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Another Cause Of Doctor Burnout: Being Forced To Give Immigrants Unequal Care

One patient’s death changed the course of Dr. Lilia Cervantes’ career.

The patient, Cervantes said, was a woman from Mexico with kidney failure who repeatedly visited the emergency room for more than three years. In that time, her heart had stopped more than once, and her ribs were fractured from CPR.

The woman finally decided to stop treatment because the stress was too much for her and her two young children. She died soon afterward, Cervantes said.

Kidney failure, or end-stage renal disease, is treatable with routine dialysis every two to three days. Without regular dialysis, which removes toxins from the blood, the condition is life-threatening: Patients’ lungs can fill up with fluid, and they’re at risk of cardiac arrest if their potassium level gets too high.

But Cervantes’ patient was undocumented. She didn’t have access to government insurance, so she had to show up at the hospital in a state of emergency to receive dialysis.

Cervantes, an internal medicine specialist and a professor of medicine at University of Colorado in Denver, said the woman’s death inspired her to focus more on research.

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“I decided to transition so I could begin to put the evidence together to change access to care throughout the country,” she said.

Cervantes said emergency dialysis can be harmful to patients: The risk of death for someone receiving dialysis only on an emergency basis is 14 times higher than someone getting standard care, she found in research published in February.

Cervantes’ newest study, published recently in the Annals of Internal Medicine, shows these cyclical emergencies harm health care providers, too. “It’s very, very distressing,” she said. “We not only see the suffering in patients, but also in their families.”

There are an estimated 6,500 undocumented immigrants in the U.S. with end-stage kidney disease. Many of them can’t afford private insurance and are barred from Medicare or Medicaid. Treatment of these patients varies widely from state to state, and in many places the only way they can get dialysis is in the emergency room.

Cervantes and her colleagues interviewed 50 health care providers in Denver and Houston and identified common concerns among them. The researchers found that providing undocumented patients with suboptimal care because of their immigration status contributes to professional burnout and moral distress.

“Clinicians are physically and emotionally exhausted from this type of care,” she said.

Cervantes said the relationships clinicians build with their regular patients conflicts with the treatment they have to provide, which might include denying care to a visibly ill patient because their condition was not critical enough to warrant emergency treatment.

“You may get to know a patient and their family really well,” she said. Providers may go to a patient’s restaurant, or to family gatherings such as barbacoas (similar to barbecues) or quinceañeras (milestone parties for 15-year-old girls).

“Then the following week, you might be doing CPR on this same patient because they maybe didn’t come in soon enough, or maybe ate something that was too high in potassium,” she said.

Other providers, Cervantes said, report detaching from their patients because of the suffering they witness. “I’ve known people that have transitioned to different parts of the hospital because this is difficult,” she said.

Melissa Anderson, a nephrologist and assistant professor at the Indiana University School of Medicine in Indianapolis who was not involved in Cervantes’ study, said Cervantes research matches her own experience. She said that when she worked at a safety-net hospital in Indianapolis, patients would come to the ER when they felt sick. But some hospitals would not provide dialysis until their potassium was dangerously high.

To avoid being turned away when their potassium level was too low, she said, patients in the waiting room would drink orange juice, which contains potassium, putting themselves at risk of cardiac arrest.

“That’s Russian roulette,” Anderson said. “That was hard for all of us to watch.”

Anderson eventually stopped working at that hospital and, like Cervantes, has worked on research and advocacy efforts to change how undocumented immigrants with kidney failure are treated.

“I practically had to take a class in immigration to understand what’s going on,” she said. “Physicians just don’t understand it, and we shouldn’t have to.”

Providers in Cervantes’ study also worried that these avoidable emergencies strain hospital resources — clogging emergency departments when undocumented patients could simply receive dialysis outside the hospital — and about the cost: Emergency-only hemodialysis costs nearly four times as much as standard dialysis, according to a 2007 study from researchers at Baylor College of Medicine.

Those costs are often covered by taxpayers through emergency Medicaid, which pays for emergency treatment for low-income individuals without insurance. In a study published in Clinical Nephrology last year, Anderson and her colleagues found that at one hospital in Indianapolis, the state paid significantly more for emergency-only dialysis than it did for more routine care.

Areeba Jawed, a nephrologist in Detroit who has performed survey research into this issue, said many providers don’t understand how much undocumented immigrants actually contribute to society, while receiving few of the societal benefits.

“A lot of people don’t know that undocumented immigrants do pay taxes,” she said. “There’s a lot of misinformation.”

“I think there are better options,” said Jawed, who has treated undocumented patients both in Detroit and Indianapolis.

As a workaround, some hospitals simply provide charity care to cover regular dialysis for undocumented patients. But Cervantes argues that a better solution is a policy fix. States are allowed by the federal government to define what qualifies as an emergency.

“Several states, like Arizona, New York and Washington, have modified their emergency Medicaid programs to include standard dialysis for undocumented immigrants,” she said.

Illinois covers routine dialysis and even passed a law allowing undocumented immigrants to receive kidney transplants, she noted.

“Ideally, we could come up with federal language and make this the national treatment strategy for undocumented immigrants,” Cervantes said.

Ultimately, Cervantes said, providers don’t want to treat undocumented patients differently.

“At the end of the day, clinicians become providers because they want to provide care for all patients,” she said.

This story is part of a partnership that includes Side Effects Public MediaNPR and Kaiser Health News.

SAMHSA announces $196 million funding opportunity for opioid treatment grants to hardest-hit states and tribes

HHS Gov News - May 30, 2018

The Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the Department of Health and Human Services (HHS) is now accepting applications for $196 million to treat opioid use disorder through its Targeted Capacity Expansion: Medication Assisted Treatment-Prescription Drug Opioid Addiction grant program.

The new funding will expand access to medication-assisted treatment and recovery support services to people with opioid use disorder. Eligibility is limited to the states, political subdivisions within states, and public and private nonprofit organizations in states with the highest rates of primary treatment admissions for heroin and prescription opioids per capita and includes those with the most dramatic increases for heroin and prescription opioids, as identified by SAMHSA’s 2015 Treatment Episode Data Set. Tribes and tribal organizations across the United States are also eligible to receive funding. The desired outcomes of this grant program include an increase in the number of people receiving medication-assisted treatment for their opioid use disorder, leading to a decrease in heroin use and prescription opioid misuse.

“This grant opportunity is made possible in part by the increased opioid funding secured from Congress by President Trump, and will help expand access to proven addiction treatment in communities hardest hit by the opioid crisis,” said HHS Secretary Alex Azar. “We know medication-assisted treatment is an effective, essential tool in fighting the opioid crisis, and HHS will continue working to expand access to it.”

By funding treatment in states with the greatest need for additional treatment resources, HHS and SAMHSA aim to reduce the number of deaths related to opioid use. “A targeted approach allows us to deliver evidence-based practices and programs where they are needed most,” explained Dr. Elinore McCance-Katz, Assistant Secretary for Mental Health and Substance Use. The funding opportunity announcement contains a list of the 35 eligible states; tribes and tribal organizations from anywhere in the United States are eligible.

Under President Trump, in April 2017, HHS unveiled a new five-point Opioid Strategy. The Strategy prioritizes efforts in five areas: 1) Improving access to prevention, treatment and recovery support services, including medication-assisted treatment; 2) Promoting the targeted availability and distribution of overdose-reversing drugs; 3) Strengthening public health data reporting and collection; 4) Supporting cutting-edge research on addiction and pain and 5) Advancing the practice of pain management. Since Fiscal Year 2017, HHS has invested over $1 billion in opioid-specific funding, including funds to state and local governments as well as civil society groups—to support treatment and recovery services, target availability of overdose-reversing drugs, train first responders and more.

Watch: Beyond Puerto Rico’s Grim Statistics, Stories Of Lives And Deaths

In an interview with Judy Woodruff on “PBS NewsHour” Tuesday, Kaiser Health News senior correspondent Sarah Varney discussed the updated estimates that more than 4,600 people died as a result of Hurricane Maria. Varney and “PBS NewsHour” producer Jason Kane are on assignment in Puerto Rico this week to continue reporting on the aftermath of the devastating Sept. 20 storm.

Looking For Lower Medicare Drug Costs? Ask Your Pharmacist For The Cash Price.

Kaiser Health News:States - May 30, 2018

As part of President Donald Trump’s blueprint to bring down prescription costs, Medicare officials have warned insurers that “gag orders” keeping pharmacists from alerting seniors that they could save money by paying cash — rather than using their insurance — are “unacceptable and contrary” to the government’s effort to promote price transparency.

But the agency stopped short of requiring insurers to lift such restrictions on pharmacists.

That doesn’t mean people with Medicare drug coverage are destined to overpay for prescriptions. Under a little-known Medicare rule, they can pay a lower cash price for prescriptions instead of using their insurance. But first, they must ask the pharmacist about that option, said Julie Carter, federal policy associate at the Medicare Rights Center, a patient advocacy group.

