Drugmakers Blamed For Blocking Generics Have Jacked Up Prices And Cost U.S. Billions

KFF Health News, May 23, 2018

Drug companies that may have engaged in 'shenanigans' to delay the entrance of cheaper competitors onto the market have raised prices and cost taxpayers more money over time.

This article first appeared May 23, 2018 on Kaiser Health News.

By Sydney Lupkin

Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.

As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.

The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.

The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples, and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid, which accounted for 63 percent of Celgene’s revenue in the first quarter of 2018, according to a company press release.

The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t [such] lucrative sources of revenue,” said Harvard Medical School instructor Ameet Sarpatwari. “In the case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”

Indeed, a KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drugmakers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5 percent to 26.3 percent for Medicare Part D in 2014, the most recent year that data are available.

The remaining drugs do not appear in the Medicare and Medicaid data.

By delaying development of generics, drugmakers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 60 percent more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.

Revlimid cost Medicare Part D $2.7 billion in 2016, trailing only Harvoni, which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40 percent per unit in just four years, the Medicare data show, and cost $75,200 per beneficiary in 2016.

Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require restricted distribution of brand-name drugs that have serious risks or addictive qualities. Drugmakers with products in the safety program sometimes say they can’t provide samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Gottlieb said in a statement.

The Department of Health and Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Sarpatwari said there’s evidence drugmakers are abusing it to stave off competition from generics.

Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anticompetitive practices.

Celgene spokesman Greg Geissman said the company has sold samples to generics manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition and safety.

“Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst are believed to have similar risks,” Geissman said.

The highest number of pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer. In 2016, that drug cost Medicare $90,700 per patient and more than $304 million overall. Meanwhile, spending per unit jumped 52 percent from 2012 through 2016.

Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen, in 2017.

Actelion spokeswoman Colleen Wilson said that the company “cooperate[s]” with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”

PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses from those it represents.

“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said PhRMA spokesman Andrew Powaleny.

Congress is considering the CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.

The bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said more transparency from the FDA is helpful, but more work from the agency is needed to end the anticompetitive tactic. “With billions of dollars at stake, a database alone will not stop this behavior,” Leahy said.

Co-sponsor Sen. Chuck Grassley (R-Iowa), chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anticompetitive practices to keep low-cost generic drugs off the market.”

The FDA hasn’t come out in support of CREATES. “They should know that this is going to require a legislative solution,” Sarpatwari said. “Why are they not stepping into this arena and saying that?”

Insurer Slashes Breast Pump Payments, Stoking Fears Fewer Moms Will Breastfeed

KFF Health News, May 23, 2018

Anthem slashed the rate it reimburses medical suppliers for breast pumps by 44%, meaning some breast pumps that used to be free under the ACA will now entail a cost to consumers.

This article first appeared May 23, 2018 on Kaiser Health News.

By Samantha Young

A sharp cut in breast pump payments by the nation’s second-largest health insurer has prompted a strong reaction from breastfeeding advocates, who warn that some new moms will not get the pumps they need and fewer babies will be breastfed.

Starting last month, Anthem Inc. slashed the rate it reimburses medical suppliers for breast pumps by 44 percent — from $169.15 to $95. The move means some breast pumps that used to be free under a provision of the Affordable Care Act will now entail a cost to consumers, according to the advocacy group MomsRising. More complex pumps, which have always required an out-of-pocket payment, will now be more expensive. It’s unclear how many women will be affected.

“It’s going to have a bigger impact on lower-income moms who can’t afford the increased out-of-pocket expense,” said Ruth Martin, vice president of Workplace Justice Campaigns for MomsRising. “Some moms will just stop breastfeeding.”

The lower payment rate applies to all commercial health plans sold by Anthem, which provides medical coverage for 40 million — or about 1 in 8 — people in the United States. The rate will not affect Anthem-run Medicaid plans, company spokesman Eric Lail said.

Anthem says that a variety of high-quality breast pumps will still be available to nursing moms at no cost, as required by the ACA.

But the lower reimbursement appears to be limiting the number of free pumps available to Anthem enrollees as medical suppliers charge them for the shortfall on models that the old Anthem rate used to fully cover.

Bob Achermann, executive director of the California Association of Medical Product Suppliers, acknowledged that lower reimbursement rates for medical equipment in general have forced suppliers to make tough decisions, including limiting customer choices.

The cost of a breast pump can vary widely, depending on the model and whether it is purchased directly from a retailer or with insurance through a medical equipment supplier. Retail prices range from as little as $12 for the most basic pumps to $400 for the higher-end ones. Some hospital-grade pumps, which can cost several thousand dollars, are typically rented by moms for roughly $80 a month.

But the amount insured consumers pay, if anything, is based on the prices their health plan negotiates with suppliers, which can be lower than retail.

Anthem declined to reveal any prices on the range of pumps it offers but listed a handful of “popular” pumps its enrollees can get for free.

“Anthem recognizes the positive health benefits that breastfeeding can have on mothers and their newborns,” the company told California Healthline in an emailed statement. “The recent [rate] adjustment … will not impact the ability of any new mother to access a high-quality, standard double electric breast pump from our contracted medical suppliers.”

To comply with the ACA’s free breast pump mandate, commercial insurers have offered certain models at no cost. That has saved families hundreds of dollars, since breast pumps often were not covered at all before the ACA. Some state Medicaid programs, including Medi-Cal, also provide this coverage.

But the no-cost pumps do not work for all mothers, experts say. Breast pumps vary from manually operated ones to electric ones to the much stronger hospital-grade variety. The design or capacity of one pump may fit the needs — or bodies — of some women but not others.

Some mothers, for example, need to pump more milk because their babies have medical conditions that make it difficult for them to drink directly from the breast. Other mothers, returning to work after maternity leave, may need to express milk for daytime feedings by caregivers — or, if they are pumping at their workplace, to minimize break time.

Women who need more complex pumps — ones that have always required coinsurance payments — now must shell out more money as a result of Anthem’s decision, breastfeeding advocates say. That, in turn, raises a key question: Will more mothers simply settle for lower-end pumps that medical experts say might frustrate them and induce them to give up breastfeeding?

Breast pumps “are not cheap,” said Karissa Soma, an Orangevale, Calif., mom who took a half-year off work to care for her 5-month-old son. “I paid almost $5,000 in hospital bills, and you add the expense to stay home. It’s already so much.”

Critics of Anthem’s decision believe it cuts against the spirit of the ACA breast pump rule, which was intended to remove barriers to breastfeeding. Research shows the health law provision, which was implemented in 2012, has induced more new moms to breastfeed their babies and to continue doing so longer than before.

“It is clear that this [Anthem] decision would have far-reaching and deleterious effects on a mother’s ability to reach their breastfeeding goals,” the United States Breastfeeding Committee and dozens of other breastfeeding advocates wrote in an April 25 letter to Anthem President and CEO Gail Boudreaux.

