When doctors told Frances Faulkenburg she had sleep apnea, she was more than ready for relief from her tired-all-the-time existence. She used to fall asleep at red lights while behind the wheel. At night, she'd wake up gasping for air, heart pounding. Her husband told her she snored.
But Faulkenburg, 47, couldn't tolerate the CPAP machine her doctor prescribed.
Health care — and how much it costs — is scary. But you're not alone with this stuff, and knowledge is power. "An Arm and a Leg" is a podcast about these issues, and its second season is co-produced by KHN.
"I just could not get used to the face mask covering both my nose and mouth," said Faulkenburg, who lives in Oviedo, Fla.
"It was claustrophobic."
CPAP, or continuous positive airway pressure, is often one of the first solutions doctors suggest for sleep apnea. With this disorder, a person's breathing stops and starts so frequently during the night that it can lead to or exacerbate health problems. The National Sleep Foundation estimates that more than 18 million American adults have sleep apnea.
A CPAP machine blows a stream of air into the back of the throat to let people breathe easier. It prevents muscles in the back of the throat from narrowing, which can constrict the airway, causing snoring or disturbed sleep.
Yet Faulkenburg quit using her CPAP and went back to feeling sleepy and tired all the time.
Many people have a negative reaction to the machines and are tempted to do the same. The big whoosh of air in your throat. The restrictive mask on your face. It can be a lot to adjust to. Studies suggest that from one-third to more than 50% of patients either stop using their CPAP machine or never bother to fill their prescription. They quit for a variety of reasons, but mostly because the device can be cumbersome and uncomfortable. Sometimes, they quit because of confusing or stringent health insurance restrictions.
But the health effects of untreated sleep apnea can be serious. People struggle with anxiety, tiredness and low productivity. There's even an increased risk of high blood pressure, heart attack and stroke.
Mary Mertens, a respiratory therapist at the Cleveland Clinic, helps patients work through problems with their CPAP machine. Patients often complain that the volume of air the machine puts out feels too intense.
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"Think about it as sticking your head out of a car window with your mouth open at 60 mph versus 25 mph," said Mertens. "The high pressure can be very overwhelming."
So Mertens' team goes to people's homes to help troubleshoot problems. That includes explaining sleep apnea and how a CPAP can help.
"Picture the air passage at the back of their throat like a garden hose with no water in it. The hose collapses down," said Mertens. That's what happens when a person with sleep apnea is sleeping.
"When we put a CPAP on somebody, it's like turning the water on for the garden hose," she said. "The hose then pops open and stays open."
At the Cleveland Clinic, about 70% of patients in the Respiratory Home Care program keep using their CPAP, Mertens said.
Follow-up is key. Mertens' team checks in with patients during the first three to five days, again between 30 and 45 days and again between 60 and 90 days.
Faulkenburg, the patient in Florida, first tried a CPAP 15 years ago but never checked back with her pulmonologist when she was struggling. And, she said, the physician never contacted her. Then several people in her social circle died in their sleep — all of them right around her age. Those stories shook Faulkenburg, and she decided to try her CPAP again.
"I got a mask that covered just my nose, which let my mouth stay closed. That ended up being the whole issue," she said. "I sleep so good, I can't sleep without my CPAP now."
Dr. Indira Gurubhagavatula, a sleep medicine physician at the University of Pennsylvania Health System, said the look of the device alone can be alarming.
"One of the first things that I hear is that the thing itself is intimidating — they see the tubing and mask and it's blowing air in their face — they have real concerns: 'Am I actually going to sleep better with that thing?'
"It is a big ask to go to bed with this thing strapped to their faces," she said.
Gurubhagavatula said people who feel claustrophobic should wear their CPAP mask during the day while reading or watching TV. That can help the nerve endings in the face get used to the mask.
"It's just like breaking in new shoes or new jeans," said Gurubhagavatula. "Once it's broken in, it's less of an issue."
Pulmonologist James Rowley, a sleep medicine physician at Detroit Medical Center, said the air pressure from the CPAP can cause a runny nose, nasal congestion or dry mouth. He said he can help by adjusting humidity settings on the machine or prescribing an antihistamine.
Medicare and private insurance companies require patients to use their CPAP very consistently — often at least four hours every night and for 70% of nights each month. Sometimes the usage is monitored.
Patients who don't comply may end up paying out-of-pocket. That's the topic of this week's episode of the podcast "An Arm and a Leg." Kaiser Health News co-produces the podcast.
Prices vary, but a fully equipped machine typically costs from $500 to $3,000, with the national average around $850. After that initial investment, masks, hoses and filters need to be replaced two or three times a year. And users have the ongoing cost of maintenance supplies — wipes and brushes to keep the machine parts clean.
Gurubhagavatula said she has patients whose machines have been taken away because they couldn't follow the insurance company rules.
"They may have child care or elder responsibilities that makes their sleep disrupted. Or they sleep in chunks of time because they work certain shifts," she said. "The rule is arbitrary because using the machine, even if part time, is beneficial."
Nate Wymer, 44, said his machine is lying around his home somewhere in Holly Springs, N.C., but he hasn't seen it in years.
"When I had the mask on I had to think about breathing out of my nose," said Wymer. "That's not something I normally do. After a couple of nights, I just couldn't do it."
"My doctor never really followed up from what I can remember, so I back-burnered it," said Wymer. "But, if you get in front of somebody, actually talk to them and make sure everything is going OK, that would have been nice."
Last week's announcement of a Trump administration overhaul of kidney care in the U.S. has reanimated an effort by federal lawmakers and kidney care advocates to extend drug coverage.
This article was first published on Wednesday, July 19, 2019 inKaiser Health News.
On Wednesday, Alexis Conell will mark seven years since she received the kidney transplant that saved her life, but the 53-year-old Chicago woman isn't exactly celebrating.
Although the federal government paid most of the costs for her 2012 transplant, a long-standing Medicare policy halted coverage three years later for the drugs that keep her body from rejecting the organ.
So when Conell lost her job suddenly last September, she also lost her health insurance — and her ability to afford the 16 daily medications she needs to survive.
"I was terrified," she said. "All you're thinking is, 'I don't want to lose my kidney.'"
For nearly a half-century, Medicare has covered patients, regardless of age, who have end-stage renal disease, including paying the costs of kidney transplants and related care, which run about $100,000 per patient.
