Tagged U.S. Congress

Must-Reads Of The Week From Brianna Labuskes

Happy Friday, where we’re 20 days and so-and-so hours (depending on when you read this) into the partial federal shutdown. As of today, it’s tied as the second-longest one in U.S. history, matching the funding gap that stretched from December ’95-January ’96 under President Bill Clinton. (Side note: The history of U.S. shutdowns is a good read for us policy nerds.)

Although health care has been somewhat insulated from the standoff (because funding for the Department of Health and Human Services had already been approved), the battle is really a lesson in the power of a ripple effect. Among the health-related things that have been touched by the impasse in some way: the CVS-Aetna merger, domestic violence victims, food stampswildfire and storm disaster funding, pollution inspections, drug approvals and the Affordable Care Act lawsuit.

But a lot of focus this week was on how the shutdown is curtailing food safety inspections by the Food and Drug Administration, especially following a year that was marked by several high-profile foodborne illness outbreaks.

Politico: FDA Looks to Restart Safety Inspections for Risky Foods Amid Shutdown


This week, my pharma files in Morning Briefing were bursting at the seams, and to be honest, I don’t see that changing anytime soon. This is definitely going to be a year of drug-pricing news, especially because it’s one of the few bipartisan topics that Capitol Hill watchers say might gain traction in a divided Congress.

In recent days, that — along with the fact that drug prices are most certainly a winning election issue — was on stark display. Democratic hopefuls for 2020 are jostling at the starting line to be the one to get THE big, flashy pharma bill out, with Vermont Sen. Bernie Sanders (joined by fellow hopeful New Jersey Sen. Cory Booker and others) as the latest to announce a proposal.

Sanders’ bundle of bills includes allowing the importation of cheaper drugs from Canada, letting Medicare negotiate prices and stripping monopolies from drug companies if their prices exceed the average price in other wealthy countries.

One interesting thing to note (from Stat’s coverage) is that even potential candidates from states that have a heavy biopharma presence (like Massachusetts Sen. Elizabeth Warren and New Jersey’s Booker) are coming out swinging against the industry — a sure sign that being firmly against Big Pharma is seen as crucial to securing the Democratic nomination.

Stat: Democrats Eyeing 2020 Put an Early Spotlight on Drug Prices

The Hill: Sanders, Dems Unveil Sweeping Bills to Lower Drug Prices

The pharma action this week wasn’t limited to the Hill, because the movers and shakers in the industry were all thinking big thoughts at the annual J.P. Morgan Healthcare Conference. There, Johnson & Johnson CEO Alex Gorsky argued that drugmakers were going to have to step up their own self-policing when it comes to pricing or face “onerous” alternatives. Looking at the stories above, I’m thinking he’s not wrong.

The Wall Street Journal: Health-Care CEOs Outline Strategies at J.P. Morgan Conference

Meanwhile, health systems tired of shortages and high prices are flocking by the dozens to the fledgling nonprofit that was created by a group of hospitals to manufacture its own generic drugs.

Stat: Generic Drug Maker Formed by Hospitals Attracts a Dozen More Members

It was hard to pick just a few pharma stories this week, considering the abundance of choices, but one that you should absolutely make time to read is this insulin-rationing piece. Insulin has become the new face of public outrage against outrageous price increases, and this piece presents a good overview of how that came to be, as well as the human toll the hikes have taken. The gut-punch sentence: “Within a month of going off [his mother’s] policy, [Alec Raeshawn Smith] would be dead.”

The Washington Post: Insulin Is a Lifesaving Drug, But It Has Become Intolerably Expensive. and the Consequences Can Be Tragic.


In a largely symbolic move, House Democrats voted to intervene in the health care lawsuit — a strategy geared more toward putting Republicans on record voting against the law (and thus against popular provisions they promised in the midterms to protect) than anything else.

The Hill: Dems Hit GOP on Health Care With Additional ObamaCare Lawsuit Vote

The vote highlighted a problem the GOP faces as it eyes 2020: For the longest time, Republicans have fallen back on “repeal and replace” as their main health care message. Now, the party is going to have to come up with a “positive vision” if they want to regain ground with voters, experts say.

The Hill: GOP Seeks Health Care Reboot After 2018 Losses


States, states, states! Everyone says that’s where the health care movement will be in the next two years, which certainly held true this week.

In California, new Gov. Gavin Newsom revealed his big health care dreams that include reshaping how prescription drugs are paid for, taking steps toward a single-payer system, reinstating the individual mandate, expanding Medi-Cal coverage for immigrants in the country illegally, and creating a surgeon general position for the state.

Reuters: New California Governor Tackles Drug Prices in First Act

Sacramento Bee: Gavin Newsom CA Health Plan Includes Individual Mandate

Meanwhile, up in Washington state, Gov. Jay Inslee proposed a “public option” health care plan for residents, a move that would set the stage for a universal coverage system. (It should be noted that Inslee is a 2020 contender.)

Seattle Times: Inslee Proposes ‘Public Option’ Health-Insurance Plan for Washington

In New York, several big health care developments emerged this week. NYC Mayor Bill de Blasio plans on investing $100 million into making sure that everyone in the city — including residents in the United States illegally — is guaranteed health coverage.

The New York Times: De Blasio Unveils Health Care Plan for Undocumented and Low-Income New Yorkers

And in Albany, Gov. Andrew Cuomo, citing the looming threat to Roe v. Wade, promised to cement a woman’s right to abortion in the state’s constitution.

The Wall Street Journal: Cuomo Vows to Codify Roe V. Wade Decision Into New York Constitution


It seems these days, you can’t swing a cat without hitting someone talking about “Medicare-for-all,” but what about a Medicaid “buy-in”? Some states are considering the option as a politically palatable alternative to help people who are struggling to buy coverage on the exchanges. The plans might not offer the full range of benefits available to traditional beneficiaries, but it could be something.

