This Time When My Water Breaks, Take Me To A Hospital Without Surprise Bills

KFF Health News, March 5, 2019

Researchers sought to determine how pregnant women who dealt with surprise medical bills from their first delivery approached decisions about their second.

This story was first published Monday, March 4, 2019, by Kaiser Health News.

By Rachel Bluth

When it comes to having a baby, that bundle of joy may bring an unexpected price tag that can affect parents' future healthcare choices.

At least that was the finding of a study published Monday in Health Affairs. It examined how consumers respond to surprise medical bills in elective — or non-emergency — situations.

Specifically, researchers used a large national sample of medical claims for obstetric patients who had two deliveries between 2007 and 2014 and who had employer-sponsored health insurance.

They focused on this group because giving birth, the authors reasoned, is one of the few elective procedures someone would repeat.

The women in this category were also generally able to plan ahead and choose in-network hospitals and in-network obstetricians, if that was their preference, to avoid paying higher out-of-network rates.

However, their hospital care might also have involved providers who were out of their network, such as anesthesiologists. Since that doctor is not bound by a contract with the patient's insurance company, the care could result in patients being asked to pay whatever their insurance did not toward the provider's bill, a practice called "balance billing."

The researchers sought to determine how women who dealt with such unexpected costs from their first delivery approached decisions about their second.

Benjamin Chartock, the lead author on the study and an associate fellow at the Leonard Davis Institute of Health Economics at the University of Pennsylvania's Wharton School for business, said the findings showed that if patients had more information about which providers were covered, they would be able to better navigate their healthcare decisions and avoid high bills.

"When someone gets a surprise out-of-network medical bill, they're pretty much helpless to respond at that episode of care," Chartock said. "But if patients require subsequent healthcare in another situation, they may have a chance to respond in subsequent procedures."

Women who got a surprise bill from their first delivery, for instance, were 13% more likely to change hospitals for the next one.

Chartock likened it to getting a bad meal at a restaurant. It makes it less likely the patron will return. "That's kind of the classic competitive response," he said.

Of the group that switched hospitals for the second delivery, 56% were less likely to get another surprise bill. And, in many cases, women used the information they got from their first experience to make more cost-effective decisions the next time around.

These results, the authors said, make a strong case for better transparency about hospital pricing.

However, that information isn't always available, and many women don't even have a choice when it comes to where they give birth. "This suggests that laws protecting patients from liability for unavoidable out-of-network medical bills may significantly benefit patients," the authors wrote.

The price tag isn't the only thing upon which women base their labor and delivery choices, but it is part of a "bundle of attributes" that patients must weigh, Chartock said. Often the choice of a doctor or hospital closest to home where patients can get follow-up care can trump concerns about a surprise bill.

"We do see high rates of switching that may be mothers who are trading off the financial benefits with potential costs of not seeing the doctor who they would have otherwise wanted or the facility they would have otherwise wanted," Chartock said.

Surprise medical bills are a growing problem for patients. A Kaiser Family Foundation poll from September found that 67% of people worry about unexpected medical bills. (Kaiser Health News is an editorially independent program of the foundation.)

The Trump administration and Democrats and Republicans alike in Congress have targeted surprise billing as an area ripe for change. State legislatures have also taken up the cause.

For Chartock, one of the key takeaways of the study was that it shows how the anticipation of surprise medical bills could cause hospitals to "lose a future stream of patients."

David Silverstein, the founder of brokenhealthcare.org — a group that advocates for healthcare price transparency — agreed.

The study shows that it is "actually costing the hospital business to have non-participating doctors in the facility," said Silverstein, who was not involved in the study. "That's a pretty big eye-opener."

Rachel Bluth: rbluth@kff.org, @RachelHBluth

Patients Question How FDA Approves Medical Devices

KFF Health News, March 5, 2019

More ailments are being treated with medical devices, including implants. And most of these, unlike pharmaceuticals, don't go through human testing before being offered to patients.

This story was first published Tuesday, March 5, 2019, by Kaiser Health News.

By Blake Farmer, Nashville Public Radio

There's no doubt that surgically implanted medical devices can improve lives.

Hip and knee replacements can help people regain their mobility. Drug pumps can deliver doses of pain-relieving medicine on demand. And metal rods can stabilize spines and broken bones.

But implanted devices can also do serious damage, as happened to Mechel Keel, who lives in Owosso, Mich.

To fix her leaky bladder, an OB-GYN stitched a flexible mesh strap inside her pelvis in 2004. But within months, the mesh hardened and started cutting her insides.

The pain kept her from returning to her job as a hairdresser. The injuries and scar tissue that developed required multiple surgeries to correct and also resulted in chronic infections.

Keel said she understands why her doctor in Tennessee thought the high-tech mesh would help. But she also now feels she was treated like "a guinea pig."

"We were the testers," she said. "There was no animal testing done. We were the animals."

Thousands of cases of complications from surgical mesh have been reported to the Food and Drug Administration. More and more ailments are being treated these days with medical devices, including implants. And most of these medical devices, unlike pills in a medicine cabinet, don't go through human testing before being offered to patients.

But some devices break down or malfunction in people's bodies, and reports about sometimes debilitating injuries have led the FDA to rethink how it assesses medical devices before allowing them to be sold.

For devices in which failure is obviously life-threatening, regulators have required some sort of human testing as part of the most stringent path — known as premarket approval. But most medical devices enter the market after manufacturers provide technical information and show that the devices are similar to others that have been legally sold previously.

The FDA has acknowledged that some seemingly safe devices have caused major problems, and the agency has elevated the risk level of those products following reports of injuries, as it did with urogynecologic surgical mesh for some uses in 2016. "Unfortunately, the FDA cannot always know the full extent of the benefits and risks of a device before it reaches the market," the agency said in a recent statement.

"We have things like metal-on-metal hips," said health journalist Jeanne Lenzer about a kind of orthopedic implant. "Outside the body, [they] seem to function just fine. They put them in little machines, rock them back and forth — they don't break. [But] put them inside people, and something very different happens."

There have been massive recalls of hip implants, for example, due to devices causing swelling and pain. And there have been problems with weakened bones in patients who received hip implants that contained plastic.

Lenzer wrote a scathing book, "The Danger Within Us," about the device industry and said she was "dumbfounded" to find out how many devices never went through human testing the way drugs do.

