soon expire if Congress does not extend them.

In July, the Congressional Budget Office estimated that the CREATES Act could save the federal government $3.7 billion over 10 years.

But even some of CREATES’ supporters say it is not enough to lower drug prices.

“The idea that Congress is going to lower prescription drug prices without reforms to Medicare is nonsensical,” said Zona, Grassley’s spokesman. He added that the CREATES Act, which Grassley originally co-sponsored, is important. “But it’s only one piece of the puzzle.”

House members are home in their districts this week, and when they return, they expect to focus on passing spending bills before a Nov. 21 deadline to advert a government shutdown, before voting on Pelosi’s plan.

In the meantime, some are cautious in their predictions about whether Congress can pass significant drug pricing legislation before 2020, when the election campaign may prompt lawmakers to retreat further into their respective partisan corners.

Chip Davis, the chief executive of the generic drugmakers’ Association for Accessible Medicines, said that even though there is increasing agreement that the government needs to act to help curb drug price increases, the two parties are approaching it in very distinct ways.

“It remains to be seen,” he added, “whether those differences of opinion can be reconciled into a package that can get enough support in both chambers.”

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Must-Reads Of The Week From Brianna Labuskes

Happy Friday! Tis the season of getting wretched colds, and I blame daylight savings as any reasonable person would. So, we’re going to make this short and sweet as I clutch my tissues and tea. Buckle up!

Election results in Kentucky (and Virginia, really) added to the ever-deepening narrative that health care can be a big political winner for Dems and an Achilles’ heel for Republicans these days. Although the GOP talking point is that Gov. Matt Bevin (who technically hasn’t conceded yet) was extremely unpopular, it’s hard to miss that Medicaid expansion was a top issue in the race. Andy Beshear, who claimed victory on Tuesday, has vowed to rescind all of Bevin’s plans for Medicaid work requirements when he takes office.

In Virginia, many lawmakers ran on health care as well (like promising to protect preexisting conditions coverage and tackling gun control regulations), helping the Dems secure the Legislature for the first time in decades.

But health care isn’t always enough to boost Dems to a win, it seems. Democrat Jim Hood failed to upset Lt. Gov. Tate Reeves, a Republican, despite Hood’s promises to expand Medicaid to about 300,000 of the state’s most needy residents.

Curiously, attacks over abortion did not seem to hurt Democrats in either Virginia or Kentucky, even though the issue loomed large in both states.

CNN: Kentucky, Virginia And Mississippi Elections: 3 Takeaways

Politico: Why Democrats Keep Winning On Health Care

In a quick sidenote on Medicaid in the Deep South: Georgia’s governor has released a long-awaited health care plan that includes a limited Medicaid expansion with work requirements. As the requirements falter elsewhere, it will be interesting to test case to watch.

The Associated Press: Georgia Governor Unveils Medicaid Plan With Work Requirement

Now over to the presidential primary race: As predicted, lots of pundits, rivals, and others have had lots of thoughts on Massachusetts Sen. Elizabeth Warren’s plan to pay for “Medicare for All,” mostly landing on: It’s just not realistic. For her numbers to add up (which they do), everything pretty much has to fall into place perfectly. Which… in a nation’s capitol known more for its bitter partisan gridlock and deference to deep-pocketed lobby interests than for its smooth roads and sunny skies, well… no one is holding their breath that this would pass.

The Washington Post Fact Checker: Warren’s Plan To Pay For Medicare-For-All: Does It Add Up?

The New York Times: Elizabeth Warren’s ‘Medicare For All’ Math

Elsewhere on the election trail, Sen. Bernie Sanders (I-Vt.) released an ambitious plan to tack the immigration crisis. Among other things, he would scrap President Donald Trump’s “public charge” rule and ensure that anyone in the country regardless of immigration status was covered by his health system.

Boston Globe: Bernie Sanders Unveils Ambitious Immigration Plan That Offer A Path For Citizenship And Dismantles ICE

Tension over patents came to a head this week as the Trump administration sued Gilead over its HIV prevention drug, the development of which relied heavily on taxpayer-funded research. This fight has been bubbling up because Gilead has been raking in billions from the drug and yet hasn’t paid the CDC any royalties.

The Washington Post: U.S. Sues Drugmaker Gilead Sciences Over Patent On Truvada For HIV Prevention

And in case you’re interested in the background of it all (you should be! It’s a fascinating case), the Post did a deep-dive back in March.

