Immunocompromised Patients Worry Vaccine Exemptions Put Them in Peril

KFF Health News, March 22, 2022

Montana Gov. Greg Gianforte's office estimates that "thousands of healthcare workers" have obtained religious exemptions and "remain in the workforce."

This article was published on Tuesday, March 22, 2022 in Kaiser Health News.

By Aaron Bolton

Charlie O'Neill received part of her husband's liver in a 2013 living donor transplant and has been taking drugs that suppress her immune system ever since to prevent her body from attacking the organ.

"I frequently get infections," she said. "Just being an immune-compromised person, you are faced with just every little cold and flu."

O'Neill lives in the small town of Pony in southwestern Montana's Madison Valley. Despite living in an uncrowded rural setting, O'Neill said, the first year of the coronavirus pandemic was terrifying. She rarely left home, waiting for COVID-19 vaccines to become available.

Even now, after being vaccinated, O'Neill said the virus is always on her mind when she drives into nearby Bozeman for groceries and other basic needs. She wears a mask and avoids people as much as she can. While vaccinations provide robust protection against hospitalization and death for the typical individual, they are far less effective in those who are immunocompromised.

O'Neill developed abscesses on her liver, requiring daily visits to the Bozeman hospital for antibiotic infusions. In a state where the governor has encouraged health workers to seek vaccination exemptions, she worried about which of the many people involved in her care were instead putting her at risk: the people checking her in at the front desk, the traveling nurses, the imaging technicians?

Gov. Greg Gianforte's office estimates that "thousands of healthcare workers" have obtained religious exemptions and "remain in the workforce," according to a recent press release.

"I so boldly ask people often just if they're vaccinated, especially if I have to take my mask off for MRIs or something like that," O'Neill said. She said she'd request someone else if a worker told her he or she were unvaccinated or declined to answer, but that hasn't happened.

Most medical staffers across the U.S. are now required to be fully vaccinated against COVID under a federal Centers for Medicare & Medicaid Services rule. While, legally, requests for religious or medical exemptions must be allowed at every institution, in much of the country they are reviewed carefully and approved judiciously. In New York City's 12-hospital public system, for example, 100% of staff members inside the hospitals are vaccinated; the few who were granted exemptions are assigned outside tasks.

But in Montana, the pendulum has swung in a different direction.

Gianforte, a Republican who opposed the federal mandate, encouraged health workers to seek religious exemptions before the Feb. 14 deadline to receive one dose of vaccine. His administration provided guidance to hospitals that said the validity of healthcare workers' religious beliefs shouldn't be questioned in seeking exemptions. Gianforte also told the state health department to create an application for religious exemptions, which is posted at the top of its website to download.

When asked for an interview with Gianforte, spokesperson Brooke Stroyke referred to the governor's open letter to health workers dated Feb. 10.

"The State of Montana will continue to press its claims that the mandate is unconstitutional or otherwise unlawful in the district and appellate courts," the letter read. "In the meantime, however, I urge those of you who are unvaccinated to consider using the religious and medical exemptions that your employers are required to offer, as well as talk to your colleagues or personal health provider about getting vaccinated."

The Equal Employment Opportunity Commission said that employers should assume a request for a religious exemption is based on sincerely held beliefs, but that if there is an objective basis for questioning the request, the employer is justified in making a limited factual inquiry.

There's no way of knowing just how many healthcare workers remain unvaccinated at any facility. Many hospitals across the state are unwilling to share the data.

Out of nearly 65 hospital facilities statewide, 11 shared their exemption rates with Montana Public Radio, Yellowstone Public Radio, and KHN. Those rates range from under 1% at two critical access hospitals operated by the U.S. Indian Health Service to 37% at Prairie Community Hospital in Terry. Four facilities reported that a quarter or more of their workers had exemptions.

Prairie Community Hospital CEO Burt Keltner said he didn't question exemption requests because losing nearly 40% of his staff would close the hospital.

"Some of the people that had made the choice that they did not want to get the vaccine were some of our best employees," he said.

Montana Hospital Association CEO Rich Rasmussen said one reason most hospitals are leery of sharing how many workers remain unvaccinated is a law passed last year prohibiting discrimination based on vaccination status. Hospitals fear that even providing percentages of unvaccinated workers could spell legal trouble for them, he said.

Centers for Disease Control and Prevention spokesperson Martha Sharan said the agency will soon publish national vaccination rates for medical staffers in CMS-certified acute care hospitals. She added that the dashboard could eventually include national data from other medical facilities participating in certain CMS programs.

CMS will post facility-level vaccination rates from those facilities on its Care Compare website in October, CMS spokesperson Beth Lynk said.

An analysis of voluntarily reported data by the CDC found that nationwide 70% of staff members at medical facilities were vaccinated as of mid-September but noted lower vaccination rates were likely in rural areas. That was before the Biden administration announced the CMS vaccine mandate, and rates have likely increased since.

Paul Conway, chair of policy and global affairs at the American Association of Kidney Patients, said the lack of transparency around COVID vaccination rates for medical workers puts immunocompromised patients in a bind.

"During COVID, if you're in a dialysis center where you're in there for hours, you're having blood exchanged, you're around a lot of different workers, you're around a lot of different patients, your susceptibility is very high," he explained.

A University of Michigan study found that a quarter of patients on dialysis died if they contracted COVID. That study used data from 2020, when vaccines weren't available until December.

Conway said the kidney patients' association wants CMS to make vaccination rates for hospitals and dialysis centers public to help patients make informed decisions. But for the time being, he said, they are on their own. That leaves them in the uncomfortable position of interrogating caregivers about their vaccination status at a time when that is a charged issue in much of the country.

"Patients always do have the right and the freedom to ask the question and, similarly, doctors and nurses also have the freedom to answer the question or not," said Joel Wu of the University of Minnesota's Center for Bioethics. "I think answering the question truthfully is important because I think it builds trust."

Roger Gravgaard, a 62-year-old kidney transplant recipient from Billings who serves as a patient advocate for kidney disease organizations, said unvaccinated staffers need to understand there are real consequences for patients like him. He is grateful all his providers have been forthcoming about being vaccinated without his even having to ask, he said.

"I feel better knowing that they're vaccinated and I would hope that they have the same feeling knowing that I've been vaccinated, because it's a two-way street," he said.

As a Former Nurse Faces Prison for a Deadly Error, Her Colleagues Worry: Could I Be Next?

KFF Health News, March 22, 2022

RaDonda Vaught's prosecution is a rare example of a healthcare worker facing years in prison for a medical error.

This article was published on Tuesday, March 22, 2022 in Kaiser Health News.

By Brett Kelman

NASHVILLE, Tenn. — Four years ago, inside the most prestigious hospital in Tennessee, nurse RaDonda Vaught withdrew a vial from an electronic medication cabinet, administered the drug to a patient, and somehow overlooked signs of a terrible and deadly mistake.

The patient was supposed to get Versed, a sedative intended to calm her before being scanned in a large, MRI-like machine. But Vaught accidentally grabbed vecuronium, a powerful paralyzer, which stopped the patient's breathing and left her brain-dead before the error was discovered.

Vaught, 38, admitted her mistake at a Tennessee Board of Nursing hearing last year, saying she became "complacent" in her job and "distracted" by a trainee while operating the computerized medication cabinet. She did not shirk responsibility for the error, but she said the blame was not hers alone.

"I know the reason this patient is no longer here is because of me," Vaught said, starting to cry. "There won't ever be a day that goes by that I don't think about what I did."

If Vaught's story followed the path of most medical errors, it would have been over hours later, when the Board of Nursing revoked her RN license and almost certainly ended her nursing career. But Vaught's case is different: This week she goes on trial in Nashville on criminal charges of reckless homicide and felony abuse of an impaired adult for the killing of Charlene Murphey, a 75-year-old patient who died at Vanderbilt University Medical Center on Dec. 27, 2017.