“If they bring it up, then we can inform them of those prices,” said Nick Newman, a pharmacist and the manager at Essentra Pharmacy in rural Marengo, Ohio. “It’s a moral dilemma for the pharmacist, knowing what would be best for the patient but not being able to help them and hoping they will ask you about the comparison.”

A simple question could unlock some savings for millions of beneficiaries.

But details may be hard to find: Medicare’s website and annual handbook don’t mention it.

“If you don’t know that there are a bunch of different prices that could be available at any given pharmacy, you don’t know what you don’t know,” said Leigh Purvis, the AARP Public Policy Institute’s director of health services research.

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Researchers analyzing 9.5 million Part D prescription claims reported in a letter in the Journal of the American Medical Association in March that a patient’s copayment was higher than the cash price for nearly 1 in 4 drugs purchased in 2013. For 12 of the 20 most commonly prescribed drugs, patients overpaid by more than 33 percent.

Although the study found that the average overpayment for a single prescription was relatively small, Newman said he had seen consumers pay as much as $30 more than the cash price.

And many beneficiaries may not know that if they pay a lower cash price for a covered drug at a pharmacy that participates in their insurance plan and then submit the proper documentation, insurers must count it toward their out-of-pocket expenses. The total of those expenses can trigger the drug coverage gap, commonly called the doughnut hole. (This year, the gap begins after the plan and beneficiary spend $3,750 and ends once the beneficiary has spent a total of $5,000.)

Daniel Nam, executive director of federal programs at America’s Health Insurance Plans, a trade group, agreed that “patients should have access to the lowest price possible at the pharmacy.” But he said Medicare’s warning, contained in a letter this month, takes aim at an increasingly rare occurrence. Gag order clauses are “not something they are incorporating into their contracts,” he said.

UnitedHealthcare, whose popular prescription drug plans dominate the market, does not include them in any of its Medicare, Medicaid or commercial insurance contracts, said Matt Burns, a company spokesman.

Pharmacy benefit managers also said gag orders are not typical. “If it is happening, it is very much an outlier,” said Mark Merritt, president and CEO of the Pharmaceutical Care Management Association.

However, some pharmacists disagree. Kala Shankle, policy and regulatory affairs director for the National Community Pharmacists Association, which represents 22,000 independent pharmacies, said insurers have punished pharmacists who violate gag orders by dropping them from the plan’s network.

In Ohio, one of several states that have banned gag orders in insurance contracts, including some Medicare drug plans, officials responded to complaints about the problem.

“The Department has received inquiries related to entities withholding cost-saving information from consumers, which sometimes results in an insured [patient] paying more for pharmacy benefits than the actual cost of such pharmacy benefits,” the department said last month.

Illinois and Ohio state legislators are considering bills to make such restrictions illegal, and similar legislation has been introduced in the U.S. Senate.

“If we didn’t have these gag clauses, there would not be a need for the legislation and policy changes movement that’s going on in the country,” said Garth Reynolds, executive director of the Illinois Pharmacists Association.

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation.

In Health Care Arena, The Prize For Calif. Insurance Commissioner Is A Bullhorn

The person who wins the four-way race to become California’s next insurance commissioner will inherit a job with broad authority over policies that cover homes, businesses, cars and even airplanes.

But medical insurance? Not so much. The commissioner’s direct control over health insurers is limited, because the California Department of Insurance — headed by the commissioner — regulates only a small slice of the market.

Still, the job carries the power of the bully pulpit, amplifying the commissioner’s voice on matters of regional, statewide and national importance.

The incumbent, Dave Jones, has used that bullhorn frequently to chastise health insurers, blast the Trump administration’s efforts to roll back the Affordable Care Act and interject his voice on subjects ranging from prescription drug prices to climate change to women’s reproductive rights.

The four candidates vying in the June 5 primary to replace Jones — who is running for attorney general — will no doubt follow his lead in making use of the soapbox the commissioner’s office provides. Three of the four are ardent supporters of a statewide single-payer system and would use the office to promote it.

One of them, Democratic state Sen. Ricardo Lara, said one of his biggest priorities is “to ensure that everyone gets health care.” He is a strong proponent of government-run health care for all Californians and author of the now-dormant legislation, SB 562, which would create such a system.

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Nathalie Hrizi, a San Francisco teacher-librarian who is the Peace and Freedom Party’s candidate, said she’s running because the commissioner’s office is “part of the political movement … for single-payer health care and socialism.” She added: “Insurance doesn’t serve a productive role in society.”

Asif Mahmood, a Los Angeles pulmonologist and a Democrat, said that as a medical practitioner, he regularly sees the financial challenges people face with the high cost of care. As a result, he said, he is best placed to find a “real solution which includes health care for all, not health care for most.”

Steve Poizner, a Silicon Valley businessman, strongly opposes the idea of government-run health care and said the candidates who are advocating it “probably should be running for a different post.” He said he would push to eliminate fraud and wasteful health spending and create a system that rewards doctors and hospitals for the quality of their care rather than the volume of their services.

Poizner, who served as insurance commissioner from 2007 to 2011 as a Republican and is running now under no party banner, leads the field with 20.7 percent of voter preferences, according to a recent poll by Probolsky Research.

Lara is in second place with 13.7 percent, followed by Mahmood with 6.3 percent, and Hrizi with 5.9 percent, the poll found. However, more than half of respondents were undecided or declined to state their preference. The candidates who finish first and second in the primary will face off in the general election Nov. 6.

The commissioner’s authority over the health insurance industry has been eroded significantly in recent years, largely because of California’s bifurcated system of regulation. Regulatory discretion has increasingly shifted to the Department of Managed Health Care (DMHC), which now oversees not only HMOs but also some PPOs, which were previously the domain of the commissioner.

This dual system often has allowed insurers to drive a wedge between the two agencies and essentially choose their regulators. Blue Shield of California, for example, one of the state’s biggest insurers, voted with its feet and is now mostly regulated by the DMHC.

The insurance commissioner has primary regulatory authority over health plans that cover just under 10 percent of Californians enrolled in commercial health plans, according to the California Health Care Foundation. (California Healthline is an editorially independent publication of the California Health Care Foundation.) Throw in the state’s nearly 13 million managed-care Medi-Cal plans, and the commissioner’s share drops to around 5 percent.

Despite this limitation, the Department of Insurance has statutory powers it can — and does — exercise. It pursues fraud, fines insurers that break the law and investigates consumer complaints about coverage. It also oversees the state’s 360,000 licensed insurance agents, with the power to investigate them, arrest them and turn them over for prosecution.

The department can also require health plans to comply with certain coverage requirements. Jones, for example, has issued rules to ensure plans have a robust network of providers, cover autism treatment and provide equal access to care for the transgender population.

The commissioner also plays a role in examining merger proposals.

One power the insurance commissioner does not have, which Jones has often lamented, is the authority to prevent insurers from imposing large premium hikes — a matter of significant public concern as rates have soared in recent years. The DMHC doesn’t have that power, either.

The commissioner does examine proposed rate increases, and on occasion Jones has persuaded insurers to reduce the size of them.

Lara proposes rolling the two regulators into one, under the insurance commissioner, and granting the newly combined agency the power to reject what it deems to be unreasonable rate hikes by insurers. That would help “bring prices down on behalf of consumers,” Lara said.

A ballot measure to allow the insurance commissioner to reject health insurance rate increases failed in 2014, as did a state bill in 2012.

In previous years, candidates talked a lot more about keeping premiums down, but this year much of the campaign rhetoric has focused on the idea of universal health care, said Stephen Shivinsky, a former Blue Shield executive who is now consulting for health insurers.

“Trump’s election changed everything,” Shivinsky said. Federal attempts to repeal the Affordable Care Act reignited questions about how health care is delivered, and “that really brought about the debate on single-payer,” he said.

Garry South, a longtime California campaign strategist, said he’s not surprised the Democratic candidates are talking up their support for universal health care, especially single-payer.

“If you’re going to run as a Democrat, you have to be for single-payer,” South said. Not doing so “would be like running for governor of California and opposing gun control.”

Poizner, the apparent front-runner, not only opposes government-run health care but also thinks it is way beyond the purview of the job he’s seeking. His goals for health care are relatively modest, including a study of how the money in California’s $400 billion health care system is spent, with an eye toward trimming the fat.

“As insurance commissioner, I want to focus on what I can get done,” he said.

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

Statement by HHS Deputy Secretary on Unaccompanied Alien Children Program

HHS Gov News - May 29, 2018

Health and Human Services Deputy Secretary Eric Hargan issued the following statement regarding the Unaccompanied Alien Children Program:

"The assertion that unaccompanied alien children (UAC) are ‘lost’ is completely false. This is a classic example of the adage ‘No good deed goes unpunished.’ The Office of Refugee Resettlement (ORR), which is part of the Department of Health and Human Services, began voluntarily making calls in 2016 as a 30-day follow-up on the release of UAC to make sure that UAC and their sponsors did not require additional services. This additional step, which is not required and was not done previously, is now being used to confuse and spread misinformation.