That's in part because of a regulatory review process known as 510(k) for a section of the FDA law covering medical devices. Manufacturers typically show their product has "substantial equivalence" to a "predicate device" that has already been legally marketed.

That standard can perpetuate problems. "You just say your device is like an old device, and the old device was never tested, nor was your device," Lenzer said.

In practice, sometimes the basis for a whole family tree of devices turns out to be defective. Pelvic mesh is a relevant example, with much of what's on the market being based on mesh that was around prior to implementation of FDA regulations for medical devices in 1976. One study found that 16% of mesh on the market was designed like products that had been pulled from the market because of safety concerns.

Thousands of women, including Keel, have filed suit — or reached settlements — with medical device companies that manufacture pelvic mesh.

"I would want nothing if you could just give me my life back," said Gloria Jones of Hillsdale, Mich., who is one of thousands who have settled with device manufacturers over faulty mesh. "They could have given me millions, but all I needed was my life back."

Jones, who has struggled to continue working through crippling abdominal pain as a middle school special-education teaching assistant, has had four surgeries to remove pieces and continues to require intravenous drugs to control infections.

"It seems like I get off one antibiotic, and three days later I have another one," she said. "I would beg anybody who is even thinking of putting mesh in their bodies to stop and get a second opinion."

In response to problems reported with mesh, the FDA started requiring human testing for some of these products in recent years. The agency held an advisory committee meeting on Feb. 12 to discuss the safety and effectiveness of mesh and how it should be regulated.

Manufacturers by and large have said they don't oppose what the FDA is trying to do, calling the changes reasonable. But they have pushed back against calls to bring regulation of medical devices in line with that of pharmaceuticals.

"If you're treating someone for high cholesterol, the testing that you go through to ensure safety and effectiveness on a chemical that's going to be used in your body to control your cholesterol is just very different than it would be for the implantation of a heart valve," said Scott Whitaker, CEO of AdvaMed, a trade association for medical device companies. "Honestly, it's apples and oranges."

Whitaker dismisses the idea that devices, which range from tongue depressors to surgical robots, should all go through human trials.

"Testing should be as complete and as thorough and as ethical and as appropriate as possible. But it doesn't all fit the same and can't all fit the same standard," Whitaker said. "And while we always strive for 100%, there are times when something might not go according to plan. It could also be because the surgery didn't go as was planned."

The FDA declined NPR’s request for an interview. But the agency has released some written justification for the regulatory revamp.

"We believe firmly in the merits of the 510(k) process," FDA Commissioner Scott Gottlieb said in a November statement, noting that applications have more than doubled in size to an average of 1,185 pages. "But we also believe that framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices."

In the same statement, the agency addressed some specific shortcomings and charted plans to make changes to the process over the next few months:

  • Pushing back on manufacturers that base any new device's marketing application on one that's more than 10 years old;
     
  • More actively watching how devices perform once they're on the market, rather than relying on patients to report problems;
     
  • Scrapping the 510(k) name for something more descriptive, such as the "Safety and Performance Based Pathway."

Dr. Michael Matheny, a Vanderbilt University professor who tracks medical devices, approves of the FDA's incremental approach and calls it thoughtful.

"It would really be unfortunate if patients wouldn't consider any medical devices at all to be used in their bodies," Matheny said. "But I do think being aware that there's nothing without risk is also important."

Matheny notes, though, that in some ways the risks can be more profound for devices than medication. If the FDA recalls pills, a patient can at least stop taking them immediately, he said. With implanted devices, patients are sort of stuck, at least for a while — and that's if surgeons can even safely remove them.

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

Blake Farmer, Nashville Public Radio: bfarmer@wpln.org, @flakebarmer

Big Pharma Gave Money To Patient Advocacy Groups Opposing Medicare Changes

KFF Health News, March 4, 2019

KHN's Pre$cription for Power database now includes nearly 14,000 transactions, totaling $163 million in donations from 26 drugmakers to 650 patient groups in 2015.

This story was first published Monday, March 4, 2019, by Kaiser Health News.

By Sydney Lupkin and Elizabeth Lucas and Victoria Knight

Dozens of patient advocacy groups, like the Bonnie J. Addario Lung Cancer Foundation and the National Coalition for Cancer Survivorship, recently appeared in national advertisements objecting to a Trump administration proposal that could limit drugs covered by Medicare providers.

But a Kaiser Health News analysis found that about half of the groups representing patients have received funding from the pharmaceutical industry.

Drugmakers funneled more than $58 million to the groups in 2015 alone, according to financial disclosures in KHN's "Pre$cription for Power" database, which tracks the little-publicized ties between patient advocacy groups and drugmakers. As patient organizations gain ground lobbying Congress and the administration, experts have begun to question whether their financial ties could push them to put drugmakers' interests ahead of the patients they represent

The advertisement, which ran in national newspapers, attacked proposed changes to Medicare Part D's "protected" drug classes, which require that "all or substantially all" drugs must be covered by all insurers. The medicines involved include oral cancer drugs, HIV medicines and antipsychotics.

The protection can have the effect of guaranteeing sales to Medicare patients no matter the price tag.

The proposed rule would give insurers more opportunities to instead steer patients toward lower-cost therapies and generics using prior authorization or step therapy, in which patients must try cheaper drugs before they can switch to options that are more expensive.

It would also allow protected drugs to be left off Medicare Part D formularies when price hikes exceed inflation or new formulations of drugs don't offer a "significant innovation" over existing versions.

"It's wrong and it will put patients' lives at risk," reads the ad paid for by the American Cancer Society Cancer Action Network above a list of 56 other patient advocacy groups who presumably agree. Underneath, a link directs readers to an online form to send pre-written emails to members of Congress and the administration.

The government proposal's goal, however, isn't to end coverage for drugs in protected classes, said Rachel Sachs, an associate law professor at Washington University in St. Louis who specializes in health care. Its goal is to give plans more leverage to bargain for better discounts. If there's a chance an insurance plan won't cover a drug, the provider has more negotiating power.

The Cancer Action Network's six-figure ad buy ran for three weeks starting Jan. 17. It appeared in print and online in The New York Times and The Washington Post, as well as local publications in Washington, D.C., according to Cancer Action Network spokeswoman Alissa Crispino. About 4,500 people used the online email tool.

It's important to make sure cancer patients can get "cutting-edge" treatments, said Keysha Brooks-Coley, vice president of federal affairs for the Cancer Action Network. "This is really an access issue," she said.

