KFF Health News

KFF Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Pelosi Aims For Feds To Negotiate Drug Prices, Even For Private Insurers

KFF Health News, June 28, 2019

But first, Democrats must agree on how best to muscle drug companies to the negotiating table.

This article was first published on Friday, June 28, 2019 in Kaiser Health News.

By Emmarie Huetteman

As House Democrats hash out a proposal empowering the federal government's top health official to negotiate lower drug prices, House Speaker Nancy Pelosi is taking it a step further and pushing a plan that could benefit even those Americans with private health insurance.

A draft plan spearheaded, but not yet released, by Pelosi and other House Democratic leaders would ensure that prices negotiated on the most expensive drugs would apply not only to the government but to all payers, including employers and insurers, a Democratic aide said.

But first, Democrats must agree on how best to muscle drug companies to the negotiating table, as well as how to prevent Americans from paying more or even losing access to the other drugs they take. Pelosi has faced pressure from progressive House Democrats, who have pushed for a more aggressive approach, including opening up all drugs to negotiations.

However bold a plan Democrats produce, any proposal to invite the federal government into price negotiations looks doomed in the Republican-controlled Senate, where GOP leaders have said they will not let it advance.

That means the fight over whether the government should cut deals with drugmakers is likely to play out on the members' 2020 election campaign trails, rather than in the halls of Congress. Democrats could again try to tar Republicans as indifferent to the struggles of Americans who cannot afford health care, while promoting their own attempts to fulfill 2018 campaign promises to address skyrocketing drug prices.

Drug prices have been on the rise for decades and, according to the Kaiser Family Foundation, spending on prescription drugs — adjusted for inflation — increased to $1,025 per capita in 2017, from $90 in 1960. (Kaiser Health News is an editorially independent program of the foundation.)

Experts say the lack of competition is much to blame for high drug costs. The federal patent system, in which companies are granted exclusive control of their drug for years and can exploit loopholes to block competitors, frees those firms to charge as much as they like. That can leave patients with no choice but to pay exorbitant prices for the drugs they need.

Under the current system, negotiations are conducted on a plan-by-plan basis between drugmakers and pharmacy benefit managers, the intermediaries who themselves have faced questions about how much they contribute to high drug costs.

Many Democrats argue that the secretary of Health and Human Services should negotiate prices, leveraging the power of the federal Centers for Medicare & Medicaid Services, the largest health care payer in the country.

Though it may change before being released, the current Democratic leadership plan would authorize the HHS secretary to negotiate the prices of the 250 most expensive drugs.

"We want them to address as many as possible, as quickly as possible," Pelosi said at a recent event after progressives pushed her to include more than the 25 drugs she initially proposed targeting.

The negotiation would begin with a price range set by HHS, the Democratic aide said, with the aim of agreeing on the maximum price that could be charged for a drug.

The Government Accountability Office would help sort out disagreements between HHS and drugmakers, although the specifics of that arrangement are still uncertain, the aide added.

Details of how the negotiated drug prices would be transferred to the private sector remain to be seen.

Limiting negotiations to the 250 most expensive drugs would tackle a piece of the drug market that accounts for about 78% of prescription drug spending, according to an analysis conducted by Patients for Affordable Drugs, an advocacy group.

Democratic leaders believe the 250-drug threshold would balance two competing interests, the aide said: maximizing the impact on prescription drug spending, while theoretically keeping the list of negotiable drugs to a number HHS could handle.

Otherwise, faced with more drugs —or all of them — to negotiate, the HHS secretary could reasonably determine that was more than the agency could manage and potentially cherry-pick which drugs to pursue, the argument goes.

An HHS spokesperson declined to answer questions about how such a proposal would look in practice.

The Congressional Budget Office cautioned in May that negotiations would likely be effective at lowering prices only if the HHS secretary were granted "some source of pressure" to use against drugmakers.

Under the Democratic leadership plan, companies that refuse to comply with negotiations would find themselves slapped with an excise tax equivalent to 50% of sales on the drug in the previous year, the aide said.

But some Democrats worry that would not be enough to pressure drug companies to negotiate. A competing proposal, from Rep. Lloyd Doggett (D-Texas) and Sen. Sherrod Brown (D-Ohio) and endorsed by the Congressional Progressive Caucus, would threaten companies with having their drugs' patents expire sooner than planned if they did not comply with the secretary's negotiations on behalf of Medicare beneficiaries.

A second Democratic aide said that proposal, still considered a draft, would cut to the heart of the problem by undermining the drugmakers' exclusivity, while protecting patients' access to prescriptions should pharmaceutical companies walk away from price talks.

"I'm for whichever plan provides the most relief for the most patients and does not allow Big Pharma to dodge responsibility for widespread price-gouging," Doggett said in a statement.

Either plan would be better than the current system, said Gerard Anderson, a health policy professor at Johns Hopkins University in Baltimore who has been advising House Democrats on their proposals.

However, he said, both proposals would require some kind of national formulary — a list of prescription drugs covered by insurance, as determined by the negotiations — to be effective.

"When you're negotiating with a company where there's three other competitors, you need to say 'I'm going to give you an exclusive contract' in order to get a good deal," Anderson said in an interview.

The Veterans Health Administration, which offers retired service members discounts through its negotiations with drugmakers, is often cited by negotiation advocates as a model that could be imitated. It regularly secures drug prices that are about 35% lower than those paid by Medicare beneficiaries, Anderson said.

Unlike Medicare, the Veterans Health Administration has a national formulary.

Although President Donald Trump said during his 2016 campaign that he supports allowing the government to negotiate better drug prices, congressional Republicans broadly oppose the idea.

The HHS secretary is barred from directly negotiating prices with drugmakers for Medicare Part D, the program's prescription drug plan, which covered more than 43 million Americans last year. Instead, the private plans that offer Part D benefits negotiate on their own.

Sen. Chuck Grassley (R-Iowa), chairman of the Finance Committee, said on the Senate floor last month that part of the appeal of Medicare Part D is that seniors can select a plan based on its formulary, allowing them access to the drugs they need.

That choice could disappear if Democrats enable negotiations, he said.

"As the senator who once again chairs the committee with jurisdiction over Medicare policy, I'm not going to let Congress unravel what's right about Medicare Part D," Grassley said.

But the Democratic aide with knowledge of the leadership's proposal dismissed that concern, saying Medicare beneficiaries would keep the option to select the plan that best suits them.

Anderson also said that concern does not hold up, explaining that there is "a huge amount of overlap" between the drugs on the Veterans Health Administration's formulary and those on most Medicare drug plan formularies.

It is unclear when House Democratic leaders might unveil their finished plan, though Pelosi is reportedly determined to do so before the 2020 election heats up.

Emmarie Huetteman: ehuetteman@kff.org, @emmarieDC

Five Things We Found In The FDA's Hidden Device Database

KFF Health News, June 27, 2019

The FDA has released two decades of previously hidden data containing millions of injuries or malfunctions by medical devices.

This article was first published on Thursday, June 27, 2019 in Kaiser Health News.

By Sydney Lupkin

After two decades of keeping the public in the dark about millions of medical device malfunctions and injuries, the Food and Drug Administration has published the once hidden database online, revealing 5.7 million incidents publicly for the first time.

The newfound transparency follows a Kaiser Health News investigation that revealed device manufacturers, for the past two decades, had been sending reports of injuries or malfunctions to the little-known database, bypassing the public FDA database that's pored over by doctors, researchers and patients. Millions of reports, related to everything from breast implants to surgical staplers, were sent to the agency as "alternative summary" reports instead.

Here's what we found in those newly public reports:

1. Blood glucose meters for patients with diabetes had more unique incidents than any other device in the database, logging 2.4 million reports over the past 20 years.

Almost all the products were made by LifeScan, which had been a Johnson & Johnson company until it was sold to a private equity firm in 2018. Common problems included displaying incorrect messages, losing power or being damaged before customers started using them, according to the database.

"When you're trying to manage a chronic disease, and especially if your numbers are dangerously high, that's life-threatening," said Linda Radach, who chairs the medical device committee for the Patient Safety Action Network.

LifeScan did not return requests for comment.

The FDA said the number of glucose meter problems in the alternative summary reporting database shouldn't be a surprise.

