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

In championing 'Medicare-for-all,' politicians put forth an idea: universal healthcare, or some system in which everyone can afford medical care. But their visions for achieving that vary wildly.

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

By Shefali Luthra

Democrats with 2020 presidential aspirations are courting the party’s increasingly influential progressive wing and staking out ambitious policy platforms.

Front and center are three words: Medicare. For. All.

That simple phrase is loaded with political baggage, and often accompanied by vague promises and complex jargon. Different candidates use it to target different voter blocs, leading to sometimes divergent, even contradictory ideas.

"People are talking about this as a goal, as a commitment, as a value as much as a specific program," said Celinda Lake, a Democratic pollster.

In championing "Medicare-for-all," politicians often put forth a general idea: universal health care, or some system in which everyone can afford medical care. But their visions for achieving that vary wildly.

Sometimes Medicare-for-all is meant to promise a single-payer health care system —meaning everyone is covered by one, often government-run health plan. In other cases, politicians who say they support "for all" actually mean "for more."

Every proposal brings its own trade-offs.

"There's not just one easy answer to what a single-payer system would do to the United States," said Jodi Liu, an economist at the nonprofit Rand Corp. who studies single-payer proposals. "What happens depends on how that change is being designed, and how it's being implemented."

Here's a primer on the Medicare-for-all debate. Keep it in your back pocket: This argument won't be disappearing anytime soon. 

Isn't Medicare-for-all what it sounds like? Medicare for everybody?

Not quite. But also, kind of.

Politicians talking about Medicare-for-all typically mean one of two things. It's either a specific proposal in which every American is covered by the same, single health plan, or the general idea that anyone has the option to get healthcare through Medicare.

The first understanding is outlined in a bill from Sen. Bernie Sanders (I-Vt.). Co-sponsors include Senate Democrats like Elizabeth Warren of Massachusetts, Kamala Harris of California, Cory Booker of New Jersey, Kirsten Gillibrand of New York and Jeff Merkley of Oregon. All have either announced a run for president or indicated they are strongly considering one.

And they are talking about this on the campaign trail.

Sanders' bill would outlaw private insurance where it competes with the public plan and change Medicare substantially by eliminating copays and other cost sharing, while expanding the program to cover long-term care, prescription drugs, dental care and vision. (As the bill is written, it's hard to see what would be left for private plans to cover.)

The program would phase in over four years and cover every American. And it's worth noting that, though many countries run a single-payer system, none offers all of those "expanded" benefits because the expense could be enormous. Also, many single-payer programs do require a degree of cost sharing, involving small copayments or deductibles.

In other cases, the "Medicare-for-all" phrase has been repurposed.

The midterms saw a wave of Democrats campaigning on it. But beyond the buzzwords, what they were actually talking about was lowering Medicare's eligibility age or giving people the option to buy in or join the program. This would leave the private insurance industry intact. It would also preserve Medicare Advantage, in which the government pays private companies to run Medicare plans.

For many voters, it's less about granular details and more about the principle, Lake suggested: "The highest level of support is when you talk about [Medicare-for-all] generally."

So are Democrats saying we should get rid of private insurance?

Democrats who have signed on to Sanders' bill have endorsed legislation that would outlaw virtually all private health insurance. That's controversial.

Private insurance covers the largest share — 56% in 2017 — of Americans. And voters are often afraid of losing what they have if it's uncertain they'll get something better in exchange. Just ask then-President Barack Obama, whose Affordable Care Act-related promise that "if you like your plan, you can keep it" sparked sharp backlash after proving untrue.

This gets at a key question: Can Medicare-for-all advocates convince voters they'll replace their health plans with something better?

After all, most Americans say they support Medicare-for-all. But some of the same polls indicate that most people with employer-sponsored insurance think their coverage would be unaffected by the switch. That’s false.

Critics also say eliminating private insurance could gut a major sector of the health economy. As of December 2018, private health coverage was directly responsible for almost 540,000 jobs, according to the Bureau of Labor Statistics. Economists note, though, that predicting how many jobs would go away — versus how many could be absorbed by the new system — is difficult, as is projecting any macroeconomic impact.

The magnitude of such a change underscores why some Democrats are trying to tread lightly for fear of land mines.

When probed on Medicare-for-all, Harris said she supported eliminating private insurance — while also saying she would, in the interim, back other bills that expand access to health care. Warren, in a televised interview, sidestepped specifics altogether. And Booker told reporters he would not outlaw private healthcare, noting that many other countries have achieved universal coverage without taking this step.

