KFF Health News

KFF Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Pricey New Treatment Roils Issues Of How To Treat Prostate Cancer

KFF Health News, October 5, 2016

Proponents say high-intensity focused ultrasound (HIFU) can have fewer negative side effects than surgery or radiation. Critics, however, say the procedure is being oversold, leading some patients to get a treatment they don't need.

This article first appeared October 5, 2016 on Kaiser Health News.

By Julie Appleby

Men hoping to avoid some side effects of prostate cancer treatment are shelling out tens of thousands of dollars for a procedure whose long-term effects are unknown and insurers, including Medicare, won't pay for.

Proponents say high-intensity focused ultrasound (HIFU) can have fewer negative side effects than surgery or radiation, while giving some patients another option between actively watching their cancer and those more aggressive steps. Critics, however, say the procedure is being oversold, leading some patients to get a treatment they don't need.

Device makers are busy selling the $500,000-and-up machines to doctors around the country and offering training courses. Billboards advertising this "new non-invasive treatment for prostate cancer" are springing up, while treatment center websites promise "a safer method" with benefits such as "no erectile dysfunction and no incontinence," although studies show those side effects can occur, but less often than with other types of more aggressive treatments. The treatment can range in cost from $15,000 to $25,000.

HIFU is the latest treatment to prompt concerns over whether there should be limits — such as requiring tracking of results — placed on expensive new technology while additional data is gathered.

"This is going to join the group of uncertain-yet-available therapies that physicians can use, yet we have no clear understanding of who will benefit in a real world population," said Art Sedrakyan, a professor of health care policy and research at Weill Cornell Medicine in New York. The treatment of prostate cancer has been a particularly controversial — and lucrative — niche, since the disease for some men can be slow growing and their tumors wouldn't be fatal. A host of new "non-surgical' treatments are now also on offer using sophisticated machines to destroy cancer cells with proton beams or other types of high dose radiation.

Using HIFU, devices direct ultrasound waves to heat prostate tissue to about 195 degrees, ablating all or just portions of the gland. Focusing on just a portion of the gland is a newer trend in prostate cancer treatment. Anesthesia is used.

HIFU machines have been used in Europe longer than in the U.S, although national health programs in the United Kingdom and elsewhere limit coverage to patients enrolled in clinical trials or other research programs. While the devices are approved in Canada, the national health program does not pay for it. Until recently, some U.S. men traveled to have the procedure done by U.S. doctors who set up shop in Mexico, the Bahamas or Bermuda.

In the U.S., advisory committees to the Food and Drug Administration twice turned down applications from manufacturers to market HIFU devices as a treatment for prostate cancer, citing not enough long-term evidence.

But in October 2015, the FDA approved Charlotte, N.C.-based SonaCare Medical's device for the ablation of prostate tissue. Data submitted by the company included an analysis of 116 men who had their entire prostrate treated and were followed for 12 months. "While the oncological outcomes form this study are inconclusive, the results provide reasonable assurance of safety and effectiveness of the device in the context of prostate tissue ablation," the FDA said in its review.

A device by Lyon, France-based EDAP gained a similar approval shortly thereafter.

Researchers say it's too soon to state conclusively that partially treating the disease works as well as totally removing it. There is also debate over the type of patients best suited for the treatment: low risk, intermediate risk or those who have failed other types of prostate cancer treatment.

Ongoing and previous studies from abroad are available, but have limitations, including fairly short follow-up periods.

"The biggest studies in the world are only four or five years into it," said Michael Koch, chairman of the urology department at Indiana University School of Medicine, a proponent of HIFU for some patients. "We don't have survival data to see if [it] does better than surgery or radiation."

To get more complete answers, some physicians say it's critical to track outcomes with de-identified patient information in a nationwide registry.

It's not a new idea. Indeed, some technologies have been granted approval by the FDA or coverage by Medicare with a condition that patients must be enrolled in clinical trials or registries.

"Short of the FDA saying to device makers, 'You need to do this,'" establishing a comprehensive tracking method is challenging, said Jim Hu, a urologist and a robotic surgery specialist at Weill Cornell.

Hu co-authored a paper in the Journal of the American Medical Association in July with Sedrakyan and UCLA urology resident Aaron Laviana calling for a registry. Meetings between registry proponents, the FDA and the device makers are ongoing, but challenges remain, Hu said.