"Approximately 10% of the U.S. population has diabetes and most rely on these devices several times a day," said FDA spokesman Michael Felberbaum. The agency also sees a "high volume" of adverse events for glucose meters in its longtime public database, called MAUDE, he said.

He reiterated that the alternative summary reporting program was intended for "well-understood" adverse events "so that we could focus more resources on identifying and taking action on new safety signals and less understood risks."

2. There were 2.1 million reports for bad dental implants. And 114,200 were reported last year.

This kind of implant goes into the bone to support an artificial tooth or implant. Many of the reports were for problems with connections between the device and the bone.

"A lot of people have gone out and gotten these and probably don't know about these risks," said Madris Tomes, a former FDA manager who now runs a website to make the notoriously clunky MAUDE easier to work with.

Dental implants were among the last device types to lose permission to report harm via alternative summary reports instead of the public database. Although the device harm data doesn't include what happened to patients, Tomes said that if a dental implant has to be removed, it often can't be replaced because the underlying bone is so damaged.

Felberbaum said that the high number of reports for dental implants is expected because these are commonly used devices, and that more companies have brought new products to market in the past two decades.

3. There were 176 deaths reported through the alternative summary reporting system.

Alternative summary reports are not supposed to include deaths, except for cardiac arrest potentially caused by certain kinds of heart valves that were implanted at least five years beforehand. Those accounted for two-thirds of the deaths in the hidden database, KHN found.

The most recent death was reported last fall by Medtronic, and it was for a MiniMed Paradigm insulin pump that was hard to program or calibrate. Deaths reported to the once-hidden database also included fatalities associated with two kinds of pacemakers, a breast implant, an intra-aortic balloon pump and a ventilator.

When asked why these were there, the FDA said its "standard practice" was to reach out to the manufacturer for more information when it detected an "ineligible event" in the alternative summary reports. Sometimes, a death was reported in error. Sometimes, the FDA required the manufacturer to report an incident to the public database as well.

KHN found that of the 59 ineligible deaths, only eight appeared to be revised in updated alternative summary reports.

"In some cases, the FDA revoked ASR exemptions following continued reporting of ineligible events in ASRs," said Felberbaum, adding that ineligible deaths represented "0.001% of all reports received through the ASR program."

When asked whether the FDA had contacted the company about the 2018 insulin pump death, Medtronic was unavailable for comment.

"One has to wonder what other information wasn't made public if something that clear-cut [the instruction not to include deaths in the ASR] was included and hidden from the public," said Diana Zuckerman, president of the nonprofit National Center for Health Research. "Did FDA notice?"

4. Surgical stapler-related malfunctions accounted for more than 66,000 previously hidden incidents since 2001.

The KHN investigation spotlighted problems with staplers, which tend to be used in minimally invasive surgery to cut and seal tissue and vessels quickly. Although the FDA received only 84 reports for stapler-related harm in the public database, it acknowledged earlier this year that it had received nearly 10,000 reports through alternative summary reporting.

The most common problems were staplers that failed to fire or fired malformed staples. Nearly 4,700 stapler problems were reported through the hidden database in 2017 alone. If a stapler fails to seal tissue properly during surgery, it can lead to serious bleeding or infection.

An FDA advisory panel last month recommended the agency switch staplers to a higher-risk classification with more safety requirements.

5. Breast implant injuries and malfunctions accounted for nearly half a million unique reports over two decades, including implants that leaked, deflated or migrated.

More than 6,600 incidents have been reported in 2019 by three companies: Allergan, Mentor and Sientra. The most common problem was rupture.

Tomes was especially concerned about cancer attributed to breast implants, which was the subject of an ICIJ investigation last fall. But without publicly available data tracking patient problems, which exists in adverse events data for drugs but not devices, it's impossible to say.

"How is the public supposed to make sense of this if they've redacted patient safety codes?" she asked.

Plus: Thousands of medical device types are still eligible for reporting outside the FDA's public database.

There are still ways that device makers can avoid submitting individual injuries and malfunctions to the MAUDE database.

To replace the ASR program, the FDA has launched the Voluntary Summary Reporting Program. More than 5,600 device types — or 87% of them — are eligible for summary reporting of device malfunctions, according to FDA records.

Patient advocates say they fear that these will be just as difficult to tally and track as ASRs. For example, a summary report for 156 injuries would appear to be a single MAUDE report with a note that it represents 156 injuries, not one.

"Why would you end one [hidden data program] just to start another?" Radach asked.

Methodology

To avoid double-counting adverse events, KHN counted each event identified with a unique report ID only once, unless otherwise noted.

Although this isn't the norm, some companies appear to have recycled report IDs, using them for more than one event. As a result, our counts may be underestimated.

Sydney Lupkin: slupkin@kff.org, @slupkin

More Seniors Are Dying In Falls. Doctors Could Do More To Reduce The Risk.

KFF Health News, June 27, 2019

Experts call for a personalized approach to preventing falls, more involvement by clinicians and motivating older adults to take action.

This article was first published on Thursday, June 27, 2019 in Kaiser Health News.

By Judith Graham

Older adults worried about falling typically receive general advice: Take an exercise class. Get your vision checked. Stop taking medications for sleep. Install grab bars in the bathroom.

A new study suggests that sort of advice hasn't proved to be very effective: Nearly three times more adults age 75 and older died from falls in 2016 than in 2000, according to a recent report in the Journal of the American Medical Association.

In 2016, 25,189 people in this age group died from falls, compared with 8,613 in 2000. The rate of fatal falls for adults 75 and older more than doubled during this period, from 51.6 per 100,000 people in 2000 to 122.2 per 100,000 people in 2016, the report found.

What's needed to check this alarming trend, experts suggest, is a more personalized approach to preventing falls, more involvement by medical practitioners and better ways to motivate older adults to take action.

Elizabeth Burns, a co-author of the report and health scientist at the U.S. Centers for Disease Control and Prevention, said it's not yet clear why fatal falls are increasing. Older adults are probably more vulnerable because they're living longer with conditions such as diabetes and cardiovascular disease and taking more brain-altering medications such as opioids, she noted.

By 2030, the CDC projects, 49 million older adults will fall each year, resulting in 12 million injuries and more than $100 billion in health-related spending.

The steep increase in fatal falls is "definitely upsetting," especially given national, state and local efforts to prevent these accidents, said Kathleen Cameron, senior director of the Center for Health Aging at the National Council on Aging.

Since 2012, the CDC has tried to turn the situation around by encouraging physicians to adopt evidence-based fall prevention practices. But doctors still are not doing enough to help older patients, Burns said.

She cites evidence from two studies. In one, published in 2016, researchers found that fewer than half of seniors who were considered high risk — people who'd fallen repeatedly or sought medical attention for falls — received a comprehensive fall risk assessment, as recommended by the CDC and the American Geriatrics Society.

These assessments evaluate a person's gait, lower-body muscle strength, balance, medication use, problems with their feet, blood pressure when rising from a sitting position, vision, vitamin D levels and home environment.

In another study, published last year, Burns found that physicians and nurse practitioners routinely failed to review older adults' medications (about 40% didn't do so), recommend exercise (48% didn't) or refer people to a vision specialist (about 62% didn't) when advising older patients about falls.

Physicians' involvement is important because older adults tend to take their doctors' advice seriously, said Emily Nabors, program manager of the Fall Prevention Center of Excellence at the University of Southern California.

Also, seniors tend to underestimate their chance of falling.

"It's very easy for people to look at a list of things that they should be concerned about and think, 'That doesn't apply to me. I walk just fine. I don't have trouble with my balance,'" said Dorothy Baker, a research scientist at Yale School of Medicine and executive director of the Connecticut Collaboration for Fall Prevention.

What's the alternative to giving seniors a laundry list of things to do and hope they pay attention? We asked experts around the country for suggestions:

Get a fall risk assessment. Doctors should ask older adults three questions about falls: Have you fallen in the past year? Do you feel unsteady when walking or standing? And are you afraid of falling?

If the answer is yes to any of these questions, you're probably a good candidate for a comprehensive fall risk evaluation.

Dr. Muriel Gillick, a geriatrician at Harvard Medical School, believes older patients and their families should "clamor" for these assessments. "Tell your doctor, 'We're really worried about falls. Can you do this kind of evaluation?'" she said.

