UnitedHealth To Exit California’s Obamacare Market

UnitedHealth Group Inc. is leaving California’s insurance exchange at the end of this year, state officials confirmed Tuesday.
The nation’s largest health insurer announced in April it was dropping out of all but a handful of 34 health insurance marketplaces it participated in. But the company had not discussed its plans in California.
UnitedHealth’s pullout also affects individual policies sold outside the Covered California exchange, which will remain in effect until the end of December.
“United is pulling out of California’s individual market including Covered California in 2017,” said Amy Palmer, a spokeswoman for the state exchange.
It’s expected that UnitedHealth will continue offering coverage to employers in California and to government workers and their families through the California Public Employees’ Retirement System.

Representatives of UnitedHealth didn’t immediately respond to a request for comment Tuesday. In April, UnitedHealth’s Chief Executive Stephen Hemsley said the company was unwilling to keep losing money on the exchange business overall.
“The smaller overall market size and shorter term, higher-risk profile within this market segment continue to suggest we cannot broadly serve it on an effective and sustained basis,” Hemsley said in a conference call with investors in April.
UnitedHealth just joined the California exchange this year, and it only had about 1,200 enrollees so the immediate impact on overall coverage numbers is minimal. The number of individual policyholders outside the state exchange wasn’t immediately known.
Palmer said UnitedHealth policyholders will know their options for 2017 coverage when health plans and rates for next year are announced in July.
Critics of the Affordable Care Act have seized on the company’s exit, state by state, as further evidence the health-law insurance exchanges aren’t sustainable financially and that premiums will rise even higher for consumers.
The Obama administration has countered that the number of health plans offering exchange policies has increased since the 2014 launch, and that it expects the individual market will continue to stabilize as adjustments are made.
Many consumer groups welcomed UnitedHealth’s arrival in Covered California in order to give people more choice and inject more competition into the market. The top four insurers in the exchange, led by Blue Shield of California and Anthem Inc., control more than 90 percent of Covered California enrollment.
The state exchange had limited UnitedHealth to selling exchange plans in several smaller markets for 2016 because it didn’t participate the first two years. Those areas are predominantly rural counties in Northern California, but they also include Santa Barbara, Ventura and San Luis Obispo counties.
In February, Covered California’s executive director, Peter Lee, criticized UnitedHealth for blaming the federal health law for its heavy losses instead of taking responsibility for its own business mistakes.
Lee said UnitedHealth made a series of blunders on rates and networks that led to steep losses on individual policies across the country.
“Instead of saying, ‘We screwed up,’ they said, ‘Obamacare is the problem and we may not play anymore,'” Lee said in a February interview with California Healthline. “It was giving an excuse to Wall Street and throwing the Affordable Care Act under the bus.”
Lee had also previously knocked UnitedHealth for sitting out the first two years of Covered California before joining in 2016.
In April, UnitedHealth said it had nearly 800,000 enrollees on exchange plans across the country. It expected that number to fall to about 650,000 by December as people drop off coverage or find other insurance.
New York and Nevada have said that UnitedHealth will participate in the individual markets there and the company has filed plans to sell similar plans in Virginia.
This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

California’s Glaring Shortage Of School Nurses

California falls significantly short of a new recommendation by an influential group of pediatricians calling for every school in the United States to have at least one nurse on site.
Fifty-seven percent of California’s public school districts, with 1.2 million students, do not employ nurses, according to research from Sacramento State University’s School of Nursing.
The call for a nurse in every school appeared this week in a policy statement by the Illinois-based American Academy of Pediatrics. The group’s new guideline replaces its previous one, which recommended that school districts have one nurse for every 750 healthy students, and one for every 225 students who need daily assistance.
The academy said the use of a numerical ratio was “inadequate to fill the increasingly complex health needs of students.”

Even when measured against that old yardstick, California’s schools are woefully deficient. Statewide, there is one nurse for every 2,784 students, according to 2014 numbers from KidsData, a program of the Lucile Packard Foundation for Children’s Health. That’s nearly four times more students per nurse than the academy had recommended.
And in some regions it is far worse than that. In Santa Cruz County, for example, there were 13,432 students for every nurse in 2014.
California’s school nursing shortage is troublesome, experts say, because nurses provide much more than basic health services to students. They help manage chronic diseases, assist with obesity prevention, and participate in emergency preparedness and behavioral assessment, among other things.
“School nursing is one of the most effective ways to keep children healthy and in school and to prevent chronic absenteeism,” said Breena Welch Holmes, lead author of the academy’s policy statement and chairwoman of its Council on School Health.