Given the well-known benefits of breast milk, the American Academy of Pediatrics recommends that new moms breastfeed for at least a year. But that’s not always easy. Breastfeeding can be hard for a new mom — and for the baby.

When 31-year-old Bakersfield, Calif., resident Megan Eskew, an Anthem enrollee, gave birth in April 2017, she needed a pump to feed her milk to her baby boy, Reid, who spent the first six days of his life in the intensive care unit and could drink only from a bottle.

The hospital-grade pump delivered the breast milk that Eskew, a first-time mom, believed was critical for Reid. When Reid left the hospital, he still needed to drink from a bottle, so Eskew selected a high-end pump that required a coinsurance payment of roughly $100 under the terms of her health plan. That was a year before Anthem cut its reimbursement.

“I’m lucky I had the financial resources to buy a pump,” Eskew said, “but not all moms have those options.”

Trump Proposes Cutting Planned Parenthood Funds. What Does That Mean?

KFF Health News, May 21, 2018

The rules now under review, according to Trump administration officials, would require facilities receiving federal family planning funds to be physically separate from those that perform abortion

This article first appeared May 18, 2018 on Kaiser Health News.

By Julie Rovner

The planned revival of a policy dating to Ronald Reagan’s presidency may finally present a way for President Donald Trump to fulfill his campaign promise to “defund” Planned Parenthood. Or at least to evict it from the federal family planning program, where it provides care to more than 40 percent of that program’s 4 million patients.

Congress last year failed to wipe out funding for Planned Parenthood, because the bill faced overwhelming Democratic objections and would not have received the 60 votes needed to pass in the Senate.

But the imposition of a slightly retooled version of a regulation, which was upheld by the Supreme Court in 1991 after a five-year fight, could potentially accomplish what Congress could not.

The rules now under review, according to Trump administration officials, would require facilities receiving federal family planning funds to be physically separate from those that perform abortion; would eliminate the requirement that women with unintended pregnancies be counseled on their full range of reproductive options; and would ban abortion referrals.

All those changes would particularly affect Planned Parenthood.

Planned Parenthood, which provides a broad array of reproductive health services to women and men, also provides abortion services using non-federal funds. Cutting off funding has been the top priority for anti-abortion groups, which supported candidate Trump.

“A win like this would immediately disentangle taxpayers from the abortion business and energize the grassroots as we head into the critical midterm elections,” Marjorie Dannenfelser, president of the anti-abortion Susan B. Anthony List, said in a statement.

In a conference call with reporters, Planned Parenthood officials said they would fight the new rules.

“We’ve been very clear, Planned Parenthood has an unwavering commitment to ensuring everyone has access to the full range of reproductive health care, and that includes abortion,” said Dawn Laguens, executive vice president of the Planned Parenthood Federation of America.

Here is a guide to what the proposal could do and what it could mean for Planned Parenthood and the family planning program:

What Is Title X?

The federal family planning program, known as “Title Ten,” is named for its section in the federal Public Health Service Act. It became law in 1970, three years before the Supreme Court legalized abortion in Roe v Wade.

The original bill was sponsored by then Rep. George H.W. Bush (R-Texas) and signed into law by President Richard Nixon.

The program provides wellness exams and comprehensive contraceptive services, as well as screenings for cancer and sexually transmitted diseases for both women and men.

In 2016, the most recent year for which statistics have been published, Title X served 4 million patients at just under 4,000 sites.

Title X patients are overwhelmingly young, female and low-income. An estimated 11 percent of Title X patients in 2016 were male; two-thirds of patients were under age 30; and nearly two-thirds had income below the federal poverty line.

What Is Planned Parenthood’s Relationship To Title X And Medicaid?

Planned Parenthood affiliates account for about 13 percent of total Title X sites but serve an estimated 40 percent of its patients. Only about half of Planned Parenthood affiliates perform abortions, although the organization in its entirety is the nation’s leading abortion provider.

Planned Parenthood also gets much more federal funding for services provided to patients on the Medicaid program (although not for abortion) than it does through Title X.

Eliminating Medicaid funding for Planned Parenthood has proven more difficult for lawmakers opposed to the organization because the federal Medicaid law includes the right for patients to select their providers. Changing that also would require a 60-vote majority in the Senate. So that particular line of funding is likely not at risk.

While opponents of federal funding for Planned Parenthood have said that other safety-net clinics could make up the difference if Planned Parenthood no longer participates in Title X, several studies have suggested that in many remote areas Planned Parenthood is the only provider of family planning services and the only provider that regularly stocks all methods of birth control.

Texas, Iowa and Missouri in recent years have stopped offering family planning services through a special Medicaid program to keep from funding Planned Parenthood. Texas is seeking a waiver from the Trump administration so that its program banning abortion providers could still receive federal funding. No decision has been made yet, federal officials said.

Why Is Planned Parenthood’s Involvement With Title X Controversial?

Even though Planned Parenthood cannot use federal funding for abortions, anti-abortion groups claim that federal funding is “fungible” and there is no way to ensure that some of the funding provided for other services does not cross-subsidize abortion services.

Planned Parenthood has also been a longtime public target for anti-abortion forces because it is such a visible provider and vocal proponent of legal abortion services.

In the early 1980s, the Reagan administration tried to separate the program from its federal funding by requiring parental permission for teens to obtain birth control. That was followed by efforts to eliminate abortion counseling.

Starting in 2011, undercover groups accused the organization of ignoring sex traffickers and selling fetal body parts in an effort to get the organization defunded. Planned Parenthood denies the allegations.

What Happened The Last Time An Administration Tried To Move Planned Parenthood Out Of Title X?

In 1987, the Reagan administration proposed what came to be known as the “gag rule.” Though the administration’s new proposal is not yet public, because the details are still under review by the Office of Management and Budget, the White House released a summary, saying the new rule will be similar although not identical to the Reagan-era proposal.

The original gag rule would have forbidden Title X providers from abortion counseling or referring patients for abortions, required physical separation of Title X and abortion-providing facilities and forbidden recipients from using nonfederal funds for lobbying, distributing information or in any way advocating or encouraging abortion. (The Planned Parenthood Federation of America, the umbrella group for local affiliates, has a separate political and advocacy arm, the Planned Parenthood Action Fund.)

Those rules were the subject of heated congressional debate through most of the George H.W. Bush administration and were upheld in a 5-4 Supreme Court ruling in 1991, Rust v. Sullivan.

Even then, the gag rule did not go into effect because subsequent efforts to relax the rules somewhat to allow doctors (but not other health professionals) to counsel patients on the availability of abortion created another round of legal fights.

Eventually the rule was in effect for only about a month before it was again blocked by a U.S. appeals court. President Bill Clinton canceled the rules by executive order on his second day in office, and no other president tried to revive them until now.

How Is The Trump Administration’s Proposal Different From Earlier Rules?

According to the summary of the new proposal, released Friday, it will require physical separation of family planning and abortion facilities, repeal current counseling requirements, and ban abortion referrals.

One of the biggest differences, however, is that the new rules will not explicitly forbid abortion counseling by Title X providers.

