Tag: Prescription Drugs

New CDC Opioid Guidelines: Too Little, Too Late for Chronic Pain Patients?

Jessica Layman estimates she has called more than 150 doctors in the past few years in her search for someone to prescribe opioids for her chronic pain.

“A lot of them are straight-up insulting,” said the 40-year-old, who lives in Dallas. “They say things like ‘We don’t treat drug addicts.’”

Layman has tried a host of non-opioid treatments to help with the intense daily pain caused by double scoliosis, a collapsed spinal disc, and facet joint arthritis. But she said nothing worked as well as methadone, an opioid she has taken since 2013.

The latest phone calls came late last year, after her previous doctor shuttered his pain medicine practice, she said. She hopes her current doctor won’t do the same. “If something should happen to him, there’s nowhere for me to go,” she said.

Layman is one of the millions in the U.S. living with chronic pain. Many have struggled to get opioid prescriptions written and filled since 2016 guidelines from the Centers for Disease Control and Prevention inspired laws cracking down on doctor and pharmacy practices. The CDC recently updated those recommendations to try to ease their impact, but doctors, patients, researchers, and advocates say the damage is done.

“We had a massive opioid problem that needed to be rectified,” said Antonio Ciaccia, president of 3 Axis Advisors, a consulting firm that analyzes prescription drug pricing. “But the federal crackdowns and guidelines have created collateral damage: patients left high and dry.”

Born of an effort to fight the nation’s overdose crisis, the guidance led to legal restrictions on doctors’ ability to prescribe painkillers. The recommendations left many patients grappling with the mental and physical health consequences of rapid dose tapering or abruptly stopping medication they’d been taking for years, which carries risks of withdrawal, depression, anxiety, and even suicide.

In November, the agency released new guidelines, encouraging physicians to focus on the individual needs of patients. While the guidelines still say opioids should not be the go-to option for pain, they ease recommendations about dose limits, which were widely viewed as hard rules in the CDC’s 2016 guidance. The new standards also warn doctors about risks associated with rapid dose changes after long-term use.

But some doctors worry the new recommendations will take a long time to make a meaningful change — and may be too little, too late for some patients. The reasons include a lack of coordination from other federal agencies, fear of legal consequences among providers, state policymakers hesitant to tweak laws, and widespread stigma surrounding opioid medication.

The 2016 guidelines for prescribing opioids to people with chronic pain filled a vacuum for state officials searching for solutions to the overdose crisis, said Dr. Pooja Lagisetty, an assistant professor of medicine at the University of Michigan Medical School.

The dozens of laws that states passed limiting how providers prescribe or dispense those medications, she said, had an effect: a decline in opioid prescriptions even as overdoses continued to climb.

The first CDC guidelines “put everybody on notice,’’ said Dr. Bobby Mukkamala, chair of the American Medical Association’s Substance Use and Pain Care Task Force. Physicians reduced the number of opioid pills they prescribe after surgeries, he said. The 2022 revisions are “a dramatic change,” he said.

The human toll of the opioid crisis is hard to overstate. Opioid overdose deaths have risen steadily in the U.S. in the past two decades, with a spike early in the covid-19 pandemic. The CDC says illicit fentanyl has fueled a recent surge in overdose deaths.

Taking into account the perspective of chronic pain patients, the latest recommendations try to scale back some of the harms to people who had benefited from opioids but were cut off, said Dr. Jeanmarie Perrone, director of the Penn Medicine Center for Addiction Medicine and Policy.

“I hope we just continue to spread caution without spreading too much fear about never using opioids,” said Perrone, who helped craft the CDC’s latest recommendations.

Christopher Jones, director of the CDC’s National Center for Injury Prevention and Control, said the updated recommendations are not a regulatory mandate but only a tool to help doctors “make informed, person-centered decisions related to pain care.”

Multiple studies question whether opioids are the most effective way to treat chronic pain in the long term. But drug tapering is associated with deaths from overdose and suicide, with risk increasing the longer a person had been taking opioids, according to research by Dr. Stefan Kertesz, a professor of medicine at the University of Alabama-Birmingham.

He said the new CDC guidance reflects “an extraordinary amount of input” from chronic pain patients and their doctors but doubts it will have much of an impact if the FDA and the Drug Enforcement Administration don’t change how they enforce federal laws.

The FDA approves new drugs and their reformulations, but the guidance it provides for how to start or wean patients could urge clinicians to do so with caution, Kertesz said. The DEA, which investigates physicians suspected of illegally prescribing opioids, declined to comment.