Prosecutors do not allege in their court filings that Vaught intended to hurt Murphey or was impaired by any substance when she made the mistake, so her prosecution is a rare example of a healthcare worker facing years in prison for a medical error. Fatal errors are generally handled by licensing boards and civil courts. And experts say prosecutions like Vaught's loom large for a profession terrified of the criminalization of such mistakes — especially because her case hinges on an automated system for dispensing drugs that many nurses use every day.

The Nashville district attorney's office declined to discuss Vaught's trial. Vaught's lawyer, Peter Strianse, did not respond to requests for comment. Vanderbilt University Medical Center has repeatedly declined to comment on Vaught's trial or its procedures.

Vaught's trial will be followed by nurses nationwide, many of whom worry a conviction may set a precedent even as the coronavirus pandemic leaves countless nurses exhausted, demoralized, and likely more prone to error.

Janie Harvey Garner, a St. Louis registered nurse and founder of Show Me Your Stethoscope, a nursing group with more than 600,000 members on Facebook, said the group has closely watched Vaught's case for years out of concern for her fate — and their own.

Garner said most nurses know all too well the pressures that contribute to such an error: long hours, crowded hospitals, imperfect protocols, and the inevitable creep of complacency in a job with daily life-or-death stakes.

Garner said she once switched powerful medications just as Vaught did and caught her mistake only in a last-minute triple-check.

"In response to a story like this one, there are two kinds of nurses," Garner said. "You have the nurses who assume they would never make a mistake like that, and usually it's because they don't realize they could. And the second kind are the ones who know this could happen, any day, no matter how careful they are. This could be me. I could be RaDonda."

As the trial begins, the Nashville DA's prosecutors will argue that Vaught's error was anything but a common mistake any nurse could make. Prosecutors will say she ignored a cascade of warnings that led to the deadly error.

The case hinges on the nurse's use of an electronic medication cabinet, a computerized device that dispenses a range of drugs. According to documents filed in the case, Vaught initially tried to withdraw Versed from a cabinet by typing "VE" into its search function without realizing she should have been looking for its generic name, midazolam. When the cabinet did not produce Versed, Vaught triggered an "override" that unlocked a much larger swath of medications, then searched for "VE" again. This time, the cabinet offered vecuronium.

Vaught then overlooked or bypassed at least five warnings or pop-ups saying she was withdrawing a paralyzing medication, documents state. She also did not recognize that Versed is a liquid but vecuronium is a powder that must be mixed into liquid, documents state.

Finally, just before injecting the vecuronium, Vaught stuck a syringe into the vial, which would have required her to "look directly" at a bottle cap that read "Warning: Paralyzing Agent," the DA's documents state.

The DA's office points to this override as central to Vaught's reckless homicide charge. Vaught acknowledges she performed an override on the cabinet. But she and others say overrides are a normal operating procedure used daily at hospitals.

While testifying before the nursing board last year, foreshadowing her defense in the upcoming trial, Vaught said at the time of Murphey's death that Vanderbilt was instructing nurses to use overrides to overcome cabinet delays and constant technical problems caused by an ongoing overhaul of the hospital's electronic health records system.

Murphey's care alone required at least 20 cabinet overrides in just three days, Vaught said.

"Overriding was something we did as part of our practice every day," Vaught said. "You couldn't get a bag of fluids for a patient without using an override function."

Overrides are common outside of Vanderbilt too, according to experts following Vaught's case.

Michael Cohen, president emeritus of the Institute for Safe Medication Practices, and Lorie Brown, past president of the American Association of Nurse Attorneys, each said it is common for nurses to use an override to obtain medication in a hospital.

Cohen and Brown stressed that even with an override it should not have been so easy to access vecuronium.

"This is a medication that you should never, ever, be able to override to," Brown said. "It's probably the most dangerous medication out there."

Cohen said that in response to Vaught's case, manufacturers of medication cabinets modified the devices' software to require up to five letters to be typed when searching for drugs during an override, but not all hospitals have implemented this safeguard. Two years after Vaught's error, Cohen's organization documented a "strikingly similar" incident in which another nurse swapped Versed with another drug, verapamil, while using an override and searching with just the first few letters. That incident did not result in a patient's death or criminal prosecution, Cohen said.

Maureen Shawn Kennedy, the editor-in-chief emerita of the American Journal of Nursing, wrote in 2019 that Vaught's case was "every nurse's nightmare."

In the pandemic, she said, this is truer than ever.

"We know that the more patients a nurse has, the more room there is for errors," Kennedy said. "We know that when nurses work longer shifts, there is more room for errors. So I think nurses get very concerned because they know this could be them."

Pfizer CEO Pushes Yearly Shots for COVID. Not So Fast, Experts Say.

KFF Health News, March 21, 2022

Critics say CEO Albert Bourla's comments create public pressure for a fourth dose before experts have time to assess the evidence.

This article was published on Monday, March 21, 2022 in Kaiser Health News.

By Arthur Allen

When Pfizer CEO Albert Bourla said March 13 that all Americans would need a second booster shot, it struck many COVID experts as a self-serving remark without scientific merit. It also set off spasms of doubt over the country's objectives in its fight against the coronavirus.

The decision on how often and widely to vaccinate against COVID-19 is part science, part policy, and part politics. Ultimately it depends on the goals of vaccination at a time when it's becoming clear that neither vaccines nor other measures can entirely stop the viral spread.

On March 15, Pfizer made a more limited request of the FDA, seeking authorization of a second booster only for people 65 and older. Advisers for the FDA and the Centers for Disease Control and Prevention are likely to approve a fourth shot for people in that age group because they're the group most likely to be hospitalized or die of COVID. Pfizer competitor Moderna on March 17 also filed for a second booster shot, although its application extended to all adults.

The vaccines' protection against COVID infection generally wanes within several months in all age groups. But experts disagree on whether frequent boosters, especially for younger people, can do anything about that. Two or three vaccinations protect most people from serious disease — but do relatively little to prevent infection, which is generally mild or asymptomatic, after three or four months.

Statements like Bourla's create public pressure for a fourth dose that could force the Biden administration's hand before government experts have time to assess the evidence, said John Moore, professor of microbiology and immunology at Weill Cornell Medical College.

It appears to be based on a yet-to-be-peer-reviewed Israeli study that examined patients only a few weeks after they had received their fourth dose of vaccine. The limited scope of the data raises questions about the duration of that protection, said Dr. Phil Krause, a former deputy director of the FDA's biologics center. Krause helped lead the agency's COVID vaccine reviews before resigning last fall.

Throughout the pandemic, repeated public proclamations by pharmaceutical company executives — broadcast widely via the media, often without supporting data — have created pressure for politicians and their scientific advisers to act.

Last summer, Bourla announced the likely need for an initial booster in April 2021, then, in August, President Joe Biden promised the first booster shots would be available to all adults starting the following month. "That created an expectation that everyone would get their slice of yummy chocolate cake," Moore said. "Who wants to be 'the cake nazi' and say, 'No cake for you?!'"

Although FDA and CDC expert panels, and some federal scientists, were hesitant about recommending the first booster for younger populations, the agencies overrode their advice and approved boosters for everyone 12 and older. That continues to be a sore point with many immunologists and infectious disease specialists.

''The last thing we need is to have corporate CEOs in March saying this is what you need in December because 'we know,'" Moore said. "How do you know?" CEO announcements have often been made before scientific evidence supporting the claims has been publicly released, meaning scientists have not had time to evaluate their validity.

The desire to react to growing signs of infection is understandable but may be futile in the face of a virus that seems to infect even the well-vaccinated. If we keep chasing the virus with boosters, "we're going to be making the drug companies very happy, since our antibodies will go down every four months," said Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia.