Stateline: Medicaid ‘Buy-In’ Could Be a New Health Care Option for the Uninsured

Speaking of MFA: A new Politico/Harvard poll shows that 4 in 5 Democrats favor Congress enacting a taxpayer-funded national health plan. Also to note, a fair amount of Republicans (60 percent) supported the idea of letting Americans under 65 buy into Medicare.

Politico: POLITICO/Harvard Poll: Many Democrats Back a Taxpayer-Funded Health Care Plan Like Medicare For All


As of Jan. 1, hospitals have had to post their prices online — which has resulted in much grumbling from industry and experts alike who say the numbers are meaningless to consumers. Centers for Medicare & Medicaid Administrator Seema Verma acknowledged the flaws with the rules this week, but still called them an important first step toward transparency.

Modern Healthcare: Verma: Chargemaster Rule Is ‘First Step’ to Price Transparency


In the miscellaneous file for the week:

• The Chinese scientist who used CRISPR to edit the genes of human embryos had scientists up in arms over the ethical dilemma late last year. But the path of medical breakthroughs is often littered with lapses such as his. Do the ends ever justify the means in these cases? And if so, where should the line be drawn?

CNN: Unethical Experiments’ Painful Contributions to Today’s Medicine

• Juul: Public health crusader? That’s the image the e-cigarette company (under ever-increasing government scrutiny for its marketing practices directed toward youths) is going with these days. But experts are calling its new ad campaign — which touts Juul products as a way to tackle adults’ smoking habits — revisionist history.

The New York Times: Juul’s Convenient Smoke Screen

• A woman who was in a vegetative state for more than 10 years reportedly gave birth last month. The workers at the nursing facility she was in didn’t realize she was even pregnant until she went into labor, raising all kinds of questions about quality of care, abuse and the medical complications of the process.

CNN: How Does Someone in a Vegetative State Have a Baby?

• HIV prevention medication has been shown to be highly effective and, quite literally, a lifesaver to vulnerable populations. But taking it was costing some people their chance at qualifying for life insurance. Now, though, one insurer has settled a lawsuit over the denials, possibly leading the way to changes in the industry.

The New York Times: Facing Legal Action, Insurer Now Will Cover People Taking Truvada, an H.I.V.-Prevention Drug


And good news! The E. coli outbreak is officially over, so you can go back to your romaine (yay?). Have a great weekend!

Podcast: KHN’s ‘What The Health?’ New Year, New Health Proposals

The new Democratic majority in the House of Representatives took its first steps on health care — voting to intervene in the appeal of a Texas-led lawsuit that found the Affordable Care Act unconstitutional in December. And around the country, Democratic governors and mayors unveiled new initiatives aimed at making health care cheaper and more accessible.

In Washington, the partial shutdown of the government has left most health agencies untouched but shuttered major parts of the Food and Drug Administration and the Indian Health Service.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Margot Sanger-Katz of The New York Times, Anna Edney of Bloomberg News and Rebecca Adams of CQ Roll Call.

Among the takeaways from this week’s podcast:

  • Much of the attention on the impact of the federal judge’s decision in Texas to invalidate the ACA has centered on how it affects people with preexisting medical conditions. But the ruling is much more far-reaching and could affect broad swaths of health care in the country.
  • The partial government shutdown has had only a small impact on the Department of Health and Human Services, which already received its funding. But the FDA, which is funded through the Agriculture Department’s appropriations bill, is affected. Officials there say they are trying to keep up with high-risk food inspections and may bring some employees back to work.
  • The FDA receives a substantial part of its budget through the fees paid by pharmaceutical companies for review of their products. But during the shutdown, the agency is not allowed to accept more fees, so it will run out of money for drug application reviews in about a month, officials said.
  • Recent efforts by some Democratic state and local officials highlight the intraparty debate over health care. New California Gov. Gavin Newsom has proposed expanding insurance premium subsidies to people making up to 600 percent of the federal poverty level (about $72,800 for an individual) — up from the law’s current 400 percent (about $48,500) — while Washington Gov. Jay Inslee wants to set up a government-run plan that would be an option for people buying their own insurance. And in New York City, Mayor Bill de Blasio wants to offer coverage to people who are in the country illegally.
  • The latest government enrollment figures show that more than 11 million people signed up for coverage offered in the ACA marketplaces. That is down a bit from prior years, but still more than industry watchers predicted given the tax penalty for not having coverage expired this year.
  • The small slippage in enrollment in the past two years, following changes made by the Trump administration and a Republican-led Congress, may signal challenges in the future, especially in small markets where getting competition has been tough.

Also this week, Julie Rovner interviews KHN senior correspondent Jordan Rau, who investigated and wrote the latest “Bill of the Month” feature for Kaiser Health News and NPR. It’s about a skiing accident that required repeat surgeries — and bills for the patient, although she did nothing wrong. You can read the story here, and its update here.

If you have a medical bill you would like NPR and KHN to investigate, you can submit it here.

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

Julie Rovner: Rewire.News’ “There’s Almost No Data About What Happens When Catholic Hospitals Deny Reproductive Care,” by Amy Littlefield

Rebecca Adams: The Washington Post Magazine’s “Life, Death and Insulin,” by Tiffany Stanley

Margot Sanger-Katz: Vox.com’s “A $20,243 Bike Crash: Zuckerberg Hospital’s Aggressive Tactics Leave Patients With Big Bills,” by Sarah Kliff

Anna Edney: The Washington Post’s “The FDA Is Still Letting Doctors Implant Untested Devices Into Our Bodies,” by Jeanne Lenzer and Shannon Brownlee

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

Where Abortion Fights Will Play Out In 2019

With Democrats now in control of the U.S. House of Representatives, it might appear that the fight over abortion rights has become a standoff.

After all, abortion-rights supporters within the Democratic caucus will be in a position to block the kind of curbs that Republicans advanced over the past two years when they had control of Congress.

But those on both sides of the debate insist that won’t be the case.