Smith has experienced pain in her left leg since a nerve was cut during surgery years ago. But in December her pharmacy stopped filling her prescriptions for painkillers.(Andy Miller / KHN)

The DEA’s pursuit of doctors put Danny Elliott of Warner Robins, Georgia, in a horrible predicament, said his brother, Jim.

In 1991, Danny, a pharmaceutical company rep, suffered an electric shock. He took pain medicine for the resulting brain injury for years until his doctor faced federal charges of illegally dispensing prescription opioids, Jim said.

Danny turned to doctors out of state — first in Texas and then in California. But Danny’s latest physician had his license suspended by the DEA last year, and he couldn’t find a new doctor who would prescribe those medications, Jim said.

Danny, 61, and his wife, Gretchen, 59, died by suicide in November. “I’m really frustrated and angry about pain patients being cut off,” Jim said.

Danny became an advocate against forced drug tapering before he died. Chronic pain patients who spoke with KHN pointed to his plight in calling for more access to opioid medications.

Even for people with prescriptions, it’s not always easy to get the drugs they need.

Pharmacy chains and drug wholesalers have settled lawsuits for billions of dollars over their alleged role in the opioid crisis. Some pharmacies have seen their opioid allocations limited or cut off, noted Ciaccia, with 3 Axis Advisors.

Rheba Smith, 61, of Atlanta, said that in December her pharmacy stopped filling her prescriptions for Percocet and MS Contin. She had taken those opioid medications for years to manage chronic pain after her iliac nerve was mistakenly cut during surgery, she said.

Smith said she visited nearly two dozen pharmacies in early January but could not find one that would fill her prescriptions. She finally found a local mail-order pharmacy that filled a one-month supply of Percocet. But now that drug and MS Contin are not available, the pharmacy told her.

“It has been a horrible three months. I have been in terrible pain,” Smith said.

Many patients fear a future of constant pain. Layman thinks about the lengths she’d go to in order to get medication.

“Would you be willing to buy drugs off the street? Would you be willing to go to an addiction clinic and try to get pain treatment there? What are you willing to do to stay alive?” she said. “That is what it comes down to.”

Why Does Insulin Cost So Much? Big Pharma Isn’t the Only Player Driving Prices

Eli Lilly & Co.’s announcement that it is slashing prices for its major insulin products could make life easier for some diabetes patients while easing pressure on Big Pharma.

It also casts light on the profiteering methods of the drug industry’s price mediators — the pharmacy benefit managers, or PBMs — at a time when Congress has shifted its focus to them.

Insulin has come to embody the perversity of the U.S. health care system as list prices for the century-old drug, which 8.4 million Americans depend on for survival, quintupled over two decades to more than $300 for a single vial. Just because Lilly — which sells about a third of the insulin in the United States — lowers its price doesn’t mean all patients will pay less, even in the long run.

Lilly capped the out-of-pocket costs of its most popular insulins at $35 effective immediately, and said that later this year the list price of its “authorized generic” Lispro — which is identical to Humalog, its bestselling brand-name insulin — would fall to $25 a vial. This followed President Joe Biden’s State of the Union address, and speeches since, in which he has blamed “Big Pharma” and its “record profits” for the incredible expense of insulin.

David Ricks, Lilly CEO, in interviews March 1 called for other manufacturers to join his company in “taking away the affordability challenges” of diabetes.

Even as Lilly promotes its altruism, this move may actually save it money, said health care analyst Sean Dickson. A federal rule taking effect next year penalizes companies that charge Medicaid high prices, especially for older, branded drugs. Lowering the list price of Humalog would allow Lilly to pay significantly less in rebates to government Medicaid programs that buy the drug.

Drugmakers have long ceased to be the only, or even primary, villain of the insulin price scandal. The three companies that produce nearly all the insulin in this country — Lilly, Sanofi, and Novo Nordisk — posted stagnant or declining revenue from their versions of the drug in recent years despite the steadily climbing list prices they charged. They’ve even advised investors that they don’t see insulin sales as a high-profit area anymore.

But while Lilly is cutting the “wholesale acquisition price,” or list price, of its big-selling insulin drugs, “will other ‘parties at play’ cause this price to increase before it hits my pharmacy counter?” asked Rebecca Kelly of Richmond, Kentucky, who has Type 1 diabetes and is an activist for lower drug prices.