The Washington Post: An HIV Treatment Cost Taxpayers Millions. The Government Patented It. But A Pharma Giant Is Making Billions.

Speaking of news from the administration, there was so much of it this week!

Let’s start with the court decision to block its expanded “conscience rule” for health care personnel who don’t want to participate in certain care due to moral reasons. The judge denounced the rule, saying it was arbitrary and unconstitutionally coercive. He also wrote that the “stated justification for undertaking rule making in the first place — a purported ‘significant increase’ in civilian complaints relating to the conscience provisions — was factually untrue.”

The New York Times: Judge Voids Trump-Backed ‘Conscience Rule’ For Health Workers

That wasn’t the only legal blow the administration suffered: elsewhere, a judge placed a temporary restraining order on a Trump rule that would have required visa-seekers to prove they can pay for health coverage before they’re allowed to live in the country.

The Associated Press: US Judge Blocks Trump’s Health Insurance Rule For Immigrants

In a separate court decision, a federal judge ruled that the U.S. government must provide mental health services to migrant families who may have been traumatized by being separated under the zero tolerance policy. The judge referred to previous federal cases that found that governments can be held liable when with “deliberate indifference” they place people in dangerous situations. This bit from The New York Times is interesting: In the past, the “state-created danger” doctrine has been applied when a police officer ejected a person from a bar late at night in very cold weather, or when a public employer failed to address toxic mold that caused workers to fall ill.

The New York Times: U.S. Must Provide Mental Health Services To Families Separated At Border

From news outside the courts, HHS is seeking to roll back Obama-era protections that keep foster care and adoption services from discriminating against LGBTQ families.

The New York Times: Adoption Groups Could Turn Away L.G.B.T. Families Under Proposed Rule

And in the midst of several public health crises, Trump has picked his choice to head the FDA: Dr. Stephen Hahn of the MD Anderson Cancer Center in Texas. If confirmed, Hahn will almost immediately have his hands full with the vaping epidemic, as well as continued fallout from the opioid crisis, not to mention public outrage over the high cost of drugs.

The Associated Press: Trump Picks Cancer Specialist From Texas Hospital To Run FDA

In case you missed it: Stat did one of the more interesting profiles on Hahn a bit ago, if you want to read up on his background.

Stat: Frontrunner To Lead FDA, Dogged By Controversies, Has Developed Knack For Confronting Them

On the topic of FDA, a look at how a controversy over a chemical that sterilizes medical equipment became a prime example of just how wrong things can go when agencies operate as silo-ed bureaucracies.

Politico: How The FDA And EPA’s Failure To Communicate Could Put Patients In Danger

Ahead of an anticipated federal ban on e-cigarettes, Juul has announced that it will end the sale of mint flavored pods. A study came out this week that found that the mint flavored ones have become more and more popular among young vapers.

The New York Times: Juul Ends E-Cigarette Sales Of Mint-Flavored Pods

Often times, when studying a disease it can be the people who don’t get it that hold the answers. That might be true with one woman who should have gotten early onset Alzheimer’s but didn’t start showing symptoms until decades later. Researchers say a mutation that the woman had protected her from the devastating disease. Learning how it did that could help scientists replicate the process for those who don’t have the mutation.

The New York Times: Why Didn’t She Get Alzheimer’s? The Answer Could Hold A Key To Fighting The Disease

It’s not always the memory that goes first. For those with frontotemporal dementia, it’s often the areas of the brain that control personality that are affected first. The resulting behavior changes can be heartbreaking.

The New York Times: The Loneliness Of Frontotemporal Dementia

And in the miscellaneous file for the week:

  • Documents show how Walgreens was in a unique position to raise giant red flags about the opioid epidemic at its height. But the company failed to do so.

The Washington Post: At Height Of Crisis, Walgreens Handled One In Five Of The Most Addictive Opioids

  • When one woman’s baby was born three months prematurely, she’d thought she’d taken care of everything that was needed to get her daughter covered under her insurance. Turns out, that wasn’t the case, and by the time she got the $898,984 bill, it was too late to fix it.

ProPublica: How One Employer Stuck A New Mom With A $898,984 Bill For Her Premature Baby

  • We often think of breath tests as being infallible ways to prevent drunken driving. But many of the machines that are stocked in police stations across the country are calibrated incorrectly. For some, that can change the whole course of their future.

The New York Times: These Machines Can Put You In Jail. Don’t Trust Them.

That’s it from me! Everyone stay healthy and don’t forget to get your flu shot.

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