Despite the Republicans’ loss of the House, anti-abortion forces gained one of their most sought-after victories in decades with the confirmation of Justice Brett Kavanaugh to the Supreme Court. Now, with a stronger possibility of a 5-4 majority in favor of more restrictions on abortion, anti-abortion groups are eager to get test cases to the high court.

And that is just the beginning.

“Our agenda is very focused on the executive branch, the coming election, and the courts,” said Marjorie Dannenfelser, president of the anti-abortion organization Susan B. Anthony List. She said the new judges nominated to lower federal courts by President Donald Trump and confirmed by the Senate reflect “a legacy win.”

The Republican majority in the U.S. Senate is expected to continue to fill the lower federal courts with judges who have been vetted by anti-abortion groups.

Abortion-rights supporters think they, too, can make strides in 2019.

“We expect 25 states to push policies that will expand or protect abortion access,” said Dr. Leana Wen, who took over as president of the Planned Parenthood Federation of America in November. If the landmark 1973 Supreme Court decision Roe v. Wade is eventually overturned, states will decide whether abortion will be legal, and under what circumstances.

Here are four venues where the debate over reproductive health services for women will play out in 2019:

Congress

The Republican-controlled Congress proved unable in 2017 or 2018 to realize one of the anti-abortion movement’s biggest goals: evicting Planned Parenthood from Medicaid, the federal-state health insurance program for people who have low incomes. Abortion opponents don’t want Planned Parenthood to get federal funds because, in many states, it functions as an abortion provider (albeit with non-federal resources).

Though Republicans have a slightly larger majority in the new Senate, that majority will still be well short of the 60 votes needed to block any Democratic filibuster.

Because Democrats generally support Planned Parenthood, the power shift in the House makes the chances for defunding the organization even slimmer, much to the dismay of abortion opponents.

“We’re pretty disappointed that, despite having a Republican Congress for two years, Planned Parenthood wasn’t defunded,” said Kristan Hawkins of the anti-abortion group Students for Life of America. “This was one of President Trump’s promises to the pro-life community, and he should have demanded it,” she added.

Another likely area of dispute will be the future of various anti-abortion restrictions that are routinely part of annual spending bills. These include the so-called Hyde Amendment, which bans most federal abortion funding in Medicaid and other health programs in the Department of Health and Human Services. Also disputed: restrictions on grants to international groups that support abortion rights, and limits on abortion in federal prisons and in the military.

However, now that they have a substantial majority in the House, “Democrats are on stronger grounds to demand and expect clean appropriations bills,” without many of those riders, said Wen of Planned Parenthood. While Senate Republicans are likely to eventually add those restrictions back, “they will have to go through the amendment process,” she said. And that could bring added attention to the issues.

With control of House committees, Democrats can also set agendas, hold hearings and call witnesses to talk about issues they want to promote.

“Even if the bills don’t come to fruition, putting these bills in the spotlight, forcing lawmakers to go on the record — that has value,” said Wen.

The Trump Administration

While Congress is unlikely to agree on reproductive health legislation in the coming two years, the Trump administration is still pursuing an aggressive anti-abortion agenda — using its power of regulation.

A final rule is expected any day that would cut off a significant part of Planned Parenthood’s federal funding — not from Medicaid but from the Title X Family Planning Program. Planned Parenthood annually provides family planning and other health services that don’t involve abortion to about 40 percent of the program’s 4 million patients.

The administration proposal, unveiled last May, would effectively require Planned Parenthood to physically separate facilities that perform abortions from those that provide federally funded services, and would bar abortion referrals for women who have unintended pregnancies. Planned Parenthood has said it is likely to sue over the new rules when they are finalized. The Supreme Court upheld in 1991 a similar set of restrictions that were never implemented.

Abortion opponents are also pressing to end federal funding for any research that uses tissue from aborted fetuses — a type of research that was authorized by Congress in the early 1990s.

“It’s very important we get to a point of banning” fetal tissue research “and pursuing aggressively ethical alternatives,” said Dannenfelser.

State Capitols

Abortion opponents having pushed through more than 400 separate abortion restrictions on the state level since 2010, according to the Guttmacher Institute, an abortion-rights think tank. In 2018 alone, according to Guttmacher, 15 states adopted 27 new limits on abortion and family planning.

“Absolutely some [of these are] an exercise in what they can get to go up to the Supreme Court,” said Destiny Lopez, co-director of the abortion-rights group All* Above All. “Sort of ‘Let’s throw spaghetti against the wall and see what sticks.’”

But 2018 also marked a turning point. It was the first time in years that the number of state actions supporting abortion rights outnumbered the restrictions. For example, Massachusetts approved a measure to repeal a pre-Roe ban on abortion that would take effect if Roe were overturned. Washington state passed a law to require abortion coverage in insurance plans that offer maternity coverage.

The Federal Courts

The fate of all these policies will be decided eventually by the courts.

In fact, several state-level restrictions are already in the pipeline to the Supreme Court and could serve as a vehicle to curtail or overturn Roe v. Wade.

Among the state laws closest to triggering such a review is an Indiana law banning abortion for gender selection or genetic flaws, among other things. Also awaiting final legal say is an Alabama law banning the most common second-trimester abortion method — dilation and evacuation.


KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation.

End Of Tax Penalty Could Fall Hardest On Previously Uninsured Californians

The elimination of the Affordable Care Act tax penalty on people who don’t have health insurance could roll back recent coverage gains for Hispanics, young people, the healthy and the poor, according to a new study.

The study, published Monday in the journal Health Affairs, stems from a 2017 survey in which researchers at Harvard University Medical School and Massachusetts General Hospital asked more than 3,000 Californians who had bought individual health care plans: “Would you have purchased health insurance coverage this year if there was no penalty?”

Nineteen percent said they would not have, and a disproportionately large number of those were in population groups most likely to be uninsured before the law took effect.