“These children are not ‘lost’; their sponsors—who are usually parents or family members and in all cases have been vetted for criminality and ability to provide for them—simply did not respond or could not be reached when this voluntary call was made. While there are many possible reasons for this, in many cases sponsors cannot be reached because they themselves are illegal aliens and do not want to be reached by federal authorities. This is the core of this issue: In many cases, HHS has been put in the position of placing illegal aliens with the individuals who helped arrange for them to enter the country illegally. This makes the immediate crisis worse and creates a perverse incentive for further violation of federal immigration law.

“The tracking of UAC after release is just one of the recent headlines that focus on the symptoms of our broken immigration system while ignoring its fundamental flaws. President Trump’s administration has been calling on Congress to put an end to dangerous loopholes in U.S. immigration laws like the practice of “catch and release,” in which federal authorities release illegal immigrants to await hearings for which few show up. In the worst cases, these loopholes are being exploited by human traffickers and violent gangs like MS-13. Until these laws are fixed, the American taxpayer is paying the bill for costly programs that aggravate the problem and put children in dangerous situations.”

The following fact sheet contains additional information:


“The Unaccompanied Alien Children Program is being abused; it was never intended to be a foster care system with more than 10,000 children in custody at an immediate cost to the federal taxpayer of over one billion dollars per year.” - Steven Wagner, Acting Assistant Secretary for Children and Families

SEPARATION OF FAMILIES AT THE BORDER: Congress’s inaction on border security has created perverse and dangerous incentives for illegal border crossings and child smuggling.

  • Anyone who crosses the border illegally is subject to federal criminal prosecution. As is the case in criminal proceedings – regardless of the immigration status of the criminal offender – the individual being prosecuted will be transferred to federal criminal custody for breaking United States law. Therefore, families with children that enter into the United States illegally will be separated when the parent is transferred to federal custody for breaking United States law. If parents do not wish to be separated from their children, they should not violate the laws of the United States or endanger minors through criminal smuggling. There are appropriate legal channels and rules to follow for legal immigration to the United States, which has the largest humanitarian-based immigration system in the world.
  • Congress needs to fix our broken immigration system by enacting legislation that will close the legal loopholes so families seeking to cross the border illegally can be returned home swiftly – ending the practice of catch-and-release. This is the most humane policy solution – and the only one that will put a stop to rampant human smuggling.
  • Closing these loopholes is also essential to protect American communities from the criminal gangs, like MS-13, who exploit these catch-and-release policies to expand their criminal enterprise.
  • Open borders policies are responsible for the permanent separation of American families whose loved ones were murdered and taken from them forever through the crimes committed by illegal immigrants.

TRACKING UAC RELEASES TO SPONSOR FAMILIES: HHS’ primary legal authority is to temporarily house and then release unaccompanied alien children (UAC) to a sponsor.

  • The United States taxpayer can no longer be responsible for being a surrogate parent for every would-be illegal immigrant who crosses our border. Under our current immigration loopholes, if anyone under the age of 18 illegally enters the United States they will be placed into HHS custody and released into the interior of the United States, rather than returned home to their country of origin. This is open borders.
  • While HHS houses and cares for UAC until the point at which UAC can be released to a sponsor, Congress has not given HHS the power or the funding to reach far beyond its primary statutory authority. Indeed, that could require billions of additional dollars.
  • The HHS Office of Refugee Resettlement (ORR) conducts a Safety and Well-Being follow up call with each child and his or her sponsor 30 days after the release date. The purpose of the follow up call is to determine whether the child is still residing with the sponsor, is enrolled in or attending school, is aware of upcoming court dates, and is safe.
  • HHS/ORR is not required by statute to make these calls. ORR does so in order to ensure that sponsors and child have access to additional supportive services, if needed.
  • A chain news organization recently reported that 1,475 unaccompanied alien children were lost by the federal government. These children are not lost. They were released to sponsors that HHS vetted and deemed appropriate. HHS simply could not reach them during our attempts to contact them. If a provider feels that the UAC who has not been reached is at risk, they may contact law enforcement or make a referral to local child welfare entities in the community where the child has been released.
  • The reason many sponsors cannot be reached is because they themselves are illegal aliens and do not want to be reached by federal authorities. This is the core problem: HHS has been put in the position of releasing illegal aliens to the individuals who helped arrange for them to be smuggled into the country, which makes the immediate crisis worse and creates a perverse incentive for even more smuggling.
  • Furthermore, the UAC program has become a gateway for MS-13, creating gang-zones in UAC placement areas like Long Island, New York.

LOCATING NECESSARY SPACE FOR UAC: Congressional failure to close catastrophic loopholes, combined with longer processing for sponsors, has created the need to find additional housing space for UAC.

  • HHS/ORR is responsible and required to care for minors who are in the country illegally without an available parent or guardian. Operating this program requires routinely evaluating the needs and capacity of an existing network of approximately 100 shelters in 14 states.
  • Additional properties identified by federal agencies are being evaluated by ORR as potential locations for temporary sheltering as a routine part of its management of UAC shelter capacity.
  • Community representatives will be notified in advance if HHS is seriously considering a local site for potentially housing UAC, as part of responsible contingency planning.
  • Additional temporary housing is only sought as a last resort when current locations are reaching capacity.
  • The sole workable solution to this problem is to change federal law so that illegal immigrants can be returned after they are apprehended.

Cameras On Preemies Let Family In, Keep Germs Out

Hospitals around the country have been upgrading their neonatal intensive care units to include personal webcams for each tiny patient. It’s a convenience for parents — and reduces worries about visitors bringing in germs.

The neonatal intensive care unit at St. Thomas Midtown in Nashville is the latest hospital to join the webcam wave, among facilities around the country from big cities to towns that are installing cameras over each infant.

At St. Thomas, Sherri Anderson has 20 years of experience as a neonatal nurse, watching parents run themselves ragged trying to be at the hospital every waking hour, sometimes commuting long distances.

“The parents go through a lot — emotionally, spiritually, physically,” Anderson said. “It’s very taxing, and sometimes they just need to go home and just recover.”

The $1,200 cameras — which St. Thomas paid for through a special fundraiser — come from a company called Natus Medical. They provide a close-up shot that anyone in the world can log on to see — using a password.

Jill Brothers had twin boys born at 27 weeks, requiring a two-month stay in the NICU. Her husband, who plays professional baseball, was away for spring training most of that time, but he could get on the computer and watch the boys’ progress.

“This has been a crucial element to just being a part and feeling like you’re involved with their growth,” she said. “There’s lots of other people in the family that have been able to log on and see the boys and see them [in] real time, which is great.”

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Brothers still came to the hospital every day, but she found herself checking the web stream when she was up in the middle of the night — to watch the boys breathing.

“I really just felt like it was safe and comfortable,” she said.

Parents’ peace of mind is only one aim, though. St. Thomas NICU nursing director Donna Darnell said the new cameras could cut down on germs sneaking into the unit from other relatives stopping by.

“There are times throughout the year that we worry about a lot of visitors. Flu season is the best example,” Darnell said.

Even during normal times, access for family and friends is highly restricted because of germs — and the cameras give many more people the opportunity to see the tiny patients.

While baby Duke Brothers stayed in the NICU, his parents could watch over him via webcam. (Blake Farmer/WPLN)((Blake Farmer/WPLN))

In the little research that has been done, parents have loved the video access. Doctors also are OK with it, but a study published in the American Journal of Perinatology found that some nurses have misgivings about being watched all day and all night.

One of the study’s authors, Dr. Gene Dempsey from the University College Cork in Ireland, helped conduct the survey and said nurses worry they will get even more after-hours calls, wanting an explanation for what’s on screen. But, he said, that doesn’t seem to happen.

“In fact some of the workers [in hospitals with these cameras] suggested that the interaction at parent level — in terms of phone calls in the evening and at nighttime — are less when the system is in place,” he said.

Dempsey’s own hospital is launching a webcam system in the next few weeks and he has made a point of getting nurses on board.

“What we’re probably going to do, and we’ve had much discussion with the nursing staff initially, is that this would be a phased-in process,” he said.

Dempsey said they’ll start with “virtual visitation hours.” At St. Thomas, the nursing director decided to turn off the livestreams whenever a nurse is working with a child — a compromise that seems to have everyone smiling for the camera.

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

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.

Benefit Change Could Raise Costs For Patients Getting Drug Copay Assistance

Since Kristen Catton started taking the drug Gilenya two years ago, she’s had only one minor relapse of her multiple sclerosis, following a bout of the flu.

She can walk comfortably, see clearly and work part time as a nurse case manager at a hospital near her home in Columbus, Ohio. This is a big step forward; two drugs she previously tried failed to control her physical symptoms or prevent repeated flare-ups.

This year, Catton, 48, got a shock. Her health insurance plan changed the way it handles the payments that the drugmaker Novartis makes to help cover her prescription’s cost. Her copayment is roughly $3,800 a month, but Novartis helps reduce that out-of-pocket expense with payments to the health plan. The prescription costs about $90,000 a year.