A registry is currently operating in England that will soon open to U.S. users of SonaCare Medical's HIFU devices. While SonaCare funds the registry, it does not have control of the data, said SonaCare CEO Mark Carol. His firm will also contribute funding to a broader U.S. registry that Hu and his co-authors support, which would incorporate results from other HIFU devices as well, calling the plan an "ambitious and worthwhile undertaking."

The evidence gathered could convince Medicare and other insurers that a treatment is valuable — and worth covering. But some practitioners may not want insurers to cover the treatment because when a treatment isn't covered, cash payments by patients can often exceed what practitioners would be paid by insurers. Currently, men usually pay for it themselves.

"The financial piece of this is somewhat perverse," said Hu. "Men are being charged $25,000 for this, yet no one feels pressure to demonstrate the efficacy of the treatment."

Adding A New Alternative To Treatment Debate

Meanwhile, the continuing debate regarding patients' treatment options has created an opportunity for HIFU.

Surgery and radiation can pose problems such as incontinence or impotence, while hormonal treatments also cause impotence and can also result in hot flashes, muscle weakness and other problems.

When the cancer is aggressive, the benefit of these approaches outweigh such side effects. But for men with lower-risk profiles, based on factors such as age, and results of tests and biopsies, the choice is more difficult. Some health care experts encourage these patients to opt instead for "active surveillance," which means keeping an eye on the cancer through regular testing.

But some men are uncomfortable just watching — and that's where HIFU could play a role.

Patients who have an area in the prostate with a higher grade tumor could choose to treat just that portion with HIFU, said Indiana University's Koch, who was part of the clinical trials of SonaCare's device in the U.S. and has accepted funding from the company.

"If we can treat [that area] with therapy, we can get them back on active surveillance," said Koch.

Others say more study is needed.

With prostate cancer, there may be a dominant tumor, but small cancer cells elsewhere in the gland, said Justin Bekelman, associate professor of radiation oncology at the University of Pennsylvania.

Still others note that patients who choose HIFU need to select physicians with lots of experience and training because the procedure is complex.

"HIFU is a steep learning curve. Some of the doctors buying these machines are not ready for it," said Jim Wickstrom, who had the procedure four years ago in Bermuda and is a big proponent. He says patients should do their research and choose only very experienced physicians who are willing to show their outcome data.

Registries could also help provide more information on outcomes, but one big challenge is who would pay for it.

"The main reason those (registry efforts) fail is the industry doesn't want to fund those studies, even if they think the treatment is better," said Sean Tunis, president and CEO of the Center for Medical Technology Policy in Baltimore and a former medical director at the Center for Medicare & Medicaid Services.

Mainly, that's because they don't need to unless required by the FDA, said Tunis. They already have marketing approval based on a limited number of studies demonstrating safety and efficacy.

Also, while registries are useful they also have limitations.

For one thing, because they are not randomly controlled trials, registries aren't the best way to compare treatment A to treatment B, said Fred Masoudi, a professor at the University of Colorado's medical school. But they can show how treatments, drugs or devices perform in common use.

"It's not a foregone conclusion that results will be the same [as in clinical trials], which is why registry programs are so important," said Masoudi, who has been involved with other such registries.

Where The Market Stands

SonaCare said it has sold more than 30 of the machines in the U.S., with medical centers in California, Florida, New York, North Carolina and Texas already using them. Competitor EDAP reported late in August that earnings from its HIFU division rose 68 percent in the first six months of 2016.

Patient advocates caution men to do a lot of research before choosing any type of treatment.

"With any procedure, there is a risk of temporary or ongoing issues with ED or incontinence," said Chuck Strand, CEO of Us Too, a prostate cancer patient group that is partially funded by industry. "Anytime anyone is looking at any therapy, we urge them to do their homework, ask lots of questions and get a second or even third opinion."

Most Hospital Palliative Care Programs Are Understaffed

KFF Health News, September 30, 2016

An analysis of palliative care programs found that only 25 percent funded teams that included a physician, an advanced practice or registered nurse, a social worker and a chaplain, the four positions that are recommended by The Joint Commission.