But coverage ends after 36 months for those younger than 65 who don't otherwise qualify for the program — and that includes payment for the vital immunosuppressive drugs that cost thousands per patient each month.
Last week's announcement of a Trump administration overhaul of kidney care in the U.S. has reanimated an effort by federal lawmakers and kidney care advocates to extend drug coverage.
"After a transplant, patients should not have to worry about whether they can afford the treatment needed to keep their transplanted kidney," Rep. Ron Kind (D-Wis.) said in a statement.
For years, Kind has been among a bipartisan coalition in Congress championing legislation targeting kidney immunosuppressive drugs — to no avail.
The sticking point was price. A 2009 estimate by the Congressional Budget Office pegged the cost at $400 million over 10 years if the government were to extend lifetime drug coverage to those patients.
Two recent federal projections show that Medicare could actually save money — between $73.4 million and $120 million over a decade — by expanding payment for anti-rejection medications to help decrease the need for patients to get additional transplants or dialysis. Depending on financing, savings could reach $300 million in that period, suggested an estimate by the Centers for Medicare & Medicaid Services.
Armed with this data, a bipartisan coalition led by Kind and Rep. Michael Burgess (R-Texas), a physician, is expected to introduce legislation by August that would narrowly extend Medicare's Part B program to provide drug coverage for kidney transplant patients who have no other option.
"We must ensure patients have access to immunosuppressant coverage to ensure the success of their transplant, which will keep costs down by decreasing the need for a re-transplant or further dialysis," said Kind.
Sens. Richard Durbin (D-Ill.) and Bill Cassidy (R-La.) are poised to introduce their own legislation, sources told KHN on background.
The efforts in Congress will hinge on whether the CBO agrees that paying for the medication would save the government money, advocates said. Even the new estimates by CMS suggest that changing the program would increase costs initially, with savings apparent only after a decade.
Dr. Emily Blumberg, president of the American Society of Transplantation, said there appears to be high-level support for change now. In championing the overhaul of U.S. kidney care policy, Health and Human Services Secretary Alex Azar has cited a personal tie, noting that his father suffered from kidney failure and received a transplant in 2014.
More than 56,000 Americans with functioning kidney transplants don't have Medicare coverage, according to data from the U.S. Renal Data System. About two-thirds pay for their medications through private insurance, Medicaid or other government programs, experts said.
But about one-third of those patients may have no other source of drug coverage, which can lead to missed doses, jeopardizing their new kidneys. A 2010 study found that nearly 70% of U.S. kidney transplant programs reported deaths or organ losses directly related to the high cost of anti-rejection drugs.
If Medicare drug coverage had been extended in 2015, it would have averted at least 375 kidney transplant failures that year alone, the latest analysis showed.
When transplants fail, patients can die — or they must return to dialysis — paid for by Medicare at a cost of about $90,000 per year, with a poor prognosis.
"It's a no-brainer that you should do this both from a moral and ethical and, now it sounds like, cost perspective," said Dr. Robert Gaston, a nephrologist at the University of Alabama-Birmingham who co-authored a call for coverage in an Institute of Medicine report two decades ago.
Conell battled end-stage renal disease for years before receiving her kidney transplant. When she lost her job abruptly last fall, she had to cancel scheduled medical appointments and lab tests.
She drained her savings, then nearly ran out of medication before she found a pharmaceutical firm program that provides the drugs she needs at a deep discount.
"If I had to pay full price for them, it would easily be $3,000 or more per month," Conell said.
When her unemployment benefits ended in April, Conell qualified for Medicaid, which covers her drugs for now. The stress has been unrelenting, said Conell, who spent a day last week in the emergency room with dangerously high blood pressure.
"I was trying to look for a job, worried about paying my bills. Ultimately, I'm worried about losing my kidney," she said, adding that the long-delayed legislation could solve the problem. "I think they should pass it, like, yesterday."
Officials have known for years that some Medicare Advantage plans overcharge for treating serious medical conditions they cannot prove their patients have.
This article was first published on Tuesday, July 16, 2019 in Kaiser Health News.
Health insurers that treat millions of seniors have overcharged Medicare by nearly $30 billion the past three yearsalone, but federal officials say they are moving ahead with long-delayed plans to recoup at least part of the money.
Officials have known for years that some Medicare Advantage plans overbill the government by exaggerating how sick their patients are or by charging Medicare for treating serious medical conditions they cannot prove their patients have.
Getting refunds from the health plans has proved daunting, however. Officials with the Centers for Medicare & Medicaid Services repeatedly have postponed, or backed off, efforts to crack down on billing abuses and mistakes by the increasingly popular Medicare Advantage health plans offered by private health insurers under contract with Medicare. Today, such plans treat over 22 million seniors, more than 1 in 3 people on Medicare.
Now CMS is trying again, proposing a series of enhanced audits tailored to claw back $1 billion in Medicare Advantage overpayments by 2020 — just a tenth of what it estimates the plans overcharge the government in a given year.
At the same time, the Department of Health and Human Services Inspector General's Office has launched a separate nationwide round of Medicare Advantage audits.
As in past years, such scrutiny faces an onslaught of criticism from the insurance industry, which argues the CMS audits especially are technically unsound and unfair and could jeopardize medical services for seniors.
America's Health Insurance Plans, an industry trade group, blasted the CMS audit design when details emerged last fall, calling it "fatally flawed."
Insurer Cigna Corp. warned in a May financial filing: "If adopted in its current form, [the audits] could have a detrimental impact" on all Medicare Advantage plans and "affect the ability of plans to deliver high quality care."
But former Sen. Claire McCaskill, a Missouri Democrat who now works as a political analyst, said officials must move past powerful lobbying efforts to hold health insurers accountable and demand refunds for "inappropriate" billings.
"There's a lot of things that could cause Medicare to go broke. This would be one of the contributing factors," she said. "Ten billion dollars a year is real money."
Catching Overbilling With A Wider Net
In the overpayment dispute, health plans want CMS to scale back — if not kill off — an enhanced audit tool that, for the first time, could force insurers to cough up millions in improper payments they've received.
For over a decade, audits have been little more than an irritant to insurers because most plans go years without being chosen for review and often pay only a few hundred thousand dollars in refunds as a consequence. When auditors uncover errors in the medical records of patients they paid the companies to treat, CMS has simply required a rebate for those patients for just the year audited — relatively small sums for plans with thousands of members.
