Opioid epidemic: Medication-Assisted Treatment need significantly exceeds capacity

A key goal of the Affordable Care Act is to help people get health insurance who may have not been able to pay for it before. But the most popular plans – those with low monthly premiums – also have high deductibles and copays. And that can leave medical care still out of reach for some.

Renee Mitchell of Stone Mountain, Georgia is one of those people. She previously put off a medical procedure because of the expense. But as the threat of losing part of her vision became a real possibility, she sought an eye specialist at Emory University, who told her she needed surgery to correct an earlier cataract procedure gone wrong.

The eye surgery is not the scariest part, she said. Cost is: “further copays [and] more out-of-pocket expenses.”

Mitchell is generally pleased with her insurance — a silver-level Obamacare plan. It’s the most popular type of plan with consumers because of the benefits it provides for the money. But she still struggles to keep up with her part of the bills. She is not alone.

“One in four adults who were fully insured for the whole year still reported they went without some needed medical care because they couldn’t afford it,” said Lydia Mitts, a senior policy analyst with the health care advocacy group, Families USA.

Mitchell still owes more than $20,000 for several years of medical expenses, with more debt accruing in interest each month. “If not for having availability on my credit card, we’d probably be in the poorhouse,” Mitchell said.

If she undergoes that eye surgery, she said, she’ll owe another $4,000 – the deductible for the operation.

“It’s a very big burden,” Mitchell said.

A recent study released by Families USA shows that a lot of people with coverage like Mitchell’s feel a similar burden, and a poll from the Kaiser Family Foundation finds the same thing. The majority of people who buy insurance on state or federal exchanges pick silver-level plans, which often carry a lower monthly premium, but may still have a high annual deductible – $1,500 or more.

“Consumers are still struggling with unaffordable, out-of-pocket costs,” says Mitts.

Many people in that situation skip follow-up care and don’t fill prescriptions. Mitts said that only adds to long-term complications and costs.

But it doesn’t have to be that way, she said. Plans in some states, including Pennsylvania, Texas, Florida and Arizona, have recently done away with deductibles on some silver-level insurance plans. And for certain basic services, including doctors’ visits and generic prescriptions, other plans are requiring only a small copay.

Still, while copays, deductibles and co-insurance weigh heavy on Renee Mitchell’s mind, they’re not her only insurance concern. Her monthly premium is also getting more expensive. This year, she said, it jumped by about $100 a month.

Mitchell wants to be clear, though: She’s not looking for a handout.

“People seem to think that we just want something for nothing,” she said. “I worked a lot of years. I took an early retirement to take care of my family. It’s not my fault, so to speak, that I’m here.”

This story is part of a reporting partnership with WABE, NPR 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.

It will be up to state officials and Congress to help consumers who can’t afford health insurance if the Supreme Court strikes down health law subsidies for millions of Americans, Health and Human Services Secretary Sylvia Burwell said Wednesday.

“The critical decisions will sit with the Congress and states and governors to determine if those subsidies are available,” Burwell told the House Ways and Means Committee.  The secretary told Congress earlier this year that the administration has no authority to undo “massive damage” that would come if the court invalidates the subsidies in the online marketplaces, or exchanges, which the federal government operates in about three dozen states.

By the end of this month, the court is expected to issue a ruling in the case, King v. Burwell.  More than 6 million people could lose those payments and many more residents could see their premiums increase because of the havoc the loss of subsidies would cause in the market.

The challengers argue that one clause in the law says those federal payments would be available to consumers only in states that run their own exchanges. But the administration has argued the legislative intent was to make subsidies available to customers in every state, regardless of how its exchange was established.

During Wednesday’s hearing, Republicans pressed Burwell to indicate what type of legislation President Barack Obama might sign to restore subsidies if the court rules for the challengers. Many Republican lawmakers have acknowledged that they would like to find a way to offer a temporary option to help consumers, but they have failed to coalesce around a specific proposal.

Burwell said while the administration would be open to considering alternatives that make health care more affordable and accessible, the president would not sign legislation from Sen. Ron Johnson, R-Wis. That bill would maintain the subsidies for current beneficiaries through August 2017 but repeal the health law’s requirements that most individuals get coverage, that larger businesses offer insurance to their workers or pay a penalty and that plans provide specific types of benefits.