This article first appeared September 30, 2016 on Kaiser Health News.

By Michelle Andrews

Most hospitals offer palliative care services that help people with serious illnesses manage their pain and other symptoms and make decisions about their treatment, while providing emotional support and assistance in navigating the health system. But hospital programs vary widely, and the majority fail to provide adequate staff to meet national guidelines, a recent study found.

A growing body of research has shown that palliative care can improve the quality of life for patients with serious illnesses and complex, long-term needs. In one study, patients with advanced cancer who had discussions with their doctor about their wishes were less likely to die in the intensive care unit, be put on a ventilator or have cardiopulmonary resuscitation, for example.

Although many people, including medical professionals, continue to associate palliative care only with end-of-life care, it is appropriate for many people in many settings who are living with debilitating long-term illnesses.

In 2013, two-thirds of hospitals with at least 50 beds reported having a palliative care program. At hospitals with 300 beds or more, the figure was 90 percent, according to a study published in the Journal of Palliative Medicine earlier this year.

But not all programs provide the same level of service. In the September issue of Health Affairs, an analysis of 410 palliative care programs found that only 25 percent funded teams in 2013 that included a physician, an advanced practice or registered nurse, a social worker and a chaplain, the four positions that are recommended by the Joint Commission, which sets hospital standards, including those for accreditation. If "unfunded" staffers were counted, those who were on loan from other units, for example, the figure rose to 39 percent.

Study coauthor Diane Meier, a professor of geriatrics and palliative medicine at the School of Medicine at Mount Sinai in New York and director of the Center to Advance Palliative Care, said she wasn't surprised by the low numbers.

"There are no regulatory or accreditation requirements that enforce the staffing guidelines," Meier said. Although the Joint Commission recommends a staffing standard, hospitals aren't currently required to have palliative care teams in order to be accredited, Meier said.

"The hope is to shine a light on the gap in what everyone agrees is the [staffing] standard. If we're invested in improving the quality of care, this is what it will take."

Panel Recommends Expansion Of Medical Services With No Cost Sharing For Women

KFF Health News, September 27, 2016

Women at average risk for breast cancer would be allowed to begin screening as early as age 40 and receive a mammogram every one or two years. Imaging tests, biopsies, or other interventions required to evaluate mammogram findings would be considered an integral part of the screening, and would be provided without charge.

This article first appeared September 27, 2016 on Kaiser Health News

By Michelle Andrews

The list of preventive services that women can receive without paying anything out of pocket under the health law could grow if proposed recommendations by a group of mostly medical providers are adopted by federal officials later this year.

The draft recommendations, which are open for public comment until Sept. 30, update the eight recommended preventive services for women. That list was developed by the Institute of Medicine — now called the National Academies of Sciences, Engineering, and Medicine — to build on existing recommendations and fill in gaps that weren't addressed in the health law. Under the IOM list, which took effect in 2012, most health plans are required to cover well-woman visits, screening and/or counseling for sexually transmitted infections, domestic violence and gestational diabetes as well as breastfeeding support and supplies.

In addition, most health plans must cover, without cost sharing, all methods of contraception that have been approved by the Food and Drug Administration. That controversial requirement led to numerous lawsuits by religious institutions and employers that object to providing such coverage, including several cases that reached the Supreme Court.

When it developed the initial list, the IOM advised that the guidelines be reviewed and updated at least every five years in order to stay current with scientific evidence. This year, the review panel also weighed in on breast cancer screening, coverage of follow-up testing or procedures as part of the preventive services and male methods of birth control.

The proposed new recommendation would allow women at average risk for breast cancer to begin screening as early as age 40 and receive a mammogram every one or two years. That is a more liberal standard than the guidelines that insurers rely on for free screening from the U.S. Preventive Services Task Force, which recommends women generally be screened every other year starting at age 50.

"We have really confused the heck out of women," said Dr. Hal Lawrence, executive vice president and chief executive officer of the American Congress of Obstetricians and Gynecologists. "Do I start at age 40, do I start at 50, do I do it every year or do I do it every other year? We wanted to get some uniformity."

ACOG was awarded a 5-year grant to manage the review process, working in conjunction with a steering committee of nearly two dozen provider groups from different women's health disciplines.