Those parties include gigantic pharmacy benefit managers — owned by CVS Health and insurance giants UnitedHealthcare and Cigna — that have aggressively played the insulin makers off one another in a way that mainly fattened their own accounts, as was revealed in a scathing 2021 Senate Finance Committee report.

In theory, when pharmacy benefit managers negotiate contracts with drug manufacturers on behalf of insurers, they pass along savings to patients. In practice, while the hard-nosed bargaining may benefit the well-insured, it can hurt patients on fixed incomes and others less able to afford their insulin.

To compete for access to insured patients, according to the report, the three insulin makers in the 2010s steadily increased rebates and fees paid to the powerful PBMs, which are owned by or allied with major insurers. This spurred drugmakers to keep raising their list prices, because the more they paid in rebates — calculated as a percentage of list price — the better their placement on insurance formularies, the complex lists of drugs insurers cover for patients.

In other words, the more the insulin makers compete, the more consumers — the unlucky ones, anyway — may pay.

“Insulin is a commodity, so formulary position is everything,” said David Kliff, who edits the website Diabetic Investor. “It’s like location in real estate.”

In 2018, Novo Nordisk, amid public rancor over rising insulin prices, considered a 50% cut, according to the report. But the company’s board decided against it, noting that “many in the supply chain will be negatively affected ($) and may retaliate.” The company also feared that irate insurers might retaliate against Novo’s blockbuster diabetes and weight-loss drugs like Ozempic, which compete against Lilly’s Mounjaro.

Sanofi and Novo Nordisk did not directly respond to Lilly’s price-dropping move but noted, in statements, that their discount programs already provide cheap insulin for those who need them. Millions of Americans have used these coupons, but patients like Kelly say they come with red tape and can be unreliable.

Lilly declined to respond to a question about how its cut in list price might affect negotiations with insurers, which have come to expect big rebates on drugs with competitively high list prices.

For example, Sanofi paid rebates worth 2% to 4% of its insulin list price in 2013, but 56% in 2018, according to the Senate report. Over that period, Sanofi tripled the price of its Lantus insulin to about $275 per vial. A 2018 study estimated it costs roughly $2 to $4 to produce a vial of analog insulin, the type used by most patients.

Most of the insulin list price increases have gone to PBMs, the go-between companies. For example, Lilly earned about $25 for each Humalog injection pen from 2013 to 2018, while the list price increased from $57 to $106. Net prices have remained stable the past few years and insulin revenues actually declined last year, according to recent Sanofi and Lilly financial reports.

Trade secrecy makes it hard to see which portions of the kickbacks end up as profit or savings for pharmacy benefit managers, insurers, pharmacies, or patients. But patients who are uninsured, are underinsured, or pay high deductibles can end up with whopping insulin bills, because their copayments are tied to the drug’s list price.

“The system transfers financial resources from sick patients to healthy, premium-paying beneficiaries, the opposite of what insurance is supposed to do,” Erin Trish, co-director of the University of Southern California Schaeffer Center for Health Policy & Economics, told a Senate Commerce Committee hearing Feb. 16.

Medicare beneficiaries, for example, paid a collective $1 billion out-of-pocket for their insulin in 2020, more than four times what they paid in 2007, according to a KFF study. So did many others.

Kelly, a 48-year-old personal trainer, got insulin through her husband’s insurance but had to pay out-of-pocket until she met a $5,000 deductible each year. So in 2019, the Kellys dropped the policy and decided to risk the open market. They ended up driving to Canada, where Kelly told KHN she spent $256 on eight vials of insulin that would have cost $2,616 at her local pharmacy. During the pandemic, she used Lilly coupons that enabled her to buy Humalog for $35 per vial, enough for about two weeks.

Despite coupon programs, surveys conducted since 2017 showed that up to a quarter of U.S. patients reported skimping on insulin because of its cost. Some patients have died while trying to ration the drug.

The contrast with other developed countries is stark. Germans with diabetes pay around $5 for a month’s worth of insulin. In the United Kingdom, patients pay nothing.

Federal legislation signed into law last year capped out-of-pocket insulin costs at $35 per month for Medicare recipients. At least 22 states and the District of Columbia have set caps on private plans as well.

The three big insulin makers have fought off competition that could lower prices across the board. They’ve done this, for example, by introducing their own, slightly less expensive “authorized generics,” which discourage other companies from entering the insulin market. It wasn’t until 2021 that a competitor brought a long-acting “biosimilar” insulin — essentially a generic version of Lantus — to the market, and it has barely made a dent. The company, Viatris, which since sold its product to Biocon Biologics, did win entry to one formulary by creating an essentially identical product, tripling its list price and offering PBMs a big rebate.