But whether those levels are a good measure of protection — especially against serious disease, and in which populations — is an open question. The answer is important because, like all vaccines, there is a small risk of adverse reactions from each shot.

There's some disagreement among experts on how well COVID vaccines to date have prevented serious disease in healthy young people, and whether and how often they should be boosted.

While a recent CDC study showed an increased risk of hospitalization among people ages 18 to 49 several months after second and third vaccine doses, the data categories in the study aren't fine-grained enough to show whether many of those who suffered severe disease had comorbidities such as chronic disease or obesity, Offit said.

But others argue there's enough evidence to show that yearly vaccines, perhaps in combination with influenza vaccinations, would be the best solution. "Given how safe the vaccines are and how effective they are, I think it probably does make sense for people to get a booster, and the most convenient would be once a year," said Dr. Otto Yang, an infectious disease specialist at UCLA. If COVID turns out to be seasonal, peaking in winter months, vaccination in the fall would provide decent protection, he said.

"We are bound to need another booster. We just don't know when or for which variant," said Dr. Daniel Douek, chief of the human immunology section at the National Institute of Allergy and Infectious Diseases.

The coronaviruses that cause about a third of all common colds appear to infect people as frequently as once a year on average, said Stanley Perlman, a coronavirus expert at the University of Iowa. Vaccines could never prevent all those infections, yet the federal approach has largely acted as if this were feasible, Offit said.

"We're coming off two years where we treated this virus like smallpox, isolating anyone with mild illness, even asymptomatic people," he said. "That's going to have to change. Because neither vaccination nor natural infection is going to protect you from mild illness for a longer period of time."

It's important for U.S. health officials to have and share with the public some clarity about the goals of the vaccination program, said Dr. Luciana Borio, a former FDA and National Security Council official who is now a senior fellow for global health at the Council on Foreign Relations. "We need people to understand that protection against all illness is not long-lasting, instead of thinking the vaccine is not working."

"The goal is not to stop transmission, it's mainly to protect the vulnerable at this point," said Dr. Norman Hearst, a family physician and public health researcher at the University of California-San Francisco.

How, in the absence of perfect vaccines, we will protect the vulnerable remains a conundrum. Borio argues that we need systems to rapidly test elderly and immunocompromised people for COVID and quickly give them treatment if their results are positive.

But this is more easily said than done, Hearst said, since people rarely seek medical help for upper respiratory diseases until the illness is too developed for antiviral drugs to work; antivirals generally work best, sometimes only, if they are taken within a few days of onset of symptoms.

For the time being, all debate on a second booster is moot, said John Wherry, chair of the Department of Systems Pharmacology and Translational Therapeutics at the University of Pennsylvania. Unless Congress reverses itself and decides to give the administration more money to fight COVID, there won't be any free vaccines — or free COVID treatments — available to the public next fall.

"We have an acute budgetary problem and we're not yet out of the woods," Wherry said. COVID numbers are spiking in Europe again, and concentrations of the virus in wastewater are starting to multiply in some areas of the U.S., indicating that a loosening of COVID restrictions may be causing spread among those who weren't infected during the omicron wave in December and January.

Offit, a vaccine inventor and longtime champion of vaccination, cautions against leaning too hard on COVID boosters for answers.

"What's our response going to be if we have another variant like omicron that sweeps across people who got two or three doses?" he asked. "Will we accept this, and say, 'OK, calm down?'"

Arthur Allen: ArthurA@kff.org, @ArthurAllen202

Money Flows into Addiction Tech, But Will It Curb Soaring Opioid Overdose Deaths?

KFF Health News, March 21, 2022

Addiction tech entrepreneurs see a $42 billion U.S. market for their products and an addiction treatment field that is ripe for disruption.

This article was published on Monday, March 21, 2022 in Kaiser Health News.

By Brian Rinker

David Sarabia had already sold two startups by age 26 and was sitting on enough money to never have to work another day in his life. He moved from Southern California to New York City and began to indulge in all the luxuries his newly minted millionaire status conveyed. Then it all went sideways, and his life quickly unraveled.

"I became a massive cocaine addict," Sarabia said. "It started off just casual partying, but that escalated to pretty much anything I could get my hands on."

At one particularly low point, Sarabia was homeless for three months, sleeping on public transportation to stay warm. Even with plenty of money in the bank, Sarabia said, he'd lost the will to live. "I'd given up," he said.

He got back on his feet, sort of, and for the next three years lived as a "functional cocaine addict" until his best friend, Jay Greenwald, died after a night of partying. Finally, Sarabia checked himself into a rehab in Southern California — ostensibly a luxurious one, although Sarabia didn't find it to be so.

Still, the place saved his life. The clinicians really cared, he recalled, although their efforts were hampered by clunky technology and poor management. He had the feeling that the owners were more interested in profits than in helping people recover.

Just days off cocaine, the tech entrepreneur was scribbling designs for his next startup idea: a digital platform that would make clinician paperwork easier, combined with a mobile app to guide patients through recovery. After he left treatment in 2017, Sarabia tapped his remaining wealth — about $400,000 — to fund an addiction tech company he named inRecovery.

With the nation's opioid overdose epidemic hitting a record high of more than 100,000 deaths in 2021, effective ways to fight addiction and expand treatment access are desperately needed. Sarabia and other entrepreneurs in the realm they call addiction tech see a $42 billion U.S. market for their products and an addiction treatment field that is, in techspeak, ripe for disruption.

It has long been torn by opposing ideologies and approaches: medication-assisted treatment versus cold-turkey detox; residential treatment versus outpatient; abstinence versus harm reduction; peer support versus professional help. And most people who report struggling with substance use never manage to access treatment at all.

Tech is already offering help to some. Those who can pay out-of-pocket, or have treatment covered by an employer or insurer, can access one of a dozen addiction telemedicine startups that allow them to consult with a physician and have a medication like buprenorphine mailed directly to their home. Some of the virtual rehabs provide digital cognitive behavior treatment, with connected devices and even mail-in urine tests to monitor compliance with sobriety.

Plentiful apps offer peer support and coaching, and entrepreneurs are developing software for treatment centers that handle patient records, personalize the client's time in rehab, and connect them to a network of peers.

But while the founders of for-profit companies may want to end suffering, said Fred Muench, clinical psychologist and president of the nonprofit Partnership to End Addiction, it all comes down to revenue.

Startup experts and clinicians working on the front lines of the drug and overdose epidemic doubt the flashy Silicon Valley technology will ever reach people in the throes of addiction who are unstably housed, financially challenged, and on the wrong side of the digital divide.

"The people who are really struggling, who really need access to substance use treatment, don't have 5G and a smartphone," said Dr. Aimee Moulin, a professor and behavioral health director for the Emergency Medicine Department at UC Davis Health. "I just worry that as we start to rely on these tech-heavy therapy options, we're just creating a structure where we really leave behind the people who actually need the most help."

The investors willing to feed millions of dollars on startups generally aren't investing in efforts to expand treatment to the less privileged, Moulin said.

Besides, making money in the addiction tech business is tough, because addiction is a stubborn beast.

Conducting clinical trials to validate digital treatments is challenging because of users' frequent lapses in medication adherence and follow-up, said Richard Hanbury, founder and CEO of Sana Health, a startup that uses audiovisual stimulation to relax the mind as an alternative to opioids.

There are thousands of private, nonprofit, and government-run programs and drug rehabilitation centers across the country. With so many bit players and disparate programs, startups face an uphill battle to land enough customers to generate significant revenue, he added.

After conducting a small study to ease anxiety for people detoxing off opioids, Hanbury postponed the next step, a larger study. To sell his product to the country's sprawling array of addiction treatment providers, Hanbury decided, he would need to hire a much larger sales team than his budding company could afford.