Those Novartis payments no longer counted toward her family plan’s $8,800 annual pharmacy deductible. That meant once she hit the drugmaker’s payment cap for the copay assistance in April, she would have to pay the entire copayment herself until her pharmacy deductible was met.

Catton is one of a growing number of consumers taking expensive drugs who are discovering they are no longer insulated by copay assistance programs that help cover their costs. Through such programs, consumers typically owe nothing or have modest monthly copayments for pricey drugs because many drug manufacturers pay a patient’s portion of the cost to the health plan, which chips away at the consumer’s deductible and out-of-pocket maximum limits until the health plan starts paying the whole tab.

Since her insurance company changed its rules, Kristen Catton is responsible for nearly $9,000 of the cost of her multiple sclerosis drug.(Courtesy of Kristen Catton)

Under new “copay accumulator” programs, that no longer happens.

In these programs, the monthly copayments drug companies make don’t count toward patients’ plan deductibles or out-of-pocket maximums. Once patients hit the annual limit on a drugmaker’s copay assistance program, they’re on the hook for their entire monthly copayment until they reach their plan deductible and spending limits.

Catton put the $3,800 May copayment on a credit card. She knows her insurer will start paying the entire tab once she hits the pharmacy deductible. But, she said, she can’t afford to pay nearly $9,000 a year out-of-pocket for the foreseeable future.

“I’m talking to my doctor to see if I can I take it every other day,” she said. “I guess I’m winging it until I can figure out what to do.”

Drug copay assistance programs have long been controversial.

Proponents say that in an age of increasingly high deductibles and coinsurance charges, such help is the only way some patients can afford crucial medications.

But opponents say the programs increase drug spending on expensive brand-name drugs by discouraging people from using more cost-effective alternatives.

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Switching to a cheaper drug may not be an option, said Bari Talente, executive vice president for advocacy at the National Multiple Sclerosis Society.

“Generally the multiple sclerosis drugs are not substitutable,” she said. “Most have different mechanisms of action, different administration and different side effect profiles.” Generics, when they’re available, are pricey too, typically costing $60,000 or more annually, she said.

Most MS drug annual copay assistance limits, if they have them, are between $9,000 and $12,000, Talente said.

Employers argue that the drug copayment programs are an attempt to circumvent their efforts to manage health care costs. For example, employers may try to discourage the use of a specialty drug when there’s a lower-cost drug available by requiring higher patient cost sharing.

There’s also the issue of fairness.

“From an employer perspective, everyone under the plan has to be treated the same,” said Brian Marcotte, president and CEO of the National Business Group on Health (NBGH), which represents large employers.

If someone needs medical care such as surgery, for example, that person doesn’t get help covering his deductible, while the person with the expensive drug might, he said.

According to an NBGH survey of about 140 multistate employers with at least 5,000 workers, 17 percent reported they have a copay accumulator program in place this year, Marcotte said. Fifty-six percent reported they’re considering them for 2019 or 2020.

If there is no comparable drug available, drug copayment programs may have a role to play if they can be structured so that participating patients are paying some amount toward their deductible, Marcotte said. But, he said, assistance programs for drugs that are available from more than source, such as a brand drug that is also available as a generic, shouldn’t be allowed.

In 2016, 20 percent of prescriptions for brand-name drugs used a drug copay assistance coupon, according to an analysis by researchers at the USC Schaeffer Center for Health Policy and Economics. Among the top 200 drugs based on spending in 2014, the study found that 132 were brand-name drugs, and 90 of them offered copay coupons. Fifty-one percent of the drugs with copay coupons had no substitute at all or only another brand drug as a close therapeutic substitute, the analysis found.

Advocates for people with HIV and AIDS say copay accumulators are cropping up in their patients’ plans and beginning to cause patients trouble. Drugs to treat HIV typically don’t have generic alternatives.

The biggest impact for the community their organizations serve may be for PrEP, a daily pill that helps prevent HIV infection, said Carl Schmid, deputy executive director at the AIDS Institute, an advocacy group. A 30-day supply of PrEP (brand-name Truvada) can cost nearly $2,000. Drug manufacturer Gilead offers a copay assistance program that covers up to $3,600 annually in copay assistance, with no limit on how much is paid per month.

“They’re at risk for HIV, they know it and want to protect themselves,” Schmid said. “It’s a public health issue.”

Earlier this month, the AIDS Institute was among 60 HIV organizations that sent letters to state attorneys general and insurance commissioners across the country asking them to investigate this practice, which has emerged in employer and marketplace plans this year.

Compounding advocates’ concerns is the fact that these coverage changes are frequently not communicated clearly to patients, Schmid said. They are typically buried deep in the plan documents and don’t appear in the user-friendly summary of benefits and coverage that consumers receive from their health plan.

“How is a patient to know?” Schmid asks. They learn of the change only when they get a big bill midway through the year. “And then they’re stuck.”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation.

Health Care Looms Large In Race For California’s Top Cop

Attorney General Xavier Becerra uses a well-worn refrain to describe his role as the state’s chief law enforcement officer: to defend California’s values.

“If that translates into fighting Donald Trump, then so be it,” he said in a recent interview.

Becerra has been one of the leading voices in California’s charge against the federal government, filing more than 30 lawsuits on health care and other issues since taking office in January of last year.

For example, Becerra, 60, succeeded in temporarily blocking the federal government from denying access to birth control nationwide, and he is leading 15 states plus the District of Columbia in a legal battle to defend the Affordable Care Act.

Democratic Gov. Jerry Brown appointed Becerra attorney general after predecessor Kamala Harris was elected to the U.S. Senate. Now, Becerra is taking his chances with voters, running against Democratic Insurance Commissioner Dave Jones, retired judge Steven Bailey and private attorney Eric Early. Bailey and Early are both Republicans.

California Attorney General Xavier Becerra

If Becerra — a former congressman representing Los Angeles — wins, his resistance against President Donald Trump is likely to continue.

It’s not surprising the Democratic candidates “would step in against the federal government on health care and other issues,” because they see opposing Trump as “good politics,” said Walter Zelman, chairman of the public health department at California State University-Los Angeles.

Jones said he agrees on the need to challenge some recent federal policies but believes Becerra is focusing too narrowly on that.

“There’s much more to the job of attorney general than just suing the Trump administration,” said Jones, 56, pointing to health care fraud and other legal targets.

California Insurance Commissioner Dave Jones

Still, the two Democrats are aligned on many health care policies, including and the concept of a single-payer system, in which the state would set the rules and pay for the coverage of all California residents.

Jones said if he were elected attorney general, he would continue to fight fraud in the health care industry and protect consumers, and would focus on ensuring that insurance markets are competitive.

The two Republican candidates oppose both a single-payer health system and the Affordable Care Act — and they criticize Becerra’s tactics. Early, 59, said he would go through every lawsuit Becerra has filed to figure out which ones to dismiss. And Bailey, 66, said “just because a tweet comes out of Washington, it doesn’t require a lawsuit to be filed the next day.”

Private attorney Eric Early

Early promotes a more aggressive strategy on mental health and opioid addiction. Bailey, who has argued there is too much government regulation in health care, said the costs of insurance are still unaffordable for many people.

The attorney general is the state’s leading law enforcement official. The scope of the job focuses heavily on public safety but also addresses civil rights, consumer fraud and environmental protections, among other issues.

The health care duties of the job include investigating Medi-Cal fraud and elder abuse, reviewing proposed sales of nonprofit hospitals and administering an index of child abuse cases.

Becerra has definitely elevated the importance of health care as an issue for the office — and Jones, with his insurance background, could push that further, said Dan Schnur, a Republican political strategist who teaches at the University of Southern California and the University of California-Berkeley. For most of California’s history, the attorney general has focused almost exclusively on criminal justice, but that has changed as recent attorneys general have taken on a broader range of issues, he added.

Although there have been no major public polls on the race, Becerra starts with a significant advantage as the incumbent, Schnur said. “There is no shortage of complaints that Becerra’s critics can level, but so far it doesn’t appear that any have risen to the level to turn him out of office,” he said.

Becerra also enjoys the advantage of an “ideal platform” to take on Trump, Schnur said.

Retired judge Steven Bailey

Since assuming office, Becerra has sued Sutter Health for alleged anticompetitive practices, arguing that the massive hospital system is overcharging consumers and driving up costs. He also has formed a strike force to take on other health care battles in the state.

He recently led 19 states and the District of Columbia in opposing a proposal by the Trump administration to change how federal family planning dollars are allocated. “We will stand up to any and all attacks on women’s reproductive rights,” Becerra said at a press conference.

Becerra refuted criticism from his opponents that he has focused too heavily on resisting the Trump administration, pointing to his work on environmental health, sex trafficking, gang violence and other issues.

Each candidate shared his health care priorities in interviews with California Healthline.