But Planned Parenthood officials say that allowing counseling while banning referrals is a distinction without a difference.

Kashif Syed, a senior policy analyst for the organization said: “Blocking doctors from telling a patient where they can get safe and legal care in this country is the definition of a gag rule.”

What Happens Next?

All proposed rules are reviewed by the Office of Management and Budget. Sometimes they emerge and are published in a few days; sometimes they are rewritten, and it takes months.

Meanwhile, Planned Parenthood officials said they will not know if they will take legal action until they see the final language of the rule. But they say they do plan to use the regulatory process to fight the changes that have been made public so far.

Vermont Legislators Pass A Drug Importation Law. So What?

KFF Health News, May 18, 2018

Challenges lie ahead for importation champions and the future of the drug pricing fight.

This article first appeared May 18, 2018 on Kaiser Health News.

By Shefali Luthra

This week, Vermont passed a first-in-the-nation law that would facilitate the state’s importation of prescription drugs wholesale from Canada. It represents the state’s effort to tackle head-on the issue of constantly climbing drug prices.

Other states, including Louisiana and Utah, have debated similar legislation and are watching Vermont’s progress closely.

After all, the issue of drug importation polls well across the political spectrum and has been endorsed by politicians ranging from candidate Donald Trump, before he became president, to liberal firebrand Sen. Bernie Sanders (I-Vt.).

So how much impact might a state law like this actually have?

Trump has since stepped back from his campaign position, and the White House did not include drug importation in its proposal last week to bring down drug prices.

And cautions abound that importation may not actually save that much money as questions swirl about whether the policy undermines drug safety standards.

Kaiser Health News breaks down the challenges that lie ahead for importation champions, and what it shows about the future of the drug pricing fight.

States need federal approval to launch any kind of importation program.

Just having a law like Vermont’s on the books is not enough to legalize importation. The next step is for the state to craft a proposal outlining how its initiative would save money without jeopardizing public health. The proposal, in turn, is then subject to approval by the federal Department of Health and Human Services.

HHS has had yea-or-nay power over state importation programs since at least 2003, because of a provision included in the law creating Medicare Part D. But it’s never actually approved such a plan. And — despite mounting political pressure — there’s little reason to think it will do so now.

In the past weeks, HHS Secretary Alex Azar has come out strongly against importation, calling it a “gimmick” that wouldn’t meaningfully bring down prices.

He also has argued that the U.S. government cannot adequately certify the safety of imported drugs.

HHS declined to comment beyond Azar’s public remarks.

Importation backers — including the National Academy for State Health Policy (NASHP), which helped craft Vermont’s bill and has worked with state lawmakers — hope he’ll reverse these positions. But few are optimistic that this will happen.

“I don’t expect that Vermont alone will be able to bring sufficient pressure to bear on Secretary Azar to convince him to change his mind,” said Rachel Sachs, an associate law professor at Washington University in St. Louis, who tracks drug-pricing laws.

A state’s importation program would also require buy-in from Canadian wholesalers. What’s in it for them?

Perhaps not much. Canadian wholesalers might stand to lose financially.

After all, pharmaceutical companies that market drugs in the United States might limit how much they sell to companies that have supply chains across the border. They could also raise their Canadian list prices.

“Almost inevitably, Canadians would cease getting better prices,” said Michael Law, a pharmaceutical policy expert and associate professor at the University of British Columbia’s Center for Health Services and Policy Research. “If I were a [Canadian] company, I wouldn’t want that to occur — and [drugmakers] could take steps to limit the supply coming north. … It probably results in [Canadians] getting higher prices.”

Trish Riley, NASHP’s executive director, dismissed this concern, saying some Canadian wholesalers have indicated interest in contracting with Vermont.

Vermont would still have to prove to HHS that its proposal would yield “substantial” savings. This won’t be easy.

In fact, some analysts suggest savings would be limited to a narrow slice of the market.

Importation could bring down the price of some generics and off-patent drugs by increasing competition, suggested Ameet Sarpatwari, a lawyer and epidemiologist at Harvard Medical School who studies drug pricing.

Many generic drugs have also seen substantial price hikes in recent years — but curbing these costs is only part of the equation.

“It’s not a panacea for the drug-pricing reform or high drug prices as a whole,” Sarpatwari said.

Branded drugs, which drive much of the American problem with prescription price tags, are distributed by a single company and, therefore, that company has greater control over supply and pricing pressure.

Drug safety looms over the debate.

The worry, according to critics, is that American regulators can’t effectively determine whether imported drugs meet the same safety standards as those sold directly in the United States. A year ago, a bipartisan group of former Food and Drug Administration commissioners made that very argument in a letter to Congress.

Azar has argued this same point, as has the influential pharmaceutical industry, represented by the Pharmaceutical Research and Manufacturers of America.

“Lawmakers cannot guarantee the authenticity and safety of prescription medicines when they bypass the FDA approval process,” said Caitlin Carroll, a PhRMA spokeswoman, in a statement released on Vermont’s law.

This position, though, draws skepticism.

In cases of drug shortages or public health emergencies, the United States has imported drugs. And many Canadian and American drugs are made and approved under similar standards, Law noted.

“In terms of general safety, it is kind of nonsense. … We share plants,” he said. “The idea that Canadian drugs are somehow unsafe is a red herring.”

An argument in favor of plans like Vermont’s focuses on the idea that because the state would import drugs wholesale — rather than enabling individuals to shop internationally — it would be able to address concerns about safety or quality, Riley said.

Plus, Sarpatwari suggested, the government has resources to track drugs that come from Canada, especially if a drug were recalled or ultimately found to have problems.

“Our technology is catching up with our ability to do effective monitoring,” he said. “Particularly when it’s coming from a well-regulated country, I think there is less fear over safety.”

States have been leading the charge on addressing the drug price issue, but their efforts reach only so far.

The federal government has taken little action to curb rising drug prices — though HHS now says it plans to change that.

So far, state legislatures have been pushing for laws to penalize price gouging, promote price transparency or limit what the state will pay.

But state initiatives often require federal permission.

Vermont’s law, which is arguably meaningless without HHS’ say-so, is just one example.

Sarpatwari pointed to a request from Massachusetts to develop a drug formulary for its Medicaid insurance program — theoretically giving the state more leverage to negotiate cheaper prices by reducing how many drugs it’s required to cover.

That proposal also is contingent upon approval from HHS. The administration has been publicly silent, though some news reports suggest it leans toward rejecting the request.

Meanwhile, Sachs said Vermont’s law, and others like it, will challenge the White House to show its mettle in taking on drug costs.

“We’re seeing explicit actions by the states to put pressure back on the federal government,” Sachs said. “The administration is publicly committed to lowering drug prices. It is being asked to make decisions which will, in some ways, show how much it really is attempting to accomplish that goal.”

Opioid Overdoses Are Rising Faster Among Latinos Than Whites Or Blacks. Why?