Still, the immense need is feeding enthusiasm for addiction tech.

In San Francisco alone, more than twice as many people died from drug overdoses as from covid over the past two years. Employers, insurers, providers, families, and those suffering addiction themselves are all demanding better and affordable access to treatment, said Unity Stoakes, president and managing partner of StartUp Health.

The investment firm has launched a portfolio of seed-stage startups that aim to use technology to end addiction and the opioid epidemic. Stoakes hopes the wave of new treatment options will reduce the stigma of addiction and increase awareness and education. The emerging tools aren't trying to remove human care for addiction, but rather "supercharge the doctor or the clinician," he said.

While acknowledging that underserved populations are hard to reach, Stoakes said tech can expand access and enhance targeted efforts to help them. With enough startups experimenting with different types of treatment and delivery methods, hopefully one or more will succeed, he said.

Addiction telehealth startups have gained the most traction. Quit Genius, a virtual addiction treatment provider for alcohol, opioid, and nicotine dependence, raised $64 million from investors last summer, and in October, $118 million went to Workit Health, a virtual prescriber of medication-assisted treatment. Several other startups — Boulder Care, Groups Recover Together, Ophelia, Bicycle Health, and Wayspring, most of which have nearly identical telehealth and prescribing models — have landed sizable funding since the pandemic started.

Some of the startups already sell to self-insured employers, providers, and payers. Some market directly to consumers, while others are conducting clinical trials to get FDA approval they hope to parlay into steadier reimbursement. But that route involves a lot of competition, regulatory hurdles, and the need to convince payers that adding another treatment will drive down costs.

Sarabia's inRecovery plans to use its software to help treatment centers run more efficiently and improve their patient outcomes. The startup is piloting an aftercare program, aimed at keeping patients connected to prevent relapse after treatment, with Caron Treatment Centers, a high-end nonprofit treatment provider based in Pennsylvania.

His long-term goal is to drive down costs enough to offer his service to county-run treatment centers in hopes of expanding care to the neediest. But for now, implementing the tech doesn't come cheap, with treatment providers paying anywhere from $50,000 to $100,000 a year to license the software.

"Bottom line, for the treatment centers that don't have consistent revenue, those on the lower end, they will probably not be able to afford something like this," he said.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Healthcare Foundation.

Brian Rinker: @_TheBrink

Missouri Tried to Fix Its Doctor Shortage. Now the Fix May Need Fixing.

KFF Health News, March 17, 2022

The bill would create a new path for training physicians, but competing legislation aims to scale back the license, though, and cap the number of years assistant physicians can practice until they funnel back into residency programs.

This article was published on Thursday, March 17, 2022 in Kaiser Health News.

By Bram Sable-Smith

Missouri state Rep. Tricia Derges is pushing a bill to give assistant physicians like herself a pathway to becoming fully licensed doctors in the state.

Not that Derges — among the highest-profile holders of the assistant physician license created in 2014 to ease a doctor shortage — is the most persuasive advocate right now.

Derges was indicted last year on charges accusing her of selling fake stem-cell treatments, illegally prescribing drugs, and fraudulently receiving COVID relief funds. Derges, who did not respond to multiple messages sent to her and her lawyer, has pleaded not guilty. But she has already been kicked out of the Republican caucus, forced to move her legislative office into a Statehouse broom closet, put on a three-year probation for her narcotics license, and denied the ability to run for reelection as a Republican following her indictment. A trial is set for June.

Her personal tribulations have jeopardized an already contentious solution for states that struggle with gaps in primary healthcare. Even some early proponents now want to rein in the assistant physician license.

Assistant physicians — sometimes called associate physicians, and not to be confused with physician assistants — are medical school graduates who have not yet completed residency training. Similar licenses also now exist in Arizona, Arkansas, Kansas, and Utah. Virginia is considering adding one, and model legislation is making such licenses easier than ever for other state legislatures to adopt.

Derges' proposed legislation would allow assistant physicians to become licensed — similar to doctors who have completed a residency — provided an assistant physician has practiced for five years with a collaborating physician, passed a licensure exam, and completed certain training requirements.

Her bill would create a new path for training physicians. Competing legislation aims to scale back the license, though, and cap the number of years assistant physicians can practice until they funnel back into residency programs.

Dr. Keith Frederick, a former state representative and orthopedic surgeon from Rolla, Missouri, proposed the original assistant physician legislation, the first of its kind in the nation.

Nearly every county in Missouri is short of primary care providers, according to the federal Health Services and Resources Administration. It'd take nearly 500 physicians to fill that void, but efforts to get doctors to practice in underserved areas have been "chronically unsuccessful," Frederick said. At the same time, thousands of medical school graduates who apply for residency programs each year are not accepted — 9,155 applicants did not match to a program in 2021 alone, or about 1 in 5 of the candidates, most coming from international medical schools.

The assistant physician license allows those medical school graduates to practice medicine in Missouri under a collaborative practice agreement with a physician, who is ultimately responsible for the care given, and on the condition that they do so in an underserved area. They can see patients, prescribe drugs, and provide certain treatments, in much the same way as nurse practitioners or physician assistants — so-called midlevel practitioners, both of which have distinct master's-level training.

Frederick's bill passed the same year it was introduced, a legislative feat he described as "pretty remarkable."

The idea did have its detractors at the time. Chief among them was the Missouri Nurses Association, which argued the state's 12,000 nurse practitioners were better suited to address primary care shortages. The association views the state's rules for nurse practitioners as among "the most severely restrictive in the nation."

Nationally, the American Medical Association, American Academy of Family Physicians, and Accreditation Council for Graduate Medical Education also opposed the license.

One initial supporter of the idea was Dr. Jeff Davis, chief medical officer for Scotland County Hospital in rural Memphis, Missouri, and an executive committee member of the Missouri Association of Osteopathic Physicians and Surgeons. Eight years after the law passed, however, Davis has no assistant physicians working with him, even though he said he has several openings that would benefit from them.

The challenge, Davis said, is Medicare will not reimburse for care provided by assistant physicians. Hospitals in rural areas often depend on revenue from that public insurance program for Americans 65 and older. But for hospitals to get paid by Medicare for the work of an assistant physician, Davis said, the assistant physician would have to work under the direct supervision of a physician whose name would be used to submit the bill.

"That doesn't make much business sense," Davis said.

Frederick hopes that having more states create an assistant physician license will force the hand of the Centers for Medicare & Medicaid Services to start reimbursing for the work done by those clinicians. The American Legislative Exchange Council adopted model associate physician legislation after Frederick presented the idea at the conservative nonprofit's summit last year.

Currently, Missouri has 348 active licenses for assistant physicians, including Dr. Trevor Cook, creator of the Association of Medical Doctor Assistant Physicians. Cook graduated in 2014 from the International American University medical school on the Caribbean island of St. Lucia.

"Unfortunately, I was one of those many, many, many, many thousands of doctors that don't match each year" into a residency program, Cook said.

Cook has practiced at Downtown Urgent Care in St. Louis since 2018, a position he called rewarding. He is supportive of a pathway for assistant physicians to become fully licensed in Missouri, like the one proposed by Derges. As to the indictment, Cook said, one person's actions are not representative of an entire group of practitioners.

A review of active assistant physician licenses in the state — including Derges' — found none under current disciplinary action. Two were previously under probation due to prior behavior.

Still, state doctor groups that initially supported the idea now want to cap the number of years someone can hold an assistant physician license, as other states have done. Under current Missouri law, assistant physicians can practice indefinitely.

"As with anything, you find out that people try to game the system and work an angle and get something that wasn't intended out of something you did in good faith," Davis said.