Jones said that “as attorney general, I’ll have even broader authority to make sure that mergers … and other market practices are not anticompetitive.”

As insurance commissioner, he has argued against certain proposed health care mergers, including one between Aetna and Humana that was later called off. And he has investigated insurance companies and arrested hundreds of people for fraud.

Jones said he would work to get guns out of the hands of those who should not possess them. He also said he would focus on expanding rehabilitation programs for people coming out of jails and prisons, and would work harder to enforce a law on mental health parity to protect patients from discrimination by insurers. The law generally requires health insurers to provide the same level of benefits for mental and substance use treatment as they do for medical care.

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Bailey, a longtime criminal and administrative law attorney before he served as a Superior Court judge in El Dorado County, said his “goal is to free the marketplace to be able to function so that consumers have as much choice as possible.”

Bailey said California’s current system reduces those choices, and that Obamacare has driven up health costs. Many people are priced out of the market unless they are wealthy, he said.

Early, a managing partner at a Los Angeles-based law firm, Early Sullivan Wright Gizer & McRae, said he would do a “deep dive” into the legal issues of mental illness, prescription drug abuse and homelessness. To do so, he said, he would bring together experts and others in the field to figure out how best to deal with people who have severe mental health and addiction problems.

One possibility, Early said, might be to involuntarily commit those with severe mental illness more frequently, so they can get the care they need. That could help slow the rise of homelessness and the increase in the number of mentally ill people in state prisons, he said.

Early also said he would take more aggressive steps against the pharmaceutical industry, which he called “one of the causes of where we are with the opioid epidemic.”

KHN's coverage in California is supported in part by Blue Shield of California Foundation.

Readout of Secretary Azar’s Final Day of Participation at the 2018 World Health Assembly

HHS Gov News - May 25, 2018

Today, Health and Human Services Secretary Alex Azar began his final day of participation at the 71st World Health Assembly (WHA) delivering remarks at the Geneva Press Club at an event sponsored by Global Health Council, Living Goods, IntraHealth International, and Frontline Health Workers Coalition focused on diverse pathways to “universal health coverage.” He highlighted that every nation is unique and that avenues to making healthcare accessible to citizens will differ and often include a mix of public and private systems with the private sector in many cases able to provide more responsive services with greater efficiencies. He emphasized that a key focus in this conversation needs to be strengthening primary health systems. He laid out four areas of emphasis vital to empowering patients in the drive toward a value-based transformation in America’s healthcare system: greater control and interoperability of health information technology; enhanced transparency around price and quality; the use of experimental models to focus on driving value throughout the system; and the elimination of government barriers to change and transformation.

Secretary Azar concluded his participation at the WHA with a bilateral meeting with public health officials from Taiwan. During his remarks earlier in the week before a plenary session of the WHA, the Secretary expressed disappointment that representatives of Taiwan had not been invited to observe the WHA, saying “it is difficult to reconcile our shared concern over cross-border infectious diseases with excluding representatives of the 23 million people of Taiwan from this gathering.”

Podcast: KHN’s ‘What The Health?’ Campaign Promises Kept, Plus ‘Nerd Reports’

Julie Rovner

Kaiser Health News


Read Julie's Stories Sarah Kliff


Read Sarah's Stories Alice Ollstein

Talking Points Memo


Read Alice's Stories Margot Sanger-Katz

The New York Times


Read Margot's Stories

President Donald Trump managed to fulfill — at least in part — two separate campaign promises this week.

To the delight of anti-abortion groups, the administration issued proposed rules that would make it difficult if not impossible for Planned Parenthood to continue to participate in Title X, the federal family-planning program. And Congress cleared for Trump’s signature a “right-to-try” bill aimed at making it easier for patients with terminal illnesses to obtain experimental medications.

Also this week, the National Center for Health Statistics and the Congressional Budget Office issued reports about Americans both with and without health insurance and the cost of subsidizing health insurance to the federal government.

And May’s “Bill of the Month” installment features some very expensive orthopedic screws.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Margot Sanger-Katz of The New York Times, Sarah Kliff of Politico and Alice Ollstein of Talking Points Memo.

Among the takeaways from this week’s podcast:

  • The Trump administration’s proposed rule to cut Title X reproductive health funding for groups that perform abortions was designed to meet demands from the president’s religious supporters, but it could backfire by mobilizing liberal voters.
  • The changes being considered might also open the door for some religious-based groups that don’t support abortion — or perhaps even contraception — to get federal Title X funding.
  • Conservatives’ campaign to get a “right-to-try” bill through Congress has been driven in large part by individual patient stories.
  • New data released by the Centers for Disease Control and Prevention this week shows the uninsured rate did not grow in 2017, despite a number of changes that the Trump administration made to the marketplace and federal promotion of it.

Plus, for “extra credit,” the panelists recommend their favorite health stories of the week they think you should read, too.

Julie Rovner: Kaiser Health News’ “When Is Insurance Not Really Insurance? When You Need Pricey Dental Care,” by David Tuller

Margot Sanger-Katz: The New York Times’ “New Cancer Treatments Lie Hidden Under Mountains of Paperwork,” by Gina Kolata

Sarah Kliff:’s “He Went to an In-Network Emergency Room. He Still Ended Up With a $7,924 Bill,” by Sarah Kliff

Alice Ollstein: AP’s “AP Interview: Unemployment Exemption Gone From Medicaid Bill,” by David Eggert

And: Talking Points Memo’s “Trump Admin Poised To Give Rural Whites A Carve-Out On Medicaid Work Rules,” by Alice Ollstein

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

Pfizer Settles Kickback Case Related To Copay Assistance For $24M

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Pfizer will pay the government nearly $24 million as part of a settlement to resolve allegations that it funneled money through a foundation resulting in illegal kickbacks.

The company is not admitting wrongdoing or liability as part of its agreement with the Department of Justice.

According to the settlement, from 2012 through 2016, Pfizer made donations to the Patient Access Network (PAN) Foundation, a copay assistance nonprofit organization, and then used a specialty pharmacy to steer Medicare patients taking its drugs toward the foundation to cover their copays.

“Pfizer knew that the third-party foundation was using Pfizer’s money to cover the copays of patients taking Pfizer drugs, thus generating more revenue for Pfizer and masking the effect of Pfizer’s price increases,” said U.S. Attorney Andrew Lelling, citing the settlement. “The Anti-Kickback Statute exists to protect Medicare, and the taxpayers who fund it, from schemes like these.”

Drugmakers can’t directly offer copay assistance to Medicare or Medicaid beneficiaries under federal law. The concern is that covering such out-of-pocket costs for expensive drugs still leaves taxpayers with the bill for the remainder of the costs. Congress didn’t want beneficiaries to be shielded from price increases, allowing drugmakers to increase prices without risking that patients will switch to cheaper alternatives.

Pfizer spokeswoman Sally Beatty stressed that the company takes compliance “very seriously.” The company continues to donate to charities that offer assistance with copays. This story also ran on USA Today. This story can be republished for free (details).

“The Company believes all individuals deserve access to medicines prescribed by their physicians,” she said in a statement provided to Kaiser Health News. “Pfizer continues to believe these programs help patients lead healthier lives.”

Joel Hay, a health policy and economics professor at the University of Southern California, disagrees. “In essence, [copay programs give] the drug companies free rein to jack the price up to whatever they want,” he said. “You totally dilute any effort on the part of the doctor or consumer to think carefully about whether these drugs are worth their cost.”

Pfizer gave the PAN Foundation $16.9 million in 2015, according to Kaiser Health News’ Pre$cription for Power database, which covers contributions from drugmakers to patient groups in 2015 but will expand over time. Asked why the settlement was only $7 million more than what Pfizer gave the PAN Foundation in 2015, the Department of Justice said its policy was not to comment on settlement amounts.

The chemotherapy drugs at the center of the alleged scheme were Sutent, which treats kidney cancer and other cancerous tumors, and Inlyta, which also treats kidney cancer.

Sutent cost Medicare Part D $183 million in 2016 before rebates, or about $47,000 per patient. Medicare’s spending for each unit of this drug had increased by 80 percent since the illegal conduct allegedly began in 2012. Inlyta cost Medicare about $73 million in 2016, or about $57,000 per patient. Medicare spent 34 percent more on each unit of the drug in 2016 than it did in 2012.

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Tikosyn, a Pfizer drug to treat an irregular heartbeat, was also part of the alleged scheme, according to the settlement. The drugmaker raised the list price of 40 Tikosyn capsules from $220 to $317 in the final three months of 2015. It cost Medicare $107 million in 2016 before rebates.

Planning a price increase, Pfizer worked with the PAN Foundation to “create and finance a fund” for Medicare patients with a specific irregular heartbeat, the settlement says. “For the next nine months, Tikosyn patients accounted for virtually all of the beneficiaries of PAN’s fund.”

Hay said the DOJ action is “long overdue.” Pfizer is one of many drug companies engaging in such behavior with various copay assistance nonprofits, he said, and the DOJ should have been aggressive about it “years if not decades earlier.”