In addition to the breast cancer screening itself, the ACOG working group proposes that if imaging tests, biopsies or other interventions are required to evaluate the mammogram findings that those be considered an integral part of the screening, which would mean they would be provided without charge to women.

Such follow-up care emerged as a theme from the panel: If additional testing or procedures are necessary following a preventive service, it should be covered as part of the service. The recommendations also clarify that some of the preventive services may require more than one visit and provide other specifics on coverage requirements.

"It's critically important for plans and people to recognize that the well-woman visit [required under the current guidelines] could happen in multiple places and require multiple visits," said Mara Gandal-Powers, senior counsel at the National Women's Law Center, which participated in the ACOG working group. "If you're a woman who needs a Pap test and a colonoscopy, you're probably not getting them from the same providers and you're hopefully not getting them at the same time."

The recommendations' specificity is important: The original IOM guidelines left implementation details vague, leading to scuffles between patient advocates and insurers over precisely what was covered, and that ambiguity required ongoing guidance from the federal government. For example, if a plan covers oral contraceptives without cost sharing, could it charge for other hormonal methods such as the contraceptive patch? Answer: No.

"It's helpful to get the real-world piece," said Dania Palanker, assistant research professor at Georgetown University's Center on Health Insurance Reforms. "For insurers, what do we mean when we say you have to cover a service?"

A spokesperson for America's Health Insurance Plans said that the trade group will likely submit comments on the proposed recommendations and declined to comment before then.

The working group recommended expanding the scope of what's covered without cost sharing in some important ways. The contraceptive coverage requirement, for example, would cover over-the-counter methods of birth control without a prescription and allow women to receive a full-year supply of contraceptives all at once, which has been shown to improve adherence.

The ACOG group also proposes covering contraception methods used by men, including condoms and vasectomy.

"The best contraceptive method for a woman at a particular time may be her partner," said Adam Sonfield, a senior policy manager at the Guttmacher Institute, a reproductive health research and policy organization.

The working group will submit its final recommendations to the Health Resources and Services Administration, part of the Department of Health and Human Services, by Dec. 1, and HRSA will make the final decision on adoption of the recommendations. If adopted before the end of the year, they would go into effect for most plans at the beginning of 2018.

CA Insurance Commissioner Wants To Try Public Option

KFF Health News, September 26, 2016

Nationally, President Obama and other prominent Democrats have revived the idea of the public option in response to insurers such as Aetna Inc. and UnitedHealth Group Inc. pulling back from the individual insurance market and many consumers facing double-digit rate hikes.

This article first appeared September 23, 2016 on Kaiser Health News

By Chad Terhune

With major insurers retreating from the federal health law's marketplaces, California's insurance commissioner said he supports a public option at the state level that could bolster competition and potentially serve as a test for the controversial idea nationwide.

"I think we should strongly consider a public option in California," Insurance Commissioner Dave Jones said in a recent interview with California Healthline. "It will require a lot of careful thought and work, but I think it's something that ought to be on the table because we continue to see this consolidation in an already consolidated health insurance market."

Nationally, President Barack Obama and other prominent Democrats have revived the idea of the public option in response to insurers such as Aetna Inc. and UnitedHealth Group Inc. pulling back from the individual insurance market and many consumers facing double-digit rate hikes.

The notion of a publicly run health plan competing against private insurers in government exchanges was hotly debated but ultimately dropped from the Affordable Care Act when it passed in 2010.

Health insurers have long opposed the idea, and other critics fear it would lead to a full government-run system.

Most of the discussion surrounding a public option, however, has focused on a nationwide plan, not one emanating from a state. In July, Democratic presidential nominee Hillary Clinton said she would "pursue efforts to give Americans in every state in the country the choice of a public-option insurance plan."

Jones offered few specifics on what a public option might look like in the Golden State.

"I don't want to begin to prejudge it," said Jones, an elected Democrat serving his second term as head of the state Department of Insurance, one of two insurance regulators in California. "I don't know whether you would start in certain areas of the state and expand from there. I think there would be significant reservations about the state running it. There would be a wide variety of governance models you could come up with."

Politically, the proposal may gain more traction in Sacramento than Washington with Democrats firmly in control of the state Legislature and many lawmakers eager to go beyond the boundaries of the federal health law. Depending on what form it took, a public option would require state legislation, some type of federal approval and some source of funding.