The lobby for brand-name drugmakers, the Pharmaceutical Research and Manufacturers of America, takes the same stance, according to its submitted comments on the proposal.

But access to drugs means more than insurance coverage, said Karuna Jaggar, the executive director of Breast Cancer Action, a patient group that was not invited to be listed in the ad and hasn't accepted corporate funding for two decades to avoid the appearance of bias. "If people can't afford it, the reality is they cannot access it."

Given the ad's selective understanding of "access" to exclude cost and the patient groups' industry ties, she asked, "Can we trust them?"

The American Cancer Society Cancer Action Network communicates with its funders, which include drugmakers and others, but the group sets its own agenda, Brooks-Coley said.

KHN launched its Pre$cription for Power database in spring 2018. It now includes nearly 14,000 transactions, totaling $163 million in donations from 26 drugmakers to 650 patient groups, in 2015. The patient groups often don't disclose their donors, so the information comes from drugmakers' financial disclosures, some of which are voluntary. Not all companies publicly disclose their charitable giving, so KHN estimates are likely low.

Although there are occasions when what's best for patients is the same as what's best for drugmakers, people should consider patient advocacy group statements with a "skeptical eye" if groups have financial ties to the pharmaceutical industry, said Matthew McCoy, a medical ethics and health policy assistant professor at the University of Pennsylvania.

Drugmakers and patient advocacy organizations have fundamentally different missions, he said. One wants to make money for shareholders. The other wants to serve patients. Since their goals will inevitably diverge, it's important that patient groups aren't swayed by their funders, he said.

It can be easy to view a pharmaceutical company as an ally when its contributions help keep the lights on, McCoy said. "I think we have a lot of evidence from research on financial conflicts of interest in other areas of healthcare to know that the influence often is unconscious to the people who are actually experiencing it."

Still, Sachs said she can understand why patient advocacy groups oppose changes to the six protected classes, even if they lead to lower drug prices.

"The question is, what happens if negotiations between pharmaceutical companies and the Part D plans fail?" Sachs said. "In at least some cases, the Part D plan will be able to say simply it's going to exclude you from coverage because of the price of the drug."

Sydney Lupkin: slupkin@kff.org, @slupkin

Elizabeth Lucas: elucas@kff.org, @eklucas

Victoria Knight: vknight@kff.org, @victoriaregisk

Medicare Trims Payments To 800 Hospitals, Citing Patient Safety Incidents

KFF Health News, March 1, 2019

The number is the highest since the federal government five years ago launched the Hospital Acquired Conditions Reduction Program, created by the Affordable Care Act.

This story was first published Friday, March 1, 2019, by Kaiser Health News.

By Jordan Rau

Eight hundred hospitals will be paid less by Medicare this year because of high rates of infections and patient injuries, federal records show.

The number is the highest since the federal government five years ago launched the Hospital Acquired Conditions Reduction Program, created by the Affordable Care Act. Under the program, 1,756 hospitals have been penalized at least once, a Kaiser Health News analysis found.

This year, 110 hospitals are being punished for the fifth straight time.

The penalties pit hospitals against one another in a race to prevent the most infections, blood clots, cases of sepsis, bedsores, hip fractures and other complications. Each year, the quarter of general hospitals with the highest rates are punished, even if their records have improved from the previous year.

Under the latest round of sanctions, each hospital will lose 1% of its Medicare payments for patients discharged between last October and this September. That comes on top of other penalties created by the health care law, such as annual payment reductions for hospitals with too many patients being readmitted.

The hospital industry has protested the HAC penalties, saying the program's design creates an arbitrary cutoff for which institutions get punished and which don't. The American Hospital Association calculated that only about 4% of the 768 hospitals penalized in 2017 had HAC scores that were statistically significantly higher than hospitals not being penalized.

"There are not statistical differences that would warrant a quarter of the hospitals in America getting a penalty," said Nancy Foster, the association's vice president for quality and patient safety.

Hospitals also complain that the ones that do the best job testing for infections and other threats to patients appear to be among the worst based on statistics, while their more lackadaisical peers look better than they might be.

Supporters of the punishments argue that the penalties are warranted in prodding hospitals to improve quality. The threat of losing money elevates the issue in many hospitals to the attention of directors and owners, said Missy Danforth, the vice president of health care ratings at the Leapfrog Group, a nonprofit devoted to patient safety.

"The fact that everyone's talking about it, from front-line nurses to boards of directors, is positioning patient safety where it should be, which is at the forefront of everyone's minds," Danforth said.

Danforth dismissed hospital complaints that the penalties are not always fairly applied. "There's a lot of really strong, good best practices to getting to zero on these infections," she said.

Hospital patients suffered an avoidable injury in 9 of every 100 patient stays in 2016, about 2.7 million times, according to a June report from the federal Agency for Healthcare Research and Quality. Those included a bad reaction to medication, an injury from a procedure, a fall or an infection.

The frequency of complications has been dropping in hospitals. The report found an overall 8% decrease from 2014 to 2016. However, the report also found a jump in the numbers of bedsores and urinary tract infections in patients with catheters during that time.

The Hospital Acquired Conditions Reduction Program assesses penalties based on a subsection of the injuries examined in the AHRQ report. For each hospital, Medicare judges infection rates related to colon surgeries, hysterectomies, urinary tract catheters and central lines inserted into veins. Medicare also counts the number of infections of methicillin-resistant Staphylococcus aureus, or MRSA, and Clostridium difficile, known as C. diff.

Finally, the government tracks the rate of blood clots, sepsis, post-surgical wounds, bedsores, hip fractures and five other types of in-hospital injuries. Because the penalties will be applied as hospitals submit claims for reimbursement, the total dollar amount of penalties for each hospital will not be known until the federal fiscal year ends in September.

Medicare excludes from consideration a number of specialized hospitals: those serving children, veterans and psychiatric patients. Maryland hospitals are also exempted because the federal government gives that state leeway in how it pays hospitals. And more than 1,000 "critical access" hospitals, which are the only institutions in their area, are also excluded.

For the remaining hospitals, penalties are assigned to the quarter of institutions with the highest HAC rates. That threshold varies slightly from year to year, and is a major reason that the number of hospitals being punished fluctuates annually. Before this, the largest number of hospitals punished was 769, two years ago.