When you join Medicare, you become eligible for a "Welcome to Medicare" prevention visit, during which doctors should evaluate your chance of falling. (This is a brief screen, not a thorough examination.) Subsequently, seniors are eligible each year for a Medicare annual wellness visit, which offers another chance for a physician to assess your fall risk.

If your doctor doesn't offer these services, ask for a referral to another medical practice, said Leslie Allison, editor-in-chief of the Journal of Geriatric Physical Therapy. Physical therapists can provide an in-depth review of walking, muscle strength and balance, she noted.

The CDC's "Stay Independent" brochure lists 12 fall-related considerations for those interested in doing a self-assessment. Pay attention to the last one, about depression, which alters attention, slows responses and is often overlooked in discussions about falls.

Get a personalized plan. A fall assessment should identify risk factors that are specific to you as well as ways to address them.

"The goal is to come up with personalized recommendations, which older adults are far more likely to take up than generic non-tailored approaches," said Elizabeth Phelan, a researcher of falls and associate professor of geriatric medicine at the University of Washington.

Take programs that address balance, for example. Some are designed for older adults who are frail, some for those who are active, and still others for those in between. "If a senior goes to a program that doesn't meet her needs, it's not going to work out," said Mindy Renfro, associate professor of physical therapy at Touro University Nevada.

The single most important intervention is exercise — but not just any kind. Notably, simply walking — the type of exercise most older adults get — won't help unless seniors have previously been sedentary. "If you're walking, by all means, don't stop: It's good for general health and well-being," Phelan said. "But to prevent falls, you need to focus on strength and balance."

Exercise such as tai chi or the Otago Exercise Program could improve strength and balance, advises Cameron of the National Council on Aging. She suggested asking an area agency on aging, senior center, YMCA or YWCA about classes. The center also has formed fall prevention coalitions in 43 states. Look for one near you here.

A national directory of resources that can help older adults make home modifications is being expanded through a new program led by USC's Leonard Davis School of Gerontology. Occupational therapists can evaluate homes and suggest changes to reduce your chance of falling. Ask your physician for a referral.

Your doctor's guidance will be needed to review medications that can contribute to falls. Using three or more psychotropic medications such as opioids, antidepressants, antipsychotics, benzodiazepines (such as Valium) and "Z" drugs for sleep (such as Ambien) puts seniors at substantial risk, said Dr. Donovan Maust, an assistant professor of psychiatry at the University of Michigan Medical School.

Be careful during transitions. Older adults coming home from the hospital or starting new medications should be especially careful about falling, because they may be weak, deconditioned, exhausted and disoriented.

A new paper from researchers at the University of Michigan and Yale University highlights this risk. They looked at 1.2 million older adults readmitted to the hospital within 30 days of being discharged in 2013 and 2014. Fall-related injuries were the third most common reason for readmissions.

In other studies, Geoffrey Hoffman, an assistant professor at the University of Michigan School of Nursing, has asked seniors and caregivers about their experiences during discharge planning. None remembered receiving information about falls or being advised that they might be at risk.

Hospital staffers should discuss fall prevention before older patients leave the hospital, Hoffman said, calling it "a time when it's critical to intervene on fall risk."

Consider the message. In research studies and focus groups, older adults report they don't like negative messages surrounding falls such as "You can hurt yourself badly or die if you don't watch out."

"Telling older adults what they need to do to be safe feels patronizing to many people and raises their hackles," Hoffman said.

Instead, seniors respond better to messages such as "taking these steps is going to help you stay independent," Burns of the CDC said.

We're eager to hear from readers about questions you'd like answered, problems you've been having with your care and advice you need in dealing with the health care system. Visit khn.org/columnists to submit your requests or tips.

Judith Graham: @judith_graham

Non-English Speakers Face Health Setback If Trump Loosens Language Rules

KFF Health News, June 24, 2019

The government acknowledges that the change would lead to fewer people with limited English skills accessing healthcare and fewer reports of discrimination.

This article was first published on Monday, June 24, 2019 in Kaiser Health News.

By Carmen Heredia Rodriguez

A federal regulation demands that certain healthcare organizations provide patients who have limited English skills a written notice of free translation services.

But the Trump administration wants to ease those regulations and also no longer require that directions be given to patients on how they can report discrimination they experience.

The changes could save $3.16 billion over five years for the healthcare industry, according to the administration.

These changes are part of a broader proposed regulation that would roll back protections banning discrimination based on gender identity. The public comment period closes Aug. 13.

The proposal would not change the government's requirements that insurers and medical facilities provide foreign language translators and interpreters for non-English speakers.

The government acknowledged in the proposal that the change would lead to fewer people with limited English skills accessing healthcare and fewer reports of discrimination. But it also questioned the need for these notices, pointing out that in some areas health organizations spend money to accommodate a small contingent of language speakers. For example, notices in Wyoming must account for the 40 Gujarati speakers — a language of India — in the state.

In all, the government said, the impact of doing away with these requirements would be "negligible."

Others disagree.

"I haven't seen any reason to believe that this will only have a negligible impact," said Mara Youdelman, managing attorney for the Washington, D.C., office of the National Health Law Program, a civil rights advocacy group. She said it "will likely result in people just not knowing their rights but not accessing care to which they’re eligible."

Regulations under Section 1557 of the Affordable Care Act require insurers, hospitals and others to include a "tagline" of free translation services for the 15 languages that are most prevalent in a state. Additionally, it requires a nondiscrimination clause and directions on how to file a complaint with the Department of Health and Human Services Office for Civil Rights.

This information must be posted on websites, in physical spaces and in "significant communications" to the patient. But the ambiguity of that phrase prompted healthcare organizations to post the required information on numerous pieces of material — such as a separate page about language options sent with each Explanation of Benefits statement from an insurer. Together, these efforts cost organizations billions of dollars.

"No one realized exactly what that definition of 'significant communication' — how much would be wrapped up in that," said Katie Keith, a Georgetown University professor who specializes in the ACA.

An estimated 25.9 million people in the United States in 2017 had limited English proficiency, the Census Bureau reported. Patients facing language barriers have a higher risk of health care complications, such as surgical infections and falls, because they may misunderstand a doctor’s orders, make mistakes preparing for procedures or improperly use medications.

In this latest proposal, however, the federal government questions whether the written notices are needed. The majority of enrollees speak English — census data from 2017 showed that 91.5% of people over age 5 spoke only English at home or spoke the language "very well." In certain states, the proposal claims, every enrollee receives a notice for translation services in a language that only a few dozen people speak in the area.

Other state and federal laws protect the rights of patients with limited language services, the proposed rule says. It also cites evidence of some enrollees not liking the extra forms and being less inclined to open their mail because of them.

"These complaints make us concerned that the Section 1557 Regulation has resulted in 'cognitive overload,'" the document stated, "such that individuals experience a diminished ability to process information" because of the additional paperwork.

Anecdotal reports cited by the government also point out that the notices did not significantly increase the number of patients using language services and reporting complaints. However, the proposed rule also estimates at least 90% of hospitals and physicians were not complying with the requirements.

Youdelman admitted she does not have concrete data showing that these taglines translate to increased access to services. However, she added, removing them wholesale without a promise to prevent discrimination in a different way is also counterproductive.

"Eliminating taglines is not the correct solution," Youdelman said. "There is a way to inform folks while being cost-conscious."

Health insurers and pharmacy benefit managers' reactions to the proposed change have been tepid. The Pharmaceutical Care Management Association — the trade organization for pharmacy benefit managers — said in an email it "believes all consumers should be informed regarding translation services." America’s Health Insurance Plans, the trade association for health insurers, said in an email that insurers would make sure consumers get the support they need to understand information — "including providing phone interpreters and written translations for customers who need them."

Keith said that if the proposal is finalized more patients would not understand information involving their health. Some of these details on insurance and billing documents are already difficult for native English speakers to dereplacecipher and could be a challenge for less fluent people.

"Anytime you’re not notifying people of their rights," Youdelman said, "you disempower them."

Carmen Heredia Rodriguez: CarmenH@kff.org, @ByCHRodriguez

Surgeons' Opioid-Prescribing Habits Hard To Kick

KFF Health News, June 21, 2019

A new data analysis shows that even as the CDC issued warnings, surgeons handed out many times the number of opioid pills needed for post-op pain.