“The basic fact is it’s illegal under the False Claims Act,” he said.

PAN Foundation President and CEO Daniel Klein said the foundation learned about the DOJ settlement Thursday.

“While PAN has received contributions from Pfizer, we endeavor to operate our patient assistance programs independent of any influence by donors,” he said. “Without the assistance PAN provides, many thousands of underinsured patients would be unable to afford their critical medications.”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation.

Readout of Secretary Azar’s Second Day of Participation at the 2018 World Health Assembly

HHS Gov News - May 24, 2018

Today, Health and Human Services Secretary Alex Azar began his second day of participation at the 71st World Health Assembly (WHA) by meeting with members of the United States delegation. The Secretary thanked those representing the United States at the WHA for the work they do to support and protect the public health of the American people. He emphasized how building strong partnerships with other nations is a critical part of preparedness for public health threats.

Secretary Azar then joined the Director of the World Health Organization (WHO), Dr. Tedros Adhanom Ghebreyesus, at a meeting of the WHO leadership to discuss the need for continued reform at the WHO to enhance global health security capacity while supporting existing efforts underway by the organization to combat threats to the public health – particularly the current outbreak of Ebola in the Democratic Republic of Congo (DRC).

The Secretary then visited the WHO Strategic Health Operations Centre (SHOC) where he received a briefing on the current status of the Ebola outbreak in the DRC and coordinated efforts underway – including surveillance, testing, communication, and vaccination – to assess and respond to conditions on the ground.

In remarks at an event organized by the International Federation of Red Cross and Red Crescent Societies, the World Medical Association, and the International Federation of Pharmaceutical Manufacturers and Associations, Secretary Azar utilized the historical example of the 1918 influenza pandemic to reiterate the importance of building robust preparedness measures. He noted that as a global community, gaps remain in our ability to prevent, detect, respond to, mitigate, and control infectious disease threats.

As part of an ongoing effort to highlight the benefit of public-private partnerships in addressing public health challenges and to encourage WHO to further engage with the private sector, Secretary Azar delivered remarks at a roundtable hosted by the Business Council for International Understanding, the Harvard Global Health Institute, and the Global Health Council. During his opening remarks, the Secretary noted that the private sector has a vested interest and critical role to play in addressing both communicable and noncommunicable diseases because no one benefits from an unhealthy workforce. He further communicated how private sector innovation and expertise can be helpful, particularly in standing up healthcare infrastructure and combating antimicrobial resistance.

Throughout the day, Secretary Azar participated in bilateral meetings with public health officials from Canada, Argentina, India, and Rwanda. In addition to strengthening relationships in support of improved global health security, discussions included other key priorities like opioid abuse and addiction, challenges in healthcare delivery, and prescription drug pricing.

‘Time’s Up’: Covered California Takes Aim At Hospital C-Section Rates

Covered California, the state’s health insurance marketplace under the Affordable Care Act, has devised what could be a powerful new way to hold hospitals accountable for the quality of their care. Starting in less than two years, if the hospitals haven’t met targets for safety and quality, they’ll risk being excluded from the “in-network” designation of health plans sold on the state’s insurance exchange.

“We’re saying ‘time’s up,'” said Dr. Lance Lang, the chief medical officer for Covered California. “We’ve told health plans that by the end of 2019 we want networks to only include hospitals that have achieved that target.”

Here’s how hospitals will be measured: They must perform fewer unnecessary cesarean sections, prescribe fewer opioids and cut back on the use of imaging (X-rays, MRIs and CT scans) to diagnose and treat back pain. Research has shown these are problem areas in many hospitals — the procedures and pills have an important place, but have been overused to the point of causing patient harm, health care analysts said.

C-sections, in particular, have come under scrutiny for years.

Hospitals get paid more to perform a C-section than a vaginal delivery and C-sections usually take less time: 40 minutes for a scheduled procedure versus 24-hour on-call staffing for vaginal deliveries. Many women who don’t need a C-section often get one anyway, according to the data — and rates vary by hospital. Even in low-risk cases, several California hospitals are delivering 40 percent of babies by C-section, Lang said. At one hospital, it’s 78 percent.

“That means that when a woman goes to a hospital, it’s the culture of the hospital that really determines whether or not she gets a cesarean section, not so much her own health,” said Lang.

C-sections are major surgery. Doing them when they’re not needed exposes women to unnecessary risks: infection, hemorrhage, even death. Babies delivered by C-section are more likely to have complications and spend more time in the neonatal intensive care unit.

That’s not quality health care, Lang said, and that’s why Covered California is telling hospitals they need to reduce their C-section rates to 23.9 percent or lower, for low-risk births.

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In this case, “low-risk” is defined as a healthy, first-time mom who has carried a single baby with its head down, all the way to full term — 39 weeks gestation.

Medi-Cal, the state health program for low-income residents, CalPERS, the retirement program for state employees, and the Pacific Business Group on Health, which represents self-insured employers, are also calling on hospitals to improve their quality measures. Together, these groups pay for the health care of 16 million Californians, or 40 percent of the state, which gives them substantial leverage with hospitals.

But only Covered California is telling hospitals that if they don’t play by the rules, they’ll be benched.

“It’s probably the boldest move we’ve seen in maternity care ever,” said Leah Binder, CEO of the Leapfrog Group, a Washington, D.C.-based nonprofit that rates hospitals on quality.

Expecting hospitals to meet external metrics for quality control is a recent phenomenon, and compliance is still largely voluntary, she said.

“Back in the ’80s and ’90s, nobody ever thought that hospitals should have to report to anyone on how they were doing,” she said. “There’s never been a culture of accountability.”

Covered California’s move is nationally significant, Binder said, given the consequences for hospitals, and the agency’s reach — 1.4 million people buy coverage through the marketplace — and they shop among plans offered by 11 state-approved insurance companies.

Insurers and business groups across the country are already keeping an eye on California’s effort, she said, to see how they might band together to demand similar change from the hospitals in their regions.

Overall, California’s hospitals are on board with the C-section goal. Of the 243 maternity hospitals in the state, 40 percent have met the target, Lang said, and another 40 percent have taken advantage of coaching and consulting to help educate doctors on how they can adjust their practices. They’re also finding they have to educate patients who request C-sections about the procedure’s risks.

“While many may prefer [the surgery], when having the full information about the risk that they may be putting themselves and their babies in, they elect not to move in that direction,” said Julie Morath, CEO of the Hospital Quality Institute, a subsidiary of the California Hospital Association. Both groups support the C-section reduction goals as “the right thing to do,” she said.

The strategy has raised some concerns among mothers who hear about the 23.9 percent target and worry about rationing.

“We don’t just chase rates,” Morath said in response to that concern, “but rather look at what the clinical needs are and how to best respond to those. So if there is an indication for a cesarean section, the mother will receive a cesarean section.”

Still, not all hospitals will find it easy to comply. State data show there are about 40 hospitals that are still far off the target, including a cluster of hospitals in East Los Angeles that treat low-income, often uninsured, patients.

“If you have somebody who is on methamphetamines and is homeless and has not gotten any prenatal care, her chance of a C-section is way higher than someone who is not all those things,” said Dr. Malini Nijagal, an OB-GYN at Zuckerberg San Francisco General Hospital. “And so the problem is, how do you adjust for the patient population of a hospital?”

At Memorial Hospital of Gardena, the C-section rate is 45.2 percent. At East Los Angeles Doctors Hospital, the rate is 48.1 percent, according to publicly available state data listed on CalHospital Compare and Yelp. Both hospitals are working diligently to lower the rates, according to Amie Boersma, director for communications for Avanti Hospitals, which owns both hospitals.

She said the hospitals will meet the 23.9 percent benchmark and are committed to doing so for the sake of their patients. Being excluded from Covered California health plan networks, she added, would make it even more difficult for those patients to get care. They would either have to pay out-of-network fees to be seen there, or they would have to travel farther to another facility that was still in the network.

“We are in underserved, economically challenged urban neighborhoods and it is vitally important that we continue to provide appropriate, high-quality care for our communities,” Boersma said.

Health plans can request an exemption from Covered California’s contract rules (in order to keep noncomplying hospitals in their networks) — as long as they document their reasoning.

“That is flexibility that we asked for to ensure that we maintain adequate access to providers,” said Charles Bacchi, CEO of the California Association of Health Plans, a trade group for insurers. “Any major changes to health plan networks must be filed with regulators. And health plans have to ensure that patients continue to receive services in a timely manner.”

So far, the prospect of exclusion, plus the coaching for hospitals on how to reduce the rates, have functioned as an effective motivator. By 2020, Covered California’s Lang predicted, all hospitals will either have met the target or be on their way.

“It’s a quality improvement project,” Lang said, “but with a deadline.”

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

KHN’s coverage of these topics is supported by The David and Lucile Packard Foundation and Heising-Simons Foundation

Watch: What’s In The White House Plan To Lower Drug Prices

President Donald Trump began talking about the high cost of prescription drugs long before he took office. He often spoke about how drug companies “got away with murder” on the campaign trail.