Kathy Ryan, a nurse in the San Diego Unified school district and president of the California School Nurses Organization, said the academy’s new guideline, which also calls for access to a physician in every school district, underscores the vital need to upgrade health services in the state’s schools.
She noted that the new recommendation is stronger than the previous ratio-based guideline for whole school districts. Having a nurse across town, even if it means a school district is meeting a numerical target, is not as effective as having a full-time nurse on site every day, she explained.
Ryan noted that when children are absent, schools loses money. So when school nurses help reduce absenteeism, they could eventually pay for themselves, she said.

California’s school nurse deficiency is due in large part to the fact that schools are not legally obliged to hire nurses, and employing them competes with other priorities for scarce funding, said Linda Davis-Alldritt, ex-president of the National Association of School Nurses and a former nursing consultant to the state’s Department of Education.
“Districts are stretched for money, and school nurses aren’t required, so they don’t see the need,” she said.
For California to attain the academy’s goal of a nurse in every school, the state legislature would need to make it a requirement, Davis-Alldritt said.
Barbara Feder Ostrov contributed to this report.
This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

When Adult Children Get Sick, It May Be Hard For Parents To Get Information

When Sean Meyers was in a car accident on a November evening three years ago, he was flown by air ambulance to the emergency department at Inova Fairfax Hospital, in Northern Virginia. With his arm broken in four places, a busted knee and severe bruising to his upper body, Meyers, 29, was admitted to the hospital. While badly hurt, his injuries didn’t seem life threatening.
When his car went off the road, Meyers had been on his way to visit his parents, who live nearby in Sterling. They rushed to the hospital that night to wait for news and to be available if Sean or the hospital staff needed anything. But beyond the barest details, no one from the hospital talked with them about their son’s condition or care, not that night nor during the next 10 days while he was hospitalized.
“All the time he was there, the hospital staff was very curt with us,” said Sam Meyers, Sean’s dad. “We couldn’t understand why we were being ignored.”

After leaving the hospital, Sean moved into his parents’ spare bedroom temporarily to continue his recovery. About a week later, he was in their kitchen one evening with his girlfriend when suddenly he collapsed. He was rushed to the nearest hospital, where he died. An autopsy revealed that he had several blood clots as well as an enlarged heart.
For Sean’s parents, the results were particularly wrenching because there’s a history of blood clots on his mother’s side of the family. How much did the hospital staff know?
“It might have saved his life if they’d talked to us,” Sam Meyers said.
A spokeswoman for Inova Fairfax said, “We cannot comment on specific patients or cases.” But she noted that information about a patient’s care can be shared in a number of circumstances.
These days, when people think about patient privacy problems, it’s usually because someone’s medical record has been breached and information has been released without their consent. But issues can also arise when patient information isn’t shared with family and friends, either because medical staff decide to withhold it or patients themselves choose to restrict who can receive information about their care.
The federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) established rules to protect the privacy of patients’ health information while setting standards for hospitals, doctors, insurers and others sharing health care information.
Stepped-up enforcement in recent years and increased penalties for improper disclosure of patient information under HIPAA may lead hospitals and others to err on the side of caution, said Jane Hyatt Thorpe, an associate professor at George Washington University’s department of health policy and an expert on patient privacy.
“For a provider who’s uncertain about what information a provider may or may not be able to share, the easiest and safest route is to say no,” she said.
However, the law is actually quite permissive about providers disclosing information to family members and others who are involved in a patient’s care, said Thorpe.