The latest CMS proposal would raise those stakes enormously by extrapolating error rates found in a random sample of 200 patients to the plan's full membership — a technique expected to trigger many multimillion-dollar penalties. Though controversial, extrapolation is common in medical fraud investigations — except for investigations into Medicare Advantage. Since 2007, the industry has successfully challenged the extrapolation method and, as a result, largely avoided accountability for pervasive billing errors.
"The public has a substantial interest in the recoupment of millions of dollars of public money improperly paid to health insurers," CMS wrote in a Federal Register notice late last year announcing its renewed attempt at using extrapolation.
Penalties In Limbo
In a written response to questions posed by Kaiser Health News, CMS officials said the agency has already conducted 90 of those enhanced audits for payments made in 2011, 2012 and 2013 — and expects to collect $650 million in extrapolated penalties as a result.
Though that figure reflects only a minute percentage of actual losses to taxpayers from overpayments, it would be a huge escalation for CMS. Previous Medicare Advantage audits have recouped a total of about $14 million, far less than it cost to conduct them, federal records show.
Though CMS has disclosed the namesof the health plans in the crossfire, it has not yet told them how much each owes, officials said. CMS declined to say when, or if, they would make the results public.
This year, CMS is starting audits for 2014 and 2015, 30 per year, targeting about 5% of the 600 plans annually.
This spring, CMS announced it would extend until the end of August the audit proposal's public comment period, which was supposed to end in April. That could be a signal the agency might be looking more closely at industry objections.
Healthcare industry consultant Jessica Smith said CMS might be taking additional time to make sure the audit protocol can pass muster. "Once they have their ducks in a row, CMS will come back hard at the health plans. There is so much money tied to this."
But Sean Creighton, a former senior CMS official who now advises the industry for healthcare consultant Avalere Health, said payment error rates have been dropping because many health plans "are trying as hard as they can to become compliant."
Still, audits are continuing to find mistakes. The first HHS inspector general audit, released in late April, found that Missouri-based Essence Healthcare Inc. had failed to justify fees for dozens of patients it had treated for strokes or depression. Essence denied any wrongdoing but agreed it should refund $158,904 in overcharges for those patients and ferret out any other errors.
Essence also faces a pending whistleblower suit filed by Charles Rasmussen, a Branson, Mo., doctor who alleges the health plan illegally boosted profits by overstating the severity of patients' medical conditions. Essence has called the allegations "wholly without merit" and "baseless."
Essence started as a St. Louis physician group, then grew into a broader holding company backed by prominent Silicon Valley venture capitalist John Doerr with his brother, St. Louis doctor and software designer Thomas Doerr, in 2007. Neither would comment on the allegations.
How We Got Here
CMS uses a billing formula called a "risk score" to pay for each Medicare Advantage member. The formula pays higher rates for sicker patients than for people in good health.
Congress approved risk scoring in 2003 to ensure health plans did not shy away from taking sick patients who could incur higher-than-usual costs from hospitals and other medical facilities. But some insurers quickly found ways to boost risk scores — and their revenues.
In 2007, after several years of running Medicare Advantage as what one CMS official dubbed an "honor system," the agency launched "Risk Adjustment Data Validation," or RADV, audits. The idea was to cut down on undeserved payments that cost CMS nearly $30 billion over the past three years.
The audits of 37 health plans revealed that on average auditors could confirm just 60% of the more than 20,000 medical conditions CMS had paid the plans to treat.
Extra payments to plans that had claimed some of its diabetic patients had complications, such as eye or kidney problems, were reduced or invalidated in nearly half the cases. The overpayments exceeded $10,000 a year for more than 150 patients, though health plans disputed some of the findings.
But CMS kept the findings under wraps until the Center for Public Integrity, an investigative journalism group, suedthe agency under the Freedom of Information Act to make them public.
Despite the alarming results, CMS conducted no audits for payments made during 2008, 2009 and 2010 as they faced industry backlash over CMS' authority to conduct them, and the threat of extrapolated repayments. Some inside the agency also worried that health plans would abandon the Medicare Advantage program if CMS pressed them too hard, records released through the FOIA lawsuit show.
CMS officials resumed the audits for 2011 and expected to finish them and assess penalties by the end of 2016. That has yet to happen amid the continuing protests from the industry. Insurers want CMS to adjust downward any extrapolated penalties to account for coding errors that exist in standard Medicare. CMS stands behind its method — at least for now.
At a minimum, argues AHIP, the health insurers association, CMS should back off extrapolation for the 90 audits for 2011-13 and apply it for 2014 and onward. Should CMS agree, it would write off more than half a billion dollars that could be recovered for the U.S. Treasury.
Three years ago, Corey Walsh, who was in a relationship with a man who was HIV-positive, got a prescription for Truvada, a drug approved by the Food and Drug Administration to prevent infection with the virus that causes AIDS.
Walsh, then 23, was covered by his parents' health insurance policy, which picked up the cost of the drug. But the price tag for the quarterly lab tests and doctor visits he needed as part of the prevention regimen cost him roughly $400, more than he could afford.
"I went back to my physician and said, 'I can't take this anymore because all these ancillary services aren't covered,'" Walsh recalled. He ended up joining a clinical trial that covered all his costs.
Walsh's experience with high out-of-pocket costs, whether for medication or related services, is common, advocates say. Last month, the U.S. Preventive Services Task Force recommended that clinicians offer prescription pre-exposure prophylaxis, or PrEP, to people at high risk of contracting HIV. The decision by the independent group of experts means that starting in 2021 most health plans are required to cover drugs that are recommended to prevent HIV, and patients can't be charged anything out-of-pocket for the medication.
But the recommendation doesn't apply to the other clinical and lab services people need if they're on PrEP, according to task force officials.
In addition to the ancillary charges, other roadblocks persist for people who need PrEP from getting it.
"Eliminating cost sharing will undoubtedly expand access to individuals for whom affordability has been a significant barrier," said Amy Killelea, senior director of health systems integration at NASTAD, an organization representing public health officials nationwide. "However, scaling up access to PrEP to individuals who need it most — including young, gay, black and Latino men — will require addressing other major systemic and structural challenges, such as stigma and provider awareness and willingness to prescribe PrEP to their patients."
President Donald Trump has emphasized the need for more efforts to fight the HIV epidemic. In his State of the Union address in February, the president vowed to eliminate HIV transmission by 2030.
Currently, Truvada for PrEP, made by Gilead, is the only drug approved to prevent HIV. The once-a-day pill is at least 90% effective in some high-risk groups, including men who have sex with men as well as heterosexual men and women who have sex with HIV-positive partners, and 70% effective in people who inject illicit drugs.