KFF Health News, May 17, 2018

While the overall death toll is still higher for whites, it's increasing faster for Latinos and blacks.

This article first appeared May 17, 2018 on Kaiser Health News.

By Martha Bebinger, WBUR

The tall, gangly man twists a cone of paper in his hands as stories from nearly 30 years of addiction pour out: the robbery that landed him in prison at age 17; never getting his high school equivalency diploma; going through the horrors of detox, maybe 40 times, including this latest bout, which he finished two weeks ago. He's now in a residential treatment unit for at least 30 days.

"I'm a serious addict," said Julio Cesar Santiago, 44. "I still have dreams where I'm about to use drugs, and I have to wake up and get on my knees and pray, 'Let God take this away from me,' because I don't want to go back. I know that if I go back out there, I'm done."

Santiago has reason to worry. Data on opioid addiction in his home state of Massachusetts show the overdose death rate for Latinos there has doubled in three years, growing at twice the rates of non-Hispanic whites and blacks.

Opioid overdose deaths among Latinos are surging nationwide as well. While the overall death toll is still higher for whites, it's increasing faster for Latinos and blacks, according to data from the Centers for Disease Control and Prevention. Latino fatalities increased 52.5 percent from 2014 to 2016, compared with 45.8 percent for whites. (Statisticians say Hispanic overdose counts are typically underestimated.) The most substantial hike was among blacks: 83.9 percent.

The data portray a changing face of the opioid epidemic.

"What we thought initially, that this was a problem among non-Hispanic whites, is not quite accurate," said Robert Anderson, mortality statistics branch chief at the CDC's National Center for Health Statistics. "If you go back into the data, you can see the increases over time in all of these groups, but we tended to focus on the non-Hispanic whites because the rates were so much higher."

There's little understanding about why overdose deaths are rising faster among blacks and Latinos than whites. Some physicians and outreach workers suspect the infiltration of fentanyl into cocaine is driving up fatalities among blacks.

The picture of what's happening among Latinos has been murky, but interviews with nearly two dozen current and former drug users and their family members, addiction treatment providers and physicians reveal that language and cultural barriers, even fear of deportation, could limit the access of Latinos to lifesaving treatment.

Bilingual Treatment Options Are Scarce

Irma Bermudez, 43, describes herself as a "grateful recovering addict." She's living in the women's residential unit at Casa Esperanza, a collection of day treatment, residential programs and transitional housing in Boston's Roxbury neighborhood.

Bermudez said the language barrier keeps anyone who can't read English out of treatment from the start, as they try to decipher websites or brochures that advertise options. If they call a number on the screen or walk into an office, "there's no translation — we're not going to get nothing out of it," Bermudez said.

Some of the Latinos interviewed for this story described sitting through group counseling sessions, part of virtually every treatment program, and not being able to follow much, if any, of the conversation. They recalled waiting for a translator to arrive for their individual appointment with a doctor or counselor and missing the session when the translator is late or doesn't show up at all.

SAMHSA, the federal Substance Abuse and Mental Health Services Administration, maintains a Find Treatment website that includes listings of treatment offered in Spanish. But several Massachusetts providers listed there could not say how many translators they have or when they are available. The SAMHSA site is available only in English, with Spanish-language translators available only by phone.

At Casa Esperanza, 100 men are waiting for a spot in the male residential program, so recovery coach Richard Lopez spends a lot of time on the phone trying to get clients into a program he thinks has at least one translator.

After battling with voicemail, said Lopez, he'll eventually get a call back; the agent typically offers to put Lopez's client on another waiting list. That frustrates him.

"You're telling me that this person has to wait two to three months? I'm trying to save this person today," he said. "What am I going to do, bring these individuals to my house and handcuff them so they don't do nothing?"

Casa Esperanza Executive Director Emily Stewart said Massachusetts needs a public information campaign via Spanish-language media that explains treatment options. She'd like that to include medication-assisted treatment, which she said is not well understood.

Some research shows Latino drug users are less likely than others to have access to or use the addiction treatment medicines, methadone and buprenorphine. One study shows that may be shifting. But, Latinos with experience in the field said, access to buprenorphine (which is also known by the brand name Suboxone) is limited because there are few Spanish-speaking doctors who prescribe it.

A Matter Of Machismo: 'It's Not Cool To Call 911'

Lopez has close ties these days with health care providers, the police and EMT rescue squads. But that has changed dramatically from when he was using heroin. On the streets, he said, "it's not cool to be calling 911" when a person sees someone overdose. "I could get shot, and I won't call 911."

It's a machismo thing, said Lopez.

"To the men in the house, the word 'help' sounds, like, degrading, you know?" he said. Calling 911 "is like you're getting exiled from your community."

Santiago said not everyone feels that way. A few men called EMTs to help revive him. "I wouldn't be here today if it wasn't for them," he said.

But Santiago and others say there's growing fear among Latinos they know of asking anyone perceived as a government agent for help — especially if the person who needs the help is not a U.S. citizen.

"They fear if they get involved they're going to get deported," said Felito Diaz, 41.

Bermudez said Latina women have their own reasons to worry about calling 911 if a boyfriend or husband has stopped breathing.

"If they are in a relationship and trying to protect someone, they might hesitate as well," said Bermudez, if the man would face arrest and possible jail time.

A Tight Social Network

Another reason some Latino drug users said they've been hit especially hard by this epidemic: A 2017 DEA report on drug trafficking noted that Mexican cartels control much of the illegal drug distribution in the United States, selling the drugs through a network of local gangs and small-scale dealers.

In the Northeast, Dominican drug dealers tend to predominate.

"The Latinos are the ones bringing in the drugs here," said Rafael, a man who uses heroin and lives on the street in Boston, close to Casa Esperanza. "The Latinos are getting their hands in it, and they're liking it."

Kaiser Health News and NPR agreed not to use Rafael's last name because he uses illegal drugs.

"Of course, I would feel more comfortable selling to a Latino if I was a drug dealer than a Caucasian or any other, because I know how to relate and get that money off them," said Lopez.

The social networks of drug use create another layer of challenges for some Latinos, said Dr. Chinazo Cunningham, who treats many patients from Puerto Rico. She primarily works at a clinic affiliated with the Montefiore Medical Center in the Bronx, in New York City.

"The family is such an important unit — it's difficult, if there is substance use within the family, for people to stop using opioids," Cunningham said.

The Burden Of Poverty

Though Latinos are hardly a uniform community, many face an additional risk factor for addiction: poverty. About 20 percent of the community live in poverty, compared with 9 percent of whites, according to the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

In Massachusetts, four times as many Latinos live below the poverty line as do whites. The majority of Casa Esperanza clients were recently homeless. The wait time for one of the agency's 37 individual or family housing units ranges from a year to a decade.

"If you've done all the work of getting somebody stabilized and then they leave and don't have a stable place to go, you're right back where you started," said Casa Esperanza's Stewart.

Cunningham said the Latino community has been dealing with opioid addiction for decades and it is one reason for the group's relatively high incarceration rate. In Massachusetts, Latinos are sentenced to prison at nearly five times the rate of whites.