These kinds of behaviors have increasingly drawn congressional attention, and drug manufacturing attack ad campaigns.

“Imagine a world where a cheaper product, yet equally effective, has a harder time selling,” Sen. Chuck Grassley (R-Iowa) said at the Feb. 16 Commerce Committee hearing. “That’s the prescription drug industry.”

Still, Lilly’s announcement may be a harbinger of better news for the most economically vulnerable people with diabetes.

California has funded a plan to make and distribute its own insulin. Separately, Civica, a nonprofit drug manufacturer, hopes by the end of 2024 to sell insulin produced in India. Civica will bypass benefit managers and provide the drug to any pharmacy that promises to sell it for no more than $30 per vial, said Allan Coukell, its senior vice president for public policy.

Civica plans to produce enough insulin for a third of all U.S. patients, he said.

March Medicaid Madness

The Host

With Medicare and Social Security apparently off the table for federal budget cuts, the focus has turned to Medicaid, the federal-state health program for those with low incomes. President Joe Biden has made it clear he wants to protect the program, along with the Affordable Care Act, but Republicans will likely propose cuts to both when they present a proposed budget in the next several weeks.

Meanwhile, confusion over abortion restrictions continues, particularly at the FDA. One lawsuit in Texas calls for a federal judge to temporarily halt distribution of the abortion pill mifepristone. A separate suit, though, asks a different federal judge to temporarily make the drug easier to get, by removing some of the FDA’s safety restrictions.

This week’s panelists are Julie Rovner of Kaiser Health News, Alice Miranda Ollstein of Politico, Rachel Cohrs of STAT News, and Lauren Weber of The Washington Post.

Among the takeaways from this week’s episode:

  • States are working to review Medicaid eligibility for millions of people as pandemic-era coverage rules lapse at the end of March, amid fears that many Americans kicked off Medicaid who are eligible for free or near-free coverage under the ACA won’t know their options and will go uninsured.
  • Biden promised this week to stop Republicans from “gutting” Medicaid and the ACA. But not all Republicans are on board with cuts to Medicaid. Between the party’s narrow majority in the House and the fact that Medicaid pays for nursing homes for many seniors, cutting the program is a politically dicey move.
  • A national group that pushed the use of ivermectin to treat covid-19 is now hyping the drug as a treatment for flu and RSV — despite a lack of clinical evidence to support their claims that it is effective against any of those illnesses. Nonetheless, there is a movement of people, many of them doctors, who believe ivermectin works.
  • In reproductive health news, a federal judge recently ruled that a Texas law cannot be used to prosecute groups that help women travel out of state to obtain abortions. And the abortion issue has highlighted the role of attorneys general around the country — politicizing a formerly nonpartisan state post. –And Eli Lilly announced plans to cut the price of some insulin products and cap out-of-pocket costs, though their reasons may not be completely altruistic: An expert pointed out that a change to Medicaid rebates next year means drugmakers soon will have to pay the government every time a patient fills a prescription for insulin, meaning Eli Lilly’s plan could save the company money.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:

Julie Rovner: The New York Times’ “A Drug Company Exploited a Safety Requirement to Make Money,” by Rebecca Robbins.

Alice Miranda Ollstein: The New York Times’ “Alone and Exploited, Migrant Children Work Brutal Jobs Across the U.S.,” by Hannah Dreier.

Rachel Cohrs: STAT News’ “Nonprofit Hospitals Are Failing Americans. Their Boards May Be a Reason Why,” by Sanjay Kishore and Suhas Gondi.

Lauren Weber: KHN and CBS News’ “This Dental Device Was Sold to Fix Patients’ Jaws. Lawsuits Claim It Wrecked Their Teeth,” by Brett Kelman and Anna Werner.

Also mentioned in this week’s podcast:

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A Health-Heavy State of the Union

The Host

Health care was a recurring theme throughout President Joe Biden’s 2023 State of the Union address on Capitol Hill this week. He took a victory lap on recent accomplishments like capping prescription drug costs for seniors on Medicare. He urged Congress to do more, including making permanent the boosted insurance premium subsidies added to the Affordable Care Act during the pandemic. And he sparred with Republicans in the audience — who jeered and called him a liar — over GOP proposals that would cut Medicare and Social Security.

Meanwhile, abortion rights advocates and opponents are anxiously awaiting a federal court decision out of Texas that could result in a nationwide ban on mifepristone, one of two drugs used in medication abortion.