Jordan Rau: jrau@kff.org, @JordanRau

Listening To Older Patients Who Want To Stop Dialysis

KFF Health News, February 28, 2019

Older adults with advanced kidney disease who want to forgo dialysis often encounter resistance from physicians, who observers suggest are more concerned with survival than with quality of life.

This story was first published Thursday, February 28, 2019, by Kaiser Health News.  

By Judith Graham

Dr. Susan Wong sat down with an 84-year-old patient in the hospital, where he’d been admitted with a flare-up of a serious autoimmune condition and deteriorating kidney function.

The older man told her he wanted to go home; he'd had a good life and was ready for its end. He didn't want aggressive care — including dialysis — having witnessed his wife and son die painfully in intensive care years ago.

Wong, an assistant professor of nephrology at the University of Washington, was prepared to follow the man’s wishes, but other physicians, eager to pursue tests and treatments, disagreed. For a week, the doctors argued about what to do. Finally, they discharged the patient, who died in hospice care a few weeks later.

Older adults with advanced kidney disease who want to forgo dialysis often encounter similar resistance from physicians, according to a new study in JAMA Internal Medicine by Wong and colleagues at the Veterans Affairs Puget Sound Health Care System in Seattle, where she's an investigator.

The researchers documented doctors' reactions by reviewing medical charts of 851 older patients with chronic kidney disease who refused dialysis at the VA health system from 2000 to 2011. In their notes, physicians frequently speculated the patients were incompetent, depressed, suicidal or irrational.

With dialysis, people are hooked up to a machine that removes waste from their blood, usually three times a week for four hours at a stretch. Many older adults find the treatments burdensome, and medical complications are common.

Yet patients who expressed reservations about this treatment were sometimes labeled as difficult or unprepared to confront the reality of their medical condition. "Still in denial about his kidney disease and his need for hemodialysis in the near future — repeat discussions with patient and wife regarding compliance," one nephrologist wrote. Even when patients were firm about declining dialysis, doctors repeatedly questioned their decisions.

"Clinical practice guidelines for advanced kidney disease are geared toward survival, not what would give patients the best quality of life or the greatest functional capacity," Wong said. Another factor at play: Nephrologists aren’t trained to ask seriously ill patients what’s most important to them and shape treatment recommendations accordingly. Although most patients want to have such conversations with a kidney specialist, few do so, studies have found.

"We don't really know how to help patients with serious illness make decisions that are right for them or what to do when they don't really want dialysis," said Dr. Jane Schell, an assistant professor of palliative care and nephrology at the University of Pittsburgh.

Conversations about the potential benefits and burdens of dialysis, as well as alternatives, are especially important for frail patients 75 and older who have two or more chronic  conditions, such as diabetes and high blood pressure, and difficulty with daily activities such as bathing or walking — a group at risk of experiencing significant complications from dialysis but not achieving longer life.

Healthier older adults have better outcomes on dialysis — a valuable treatment for many people. "We shouldn't limit access to dialysis based on age, but we should have meaningful conversations about goals of care and make it clear that dialysis is a choice and that patients have alternatives," said Dr. Bjorg Thorsteinsdottir, an assistant professor of internal medicine and bioethics at the Mayo Clinic.

Options that should be discussed include comprehensive conservative care, which calls for preserving as much kidney function as possible, managing a patient's health problems, dealing with symptoms such as nausea, swelling, itchiness, pain and breathing difficulties, and preparing for end-of-life care; peritoneal dialysis or hemodialysis at home; and palliative dialysis, a less intensive version of this treatment that keeps people alive for longer but isn’t meant to restore kidney function.

Comprehensive conservative care programs are few and far between (in New York City, Pittsburgh, Seattle, San Francisco and a few other locations), but efforts are underway to change that. With funding from the American Society of Nephrology, Schell and colleagues at the University of Pittsburgh have developed an online conservative care curriculum set to debut in March. Nineteen nephrology training programs for physicians are set to participate.

Also, the Pathways Project, funded by the Gordon and Betty Moore Foundation, is working to make palliative care (also known as supportive care) for patients with advanced kidney disease widely available. (KHN’s coverage of end-of-life and serious illness issues is also supported in part by the Gordon and Betty Moore Foundation.) Dr. Alvin Moss, co-investigator of the project and professor of medicine at West Virginia University School of Medicine, said the project hopes to sign up 10-15 dialysis centers this year.

Sometimes, patients choose a time-limited trial of dialysis with the understanding that they can change their minds down the road.

Cyndy Patton's 86-year-old mother, Isabel, learned last spring she had advanced kidney disease after going to a Pittsburgh hospital, sickened by repeated bouts of vomiting. Physicians suggested she try dialysis for a few weeks and see if her kidneys might rejuvenate. (The older woman had survived open-heart surgery and a stroke and was living on her own after her husband’s death.)

After a week in the hospital and another week in a rehabilitation center, there was no change: Patton's mother still needed dialysis. Five weeks later, she confessed to her daughter that the treatment was making her miserable. But giving it up felt like committing suicide, she told Patton — an unacceptable option.

A week later, Isabel had changed her mind. "This is not a life I care to lead, being hooked up to these machines," she told Patton. "What am I doing this for?" The older woman had consulted with Schell at the University of Pittsburgh about palliative care and hospice care, and she chose hospice.

Dialysis ended and the family gathered at Isabel's bedside. "She was all ready to die — but she didn't, and is still living to this day," Patton said.

It's an example of how hard it can be to predict what will happen to any given patient with advanced kidney disease. What's important for the patient to understand is that "it's not always all or nothing — dialysis or death," Thorsteinsdottir said.

"Patients have to be very assertive and tell their medical team: This is what I want and what I don't want," Moss said. For more information, he suggested people explore the websites of the Coalition for Supportive Care of Kidney Patients (he chairs that organization), the National Kidney Foundation and the American Association of Kidney Patients, and "really spend some time learning about your options."

Judith Graham: @judith_graham

Progressives Tout 'Medicare-For-All' But States Eye 'Medicaid Buy-In'

KFF Health News, February 26, 2019

As 'Medicare-for-all' has become a rallying cry for progressive Democrats, several states are looking at offering consumers a government-sponsored plan to provide a more affordable health option.

This story was first published Tuesday, February 26, 2019, by Kaiser Health News.