This article was first published on Friday, June 21, 2019 in Kaiser Health News.

By Julie Appleby and Elizabeth Lucas June 21, 2019

As opioid addiction and deadly overdoses escalated into an epidemic across the U.S., thousands of surgeons continued to hand out far more pills than needed for postoperative pain relief, according to a KHN-Johns Hopkins analysis of Medicare data.

Many doctors wrote prescriptions for dozens of opioid tablets after surgeries — even for operations that cause most patients relatively little pain, according to the analysis, done in collaboration with researchers at Johns Hopkins School of Public Health. It examined almost 350,000 prescriptions written for patients operated on by nearly 20,000 surgeons from 2011 to 2016 — the latest year for which data are available.

Some surgeons wrote prescriptions for more than 100 opioid pills in the week following the surgery. The total amounts often exceeded current guidelines from several academic medical centers, which call for zero to 10 pills for many of the procedures in the analysis, and up to 30 for coronary bypass surgery.

While hundreds of state and local lawsuits have been filed against opioid manufacturers, claiming they engaged in aggressive and misleading marketing of these addictive drugs, the role of physicians in contributing to a national tragedy has received less scrutiny. Research shows that a significant portion of people who become addicted to opioids started with a prescription after surgery.

In sheer numbers, opioid prescribing in the U.S. peaked in 2010, but it remains among the highest in the world, according to studies and other data.

In 2016, opioids of all kinds were linked to 42,249 deaths, up from the 33,091 reported in 2015. The opioid-related death rate jumped nearly 28% from the year before, according to the CDC.

Yet long-ingrained and freewheeling prescribing patterns changed little over the six years analyzed. KHN and Johns Hopkins examined the prescribing habits of all U.S. surgeons who frequently perform seven common surgical procedures and found that in the first week after surgery:

Coronary artery bypass patients operated on by the highest-prescribing 1% of surgeons filled prescriptions in 2016 exceeding an average of 105 opioid pills.
Patients undergoing a far less painful procedure — a lumpectomy to remove a breast tumor — were given an average of 26 pills in 2016 the week after surgery. The highest-prescribing 5% of surgeons prescribed 40 to 70 pills on average.
Some knee surgery patients took home more than 100 pills in the week following their surgery.

Those amounts — each "pill" in the analysis was the equivalent of 5 milligrams of oxycodone — are many times what is currently recommended by some physician groups to relieve acute pain, which occurs as a result of surgery, accident or injury. The analysis included only patients not prescribed opioids in the year before their operation.

"Prescribers should have known better" based on studies and other information available at the time, said Andrew Kolodny, co-director of opioid policy research at Brandeis University and director of the advocacy group Physicians for Responsible Opioid Prescribing.

While the dataset included only prescriptions written for patients on Medicare, the findings may well understate the depth of the problem, since doctors are more hesitant to give older patients the powerful painkillers because of their sedating side effects.

Surgeons’ prescribing habits are significant because studies show that 6% of patients who are prescribed opioids after surgery will still be taking them three to six months later, having become dependent. The likelihood of persistent use rises with the number of pills and the length of time opioids are taken during recuperation.

Also, unused pills in medicine cabinets can make their way onto the street.

Dr. Marty Makary, a surgical oncologist at Johns Hopkins, admits that he too once handed out opioids liberally. Now he is marshaling a campaign to get surgeons to use these powerful painkillers more consciously and sparingly. "I think there's an 'aha' moment that many of us in medicine have had or need to have," he said.

But old habits are hard to kick.

KHN contacted dozens of the surgeons who topped the ranks of opioid prescribers in the 2016 database. They hailed from small, community hospitals as well as major academic medical centers. The majority declined to comment, some bristling when questioned.

Some of those surgeons were critical of the analysis, saying it didn't take into account certain essential factors. For example, it was not possible to determine whether patients had complications or needed higher amounts of pain medication for another reason. And some surgeons had only a handful of patients who filled prescriptions, making for a small sample size.

But surgeons also indicated that the way they prescribe pain pills was less than intentional. It was sometimes an outgrowth of computer programs that default to preset amounts following procedures, or practice habits developed before the opioid crisis. Additionally, they blame efforts in the late 1990s and early 2000s that encouraged doctors and hospitals to consider pain as "the fifth vital sign." A major hospital accrediting group required providers to ask patients how well their pain was treated. Pharmaceutical companies used the fifth vital sign campaign as a way to promote their opioid treatments.

Makary, who oversaw the analysis of the Medicare dataset, said that, while opioid prescribing is slowly dropping, to date many surgeons have not paid enough attention to the problem or responded with sufficient urgency.

Dr. Audrey Garrett, an oncologic surgeon in Oregon, said she was "surprised" to hear that she was among the top tier of prescribers. She said she planned to re-evaluate her clinic's automated prescribing program, which is set to order specific amounts of opioids.

KHN will analyze data for 2017 and subsequent years when it becomes available to follow how prescribing is changing.

The analysis examined prescribing habits after seven common procedures: coronary artery bypass, minimally invasive gallbladder removal, lumpectomy, meniscectomy (which removes part of a torn meniscus in the knee), minimally invasive hysterectomy, open colectomy and prostatectomy.

Across the board, the analysis showed that physicians gave a large number of narcotics when fewer pills or alternative medications, including over-the-counter pain relief tablets, could be equally effective, according to recent guidelines from Makary and other academic researchers.

On average, from 2011 to 2016, Medicare patients in the analysis took home 48 pills in the week following coronary artery bypass; 31 following laparoscopic gallbladder removal; 28 after a lumpectomy; 41 after meniscectomy; 34 after minimally invasive hysterectomy; 34 after open colon surgery; and 33 after prostatectomy.

According to post-surgical guidelines spearheaded by Makary for his hospital last year, those surgeries should require at most 30 pills for bypass; 10 pills for minimally invasive gallbladder removal, lumpectomy, minimally invasive hysterectomy and prostatectomy; and eight pills for knee surgery. It has not yet published a guideline for open colon surgery.

The Johns Hopkins' doctors developed their own standards because of a dearth of national guidelines for post-surgical opioids. They arrived at those figures after reaching a consensus among surgeons, nurses, patients and other medical staff on how many pills were needed after particular surgeries.

Hoping to reduce overprescribing, Makary is preparing to send letters next month to surgeons around the country who are among the highest opioid prescribers under a grant he received from the Arnold Foundation, a nonprofit group whose focus includes drug price issues. (Kaiser Health News also received funding from the Arnold Foundation.)

Even if the prescription numbers have fallen since 2016, the amounts given today are likely still excessive.

"When prescribing may have been five to 20 times too high, even a reduction that is quite meaningful still likely reflects overprescribing," said Dr. Chad Brummett, an anesthesiologist and associate professor at the University of Michigan.

Brummett is also co-director of the Michigan Opioid Prescribing Engagement Network, a collaboration of physicians that makes surgery-specific recommendations, many of them in the 10- to 20-pill range.

"Reducing unnecessary exposure is key to reducing the risk of new addiction," said former Food and Drug Administration commissioner Scott Gottlieb. In August 2018, when Gottlieb was at the agency's helm, it commissioned a report from the National Academy of Sciences on how best to set opioid prescribing guidelines for acute pain from specific conditions or surgical procedures. Its findings are expected later this year.

"There are still too many 30-tablet prescriptions being written," said Gottlieb.

Healers Sowing Disease?

Naturally, surgeons rankle at the idea that they played a role in the opioid epidemic. But studies raise serious concerns.

Transplant surgeon Dr. Michael Engelsbe, director of the Michigan Surgical Quality Collaborative, points to the study showing 6% of post-op patients who get opioids for pain develop long-term dependence. That means a surgeon who does 300 operations a year paves the way for 18 newly dependent people, he said.

Many patients do not need the amounts prescribed.

Intermountain Healthcare, a not-for-profit system of hospitals, clinics, and doctors in Utah, began surveying patients two years ago to find out how much of their prescribed supply of opioids they actually took following surgery.

"Globally, we were overprescribing by 50%," said Dr. David Hasleton, senior medical director.

But Intermountain approached individual doctors carefully. "If you go to a prescriber to say, 'You are overprescribing,' it never goes well. A common reaction is, 'Your data is wrong' or 'My patients are different than his,'" said Hasleton.