Gilead estimated that 200,000 people now receive Truvada. The Centers for Disease Control and Prevention estimated that in 2015 there were 1.1 million people in the United States who could benefit from PrEP.
With a monthly price tag approaching $2,000, many private health plans have put the drug in a specialty drug tier with high copayments or coinsurance. Those payments will disappear when the task force recommendations take effect in 2021.
Truvada is generally covered in state Medicaid programs, as is the required clinical and lab work. But in the southern part of the country, where many states have not expanded Medicaid under the Affordable Care Act and HIV infection rates are high, there may be less access to the medication and other services.
Gilead offers a medication assistance program for uninsured people and a copay assistance program for those with private coverage that can fill gaps.
Gilead has submitted another HIV drug, Descovy, for FDA approval for PrEP, and a generic version of Truvada is expected next year.
It's unclear how these options might affect people's access to and ability to afford PrEP.
"Often it takes more than one generic for the price of a drug to drop," said Jennifer Kates, a senior vice president at the Kaiser Family Foundation. (KHN is an editorially independent program of the foundation.)
The new preventive coverage requirement may lead to private insurers or Medicaid programs trying to limit access by imposing prior authorization requirements, some advocates worry. Insurers might, for example, require doctors to show that the patient is HIV-negative and meets the risk criteria before approving the prescription. That can have serious repercussions.
"Anytime there's a delay at the pharmacy or on the provider's end, patients will give up," said John Peller, president and CEO of the AIDS Foundation of Chicago.
Once again, the fate of the Affordable Care Act is before the courts. The health law has traveled all the way to the Supreme Court (twice!) and is highly likely to make another visit.
On that path, the law made a stop Tuesday before a three-judge panel of the 5th Circuit Court of Appeals in New Orleans. Both sides presented arguments, interrupted, at times, by sharp questions from two of the judges.
For those just tuning in, the Trump administration is not defending the nine-year-old ACA.
In doing so, Department of Justice lawyers appeared to use strategies and take positions that sounded somewhat unconventional to a layperson. But are they?
KHN checked with some legal experts for their take.
For starters, this is the third time the administration has changed its position. Does this often happen?
No. It's unusual for an administration to shift its own legal opinions during the case, say experts.
When the lawsuit was filed, the administration said only the parts of the law tied to a requirement that most Americans carry insurance, the so-called individual mandate, should be tossed. (That's a pretty big part, which includes protections for people with preexisting conditions.)
The red-state plaintiffs, conversely, argued that the entire law should go, pointing to Congress' 2017 vote to zero out the individual mandate's tax penalty. The Supreme Court's 2012 decision to preserve the ACA hinged on that penalty.
But, last December, aUnited States district court judge in Texas sided with the states, saying the whole law should be tossed, which would affect provisions as diverse as the preexisting condition protections, Medicaid expansion and calorie counts on restaurant menus.
"You don't usually say, 'Oh, never mind,'" said Tom Miller, resident fellow at the conservative American Enterprise Institute. "It's unusual to do that flip."
But that's not the last flip. Another change came up in legal papers filed shortly before the Tuesday hearing and in oral arguments.
DOJ attorney August Flentje told the appeals court that, well, maybe only those provisions of the law that directly affect the plaintiffs — the 18 states — should be struck.
"It's complicated," he admitted, calling to mind a similar statement made in 2017 by President Donald Trump amid the repeal debate in Congress: "Nobody knew that healthcare could be so complicated."
Even as this legal challenge works its way through the courts, the ACA remains the law of the land. The evolving legal positions, however, are fodder for professors.
"I'm teaching a class this fall and this gives me more material," said Miller. "But if I had to consistently try to argue a position at the DOJ, I would go crazy."
So, the government wants to skewer some provisions of the law, but not others — and have those changes apply only in some states. How would that work?
Questions about that argument came from 5th Circuit Judge Jennifer Walker Elrod, appointed by President George W. Bush in 2007.
The government wants to have it apply "in certain states and strike it down in certain states?" Elrod asked. "The government believes that's a possibility?"
Unasked but implicit: How would some states enforce the law and not others?
Flentje said "a lot of that would have to get sorted out" but not until after all the appeals in the case are exhausted.
Behind the argument may well be an ongoing dispute in the legal community about whether lower-court judges should make decisions that have nationwide implications, said John Malcolm, director of the conservative Heritage Foundation's Edwin Meese III Center for Legal and Judicial Studies. Still, it would be difficult, he said, for the ACA to be declared unconstitutional in some states, but remain in effect elsewhere.
Beyond that legal question, such a position has financial and policy implications for consumers and state regulators.
"It would create a very untenable situation for the rest of the states," said Mila Kofman, executive director of the DC Health Benefit Exchange Authority, where individuals and small businesses buy health insurance.
Some of the very sickest people in the states where the rules were dropped would likely move to states keeping the preexisting condition protections so they could maintain their insurance, she said. That could drive up costs in those areas.
Arguments Tuesday revolved around whether parts of the law were "severable" from other parts. Did it seem the government wants it both ways — to toss the entire law, but also keep parts of it?
Elrod again queried Flentje.
The government wants the health insurance provisions to go, but "you would leave in the calorie guide?" Elrod asked, referring to the ACA's requirement that chain restaurants display calorie counts of menu items.
Flentje said the government's "argument on scope is totally separate from argument on severability."
She pressed him for clarification: "So, are you saying it's entirely inseverable, or arguing that some parts can be kept?"
The government's position remains that "the entire act is not severable," he replied, adding, however that the judgment could be "narrowed a bit to provisions that injure and impact the plaintiffs."
He suggested some of those details would still have to be worked out.
"They've gone from saying a couple of provisions have to go to the whole thing has to go, to now there are some things we might not have to get rid of," said Miller. "But they've never defined how far back down the ladder to go."
A ruling by the appeals court isn't expected for weeks or months, and some questions may well return to the district court.
A growing number of health systems and insurers providing real-time drug pricing information to physicians so they can help patients avoid 'sticker shock' at the pharmacy.
This article was first published on Wednesday, July 10, 2019 in Kaiser Health News.
When Mary Kay Gilbert saw her doctor in May for a skin infection on her leg, she wasn't surprised to receive a prescription for an antibiotic cream.