“Especially for lower-income consumers who are potentially eligible for subsidies, it’s really important to try to understand how eliminating the penalty might affect their choices,” said Vicki Fung, lead author of the study and an assistant professor of medicine at Harvard Medical School.

The federal penalty for not having health coverage disappeared Jan. 1, following the decision by the Republican-controlled Congress to reduce it to zero in the 2017 tax reform package. While it was in effect, the penalty potentially cost a taxpayer thousands of dollars a year — though the ACA allowed numerous exemptions from coverage based on financial hardship and other personal circumstances.

The researchers behind the Health Affairs study estimated that if the people who said they would drop insurance in the absence of a penalty had not been enrolled in a health plan, premiums would have been 4 to 7 percent higher that year. Covered California, the state’s Obamacare exchange, said last summer that the elimination of the penalty added nearly 4 percentage points to its average 2019 premium.

The study concluded that other states could be harder hit than California by the elimination of the penalty. Premium increases of the magnitude they estimated for the Golden State are unlikely to destabilize its individual insurance market, they said.

Covered California has spent hundreds of millions of dollars promoting its health plans to consumers — more than the federal government spends for the 39 states that use the federal healthcare.gov exchange.

Still, the loss of coverage caused by ending the tax penalty could fall heavily on many Californians, the study suggests.

About 31 percent of Hispanics responding to the survey said they would not buy health insurance if it were not required, compared with 13 percent of whites, Fung said. (Hispanics can be of any race.)

About 22 percent of people without chronic conditions said they would not have bought insurance if there were no penalty, compared with 12 percent of those with two or more chronic illnesses, according to the study. And more than twice as many men aged 18 to 30 said they would have dropped coverage than among those 51 and older.

The percentage of health plan enrollees who said they would skip coverage in the absence of the penalty was also higher among those with lower income and education levels.

The study’s findings largely echo what other policy analysts have found. But most of their studies have involved statistical models, rather than direct surveys of consumers, Fung said.

A University of California-Berkeley study released in November projected that between 150,000 and 450,000 fewer Californians would enroll in coverage in 2020 without the penalty. An analysis by the Congressional Budget Office estimated that repealing the penalty would induce 4 million people nationally to forgo coverage this year, and 13 million in 2027.

About 1.3 million Californians bought health insurance through Covered California in 2018. A vast majority of them qualified for federal tax credits that lower their premiums, and about 44 percent also got subsidies to reduce what they pay out-of-pocket when they seek care.

The Health Affairs study “really underscores the need for state policies to protect the gains we’ve made and to continue progress toward universal coverage, such as state-level individual mandates and subsidies to buy coverage,” said Laurel Lucia, director of the health care program at the UC-Berkeley Labor Center and one of the authors of the UC-Berkeley study.

Legislative proposals last year to create state-based financial aid for purchasing insurance failed, but their proponents have renewed hope for some of their ideas under California’s new Democratic governor, Gavin Newsom.


This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

Democrats Fight Back Against Lawsuit Threatening Health Law

Democrats on Thursday officially launched their pushback against a December federal court decision that declared the Affordable Care Act unconstitutional.

A group of 17 Democratic state attorneys general formally appealed the Dec. 14 decision in Texas v. U.S. issued by U.S. District Judge Reed O’Connor. In the case filed by 18 Republican state attorneys general and two GOP governors, O’Connor ruled that when Congress in 2017 reduced the tax penalty for not having insurance to zero, the rest of the law became invalidated.

“Our coalition of attorneys general has been working around the clock to challenge the decision from the Northern District of Texas that threatens our entire health care system,” said California AG Xavier Becerra, who is leading the Democratic group. “This case could impact children, seniors, women, families and workers who have their own insurance through employers,” he said.

The far-reaching impact of invalidating the law cannot be overstated. Even Republican health efforts — including many Trump administration initiatives — would be threatened by the disappearance of the ACA.

There was a brief lag between O’Connor’s opinion and the Democrats’ appeal because the judge did not issue last month’s ruling as a formal, final decision, given it didn’t address other aspects of the GOP challenge. At the request of the Democratic attorneys general, on Dec. 30 the judge finalized his findings for this part of the case, and clarified that the law would remain in effect during the appeals process.

Separately, the brand-new Democratic majority in the U.S. House voted to support the appeal of the decision on their first day in charge of the chamber.

They approved language authorizing House Speaker Nancy Pelosi “to intervene, otherwise appear, or take any other steps in any other cases involving the Patient Protection and Affordable Care Act,” better known as the ACA.

House Democrats also filed a motion to intervene in the defense of the ACA against the GOP-led lawsuit.

Republicans on the House floor were not impressed. “That effort does not preserve preexisting conditions,” Rep. Greg Walden (R-Ore.), now the ranking member of the House Energy and Commerce Committee, said on the floor. Walden, who helped lead the GOP’s unsuccessful “repeal-and-replace” effort in the last Congress, suggested that lawmakers should instead pass a law reaffirming the preexisting condition protections.

Some backers of the law agreed with Walden. “The House should pass a bill. Send it to the Senate. See what happens,” tweeted University of Michigan law professor Nicholas Bagley.

In an op-ed written with fellow Michigan law professor Richard Primus, Bagley said Congress could more effectively remove the legal threat to the law by raising the mandate penalty to a dollar, by repealing the mandate entirely or by clarifying that eliminating the mandate penalty does not require the invalidation of the rest of the law.

“Any of these solutions could be accomplished in a one-sentence statute, and any one of them would end the Texas lawsuit,” they wrote.

California Healthline’s California politics correspondent Samantha Young contributed to this report.

Must-Reads Of The Week From Brianna Labuskes

Happy New Year! Welcome to 2019 and the 116th Congress! I hope everyone had a wonderful and restful break, because now the fun (or something in that neighborhood) starts again.

Democrats are raring to go now that the new class has been sworn in and Nancy Pelosi has retaken the House gavel. They’re setting the stage to put Republicans in the political hot seat with a vote to formally intervene in the Affordable Care Act lawsuit currently moving through the courts.