For the analysis, KHN attempted to contact more than 50 surgeons whose 2016 numbers ranked them among the top prescribers in each surgical category.

One who did agree to speak was Dr. Daniel J. Waters, who 13 years ago had his chest cut open to remove a tumor, an operation technically similar to what he does for a living: coronary artery bypass.

"So I have both the doctor perspective and the patient perspective," said Waters, who practices in Mason City, Iowa.

In 2016, Waters' Medicare bypass patients who filled their prescriptions took home an average of nearly 157 pills each, according to the KHN-Johns Hopkins analysis.

"When I went home from the hospital, 30 would not have been enough," said Waters of the number recommended by the Hopkins team for that surgery.

But he said he has recently curbed his prescribing to 84 pills.

Nationally, the average prescription filled for a coronary artery bypass was 49 pills in 2016 and had changed little since 2011, the analysis shows.

Others who spoke with KHN said they had developed the habit of prescribing copiously — sometimes giving out multiple opioid prescriptions — because they didn't want patients to get stuck far from the office or over a weekend with pain or because they were trying to avoid calls from dissatisfied, hurting patients.

In the KHN-Johns Hopkins data, the seven patients of Dr. Antonio Santillan-Gomez who filled opioid prescriptions after minimally invasive hysterectomies in 2016 received an average of 77 pills each.

A gynecologic oncologist, Santillan-Gomez said: "I'm in San Antonio, and some of my patients come from Laredo or Corpus Christi, so they would have to drive two to three hours for a prescription."

Still, he said, since e-prescribing of opioids became more widespread in the past few years, he and other surgeons in his group have limited prescriptions to 20 to 30 pills and encouraged patients to take Tylenol or other over-the-counter medications if they run out. E-prescribing can not only help track patients getting opioids but also reduce the problem of patients having to drive back to the office to get a written prescription.

Dr. Janet Grange, a breast surgeon in Omaha, Neb., said that in her experience, opioid dependence had not been a problem.

"I can absolutely tell you I don't have even 1% who become long-term opioid users," said Grange.

The analysis showed that Grange had 12 opioid-naïve Medicare patients who had a lumpectomy in 2016. Eight of them filled prescriptions for an average of 47 pills per patient.

She called Johns Hopkins' zero-to-10-pill pain-control recommendation following that procedure "miserly."

The Pendulum Swings

Some of the higher-prescribing surgeons in the KHN-Johns Hopkins analysis reflected on their potential contribution to a national catastrophe and are changing their practice.

"That is a shocking number," said oncologist Garrett, speaking of the finding that 6% of patients who go home with opioids will become dependent. "If it's true, it’s something we need to educate physicians on much earlier in their medical careers."

Garrett, in Eugene, Ore., said she has cut back on the number of pills she gives patients since 2016. The KHN-Johns Hopkins analysis showed that seven of her 13 opioid-naïve Medicare patients undergoing minimally invasive hysterectomies filled a prescription for opioids in 2016. Those patients took home an average of 76 pills each.

Johns Hopkins guidelines call for no more than 10 opioid pills following this procedure, while Brummett's Michigan network recommends no more than 15.

Surgeon and researcher Dr. Richard Barth, once a heavy prescriber himself, said that his own experience convinced him that physicians' preconceptions about how much pain relief is needed are often way off.

The analysis showed his lumpectomy patients in 2013 filled an average of 33 pills in the week after surgery. By 2016, that average had dropped to seven pills. Many patients, he said, can do just fine after lumpectomy with over-the-counter medications — and often no opioids at all.

The key, he said, is to set patients' expectations upfront.

"I tell them it's OK to have a little discomfort, that we're not trying to get to zero pain," said Barth, who is chief of general surgery at Dartmouth-Hitchcock Medical Center and has published extensively on opioid prescribing.

After lumpectomy, "what I recommend is Tylenol and ibuprofen for at least a few days and to use the opioids only if the discomfort isn't relieved by those."

Indeed, the data analysis showed that a significant number of patients given prescriptions for opioids never filled them because they don’t need that level of pain relief.

Between 2011 and 2016, for example, only 62% of lumpectomy patients in the analysis filled prescriptions, similar to hysterectomy patients.

In 2016, patients of Dr. Kimberli Cox, a surgeon in Peoria, Ariz., were prescribed about 59 pills in the week following lumpectomy, well above the recommendations from both Johns Hopkins and others.

But the KHN-Johns Hopkins analysis of that year’s data shows that half of her patients never filled a painkiller prescription — a fact she acknowledges has changed her thinking.

"I am now starting to prescribe less because many patients say, 'You gave me too many' or 'I didn’t fill it," she said.

Julie Appleby: jappleby@kff.org, @Julie_Appleby

Elizabeth Lucas: elucas@kff.org, @eklucas

Stem Cell Company Persuades Employers To Steer Workers Toward Controversial Therapy

KFF Health News, June 20, 2019

Instead of dealing with disapproving insurance executives, Regenexx appeals directly to employers large enough to fund their own health plans.

This article was published by Kaiser Health News on June 20, 2019. It was also published by Time.

By Liz Szabo, Kaiser Health News

A Midwestern grocery chain, Hy-Vee, is taking an unusual—and highly controversial—approach to reducing health care costs.

Before employees in certain cities can undergo knee replacement, they first must visit a stem cell provider. Hy-Vee has contracted with one of the United States' leading stem cell companies—Regenexx, based in Des Moines, Iowa—that claims injections of concentrated bone marrow or platelets can help patients avoid expensive joint surgery.

Regenexx has persuaded over 100 employers to include its services in their health insurance plans. In a marketing booklet, Regenexx, whose injections range in price from $1,500 to $9,000, notes that its treatments cost a fraction of major surgery. A single knee replacement, for example, ranges from $19,000 to $30,000 in the U.S.

The benefits of stem cells are hotly debated in the medical community, and federal regulators have warned the public to beware of clinics that peddle unapproved injections as a cure-all. Many doctors and ethicists say they fear the public is being misled about how well stem cells work—and whether the procedures save their money or waste it.

"This definitely is not a high-quality, proven treatment," said Dr. Freddie Fu, chairman of orthopedic surgery at the University of Pittsburgh Medical Center.

Knee Pain and the Bottom Line

Health insurance typically doesn't cover stem cell injections, with the exception of certain accepted treatments, such as bone-marrow transplants for cancer and aplastic anemia. Aetna, the United States' third-largest health insurer, dismisses stem cells and platelet injections as experimental; Anthem, the country's second-biggest health insurance provider, classifies the injections as "not medically necessary." Without insurance coverage, patients are forced to pay out-of-pocket or forgo treatment.

So instead of dealing with disapproving insurance executives, Regenexx appeals directly to employers large enough to fund their own health plans. These businesses have the freedom to customize their plans, covering services that aren't part of a standard insurance package. Over half of U.S. workers insured through their jobs belong to such plans, according to the Employee Benefit Research Institute, a D.C.-based nonprofit.

Perhaps Regenexx's best-known corporate client is Des Moines-based Meredith Corp., which owns multiple TV and radio stations, as well as magazines such as Better Homes & Gardens. (Meredith owned Time magazine until September 2018.)

In a statement, Regenexx said its goal is to "replace more invasive surgical orthopedics" with nonsurgical options, noting that recent research has found many joint operations are ineffective. On its website, Regenexx claims its procedures "repair and regenerate damaged or degenerated bone, cartilage, muscle, tendons, and ligaments." In a bone marrow stem cell procedure, for example, a doctor withdraws bone marrow cells from a patient's hip, concentrates them, then reinjects them into a problem area, such as an arthritic knee. Doctors target the exact location in the joint using ultrasound. For a "platelet-rich plasma" treatment, doctors draw blood, concentrate the platelets, then inject them into the target area.

Regenexx, previously known as Regenerative Sciences, is one of the oldest stem cell companies in the U.S. When it opened its doors in 2005, it had only a handful of competitors. Today, there are more than 1,000 stem clinics in the U.S., said Leigh Turner, an associate professor at the University of Minnesota's Center for Bioethics, who has published a series of articles describing the stem cell market.