For example, Germany has universal healthcare but leaves private insurance intact, while heavily regulating the industry and requiring plans be not-for-profit.

So what other options are Democrats talking about?

Voters should get familiar with two other ideas: lowering Medicare's eligibility age, and the "public option," either through a Medicare or Medicaid buy-in.

These concepts are decidedly not Medicare-for-all — think "Medicare for more" or Medicaid for more."

Lowering the eligibility age loops more people into the current system and is seen by advocates as a potential step toward single-payer, said Alex Lawson, head of the left-leaning Social Security Works, who has been involved in drafting Medicare-for-all legislation.

The public option lets people purchase coverage through Medicare or Medicaid. It has attracted criticism from Democrats aligned with the Sanders wing, who argue it's settling for less.

Senate Democrats have introduced bills advancing such ideas — including Merkley, who pushed a Medicare-based public option to let individuals and employers buy Medicare coverage, while also attaching himself to Sanders' measure. A proposal from Sens. Tim Kaine (D-Va.) and Michael Bennet (D-Colo.) would extend that option only to individuals. (Bennet is also purportedly weighing a 2020 bid.)

Said Liu, the health economist: "The devil is in the details."

Shouldn't we consider who would pay? Would this make things better?

Any health system comes with trade-offs, winners and losers. Would Medicare-for-all mean higher taxes? Probably. Opponents would definitely say it does, an argument that, polling shows, weakens support.

Would the average person pay more? That’s hard to know.

People would not pay what they currently do for health insurance, an outlay that's only getting more expensive. They would also likely get more generous health coverage. And lawmakers are pitching various other bills — see Warren's wealth tax, Sanders' estate tax or the 70% marginal tax on the wealthy touted by Rep. Alexandria Ocasio-Cortez (D-N.Y.) — that backers argue would generate revenue to pay for something like Medicare-for-all.

Perhaps more significant, at least politically, are the implications for healthcare stakeholders like hospitals, insurers and drugmakers. All stand to lose under single-payer, especially if it's used to bring down health care costs. They're already working to make their opposition felt. (That said, opposition from the health industry is not universal.)

When Democrats say they want Medicare-for-all, then do they really mean single-payer?

There has been a lot of brouhaha on this.

Take the backlash when Harris, after backing single-payer, said she also supported "Medicare-" and "Medicaid for more"-type policies. Her spokesman compared that to "wanting a burrito" while being willing to accept tacos in the meantime.

Of course, Harris isn't the only one to straddle those plans. Merkley, Gillibrand, Booker and Warren have put their names to multiple health reform bills. So, in fact, has Sanders, who voted to support, among other bills, the Affordable Care Act — decidedly not single-payer.

So are Democrats wavering? Is saying "Medicare-for-all," or even single-payer, a hook to win votes, or a bargaining strategy to end up with a public option instead?

It just isn't that simple.

"None of us can see into the hearts of anybody. And it's not a low-bar thing to sponsor a bill," said Lawson of Social Security Works. In a presidential campaign, though, "people will want to hedge."

But, he added, Medicare-for-all's popularity — even as a concept — shows something significant.

"There is a consensus that the current system needs to fundamentally transform," he said. "There's a commitment to do that. Then we have to argue out the details."

Shefali Luthra: ShefaliL@kff.org, @Shefalil

Utah's proposal to limit federal and state funding on Medicaid is a radical change. Anti-poverty advocates are concerned that caps could limit how many people are enrolled and restrict services.

This article was published February 14, 2019, by Kaiser Health News.

By Phil Galewitz

Utah this week became the 35^th state to approve expanding Medicaid under the Affordable Care Act, but advocates for the poor worry its unusual financing could set a dangerous precedent and lead to millions of people losing coverage across the country.

That’s because the plan includes unprecedented annual limits on federal and state spending.

Those restrictions would be a radical change for Medicaid. Since it began in 1966, the state-federal health program for low-income residents has been an open-ended entitlement for anyone who meets eligibility criteria. State and federal spending must keep pace with enrollment.

Joan Alker, executive director of the Georgetown University Center for Children and Families, is concerned that the state and federal Medicaid funding caps can limit how many people are enrolled and what services they receive. She said no state has before tried to cap its own funding.

"This is a way for the state to look like it's doing expansion when they are really doing very little," she said.