By Michelle Andrews

Laura Lucero Y Ruiz De Gutierrez has a heart condition and fibromyalgia and is in danger of developing diabetes. She has health insurance through her husband's job. But, between the $800 monthly premium for the couple's coverage and the $2,100 deductible she has to pay down before insurance starts picking up the tab, she doesn't feel she can afford to go to the doctor when she needs to.

She hopes that may soon change. Identical bills proposed in recent weeks in the New Mexico House and Senate would make Gutierrez eligible to buy in to a public health plan modeled on Medicaid. She also could receive state-funded assistance that would save her hundreds of dollars a month on premiums.

As "Medicare-for-all" has become a rallying cry for progressive Democrats, New Mexico is one of several states looking at offering consumers a different government-sponsored plan to provide a more affordable health option.

The proposals, often referred to as "Medicaid buy-in" plans, would typically offer benefits similar to what is available in Medicaid, the state-federal health plan for low-income people.

"Medicare-for-all is not going to happen legislatively in the next couple years. But in the meantime states are saying, 'What about "Medicaid for more"?'" said Heather Howard, who directs Princeton University’s state health and value strategies program and is working closely with some of the states.

A report commissioned by New Mexico projected that up to 16,000 people would enroll in a program like the one originally proposed in the bills, and their premiums would be 15% to 28% lower than plans sold on the individual market.

Gov. Michelle Lujan Grisham favors a Medicaid buy-in option. She doesn't have a position on the current bill, but she is following it closely, said Nora Sackett, the governor's deputy press secretary.

In addition to the governor's and lawmakers' interest, other stakeholders have been deeply involved, increasing the odds of success, Howard said.

Lawmakers in Colorado, Oregon, Washington and Minnesota are among others exploring similar options, said Howard. Nevada lawmakers passed a bill last year that would have set up a Medicaid buy-in plan, but the Republican governor vetoed it.

"The proposals take on different flavors depending on the state" and what officials are trying to accomplish, she said, whether it's increasing the number of people with insurance, making coverage more affordable or helping states avoid "bare" counties where no marketplace plans are offered.

States that want to offer a buy-in option might opt to try to expand Medicaid directly, or offer a plan that builds on but is not part of their Medicaid program, with similar benefits, providers and reimbursement rates. Or they may offer a public option insurance plan that isn't based on Medicaid. Depending on how they structure their plan, states may have to get approval from the federal government to move ahead.

A federal bill that would allow states to open up their Medicaid programs to all residents was reintroduced earlier in February by Sen. Brian Schatz (D-Hawaii) and Rep. Ben Ray Luján (D-N.M.).

In New Mexico, the buy-in plan would be similar to the state's Medicaid program. It would be offered outside the exchange and would not require federal approval to implement. The state would provide financial assistance to help low-income people buy in to it.

New Mexico's bill would target individuals who aren't eligible for Medicaid or Medicare or those who can't get the Affordable Care Act's premium subsidies because their incomes are above 400% of the federal poverty level (about $50,000 for one person or $103,000 for a family of four). It also includes immigrants who are in the country without legal status.

The measure would also help people, like Gutierrez, who are vulnerable to the ACA's so-called family glitch. Her husband's $100 monthly premium for single coverage is considered affordable under the law because it costs less than 9.86% of their family income of about $46,000 a year. That makes her ineligible for premium subsidies on the exchange, even though the $800 premium for the two of them far exceeds that affordability percentage. Their three children already have Medicaid coverage.

"Right now, I pay to have the healthcare, but I can't afford to use it," said Gutierrez, 42.

The bill would provide premium and cost-sharing assistance for people with incomes less than 200% of the federal poverty level, or $60,340 for a family of five. The new coverage would take effect by January 2021.

Gutierrez, whose family lives in Albuquerque, would be eligible for financial assistance to help her buy in to the Medicaid option, while her husband stayed on his employer plan. Because their $46,000 annual income is just above 150% of the federal poverty level, her monthly premium would likely be about $160 per month for a comprehensive plan with a $150 deductible, according to estimates by Manatt Health, which did the original state analyses of buy-in options that were published before the bills were introduced in January.

New Mexico has high levels of poverty, and 40% of all New Mexico residents are already enrolled in the state Medicaid program, compared with about 23% nationwide.

"It's the cornerstone" of our healthcare system, said Colin Baillio, director of policy and communication at Health Action New Mexico, an advocacy group. The legislation would use "those levers that Medicaid has to provide comprehensive coverage and a comprehensive provider network."

The bills were passed by two legislative committees in mid-February, with instructions for further study to examine expanding the buy-in plan to more groups. They now move to two other legislative committees for consideration, Baillio said.

Hospitals and other healthcare providers would be reimbursed at Medicaid rates, which are lower than those for commercial plans. Still, to the extent that people who are uninsured enroll in the new plan, providers stand to gain financially.

"We're obviously very supportive of anything that expands coverage," said Jeff Dye, president of the New Mexico Hospital Association. "It's the issue of getting some payment versus no payment for services rendered."

If the Medicaid buy-in bill passes, Blanca Ivon Rodriguez and her husband, Hugo Montes, could have health insurance for the first time since they moved to New Mexico 14 years ago. The couple and their oldest son, now 18, are immigrants from Mexico who are in the state without proper legal status. Their two younger children, who were born in the United States, are enrolled in Medicaid.

Montes works as a plumber and Rodriguez is studying early childhood development at a community college near their home in Albuquerque. Because they're undocumented, they’re not permitted to buy health insurance on the exchanges, even if they’re willing to pay full price.

Like many people without insurance, they wait until they're really sick before seeking help. When Rodriguez developed pneumonia a few years ago, the waiting lists for an appointment at community clinics that would see her without insurance were long. Finally, when she could no longer breathe comfortably, she went to the emergency department.

"It would bring us peace of mind not having to worry about our healthcare situation," said Rodriguez, 41, through a translator.

Providing healthcare for residents who are undocumented is "an underlying issue with many states that are considering a Medicaid buy-in," said Chiquita Brooks-LaSure, managing director at Manatt Health, who co-authored the reports evaluating Medicaid buy-in options for New Mexico.

The New Mexico bill also would provide some relief for Leah Steimel's family. Neither she nor her husband has employer-sponsored coverage, and with family income of about $100,000 they don’t qualify for ACA premium tax credits. They pay more than $1,900 a month for a silver-level plan with a $10,000 deductible to cover themselves and two of their kids (the third is over age 26).