He has continued these attacks, and in April the Trump administration unveiled a 44-page blueprint.

But what’s in it?

KHN’s Sarah Jane Tribble breaks it down, explaining the real-life consequences.

Drugmakers Blamed For Blocking Generics Have Jacked Up Prices And Cost U.S. Billions

Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.

As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.

The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.

The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples, and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid, which accounted for 63 percent of Celgene’s revenue in the first quarter of 2018, according to a company press release.

The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t [such] lucrative sources of revenue,” said Harvard Medical School instructor Ameet Sarpatwari. “In the case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”

Indeed, a KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drugmakers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5 percent to 26.3 percent for Medicare Part D in 2014, the most recent year that data are available.

The remaining drugs do not appear in the Medicare and Medicaid data.

(Story continues below.)

By delaying development of generics, drugmakers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 60 percent more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.

Revlimid cost Medicare Part D $2.7 billion in 2016, trailing only Harvoni, which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40 percent per unit in just four years, the Medicare data show, and cost $75,200 per beneficiary in 2016.

Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require restricted distribution of brand-name drugs that have serious risks or addictive qualities. Drugmakers with products in the safety program sometimes say they can’t provide samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Gottlieb said in a statement.

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The Department of Health and Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Sarpatwari said there’s evidence drugmakers are abusing it to stave off competition from generics.

Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anticompetitive practices.

Celgene spokesman Greg Geissman said the company has sold samples to generics manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition and safety.

“Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst are believed to have similar risks,” Geissman said.

The highest number of pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer. In 2016, that drug cost Medicare $90,700 per patient and more than $304 million overall. Meanwhile, spending per unit jumped 52 percent from 2012 through 2016.

Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen, in 2017.

(Story continues below.)

Actelion spokeswoman Colleen Wilson said that the company “cooperate[s]” with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”

PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses from those it represents.

“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said PhRMA spokesman Andrew Powaleny.

Congress is considering the CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.

The bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said more transparency from the FDA is helpful, but more work from the agency is needed to end the anticompetitive tactic. “With billions of dollars at stake, a database alone will not stop this behavior,” Leahy said.

Co-sponsor Sen. Chuck Grassley (R-Iowa), chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anticompetitive practices to keep low-cost generic drugs off the market.”

The FDA hasn’t come out in support of CREATES. “They should know that this is going to require a legislative solution,” Sarpatwari said. “Why are they not stepping into this arena and saying that?”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation.

HHS Announces Proposed Update to Title X Family Planning Grant Program

HHS Gov News - May 23, 2018

The U.S. Department of Health and Human Services (HHS) is issuing a proposal to update the regulations governing the Title X family planning program, which focuses on serving low-income Americans. The proposed update to the regulations ensures compliance with statutory program integrity provisions governing the program and, in particular, the statutory prohibition on funding “programs where abortion is a method of family planning.” (42 U.S.C. § 300a-6) The proposed update to the regulations, which were last revised 18 years ago, would also make notable improvements designed to increase the number of patients served and improve their quality of care.

The Title X program serves approximately 4 million people annually, and the proposed update seeks to ensure a holistic and health-centered approach; safeguarding the short and long-term family planning needs of more women, men, and adolescents in need of services. It is of utmost importance that individuals in low-income communities receive comprehensive family planning services, and care that promotes the welfare of adults and youth. It is equally important that, as stewards of taxpayer funds, the Department assures that the program operates according to statutory requirements.

Key elements of the proposed update include:

  • Requiring clear financial and physical separation between Title X funded projects and programs or facilities where abortion is a method of family planning.
    • This separation will ensure adherence to statutory restrictions and provide clarity about permissible and impermissible activities for Title X projects.
  • Improving program transparency by requiring more complete reporting by grantees about subrecipients and other program partners and their Title X funded activities, to ensure quality provision of family planning services and compliance with statutory and regulatory requirements.
  • Protecting Title X health providers so that they are not required to choose between the health of their patients and their own consciences, by eliminating the current requirement that they provide abortion counseling and referral. The proposal would not bar non-directive counseling on abortion, but would prohibit referral for abortion as a method of family planning.
  • Protecting women and children who have experienced child abuse, child molestation, incest, sexual abuse, rape, intimate partner violence, and trafficking by:
    • Requiring annual training for staff at Title X clinics and ensuring they have a site-specific protocol in place to protect victims.
    • Requiring compliance with State and local laws on reporting or notification of these crimes.
    • Providing counseling to minors on how to resist attempts to coerce them into sexual activities.
  • Requiring clinics to encourage meaningful parent/child communication and, as required by federal law, encourage family participation in a minor’s decision to seek family planning services, giving practical ways to begin – and maintain – such communication.
  • Maintaining the patient/doctor confidential relationship within the statutory requirements.
  • Permitting individuals to qualify for Title X services if they are unable to obtain employer-sponsored insurance coverage for certain contraceptive services due to their employer’s religious beliefs or moral convictions.
  • Providing high quality comprehensive family planning services to those currently unserved, while ensuring the integrity of the Title X program, consistent with statutory requirements.

The proposed update can be found here:

Readout of Secretary Azar’s First Day of Participation at the 2018 World Health Assembly

HHS Gov News - May 23, 2018

Health and Human Services Secretary Alex Azar began his participation at the World Health Assembly (WHA) as head of the United States delegation by delivering remarks during a plenary session of the WHA. Speaking to representatives of the Member States, Secretary Azar laid out key priorities for the United States and the World Health Organization (WHO) and challenged the WHO to keep its focus on its primary mission of preventing, detecting, and responding to public health emergencies. The Secretary’s remarks included:

  • An announcement of up to $7 million in additional assistance to go towards the response to the Ebola outbreak in the Democratic Republic of Congo – making the total U.S. commitment up to $8 million; 
  • A recognition that it is disappointing and inappropriate that Taiwan was not invited to observe the WHA; and
  • A focus on the importance of private-sector engagement and innovation, particularly when it comes to access to medications.

Secretary Azar highlighted the Trump Administration’s efforts to reduce drug prices for patients of the United States while ensuring other countries contribute their fair share to pharmaceutical innovation.

The Secretary’s full remarks are available here:

After the speech, Secretary Azar participated in an event to champion the creation of a global research and development hub focused on antimicrobial resistance (AMR). During his remarks, the Secretary noted the strong U.S. commitment made through HHS agencies to address this challenge, and announced that CARB-X – a public-private partnership to address AMR – now included the support of the United Kingdom and the Bill and Melinda Gates Foundation.

Later in the day, at an event sponsored by the United States government, Secretary Azar joined several nations in remembering the 100th anniversary of the 1918 influenza pandemic and recommended the need for a frank discussion and close collaboration to ensure the world is better prepared to protect against a potential pandemic flu.

Throughout the day, Secretary Azar spoke with representatives from multiple nations participating in the WHA and held meetings with health ministers and officials from the Republic of Korea, Ukraine, Brazil, Germany, the United Kingdom, and Saudi Arabia. Discussions covered a range of global health issues, and the Secretary expressed the commitment of the United States under the Trump Administration toward strengthening global health security efforts.

Insurer Slashes Breast Pump Payments, Stoking Fears Fewer Moms Will Breastfeed

A sharp cut in breast pump payments by the nation’s second-largest health insurer has prompted a strong reaction from breastfeeding advocates, who warn that some new moms will not get the pumps they need and fewer babies will be breastfed.

Starting last month, Anthem Inc. slashed the rate it reimburses medical suppliers for breast pumps by 44 percent — from $169.15 to $95. The move means some breast pumps that used to be free under a provision of the Affordable Care Act will now entail a cost to consumers, according to the advocacy group MomsRising. More complex pumps, which have always required an out-of-pocket payment, will now be more expensive. It’s unclear how many women will be affected.

“It’s going to have a bigger impact on lower-income moms who can’t afford the increased out-of-pocket expense,” said Ruth Martin, vice president of Workplace Justice Campaigns for MomsRising. “Some moms will just stop breastfeeding.”

The lower payment rate applies to all commercial health plans sold by Anthem, which provides medical coverage for 40 million — or about 1 in 8 — people in the United States. The rate will not affect Anthem-run Medicaid plans, company spokesman Eric Lail said.

Anthem says that a variety of high-quality breast pumps will still be available to nursing moms at no cost, as required by the ACA.

But the lower reimbursement appears to be limiting the number of free pumps available to Anthem enrollees as medical suppliers charge them for the shortfall on models that the old Anthem rate used to fully cover.

Bob Achermann, executive director of the California Association of Medical Product Suppliers, acknowledged that lower reimbursement rates for medical equipment in general have forced suppliers to make tough decisions, including limiting customer choices.

The cost of a breast pump can vary widely, depending on the model and whether it is purchased directly from a retailer or with insurance through a medical equipment supplier. Retail prices range from as little as $12 for the most basic pumps to $400 for the higher-end ones. Some hospital-grade pumps, which can cost several thousand dollars, are typically rented by moms for roughly $80 a month.