But Gilbert, 54, a nurse and health consultant, was shocked when her physician clicked on the desktop computer and told Gilbert the medicine would cost $30 on her Blue Cross and Blue Shield plan.
"I was like, 'Wow — that's pretty cool that you know that information,'" she recalled telling the doctor in Edina, Minn.
Allina Health, a large Minnesota hospital network to which Gilbert's doctor belongs, is one of a growing number of health systems and insurers providing real-time drug pricing information to physicians so they can help patients avoid "sticker shock" at the pharmacy.
The pricing tool, which is embedded in physicians' electronic health record and prescribing system, shows how much patients will pay out-of-pocket based on their insurance and the pharmacy. It allows the doctor to find a cheaper alternative when possible and start the process of getting authorization for a drug, if the insurer requires that.
The soaring cost of drugs has been front and center in the growing national debate about revamping U.S. healthcare.
Consumers abandon hundreds of thousands of prescriptions each year at the pharmacy, often because of high prices, jeopardizing their health and often leading to higher costs down the road, studies show.
Experts say the tool can help consumers — who are facing increasing copayments and higher deductibles — learn about cheaper options in the doctor's office.
Still, doctors have been slow to adopt the technology, sometimes because of concerns about getting bogged down in long discussions about drug costs. Humana, for example, introduced its drug pricing tool to its network doctors in 2015. Today, fewer than 10% are using it, company officials said.
But the tool has serious limitations too. Because price negotiations among insurers, drugmakers and middlemen are often highly competitive and secretive, the tools often don't have data for everyone. For example, Allina's works for only about half its patients. That's because not all pharmacy benefit managers share their data on health plan enrollee costs, and those that do often provide only a fraction of their information.
"It's a chicken-and-egg thing where doctors don't use it because they don't have the data for all their patients, and health plans don't promote it to physicians because doctors don't have the technology in place," said Anthony Schueth, a health information technology consultant in Jacksonville, Fla. "It can be a powerful tool when it works, but at the moment the drivers are not there across the board for widespread adoption."
At a hearing last month, Sen. Martha McSally (R-Ariz.) pressed a top Trump administration health official about why many patients lack access to information on prescription drug prices at their doctor's office.
"This is America. Why can't we have this tool available tool now?" she asked. "The data is out there; the information is out there. What is it going to take to make this happen?"
The technology got a boost last month when the Centers for Medicare & Medicaid Services mandated that all Medicare drug plans embed such a tool in their doctors' electronic prescribing system starting in 2021.
The details of what consumers spend out-of-pocket for drugs is provided by pharmacy benefit managers, or PBMs. They are the middlemen that negotiate with drugmakers on the prices insurers will pay for the medications and which ones the insurers will cover. So a tool's usefulness is undermined when key PBMs are not included in the listings.
For example, a drug pricing tool sold by Arlington, Va.-based Surescripts, which is owned partly by the PBMs CVS Caremark and Express Scripts, includes data from those companies, but not OptumRx, a PBM owned by insurance titan UnitedHealth. And the OptumRX drug pricing tool includes Optum data but not that of Express Scripts and CVS.
Demetrios Kouzoukas, who heads the Medicare program for CMS, said he hopes the program's new drug mandate will spark the industry to provide doctors and patients access to a pricing tool, regardless of their insurance.
"What we are hoping and expecting is that there will be a standard that's developed by the industry … so that the tool is available in all the electronic health records, for all the doctors and all patients, and spreads even beyond Medicare," he told McSally at the hearing.
Given the competitive nature of the industry, cooperation does not seem to be on the horizon, some industry officials say.
"I don't see any chance that there will be a centralized system that will connect all of the plans/PBMs with all of the EHR systems currently in use anytime soon," said Thomas Borzilleri, CEO of InteliSys Health, a health technology company based in San Diego.
However, the National Council for Prescription Drug Programs, a nonprofit group that helps set guidelines for the pharmacy industry, has been working on standards for a drug pricing tool. John Klimek, a senior vice president, predicts that by next year doctors across the country will be able to use the same drug pricing tool to look up all their patients' drug costs, regardless of the insurer.
Even without such a standard in place, doctors and hospitals have an incentive to use the tool beyond offering a cost-saving service to their patients: It can save providers money, too.
For example, Allina, which owns or operates about a dozen hospitals and dozens of clinics in Minnesota and Wisconsin, gets a set fee from some insurers to care for all of a patient's health needs. So the doctors and health system benefit when they can reduce costs and improve patients' adherence to taking their medication, said Dr. David Ingham, a family doctor also from Edina, one of 600 primary care doctors at Allina using the tool.
"When we prescribe a more expensive medication, we share less revenue from the insurance contract," he said.
For example, he noted that the tool helped him prescribe inhalers to asthma patients.
"I pulled up one medication I normally use, and it said it would be $240 out-of-pocket, but it suggested an alternative for $20 that was pharmacologically equivalent. I sheepishly asked the patient which we should choose," he said.
Dr. Norman Rosen, a family physician in Orange, Calif., who is employed by Providence St. Joseph Health System, is one of 800 doctors at the hospital testing the Blue Shield of California drug pricing tool this year. Based on the first few months of use, the tool is expected to save patients a total of more than $100,000 in out-of-pocket costs this year, according to the companies.
Without the tool, Rosen said, it would be impossible for him to quickly know what drugs are covered by which insurers and what the copays are. He said he already has saved some patients several thousand dollars a year by changing their blood pressure and diabetes medications.
"It doesn't take a lot of time, and this can be an important intervention because one of the fears we have is a patient not taking their medication because it's too expensive," Rosen said.
As California prepares to expand Medicaid coverage to young adults living in the state illegally, the number of undocumented immigrant children in the program is slowly declining, new state data show.
Unauthorized immigrant children have been eligible for Medi-Cal, the state's Medicaid program for low-income residents, since May 2016, and their enrollment peaked nearly a year later at 134,374, according to data from the state Department of Healthcare Services.
Since then, enrollment has stayed mostly flat or fallen. Last February, the latest month for which data are available, 127,845 undocumented immigrant children through age 18 were enrolled in Medi-Cal, down about 5% from the April 2017 peak.
This drop mirrors statewide and national trends for all children enrolled in Medicaid and the Children's Health Insurance Program, a separate public program that some states use to cover low-income children.
From December 2017 to December 2018, overall child enrollment in both programs dropped 2.2% nationally and 3% in California, according to a recent report from Georgetown University's Health Policy Institute.