Dr. Sterling Ransone, president of the American Academy of Family Physicians, said he already had concerns about the quality of care provided by assistant physicians, citing a 2018 JAMA article that found they had lagging test scores compared with their counterparts in residency programs. He said he's doubtful about creating an alternative pathway to full physician licensure.

"I would personally have trouble supporting it without a lot more information to verify quality standards," Ransone said.

The American Medical Association favors a bill in Congress that would increase the number of residency positions in the U.S. by 14,000 over the next seven years.

Dr. Kevin Klauer, CEO of the American Osteopathic Association, didn't shut the door on a role for assistant physicians but said he was skeptical: "We have to be responsible to make sure that we've put all the safeguards in with training and verification and monitoring, so that healthcare that is delivered by a physician is up to the standards that it should be."

Frederick called those concerns "purely turf protection" amid what he said is a tremendous healthcare shortage.

"We have all these people that are highly trained," Frederick said. "Why would you waste that resource?"

Bram Sable-Smith: brams@kff.org, @besables

COVID's 'Silver Lining': Research Breakthroughs for Chronic Disease, Cancer, and the Common Flu

KFF Health News, March 17, 2022

Ambitious scientific endeavors have provided technological windfalls for consumers.

This article was published on Thursday, March 17, 2022 in Kaiser Health News.

By Liz Szabo

The billions of dollars invested in COVID vaccines and COVID-19 research so far are expected to yield medical and scientific dividends for decades, helping doctors battle influenza, cancer, cystic fibrosis, and far more diseases.

"This is just the start," said Dr. Judith James, vice president of clinical affairs for the Oklahoma Medical Research Foundation. "We won't see these dividends in their full glory for years."

Building on the success of mRNA vaccines for COVID, scientists hope to create mRNA-based vaccines against a host of pathogens, including influenza, Zika, rabies, HIV, and respiratory syncytial virus, or RSV, which hospitalizes 3 million children under age 5 each year worldwide.

Researchers see promise in mRNA to treat cancer, cystic fibrosis, and rare, inherited metabolic disorders, although potential therapies are still many years away.

Pfizer and Moderna worked on mRNA vaccines for cancer long before they developed COVID shots. Researchers are now running dozens of clinical trials of therapeutic mRNA vaccines for pancreatic cancer, colorectal cancer, and melanoma, which frequently responds well to immunotherapy.

Companies looking to use mRNA to treat cystic fibrosis include ReCode Therapeutics, Arcturus Therapeutics, and Moderna and Vertex Pharmaceuticals, which are collaborating. The companies' goal is to correct a fundamental defect in cystic fibrosis, a mutated protein.

Rather than replace the protein itself, scientists plan to deliver mRNA that would instruct the body to make the normal, healthy version of the protein, said David Lockhart, ReCode's president and chief science officer.

None of these drugs is in clinical trials yet.

That leaves patients such as Nicholas Kelly waiting for better treatment options.

Kelly, 35, was diagnosed with cystic fibrosis as an infant and has never been healthy enough to work full time. He was recently hospitalized for 2½ months due to a lung infection, a common complication for the 30,000 Americans with the disease. Although novel medications have transformed the lives of most people with CF, they don't work in 10% of patients. About one-third of patients who don't benefit from the new medications are Black and/or Hispanic, said JP Clancy, vice president of clinical research for the Cystic Fibrosis Foundation.

"Nobody wants to be hospitalized," said Kelly, who lives in Cleveland. "If something could decrease my symptoms even 10%, I would try it."

Predicting Which COVID Patients Are Most Likely to Die

Ambitious scientific endeavors have provided technological windfalls for consumers in the past; the race to land on the moon in the 1960s led to the development of CT scanners and MRI machines, freeze-dried food, wireless headphones, water purification systems, and the computer mouse.

Likewise, funding for AIDS research has benefited patients with a variety of diseases, said Dr. Carlos del Rio, a professor of infectious diseases at Emory University School of Medicine. Studies of HIV led to the development of better drugs for hepatitis C and cytomegalovirus, or CMV; paved the way for successful immunotherapies in cancer; and speeded the development of COVID vaccines.

Over the past two years, medical researchers have generated more than 230,000 medical journal articles, documenting studies of vaccines, antivirals, and other drugs, as well as basic research into the structure of the virus and how it evades the immune system.

Dr. Michelle Monje, a professor of neurology at Stanford University, has found similarities in the cognitive side effects caused by COVID and a side effect of cancer therapy often called "chemo brain." Learning more about the root causes of these memory problems, Monje said, could help scientists eventually find ways to prevent or treat them.

James hopes that computer technology used to detect COVID will improve the treatment of other diseases. For example, researchers have shown that cellphone apps can help detect potential COVID cases by monitoring patients' self-reported symptoms. James said she wonders if the same technology could predict flare-ups of autoimmune diseases.

"We never dreamed we could have a PCR test that could be done anywhere but a lab," James said. "Now we can do them at a patient's bedside in rural Oklahoma. That could help us with rapid testing for other diseases."

One of the most important pandemic breakthroughs was the discovery that 15% to 20% of patients over 70 who die of COVID have rogue antibodies that disable a key part of the immune system. Although antibodies normally protect us from infection, these "autoantibodies" attack a protein called interferon that acts as a first line of defense against viruses.

By disabling key immune fighters, autoantibodies against interferon allow the coronavirus to multiply wildly. The massive infection that results can lead the rest of the immune system to go into hyperdrive, causing a life-threatening "cytokine storm," said Dr. Paul Bastard, a researcher at Rockefeller University.

The discovery of interferon-targeting antibodies "certainly changed my way of thinking at a broad level," said E. John Wherry, director of the University of Pennsylvania's Institute for Immunology, who was not involved in the studies. "This is a paradigm shift in immunology and in COVID."

Antibodies that disable interferon may explain why a fraction of patients succumb to viral diseases, such as influenza, while most recover, said Dr. Gary Michelson, founder and co-chair of Michelson Philanthropies, a nonprofit that funds medical research and recently gave Bastard its inaugural award in immunology.

The discovery "goes far beyond the impact of COVID-19," Michelson said. "These findings may have implications in treating patients with other infectious diseases" such as the flu.

Bastard and colleagues have also found that one-third of patients with dangerous reactions to yellow fever have autoantibodies against interferon.

International research teams are now looking for such autoantibodies in patients hospitalized by other viral infections, including chickenpox, influenza, measles, respiratory syncytial virus, and others.

Overturning Dogma

For decades, public health officials created policies based on the assumption that viruses spread in one of two ways: either through the air, like measles and tuberculosis, or through heavy, wet droplets that spray from our mouths and noses, then quickly fall to the ground, like influenza.

For the first 17 months of the COVID pandemic, the World Health Organization and the Centers for Disease Control and Prevention said the coronavirus spread through droplets and advised people to wash their hands, stand 6 feet apart, and wear face coverings. As the crisis wore on and evidence accumulated, researchers began to debate whether the coronavirus might also be airborne.

Today it's clear that the coronavirus — and all respiratory viruses — spread through a combination of droplets and aerosols, said Dr. Michael Klompas, a professor at Harvard Medical School and infectious disease doctor.

"It's not either/or," Klompas said. "We've created this artificial dichotomy about how we think about these viruses. But we always put out a mixture of both" when we breathe, cough, and sneeze.

Knowing that respiratory viruses commonly spread through the air is important because it can help health agencies protect the public. For example, high-quality masks, such as N95 respirators, offer much better protection against airborne viruses than cloth masks or surgical masks. Improving ventilation, so that the air in a room is completely replaced at least four to six times an hour, is another important way to control airborne viruses.

Still, Klompas said, there's no guarantee that the country will handle the next outbreak any better than this one. "Will we do a better job fighting influenza because of what we've learned?" Klompas said. "I hope so, but I'm not holding my breath."