At times, Regenexx has clashed with the Food and Drug Administration. In 2010, for example, Regenexx sued the FDA, claiming the agency lacked the authority to regulate its procedures, which involved culturing stem cells before reinjecting them into patients. Regenexx lost its case and was countersued by the FDA, which charged that Regenexx was marketing an unapproved drug. In 2014, the U.S. Court of Appeals in Washington sided with the FDA, forcing Regenexx to stop performing the controversial procedures. Today, Regenexx performs this procedure only in the Cayman Islands, where the government allows it. The Cayman Islands, where there is less government regulation of health care, has become known as a medical tourism destination, Turner said.

Regenexx says that the treatments offered at its U.S. clinics comply with FDA regulations, which require that cells injected into patients undergo no more than "minimal manipulation."

On its website, Regenexx lists more than two dozen studies led by its doctors. For example, its chief medical officer, Dr. Chris Centeno, published a small study last year that found patients with knee arthritis who received bone marrow and platelets fared better than those randomly assigned to exercise therapy. Regenexx says it tries to be transparent about its results, noting that it posts data on patient results. In a statement, the company said most patients it treats for knee pain have good functioning five years later.

A Regenexx marketing booklet says 70% of orthopedic surgeries "can be completely avoided with a Regenexx procedure"—a claim Fu called "silly."

"There is zero evidence that you can replace 70% of surgeries with stem cells," he said.

Recent research suggests stem cells and platelets may work no better than placebos, Fu added. In a recent analysis, over 80% of patients with knee arthritis experienced a noticeable improvement in pain after receiving simple saltwater injections, writes Dr. Benjamin Rothrauff, a postdoctoral fellow who works with Fu at the University of Pittsburgh.

There's also no definitive evidence stem cells and platelets can regrow lost cartilage, Fu said. A 2018 review concluded platelets have "marginal effectiveness," and experts note that most published studies are so small or poorly designed that their results aren't reliable.

Is Regenexx Actually Saving Employers Money?

If Regenexx treatments worked as well as the company claims, insurance companies would rush to cover them, Turner said. But the notion that Regenexx will save employers money hasn't been proven and is "a boastful claim with no clinical merit," said Henry Garlich, director of health care value solutions and enhanced clinical programs at Blue Shield of California, who has reviewed Regenexx's publications.

"The problem is that we don't have enough data. When a company does not have this type of evidence, then they will go direct to the consumer market," Garlich said. "Some vulnerable individuals, including companies that want to reduce their health care costs, may buy what they're selling." If Regenexx procedures don't work, Garlich said, an employer could end up paying twice—once for stem cells and once for knee replacement.

Some employers are, in fact, skeptical. The Des Moines Public Schools has opted not to add Regenexx to its employee health plan, said Catherine McKay, director of employee services for the school system. She said a salesman for a local stem cell clinic, which has since merged with Regenexx, told her the treatments could save the school system lots of money. McKay wasn't sold.

"My experience with them has not been great, in terms of marketing and sales. They're very, very pushy," McKay said. "They claim they can get people back to work earlier" than surgery. "But if I still need knee surgery a year down the road, that doesn't cut my costs."

The Des Moines school system has agreed to consider covering Regenexx procedures as part of its workers' compensation program on a case-by-case basis, McKay said. The school system has not signed a contract with Regenexx, however, and hasn't included Regenexx in its health plan.

McKay said she knows of two school employees who have tried Regenexx. While one employee was satisfied with the results, McKay said, another "went through a couple procedures and ended up needing surgery anyway."

Corporate executives have become some of Regenexx's biggest boosters. Hy-Vee's former chairman and CEO, Ric Jurgens, appears in a Regenexx marketing brochure and says that he turned to Regenexx because of heel pain. The brochure, which was removed from a Regenexx website after Kaiser Health News began reporting this story, quotes Jurgens as saying, "I knew that giving our employees the chance to explore options besides surgery was in their best interest."

Hy-Vee did not make Jurgens or other employees available to interview.

Steve Lacy, Meredith's former CEO and current board chairman, said he underwent a Regenexx procedure two years after his company began covering stem cell treatments. He had been facing knee surgery and thought stem cells were worth a try. The procedure got him back to doing everything he wants to do, Lacy said, even running several days a week. He also has done daily physical therapy for over two years. "The rehab and recovery is far less onerous" with the Regenexx procedure than with surgery, Lacy said. "If the procedure doesn't work for an individual, there's no harm."

Meredith has spent about $400,000 in four years on 85 employees who have had Regenexx treatments, or about $4,700 a patient, said Meredith spokesman Art Slusark. That's a small share of the roughly $75 million a year that Meredith spends on its medical plan, he said.

At its headquarters, Meredith has promoted Regenexx procedures through email, posters and "lunch-and-learn" sessions in the office, said Jenny McCoy, Meredith's corporate communications director.

McCoy herself has become a poster child for Regenexx's benefits. She and two other Meredith employees appear with Lacy in a marketing video on the Regenexx site. Although McCoy had begun to experience knee and hip pain during exercise, she said in an interview that her pain was not severe enough to need surgery. McCoy underwent platelet injections two years ago and is pain-free today, she said.

"I thought, 'If Meredith is covering it, I might as well have it done early before [the pain] causes me too many problems,'" said McCoy, 52. Given the price tag, she said, "I would not have done it otherwise. I wouldn't have even known about it." In the Regenexx marketing video, Lacy is shown saying stem cells saved Meredith roughly $700,000 in one year. Lacy said he estimated that number by comparing what Meredith spent on Regenexx with what it would have spent on hip and knee replacements.

But Slusark said Meredith hasn't examined employee medical records to determine how many were eligible for surgery or how many needed joint surgery after trying Regenexx. "We don't spend a lot of time calculating savings," Slusark said.

Without that medical information, Meredith can't accurately estimate how much money it saved, if any, Fu said. He noted that relatively few people with joint pain undergo surgery, which doctors typically view as a last resort for patients who have exhausted all other treatment options. Although 14 million Americans have knee arthritis, the Arthritis Foundation estimates that doctors perform only about 757,000 knee replacements each year.

Before recommending joint replacement, doctors often tell patients to try exercise, physical therapy, weight loss, supportive shoe inserts or steroid injections, Garlich said. Physical therapy, in particular, helps many patients, said Fu; it's possible that PT, and not the stem cell injections, should get the credit for Lacy's recovery.

How the Patients Feel

Regenexx has posted video interviews of dozens of satisfied customers on its website, including a refinery worker treated for a non-healing wrist fracture, a snowboarder who had stem cell therapy in his knees and an avid weightlifter with multiple shoulder problems. All say Regenexx helped them.

Other Regenexx patients say the treatments wasted their time and money. Several patients who posted online reviews of the company agreed to be interviewed for this article.

One is Amanda Lynch, a 42-year-old Australian trapeze artist who lives in Montreal. Lynch said she spent $7,700 last year to treat an injured ligament at a Regenexx clinic in Colorado. Doctors administered a series of injections in her knee over several days, including platelets and her bone marrow, Lynch said. She shared copies of the emails she exchanged with the clinic, a bill from Regenexx and a document in which doctors evaluated her candidacy for treatment.

But within a few months, Lynch had to undergo surgery in Montreal for both knees, she said, paying an additional $16,100, according to her medical bill. Because Lynch is Australian, she was not eligible for free care in the Canadian health system and had to pay out-of-pocket.

Roland Jersevic, a 67-year-old lawyer living in Saginaw, Mich., said he needed knee replacement after his stem cell treatments failed to relieve his arthritis. Jersevic said he went to a Regenexx clinic in Toledo, Ohio, in 2015 to get help with severe arthritis in his knees, which had caused his legs to bow. "The pain was horrendous all the time," he said. Jersevic's medical bills, obtained for this article, show that he paid the clinic $7,500 out-of-pocket because his insurance wouldn't cover stem cell therapy. "They told me they were going to regrow my cartilage," he said, referring to Regenexx. "I wanted it to work."

Although the fat and bone marrow injections may have given Jersevic a "little bit" of temporary relief, his pain soon returned, he said. Regenexx offered to administer more injections, at an additional cost, Jersevic said. "At that point, I had lost all faith in what they were doing. To spend more money on a booster—what for? It wasn't working."