"It's great that we're now talking about it because the opioid epidemic is affecting other populations," Cunningham said. "It's a little bit bittersweet that this hasn't been addressed years before. But it's good that we're talking about treatment rather than incarceration, and that this is a medical illness rather than a moral shortcoming."

Nationally, says the CDC's Anderson, there's no sign that the surge of overdose deaths is abating in any population.

"We've already had two years of declining life expectancy in the U.S., and I think that when we see the 2017 data we'll see a third year," said Anderson. "That hasn't happened since the great influenza pandemic in the early 1900s."

The fatality counts for 2017 are expected out by the end of this year.

California Hospital Giant Sutter Health Faces Heavy Backlash On Prices

KFF Health News, May 16, 2018

The state's top cop is suing Sutter, accusing one of the nation's biggest health systems of systematically overcharging patients and illegally driving out competition.

This article first appeared May 16, 2018 on Kaiser Health News.

By Chad Terhune

Cooking dinner one night in March, Mark Frizzell sliced his pinkie finger while peeling a butternut squash and couldn’t stop the bleeding.

The 51-year-old businessman headed to the emergency room at Sutter Health’s California Pacific Medical Center in San Francisco. Sutter charged $1,555 for the 10 minutes it treated him, including $55 for a gel bandage and $487 for a tetanus shot.

“It was ridiculous,” he said. “Health insurance costs are through the roof because of things like this.”

California Attorney General Xavier Becerra couldn’t agree more. The state’s top cop is suing Sutter, accusing one of the nation’s biggest health systems of systematically overcharging patients and illegally driving out competition in Northern California.

For years, economists and researchers have warned of the dangers posed by large health systems across the country that are gobbling up hospitals, surgery centers and physicians’ offices — enabling them to limit competition and hike prices.

Becerra’s suit amounts to a giant test case with the potential for national repercussions. If California prevails and is able to tame prices at Northern California’s most powerful, dominant health system, regulators and politicians in other states are likely to follow.

“A major court ruling in California could be a deterrent to other hospital systems,” said Ge Bai, an assistant professor at Johns Hopkins University who has researched hospital prices nationwide. “We’re getting to a tipping point where the nation cannot afford these out-of-control prices.”

Reflecting that sense of public desperation, Sutter faces two other major suits — from employers and consumers — which are wending their way through the courts, both alleging anticompetitive conduct and inflated pricing. Meanwhile, California lawmakers are considering a bill that would ban some contracting practices used by large health systems to corner markets.

Sutter, a nonprofit chain, is pushing back hard, denying anticompetitive behavior and accusing Becerra in court papers of a “sweeping and unprecedented effort to intrude into private contracting.” Recognizing the broader implications of the suit, both the American Hospital Association and its California counterpart asked to file amicus briefs in support of Sutter.

In his 49-page complaint, Becerra cited a recent study finding that, on average, an inpatient procedure in Northern California costs 70 percent more than one in Southern California. He said there was no justification for that difference and stopped just short of dropping an expletive to make his point.

“This is a big 'F' deal,” Becerra declared at his March 30 news conference to unveil the lawsuit. In an interview last week, he said, “We don't believe it's fair to allow consolidation to end up artificially driving up prices. … This anticompetitive behavior is not only bad for consumers, it's bad for the state and for businesses.”

To lessen Sutter’s market power, the state’s lawsuit seeks to force Sutter to negotiate reimbursements separately for each of its hospitals — precluding an “all or nothing” approach — and to bar Sutter employees from sharing the details of those negotiations across its facilities. Becerra said Sutter has required insurers and employers to contract with its facilities systemwide or face “excessively high out-of-network rates.”

Heft In The Marketplace

Overall, Sutter has 24 hospitals, 36 surgery centers and more than 5,500 physicians in its network. The system boasts more than $12 billion in annual revenue and posted net income of $958 million last year.

The company’s heft in the marketplace is one reason why Northern California is the most expensive place in the country to have a baby, according to a 2016 report. A cesarean delivery in Sacramento, where Sutter is based, cost $27,067, nearly double what it costs in Los Angeles and New York City.

For years, doctors and consumers have also accused Sutter of cutting hospital beds and critical services in rural communities to maximize revenue. “Patients are the ones getting hurt,” said Dr. Greg Duncan, an orthopedic surgeon and former board member at Sutter Coast Hospital in Crescent City, Calif.

Sutter says patients across Northern California have plenty of providers to choose from and that it has held its average rate increases to health plans to less than 3 percent annually since 2012. It also says it does not require all facilities to be included in every contract — that insurers have excluded parts of its system from their networks.

As for emergency room patients like Frizzell, Sutter says its charges reflect the cost of maintaining services round-the-clock and that for some patients urgent-care centers are a less costly option.

“The California Attorney General’s lawsuit gets the facts wrong,” Sutter said in a statement. “Our integrated network of high-quality doctors and care centers aims to provide better, more efficient care — and has proven to help lower costs.”

Regulators in other states also have sought to block deals they view as potentially harmful.

In North Carolina, for instance, the state’s attorney general and treasurer both expressed concerns about a proposed merger between the University of North Carolina Health Care system and Charlotte-based Atrium Health. The two dropped their bid in March. The combined system would have had roughly $14 billion in revenue and more than 50 hospitals.

Last year, in Illinois, state and federal officials persuaded a judge to block the merger between Advocate Health Care and NorthShore University HealthSystem. The Federal Trade Commission said the new entity would have had 60 percent market share in Chicago’s northern suburbs. Still, Advocate won approval for a new deal with Wisconsin’s Aurora Health Care last month, creating a system with $11 billion in annual revenue.

Antitrust experts say states can deliver a meaningful counterpunch to health care monopolies, but they warn that these cases aren’t easy to win and it could be too little, too late in some markets.

“How do you unscramble the egg?” said Zack Cooper, an assistant professor of economics and health policy at Yale University. “There aren’t a lot of great solutions.”

A Seven-Year Investigation

California authorities took their time sounding the alarm over Sutter — a fact Sutter is now using against the state in court.

The state attorney general’s office, under the leadership of Democrat Kamala Harris, now a U.S. senator, started investigating Sutter seven years ago with a 2011 subpoena, court documents show. Sutter said the investigation appeared to go dormant in March 2015, just as Harris began ramping up her Senate campaign.

Becerra, a Democrat and former member of Congress, was appointed to replace Harris last year, took over the investigation and sued Sutter on March 29. His aggressive action comes as he prepares for a June 5 primary against three opponents.

Sutter faces a separate class-action suit in San Francisco state court, spearheaded by a health plan covering unionized grocery workers and representing more than 2,000 employer-funded health plans. The plaintiffs are seeking to recoup $700 million for alleged overcharges plus damages of $1.4 billion if Sutter is found liable for antitrust violations. Sutter also has been sued in federal court by five consumers who blame the health system for inflating their insurance premiums and copays. The plaintiffs are seeking class-action status.