Fighting Chronic Disease

Lauren Nichols, 32, remembers exactly when she developed her first COVID symptoms: March 10, 2020.

It was the beginning of an illness that has plagued her for nearly two years, with no end in sight. Although Nichols was healthy before developing what has become known as "long COVID," she deals with dizziness, headaches, and debilitating fatigue, which gets markedly worse after exercise. She has had shingles — a painful rash caused by the reactivation of the chickenpox virus — four times since her COVID infection.

Six months after testing positive for COVID, Nichols was diagnosed with chronic fatigue syndrome, also known as myalgic encephalomyelitis, or ME/CFS, which affects more than 1 million Americans and causes many of the same symptoms as COVID. There are few effective treatments for either condition.

In fact, research suggests that "the two conditions are one and the same," said Dr. Avindra Nath, clinical director of the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health. The main difference is that people with long COVID know which virus caused their illness, while the precise virus behind most cases of chronic fatigue is unknown, Nath said.

Advocates of patients with long COVID want to ensure that future research — including $1.15 billion in targeted funding from the NIH — benefits all patients with chronic, post-viral diseases.

"Anything that shows promise in long COVID will be immediately trialed in ME/CFS," said Jarred Younger, director of the Neuroinflammation, Pain and Fatigue Laboratory at the University of Alabama-Birmingham.

Patients with chronic fatigue syndrome have felt a kinship with long COVID patients, and vice versa, not just because they experience the same baffling symptoms, but also because both have struggled to obtain compassionate, appropriate care, said Nichols, vice president of Body Politic, an advocacy group for people with long COVID and other chronic or disabling conditions.

"There is a lot of frustration about being written off by the medical community, being told that it's all in one's head, that they just need to see a psychiatrist or go to the gym," said Dr. David Systrom, a pulmonary and critical care physician at Brigham and Women's Hospital in Boston.

That sort of ignorance seems to be declining, largely because of increasing awareness about long COVID, said Emily Taylor, vice president of advocacy and engagement at Solve M.E., an advocacy group for people with post-infectious chronic illnesses. Although some doctors still refuse to believe long COVID is a real disease, "they're being drowned out by the patient voices," Taylor said.

A new study from the National Institutes of Health, called RECOVER (Researching COVID to Enhance Recovery), is enrolling 15,000 people with long COVID and a comparison group of nearly 3,000 others who haven't had COVID.

"In a very dark cloud," Nichols said, "a silver lining coming out of long COVID is that we've been forced to acknowledge how real and serious these conditions are."

Liz Szabo: lszabo@kff.org, @LizSzabo

How to Avoid Surprise Bills — And the Pitfalls in the New Law

KFF Health News, March 16, 2022

The law's protections against the infuriating, expensive scourge of surprise medical bills may be only as good as a patient's knowledge.

This article was published on Wednesday, March 16, 2022 in Kaiser Health News.

By Dan Weissmann   

Patients are no longer required to pay for out-of-network care given without their consent when they receive treatment at hospitals covered by their health insurance since a federal law took effect at the start of this year.

But the law's protections against the infuriating, expensive scourge of surprise medical bills may be only as good as a patient's knowledge — and ability to make sure those protections are enforced.

Here's what you need to know.

Meet the No Surprises Act.

Studies have shown that about 1 in 5 emergency room visits result in a surprise bill.

Surprise bills frequently come from emergency room doctors and anesthesiologists, among others — specialists who are often outside a patient's insurance network and not chosen by the patient.

Before the law took effect, the problem went something like this: Say you needed surgery. You picked an in-network hospital — that is, one that accepts your health plan and has negotiated prices with your insurer.

But one of the doctors who treated you didn't take your insurance. SURPRISE! You got a big bill, separate from the bills from the hospital and other doctors. Your insurer didn't cover much of it, if it didn't deny the claim outright. You were expected to pay the balance.

The new law, known as the No Surprises Act, stipulates, in broad terms, that patients who seek care from an in-network hospital cannot be billed more than the negotiated, in-network rate for any out-of-network services they receive there.

Instead of leaving the patient with an unexpected bill that insurance will not cover, the law says, the insurance company and the healthcare provider must work out how the bill gets paid.

But the law builds in wiggle room for providers who wish to try end runs around the protections.

Caution: The law leaves out plenty of medical care.

The changes come with a lot of caveats.

Although the law's protections apply to hospitals, they do not apply at many other places, like doctors' offices, birthing centers, or most urgent care clinics. Air ambulances, often a source of exorbitant out-of-network bills, are covered by the law. But ground ambulances are not.

Patients need to keep their heads up to avoid the pitfalls that remain, said Patricia Kelmar, healthcare campaigns director for the nonprofit Public Interest Research Group, which lobbied for the law.

Say you go for your annual checkup, and your doctor wants to run tests. Conveniently, there's a lab right down the hall.

But the lab may be out of network — despite sharing office space with your in-network doctor. Even with the new law in effect, that lab doesn't have to warn you it is out of network.

Beware the "Surprise Billing Protection Form."

Out-of-network providers may present patients with a form addressing their protections from unexpected bills, labeled "Surprise Billing Protection Form."

Signing it waives those protections and instead consents to treatment at out-of-network rates.

"The form title should be something like the I'm Giving Away All of My Surprise Billing Protections When I Sign This Form, because that's really what it is," Kelmar said.

Your consent must be given at least 72 hours before receiving care — or, if the service is scheduled on the same day, at least three hours in advance. If you've waited weeks to book a procedure with a specialist, 72 hours may not feel like sufficient advance warning to allow you to cancel the procedure.

Among other things, the form should include a "good faith estimate" of what you'll be charged. For nonemergency care, the form should include the names of in-network providers you could see instead.

It should also inform you of an unfortunate catch-22: The provider can refuse to treat you if you refuse to waive your protections.

It is against the law for some providers to give you this form at all. Those include emergency room doctors, anesthesiologists, radiologists, assistant surgeons, and hospitalists.

Keep your antennae up on costs. Many patients report they are merely handed an iPad for recording their signature in emergency rooms and doctors' offices. Insist on seeing the form behind the signature so you know exactly what you are signing.

If you notice a problem, don't sign, Kelmar said. But if you find yourself in a jam — say, because you get this form and urgently need care — there are ways you can fight back:

  • Write on the form that you are "signing under duress" and note the problem (e.g., "Emergency medicine facilities are not allowed to present this form").
     
  • Take a picture of the form with your notes on it. Consider also shooting a video of yourself with the form, describing how it violates federal law.
     
  • Report it! There is a federal hotline (1-800-985-3059) and a website for reporting all violations of the new law barring surprise bills. Both the hotline and website help patients figure out what to do, as well as collect complaints.

Speaking of that "good faith estimate" …

The new "good faith estimate" benefit applies anywhere you receive medical care.

Once you book an appointment, the provider must give advance notice of what you could expect to pay without insurance (in other words, if you do not have insurance or choose not to use it). Your final bill may not exceed the estimate by more than $400 per provider.

Theoretically, this gives patients a chance to lower their costs by shopping around or choosing not to pay with insurance. It is particularly appealing for patients with high-deductible insurance plans, but not exclusively: The so-called cash price of care can be cheaper than paying with insurance.

Also: It wouldn't hurt to ask if this is an all-inclusive price, not just a base price to which other incidental services may be added.

It is not enough to ask: "Do you take my insurance?"

It still falls to patients to determine whether medical care is covered. Before you find yourself in a treatment room, ask if the provider accepts your insurance — and be specific.

Kelmar said the question to ask is, "Are you in my insurance plan's network?" Provide the plan name or group number on your insurance card.

The reality is, your insurance company — Blue Cross Blue Shield, Cigna, etc. — has a bunch of different plans, each with its own network. One network may cover a certain provider; another may not.

Keep an eye on your mailbox.