I’m pretty sure everyone at this point realizes that vowing to protect preexisting conditions was (and will be) a winning issue on the campaign trail. The Democrats’ move will (and, let’s be honest, is designed to) put the GOP in the awkward position of voting against those popular provisions.

The Washington Post: The New Congress: Pelosi Retakes House Gavel As Shutdown Continues

The Washington Post: House Democrats Vote to Defend ACA in Court — and Jam Republicans

Then on the states’ side of things, the attorneys general leading the defense of the health law have filed an appeal against the federal judge’s ruling (from December, I know it feels ages ago) that the ACA can’t stand without the individual mandate penalty. The filing was, obviously, completely expected, but it does continue to move the case down a long legal path likely to end at the Supreme Court.

The Wall Street Journal: Democratic-Led States Appeal Ruling Invalidating Affordable Care Act


Stories about excessive human waste piling up in national parks are grabbing headlines, but when it comes to the shutdown the issues go much deeper than that for Native Americans. Because of treaties, tribes receive a significant amount of the funding they need to provide basic services (like running health clinics) from the federal government. So, the shutdown cuts deeper for them than in other places in the country.

“The federal government owes us this: We prepaid with millions of acres of land. We don’t have the right to take back that land, so we expect the federal government to fulfill its treaty and trust responsibility,” said Aaron Payment, the chairman of the Sault Ste. Marie Tribe, in The New York Times’ coverage.

The New York Times: Shutdown Leaves Food, Medicine and Pay in Doubt in Indian Country

P.S. If you’re confused about the shutdown and what health programs are affected, 1) you’re not alone, and 2) read KHN’s roundup, which, without bias, is the most comprehensive health-related breakdown I’ve seen. Cliff notes, though: Most big-ticket items (like Medicaid and Medicare) were already funded by Congress earlier in the year and are insulated from the standoff’s dramatics.

Kaiser Health News: How The Government Shutdown Affects Health Programs


Bristol-Myers Squibb kicked off the year with a huge $74 billion deal with Celgene. The experts at Stat break down exactly what the acquisition means for the industry. A big takeaway is that one of the sector’s largest companies will essentially cease to exist. The deal could also spark more megamergers and further consolidation of the biotech landscape — which, as you can imagine, will not be good for drug prices.

Stat: 9 Big Takeaways From the $74 Billion Bristol-Celgene Deal

Next week, movers and shakers in the biotech industry will be flocking to San Francisco for the annual J.P. Morgan Healthcare Conference. It’s the place to see and be seen, but some attendees want to be anywhere but there. Why? The location.

Stat: Will San Francisco’s Issues Push People Away From J.P. Morgan?


Adding work requirements to Medicaid has proven to be the honey it takes to make expanding coverage more palatable to Republican states. But, in Arkansas — the testing ground for what exactly those rules look like in practice — thousands of residents are getting kicked off the Medicaid rolls. A picture of confusion, flawed technology and basic human error is emerging as advocates try to figure out what is going wrong.

Politico: Conservative Health Care Experiment Leads to Thousands Losing Coverage


If you managed to tune out a bit from the news over the holidays, here are some developments you should know about:

A second migrant child died in U.S. custody, prompting President Donald Trump to attempt to shift blame to the Democrats. The administration has been under ever-increasing scrutiny for the quality of care the young migrant children are receiving.

The New York Times: Trump Blames Democrats Over Deaths of Migrant Children in U.S. Custody

Hospitals were handed a major victory when a judge blocked cuts to the 340B drug program, which requires pharmaceutical manufacturers to sell drugs at discounts to hospitals serving large proportions of low-income and vulnerable people, such as children or cancer patients. The judge said the administration overstepped its authority in its push to try to lower drug prices.

Stat: Judge Blocks Trump Administration Cuts to 340B Hospital Payments

A damning investigation into the nation’s major hospital watchdog found that more than 100 psychiatric hospitals have remained fully accredited by the commission despite serious safety lapses, some of which were connected to the death, abuse or sexual assault of patients.

The Wall Street Journal: Psychiatric Hospitals With Safety Violations Still Get Accreditation


And in my miscellaneous file: 

• The old and powerful veteran advocacy groups — aka the “Big Six” — have been major players on Capitol Hill for years. But their power is diminishing as leaner, more efficient and more tailored groups chip away at the establishment and reflect the priorities of a new generation of veterans.

The New York Times: Their Influence Diminishing, Veterans Groups Compete With Each Other and Struggle With the V.A.

• The prominent Memorial Sloan Kettering Cancer Center has not been having a good fall. That’s in part due to the fabulous reporting done by The New York Times and ProPublica, which revealed conflicts of interest among the organization’s leaders. If you haven’t kept up with the story, this offers a great overview on how this ethical morass is playing out not only there but across the country as well.

The New York Times: Memorial Sloan Kettering’s Season of Turmoil

• Does medication-assisted treatment for opioid addiction simply replace one drug with another? Or is it necessary to stop a relentless and sweeping epidemic that has claimed far too many victims? That’s the raging debate as experts try to get their arms around the crisis.

The New York Times: In Rehab, ‘Two Warring Factions’: Abstinence Vs. Medication

• An outbreak of cancer in children is pitting families deep in Trump Country against the president’s agenda to roll back health and environmental restrictions.

The New York Times: A Trump County Confronts the Administration Amid a Rash of Child Cancers

• Between salmonella in turkeys and E. coli in romaine lettuce, the country was beset with foodborne illness outbreaks last year. But one of the biggest recalls is one you probably haven’t even heard about.

New Food Economy: The Listeria Scare That Hit Whole Foods, Trader Joe’s, and Walmart Led to 100 Million Pounds of Recalled Product — And No One Noticed


Apparently, New Year’s resolutions won’t bring you joy (whether you achieve them or not), but if one of yours is to switch up your diet, check out the newly released rankings from U.S. News & World Report.