“Something that repeals the Affordable Care Act is not something the president will sign,” Burwell said.

A recent report from the American Academy of Actuaries said some changes favored by Johnson and other Republicans, such as eliminating the individual mandate, “could threaten the viability” of the health insurance market for individual plans.

Echoing comments she made last week, Burwell said the administration will work with states to help mitigate the consequences for consumers if the Supreme Court ruled against federal subsidies.

The session was billed as a hearing on the HHS budget fiscal 2016 request, but it quickly veered to Republican attacks on the sweeping 2010 health law while Democrats rushed to defend it.

“Whatever the Supreme Court decides this month, I think the lesson is clear: Obamacare is busted. It just doesn’t work. And no quick fix can change this fact,” said Ways and Means Chairman Paul Ryan, R-Wis. “Its very linchpin—its central principle—is government control. That means higher prices, fewer choices, and lower quality.”

Rep. Sander Levin of Michigan, the panel’s ranking Democrat, replied in kind. “What’s busted,” he said, “is not the ACA but  [Republican] attacks on it. Endless attacks. Never coming up with a single comprehensive alternative all these years. So you sit as armchair critics while millions of people have insurance who never had it before. You’re livid because it’s getting better.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

In the U.S., an average of 21 people die every day waiting for an organ transplant, and the wait times can range from four months for a heart to five years for a kidney, dependent on the how sick the patient is, according to the Organ Procurement and Transplantation Network (OPTN) and the Gift of Life Donor Program.

But public policies have done little to close this gap between supply and demand, according to a study published earlier this month in JAMA Internal Medicine.

In this look at the national impact of a variety of state policies on organ donation, researchers examined for the first time the effects of policies in 50 states between 1988 and 2010.

“We found that state policies … during the past two decades had little to no effect,” the authors wrote.

The only meaningful gains, they noted, resulted from state revenue streams to support recruitment activities such as community outreach, worksite campaigns, and efforts to educate physicians, lawyers and other professionals who may play a role in promoting organ donation. Such dedicated resources were associated with an increase of about 15 transplants per state per year, or a 5.3 percent boost in donated organs.

Other policies they examined, such as leave-of-absence programs for government workers, school-based organ-donation education programs and tax benefits to help offset the costs of donation, had only minimal impact.

The data used in the study came from the United Network for Organ Sharing and the federal procurement network, which tracked organ donation signups and transplants and researchers tied that information to state policies.

“The next step in research would be thinking through alternative policy designs,” said Erika Martin, a study author and assistant professor of health policy at the University of Albany, N.Y. “Hopefully our study can start a conversation about how these more passive designs aren’t pushing the envelope.”

Some experts suggest that efforts to boost the number of living donors could address the shortfall.

For instance, while about 123,193 people are waiting for organ transplants, nearly 102,000 of them need kidneys – mostly because of complications from diabetes, according to Sigrid Fry-Revere, president of the American Living Donor Fund. She was not associated with the study. And kidneys are likely organs for living donation because the donor’s remaining, healthy kidney will compensate.

But here’s where some say public policies fall short.

Organ recipients’ health insurance covers medical costs for the donors’ surgery. If the recipient has the financial means, he or she can, reimburse the donor for travel and lodging costs, but they can’t — by law — pay for anything else. Donors are then responsible for their post-medical care costs, lost wages, spousal travel and lodging costs and even the possibility of losing their job – between $5,000 to $20,000 in additional costs on average — which make donation financially challenging.

Anastasia Darwish, executive director of the American Transplant Foundation, which has helped 349 living donors cover these costs, is among those who say current policies are inadequate.

“This isn’t about compensation, it’s about removing the barriers toward living donation,” said Darwish, who was not involved in the study.

Some state policies try to offset this burden with a tax credit for those who donate an organ, but it equates to only about $600 – a small share of the donor’s costs. But, according to a 2012 study, it would take around $10,000 to motivate someone to donate an organ. In addition, transplant advocates say that getting the tax credit requires filing complex tax forms and many people may not know the program exists.

“The people that need the help are people that a measly tax credit would not help a year later,” Fry-Revere said, whose group provides grants to donors for after-care and lost wages. She suggests a system where a kidney donor could donate to someone on the top of the wait list in exchange for getting a loved one moved further up on the list.