Jersevic had both knees replaced in summer 2016, his medical records show, and his insurance paid most of the bill. His knee pain is gone, and Jersevic said he felt well enough to return to track-and-field competitions—including hurdles and pole vaulting—in 2017.

"When your knees are that bad, it's not going to work for you," Jersevic said. "They should tell you it's not going to work for you. But they want the cash."

In response, Regenexx noted that many patients who undergo knee surgery are also unhappy with the results. Research suggests that up to one-third of those who have knees replaced continue to experience chronic pain, while one-fifth report that they are dissatisfied with the results of their surgery.

"We are disappointed to learn of any patients who didn't have a positive outcome," Regenexx said in a statement. "Our goal at Regenexx is to achieve the best possible clinical efficacy, and we are actively researching to find out why some patients respond better than others."

Sen. Alexander Details His Plan To Fix Surprise Medical Bills

KFF Health News, June 20, 2019

The provider community has pushed back on any attempt to set a 'benchmark' for physician pay, like the one in Alexander and Murray's bill.

This article was published by Kaiser Health News on June 19, 2019.

By Rachel Bluth, Kaiser Health News

Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.), who are pushing a major legislative package to lower health costs, announced their favored solution to handle disputes about surprise medical bills.

Those unexpected and often high charges patients face when they get care from a doctor or hospital that isn't in their insurance network are a perpetual complaint from consumers.

Alexander and Murray formally introduced their wide-ranging bill Wednesday, but they had offered a broad outline before without taking a stand on how to mediate between health care providers and patients on the surprise bills.

When a patient is seen by a doctor who isn't in their network, the Alexander-Murray bill says insurance would pay them the "median in-network rate," meaning the rate would be similar to what the plan pays other doctors in the area for the same procedure. If there aren't enough other doctors covered by the plan to compute a median in-network, the plan would use a database of local charges that is "free of conflicts of interest."

Alexander said in a written statement that his decision was swayed by an assessment by the Congressional Budget Office, which "indicated that the benchmark solution is the most effective at lowering health care costs."

According to early numbers from a CBO report, benchmarking could save $25 billion over the next 10 years. Loren Adler, associate director of USC-Brookings Schaeffer Initiative for Health Policy, said that means commercial insurance premiums would be reduced by about a half-percent.

"That's pretty significant for federal policy," Adler said.

The formula is similar to what a different group of bipartisan senators, led by Sen. Bill Cassidy (R-La.), proposed earlier this year. The critical difference is that in the Cassidy bill if the insurer and doctor can't agree on a median-in-network rate, they can take their case to an independent arbitrator.

The provider community has pushed back on any attempt to set a "benchmark" for physician pay, like the one in Alexander and Murray's bill.

At a hearing Tuesday before the Health, Education, Labor and Pensions Committee — of which Alexander and Murray are the chairman and ranking member, respectively — Tom Nickels, executive vice president of the American Hospital Association, said benchmarking would hurt efforts to set up broad insurance networks because providers and insurers would already know what they would be paid for surprise bills and it would be hard to recruit physicians to adequately staff hospitals.

"Health plans and hospitals have a long-standing history of resolving out-of-network emergency service claims, and this process should not be disrupted," he said in written testimony.

Alexander also pointed out that Rep. Frank Pallone (D-N.J.), chairman of the House Energy and Commerce Committee, and Rep. Greg Walden (R-Ore.), the ranking member of that committee, have also recommended this proposal.

Although it isn't the most aggressive solution the committee could have picked, according to Adler, it's still a positive step, and he said it was promising that an influential health committee in the Senate and an influential health committee in the House are on the same page.

"There's some logic to moving trains in the same direction," Adler said.

The Alexander-Murray legislation says that any care the patient receives would count toward their in-network cost sharing, like their deductible, coinsurance or copay.

Once they are stable and lucid after an emergency, patients must be given written notice that they are going to be seen by an out-of-network doctor, an estimate of how much that could cost, and a list of in-network doctors or facilities where they could seek care.

The bill specifies that the notice must be short, easy to read and that consent to see an out-of-network doctor is clearly optional. If the patient doesn't get this document, they can only be billed at an in-network rate.

Study: Arkansas Medicaid Work Requirement Hits Those Already Employed

KFF Health News, June 20, 2019

The study found no evidence that beneficiaries who lost coverage secured either jobs or other insurance coverage. In fact, it noted a dip in the employment rate among those eligible for Medicaid.

This article was published by Kaiser Health News on June 19, 2019.

By Phil Galewitz, Kaiser Health News

The Medicaid work requirement plan devised by Arkansas and approved by the Trump administration backfired because it caused thousands of poor adults to lose coverage without any evidence the target population gained jobs, a new study finds.

In fact, the requirement had only a limited chance for success as nearly 97% of Arkansas residents ages 30-49 who were eligible for Medicaid—those subject to the mandate—were already employed or should have been exempt from the new law, according to the study published Wednesday in the New England Journal of Medicine.

Yet the state's mandate—the first of its kind in the nation—resulted in 18,000 of the 100,000 targeted people falling off the Medicaid rolls. And despite administration officials' statements that many of them may have found jobs, the study by researchers at Harvard found no evidence they secured either jobs or other insurance coverage. In fact, it noted a dip in the employment rate among those eligible for Medicaid.

The researchers said the uninsured rate increased among 30- to 49-year-old Arkansans eligible for Medicaid from 10.5% in 2016 to 14.5% in 2018, while the employment rate fell from about 42% to just below 39%.

While the thousands of Arkansas residents losing Medicaid coverage has been documented since last year, the Harvard study is the first to provide evidence that the change left them uninsured and did not promote employment.

The results, based on a telephone survey of about 3,000 low-income adults in Arkansas, concluded that the law befuddled enrollees and that its mandatory reporting requirements led many to unnecessarily lose coverage.

"Lack of awareness and confusion about the reporting requirements were common, which may explain why thousands of individuals lost coverage," the researchers wrote.

Asked whether the findings mean the administration should pull the plug on work requirements, co-author Benjamin Sommers, a professor of health policy and economics at Harvard, replied, "It's time for them to pump the brakes at the very least."

As millions of nondisabled adults gained Medicaid coverage following the 2010 passage of the Affordable Care Act, conservatives pushed for requiring people to work or do other kinds of "community engagement" to keep their Medicaid, much as food stamps and welfare cash benefit programs do. The Trump administration embraced that ideal and has made Medicaid work requirements a central feature of its plan to restructure the federal-state entitlement program, which has more than 70 million enrollees.

Arkansas put the plan into action in spring 2018.

But in March, a federal judge struck down Arkansas' mandate and a plan to begin one in Kentucky. U.S. District Judge James Boasberg ruled the work requirement violated federal law because it failed to meet the core objective of Medicaid — getting medical coverage to the poor.

The Trump administration is appealing that ruling and, meanwhile, has approved similar plans in eight other states, including New Hampshire, which is scheduled to start cutting coverage in August for those not meeting the rules. New Hampshire's law also is being challenged in court by Medicaid advocates.

Six more states have pending applications to add work mandates.

Seema Verma, administrator of the Centers for Medicare & Medicaid Services, defends the work requirements, saying they "are not some subversive attempt to just kick people off of Medicaid. Instead, their aim is to put beneficiaries in control with the right incentives to live healthier, independent lives."

Arkansas officials disputed the thrust of the study, noting that the requirement was short-lived because the judge intervened before it was in effect even a year and researchers did not find out why people who were dismissed from Medicaid didn't reapply.

"So you cannot describe this as the robust evaluation that we want and expect of a demonstration project that truly has national significance," said Amy Webb, a spokeswoman for the state's Medicaid program. "The best way to get answers to everyone's questions about the impact of work and community engagement requirements would be to let Arkansas continue what was started and conduct a true evaluation that follows people over time."

Under the Arkansas law, targeted enrollees were notified by the state via mail and informational flyers that they were required to work 80 hours a month, participate in another qualifying activity such as job training or community service, or meet criteria for an exemption such as pregnancy, a disability or parenting a child.

If they were out of compliance for three months during a calendar year or failed to report their status to the state through online reports, they could lose coverage.

For the first several months of its new mandate, Arkansas required enrollees to use an online portal for that reporting, a problem since 20% lacked internet access and another 20% lacked fast broadband. The state online portal also was unavailable after 9 p.m. each day.