Cómo afecta el cierre del gobierno a los programas de salud

No parece haber un final a la vista para el actual cierre parcial del gobierno, el tercero desde el inicio de la administración Trump.

Sin embargo, para la gran mayoría de los esfuerzos de salud pública del gobierno federal, el negocio sigue como siempre.

Esto se debe a que el Congreso ya ha aprobado cinco de sus principales proyectos de ley de asignaciones, financiando a cerca de tres cuartas partes del gobierno federal, incluido el Departamento de Salud y Servicios Humanos (HHS) y el Departamento de Asuntos de Veteranos (VA).

Pero hay siete proyectos de ley pendientes, incluidos los que financian a los departamentos de Interior, Agricultura y Justicia, y eso restringe algunas iniciativas importantes relacionadas con la salud.

El cierre en sí no se trata de políticas de salud. Es el resultado de las diferencias de opinión entre la administración y los demócratas del Congreso con respecto al muro que Trump quiere construir en la frontera. Pero, sin embargo, es de largo alcance. Así es cómo están las cosas:

La financiación para los programas de salud de “alto impacto” ya está en marcha, aliviando gran parte del impacto potencial inmediato del cierre.

Dado que los fondos del HHS se establecen hasta septiembre, los programas gubernamentales de atención médica más importantes, como Obamacare, Medicare y Medicaid, están protegidos.

Esto también se aplica a la vigilancia de salud pública, como el seguimiento del virus de la gripe, una responsabilidad de los Centros para el Control y Prevención de Enfermedades (CDC). Los Institutos Nacionales de Salud (NIH), que supervisan las principales investigaciones biomédicas, también están seguros. Es un marcado contraste con el cierre de enero de 2018, que envió a casa a casi la mitad del personal de HHS.

Pero algunas otras operaciones de salud pública son vulnerables debido a flujos de financiamiento más complicados.

Aunque la Administración de Drogas y Alimentos (FDA) se encuentra bajo el paraguas del HHS, recibe fondos importantes para sus operaciones de inocuidad de los alimentos a través del proyecto de ley de gastos del Departamento de Agricultura, que está totalmente atrapado en el cierre.

El año pasado, eso contabilizó un estimado de $2.9 mil millones para respaldar, entre otras cosas, estos esfuerzos de supervisión de la FDA, que involucran de todo, desde el retiro de alimentos por posibles contaminaciones hasta las inspecciones de rutina de las instalaciones y la regulación de cosméticos. No tener esos dólares ahora significa, según el plan de contingencia de la FDA, que aproximadamente el 40% de la agencia, miles de trabajadores federales, se mantendrá suspendido hasta nuevo aviso.

Las responsabilidades de la FDA para la aprobación y supervisión de medicamentos están financiadas por las tarifas de los usuarios y generalmente no se ven afectadas. La regulación de los productos del tabaco también continúa.

Los servicios de salud para los nativos americanos también están suspendidos.

Debido a que el Congreso aún tiene que aprobar los fondos para el Servicio de Salud para Indígenas (IHS), que está a cargo del HHS, pero obtiene su dinero a través del Departamento del Interior, IHS siente todo el peso del cierre. Los únicos servicios que pueden continuar son aquellos que satisfacen las “necesidades inmediatas de los pacientes, el personal médico y las instalaciones médicas”, según el plan de contingencia frente al cierre.

Eso incluye clínicas administradas por IHS, que brindan atención médica directa a tribus de todo el país. Estas instalaciones están abiertas y muchos empleados se reportan a trabajar porque se los considera “exceptuados”, dijo Jennifer Buschik, vocera de la agencia. Pero no se les pagará hasta que el Congreso y la administración lleguen a un acuerdo.

Otros programas de IHS están teniendo un impacto más directo. Por ejemplo, la agencia ha suspendido las subvenciones que apoyan los programas de salud tribales, así como las clínicas de salud preventivas administradas por la Oficina de Programas Urbanos de Salud Indígena.

Los esfuerzos de salud pública del Departamento de Seguridad Nacional (DHS) y de la Agencia de Protección Ambiental (EPA) enfrentan serias limitaciones.

La Oficina de Asuntos de Salud del Departamento de Seguridad Nacional evalúa las amenazas que presentan enfermedades infecciosas, pandemias y ataques biológicos y químicos. En estos días tiene menos personal, y se seguirá reduciendo, según el plan de contingencia de cierre del departamento.

Es probable que otros trabajadores de salud del DHS trabajen sin remuneración, por ejemplo, inspectores de salud en la frontera, dijo Peter Boogaard, quien fue vocero de la agencia bajo la administración Obama. Según el plan de DHS, la gran mayoría de los empleados de la patrulla fronteriza continuarán trabajando durante el cierre.

EPA también se ha quedado sin fondos. De acuerdo con su plan de contingencia, mantiene a más de 700 empleados sin paga, incluidos aquellos que trabajan en actividades donde la “amenaza para la vida o la propiedad es inminente”. (Más de 13,000 trabajadores de EPA han sido despedidos).

Eso limita la capacidad de la agencia para realizar actividades que incluyen inspeccionar el agua que beben las personas y regular los pesticidas.

Pero no se trata solo sobre regulaciones. Los riesgos para la salud pública son viscerales y, a veces, francamente, bastante desagradables.

Solo hay que mirar las noticias sobre el Servicio de Parques Nacionales, que ha interrumpido el mantenimiento de baños y el servicio de recolección de basura por falta de fondos. El domingo 30, el Parque Nacional de Yosemite en California cerró sus campamentos. El miércoles 2, el Parque Nacional Joshua Tree, también en California, hizo lo mismo.

¿Por qué? Según un comunicado de prensa: “El parque se ve obligado a tomar esta acción por motivos de salud y seguridad a medida que se llenan los contenedores de los inodoros”.

Podcast: KHN’s ‘What The Health?’ Ask Us Anything!

This week, KHN’s “What the Health?” panelists answered questions submitted by listeners.