Fry-Revere says incentives are needed, but it’s more about making it financially feasible for a friend or loved one to donate an organ. Pure monetary rewards for donated organs, she argues, could quickly pave the way for the poorest people being exploited.

Few — and only the most needy — would “take the $5,000 for a kidney, and it would get a bad reputation,” Fry-Revere said.

Dr. Sally Satel, psychiatry lecturer at the Yale University School of Medicine, suggested taking financial incentives even further — to go beyond softening the financial ramifications of donation to repay donors through money put into retirement funds, payment for college or the like.

“It is time to test incentives, to reward people who are willing to save the life of a stranger through donation,” she wrote in an commentary accompanying the study. “Altruism is not enough. Pilot trials of incentives are needed.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

As the Supreme Court weighs the fate of a major part of the Affordable Care Act, President Barack Obama Tuesday laid out the moral underpinnings of the law in a speech to the Catholic Health Association.

Noting some of the individuals who make up the millions of Americans who have gained insurance coverage or new protections in the five years since the law was enacted, the president said:  “Behind every single story was a simple question – what kind of country do we want to be?”

Obama’s tone was much more conciliatory than it was the day before, when during a news conference wrapping up the G-7 meeting  in Germany he said of the case now before the Supreme Court, “Frankly, it probably shouldn’t even have been taken up.”

The court is expected to issue a ruling in the case, King v. Burwell, by the end of the month. It challenges the legality of insurance subsidies provided to those in the three-quarters of states that opted not to set up their own insurance marketplace and instead use the one run by the federal government. More than 6 million people could lose those payments and many more residents could see their premiums increase because of the havoc the loss of subsidies would cause in the market.

The president on Monday also reiterated the administration’s assertion that it has no specific contingency plan should the court strike down the subsidies, because it does not think that’s likely to happen and has little discretion to offer relief to consumers. “I think it’s important for us to go ahead and assume that the Supreme Court is going to do what most legal scholars who’ve looked at this would expect them to do,”  Obama said, which is uphold the subsidies.

In the speech to the Catholic Health Association, which was a key ally in passing the health law, Obama did take a swipe or two at those who continue efforts to overturn it.

“There’s something just deeply cynical about the ceaseless, endless, partisan attempts to roll back progress,” he said, alluding to ongoing Republican efforts to repeal and replace the law.

Congressional Republicans have been adamant that they will have a plan if the court strikes down subsidies. But so far they have not agreed on a  single proposal.

On Tuesday, Sen. Bill Cassidy, R-La., introduced another in a long series of GOP alternatives to Obamacare. This one, however, is co-sponsored by Senate Majority Leader Mitch McConnell, R-Ky.,  and Majority Whip John Cornyn, R-Texas. Their “Patient Freedom Act” would allow states to continue to use state insurance exchanges set up under the Affordable Care Act or instead use the funding for subsidies to help people buy insurance to underwrite health savings accounts.

Such bills are unnecessary, the president said, because the current federal health law is working. “This isn’t about myths or rumors that folks try to sustain.  There is a reality that people on the ground, day to day, are experiencing.  Their lives are better.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

The first thing out of John Iovine’s mouth is an apology.

“You got to forgive me if I don’t remember too much,” he says. “I had a stroke.”

Signs of that stroke are everywhere — the bed in the dining room, a shower installed in the pantry. John is thin and sits in blue pajama pants in the wheelchair he uses to get around.

He may, however, have overstated his memory problems.

“We went to Harding … that’s the school right up here,” he says. It was 1952, and that’s where he saw the woman who would become his wife — “this girl, in this long red sweater, and her red hair. And I said, ‘That’s the girl for me,’ ” he says of Carol Iovine.

“I came out on top,” he says, laughing.

Carol, who is sitting next to her husband, explains that John’s stroke came in the middle of a bad run of health. First, he developed an ulcer, she says. Then he needed an abdominal surgery. After that came the stroke — and more.

“He had pneumonia, jaundice, sepsis; clot in the right lung,” she adds. All of that hit between October 2013 and January 2014.

John, a former house painter, spent 79 days in the hospital — some of that unconscious, and nearly all of it stuck in a bed.

“Aw, man — it was hell,” he says.

Sink or Swim

John Iovine finally went home in April 2014, after several months in a rehab facility.

And this point in patients’ recovery — when they’ve been discharged and have to sink or swim on their own — is the stage that everyone in the health system is paying special attention to right now. For too long, too many people like John Iovine would take a dive at this stage and end up back in the hospital again.