The study found one-third of individuals subject to the policy had not heard anything about it, and 44% were unsure whether the requirements applied to them.

The findings back up arguments from advocates for the poor and nonpartisan experts that many Medicaid enrollees already have jobs. They also directly contradict claims by federal and Arkansas officials that many of those who lost coverage found a job.

In a hearing before the Senate Finance Committee earlier this year, Health and Human Services Secretary Alex Azar noted that only 1,452 of the 18,000 people who lost coverage because of the work requirement rules reapplied for Medicaid. He added that likely meant most no longer needed the government assistance.

"That seems a fairly strong indication that those people got a job and insurance elsewhere and didn't need the coverage," Azar said.

Sommers said the Arkansas experiment answers many questions about how work requirements could function nationally, although he acknowledged that other states might do a better job promoting the program and making it easier for enrollees to report their status.

"There are just not that many people [enrolled in Medicaid] who aren't working but could," Sommers said.

He noted Arkansas added the work requirement feature without adding new funding for job training or child support to help people who want to work.

Federal officials who approve the waivers allowing states to use work requirements should take note of the results, he said. "It does not make sense to keep approving the same waiver without doing anything differently," Sommers said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

1 In 6 Insured Hospital Patients Get A Surprise Bill For Out-Of-Network Care

KFF Health News, June 20, 2019

As many as 26% of admissions from the emergency room resulted in a surprise medical bill.

This article was published by Kaiser Health News on June 20, 2019.

By Rachel Bluth, Kaiser Health News

About 1 in 6 Americans were surprised by a medical bill after treatment in a hospital in 2017 despite having insurance, according to a study published Thursday.

On average, 16% of inpatient stays and 18% of emergency visits left a patient with at least one out-of-network charge. Most of those came from doctors offering treatment at the hospital, even when the patients chose an in-network hospital, according to researchers from the Kaiser Family Foundation. Its study was based on large employer insurance claims. (Kaiser Health News is an editorially independent program of the foundation.)

The research also found that when a patient is admitted to the hospital from the emergency room, there's a higher likelihood of an out-of-network charge. As many as 26% of admissions from the emergency room resulted in a surprise medical bill.

"Millions of emergency visits and hospital stays left people with large employer coverage at risk of a surprise bill in 2017," the authors wrote.

The researchers got their data by analyzing large-employer claims from IBM's MarketScan Research Databases, which include claims for almost 19 million individuals.

Surprise medical bills are top of mind for American patients, with 38% reporting they were "very worried" about unexpected medical bills.

Surprise bills don't just come from the emergency room. Often, patients will pick an in-network facility and see a provider who works there but isn't employed by the hospital. These doctors, from outside staffing firms, can charge out-of-network prices.

"It's kind of a built-in problem," said Karen Pollitz, a senior fellow at the Kaiser Family Foundation and an author of the study. She said most private health insurance plans are built on networks, where patients get the highest value for choosing a doctor in the network. But patients often don't know whether they are being treated by an out-of-network doctor while in a hospital.

"By definition, there are these circumstances where they cannot choose their provider, whether it's an emergency or it's [a doctor] who gets brought in and they don't even meet them face-to-face."

The issue is ripe for a federal solution. Some states have surprise-bill protections in place, but those laws don't apply to most large-employer plans because the federal government regulates them.

"New York and California have very high rates of surprise bills even though they have some of the strongest state statutes," Pollitz said. "These data show why federal legislation would matter."

Consumers in Texas, New York, Florida, New Jersey and Kansas were the most likely to see a surprise bill, while people in Minnesota, South Dakota, Nebraska, Maine and Mississippi saw fewer, according to the study.

Legislative solutions are being discussed in the White House and Congress. The leaders of the Senate Health, Education, Labor and Pensions Committee introduced a package Wednesday that included a provision to address it. The legislation from HELP sets a benchmark for what out-of-network physicians will be paid, which would be an amount comparable to what the plan is paying other doctors for that service.

That bill is set for a committee markup next week.

Other remedies are also being offered by different groups of lawmakers.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Good Health Goes Beyond Having A Doctor And Insurance, Says AMA's Equity Chief

KFF Health News, June 19, 2019

Aletha Maybank, MD, a pediatrician, is talks to Kaiser Health News about her challenges and priorities as the American Medical Association's Equity Chief.

This article was first published on Wednesday, June 19, 2019 in Kaiser Health News.

By Carmen Heredia Rodriguez

Part of Dr. Aletha Maybank's medical training left a sour taste in her mouth.

Her superiors told her not to worry about nonmedical issues affecting her patients' quality of life, she said, because social workers would handle it. But she didn't understand how physicians could divorce medical advice from the context of patients' lives.

"How can you offer advice as recommendations that's not even relevant to how their day-to-day plays out?" Maybank asked.

Today, Maybank is continuing to question that medical school philosophy. She was recently named the first chief health equity officer for the American Medical Association. In that job, she is responsible for implementing practices among doctors across the country to help end disparities in care. She has a full agenda, including launching the group's Center for Health Equity and helping the Chicago-based doctors association reach out to people in poor neighborhoods in the city.

A pediatrician, Maybank previously worked for the New York City government as deputy commissioner for the health department and founding director of the city's health equity center.

Carmen Heredia Rodriguez of Kaiser Health News recently spoke with Maybank about her new role and how health inequities affect Americans. This transcript has been edited for length and clarity.

Q: Can you tell me what health equity means to you, and what are some of the main drivers that are keeping health inequitable in this country?

The AMA policy around health equity is optimal health for all people.

But it's not just an outcome; there's a process to get there. How do we engage with people? How do we look at and collect our data to make sure our practices and processes are equitable? How do we hire differently to ensure diversity? All these things are processes to achieve health equity.

In order to understand what produces inequities, we have to understand what creates health. Health is created outside of the walls of the doctor's office and at the hospital. What are patients' jobs and employment like? The kind of education they have. Income. Their ability to build wealth. All of these are conditions that impact health.

Q: Is there anything along your career path that really surprised you about the state of healthcare in the U.S.?

There's the perception that all of our health is really determined by whether you have a doctor or not, or if you have insurance. What creates health is much beyond that.

So if we really want to work on health and equity, we have to partner with people who are in the education space and the economic space and the housing spaces, because that's where health inequities are produced. You could have insurance coverage. You could have a primary care doctor. But it doesn't mean that you're not going to experience health inequities.

Q: Discrimination based on racial lines is one obvious driver of health inequities. What are some of the other populations that are affected by health inequity?

I think structural racism is a system that affects us all.

It's not just the black-white issue. So, whether it's discrimination or inequities that exist among LGBT youth and transgender [or] nonconforming people, or if it's folks who are immigrants or women, a lot of that is contextualized under the umbrella of white supremacy within the country.

Q: And what are some of your priorities?

A large part of my work will be how I build the organizational capacity to better understand health equity. The reality in this country is folks aren't comfortable talking about those issues. So, we have to destigmatize talking about all of this.

Q: Are there any particular populations or relationships that you plan to focus on?

The AMA excluded black physicians until the 1960s. So one question is, How do we work to heal relationships as well as understand the impact of our past actions? AMA definitely issued an apology in the early 2000s, and my new role is also a step in the right direction. However, there is more that we can and should do.

Another priority now is, How do we work, and who do we work with, in our own backyard of Chicago? What can we do to work directly with people experiencing the greatest burden of disease? How do we ensure that we acknowledge the power, assets and expertise of communities so that we have the process and solutions driven and led by communities? To that end, we've begun working with West Side United via a relationship at Rush Medical Center. West Side United is a community-driven, collective neighborhood planning, implementation and investment effort geared toward optimizing economic well-being and improved health outcomes.

Q: Is there anything else you feel is important to understand about health equity?

Health equity and social determinants of health have become jargon. But we are talking about people's lives. We were all born equal. We are clearly not all treated equal, but we all deserve equity. I don't live outside of it, and none of us really do. I am one of those women who were three to four times more likely to die at childbirth because I'm black. So I don't live outside of this experience. I'm talking about my own life.

Carmen Heredia Rodriguez: CarmenH@kff.org, @ByCHRodriguez

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Aletha Maybank, MD, a pediatrician, is talks to Kaiser Health News about her challenges and priorities as the American Medical Association's Equity Chief.

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