San Francisco County Superior Court Judge Curtis E.A. Karnow granted Becerra’s request to consolidate his case with the grocery workers’ suit, which is slated for trial in June 2019.

The judge sanctioned Sutter in November after finding that Sutter was “grossly reckless” in intentionally destroying 192 boxes of evidence that were relevant to antitrust issues. As a result, Karnow said, he will consider issuing jury instructions that are adverse to Sutter.

In a note to employees, Sutter chief executive Sarah Krevans said she deeply regretted the situation but “mistakes do happen.”

In an April 27 court filing, Sutter’s lawyers criticized the state for piggybacking onto the grocery workers’ case. “The government sat on its hands for seven years, exposing the public to the alleged anticompetitive conduct. … Rather than driving the agenda, the Attorney General seeks to ride coattails.”

Outside court, California legislators are taking aim at “all or nothing” contracting terms used by Sutter and other hospital chains. The proposed law stalled last year amid opposition from the hospital industry. But consumer and labor groups are seeking to revive it this year.

In the meantime, Frizzell said he will probably wind up at one of Sutter’s hospitals again despite his disgust over his ER bill. “Most of the hospitals here are Sutter,” he said. “It’s difficult to avoid them.”

Lack Of Insurance Exposes Blind Spots In Vision Care

KFF Health News, May 15, 2018

As many as 16 million people in the United States have undiagnosed or uncorrected 'refractive' errors that could be fixed with eyeglasses, contact lenses, or surgery.

This article first appeared May 15, 2018 on Kaiser Health News.

By Michelle Andrews

Every day, a school bus drops off as many as 45 children at a community eye clinic on Chicago's South Side. Many of them are referred to the clinic after failing vision screenings at their public schools.

Clinicians and students from the Illinois College of Optometry give the children comprehensive eye exams, which feature refraction tests to determine a correct prescription for eyeglasses and dilation of their pupils to examine their eyes, including the optic nerve and retina.

No family pays out-of-pocket for the exam. The program bills insurance if the children have coverage, but about a third are uninsured. Operated in partnership with Chicago public schools, the program annually serves up to 7,000 children from birth through high school.

"Many of the kids we're serving fall through the cracks," said Dr. Sandra Block, a professor of optometry at the Illinois College of Optometry and medical director of the school-based vision clinics program. Many are low-income Hispanic and African-American children whose parents may not speak English or are immigrants who are not in the country legally.

Falling through the cracks is not an uncommon problem when it comes to vision care. According to a 2016 report from the National Academies of Sciences, Engineering and Medicine, as many as 16 million people in the United States have undiagnosed or uncorrected "refractive" errors that could be fixed with eyeglasses, contact lenses or surgery. And while insurance coverage for eye exams and corrective lenses clearly has improved, significant gaps remain.

The national academies' report noted that impaired vision affects how people experience their world, including normal communication and social activities, independence and mobility. Not seeing clearly can hamper children's academic achievement, social development and long-term health.

But when people must choose, vision care may lose out to more pressing medical concerns, said Block, who was on the committee that developed the report.

"Vision issues are not life-threatening," she said. "People get through their day knowing they can't see as well as they'd like."

Insurance can make regular eye exams, glasses and treatment for medical problems such as cataracts more accessible and affordable. But comprehensive vision coverage is often achieved only through a patchwork of plans.

The Medicare program that provides coverage for millions of Americans age 65 and older doesn't include routine eye exams, refraction testing or eyeglasses. Some tests are covered if you're at high risk for a condition such as glaucoma, for example. And if you develop a vision-related medical condition such as cataracts, the program will cover your medical care.

But if you're just a normal 70-year-old and you want to get your eyes examined, the program won't cover it, said Dr. David Glasser, an ophthalmologist in Columbia, Md., who is a clinical spokesman for the American Academy of Ophthalmology. If you make an appointment because you're experiencing troubling symptoms and get measured for eyeglasses while there, you'll likely be charged anywhere from about $30 to $75, Glasser said.

There are a few exceptions. Medicare will pay for one pair of glasses or contact lenses following cataract surgery, for example. Some Medicare Advantage plans offer vision care.

Many commercial health insurance plans also exclude routine vision care from their coverage. Employers may offer workers a separate vision plan to fill in the gaps.

VSP Vision Care provides vision care plans to 60,000 employers and other clients, said Kate Renwick-Espinosa, the organization's president. A typical plan provides coverage for a comprehensive eye exam once a year and an allowance toward standard eyeglasses or contact lenses, sometimes with a copayment. Also, individuals seeking plans make up a growing part of their business, she said.

Vision coverage for kids improved under the Affordable Care Act. The law requires most plans sold on the individual and small-group market to offer vision benefits for children younger than 19. That generally means that those plans cover a comprehensive eye exam, including refraction, every year, as well as a pair of glasses or contact lenses.

But since pediatric eye exams aren't considered preventive care that must be covered without charging people anything out-of-pocket under the ACA, they're subject to copays and the deductible.

Medicaid programs for low-income people also typically cover vision benefits for children and sometimes for adults as well, said Dr. Christopher Quinn, president of the American Optometric Association, a professional group.

But coverage alone isn't enough. To bring down the number of people with undiagnosed or uncorrected vision, education is key to helping people understand the importance of eye health in maintaining good vision. Just as important, it can also reduce the impact of chronic conditions such as diabetes, the national academies' report found.

"All health care providers need to at least ask vision questions when providing primary care," said Block.

Why Did Novartis Pay Trump’s Lawyer $1.2 Million? Look At Its Drug Prices

KFF Health News, May 11, 2018

Hiring the president’s personal attorney matches a history of aggressively courting government officials by a corporation with much to lose in the debate over high drug prices.

This article first appeared Friday, May 11, on Kaiser Health News.

By Jay Hancock, Kaiser Health News

President Donald Trump didn’t mention Novartis or other drugmakers by name last year when he said the industry is “getting away with murder.”

Yet executives at the Switzerland-based pharmaceutical giant shelled out $1.2 million to Trump lawyer Michael Cohen to “advise” its executives on health policy and what was happening in the Trump White House.

Novartis paid more money to Cohen than did any of his clients revealed thus far.

The company said it quickly determined he was unable to deliver the help but paid the full amount owed in his contract. “We made a mistake” in hiring him, CEO Vasant Narasimhan told Novartis employees on Thursday.

Hiring the president’s personal attorney matches a history of aggressively courting government officials by a corporation with much to lose in the debate over high drug prices.

Novartis has nine blockbuster drugs generating around $1 billion or more in annual sales and priced so high in some cases that patients have trouble affording them even with insurance. Another nine drugs produce more than $500 million in sales.

High costs and copayments for Novartis’ Gleevec, which treats a form of leukemia, are associated with patients delaying or skipping doses, said researcher Stacie Dusetzina of Vanderbilt University.

Gleevec often must be taken for life and costs $148,000 a year — three times more than when it came out, according to Connecture, which provides technology to help people save money on prescriptions.