“If the physician thinks it’s in [the] patient’s best interest to share information with mom or dad or whatever, they may do so,” she said.
They may also decide not to share information, however.
Generally, if a patient is unconscious and unable to give permission to discuss his medical information, a doctor may share details about his health with family and friends. But even if the patient is alert and able to make a choice, a health care provider can use discretion in deciding how much to tell family and friends.
Dr. Wanda Filer, president of the American Academy of Family Physicians, recalled a patient who was an HIV-positive sex worker who didn’t want his family to know about his health, even as he was dying. She honored his wishes. “The family was left in the dark,” she said.
State laws may be more restrictive than HIPAA, requiring patient permission to disclose information to others, said Elizabeth Gray, a research scientist at George Washington University’s department of health policy. However, Virginia law generally follows HIPAA on disclosures, said Gray.
In Sean Meyers’ case, there are unanswered questions. For example, “we don’t know what the patient actually said to the providers,” said Filer.
“HIPAA does allow information to be shared with family or friends based on the patient’s wishes or, if the patient cannot make his/her wishes known, then based on the family member’s or friend’s involvement in the patient’s care,” the spokeswoman for Inova said. The health system’s privacy policy states that it may disclose a patient’s medical information to a friend or family member as permitted under HIPAA and provides details about how to request a form to restrict such disclosures.
There’s no surefire way to avoid lapses in communication or ensure that providers get all the relevant information about a patient’s health. Most smartphones today allow people to store health care information that can be accessed by emergency personnel, said Joy Pritts, a privacy consultant who is a former chief privacy officer in the Office of the National Coordinator for Health Information Technology at the federal Department of Health and Human Resources. In addition to listing allergies and other health concerns, people could state their wishes about disclosing their health information.
In the case of adult children, it may be useful for the child to carry a signed document that authorizes health care providers to disclose and discuss health care information with the parents for a set period of time, said Pritts.
It’s no guarantee, but if a provider is on the fence about disclosing information, “it might help,” said Thorpe.
Please contact Kaiser Health News to send comments or ideas for future topics for the Insuring Your Health column.Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

Virginia Insurer’s Decision To Drop Bronze Plans Prompts Concerns

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News that a CareFirst BlueCross BlueShield subsidiary will stop selling bronze level plans on the Virginia marketplace next year prompted some speculation that it could signal a developing movement by insurers to drop that level of coverage altogether. The reality may be more complicated and interesting, some experts said, based on an analysis of plan data.
Bronze plans provide the least generous coverage of the four metal tiers offered on the insurance marketplaces, paying 60 percent of benefits on average, compared to 70 percent for silver plans, which are far more popular. During the 2016 open enrollment period, 23 percent of marketplace customers signed up for a bronze plan, compared with 68 percent who chose silver, 6 percent who picked gold and 2 percent who chose a platinum plan.
Next year, the CareFirst BCBS subsidiary Group Hospitalization and Medical Services will no longer offer bronze plans on the Virginia marketplace, and bronze plan members will be transitioned into silver plans, said a spokesperson for the insurer. The company will continue to offer bronze plans on other exchanges, however.

The decision spurred some health policy analysts and health law critics to question whether other insurers would follow suit. Part of that reasoning had to do with the health law’s risk adjustment program. In the program, individual and small group insurers that enroll sicker, generally costlier members receive payments from insurers that enroll healthier, less costly members. Since bronze plans may attract healthier people, insurers may stop selling them to avoid risk adjustment program payments, some argue.
Between 2015 and 2016, the number of bronze plans offered on the marketplaces increased less than 1 percent, while the number of silver plans grew by 2.9 percent, according to data from the Robert Wood Johnson Foundation.
It’s too soon to say whether CareFirst’s shift signals a trend in insurers pulling back from the bronze metal tier, said Katherine Hempstead, who leads RWJF’s work on health insurance coverage. But even if that happens, it’s unclear that the impact on consumers would be negative.
Bronze and silver plans may become more similar as time passes, Hempstead said.
Insurers have some wiggle room in designing plans. Although bronze plans must pay 60 percent of costs on average, they can range from 58 to 62 percent. Likewise, every silver plan doesn’t have to pay exactly 70 percent of costs on average, a plan can pay from 68 to 72 percent. Issuers can design plans that pay at the low or high end of these ranges and still meet the criteria for a bronze or silver plan.
An analysis of the premiums for bronze and silver plans in Census regions across the country reveals that average prices for the two types of plans moved toward each other slightly between 2015 and 2016, Hempstead said. In addition, looking across all regions the highest priced bronze plan was significantly more expensive than the cheapest silver plan in each region in 2016.
A recent analysis by the actuarial firm Milliman found that while people who purchased silver plans tended to get those with lower premiums, those turning to bronze plans chose the more expensive options. “Many issuers found it difficult to develop [bronze] plans that were palatable to consumers and in the bottom portion of the metallic level range,” the report concluded.
“It’s interesting if the industry standardizes itself,” Hempstead said, “and what if the most common plan becomes a sort of bronzy silver?”
Please contact Kaiser Health News to send comments or ideas for future topics for the Insuring Your Health column.Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