Some experts attribute the enrollment drop among all children to a strong economy because more people have jobs — and access to employer-sponsored health insurance. But Medicaid researchers say there are likely other factors at play for immigrant children.
The decline in their enrollment is more likely due to a shift in migration patterns and rising fear among their families in response to anti-immigrant rhetoric and federal crackdowns on unauthorized immigrants, said Edwin Park, a health policy research professor at Georgetown University.
"It's likely the overall hostile environment for immigrant families is playing a critical role in enrollment," Park said. "You should have seen a continued ramp-up" in sign-ups because the program is still relatively new. California along with Illinois, Massachusetts, New York, Oregon and Washington, plus the District of Columbia, provide public health coverage for undocumented immigrant children.
Last year, California allocated $365.2 million to cover these children. Even though Medicaid is a joint state-federal program, California must pay for the expanded benefits for unauthorized immigrants itself.
Starting next year, as part of the 2019-20 state budget signed last month by Gov. Gavin Newsom, the state will expand Medi-Cal coverage to young adult unauthorized immigrants ages 19 through 25. Officials estimate 90,000 young adults will join in the first year.
President Donald Trump criticized California's move and threatened to "stop it."
"The Democrats want to treat the illegals with healthcare and with other things, better than they treat the citizens of our country," Trump said on July 1.
The state Department of Healthcare Services, which administers Medi-Cal, said undocumented immigrant children might be leaving the program because they age out of eligibility when they turn 19 or move out of state.
Randy Capps, director of research at the Washington, D.C.-based Migration Policy Institute, said a shift in immigration patterns into and out of California could also affect their enrollment.
The number of people coming into the country illegally is down, especially from Mexico, according to a Pew Research Center report released in June. That is notable in California, where Mexican nationals make up the majority of the state's undocumented immigrant population.
The report estimates there were 4.9 million unauthorized immigrants from Mexico in the U.S. in 2017, down from 6.9 million in 2007.
"All data suggest a downward trend on illegal immigration, especially of Mexican origin," Capps said.
In California, "with the recent economic boom, that may be accelerating because the cost of living is escalating astronomically," he said. "Housing is becoming prohibitively expensive for undocumented immigrants in large parts of the state."
Although there have been an increasing number of Central American migrants trying to enter the U.S. at the southern border this year, most are claiming asylum and are not considered undocumented immigrants.
As a result, most of those children wouldn't qualify for Medi-Cal under this program, explained Gabrielle Lessard, a staff attorney with the National Immigration Law Center.
But the rhetoric surrounding the Central American refugees has been heated, and Trump has made tough talk on immigration a centerpiece of his presidency.
Last month, Trump warned of "massive" deportation raids that would have targeted about 2,000 families — but they were postponed after he gave members of Congress time to make changes to asylum laws. He said the raids might begin this week.
His administration also has pursued policies targeting immigrants. For instance, last fall, the federal government introduced its "public charge" proposal, which would consider immigrants' use of public benefit programs including Medi-Cal, CalFresh and Section 8 housing vouchers as a reason to deny lawful permanent residency — or green card status.
That proposed rule has not taken effect, and it's not clear whether it will. If implemented, the policy would mostly affect legal immigrants, but it could also affect undocumented immigrants should they become eligible to seek legal status in the future.
In response, unauthorized immigrant families have been forgoing care, missing doctors' appointments and asking whether they should disenroll from Medicaid coverage, health centers across California and the country have reported.
Lessard suspects that unauthorized immigrants could be pulling their children out of Medi-Cal or simply not renewing their coverage.
"This community has been so terrorized by the administration that people are afraid to show up to their appointments at health centers," she said. "So the prospect of giving your information to the government, even though it's the state government, is really terrifying to a lot of people."
The fate of the Affordable Care Act is again on the line Tuesday, as a federal appeals court in New Orleans takes up a case in which a lower court judge has already ruled the massive health law unconstitutional.
Not only would such a decision immediately affect the estimated 20 million people who get their health coverage through programs created under the law, ending the ACA would also create chaos in other parts of the healthcare system that were directly or indirectly changed under the law's multitude of provisions, such as calorie counts on menus, a pathway for approval of generic copies of expensive biologic drugs and, perhaps most important politically, protections for people with preexisting conditions.
"Billions of dollars of private and public investment — impacting every corner of the American health system — have been made based on the existence of the ACA," said a friend-of-the-court brief filed by a bipartisan group of economists and other health policy experts to the 5th Circuit Court of Appeals. Upholding the lower court's ruling, the scholars added, "would upend all of those settled expectations and throw healthcare markets, and 1/5 of the economy, into chaos."
Here are five important things to know about the case:
It was prompted by the tax bill Republicans passed in 2017.
The big tax cut bill passed by the GOP Congress in December 2017 eliminated the penalty included in the ACA for failure to maintain health insurance coverage. The lawsuit was filed in February 2018 by a group of Republican attorneys general and two governors. They argued that since the Supreme Court had upheld the ACA in 2012 specifically because it was a valid exercise of Congress' taxing power, taking the tax away makes the entire rest of the law unconstitutional.
Last December, Judge Reed C. O'Connor agreed with the Republicans. "In some ways the question before the court involves the intent of both the 2010 and 2017 Congresses," O'Connor wrote in his decision. "The former enacted the ACA. The latter sawed off the last leg it stood on."
State and federal Democrats are defending the law.
Arguing that the rest of the law remains valid is a group of Democratic attorneys general, led by California's Xavier Becerra.
"Our argument is simple," said Becerra in a statement last Friday. "The health and wellbeing of nearly every American is at risk. Healthcare can mean the difference between life and death, financial stability and bankruptcy. Our families' wellbeing should not be treated as a political football."
The Democratic-led House of Representatives has also been granted "intervenor" status in the case.
The Trump administration has taken several positions on the lawsuit.
The defendant in the case is technically the Trump administration. Traditionally, an administration, even one that did not work to pass the law in question, defends existing law in court.
Not this time. And it is still unclear exactly what the administration's position is on the lawsuit. "They have changed their position several times," Sen. Chris Murphy (D-Conn.) told reporters on a conference call Monday.
When the administration first weighed in on the case, in June 2018, it said it believed that without the tax penalty only the provisions most closely connected to that penalty — including requiring insurers to sell policies to people with preexisting conditions — should be struck down. The rest of the law should stay, the Justice Department argued.