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But the amount insured consumers pay, if anything, is based on the prices their health plan negotiates with suppliers, which can be lower than retail.

Anthem declined to reveal any prices on the range of pumps it offers but listed a handful of “popular” pumps its enrollees can get for free.

“Anthem recognizes the positive health benefits that breastfeeding can have on mothers and their newborns,” the company told California Healthline in an emailed statement. “The recent [rate] adjustment … will not impact the ability of any new mother to access a high-quality, standard double electric breast pump from our contracted medical suppliers.”

To comply with the ACA’s free breast pump mandate, commercial insurers have offered certain models at no cost. That has saved families hundreds of dollars, since breast pumps often were not covered at all before the ACA. Some state Medicaid programs, including Medi-Cal, also provide this coverage.

But the no-cost pumps do not work for all mothers, experts say. Breast pumps vary from manually operated ones to electric ones to the much stronger hospital-grade variety. The design or capacity of one pump may fit the needs — or bodies — of some women but not others.

Some mothers, for example, need to pump more milk because their babies have medical conditions that make it difficult for them to drink directly from the breast. Other mothers, returning to work after maternity leave, may need to express milk for daytime feedings by caregivers — or, if they are pumping at their workplace, to minimize break time.

Women who need more complex pumps — ones that have always required coinsurance payments — now must shell out more money as a result of Anthem’s decision, breastfeeding advocates say. That, in turn, raises a key question: Will more mothers simply settle for lower-end pumps that medical experts say might frustrate them and induce them to give up breastfeeding?

Karissa Soma of Orangevale, Calif., holding her 5-month-old son, Cotton, says the cost of having a baby is hard enough on families without the extra expense of a breast pump. (Courtesy of Karissa Soma)

Breast pumps “are not cheap,” said Karissa Soma, an Orangevale, Calif., mom who took a half-year off work to care for her 5-month-old son. “I paid almost $5,000 in hospital bills, and you add the expense to stay home. It’s already so much.”

Critics of Anthem’s decision believe it cuts against the spirit of the ACA breast pump rule, which was intended to remove barriers to breastfeeding. Research shows the health law provision, which was implemented in 2012, has induced more new moms to breastfeed their babies and to continue doing so longer than before.

“It is clear that this [Anthem] decision would have far-reaching and deleterious effects on a mother’s ability to reach their breastfeeding goals,” the United States Breastfeeding Committee and dozens of other breastfeeding advocates wrote in an April 25 letter to Anthem President and CEO Gail Boudreaux.

Given the well-known benefits of breast milk, the American Academy of Pediatrics recommends that new moms breastfeed for at least a year. But that’s not always easy. Breastfeeding can be hard for a new mom — and for the baby.

When 31-year-old Bakersfield, Calif., resident Megan Eskew, an Anthem enrollee, gave birth in April 2017, she needed a pump to feed her milk to her baby boy, Reid, who spent the first six days of his life in the intensive care unit and could drink only from a bottle.

The hospital-grade pump delivered the breast milk that Eskew, a first-time mom, believed was critical for Reid. When Reid left the hospital, he still needed to drink from a bottle, so Eskew selected a high-end pump that required a coinsurance payment of roughly $100 under the terms of her health plan. That was a year before Anthem cut its reimbursement.

“I’m lucky I had the financial resources to buy a pump,” Eskew said, “but not all moms have those options.”

KHN’s coverage of these topics is supported by California Health Care Foundation, The David and Lucile Packard Foundation and Heising-Simons Foundation

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

Are You And Your Primary Care Doc Ready To Talk About Your DNA?

If you have a genetic mutation that increases your risk for a treatable medical condition, would you want to know? For many people the answer is yes. But such information is not commonly part of routine primary care.

For patients at Geisinger Health System, that could soon change. Starting in the next month or so, the Pennsylvania-based system will offer DNA sequencing to 1,000 patients, with the goal to eventually extend the offer to all 3 million Geisinger patients.

The test will look for mutations in at least 77 genes that are associated with dozens of medical conditions ranging from heart disease to cancer, as well as variability in how people respond to pharmaceuticals based on heredity.

“We’re giving more precision to the very important decisions that people need to make,” said Dr. David Feinberg, Geisinger’s president and CEO. In the same way that primary care providers currently suggest checking someone’s cholesterol, “we would have that discussion with patients,” he said. “‘It looks like we haven’t done your genome. Why don’t we do that?’”

Some physicians and health policy analysts question whether such genetic information is necessary to provide good primary care — or feasible for many primary care physicians.

The new clinical program builds on a research biobank and genome-sequencing initiative called MyCode that Geisinger started in 2007 to collect and analyze its patients’ DNA. That effort has enrolled more than 200,000 people.

Like MyCode, the new clinical program is based on whole “exome” sequencing, analyzing the roughly 1 percent of the genome that provides instructions for making proteins, where most known disease-causing mutations occur.

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Using this analysis, clinicians might be able to tell Geisinger patients that they have a genetic variant associated with Lynch syndrome, for example, which leads to increased risk of colon and other cancers, or familial hypercholesterolemia, which can result in high cholesterol levels and heart disease at a young age. Some people might learn they have increased susceptibility to  malignant hyperthermia, a hereditary mutation that can be fatal since it causes a severe reaction to certain medications used during anesthesia.

Samples of a patient’s blood or spit are used to provide a DNA sample. After analysis, the results are sent to the patient’s primary care doctor.

Before speaking with the patient, the doctor takes a 30-minute online continuing education tutorial to review details about genetic testing and the disorder. Then the patient is informed and invited to meet with the primary care provider, along with a genetic counselor if desired. At that point, doctor and patient can discuss treatment and prevention options, including lifestyle changes like diet and exercise that can reduce the risk of disease.

About 3.5 percent of the people who’ve been tested through Geisinger’s research program had a genetic variant that could result in a medical problem for which clinicians can recommend steps to influence their health, Feinberg said. Only actionable mutations are communicated to patients. Geisinger won’t inform them if they have a variant of the APOE gene that increases their risk for Alzheimer’s disease, for example, because there’s no clinical treatment. (Geisinger is working toward developing a policy for how to handle these results if patients ask for them.)

Wendy Wilson, a Geisinger spokeswoman, said that what they’re doing is very different from direct-to-consumer services like 23andMe, which tests customers’ saliva to determine their genetic risk for several diseases and traits and makes the results available in an online report.

“Geisinger is prescribing DNA sequencing to patients and putting DNA results in electronic health records and actually creating an action plan to prevent that predisposition from occurring. We are preventing disease from happening,” she said.

Geisinger will absorb the estimated $300 to $500 cost of the sequencing test. Insurance companies typically don’t cover DNA sequencing and limit coverage for adult genetic tests for specific mutations, such as those related to the breast cancer susceptibility genes BRCA1 or BRCA2, unless the patient has a family history of the condition or other indications they’re at high risk.

“Most of the medical spending in America is done after people have gotten sick,” said Feinberg. “We think this will decrease spending on a lot of care.”

Some clinicians aren’t so sure. Dr. H. Gilbert Welch is a professor at the Dartmouth Institute for Health Policy and Clinical Practice who has authored books about overdiagnosis and overscreening, including “Less Medicine, More Health.”

He credited Geisinger with carefully targeting the genes in which it looks for actionable mutations instead of taking an all-encompassing approach. He acknowledged that for some conditions, like Lynch syndrome, people with genetic mutations would benefit from being followed closely. But he questioned the value of DNA sequencing to identify other conditions, such as some related to heart disease.

“What are we really going to do differently for those patients?” he asked. “We should all be concerned about heart disease. We should all exercise, we should eat real food.”

Welch said he was also concerned about the cascading effect of expensive and potentially harmful medical treatment when a genetic risk is identified.

“Doctors will feel the pressure to do something: start a medication, order a test, make a referral. You have to be careful. Bad things happen,” he said.

Other clinicians question primary care physicians’ comfort with and time for incorporating DNA sequencing into their practices.

A survey of nearly 500 primary care providers in the New York City area published in Health Affairs this month found that only a third of them had ordered a genetic test, given patients a genetic test result or referred one for genetic counseling in the past year.

Only a quarter of survey respondents said they felt prepared to work with patients who had genetic testing for common diseases or were at high risk for genetic conditions. Just 14 percent reported they were confident they could interpret genetic test results.

“Even though they had training, they felt unprepared to incorporate genomics into their practice,” said Dr. Carol Horowitz, a professor at the Icahn School of Medicine at Mount Sinai in New York, who co-authored the study.

Speaking as a busy primary care practitioner, she questioned the feasibility of adding genomic medicine to regular visits.

“Geisinger is a very well-resourced health system and they’ve made a decision to incorporate that into their practices,” she said. In Harlem, where Horowitz works as an internist, it could be a daunting challenge. “Our plates are already overflowing, and now you’re going to dump a lot more on our plate.”