This week’s panelists are Julie Rovner of KHN, Alice Miranda Ollstein of Politico, Rachel Cohrs of Stat, and Sarah Karlin-Smith of the Pink Sheet.

Among the takeaways from this week’s episode:

  • President Joe Biden’s State of the Union address emphasized recent victories against high health care costs, like Medicare coverage caps on insulin and out-of-pocket caps on prescription drug spending. Biden’s lively, informal exchange with lawmakers over potential cuts to Medicare and Social Security seemed to steal the show, though the political fight over cutting costs in those entitlement programs is rooted in a key question: What constitutes a “cut”?
  • Biden’s calls for bipartisanship to extend health programs like pandemic-era subsidies for Affordable Care Act health plans are expected to clash with conservative demands to slash federal government spending. And last year’s Senate fights demonstrate that sometimes the opposition comes from within the Democratic Party.
  • While some abortion advocates praised Biden for vowing to veto a federal abortion ban, others felt he did not talk enough about the looming challenges to abortion access in the courts. A decision is expected soon in a Texas court case challenging the future use of mifepristone. The Trump-appointed judge’s decision could ban the drug nationwide, meaning it would be barred even in states where abortion continues to be legal.
  • The FDA is at the center of the abortion pill case, which challenges its approval of the drug decades ago and could set a precedent for legal challenges to the approval of other drugs. In other FDA news, the agency recently changed policy to allow gay men to donate blood; announced new food safety leadership in response to the baby formula crisis; and kicked back to Congress a question of how to regulate CBD, or cannabidiol, products.
  • In drug pricing, the top-selling pharmaceutical, Humira, will soon reach the end of its patent, which will offer a telling look at how competition influences the price of biosimilars — and the problems that remain for lawmakers to resolve.

Also this week, Rovner interviews Kate Baicker of the University of Chicago about a new paper providing a possible middle ground in the effort to establish universal health insurance coverage in the U.S.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week they think you should read, too:

Julie Rovner: The New York Times’ “Don’t Let Republican ‘Judge Shoppers’ Thwart the Will of Voters,” by Stephen I. Vladeck

Alice Miranda Ollstein: Politico’s “Mpox Is Simmering South of the Border, Threatening a Resurgence,” by Carmen Paun

Sarah Karlin-Smith: KHN’s “Decisions by CVS and Optum Panicked Thousands of Their Sickest Patients,” by Arthur Allen

Rachel Cohrs: ProPublica’s “UnitedHealthcare Tried to Deny Coverage to a Chronically Ill Patient. He Fought Back, Exposing the Insurer’s Inner Workings,” by David Armstrong, Patrick Rucker, and Maya Miller

Also mentioned in this week’s podcast:

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KHN’s ‘What the Health?’: Congress Races the Clock

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The lame-duck Congress is making slow progress on its long to-do-before-the-end-of-the-year list. Democrats agreed to lift the covid-19 vaccine mandate for the military as part of the big defense authorization bill, but efforts to ease federal restrictions on marijuana didn’t succeed.

Meanwhile, the fight against high drug prices has spread to employers, which are trying a variety of strategies to spend less on prescription drugs while still giving workers access to needed medications.

This week’s panelists are Julie Rovner of KHN, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico, Anna Edney of Bloomberg News, and Sandhya Raman of CQ Roll Call.

Among the takeaways from this week’s episode:

  • The race to the holiday break is on, with no agreement so far on spending as current government funding is set to expire on Dec. 16. Although another continuing resolution is expected, it would likely leave out measures such as addressing mental health, so lawmakers would need to start over next year. The annual defense authorization bill is also in the works and would end the military’s covid vaccine mandate.
  • In the wake of the infant formula shortage, an FDA advisory group report this week said the agency’s work on food regulation needs a major overhaul, especially when it comes to enforcement power and leadership.
  • In drug pricing news, Americans can expect to see the costs of covid testing, vaccines, and treatments rise as federal subsidies run out and leave the pandemic response subject to the same cost and access disparities common to the nation’s health care system. Meanwhile, entrepreneur Mark Cuban’s discount prescription drugs company is teaming up with EmsanaRx, a nonprofit pharmacy benefit manager — thereby cutting out for-profit PBMs in another attempt to cut costs for patients.
  • Health care providers are pushing Congress to stop a long-planned cut in Medicare payments, while a new report from KFF shows the three largest for-profit hospital chains are seeing operating margins that exceed pre-pandemic levels. The Centers for Medicare & Medicaid Services also issued new rules this week on “prior authorization” that providers say could temper the bureaucratic hassle of dealing with Medicare. And private equity firms are getting into the game of running clinical trials, while in insurance, UnitedHealth Group is buying up providers.
  • On reproductive health, an Alabama woman is suing the county government that jailed her on the suspicion she had exposed her fetus to drugs. Her issue? She was not pregnant. The case raises questions about how changes to abortion access are playing out across the country.