Va. Insurer’s Decision To Drop Bronze Plans Prompts Concerns

andrewsthumb

News that a CareFirst BlueCross BlueShield subsidiary will stop selling bronze level plans on the Virginia marketplace next year prompted some speculation that it could signal a developing movement by insurers to drop that level of coverage altogether. The reality may be more complicated and interesting, some experts said, based on an analysis of plan data.
Bronze plans provide the least generous coverage of the four metal tiers offered on the insurance marketplaces, paying 60 percent of benefits on average, compared to 70 percent for silver plans, which are far more popular. During the 2016 open enrollment period, 23 percent of marketplace customers signed up for a bronze plan, compared with 68 percent who chose silver, 6 percent who picked gold and 2 percent who chose a platinum plan.
Next year, the CareFirst BCBS subsidiary Group Hospitalization and Medical Services will no longer offer bronze plans on the Virginia marketplace, and bronze plan members will be transitioned into silver plans, said a spokesperson for the insurer. The company will continue to offer bronze plans on other exchanges, however.

The decision spurred some health policy analysts and health law critics to question whether other insurers would follow suit. Part of that reasoning had to do with the health law’s risk adjustment program. In the program, individual and small group insurers that enroll sicker, generally costlier members receive payments from insurers that enroll healthier, less costly members. Since bronze plans may attract healthier people, insurers may stop selling them to avoid risk adjustment program payments, some argue.
Between 2015 and 2016, the number of bronze plans offered on the marketplaces increased less than 1 percent, while the number of silver plans grew by 2.9 percent, according to data from the Robert Wood Johnson Foundation.
It’s too soon to say whether CareFirst’s shift signals a trend in insurers pulling back from the bronze metal tier, said Katherine Hempstead, who leads RWJF’s work on health insurance coverage. But even if that happens, it’s unclear that the impact on consumers would be negative.
Bronze and silver plans may become more similar as time passes, Hempstead said.
Insurers have some wiggle room in designing plans. Although bronze plans must pay 60 percent of costs on average, they can range from 58 to 62 percent. Likewise, every silver plan doesn’t have to pay exactly 70 percent of costs on average, a plan can pay from 68 to 72 percent. Issuers can design plans that pay at the low or high end of these ranges and still meet the criteria for a bronze or silver plan.
An analysis of the premiums for bronze and silver plans in Census regions across the country reveals that average prices for the two types of plans moved toward each other slightly between 2015 and 2016, Hempstead said. In addition, looking across all regions the highest priced bronze plan was significantly more expensive than the cheapest silver plan in each region in 2016.
A recent analysis by the actuarial firm Milliman found that while people who purchased silver plans tended to get those with lower premiums, those turning to bronze plans chose the more expensive options. “Many issuers found it difficult to develop [bronze] plans that were palatable to consumers and in the bottom portion of the metallic level range,” the report concluded.
“It’s interesting if the industry standardizes itself,” Hempstead said, “and what if the most common plan becomes a sort of bronzy silver?”
Please contact Kaiser Health News to send comments or ideas for future topics for the Insuring Your Health column.Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

Blue Shield ‘Lifts The Veil’ On Executive Pay

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In its first detailed disclosure on executive pay, nonprofit Blue Shield of California said Chief Executive Paul Markovich made $3.5 million last year — a 40 percent increase since he took the top job in 2013.
The San Francisco-based health insurer has faced criticism for years from consumer advocates about its lack of transparency on executive compensation, and the issue attracted even more scrutiny after a state audit raised questions about the insurer’s big pay increases.
In 2014, following that audit, the state revoked Blue Shield’s state tax exemption, which it had held since its founding in 1939.
In the report issued Thursday, Blue Shield for the first time listed total compensation for its 10-highest paid executives by name. The company also offered details, such as base salary and incentive awards.
Markovich made $2.5 million in 2013, $3 million the following year and $3.5 million last year. That 2015 compensation included a base salary of $1.07 million and incentive plan payouts of $2.45 million.
Blue Shield is California’s third-largest health insurer with 4 million members and $14.8 billion in annual revenue. The company’s 10-member board is led by chairman Robert Lee, a retired Pacific Bell executive, and also includes Leon Panetta, former Defense Secretary and past director of the Central Intelligence Agency.