The idea of a California-style public option drew mixed reaction. Some consumer groups say they welcome another run at the public option after a disappointing outcome in 2010.

"We're certainly very interested," said Anthony Wright, executive director of Health Access California. "This is something we advocated for in its most ambitious form during the debate over health reform and there are elements of the proposal that could be adapted for California."

Some health-policy experts questioned whether the proposal would backfire, ultimately reducing competition.

"I don't know what would compel other insurers to stay in the market, so the public option could quickly become the only option," said Katherine Hempstead, who directs the Robert Wood Johnson Foundation's work on health insurance coverage. "I think that is only a clear win when the alternative is nothing."

State Sen. Ed Hernandez (D-West Covina), chairman of the Senate Health Committee, said a public option could make sense in some underserved areas. But he said it may not address the problem of large health systems dictating high prices, and it could interfere with the progress made by the Covered California insurance exchange.

Covered California said 7.4 percent of its 1.4 million enrollees will only have two health plans to choose from for 2017. The state's biggest markets of Los Angeles, San Francisco and Orange County all feature six to seven insurers.

"I don't know if a public option will create a lower price [for] the consumer," Hernandez said. "Covered California has done a good job of keeping rates fairly stable and it has enough plans."

Health insurers agreed. "Covered California has arguably one of the strongest and most stable exchanges in the country. There is robust consumer choice so we don't think we need to mess with something that isn't broken," said Nicole Evans, a spokeswoman for the California Association of Health Plans, a trade group.

For years, Jones has criticized the lack of competition in Covered California, and more recently he has opposed the mergers proposed by industry giants Anthem Inc. and Aetna Inc., saying they're anticompetitive.

Anthem wants to acquire Cigna, while Aetna is trying to merge with Humana, but the U.S. Justice Department has sued to block both deals.

Covered California has fared better than many states in terms of insurer competition. Eleven health plans are participating in the state-run exchange for 2017, but UnitedHealth is dropping out after just one year in California's individual market.

Consumer advocates had hoped UnitedHealth would become a strong rival to the state's four largest insurers. Anthem, Blue Shield of California, Kaiser Permanente and Health Net (now a unit of Centene) account for 90 percent of the state's exchange enrollment.

After modest 4 percent rate increases in 2015 and 2016, Covered California premiums are set to climb by 13.2 percent on average next year.

Jones said he anticipates that critics will cite the failure of numerous co-ops across the country as evidence a public option won't work. But he said that criticism is unjustified because the Republican-led Congress eliminated crucial funding that many of the co-ops were depending on.

The co-ops are nonprofit insurers backed with federal loans and designed as an alternative to commercial health plans.

California Aims To Limit Surprise Medical Bills

KFF Health News, September 16, 2016

After several failed attempts the California legislature has passed a bill which aims to protect patients from balance billing. Gov. Jerry Brown has until the end of September to sign or veto the legislation. He is expected to sign it into law.

This article first appeared September 16, 2016 on Kaiser Health News

By Stephanie O'Neill, KPCC

When it comes to navigating the intricacies of health insurance, Cassie Ray considers herself a pro. She actually reads her policy, including the fine print.

So when the 57-year-old from Fairfield, California, needed routine follow-up surgery after a mastectomy, she did her homework. "I looked up on my insurer's network and made sure the outpatient facility that I was being referred to was in my network," Ray said.

A month later, she received an unwelcome surprise: a $580 bill for an out-of-network anesthesiologist.

"I called the facility back, and at first, I felt like, this has to be a mistake. They'll fix it," Ray said.

Instead, the clinic said her only option was to negotiate the bill directly with the doctor. Ray's experience illustrates the surprise of balance billing.

The unexpected charges come when patients are treated by an out-of-network provider at an in-network facility.

After several failed attempts in recent years, the California legislature passed AB-72, which aims to protect patients' pocketbooks when they're hit by these surprise bills. Gov. Jerry Brown has until the end of September to sign or veto the legislation. He is expected to sign it into law.

A 2015 Consumers Union survey suggests the surprise bill phenomenon is fairly common. It found nearly 1 in 4 Californians who'd had hospital visits or surgery in the prior two years reported receiving an unexpected bill from an out-of-network provider.