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

Julie Rovner: The AP Stylebook’s “Abortion Topical Guide,” by The Associated Press

Anna Edney: The Washington Post’s “Drugs Killed 8 Friends, One by One, in a Tragedy Seen Across the U.S.,” by Lenny Bernstein and Jordan-Marie Smith

Joanne Kenen: Columbia Journalism Review’s “Anonymous Woman,” by Becca Andrews

Sandhya Raman: CQ Roll Call’s “At International Conference, Dobbs Dominates Debate,” by Sandhya Raman

Also mentioned in this week’s podcast:

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KHN’s ‘What the Health?’: Biden Hits the Road to Sell Democrats’ Record

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What do pandemic preparedness, mental health care services, and over-the-counter hearing aids have in common? They are all things President Joe Biden touted on the campaign trail this week as he tries to maintain Democrats’ majorities in Congress in the midterm elections Nov. 8.

Biden is also campaigning on his support for abortion, promising to sign a bill codifying abortion rights if Democrats retain control of the House and Senate. Recent polls, however, have shown abortion slipping as a top voting issue.

This week’s panelists are Julie Rovner of KHN, Sarah Karlin-Smith of the Pink Sheet, Sandhya Raman of CQ Roll Call, and Mary Agnes Carey of KHN.

Among the takeaways from this week’s episode:

  • Among initiatives recently highlighted by the White House is a plan to prepare for future pandemics and thwart any bioterror attacks. But the question is where that money would come from. Republicans in Congress already have balked at providing more money for public health funding for some covid-19 and monkeypox programs.
  • Powerful advocates in the Senate — Sens. Patty Murray (D-Wash.) and Sen. Richard Burr (R-N.C.) — have supported legislation to advance the national public health strategy, but there is very little time in this session to push such a package through. And Burr is retiring at the end of the year, so it’s not clear who on the Republican side of the aisle might be willing to take up the baton.
  • Although the abortion issue appeared to be helping Democrats’ midterm prospects after the Supreme Court overturned Roe v. Wade in June, some of that excitement may be receding as the economy and other issues move to the forefront of voters’ concerns. But there are few precedents in recent U.S. history to guide voters in evaluating the issue of abortion today or reacting to such a major, sudden change.
  • Even if the Democrats were to keep hold of the levers of power on Capitol Hill, they would have a tough time pushing through an abortion bill. No one expects the party to take control of 60 seats in the Senate — needed to overcome a filibuster – and Democrats might not have the votes to get rid of the filibuster, either. Nearly all Republicans are expected to oppose any such effort.
  • One obstacle to passing national legislation securing abortion rights is that over the half-century since deciding Roe, the Supreme Court has approved a variety of state laws that limit access, such as allowing parents to be notified if a teen were to seek an abortion. Many Democrats object to those restrictions and would want to exclude them from any new law, while other members of Congress would demand them.
  • Biden’s promise was designed to remind voters who care about this issue to come out to the polls in three weeks, but it was also a reminder to many progressives of the failure of the administration to prepare and have a strategy to protect abortion rights ready when the Supreme Court ruling came down.
  • Indiana Attorney General Todd Rokita is not backing down from his criticism of an Indianapolis doctor who performed an abortion on a 10-year-old Ohio girl who could not get the procedure there because of a strict new state law. The doctor has shown that she followed all Indiana procedures, but Rokita’s criticism continues to concern others who support abortion access. That chilling effect may well be part of Rokita’s strategy.
  • Pharmacists are also worried about their liability in states with strict abortion limits. Federal officials have announced a probe of CVS and Walgreens after complaints that they are not readily filling prescriptions for drugs that can be used for many medical indications but also could terminate an early pregnancy.
  • An advisory committee for the FDA this week recommended removing from the market a drug used to prevent preterm births. The drug, Makena, was first approved in 2011 through an accelerated pathway that requires the company to conduct follow-up studies assessing the drug’s efficacy. Those trials found that Makena didn’t help pregnancies progress to later gestational age or improve the health of the premature babies.
  • If the FDA accepts the committee’s recommendation, it would be a rare step. It would be only the second time that a drug approved on the accelerated pathway has been withdrawn over a sponsor’s objections.
  • This week also marked a milestone for people with mild to moderate hearing loss. Starting last Monday, the government approved over-the-counter sales of hearing aids. The move is expected to dramatically reduce the prices of the devices and open a potentially giant market of consumers now able to afford them.