After O'Connor's ruling, however, the administration changed its mind. In March, a spokeswoman for the Justice Department said it had "determined that the district court's comprehensive opinion came to the correct conclusion and will support it on appeal."
Now it appears the administration is shifting its opinion again. In a filing with the court late last week, Justice Department attorneys argued that perhaps the health law should be invalidated only in the GOP states that are suing, rather than all states. It is unclear how that would work.
Legal scholars — including those who oppose the ACA — consider the case dubious.
In a brief filed with the appeals court,legal scholars from both sides of the fight over the ACA agreed that the lawsuit's underlying claim makes no sense.
In passing the tax bill that eliminated the ACA's tax penalty but nothing else, Congress "made the judgment that it wanted the insurance reforms and the rest of the ACA to remain even in the absence of an enforceable insurance mandate," wrote law professors Jonathan Adler, Nicholas Bagley, Abbe Gluck and Ilya Somin. Bagley and Gluck are supporters of the ACA; Adler and Somin have argued against it in earlier suits. "Congress itself — not a court — eliminated enforcement of the provision in question and left the rest of the statute standing. So congressional intent is clear."
It could end up in front of the Supreme Court right in the middle of the 2020 election.
Depending on what happens at the appeals court level, the health law could be back in front of the Supreme Court — which has upheld the health law on other grounds in 2012 and 2015 — and land there in the middle of next year's presidential campaign.
Democrats are already sharpening their rhetoric for that possibility.
"President Trump and Republicans are playing a very dangerous game with people's lives," Senate Minority Leader Chuck Schumer told reporters on a conference call Monday.
Murphy said he is most concerned that if the lower court ruling is upheld and the health law struck down, Republicans "won't be able to come up with a plan" to put the healthcare system back together.
"Republicans tried to come up with a replacement plan for 10 years, and they couldn't do it," he said.
Despite hospital systems and health officials calling out the need for more primary care doctors, graduates of U.S. medical schools are becoming less likely to choose to specialize in one of those fields.
A record-high number of primary care positions was offered in the 2019 National Resident Matching Program — known to doctors as "the Match." It determines where a medical student will study in their chosen specialty after graduation. But this year, the percentage of primary care positions filled by fourth-year medical students was the lowest on record.
"I think part of it has to do with income," said Mona Signer, the CEO of the Match. "Primary care specialties are not the highest paying." She suggested that where a student gets a degree also influences the choice. "Many medical schools are part of academic medical centers where research and specialization is a priority," she said.
The three key primary care fields are internal medicine, family medicine and pediatrics. According to the 2019 Match report, 8,116 internal medicine positions were offered, the highest number on record and the most positions offered within any specialty, but only 41.5% were filled by seniors pursuing their M.D.s from U.S. medical schools. Similar trends were seen this year in family medicine and pediatrics.
In their final year of medical school, students apply and interview for residency programs in their chosen specialty. The Match, a nonprofit group, then assigns them a residency program based on how the applicant and the program ranked each other.
Since 2011, the percentage of U.S.-trained allopathic, or M.D., physicians who have matched into primary care positions has been on the decline, according to an analysis of historical Match data by Kaiser Health News.
But, over the same period, the percentage of U.S.-trained osteopathic and foreign-trained physicians matching into primary care roles has increased. 2019 marks the first year in which the percentage of osteopathic and foreign-trained doctors surpassed the percentage of U.S. trained medical doctors matching into primary care positions.
Medical colleges granting M.D. degrees graduate nearly three-quarters of U.S. students moving on to become doctors. The rest graduate from osteopathic schools, granting D.O. degrees. The five medical schools with the highest percentage of graduates who chose primary care are all osteopathic institutions, according to the latest U.S. News & World Report survey.
Beyond the standard medical curriculum, osteopathic students receive training in manipulative medicine, a hands-on technique focused on muscles and joints that can be used to diagnose and treat conditions. They are licensed by states and work side by side with M.D.s in physician practices and health systems.
Although the osteopathic graduates have been able to join the main residency match or go through a separate osteopathic match through this year, in 2020 the two matches will be combined.
Physicians who are trained at foreign medical schools, including both U.S. and non-U.S. citizens, also take unfilled primary care residency positions. In the 2019 match, 68.9% of foreign-trained physicians went into internal medicine, family medicine and pediatrics.
But, despite osteopathic graduates and foreign-trained medical doctors taking up these primary care spots, a looming primary care physician shortage is still expected.
The Association of American Medical Colleges predictsa shortage of between 21,100 and 55,200 primary care physicians by 2032. More doctors will be needed in the coming years to care for aging baby boomers, many of whom have multiple chronic conditions. The obesity rate is alsoincreasing, which portends more people with chronic health problems.
Studies have shown that states with a higher ratio of primary care physicians have better health and lower rates of mortality. Patients who regularly see a primary care physician also have lower health costs than those without one.
But choosing a specialty other than primary care often means a higher paycheck.
According to a recently published survey of physicians conducted by Medscape, internal medicine doctors' salaries average $243,000 annually. That's a little over half of what the highest earners, orthopedic physicians, make with an average annual salary of $482,000. Family medicine and pediatrics earn even less than internal medicine, at $231,000 and $225,000 per year, respectively.
Dr. Eric Hsieh, the internal medicine residency program director at the University of Southern California's Keck School of Medicine, said another deterrent is the amount of time primary care doctors spend filling out patients' electronic medical records.
"I don't think people realize how involved electronic medical records are," said Hsieh. "You have to synthesize everything and coordinate all of the care. And something that I see with the residents in our program is that the time spent on electronic medical records rather than caring for patients frustrates them."
The Medscape survey confirms this. Internists appear to be more burdened with paperwork than other specialties, and 80% of internists report spending 10 or more hours a week on administrative tasks.
The result: Only 62% of internal medicine doctors said they would choose to go into their specialty again — the lowest percentage on record for all physician specialties surveyed.
Elsa Pearson, a health policy analyst at Boston University, said one way to keep and attract primary care doctors might be to shift some tasks to health care providers who aren't doctors, such as nurse practitioners or physician assistants.
"The primary care that they provide compared to a physician is just as effective," said Pearson. They wouldn't replace physicians but could help lift the burden and free up doctors for more complicated care issues.
Pearson said more medical scribes, individuals who take notes for doctors while they are seeing patients, could also help to ease the doctors' burden of electronic health record documentation.