"They can range in price from a hundred dollars to many thousands," said Betsy Imholz, special projects director for Consumers Union. "So it's a big financial burden on consumers."

In Ray's case, she said she tried to speak with a manager at the outpatient clinic, but no one returned her repeated calls. Then the bills stopped coming, so she figured all was resolved. Soon after, however, her bill was sent to collections.

"I was so frustrated," she recalled. "I was just in tears as I was dealing with it."

Ray said it took about seven months of wrangling before her insurance company finally paid the bill and she was able to clean up her credit rating.

"My immediate response was, there does need to be a law to fix this," said Ray. "This is so wrong."

The legislation, by Assemblyman Rob Bonta (D-Oakland) and six colleagues, would limit a patient's financial obligation to no more than what he would have owed if the provider had been in-network.

While agreeing that "patients should never have surprise bills," Dr. Karen Sibert, president-elect of the California Society of Anesthesiologists, said her organization and a number of other specialty medical groups oppose AB-72.

At issue, Sibert said, is the bill's formula for paying doctors who fill the gap left when insurance companies don't have enough providers in their networks. The legislation would set the payment rate at either the amount the insurer normally pays a doctor on contract for such services or 125 percent of the Medicare rate, whichever is greater.

That's insufficient, argued Sibert. "It's a problem because it removes any incentive for insurance companies to reach fair contracts with physicians."

Without such an incentive, she said, insurance companies will continue to have inadequate provider networks.

The powerful California Medical Association agrees with Sibert about the bill's payment formula, but it has shifted its position on AB-72 from opposed to neutral, said Janus Norman, the Association's vice president of governmental affairs.

There are a few reasons for the change of heart, he said. First, the bill would create stricter oversight of how in-patient services are delivered, and it would allow for tougher regulations on insurers if the state finds their provider networks to be inadequate.

The provision regarding tougher regulations, "is one improvement that AB-72 included that prior legislation did not," he said.

In addition, the measure would give out-of-network doctors the chance to appeal payment disputes with insurers through an independent third party, and the decision would be binding, another important change from previous versions of the bill, Norman said.

The California Association of Health Plans and the Association of California Life and Health Insurance Companies don't have a formal position on AB-72, according to an analysis by the Assembly Health Committee. Instead, they have expressed "concerns" about the measure, the committee said.

"While they laud the authors' efforts to protect consumers from balance billing," the analysis said, the insurer groups worry that the legislation might lead to higher premiums and cost-sharing, and that the bill's dispute resolution process might spark more lawsuits between providers and health insurance firms.

Anthony Wright, executive director of Health Access California, a consumer health care advocacy coalition, said Gov. Brown took an interest in the legislation.

"The governor's office did provide input during the negotiation process and we are hopeful that he will sign it," he said.

Consumers Union's Imholz said the California Medical Association's neutral position on the legislation was key in getting AB-72 across the finish line.

She predicts that if Brown signs the measure, a number of other states now considering similar protections against surprise bills will likely follow suit next year.

Geographic, Racial Disparities In Stroke Treatment Tracked In New Study

KFF Health News, September 15, 2016

Researchers found stroke patients living in the Northeast states had more than twice the odds of receiving tPA — a powerful anti-coagulant that can break up the clot causing the stroke — than those living in the Midwest and the South.

This article first appeared September 14, 2016 on Kaiser Health News

By Carmen Heredia Rodriguez

In the United States, one out of every 20 deaths is caused by stroke. And yet, based on new research, race and geography prevent some of the most vulnerable from obtaining effective treatments.

The findings come from a report published Wednesday in the journal Neurology. Researchers found stroke patients living in the Northeast states had more than twice the odds of receiving tPA — a powerful anti-coagulant that can break up the clot causing the stroke — than those living in the Midwest and the South.gracias

The researchers also found race played a role in determining the patients who received treatment. African-Americans who were evaluated for stroke severity were 26 percent less likely to get the medication. Other minorities faced 17 percent higher odds of not securing the drug.

Overall, a quarter of patients eligible for the medication did not receive it.