“While we have been providing reports as required to regulators, it left something to the imagination,” said company spokesman Steve Shivinsky. The company wanted to “lift the veil and make sure we are going above and beyond what is required so there is a higher level of transparency.”
Consumer advocates said Blue Shield waited far too long to share details with their policyholders and the public.
“This is the kind of information that should have been forthcoming from Blue Shield a long time ago,” said Anthony Wright, executive director of Health Access, a consumer advocacy group. “We are paying for these salaries through our premiums.”
This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

Missouri Hospitals Seek To Focus Readmission Penalties On Patient Poverty

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Christian Hospital says its costly difference of opinion with Medicare hinges on how to count the large number of poor people that the St. Louis hospital treats.
Medicare penalizes hospitals that readmit too many patients within 30 days of discharge, and Christian expects to lose almost $600,000 in reimbursements this year, hospital officials said. Christian is one of 14 hospitals in the BJC HealthCare System.
Steven Lipstein, chief executive of BJC, which includes Barnes-Jewish hospital in St. Louis, said Medicare doesn’t play fair because its formula for setting penalties does not factor in patients with socioeconomic disadvantages — low-income, poor health habits and chronic illnesses for instance — that contribute to repeated hospitalizations.

If Medicare did that, Christian’s penalty would have been $140,000, Lipstein said.
As every hospital executive knows, half a million dollars pays for “a whole lot of nurses.”
In total, hospitals around the country lost $420 million last year under Medicare’s Hospital Readmissions Reduction Program, an initiative of the federal health law that seeks to push hospitals to deliver better patient care.
Since the program began in 2012, “recent trends in readmissions suggest that (it) is having the desired impact,” Health Affairs reported in January.
Hospitals have lobbied Congress and Medicare to change the rules and gained some ground May 18 when Rep. Patrick Tiberi, R-Ohio, introduced a bill in the House to adjust Medicare’s program to account for socioeconomic status. The bill was co-sponsored by Rep. Jim McDermott, D.-Wash.
Meanwhile, the Missouri Hospital Association is trying to pull public opinion behind it.

This year, the association overhauled its consumer website, Focus On Hospitals, to include not only the federal readmissions data, but also each member’s readmissions statistics, adjusted for patients’ Medicaid status and neighborhood poverty rates.
The federal government already adjusts its readmissions data for age, past medical history and other diseases or conditions, and that’s public on Medicare’s Hospital Compare website.
The association explains its adjustment methodology in an article on the site. “There is emerging national research that suggest poverty and other community factors increase the likelihood a patient will have an unplanned admission to the hospital within 30 days of discharge,” it states.
The hospital group’s alternative data — Lipstein’s source for how Christian could have reduced its 2015 penalty — comes from a study it commissioned. One finding: Missouri hospitals’ readmissions rates improved by 43 to 88 percent when patients’ poverty levels were considered.
“The question is, has [readjustment] been done in a just and fair way,” Lipstein said. The Missouri Hospital Association “has provided methodology that suggests what the feds are doing is unfair.”
The controversy over penalties is likely to grow beyond the readmissions question. Federal health officials have announced that they want to shift from paying doctors and hospitals based on the services they provide and move toward a value-based system that encourages a better quality of care and better outcomes while controlling costs.
Medicare bases penalties on readmissions on the care of Medicare patients who were originally hospitalized for one of these five conditions — heart attacks, heart failure, pneumonia, chronic lung problems and elective hip or knee replacements.
This year, Medicare penalized almost half of all hospitals — 2,592 to be exact — for excessive readmissions. More than 500 were fined 1 percent of their Medicare payments, or more, for the fiscal year that will end Sept. 30.
Still, the system harms so-called safety-net hospitals most, said Herb Kuhn, the Missouri Hospital Association’s president.
“Hospitals in difficult neighborhoods are getting worse scores, and those in affluent [ones] are getting better. It’s time to adjust [rates] for the disease of poverty,” he said.
Kuhn’s experience makes him an influential voice on health policy issues. He was deputy administrator of the Centers for Medicare & Medicaid Services from 2006 to 2009 and before that, director of the agency’s Center for Medicare Management. In April, Kuhn completed a three-year term on the Medicare Payment Advisory Commission, which advises Congress.
The commission proposed an alternative to Medicare’s readmission penalties last year. Others are also studying modifications.
The Centers for Medicare & Medicaid Services has taken a cautious stance, but last year CMS announced it is working with the National Quality Forum, a nonprofit group whose research influences CMS’s quality metrics, on a trial to test socioeconomic risk adjustment.
But Leah Binder, CEO of the Leapfrog Group, a nonprofit patient safety group, says Medicare’s readmission penalties have pushed hospitals to improve care and adjusting the data for patients’ poverty levels could deter them.
“Hospitals are paid a lot of money. I think they can find a way to handle their readmissions, the way they should have been handling them all along,” Binder said.Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