Buying in to Medicaid would be tempting, said Steimel, 59, who works as a community health consultant with some of the groups advocating for the buy-in. Sure, she said, she wonders if the Medicaid plan would be as easy to use as a regular commercial plan and have access to as many providers.

"But being able to pay into something that would reduce by even a third what I'm paying now, I'd love that," she said.

Michelle Andrews: andrews.khn@gmail.com, @mandrews110

HHS Finalizes Rule Seeking To Expel Planned Parenthood From Family Planning Program

KFF Health News, February 25, 2019

Under the new rules, Title X recipients would be banned from making abortion referrals in almost all cases. This would reverse existing rules, which require that a referral be given if a woman requests one.

This story was first published Friday, February 22, 2019, by Kaiser Health News.

By Julie Rovner

The Trump administration Friday finalized a regulation intended to push Planned Parenthood out of the Title X federal family planning program, keeping a campaign promise to anti-abortion groups.

The program provides contraceptives, screening and treatment for sexually transmitted diseases and other primary health services to 4 million patients each year, many of them low-income or uninsured, at more than 4,000 clinic sites. Planned Parenthood serves about 40% of that caseload.

None of the funds provided for Title X services may be used for abortion. That has been true since the program was created in 1970. But abortion opponents have for decades complained that since many Planned Parenthood affiliates that receive Title X support also provide abortion, the federal family planning money can be improperly commingled with funds used for the procedure.

The new regulations erase previous program rules requiring that women with unintended pregnancies be given "nondirective counseling" on all options, including birth, adoption and abortion.

Under the new rules, Title X recipients would be banned from making abortion referrals in almost all cases. This would reverse existing rules, which require that a referral be given if a woman requests one. Counseling would still be allowed but no longer required.

The new rules "will ensure compliance with, and enhance implementation of, the statutory requirement that none of the funds appropriated for Title X may be used in programs where abortion is a method of family planning," says the executive summary.

Organizations would also have to physically separate facilities that provide Title X-funded services from those that provide abortions.

Abortion-rights and family planning provider groups were quick to decry the regulations. Planned Parenthood called the new rules a dealbreaker.

"This is direct interference with the practice of medicine and our ethical obligations to our patients," the organization’s president, Leana Wen, MD, told reporters on a conference call Friday. "Planned Parenthood cannot participate in a program that would force our providers to compromise their ethics."

Other family planning groups called the rules out as well.

"This rule intentionally strikes at the heart of the patient-provider relationship, inserting political ideology into a family planning visit, which will frustrate and ultimately discourage patients from seeking the health care they need," Clare Coleman, president and CEO of the National Family Planning & Reproductive Health Association, the group that represents Title X recipients, said in a statement.

The American Medical Association said, "The patient-physician relationship relies on trust, open conversation and informed decision making and the government should not be telling physicians what they can and cannot say to their patients."

But abortion foes have been pushing hard for the changes.

"We thank President Trump for taking decisive action to disentangle taxpayers from the big abortion industry led by Planned Parenthood," said Marjorie Dannenfelser, president of the anti-abortion Susan B. Anthony List. "The Title X program was not intended to be a slush fund for abortion businesses."

Added Kristan Hawkins of the group Students for Life of America, "This is a life-saving policy change, as abortion vendors have used these family planning resources to underwrite their deadly enterprise."

Defunding Planned Parenthood has been a goal of the anti-abortion movement for decades. Republicans thought they could make the group ineligible to provide care to Medicaid patients at part of their bill — which did not pass — to rewrite the Affordable Care Act in 2017. The Planned Parenthood provisions were struck from the bill under Senate rules even before the measure collapsed.

New York Attorney General Letitia James and Oregon Attorney General Ellen Rosenblum promised to file suit against the regulation. California Attorney General Xavier Becerra also said he is prepared to sue, particularly because an estimated one-quarter of all women potentially affected by the changes live in California.

However, a similar set of rules, issued by President Ronald Reagan’s administration in 1987, were eventually upheld by the Supreme Court in 1991.

The rules will take effect in stages, starting 60 days after they are published in the Federal Register. The portion requiring physical and financial separation would not take effect for a year.

Update: This story was updated several times to add comments and more information as it became available.

Julie Rovner: jrovner@kff.org, @jrovner

The Measles Success Story In California Shows Signs Of Fading

KFF Health News, February 22, 2019

Vaccination exemptions signed by doctors on medical grounds have more than tripled. This suggests that parents who once cited personal beliefs to avoid inoculating their kids might be claiming medical reasons instead.

By Harriet Blair Rowan, Kaiser Health News

This story was first published Friday, February 22, 2019, by Kaiser Health News.

A rash of recent measles outbreaks in New York, Texas, and Washington state shines a light on California's largely successful effort in recent years to suppress the disease—though some of the shine might be fading.

A serious measles outbreak that started at Disneyland in December 2014 and carried over into 2015 contributed to a steep increase in vaccination rates among California kindergartners over the following three years. But the gains stopped last year, according to the most recent available data.

In the 2013-14 school year, which immediately preceded the Disneyland outbreak, the percentage of kindergartners enrolled in schools boasting vaccination rates of 95% or above—considered the optimal level to avoid contagion—stood at 57%. By the 2016-17 academic year, the percentage of kindergarten pupils in schools with optimal vaccination rates had hit 90%. In 2017-18, however, it dipped slightly back below 90%.

Measles has again gained attention because of five outbreaks so far this year in the U.S., including a serious one in Washington state. Through the first week of February, 101 measles cases have been reported across 10 states. That's compared with a preliminary count of 372 for all of 2018 and 120 in 2017.

California's favorable trend accelerated dramatically after officials, galvanized by the Disneyland-linked infections, implemented a law in 2016 that eliminated a loophole through which parents were allowed to enroll their children in school without vaccinating them if they claimed that vaccinations violated their personal beliefs.

But another kind of exemption was still allowed. Over the past three years, vaccination exemptions signed by doctors on medical grounds have more than tripled, though they are still at a low level. This suggests that parents who once cited personal beliefs to avoid inoculating their kids might be claiming medical reasons instead.

Could this trend be contributing to the loss of momentum in vaccination rates?

"I think that's definitely a concern," said Dr. James Watt, chief of the Division of Communicable Disease Control at the California Department of Public Health. He said, however, that the elimination of personal belief exemptions in the 2016 law still far outweighs the rise of medical excuses. "So that's reassuring to some degree," he said.