Novartis also makes drugs for psoriasis and multiple sclerosis that cost more than $100,000 a year. The price tag for Kymriah, a Novartis leukemia treatment approved last year, is $475,000.

The company earned $7.7 billion in profits last year on worldwide sales of $49 billion.

Novartis’ political action committee has been a sizable contributor on Capitol Hill, donating $204,500 last year to candidates for federal office and other political causes.

The company spent $8.8 million lobbying U.S. lawmakers in 2017, its highest amount ever, according to the Center for Responsive Politics. That doesn’t count the previously undisclosed payments to Cohen, which the company said were for consulting, not lobbying.

One issue that especially interests the company: the importation of drugs from Canada and other countries, which would undercut its high U.S. prices and badly hurt profits. Novartis sells its drugs for a fraction of U.S. prices in other developed countries. In 2015, Gleevec sold for $38,000 a year in Canada while a generic version of the same drug sold for only $8,800.

Importation was one of Novartis’ most lobbied issues last year.

Consumers Brace For Premium Hikes While Lawmakers Grasp At Remedies

KFF Health News, May 11, 2018

Insurers in several states are seeking big premium increases for people who buy their own insurance, renewing concerns about the potential for 'bare' counties with no insurer selling coverage.

This article first appeared May 11, 2018, on Kaiser Health News.

By Julie Rovner, Kaiser Health News

As some insurers angle for hefty premium hikes and concerns grow that more Americans will wind up uninsured, the federal health law is likely — once again — to play big in both parties’ strategies for the contentious 2018 election.

Candidates are already honing talking points: Is the current dysfunction the result of the law or of GOP attempts to dismantle it?

The impact of changes to the law made by Republicans over the past year — modifications short of the “repeal and replace” they promised — is becoming clear. Initial announcements show health insurers in several states are seeking big increases in premiums for next year for people who buy their own insurance. That is renewing concerns about the potential for “bare” counties that will have no insurer selling coverage and hints that the number of uninsured Americans could again be on the rise.

“It’s sort of Insurance 101,” said Sabrina Corlette, a research professor at Georgetown University’s Health Policy Institute. Insurers “are facing a smaller and sicker risk pool as a result of both Trump administration and congressional action, and that means higher premiums,” she said.

“A number of policy changes definitely impacted rates,” said Jeanette Thornton, a senior vice president for the trade group America’s Health Insurance Plans.

Among those changes are the elimination of the tax penalty for those who forgo insurance, included in December’s tax overhaul, and President Donald Trump’s cancellation of federal payments to insurers who provide discounts to some low-income customers.

Democrats say they will make sure voters know that Republicans deserve the blame.

“Senate Democrats will be on the floor of the U.S. Senate every week talking to the American public about these rate increases and make sure they know about this campaign of sabotage,” said Sen. Chris Murphy (D-Conn.).

Republicans, however, say Democrats are at fault for blocking bipartisan legislation, which might not even have had enough GOP votes to pass. The effort sought to stabilize the Affordable Care Act’s marketplace through measures such as setting up reinsurance funding to help keep an individual insurer from facing devastating losses and guarantees for insurers to help pay their share of the out-of-pocket expenses for low-income customers.

“Democrats could have worked with us to lower premiums by as much as 40 percent but instead choose to cling to an unworkable law,” Sen. Lamar Alexander (R-Tenn.), chairman of the Health, Education, Labor and Pensions Committee, said on the Senate floor Tuesday. “So if you have an insurance premium that is going up 40 percent next year, on top of an over 105 percent increase since 2013, you can thank a Democrat.”

The heightened political rhetoric comes after the first two states unveiled insurance company premium requests for policies on the individual market for 2019.

These are not final rates, but they give an idea of what premiums for next year might be for people who don’t get insurance through their job or the government and buy their own coverage on the individual market.

That market included about 15.6 million people, both inside and outside the ACA insurance marketplaces, in the final quarter of 2017, according to the consulting firm Mark Farrah Associates.

State deadlines for filing next year’s rates run from May through July. Once insurers have made their initial premium requests, state regulators negotiate final rates before open enrollment begins in the fall.

In Virginia and Maryland, insurers are seeking a wide range of significant increases, from about 15 percent for some plans up to more than 91 percent for one Maryland PPO.

Analysts are not surprised by the requested rate hikes and predict more to come. The first requests in past years have often moderated before being finalized, but this year’s political uncertainties could play a bigger role.

The Congressional Budget Office estimated that the elimination of the tax penalty for people without health insurance, which was included in last December’s tax law, by itself would result in premium increases of around 10 percent per year. That’s because without the prospect of a fine, healthier people would be more likely to forgo coverage, making the pool of people who continue to buy insurance sicker and more expensive for insurers.

Separately, Trump roiled the individual insurance market by canceling federal “cost-sharing reduction” payments for moderate-income insurance buyers.

The administration is also trying to extend the availability of short-term insurance plans, which frequently offer only bare-bones coverage, and “association health plans,” which can provide cheaper alternatives for those who are considered healthy. But such plans don’t include all the benefits of ACA plans. Analysts say both types of options would draw even more healthy people out of ACA plans..

The insurance industry acknowledges the actions have boosted next year’s rates.

Chet Burrell, the CEO of CareFirst Blue Cross Blue Shield, which serves both Maryland and Virginia markets, told The Washington Post that “continuing actions on the part of the administration to systematically undermine the market … make it almost impossible to carry out the mission.”

AHIP’s Thornton cautioned that it is still early in the process and many things could change. Maryland, for example, has passed legislation to create a “reinsurance” pool that could substantially lower premiums for next year. It still requires formal permission from the Trump administration, however.

And while Congress could still help ameliorate next year’s increases, that appears increasingly unlikely.

In a sign that the bipartisanship that characterized the effort last fall has broken down, Alexander said in his Senate speech that he plans to move on to other health issues, including ways to address the opioid crisis.

“Given Democrats’ attitude, I know of nothing the Republicans and Democrats can agree on to stabilize the individual health insurance market,” he said.

Sen. Susan Collins (R-Maine), who was promised a vote on her bipartisan bill by Senate Majority Leader Mitch McConnell (R-Ky.) that never materialized, now blames Democrats.

In a column she wrote for her home-state Portland Press-Herald late last month, Collins said Democrats refused to accept additional restrictions on abortion funding.

“Although federal funding has not been used to pay for elective abortions for decades, some Democrats reopened the long-settled debate on the Hyde Amendment in order to block these much-needed insurance reforms,” she wrote.

Democrats, however, say it was Republicans who reopened the abortion debate by demanding language to create new, permanent restrictions that could eliminate abortion even in private insurance plans.

Even so, some say they still hope consensus may be reached.

“Patients and families deserve better than the higher costs and dysfunction they are getting under Trumpcare by sabotage,” Sen. Patty Murray (D-Wash.) told reporters Tuesday. “And as soon as Republicans are ready to work again in a bipartisan way and act actually to lower families’ costs, Democrats will be at the table.”