Inventing A Machine That Spits Out Drugs In A Whole New Way

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In a lab at the Massachusetts Institute of Technology, all the work that happens in a vast pharmaceutical manufacturing plant happens in a device the size of your kitchen refrigerator.
And it’s fast. This prototype machine produces 1,000 pills in 24 hours, faster than it can take to produce some batches in a factory. Allan Myerson, a professor of chemical engineering at MIT and a leader of the effort, says it could become eventually an option for anyone who makes medications, which typically require a lengthy and complex process of crystallization.
“We’re giving them an alternative to traditional plants and we’re reducing the time it takes to manufacturer a drug,” he said.
The Defense Department is funding this project because the devices could go to field hospitals for troops, hard-to-reach areas to help combat a disease outbreak, or be dropped at strategic spots across the U.S.

“If there was an emergency you could have these little plants located all over. You just turn them on and you start turning out different pharmaceuticals that are needed,” Myerson said.
Sounds simple? It’s not. This mini drug plant represents a sea change in how medications have been made for a long time.
“For roughly two centuries, to be honest,” says Tim Jamison, a professor of chemistry at MIT and one of Myerson’s partners, along with Klavs Jensen, a professor of chemical engineering at MIT. “The way that we tend to do chemistry is in flasks and beakers and that sort of thing, and we call that batch chemistry — one batch at a time,” he says.
That’s the way virtually all pharmaceuticals are made. Big batches of chemicals are synthesized, then they have to cool down, then are synthesized again to create new compounds. Then those compounds have to crystallize, filter and dry. Powders are added to make a tablet or capsule. These steps that can take months. This new device, says Jamison, produces medicine in one fast continuous process.
“We had to figure out new ways to make molecules, new ways to think about making molecules but from my perspective that has also provided us with a lot of opportunities that are very powerful,” said Jamison. His lab and Myerson’s also are collaborating with the Novartis-MIT Center for Continuous Manufacturing, which is funded by the pharmaceutical company Novartis.
The prototype raises the possibility that hospitals and pharmacies could make their own pills as needed, says James McQuivey, an analyst at Forrester Research.
“If it can done at lower cost, here’s one way at least that we could reduce the exorbitant cost of medications and that could a social good as well as an economic good,” McQuivey said.
Most of the cost of an expensive drug is not the materials or manufacturing or transportation said McQuivey; it’s in the drug makers’ monopoly control. So, he said, “If we can distribute the manufacturing of anything, pharmaceuticals included, so that more people have the opportunity to manufacture it, now there will be competition among those manufacturers.”
Drug makers have at least two big concerns about the widespread use of this device, says Dr. Paul Beninger, who oversees pharmaceutical safety at manufacturer Genzyme Sanofi. He said first and foremost, the drug industry worries about intellectual property rights.
Drug manufacturers own exclusive rights to produce the drugs they develop for a period of time, typically three to five years depending on how much is new in the drug. His other worry is safety, including monitoring of machines to ensure quality and safety.
“There are some really significant issues that this MIT project has to deal with if they’re going to try and make this a successful venture,” he said.
MIT researchers say continuous monitoring would be built into the continuous production process. The Food and Drug Administration is working on how to oversee this type of process.
On the patent concern, MIT developers say the device is being tested to make generic drugs for now, but that pharmacies or hospitals might someday license the right to produce drugs that have just been approved, not existing ones.
For now, their focus is on making an even smaller more portable unit, producing more and more complex drugs and seeking FDA approval for the device.
This story is part of a reporting partnership with NPR, WBUR and Kaiser Health News.Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