Overall, California's measles vaccination rate is now 96.9%, well above the desired threshold. Watt said, "We do have this particular concern, as we have in the past, about places where there may be pockets of low immunization coverage"—such as individual schools.

Three rural Northern California counties—Sutter, Trinity, and Nevada—have measles vaccination rates below the 90% threshold widely considered the minimum level for effectively stopping the spread of the disease, according to data from the public health department.

Measles causes a high fever and a distinctive rash, and can lead in some cases to severe complications in children such as encephalitis and pneumonia, which can be fatal.

The federal Centers for Disease Control and Prevention recommends that children get their first dose of measles vaccine (MMR), which also protects against mumps and rubella, at 12 to 15 months of age and a second dose between ages 4 and 6.

Trump Plan To Beat HIV Hits Rough Road In Rural America

KFF Health News, February 21, 2019

Health officials and doctors treating patients with HIV welcome extra funding but say strategies that work in progressive cities like Seattle won't necessarily work in rural areas, especially in the South.  

This article was published on February 21, 2019, in Kaiser Health News.

By Jackie Fortier, StateImpact Oklahoma

In addition to sending extra money to 48 mainly urban counties, Washington, D.C., and San Juan, Puerto Rico, Trump's plan targets seven states where rural transmission of HIV is especially high.

Health officials and doctors treating patients with HIV in those states say any extra funding would be welcome. But they say strategies that work in progressive cities like Seattle won't necessarily work in rural areas of Alabama, Arkansas, Kentucky, Mississippi, Missouri, Oklahoma and South Carolina.

Stigma around HIV and AIDS and around being gay runs deep in parts of Oklahoma, said Dr. Michelle Salvaggio, medical director of the Infectious Diseases Institute at the University of Oklahoma Health Sciences Center in Oklahoma City. The institute is one of two federally funded HIV clinics in Oklahoma; the other is in Tulsa, the state's second-largest city.

A Long Drive For Anonymity

Salvaggio's clinic has six exam rooms where she sees patients, many of whom drive hours for treatment. The clinic used to employ a case manager in rural Woodward County, a little more than two hours’ drive northwest of Oklahoma City.

But Salvaggio said that ended up being a waste of money. "We had to let that position go, because nobody would go see her,' Salvaggio said. "Because they didn’t want to be seen walking into the HIV case manager's office in that tiny town — that can only mean one thing."

In Oklahoma, as in much of the U.S., black gay and bisexual men have the highest risk of HIV infection. Other groups with elevated risk in Oklahoma include Latinos, heterosexual women and Native Americans.

Salvaggio applauds the goal of ending HIV transmissions within 10 years but said she doesn't think it's feasible in Oklahoma. The plan fails to recognize the particular ways different populations experience the epidemic, she said.

Native Americans in Oklahoma, for example, can't count on the anonymity of a large health clinic.

"When they go into an Indian Health Service clinic, it is possible that they will see their cousin behind the desk, and their cousin's brother-in-law working in medical records, and their niece's boyfriend working in the pharmacy," Salvaggio said.

Even if Native Americans have access to HIV care at the clinic, she said, "they are literally in fear of being outed."

Social Support Services Needed

Ky Humble's hometown is Afton, Okla., which had a population of about 800 when he was growing up. He belongs to the Cherokee Nation and was raised a Southern Baptist. He doesn't remember learning about HIV at all when he was in school.

"Even if I did, it clearly wasn't enough," Humble said. "I knew I was gay in middle school; I think I would have paid attention."

When he was diagnosed with HIV six years ago, at age 21, Humble felt as if his life was ending.

"I knew that that was a thing, [but] I was very ignorant," he recalled. "I was two weeks away from graduating from college — you're supposed to be on top of the world. I thought it was a death sentence."

He called his mom right away. She immediately drove across the state to be with him.

"We just sat there and cried for six hours straight," Humble said. "And then we actually went [out] and bought several books on HIV, and just started reading them — to try to figure out what was going on."

Today, Humble is healthy. His HIV levels are undetectable and he gets regular medical treatment to keep it that way. He now lives in Oklahoma City, but his family still lives in his hometown. He said some people back in Afton know he has HIV, and some don't.

"It's like coming out as diabetic," Humble said. "I don't necessarily tell people that I'm HIV-positive. It's just part of who I am; it doesn't define me."

He said he is cautiously optimistic that the Trump administration's plan could mean more funding for HIV prevention in Oklahoma. But rural Oklahomans, Humble said, also need access to "wraparound services" — such as food pantries, mental health therapy and transportation assistance — to help them deal with the disease.

"I have friends who have HIV and live in rural areas, and just getting to appointments is challenging," he said.

Oklahoma's Uninsured Rate Is Second-Highest In U.S.

Exactly how much money the president's HIV plan will get is up to Congress. But even inexpensive, proven methods for fighting HIV — like distributing condoms — can be a tough sell in a state that doesn't mandate comprehensive sex education.

Informational HIV talks with teenagers often turn into a basic health class for dispelling myths, said Andy Moore, clinic administrator of the Infectious Diseases Institute at the University of Oklahoma.

"We’ve had teenagers write questions like 'I've heard that if you douche with Mountain Dew after sex that it kills sperm,'" Moore said. They earnestly want to know if that’s true. "We have to back way up and explain what sex is, how babies are made, different types of sex — before we can teach them about HIV prevention," he said.

Another issue in Oklahoma, Moore said, is that people aren't getting diagnosed with HIV until they're already sick because of AIDS, or close to that point.

"Which indicates that they didn't get tested until they had been living with the disease for six, eight, 10 years," Moore said. "We have one of the highest rates of late testing."

Salvaggio said thousands of people across Oklahoma would need to be tested for HIV to reach the administration's goal. And Oklahoma has the second-highest uninsured rate in the nation after Texas — meaning many people don't have a primary care doctor, let alone prescription drug coverage for drugs like Truvada, which can be used to prevent HIV infection.

It's also one of 14 states that haven't expanded Medicaid under the Affordable Care Act. So, even if more people were tested for HIV, getting those who need it into treatment wouldn't be easy, Salvaggio said.

Healthcare in Oklahoma is underfunded, she said, and couldn't cope with a sudden influx of new patients. "I don't know what we'd do with all those new patients," she said. "We don't have a facility to see them in, and we don't have [the] providers."