To make sure no one bills you more than expected, pay attention to your mail. Hospital visits, in particular, can generate lots of paperwork. Anything billed should be itemized on a statement from your insurer called an explanation of benefits, or EOB.

Notice anything off? Make some calls before you pay — to your insurer, to the provider, and, of course, to the new federal hotline: 1-800-985-3059.

Dan Weissmann is the host of "An Arm and a Leg," a podcast about the cost of healthcare. This column is adapted from his newsletter First Aid Kit.

Want Vulnerable Californians to Have Healthier Pregnancies? Doulas Say the State Must Pay Up.

KFF Health News, March 15, 2022

Studies have associated doula care with a range of better birth outcomes, such as lower rates of cesarean sections, fewer babies with low birth weights, and more breastfeeding.

This article was published on Tuesday, March 15, 2022 in Kaiser Health News.

By Rachel Bluth

SACRAMENTO, Calif. — This was supposed to be the year that low-income Californians could hire a doula to guide them through pregnancy and advocate for them in the hospital.

But the new benefit for people enrolled in Medi-Cal, the state's Medicaid health insurance program, has been delayed twice as the state and doulas — nonmedical workers who help parents before, during, and after birth — haggle over how much they should get paid.

The state initially proposed a flat rate of $450 per birth, covering all prenatal and postnatal visits, on-call time during the pregnancy, and labor and delivery — which often lasts 12 or more hours.

Doulas say that amount is too low, and far less than their clients would pay out-of-pocket. It's also below what doulas receive from Medicaid programs in most other states that offer the benefit.

The only state that pays less is Oregon, where doulas receive up to $350 per birth. The reimbursement rates of other states that offer doula services through Medicaid are usually between $770 and $900. When Rhode Island implements its benefit in July, it will be the highest-paying state, offering doulas up to $1,500.

In most states that offer a doula benefit, the rate Medicaid programs pay is a maximum, which doulas receive if the patient attends every prenatal and postnatal visit. Unlike obstetricians, who see many patients in a day, most doulas accept only a few clients a month.

"We're talking six to nine months of face time, screen time, texting time, research, resources, and dollars. $450? That's wild," said Chantel Runnels, a doula in Riverside County, California, who usually charges clients about $1,000.

"It feels limiting," Runnels said. "Like there is no value on our time."

Doulas do not deliver babies. They provide resources to navigate the healthcare system, information on sleep or nutrition, and postpartum coaching and lactation support. They also support mothers during birth to make sure their wishes are being respected by the hospital.

Doulas are unregulated, and most of their work is for patients who pay out-of-pocket. Most private insurance does not cover doulas, said Cassondra Marshall, an assistant professor at the University of California-Berkeley School of Public Health who has conducted research on doulas in the Bay Area. Tricare, the health insurance program for active-duty members of the military, began covering doulas this year, paying them about $970 for labor support and six visits.

The structure of California's benefit is still being determined. Doulas and the state aren't in sync on credentialing and training — in addition to pay, said Anthony Cava, a spokesperson for the California Department of Healthcare Services, which administers Medi-Cal. Doulas also told the state they want to bill separately for labor and prenatal and postnatal visits, instead of receiving a bundled flat rate.

The state "recognizes rates must be adequate" to attract enough providers and reduce health disparities, Cava said in a statement. "We are considering input received from the doula stakeholders, and are also reviewing other states' doula programs and their payment structures and associated rates for similar services," Cava said.

Cava said the state's $450 proposal was modeled after the rates in other states, including Oregon, which was one of the first states to include doula benefits in its Medicaid package, in 2014.

But Oregon's $350 maximum payment is too low to attract enough doulas, said Amy Chen, a senior attorney with the National Health Law Program who studies doula Medicaid benefits across states. "One of the big challenges is that the reimbursement rate is so low that doulas just can't do it," Chen said.

From 2018 through 2021, Oregon paid for doulas in 310 births, about 0.39% of the births to Medicaid enrollees during that period, according to state officials.

It's a "lower uptake" than the state had hoped for, Oregon Health Authority spokesperson Aria Seligmann said in a statement. We're "currently reevaluating the reimbursement rate to ensure doulas' services are appropriately valued," Seligmann said.

Doulas in Oregon must spend about 100 hours learning how to charge Medicaid and must upgrade their software, phones, and medical record systems to comply with privacy laws — all on their own dime, said Raeben Nolan, vice president of the Oregon Doula Association. "Very few people are willing to go through the hoops," Nolan said.

Five Medicaid programs offer a doula benefit, and six more (including California's) are implementing one soon.

Offering a doula benefit in Medi-Cal is one of the as-yet-unfulfilled promises of the "Momnibus" Act that was signed by Gov. Gavin Newsom last year. Lawmakers and advocates hope that by providing doulas to the state's poorest and most vulnerable women, California will help address racial disparities, improve birth outcomes, and diversify and expand its healthcare workforce. The benefit was originally supposed to kick in Jan. 1 but is now slated to start in January 2023 — if doulas and the state can come to an agreement. 

California is embarking on a massive transformation of its Medicaid program that will expand benefits beyond healthcare and into the realm of social services. As part of this transformation, the state plans to bring several types of nontraditional healthcare workers into the Medi-Cal workforce, including promotores, peer mental health counselors, and doulas.

The maternal mortality rate is rising nationally, and the rate for Black mothers is nearly three times that of white mothers. Studies have associated doula care with a range of better birth outcomes, such as lower rates of cesarean sections, fewer babies with low birth weights, and more breastfeeding.

Since 2019, at least 10 pilot programs around California have provided doula services to Black parents or Medi-Cal enrollees, funded by a mix of public funds, grants, and private insurance. The services were free to patients, and participating doulas were paid a maximum of $1,000 per birth in Riverside County to $3,000 in Alameda County.

TaNefer Camara is a maternal health strategist in Oakland, where she charges $3,000 for doula work. She became a doula to help other women of color but said she couldn't take on many Medi-Cal patients at what she called the "laughable" rate of $450. "You don't need to go into poverty to try and fix a situation such as maternal healthcare," she said.

Marshall, of UC-Berkeley, found that doulas who were paid a flat rate for all their services often had to work multiple jobs to make ends meet. "The flat rate lump sums aren't nearly enough for all that they're doing," Marshall said.

Minnesota has been offering a doula benefit since 2014. But the state found that a maximum reimbursement rate of $411 was too low, and the legislature increased it in 2019 to $770.

California's proposed rate is off base, said Ashley Kidd-Tatge, a doula and the doula coordinator at Everyday Miracles, a nonprofit organization that matches Medicaid beneficiaries with doulas in the Twin Cities. Most doulas in her area charge non-Medicaid patients $800 to $1,500 per birth.

"$450 is incredibly low," Kidd-Tatge said. "I don't know too many folks, even in the Twin Cities, who would entertain that rate."

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Healthcare Foundation.

Rachel Bluth: rbluth@kff.org, @RachelHBluth

'An Arm and a Leg': Need an Expensive Drug? Here's What You Need to Know

KFF Health News, March 15, 2022

It's an invention by the insurance industry to make sure only your money counts toward your yearly deductible — not any assistance you might receive from a drug company.

This podcast was released on Tuesday, March 15, 2022 in Kaiser Health News.

Lillian Karabaic teaches personal finance to millennials through a podcast and community called Oh My Dollar! — and she needs an expensive drug to treat a chronic condition. That makes her an expert on one of the most complex arrangements in the American health care system: the copay accumulator.

In short, it's an invention by the insurance industry to make sure only your money counts toward your yearly deductible — not any assistance you might receive from a drug company.