FDA Considering Pricey Implant As Treatment For Opioid Addiction

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Amid a raging opioid epidemic, many doctors and families in the U.S. have been pleading for better treatment alternatives. One option now under consideration by the Food and Drug Administration is a system of implanted rods that offer controlled release of buprenorphine — a drug already used in other forms to treat opioid addiction.
Because it’s implanted in the skin, this version of the drug can’t easily be sold on the illegal market, proponents say — a key treatment advantage. The FDA is expected to decide whether to approve the device — called Probuphine — within a week.

The implant system includes four rods, each about the size of a match stick, explained Dave, a paramedic in a small town outside of Boston; he was one of the patients recruited to test the device last year. Dave’s worried about reprisal if co-workers find out he is addicted to opioid pain pills, so NPR agreed to use only his first name.
“My implants were placed in my left arm, just above my elbow on the inside,” he explained. He’s been in recovery for four years — previously with the help of daily buprenorphine pills. Last year, he agreed to be part of an experiment that delivered regular doses of the drug to him via an implant instead. He’s sold on the new approach.
“I felt completely normal all the time,” he said.
Probuphine implants, inserted under the skin by a trained doctor, are left in place for six months at a time. Dave said the rods are convenient, safe and discreet — they provided steady relief from his cravings.
When he takes the daily buprenorphine pills, he said, he has to be careful to hide them so that his 2-year-old granddaughter can’t get into them. And though he’s supposed to take the tablets at least 15 minutes before he eats or drinks anything, he sometimes forgets. Or he forgets to take the pills at all.
“With the implant, you didn’t have to worry about that,” he said. “It was just there, and you felt good all the time.”
The device doesn’t work for everyone. During the study, 12 percent of patients who had implants relapsed. But the relapse rate for the pill version of the drug was 28 percent.
And there’s a second reason implants can be better than pills, said Braeburn Pharmaceuticals CEO Behshad Sheldon: A lot of buprenorphine winds up being sold illegally on the street. Though the drug produces a less intense high than most opioids, it is still sometimes abused.
“Buprenorphine is the third most confiscated opioid by the DEA, so there’s certainly diversion going on,” Sheldon said.
But during the clinical trial, she said, there were no cases of anyone trying to remove their implant so they could get to the drug inside and sell it.
An FDA advisory committee recommended approval of the implant in January, and a final decision from the agency is expected by May 27.
“Anything that might help people beat their opioid addiction is a good idea,” said Dr. Barbara Herbert, president of the Massachusetts Society of Addiction Medicine. But she said she also has reservations about this method of delivering treatment.
The main one is price. The company says it will price the implants to be competitive with other injectable treatments used to battle opioid addiction, including a shot that costs about $1,000 a month. Buprenorphine pills, in comparison, typically cost $130 to $190 for a month’s supply.
Herbert said a high price may force providers to turn patients away — or cut back on other services.
“High profits in the middle of this epidemic are really unconscionable,” she said.
Sheldon, of Braeburn Pharmaceuticals, said the company will offer rebates to make sure appropriate patients can get access to the implant. She plans to negotiate with insurers and providers on a price that takes both their cost and savings into account, she said.
“And if they don’t realize those savings, we’re happy to rebate them even further,” Sheldon said.
If the implant is approved, demand for it is expected to be high even with the high price-tag, addiction specialists say.
Dave, the New England paramedic in recovery, said he’s thought about trying to wean himself off the treatment drugs altogether.
“But then, the more I think about it, it scares the hell out of me,” he said. “I’m scared of going backward. I honestly don’t know what would happen.”
That’s a fear voiced by many of the growing number of Americans who have come to see their addiction as a chronic disease, a condition they may have to live with — and need treatment for — for many years.
This story is part of NPR’s reporting partnership with WBUR and Kaiser Health News.Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.