Under Trump Proposal, Lawful Immigrants Might Be Inclined To Shun Health Benefits

KFF Health News, May 11, 2018

Health advocates say a proposed policy could frighten a broad group of immigrants who will avoid government-supported health coverage, creating public health problems that could prove dire.

This article first appeared May 11, 2018 on Kaiser Health News.

By Christina Jewett and Melissa Bailey and Paula Andalo

The Trump administration is considering a policy change that might discourage immigrants who are seeking permanent residency from using government-supported health care, a scenario that is alarming some doctors, hospitals and patient advocates.

Under the proposed plan, a lawful immigrant holding a visa could be passed over for getting permanent residency — a green card — if they use Medicaid, a subsidized Obamacare plan, food stamps, tax credits or a list of other non-cash government benefits, according to a draft of the plan published by The Washington Post. Even the use of such benefits by a child who is a U.S. citizen could jeopardize a parent’s chances of attaining lawful residency, according to the document.

Health advocates say such a policy could frighten a far broader group of immigrants who will avoid government-supported health coverage, creating public health problems that could prove dire. About 3 million people received green cards from 2014 through 2016, government records show. Immigrants with visas or those who may have no legal status but plan to seek citizenship based on a close family relationship would be affected.

“We are very concerned that this rule, if finalized, would have a significant impact on health in this country,” said Erin O’Malley, senior director of policy for America’s Essential Hospitals, which discussed the plan with Trump administration officials in mid-April.

O’Malley said she fears that some visa holders and their families would steer clear of getting routine treatment and resort to going to emergency rooms for medical care. Such a change would “undermine the stability of our hospitals by creating uncompensated care costs and creating sicker patients,” O’Malley said.

The policy change could force a mother to weigh the need for hospital inpatient care for an ailing newborn against losing her legal immigration status, said Wendy Parmet, director of the Center for Health Policy and Law at Northeastern University.

“The administration, in the draft, talks about self-sufficiency,” she said. “But we don’t expect that of [babies]” who are U.S. citizens because they were born in this country. “It’s extremely hardhearted.”

Pushback has begun even though the proposal is in the earliest stages of the rulemaking process.

Washington state Gov. Jay Inslee, a Democrat, is sending staff in mid-May to meet with the White House Office of Management and Budget, which is vetting the proposed rule. Inslee sent a letter on April 24 urging OMB Director Mick Mulvaney to consider the impact on tax-paying, lawful immigrants.

“This will undoubtedly lead to people across the U.S. going hungry, not accessing needed medical care, losing economic self-sufficiency, and even becoming homeless,” Inslee wrote.

The leaked draft said immigration officials would count the use of one or more non-cash benefits by the applicant within three years as a “heavily weighed negative factor” in deciding whether to grant permanent residency.

On March 29, the Department of Homeland Security sent a version of the proposal to OMB, which reviews it for conflicts with existing law. Next, it will be published as a proposed rule that the public can comment on before it’s finalized.

Marilu Cabrera, public affairs officer with the U.S. Citizenship and Immigration Services, declined to comment on whether the draft published by the Post mirrors what the OMB is reviewing.

Fear in immigrant communities already weighs on physicians. Dr. Julie Linton, a spokeswoman for the American Academy of Pediatrics, treats many Latino immigrant families at an outpatient clinic in Winston-Salem, N.C. She said one woman from Mexico, who had a newborn baby and three other children, told Linton she was afraid to keep her family enrolled in the nutrition program for Women, Infants, and Children (WIC). “Is it safe to use WIC?” the woman asked her.

Linton said questions like that put pediatricians in a tough position. She said evidence shows enrolling in WIC leads to better health outcomes for kids. But what if it also puts the family at risk of being split apart?

“It feels very frightening to have a family in front of me, and have a child with so much potential … and be uncertain how to advise them” on whether to accept public benefits, Linton said.

Maria Gomez, president of Mary's Center, which runs health clinics in Washington, D.C., and Maryland, said she’s seeing three to four people a week who are not applying for WIC and are canceling their appointments to re-enroll in Medicaid.

The leaked draft of the proposal zeroes in on who is considered a “public charge.” The concept emerged in immigration law in 1882, when Congress sought to bar immigrants who were “idiots, lunatics” or those likely to become a burden on the government.

The notion of a “public charge” last surfaced in 1999, when the immigration service clarified the concept. Then and now, an immigrant considered a “public charge” is inadmissible to the U.S. if the person is likely to rely on the government for income, or lives in a government-funded long-term institution.

Yet the guideline published in 1999 clarified that legal residents were free to access non-cash benefits like Medicaid, food stamps and assistance for heating bills. “These benefits are often provided to low-income working families to sustain and improve their ability to remain self-sufficient,” the guideline says.

The proposal, as drafted, would upend that.

Under such a policy, anyone who had recent or ongoing use of a non-cash government benefit in the previous 36 months would likely be deemed a “public charge,” and therefore inadmissible to the U.S. The use of such benefits by a spouse, dependent parent or child would also be taken into account.

Applicants who have “expensive health conditions” such as cancer, heart disease or “mental disorders” and had used a subsidized program would also get a “heavily weighed” negative mark on their application, the draft says.

Marnobia Juarez, 48, battled cancer successfully and is hoping her husband’s green card application is approved; she also dreams of one day getting her own. She said she never wanted to apply for public benefits until she was diagnosed with breast cancer in 2014. Since then, she has been treated at no cost under a program run by the state of Maryland.

"I'm alive thanks to this program," said Juarez, who is a health volunteer with an immigrant advocacy group. “You don't play with life, and they are playing with life."

The draft says immigrants could post a minimum $10,000 bond to help overcome a determination that they are likely to be a “public charge.”

Such changes would affect people sponsored by a U.S. citizen family member, most employment-based immigrants, diversity visa immigrants and “certain non-immigrants,” the draft says. In 2016, 1.2 million people got their lawful permanent residence status, or a green card. Of the total, 566,000 were immediate relatives or spouses of U.S. citizens and 238,000 more were family-sponsored, Department of Homeland Security data show.

Some immigrants, such as refugees and asylees, would not be affected. Nor would the proposed changes apply to undocumented immigrants.

“We’re talking about middle-class and working families,” said Madison Hardee, senior policy attorney with the Center for Law and Social Policy, which has organized a coalition to fight the proposal. “This could really put parents in an impossible situation between seeking health assistance for their children and obtaining a permanent legal status in the U.S.”

The list of benefits includes the Children’s Health Insurance Program, known as CHIP; non-emergency Medicaid; the Supplemental Nutrition Assistance Program, or food stamps; WIC; and short-term institutionalization at government expense and others. The leaked draft notes that foreign-born and native-born Americans use such programs at similar rates.

The draft says the proposal is meant to ensure that people seeking to “change their nonimmigrant status are self-sufficient.” It notes “relevant congressional policy statements,” including one that says “the availability of public benefits [should] not constitute an incentive for immigration to the United States.”

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