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

More States Say Doctors Must Offer Overdose Reversal Drug Along With Opioids

KFF Health News, February 21, 2019

Such co-prescribing mandates are emerging as the latest tactic in a war against an epidemic that has claimed hundreds of thousands of lives over the past two decades.

This article was published on February 21, 2019, in Kaiser Health News.

By Barbara Feder Ostrov

In a growing number of states, patients who get opioids for serious pain may leave their doctors' offices with a second prescription — for naloxone, a drug that can save their lives if they overdose on the powerful painkillers.

New state laws and regulations in California, Virginia, Arizona, Ohio, Washington, Vermont and Rhode Island require physicians to "co-prescribe" or at least offer naloxone prescriptions when prescribing opioids to patients considered at high risk of overdosing. Patients can be considered at high risk if they need a large opioid dosage, take certain other drugs or have sleep apnea or a history of addiction.

Such co-prescribing mandates are emerging as the latest tactic in a war against an epidemic of prescription and illegal opioids that has claimed hundreds of thousands of lives over the past two decades.

The Food and Drug Administration is considering whether to recommend naloxone co-prescribing nationally (an FDA subcommittee recently voted in favor), and other federal health officials already recommend it for certain patients. And the companies that make the drug are supportive of the moves. It's not hard to see why: An FDA analysis estimated that more than 48 million additional naloxone doses would be needed if the agency officially recommended co-prescribing nationally.

Most states have limited the volume of opioids doctors can prescribe at one time and dramatically expanded access to naloxone. In California, for example, pharmacists can provide naloxone directly to consumers who are taking illegal or prescription opioids or know someone who is.

In the states with co-prescribing rules, patients aren't required to fill their naloxone prescriptions, and those with cancer or who are in nursing homes or hospice typically are exempted.

Kristy Shepard of Haymarket, Va., was surprised to find a naloxone prescription waiting for her recently when she went to the pharmacy to pick up her opioid meds. Her first instinct was not to fill it. She did so only after the nurse in her doctor's office pressured her to. The doctor had never talked to her about Virginia's new co-prescribing law, she said.

"It's so silly. I didn't feel like I needed it. Unless I plan to hurt myself, I’m not likely to overdose," said Shepard, 41, a registered nurse and hospital administrator who can no longer work and has applied for disability benefits.

But it may not be as difficult as some people think to overdose on prescription painkillers.

"You can take pain meds responsibly, and you can be at risk for an accidental overdose even when you’re doing everything right," said Dr. Nathan Schlicher, an emergency medicine physician in Washington state and a member of the state hospital association's opioid task force.

Two million Americans have an addiction to prescription painkillers, according to the FDA. And nearly 218,000 people in the U.S. died from overdosing on them from 1999 to 2017, according to the Centers for Disease Control and Prevention. During that same period, prescription opioid deaths rose fivefold, the CDC data show.

In California, doctors wrote nearly 22 million opioid prescriptions in 2017 and 1,169 people died that year from overdosing on prescription opioids. Common prescription opioids include Vicodin, OxyContin, Percocet, morphine, codeine and fentanyl.

To counter this trend, "states are scrambling for any policy lever they can find," said Kitty Purington, senior program director at the National Academy for State Health Policy.

Even before the state mandates, pain specialists considered it good practice to prescribe naloxone along with opioid painkillers for some patients, particularly those with a history of substance abuse.

Doctor lobbying groups typically resist government rules regarding their practice, but medical associations in some states supported or at least remained neutral on naloxone co-prescribing mandates.

The companies that make the drug have spent hundreds of thousands of dollars collectively lobbying for their interests at the state level.

Kaléo, which makes the naloxone auto-injector Evzio, spent $77,200 in 2017-18 lobbying California lawmakers on bills expanding access to naloxone, including the state's co-prescribing law, which requires doctors to offer prescriptions for naloxone to high-risk patients who get opioids.

In December, Kaléo introduced a lower-cost generic version of the injector after a Senate investigation found the company had raised the price of its branded version 600% from 2014 to 2017, to $4,100 for two injectors.

Adapt Pharma, which makes the naloxone nasal spray Narcan, spent $48,000 to lobby California lawmakers on the co-prescribing legislation.

One advantage of the co-prescribing rules is that they foster important doctor-patient conversations about the risks of opioids, said Dr. Farshad Ahadian, medical director at the UC San Diego Health Center for Pain Medicine.

"Most providers probably feel that it’s better for physicians to self-regulate rather than practice medicine from the seat of the legislature," Ahadian said. "The truth is there's been a lot of harm from opioids, a lot of addiction. It's undeniable that we have to yield to that and to recognize that public safety is critical."

But some doctors — not to mention patients — have reservations about the new requirements. Some physicians say it will be nearly impossible for states to enforce the mandates. Others worry that prescribing naloxone to patients who live alone is useless, because it typically must be administered by another person — ideally one who has been trained to do it.

Patients fear that naloxone prescriptions could unfairly stigmatize them as drug addicts and cause life insurers to deny them coverage.

Shepard, the disabled Virginia nurse and a mother of four, said she worries that her naloxone prescription could affect her chances of getting additional life insurance — a pressing question, she said, as her lupus worsens over time.

And a Boston-area nurse who worked at an addiction treatment program was turned down by two life insurers simply because she carried naloxone for her patients.

The decision to prescribe naloxone "is something that should be between a doctor and a patient, because every situation is unique," said Katie O'Leary, a 31-year-old movie production company office manager who lives in Los Angeles and was diagnosed with complex regional pain syndrome about five years ago.

"So many patients already jump through so many hoops to get their meds," O'Leary said. "And if you live alone and don’t have family or friends to take care of you, the naloxone might not be something that could actually help."

Opioid addiction and overdoses are a complex problem, and naloxone is just one part of the solution, said Dr. Ben Bobrow, a professor of emergency medicine at the University of Arizona College of Medicine.

"In the past, pain was the fifth vital sign; we thought we were doing a bad job if we were undertreating pain," Bobrow said. "Inadvertently, we were harming people. We ended up getting all these people hooked. Now it's our job to help them find other [ways] of treating their pain."

California Healthline digital reporter Harriet Blair Rowan contributed to this report.

KHN’s coverage of these topics is supported by KHN

Barbara Feder Ostrov: barbarao@kff.org, @barbfederostrov

Pages