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

Julie Rovner: KHN and NPR’s “Kids’ Mental Health Care Leaves Parents in Debt and in the Shadows,” by Yuki Noguchi

Sarah Karlin-Smith: Scientific American’s “Some People Really Are Mosquito Magnets, and They’re Stuck That Way,” By Daniel Leonard

Sandhya Raman: Journal of the National Cancer Institute’s “Use of Straighteners and Other Hair Products and Incident Uterine Cancer,” by Che-Jung Chang, et al.

Mary Agnes Carey: KHN’s “Blind to Problems: How VA’s Electronic Record System Shuts Out Visually Impaired Patients,” by Darius Tahir

Also mentioned in this week’s episode:

KHN’s “Say What? Hearing Aids Available Over-the-Counter for as Low as $199, and Without a Prescription,” by Phil Galewitz

Politico’s “‘Michigan Could Become Texas’ — Voters See Stark Choice on Abortion Referendum” by Alice Miranda Ollstein

To hear all our podcasts, click here.

And subscribe to KHN’s What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.

KHN’s ‘What the Health?’: Wrapping Up Summer’s Health News

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Congress and President Joe Biden are officially on summer vacation, but they left behind a lot of health policy achievements. The president returned this week from his South Carolina beach retreat to sign the Inflation Reduction Act, which, among other things, allows Medicare to negotiate drug prices for the first time.

The law also preserves the enhanced subsidies for premiums on insurance purchased through the Affordable Care Act’s marketplaces. Congress added those more generous subsidies in 2021, but they would have expired at the end of the year.

Meanwhile, even though Democrats were unable to secure additional Medicare vision, hearing, and dental benefits into the final version of the budget bill, this week the FDA established ground rules for the sale of over-the-counter hearing aids, something ordered by Congress in 2017.

This week’s panelists are Julie Rovner of KHN, Anna Edney of Bloomberg, Alice Miranda Ollstein of Politico, and Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico.

Among the takeaways from this week’s episode:

  • Despite the new law’s provisions allowing Medicare to negotiate some drug prices, enrollees will have to wait several years to see the benefits of those negotiations. That makes it challenging for Democrats to use the measure as a campaign promotion. Plus, Republicans may try to use the intervening years, while the price negotiating process is being set up, to batter Democrats’ efforts.
  • Other Medicare provisions, such as the new limit on out-of-pocket drug spending and caps on insulin spending, will provide more immediate benefits.
  • The act’s extension of ACA premium subsidies is also a hard victory to illuminate for consumers, who won’t see their costs fall and would likely have only noticed a difference if the measure had failed to pass and the program had ended.
  • Nonetheless, ad campaigns are already beginning to target the Republican opposition to popular health issues. No GOP lawmakers voted to support the measure.
  • Hearing aids fitting the new category are expected to be significantly less expensive for people with mild to moderate hearing loss. Still unanswered, however, is whether these new devices will work adequately.
  • The Centers for Disease Control and Prevention released new covid-19 guidelines last week that relax previous recommendations. The announcement highlights the growing disdain among the public for continuing the isolating prevention strategies of the past several years. But perhaps overlooked is the growing number of people suffering from long-term covid symptoms and how the condition damages their lives and the economy.
  • The CDC also announced this week that it will reorganize to better meet public health crises after a study of its covid response identified problems, especially in communicating with the public.
  • Although much of the opposition to abortion restrictions arising since the Supreme Court overturned Roe v. Wade has been propelled by women, men are also playing a role both in the politics ahead and in wide-ranging personal decisions, such as what states to choose for college or seeking vasectomies.

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

Julie Rovner: The Los Angeles Times’ “The CDC Loosened Its COVID Rules. Who Fills in This Public Health Vacuum?” by Wendy Netter Epstein and Daniel Goldberg

Alice Miranda Ollstein: MedPage Today’s “Falls From Higher Border Walls Overwhelm Trauma Services,” by Cheryl Clark

Joanne Kenen: Harper’s Magazine’s “A Hole in the Head,” by Zachary Siegel

Anna Edney: Stat’s “Parents and Clinicians Say Private Equity’s Profit Fixation Is Short-Changing Kids With Autism,” by Tara Bannow

Also mentioned in this week’s episode:

The Washington Post’s “Florida Court Rules 16-Year-Old Is Not ‘Sufficiently Mature’ for Abortion,” by Brittany Shammas and Kim Bellware

The Atlantic’s “The Pandemic’s Soft Closing,” by Katherine J. Wu

Politico’s “Tim Kaine Has Long Covid. That’s Not Moving Congress to Act,” by Alice Miranda Ollstein

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And subscribe to KHN’s What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.