If Utah's plan is approved, Alker added, other states that have already expanded Medicaid and some that are considering it will likely seek to strike a similar deal.

Limiting spending on Medicaid has been a longtime goal of fiscal conservatives, but opposition to the idea helped blow up Republican efforts to repeal and replace the ACA in 2017.

Also fueling criticism: The law signed by Utah Gov. Gary Herbert on Monday expands Medicaid only to people earning up to 100% of the federal poverty level instead of the 138% mark set by the ACA and approved by Utah voters in a referendum supporting expansion in November. Both the Obama and Trump administrations have refused in the past to accept that condition.

The proposal also includes a work requirement for adults who gain coverage through the expansion.

Utah's proposal needs federal approval, and state officials said they hope to have that in time to expand Medicaid to 90,000 adults on April 1.

The state expects to adopt annual spending caps after negotiations with the Trump administration.

Congressional Republicans and President Donald Trump tried to cap federal Medicaid payments as part of their health law repeal efforts in 2017. But that move met stiff opposition from Democrats, hospital and patient advocates and some Republican lawmakers. They warned it would lead to cuts in benefits and enrollment.

Utah's proposal to limit federal spending was necessary to get the Trump administration to approve its application to only partially expand Medicaid, the state’s top Medicaid official said.

"We were looking for a way to make our waiver more attractive to the federal government," said Nathan Checketts, Utah's Medicaid director.

He said the Trump administration last year was skeptical of the state’s proposal to expand Medicaid to adults with incomes below 100% of the federal poverty level — about $12,500 annual income for an individual — instead of 138% of the poverty level, about $17,000 in annual income. That’s because it would mean higher federal spending, since people earning between 100% and 138% of poverty would be eligible for federal subsidies to help pay for premiums for insurance they buy on the ACA exchange.

By capping funding at a negotiated per capita rate, the federal government could better control its spending, Checketts said.

Under Trump, the federal Centers for Medicare & Medicaid Services has not approved requests by Arkansas and Massachusetts to get the higher federal match rate for partial expansion.

CMS, Checkett added, has been open to a deal since after Election Day. "They've become more receptive to our request than they were last year, but there are no guarantees," he said.

Under the proposed deal, the federal government would pay 90% of the costs for anyone coming into Medicaid through expansion — the rate set by the ACA. In traditional Medicaid, the state receives a 70% federal match.

The federal spending cap would vary based on how many people are enrolled under expansion. If the costs for covering the expansion population exceeded the federal spending cap, the state could limit how many people it enrolled, Checketts said.

The law also includes a state funding cap so Utah officials can limit enrollment if spending were to exceed the budget, Checketts said. The federal government would also have to approve a state spending cap.

"The state has to balance its budget every year, and this allows the state to align its budget and a certain amount of money to put toward this population and not any more," he said.

If CMS does not grant the waiver for a partial expansion, the bill requires the state to establish a full expansion in 2020.

Jessie Mandle, senior health policy analyst for Voices for Utah Children, an advocacy group, said the plan is tough to swallow for advocates who have been fighting for expansion for more than six years.

"This will create more barriers and restraints to care," she said. "This was not the way voters chose to expand."

Utah's plan to seek a per capita spending cap comes even though the state’s per capita Medicaid spending is among the lowest, according to a report last year by the Utah Foundation, a nonpartisan research group.

The average cost for each Medicaid enrollee in Utah was $5,326 in 2014, the most recent year for which that figure is available, the report found. That number was the 10th lowest in the United States.

Nationwide, Utah also had the lowest percentage of its population enrolled in Medicaid as of 2016, the report said.

Phil Galewitz: pgalewitz@kff.org, @philgalewitz

Experts say most providers are vigilant in properly storing their vaccines, but a recent spate of problems related to improper storage and packaging has led to concerns that the vaccines administered are less than effective.

This article was published February 12, 2019, by Kaiser Health News.

By Carmen Heredia Rodriguez

By correcting one potential error, the Ventura County (Calif.) Health Care Agency accidentally made another — and jeopardized vaccines given to thousands of people in the process.

In October 2017, county health officials, concerned that vaccines were getting too warm while being transported to clinics, changed their protocol. But a routine audit in November found that the ice packs they were using may have frozen some of the medicines and lowered their effectiveness. The agency then offered to reimmunize everyone who had received a vaccine that was delivered in faulty packaging.

"There's no way to tell whether or not they were ineffective," said Jason Arimura, director of pharmacy services for Ventura County Medical Center. Out of an abundance of caution, "we just notified everyone."