Among the topics covered were why Medicare doesn’t cover most dental care, how to address high drug prices and what federal officials do with all that data they collect from health care providers.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Joanne Kenen of Politico, Stephanie Armour of The Wall Street Journal and Paige Winfield Cunningham of The Washington Post.

The panel addressed questions including the following:

  • “Besides your podcast, what resources, including books and journals, do you recommend people read to build basic knowledge about the U.S. payer system?”
  • “What is the likelihood that Congress will pass legislation to include full dental care in Medicare, say in the next 10 years?”
  • “CMS collects an extraordinary amount of data from its various quality reporting programs. … What does the agency do with this data and is there any evidence quality reporting improves patient outcomes or achieves other policy aims?”
  • “Do you have a view on whether Medicare paying less money for prescription drugs would lead to drug companies charging more to private insurers?”
  • “There’s been a lot of back-and-forth lately between the National Institutes of Health, the Department of Health and Human Services and the media regarding fetal tissue research. HHS is currently doing a review, and the Trump administration just posted a ban to the NIH labs to stop procuring any new fetal tissue. This jeopardizes many research studies, especially those studying HIV. What do you think the long-term consequences of this will be?”

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

Podcast: KHN’s ‘What The Health?’ Ask Us Anything!

This week, KHN’s “What the Health?” panelists answered questions submitted by listeners.

Among the topics covered were why Medicare doesn’t cover most dental care, how to address high drug prices and what federal officials do with all that data they collect from health care providers.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Joanne Kenen of Politico, Stephanie Armour of The Wall Street Journal and Paige Winfield Cunningham of The Washington Post.

The panel addressed questions including the following:

  • “Besides your podcast, what resources, including books and journals, do you recommend people read to build basic knowledge about the U.S. payer system?”
  • “What is the likelihood that Congress will pass legislation to include full dental care in Medicare, say in the next 10 years?”
  • “CMS collects an extraordinary amount of data from its various quality reporting programs. … What does the agency do with this data and is there any evidence quality reporting improves patient outcomes or achieves other policy aims?”
  • “Do you have a view on whether Medicare paying less money for prescription drugs would lead to drug companies charging more to private insurers?”
  • “There’s been a lot of back-and-forth lately between the National Institutes of Health, the Department of Health and Human Services and the media regarding fetal tissue research. HHS is currently doing a review, and the Trump administration just posted a ban to the NIH labs to stop procuring any new fetal tissue. This jeopardizes many research studies, especially those studying HIV. What do you think the long-term consequences of this will be?”

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

How The Government Shutdown Affects Health Programs

There seems to be no end in sight for the current partial government shutdown, the third since the beginning of the Trump administration.

For the vast majority of the federal government’s public health efforts, though, it’s business as usual.

That’s because Congress has already passed five of its major appropriations bills, funding about three-fourths of the federal government, including the Department of Health and Human Services and the Department of Veterans Affairs.

But seven bills are outstanding — including those that fund the Interior, Agriculture and Justice departments — and that puts the squeeze on some important health-related initiatives.

The shutdown itself is not about health policies. It’s the result of differences of opinion between the administration and congressional Democrats regarding Trump’s so-called border wall. But it’s far-reaching, nonetheless. Here’s where things stand:

Funding for “big-ticket” health programs is already in place, alleviating much of the shutdown’s immediate potential impact.

Since HHS funding is set through September, the flagship government health care programs — think Obamacare, Medicare and Medicaid — are insulated.

That’s also true of public health surveillance, like tracking the flu virus, a responsibility of the Centers for Disease Control and Prevention. The National Institutes of Health, which oversees major biomedical research, is also fine. It’s a stark contrast to last January’s shutdown, which sent home about half of HHS’s staff.

But some other public health operations are vulnerable because of complicated funding streams.  

Although the Food and Drug Administration falls under the HHS umbrella, it receives significant funding for its food safety operations through the Department of Agriculture, which is entirely caught up in the shutdown.

The USDA provided an estimated $2.9 billion last year to the FDA for these oversight efforts, which involve everything from food recalls to routine facility inspections and cosmetics regulation. Not having those dollars now means, according to the FDA contingency plan, that about 40 percent of the agency — thousands of government workers — is furloughed.

The FDA’s responsibilities for drug approval and oversight are funded by user fees and are not affected. Regulation of tobacco products is also continuing.

Health services for Native Americans are also on hold.

Because Congress has yet to approve funding for the Indian Health Service, which is run by HHS but gets its money through the Department of the Interior, IHS feels the full weight of the shutdown. The only services that can continue are those that meet “immediate needs of the patients, medical staff, and medical facilities,” according to the shutdown contingency plan.

 

That includes IHS-run clinics, which provide direct health care to tribes around the country. These facilities are open, and many staffers are reporting to work because they are deemed “excepted,” said Jennifer Buschik, an agency spokeswoman. But they will not be paid until Congress and the administration reach a deal.

Other IHS programs are taking a more direct hit. For example, the agency has suspended grants that support tribal health programs, as well as preventive health clinics run by the Office of Urban Indian Health Programs.

Public health efforts by Homeland Security and the EPA face serious constraints.

The Department of Homeland Security’s Office of Health Affairs assesses threats posed by infectious diseases, pandemics and biological and chemical attacks. It is supposed to be scaling back, according to the department’s shutdown contingency plan. This office is just one component of the 204-person Countering Weapons of Mass Destruction Office, which is retaining about 65 employees during the funding gap.

Other DHS health workers are likely to work without pay — for instance, health inspectors at the border, said Peter Boogaard, who was an agency spokesman under the Obama administration. According to DHS’s plan, the vast majority of border patrol employees will continue working through the shutdown.

The Environmental Protection Agency has also run out of funding. According to its contingency plan, it’s keeping on more than 700 employees without pay, including those who work on Superfund sites or other activities where the “threat to life or property is imminent.” (More than 13,000 EPA workers have been furloughed.)