The industry calls these returns to the hospital preventable readmissions, and they are a huge drain on finances, costing Medicare alone $15 billion annually. That’s why Medicare launched an initiative a few years ago that penalizes hospitals that see too many patients readmitted too soon. And in turn, that spurred many hospitals to pay more attention to the problem.

Now insurance companies are also taking a stab at a solution.

“We are trying to identify which patients are likely to be hospitalized in the next three months — so that’s our target,” says Somesh Nigam. He’s the chief informatics officer for Independence Blue Cross, a Philadelphia-based insurance firm.

Independence Blue Cross, he says, is working to identify all those among its customers who are sick or frail enough to be on the edge of hospitalization.

To do so, the company runs algorithms on the huge amounts of health data at its disposal: billing claims, lab readings, medications, height, weight and family history. It also throws in information about the client’s neighborhood, including poverty rates.

“The health care data we provided to build these algorithms is equivalent, I think, to [all the data in] five Wikipedias,” says Nigam.

The computer algorithm sifts through all that information and pops out a score for each individual patient, identifying those it deems at highest risk.

Independence Blue Cross then assigns each high scorer a staff member — what it calls a “health coach,” who will work at no charge to the client to see what extra services may be helpful.

“This coordinated effort then works for the patient,” Nigam says. The coach may assemble health information tailored to the patient’s needs; make medical appointments; resolve medication issues, or maybe help arrange transportation to the doctor’s office. Sometimes the coach helps arrange for a home care nurse.

“And all of that,” Nigam says, “is beginning to show a pretty significant drop in hospitalization rates in our region.”

Independence Blue Cross has identified 18,000 clients for this sort of extra attention and, as just one sign of success, has already seen a 40 to 50 percent reduction in expected hospital admission rates for people with congestive heart failure.

Early successes include the Iovines.

Life Changing

Carol Iovine’s life changed, too, after her husband’s stroke: She’s having to manage his new medications, and she helps John shower and get to the toilet. They need to hire a wheelchair-accessible van for each appointment and therapy session, and there are many.

She says having the support of John’s health coach has made a big difference in helping her manage her husband’s needs.

“He was supposed to get blood work, and they wanted me to take him to the ER to get blood work,” Carol remembers. ” ‘Uh-uh,’ I said. ‘No way.’ ”

She called their health coach Donna Crockett, and told her the problem. “And the next thing,” Carol Iovine says, “a nurse was here taking blood.”

Big picture: The money the health insurance plan spends on having Crockett arrange a visiting nurse, or streamline appointments is nothing compared to the cost of a hospital admission.

Writing the Rules

That promise of savings has a lot of health care specialists taking a harder look at the useful potential — and possible drawbacks — of these predictive computer formulas.

“There is a lot of interest in the area right now,” says Glenn Cohen, a professor at Harvard’s law school, who has written about the legal and ethical concerns raised by the collision of health care and big data. “It is a great coming together of the health care world and the computer science world, as well as the patient experience world.”

Still, he has some qualms.

“There are questions of whether people whose data is going to be used to build the engine have the right to opt out,” Cohen says. “Do they have to affirmatively opt in? Do they have to even be notified it’s being used?” These are still gray areas, he says.

The field is so new it doesn’t yet have established standards for how this information should be handled, Cohen says.

Independence Blue Cross says it follows federal health privacy guidelines regarding anonymity, and is only using the information to better serve its members. But it doesn’t ask the clients who subscribe to its health plans if they want to opt in.

“The data is only used to improve or coordinate care,” Nigam says. “And that is something that you would agree is our role.”

Health-wise, coordinated care seems to have made all the difference for John Iovine. He hasn’t been hospitalized in the year since Independence Blue Cross assigned him a health coach.

The insurer says the early results from its hospitalization efforts are so promising that the company is expanding its efforts. The firm is partnering with New York University’s Langone Medical Center on a next target — Type 2 diabetes. The goal is to spot those most at risk of getting diabetes before they start showing symptoms — and then intervene, in hopes of preventing the illness.

This story is part of a partnership that includes WHYY, NPR 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.

Even in Kentucky, which championed the 2010 health care law by expanding Medicaid and running its own insurance marketplace, about half of poor people say they have heard little about the Affordable Care Act, according to a Harvard University study published Monday in Health Affairs.