The number of patients affected: 23,000.

Ventura County is far from the only case of vaccines feared to be ineffective reaching patients. In the past 13 months alone, 117 children received possibly compromised vaccines against polio, meningococcal disease and the human papillomavirus at an Indian Health Service clinic in Oklahoma City because of improper refrigeration. Similar issues with temperature control prompted a health clinic in Indianapolis to send letters offering to revaccinate 1,600 people last January, according to local news reports.

Last week, Kentucky officials announced that potentially ineffective and contaminated vaccines were administered at multiple businesses across Kentucky, Ohio and Indiana. The statement did not disclose how many people were affected.

The federal government sets standards on the storage of vaccines. However, not all healthcare providers are accountable under those guidelines.

The Vaccines for Children (VFC) program, which offers these drugs at no cost for kids from low-income families, requires clinics, doctors and other providers to undergo annual audits and use top-grade equipment, such as continuous temperature-monitoring devices. It also requires that problems be reported to federal authorities.

More than 44,000 doctors participate in the program and provide vaccines to 90% of the children in the country, according to the Centers for Disease Control and Prevention.

But medical facilities outside of the program — like many pharmacies and internists with private practices who are treating adults or children not in the VFC program — have no comparable federal oversight. In fact, storing vaccines and reporting cases of patients receiving ineffective drugs is largely up to their discretion. The vaccines involved in the Ventura County recall were not part of the Vaccines for Children program.

Experts said most hospitals, clinics and doctors are vigilant in properly storing their vaccines. And research suggests that compromised vaccines given to patients are not harmful.

L.J Tan, chief strategy officer for the nonprofit vaccination advocacy group Immunization Action Coalition, said the nation's vaccine stock is likely one of "the safest in the world."

But improperly handling these medications means wasting expensive drugs, and using compromised vaccines "could create a pocket of underimmunized individuals," said Dr. Julie Boom, a pediatrician and director of the immunization project at Texas Children’s Hospital. "And we don't want that to happen."

In Ventura County, the temperature problems affected vaccines for flu, tetanus, diphtheria, whooping cough and hepatitis B. County health officials told patients who had received tuberculosis testing and some who had received penicillin to treat syphilis that their medicines also may have been compromised.

Through January, approximately 1,200 have come back to be revaccinated, Arimura said. Revaccinating all 23,000 people would cost $1.3 million, he added.

Vaccines are extremely sensitive to temperature fluctuations. In some cases, exposing a vaccine to the wrong environment once can effectively kill live viruses and harm proteins in the vaccines, said Tan. Generally, temperature problems occur during transportation of medicines.

Without proper monitoring, it is nearly impossible to tell whether vaccines have been exposed to extreme temperatures, said Boom.

A 2012 report by the inspector general at the Department of Health and Human Services found that, in a two-week period, three-quarters of the 45 healthcare providers who were sampled — all of which participated in the Vaccines for Children program — exposed their vaccines to improper temperatures for at least five cumulative hours.

A separate study by researchers at the federal Centers for Disease Control and Prevention published in 2015 found that 23% of the vaccination errors reported to the federal surveillance system from 2000 to 2013 involved improper storage or the use of expired vaccines.

Since these reports, the CDC put in place additional requirements for the children’s program, including recording the minimum and maximum temperature of the vaccine storage unit daily.

Dr. Paul Hunter, associate professor of family medicine and community health at the University of Wisconsin, said the federal oversight is "very good."

"In the big picture, they do it very consistently," he said.

For doctors and clinics outside the federal surveillance system, financial concerns often force them to take special care with vaccines and similar medicines. One vaccine dose can cost hundreds of dollars.

Sanford Health, a South Dakota-based health care system with operations across the Midwest, is working to make the federal requirements the standard for vaccines among its health care providers. The system started Vax Champ, a six-month training program for nurses to learn how to store and handle vaccines. The program requires participants to periodically take photos of their vaccine stocks and send in a list of all their inventory for review.

Funding for the program came from the vaccine manufacturer Sanofi Pasteur.

Andrea Polkinghorn, immunization strategy leader for Sanford Health, said vaccine storage systems vary widely among providers. Purchasing pharmaceutical-grade storage equipment is costly, she said, and providers are in different phases of the upgrade.

"But when you compare that to the projected loss of vaccines," Polkinghorn said, "the end is worth the means."

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