KHN’s ‘What the Health?’: Drug Price Bill Is a Go in the Senate

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President Joe Biden is the latest top Washington official to test positive for covid-19, following Vice President Kamala Harris, Speaker of the House Nancy Pelosi, and Senate Majority Leader Chuck Schumer. But work continues, particularly on a Senate bill that could, for the first time, allow Medicare to negotiate prescription drug prices and cap seniors’ out-of-pocket medication costs.

Meanwhile, both supporters and opponents of abortion rights are struggling to find their footing in the wake of the Supreme Court’s overturn of the federal right to abortion in Roe v. Wade.

This week’s panelists are Julie Rovner of KHN, Shefali Luthra of The 19th, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico, and Rachel Cohrs of Stat.

Among the takeaways from this week’s episode:

  • Although some Democrats and many political pundits are criticizing the Senate for scaling back the president’s Build Back Better agenda to be mostly a health care bill, the proposal in that bill to allow Medicare to negotiate prices for some drugs would be a major change that drugmakers have successfully fought for two decades.
  • The bill, which hasn’t been released in full, will include only those provisions that have been approved by Sen. Joe Manchin (D-W.Va.), because all 50 members of the Democratic caucus in the Senate will be needed to pass the bill. In addition to allowing price negotiations on 10 drugs in the first year, the legislation would penalize drugmakers that raise prices above the rate of inflation and limit Medicare beneficiaries’ out-of-pocket drug spending to $2,000 a year.
  • The bill is also expected to include provisions to extend for an additional two years the enhanced subsidies for premiums on health policies purchased through the Affordable Care Act’s marketplace. Those details have not yet been released.
  • Progressives have been dismayed at the administration’s lackluster answer to the Supreme Court’s decision overturning Roe. Even as the White House notes that there are limits to what the president can do, the administration has been more cautious than many expected in announcing how it plans to respond. For example, immediately after the Supreme Court released the decision, the administration said it would guard women’s access to medication abortions — but there has been little follow-up.
  • The Indiana doctor who treated a 10-year-old rape victim seeking an abortion is threatening a defamation lawsuit against the state’s attorney general, who incorrectly said on national television that she didn’t file the necessary paperwork.
  • The case of that 10-year-old has put anti-abortion groups on the defensive and suggested that they are split on how to handle situations like this. Some leaders suggest the child should have gone forward with the pregnancy, while other groups said people who have been raped should not have to carry a baby to term.
  • Texas Attorney General Ken Paxton is continuing his push to restrict abortion. The state basically shut down most abortions last September with a strict law that allows community members to sue doctors and others who help a woman get an abortion beyond six weeks of pregnancy. Now, Paxton is challenging the Biden administration’s statement that federal law entitles people seeking emergency care because of pregnancy problems to get an abortion. Paxton has said that federal law does not preempt the state’s restrictions.
  • Texas’ hard line on abortion could have an economic impact within the state. Some young people and companies are not in favor of the abortion policies and some are threatening to leave the state.

Also this week, Rovner interviews Dr. Jack Resneck Jr., a California dermatologist who is the new president of the American Medical Association.

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

Julie Rovner: KHN’s “Conservative Blocs Unleash Litigation to Curb Public Health Powers,” by Lauren Weber and Anna Maria Barry-Jester

Shefali Luthra: Stat’s “Health Care’s High Rollers: As the Pandemic Raged, CEOs’ Earnings Surged,” by Bob Herman, Kate Sheridan, J. Emory Parker, Adam Feuerstein, and Mohana Ravindranath

Rachel Cohrs: Politico’s “Anthony Fauci Wants to Put Covid’s Politicization Behind Him,” by Sarah Owermohle

Joanne Kenen: Inside Climate News’ “When the Power Goes Out, Who Suffers? Climate Epidemiologists Are Now Trying to Figure That Out,” by Laura Baisas

Also mentioned on this week’s podcast:

To hear all our podcasts, click here.

And subscribe to KHN’s What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.