Another solution is spreading the word about the loan forgiveness programs available to those who choose to pursue primary care, usually in an underserved area of the country, said Dr. Tyree Winters, the associate director of the pediatric residency program at Goryeb Children's Hospital in New Jersey.
"The trend has been more so thinking about the amount of debt that a student has, compared to potential income in primary care," said Winters. "But that's not considering things like medical debt forgiveness through state or federal programs, which really can help individuals who want to choose primary care."
KHN data correspondent Sydney Lupkin contributed to this report.
The California agency that regulates doctors is investigating at least four physicians for issuing questionable medical exemptions to children whose parents did not want them immunized.
The Medical Board of California's investigations are unfolding amid the nation's worst measles outbreak in more than a quarter-century, as California lawmakers consider controversial legislation to tighten the requirements for exempting children from the vaccinations required to attend schools and day care centers.
Last month, the Department of Consumer Affairs, which oversees the medical board, sued in state court to obtain medical records for patients of Sacramento-area pediatricians Dr. Kelly Sutton and Dr. Michael Fielding Allen.
In the past nine months, the board also has sought patients' records in connection with two Santa Rosa physicians under investigation for writing allegedly inappropriate exemptions.
The state acted on the Sutton and Allen cases following complaints to the medical board from Dr. Wendy Cerny, assistant chief of pediatrics at a Kaiser Permanente clinic in Roseville, court documents show. (Kaiser Health News, which produces California Healthline, is not affiliated with Kaiser Permanante.) Cerny contacted the board about Sutton in February 2017 and followed up with an email about Allen 15 months later, according to the documents.
Cerny became concerned after seeing permanent medical exemptions for Kaiser Permanente pediatric patients written by Sutton and Allen that cited reasons including "a personal history of genetic defect," food and environmental allergies, "neurological vulnerability" and a family history of mental health disorders, according to the legal documents.
The doctors under investigation are not Kaiser Permanente doctors, but parents went to them for vaccination exemptions. In one case, Sutton issued a "lifelong medical exemption from all vaccines" to a boy before his family joined Kaiser Permanente, according to Cerny's complaint. When one of Cerny's colleagues refused to write similar exemptions for the boy's two younger siblings, the mother said she would go back to Sutton to get them, the complaint says.
"We feel this doctor and perhaps her colleagues … are making easy money on these exemptions that are not based on true medical need and are actually putting children and other people in the community at risk for contracting and spreading serious infectious diseases," Cerny wrote in her complaint about Sutton.
A physician appointed by the medical board to review exemptions issued by Sutton and Allendescribed them as "either of questionable validity or patently without medical basis."
Vaccine exemptions for medical reasons should be rare, according to the Centers for Disease Control and Prevention. They are typically reserved for children with severely compromised immune systems, like those being treated for cancer or those who are allergic to a vaccine component or have previously had a severe reaction to a vaccine.
A spokesman for the medical board declined to comment on the cases. The agency generally does not acknowledge investigations publicly unless a formal accusation is filed against a physician.
But the board's legal efforts to obtain patient records sheds rare light on how the agency handles such complaints.
It "tells me that there are doctors who are giving problematic exemptions and the Medical Board of California is taking this issue very seriously," said Dorit Reiss, a professor at University of California-Hastings College of the Law in San Francisco who researches vaccine law.
Sutton and Allen did not respond to phone calls and emails seeking comment.
Sutton, based in Fair Oaks, is known as a go-to doctor for medical vaccine exemptions. She offers a $97 "program" that purports to "help protect your child from the 'One Size Fits All' California vaccine mandate."
Cerny submitted copies of exemption letters by Sutton and Allen in the complaints she filed with the medical board, but the names of the patients were blacked out. The board wants the names of those children and their parents, and it asked the court to compel the Permanente Medical Group, a subsidiary of Kaiser Permanente, to hand over unredacted versions of the letters.
The board also wants Kaiser Permanente to hand over the patients' medical charts, which it believes will help determine whether the exemptions written by Sutton and Allen were indeed unmerited.
In June, Superior Court Judge Ethan Schulman ordered the Permanente Medical Group to disclose the names of the patients known to have received medical exemptions from Allen, as well as the names and addresses of their parents. He has not yet issued a ruling in the Sutton case.
Kaiser Permanente said it would comply with court orders.
"We take the health and safety of our members, patients and communities very seriously," said Dr. Stephen Parodi, associate executive director of the Permanente Medical Group, via email.
In a case similar to Sutton's and Allen's, a judge orderedthe Permanente Medical Group in November to provide the names of patients and parents subpoenaed in a medical board investigation of Dr. Kenneth Stoller, a Santa Rosa physician who gave vaccine exemptions to children who were Kaiser Permanente patients, as well as to others in the Mammoth Unified School District.
Stoller, who is not affiliated with Kaiser Permanente, is also being investigated by the city attorney of San Francisco, where he used to practice. He didn't respond to a request for comment.
In April, Judge Schulman granted a petition from the state ordering Dr. Ron Kennedy to hand over the medical records of children to whom he had issued vaccination exemptions. Kennedy, a psychiatrist who runs an anti-aging clinic in Santa Rosa, has written numerous exemptions for kids, according to court records.
Kennedy's lawyer, Michael Machat, said his client has handed over the records as ordered.
"The medical board has adopted the practice of thinking it can invade people's privacy and search children's private medical records to see whether or not the doctors are following the law," Machat said. "Where does this stop?"
To date, the only doctor sanctioned for inappropriate medical vaccine exemptions is Southern California pediatrician Robert Sears, the well-known author of "The Vaccine Book."
In 2015, California banned all philosophical and religious exemptions for immunizations in the wake of a large measles outbreak that originated at Disneyland. It is one of four states to have done so, and its vaccination rate rose sharply for three years after the law was tightened. But vaccination rates have declined in the past two years, in part because many parents opposed to vaccines have found doctors willing to write questionable medical exemptions — sometimes for a fee.
California's vaccination policies are once again drawing national attention in the wake of the nation's recent measles outbreak, which totaled 1,095 cases as of June 27. In California, 55 cases were reported as of June 26.
A bill pending in the California legislature, SB-276, would impose more oversight on vaccine exemptions written by doctors. After it passed the state Senate in May, it was softened to appeaseGov. Gavin Newsom but would still allow the state Department of Public Health to review some exemptions. It also would prevent doctors who are under investigation for writing unwarranted exemptions from issuing new ones.
Newsom has said he will sign the legislation if it lands on his desk.