That limits the agency’s capacity for activities including inspecting water that people drink and regulating pesticides.

But it’s not just regulation. The public health stakes are visceral — and sometimes, frankly, pretty gross.

Just look at the National Park Service, which has halted restroom maintenance and trash service for lack of funding. On Sunday, Yosemite National Park in California closed its campgrounds. On Wednesday, Joshua Tree National Park, also in California, did the same.

Why? Per a park service press release: “The park is being forced to take this action for health and safety concerns as vault toilets reach capacity.”

How Sen. Orrin Hatch Changed America’s Health Care

Sen. Orrin Hatch, the Utah Republican retiring from 42 years in the Senate as a new generation is sworn in, leaves a long list of achievements in health care. Some were more controversial than others.

Hatch played key roles in shepherding the 1983 Orphan Drug Act to promote drug development for rare diseases, and the 1984 National Organ Transplant Act, which helped create a national transplant registry. And in 1995, when many people with AIDS were still feeling marginalized by society and elected leaders, he testified before the Senate about reauthorizing funding for his Ryan White CARE Act to treat uninsured people who have HIV.

“AIDS does not play favorites,” Hatch told other senators. “It affects rich and poor, adults and children, men and women, rural communities and the inner cities. We know much, but the fear remains.”

Hatch, now 84, co-sponsored a number of bills with Democrats over the years, often with Sen. Ted Kennedy of Massachusetts. The two men were sometimes called “the odd couple,” for their politically mismatched friendship.

In 1997, the two proposed a broad new health safety net for kids — the Children’s Health Insurance Program.

“This is an area the country has made enormous progress on, and it’s something we should all feel proud of — and Senator Hatch should too,” said Joan Alker, executive director of Georgetown University’s Center for Children and Families.

Before CHIP was enacted, the number of uninsured children in America was around 10 million. Today, it’s under half that.

Hatch’s influence on American health care partly came from the sheer number of bills he sponsored — more than any other living lawmaker — and because he was chairman of several powerful Senate committees.

“History was on his side because the Republicans were in charge,” said Dr. David Sundwall, an emeritus professor in public health at the University of Utah and Hatch’s health director in the 1980s.

When Ronald Reagan was elected president in 1981, the Senate became Republican-controlled for the first time in decades. Hatch was appointed chairman of what is now known as the Health, Education, Labor and Pensions Committee. The powerful legislative group has oversight of the Food and Drug Administration, Centers for Disease Control and Prevention and the National Institutes of Health.

“He was virtually catapulted into this chairmanship role,” Sundwall said. “This is astonishing that he had chairmanship of an umbrella committee in his first term in the Senate.”

In 2011, Hatch was appointed to the influential Senate Finance Committee, where he later became chairman. There he helped oversee the national health programs Medicare, Medicaid and CHIP.

Hatch’s growing influence in Congress did not go unnoticed by health care lobbyists. According to the watchdog organization Center for Responsive Politics, in the past 25 years of political campaign funding, Hatch ranks third of all members of Congress for contributions from the pharmaceutical and health sector. (That’s behind Democratic senators who ran for higher office — President Barack Obama and presidential nominee Hillary Clinton).

“Clearly, he was PhRMA’s man on the Hill,” said Dr. Jeremy Greene, referring to the trade group that represents pharmaceutical companies. Green is a professor of the history of medicine at Johns Hopkins University School of Medicine. Though Hatch did work to lower drug prices, Greene said, the senator’s record was mixed on the regulation of drug companies.

For example, an important piece of Hatch’s legislative legacy is the 1984 Hatch-Waxman Act, drafted with then-Rep. Henry Waxman, an influential Democrat from California. While the law promoted the development of cheaper, generic drugs, it also rewarded brand-name drug companies by extending their patents on valuable medicines.

The law did spur sales of cheaper generics, Greene said. But drugmakers soon learned how to exploit the law’s weaknesses.

“The makers of brand-name drugs began to craft larger and larger webs of multiple patents around their drugs,” aiming to preserve their monopolies after the initial patent expired, Greene said.

Other brand-name drugmakers preserved their monopolies by paying makers of generics not to compete.

“These pay-for-delay deals effectively hinged on a part of the Hatch-Waxman Act,” Greene said.

Hatch also worked closely with the dietary supplement industry. The multibillion-dollar industry specializing in vitamins, minerals, herbs and other “natural” health products, is concentrated in his home state of Utah.

“There was really no place for these natural health products,” said Loren Israelsen, president of the United Natural Products Alliance and a Hatch staffer in the late 1970s.

As the industry grew, there was a debate over how to regulate it: Should it be more like food or like drugs? In 1994, Hatch sponsored the Dietary Supplement Health and Education Act, known as DSHEA, which treats supplements more like food.

“It was necessary to have someone who was a champion who would say, ‘All right, if we need to change the law, what does it look like,’ and ‘Let’s go,’” Israelsen said.

Some legislators and consumer advocacy groups wanted vitamins and other supplements to go through a tight approval process, akin to the testing the Food and Drug Administration requires of drugs. But DSHEA reined in the FDA, determining that supplements do not have to meet the same safety and efficacy standards as prescription drugs.

That legislative clamp on regulation has led to ongoing questions about whether dietary supplements actually work and concerns about how they interact with other medications patients may be taking.

DSHEA was co-sponsored by Democrat Tom Harkin, then a senator from Iowa.

While that kind of bipartisanship defined much of Hatch’s career, it has been less evident in recent years. He was strongly opposed to the Affordable Care Act, and in 2018 called supporters of the heath law among the “stupidest, dumb-ass people” he had ever met. (Hatch later characterized the remark as “a poorly worded joke.”)

In his farewell speech on the Senate floor in December, Hatch lamented the polarization that has overtaken Congress.

“Gridlock is the new norm,” he said. “Like the humidity here, partisanship permeates everything we do.”

This story is part of a partnership that includes KUER, NPR and Kaiser Health News.


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.