Awareness of Obamacare was even lower in Arkansas and Texas—two states that have not embraced the law as warmly. The study — which surveyed nearly 3,000 low-income residents in the three states last December– found 55 percent of those Texans and 57 percent of those Arkansans had heard little or nothing about the law’s extension of health coverage. Arkansas expanded Medicaid eligibility to cover more people under the law, but the state legislature prohibited spending public money to promote that or the federal subsidies available to help people buy private Obamacare plans. Texas did not expand Medicaid and restricted private groups wanting to help people enroll in new insurance options.

Such assistance was critical to whether people completed the application for coverage process, the study found. In fact, enrollment assistance led to a nearly 10 percentage point increase in the probability of people getting coverage, the study found.

Not surprisingly, enrollment rates in Medicaid and the private health plans sold on the online Obamacare marketplace were higher in Kentucky, followed by Arkansas, with Texas having the lowest enrollment rate.  That was true even for applicants eligible for subsidized private coverage in all three states because their incomes fell between the federal poverty level (about $11,800 for an individual) and 138 percent of poverty (about $16,300). In Arkansas and Kentucky, people making up to 138 percent of the federal poverty level also had option to sign up for Medicaid. In Texas, they did not have that option.

The survey showed less than half of poor people in the three states said the law has helped them, though the rate of those saying they had been helped ranged from 40 percent in Kentucky, to 30 percent in Arkansas, down to 21 percent in Texas.

The findings confirmed what most experts have long presumed: State policies have a big impact not only on eligibility, but also on who chooses to apply for coverage and whether they successfully enroll.

That came as no surprise to enrollment workers in Arkansas and Texas.

Mimi Garcia, Texas state director for Enroll America, said her enrollment assisters have encountered people who thought the health law didn’t exist in their state because state leaders opposed it. “It’s definitely been an uphill battle,” competing with the governor and Republicans who constantly bash the law, she said.  Even if assisters get past that hurdle, explaining how insurance works to those who have never had it can be tricky. “This is all pretty intimidating,” she said.

Marquita Little, health policy director for Arkansas Advocates for Children and Families, said the study highlights just how important personal assistance is signing people up for Medicaid or subsidized coverage. Arkansas is exploring starting a state insurance exchange, though probably not until 2016 or 2017.

Few states have seen the impact of Obamacare more than Kentucky.

Since the fall of 2013, Medicaid enrollment in Kentucky has jumped by more than 500,000 people, or 88 percent, the highest increase in the country.  Another 109,000 people have enrolled in a private health plan through the state’s exchange. Since 2014, Kentucky’s uninsured rate has fallen from 20.4 to 9.8, the second largest decrease in the nation, according to latest Gallup poll. Arkansas has seen the biggest percentage drop in uninsured, from 22.5 percent to 11.4 percent.

While many of Kentucky’s poor may be unfamiliar with the terms “Affordable Care Act,” or “Obamacare,” they are familiar with Kynect, the state’s exchange. The Harvard survey did not ask people if they had heard of Kynect. But a survey by the Foundation for a Healthy Kentucky in January 2014 found 80 percent of Kentucky residents were aware of Kynect, and only 30 percent of low-income adults were not.

Benjamin Sommers, the study’s lead author and an assistant professor at the Harvard T.H. Chan School of Public Health, said the political fighting over the health law — which many predicted would end years ago — has hurt efforts to educate people about its benefits. “People are hearing conflicting messages,” he said.

Another factor in low awareness, he said, is that many poor people lead busy lives and don’t make health insurance a priority when they are healthy.

That lack of knowledge has implications because the biggest factor determining if people apply is not their political affiliation, nor education, but whether they are aware of the law, he said.

Among those who did not apply, the most common explanation was that they thought coverage cost too much, the study found. But in Arkansas and Kentucky, those surveyed could get Medicaid for free and in Texas those between the federal poverty level and 138 percent of the poverty level could get subsidies that would make the total cost nominal.  “People are worried about the cost when they don’t have to be,” Sommers 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.

Advocates for children with rare diseases are watching closely a congressional effort to streamline the nation’s drug approval process because the bill includes a provision extending a federal program that rewards companies making remedies for these young patients.