Drug companies offer copay assistance to patients whose plans make them pay a percentage of a medicine's price so that they charge insurers more. For instance, if a drug's monthly cost is $10,000, few people with a 20% copay could afford $2,000 a month. But if the drug company helps you with that $2,000 — sometimes they call it a "coupon" — it can charge your insurer $8,000 a month. Copay accumulators say these coupons can't count toward an insurance plan's out-of-pocket maximum.

It's confusing, but Karabaic was well aware of how it works. Still, she recently got socked with an unexpected $3,000 charge — and expects to lose her very organized fight against it.

Finding out whether an insurance plan includes one of these policies can be extremely tough. Researchers from the AIDS Institute looked at hundreds of plans across the country and developed a tip sheet to help guide searches. A dozen states have banned copay accumulators, and more are considering doing so.

For tips on how to avoid overpaying for drugs — when that's possible — check out the latest edition of our First Aid Kit newsletter.

Here's a transcript of the episode.

"An Arm and a Leg" is a co-production of KHN and Public Road Productions.

To keep in touch with "An Arm and a Leg," subscribe to the newsletter. You can also follow the show on Facebook and Twitter. And if you've got stories to tell about the health care system, the producers would love to hear from you.

To hear all KHN podcasts, click here.

And subscribe to "An Arm and a Leg" on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.

MA Plans Send Pals to Seniors' Homes for Companionship — And Profits

KFF Health News, March 15, 2022

Medicare plans pay Papa, a for-profit company, a per-member fee monthly.

This article was published on Tuesday, March 15, 2022 in Kaiser Health News.

By Phil Galewitz

Widowed and usually living alone, Gloria Bailey walks with a cane after two knee replacement surgeries and needs help with housekeeping.

So she was thrilled last summer when her Medicare Advantage plan, SummaCare, began sending a worker to her house in Akron, Ohio, to mop floors, clean dishes, and help with computer problems. Some days, they would spend the two-hour weekly visit just chatting at her kitchen table. "I love it," she said of the free benefit.

Bailey, 72, is one of thousands of seniors around the country being visited each week by employees of Papa Inc. Known as "Papa pals," their primary aim is to provide companionship to seniors along with helping with errands and light housework duties. Since 2020, more than 65 Medicare Advantage plans nationwide have signed up with Papa, a Miami-based company, to address members' loneliness — a problem exacerbated by the pandemic.

"It's the best thing ever" to counteract social isolation, said Anne Armao, a vice president at SummaCare. More than 12% of the company's 23,000 Ohio Medicare members used the Papa benefit last year.

But SummaCare and other health plans also stand to benefit by sending Papa pals into members' homes. The workers can help the plans collect more money from Medicare by persuading members to get annual wellness exams, fill out personal health risk assessments, and undergo covered health screenings.

Accomplishing these steps helps plans in two ways:

  • By gleaning more information, plans may discover members have health issues that may earn higher reimbursement rates from Medicare.
     
  • Plans can boost their star ratings, which are based on more than 40 performance measures, including cancer, diabetes, and blood pressure screenings; outcome measures such as controlling hypertension; and overall satisfaction with the plan. Plans that score at least four stars on a five-star scale receive bonuses from Medicare.

Bonus payments from the star ratings make up an increasing share of federal payments to these private Medicare Advantage plans, which are an alternative to traditional Medicare. In 2021, Medicare paid plans $11.6 billion in bonus pay, double the amount in 2017.

The federal government's base pay for the plans is a monthly fee for each member, but it increases that amount based on the members' health risks. So plans also get billions of dollars a year in extra payments by pinpointing members' health problems through a variety of measures, including the health risk assessments.

Yet federal investigators have found these diagnoses do not always result in additional treatment or follow-up care to beneficiaries. As a result, the federal government is probably overpaying the Medicare health plans and wasting billions in taxpayer dollars, according to the Medicare Payment Advisory Commission that advises Congress.

In a report last September, the Health and Human Services inspector general found 20 Medicare Advantage companies generated $5 billion in extra payments from the federal government for diagnoses identified through health risk assessments and chart reviews without documentation that the patients were treated for these issues.

Nearly half of Medicare enrollees get their coverage through Medicare Advantage.

David Lipschutz, associate director of the Center for Medicare Advocacy, said Papa pals provide an important benefit to seniors by helping them with chores, reducing their loneliness, and getting them to medical appointments. But the benefit can also help the insurers' bottom lines.

"If there is one thing these plans are good at is maximizing their profit," he said.

Medicare Advantage plans often give doctors financial incentives to get patients to undergo health assessments. Plan workers repeatedly call patients with offers to send nurses or doctors to their homes to complete them. Lipschutz said health risk assessments are useful only if the health plans act on the information by making sure patients are getting treatment for those issues.

Armao said the health risk assessment and annual wellness exam reminders are on the list of things Papa employees are told to ask about on visits.

"They are our eyes and ears who can learn so much from members in their homes," she explained. Pals look in refrigerators to see if members have enough to eat, check on how members are feeling, and remind them to take prescriptions. SummaCare even directs pals to ask whether members have urinary incontinence or are up to date on cancer screenings.

Andrew Parker, who founded Papa in 2017 after finding a couple of college students to visit with his grandfather, take him to doctor appointments, and do other errands, said he estimates his company will provide more than a million hours of companionship in 2022. The Medicare plans pay Papa, a for-profit company, a per-member fee monthly.

"Papas [pals] are very proactive and will call you to see how you are feeling and, maybe not on the first day but over the course of the program, can ask, 'Did you know your health plan would prefer if you had a wellness exam and it could help you with your health?'" he said. "A pal is a trusted adviser who can get them to think about benefits they do not know about."

He said insurers often don't know a member is facing a health issue until they see a medical claim. "We can identify things they don't know about," he said.

Until recently, Medicare rarely paid for non-health services. But Papa began working with Medicare Advantage plans in 2020, just one year after the program began allowing the private insurers to have more flexibility addressing members' so-called social needs, such as transportation, housing, and food, which are not typically covered by Medicare but could influence health. Papa's goal of addressing members' loneliness took on even more significance during the pandemic when many seniors became socially isolated as they sought to reduce their risk of getting infected.

Papa has more than 25,000 pals whose average age is mid-30s. Before being hired, pals must undergo a criminal background check and a driving record review as part of the vetting process. After being hired, pals are trained on empathy, cultural competency, and humility.

Michael Walling, 22, who works as a Papa pal near his home in Port Huron, Michigan, said most seniors are receptive to getting help or a chance to talk to someone for a couple of hours.

One of his clients has trouble walking so Walling helps vacuum and mop her trailer and take her to the grocery store. On Christmas Eve, he even took her out to lunch. "It was to be my day off, but I didn't want her to be alone on the holiday," he said.

Tim Barrage, a former parole officer, who visits Bailey and about a dozen other seniors in the Akron area each week, turned to Papa because he was looking for a flexible part-time job to supplement income from his firearms safety training businesses.

"I've done work in the garden, hanging up and taking down Christmas decorations, cleaning ovens or stovetops," he said.

Each time he arrives at a member's home, Papa directs him to check to see how the member is feeling overall and then periodically ask about issues that can include the wellness exam and health risk assessment. At the end of the visit, he reports to Papa about what services he provided and how the member interacted with him. He alerts his supervisors at Papa to a member's potential health issues, and Papa connects with the health plan to address them.

Jennifer Kivi, manager of Medicare product development for Priority Health, a Michigan health plan, said members who have used the Papa service said it makes them feel less lonely. "If we can reduce their loneliness, it helps members feel better and their physical health will improve," she said.

The insurer doesn't want its Papa pals to ask members a long list of health questions, but they can ask about cancer or diabetes screenings, which also can bolster a plan's ratings. "What we have seen is you can have a doctor tell them and their insurance company tell them they need it, but a Papa pal can start to build that relationship with them, and it means a lot more coming from them," she said.

Phil Galewitz: pgalewitz@kff.org, @philgalewitz

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