The reward program, the advocates say, offers hope to families that often have very few options. Approximately 15 million children are diagnosed with rare diseases, and 35 percent of deaths in the first year of life are caused by them.

“Treatments aren’t getting to kids, and kids deserve more than the leftovers,” said Nancy Goodman, the founder and executive director of the advocacy group Kids v Cancer whose 10-year-old son died from brain cancer. She helped push for the original reward program in the hope that children like her son would have access to a wider range of treatments.

The extension of that program is part of the bipartisan 21st Century Cures bill, which seeks to rewrite the rules for drug development to make innovative treatments available faster. The overall bill has generated support on Capitol Hill, but some critics contend that it has the potential to undermine drug safety and profit drug makers.

Children’s advocates say there is a shortage of good therapies for rare and often deadly pediatric diseases that can include a wide variety of conditions including cancer, skull deformities or enzyme deficiencies. Pharmaceutical companies have historically been hesitant to test drugs for children because of concerns about potential negative outcomes, children’s inability to consent to treatment and the perception that the market for these drugs was limited. So doctors often have been left to use adult-tested drugs on sick children without the studies that show pediatric safety or effectiveness.  But drugs used on adults don’t always work on children in the same way because of differences in metabolism and maturation of organs.

The advocates say more research needs to be conducted with children. But that testing is a sensitive process. It can be very costly, and it requires extra care because there are more stringent ethical protocols to protect these minors. Bad results—either injuries or deaths – can set back research efforts and have financial consequences for the company.

With that in mind, Congress in 2011 set up a program to help promote more pediatric drug research. It gives creators of medicine for rare pediatric diseases a voucher that they can use to have another one of their drugs approved quicker than usual – six months vs. a process that can run a year or often more.

Drug makers can also sell that voucher, which can be a big windfall for a small drug company trying to recoup research and development costs. There have been four vouchers given out since 2014, and one was sold for $67.5 million and a second for $125 million.

The voucher program, which advocates say holds big potential, expires next year. The cures bill seeks to extend it another three years.

“A lot of companies are reluctant to get into pediatric drug development because it’s very difficult if something goes really wrong,” said Alexander Gaffney of the Regulatory Affairs Professionals Society, an association for people involved in overseeing health care or the quality of health care products.

Drugs that are approved for cancer in adults are commonly not approved in kids. “Children are not simply small adults, they metabolize drugs very differently,” Gaffney said.

Critics say that however well-intentioned the voucher program is, it could have some unintended consequences. For example, a company could get a drug approved by the Food and Drug Administration but never bring it to market, if the maker decides it would not generate enough money. Yet the company would still pocket the priority review voucher.

Because of the speed sought by the program, vouchers could be given out without some of the safeguards that come in more traditional testing. For example, the research might not uncover that the drug could be fatal to a child after a few months or years.

Diana Zuckerman, president of the National Center for Health Research, a nonprofit group that seeks to represent children and families on health research policy issues, says the rush in moving drugs through the system can obscure problems. Drug makers “shouldn’t be able to sell it [or use it] unless it works,” she said.

She noted that in some studies, as few as 10 kids are included because the disease is so rare. With such a small population size, the company is not likely looking at big profits.

“When you’re doing a study of rare disease, it’s a small sample size and it’s easy to manipulate the data to make it look better than it is,” said. “You don’t want an incentive to represent the company wrongly in the short-term,” to get the voucher for another larger drug.

Julia Jenkins, executive director of the EveryLife Foundation for Rare Diseases, an advocacy group pushing for drug companies to spend more on drug development, wants the pediatric drug voucher program extended. She notes that the program is still too new for officials to evaluate whether it is effective.

One problematic part of the current House version, she said, is that it only extends the program for three years, and drug companies generally need 10 years to scratch up investors and research a new drug. The potential reward of expedited drug review might not be enough to allow a company to make a financial plan for a drug based on the program.

The bigger cures bill covers more than 60 health issues, including a $10 billion boost in funding for the National Institutes of Health and $550 million in extra money for the FDA over the next five years. Other provisions include creating a database of genomic information from a million U.S. patient volunteers and allowing the FDA to approve drugs without the gold-standard clinical trial, instead using smaller observational studies or clinical experiences.

The bill passed the House Energy and Commerce Committee unanimously in May and is expected to come up for a vote in the full House.  Senators are in the early stages of working on a similar bill.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.