Researchers analyzed data from nearly 62,000 patients tracked from 2003 to 2011 in a voluntary national hospital database set up by the American Heart Association. The group of patients all experienced ischemic strokes — those caused by blood clots in the brain and not those caused by burst blood vessels — and arrived at a hospital within two hours after their symptoms began. The drug is most effective when used within the first three hours after the onset of symptoms.

Lee Schwamm, vice-chairman of the neurology department at Massachusetts General Hospital and the lead author of the report, said he is not sure why so many people are not given access to tPA. But, he speculates the issue may lie in doctors not recognizing stroke in the first place.

"Some of this may be a failure of recognition rather than a failure to provide treatment to a person who presents these symptoms," he said.

According to the latest data from the Centers for Disease Control and Prevention, stroke is the fifth leading cause of death in the United States. The condition afflicts more than 795,000 people each year and kills nearly 130,000 of them.

African-Americans and Hispanics are more likely to have a stroke and die from the condition than whites.

High blood pressure, cholesterol and smoking raise the risk of having a stroke. And while half of the American population lives with one or more of these risk factors, a CDC survey in 2005 revealed less than 40 percent of respondents could name all of the symptoms of a stroke. Those include sudden numbness, lack of coordination and slurred speech

Mike Wacholder, 74, had a stroke while walking into his office in Troy, New York, four years ago. He first noticed himself leaning to the left as he walked. Although he went to the doctor within four hours of his first symptoms, his physician sent him back to work. He finally received a diagnosis nearly 11 hours later after collapsing and being rushed to the emergency room. While his brain function remains largely intact, the stroke disabled the left side of his body.

Wacholder said his experience taught him stroke patients need to advocate on their own behalf. Many patients are not educated enough about stroke to talk about their care, he said.

"The patient has to be able to express what's on their mind," he said.

Wacholder's long wait before arriving at the hospital eliminated his chance to obtain tPA.

Yet, even those who meet the recommended window of opportunity to obtain treatment fall through the cracks. Patients who arrived at the hospital more than 45 minutes after the onset of their symptoms had a 21 percent higher chance of not receiving tPA. At the hospital, those who waited more than 25 minutes for a CT scan were 41 percent less likely to receive the treatment.

Susan Gaunt, stroke program coordinator and stroke clinical nurse specialist at Gwinnett Medical Center outside of Atlanta, said providers in her facility are frustrated because so few patients arrive at the hospital in time to qualify for tPA.

Less than half of them use an ambulance for transport, she said, which means physicians and nurses must use up some initial care time doing routine medical protocol like placing an IV instead of pinpointing a diagnosis.

"Time is really drained," she said.

Georgia is located in America's "Stroke Belt," the region of the nation where stroke rates are high. According to the Georgia State Department of Health, stroke is the fourth leading cause of death in the state. In 2013 alone, the condition led to 21,000 hospitalizations and more than a billion dollars in medical costs.

Gaunt has worked on community outreach across the Peach State since 2004, educating the public about stroke and its risks.

"We do do a lot of community events," Gaunt said. "But it doesn't seem to be enough."

CDC Deploys New Rapid Response Teams To Fight Zika

KFF Health News, September 14, 2016

CDC Emergency Response Teams bring expanded expertise to contain an outbreak as quickly as possible.

This article first appeared September 14, 2016 on Kaiser Health News

By Virginia Anderson

ATLANTA — It was a call that public health officials were dreading, but for which they had prepared. An elderly man in Salt Lake City died after contracting the Zika virus, the first fatality from the disease in the continental United States. His son, who had been a caregiver, also had become sick, but health officials did not know how.

Dr. Shannon Novosad was on a plane to Utah the next day, one of 10 detectives looking for answers about this case to help other professionals deal with this rapidly growing health problem.

Novosad is a critical care pulmonologist by training, but she is also in a two-year fellowship at the Centers for Disease Control and Prevention's Epidemiological Intelligence Service. Her colleagues in the program include about 80 medical and scientific professionals who study disease prevalence, patterns and control. The group includes dentists, doctors, veterinarians and entomologists.

For many years CDC has sent epidemiologists, or scientists who analyze disease outbreaks and study ways to prevent future ones, to major disease outbreaks. That work continues, said Kristen Nordlund, a communications specialist with the CDC.

But building on its experiences with Ebola in 2014, the agency also has created new rapid response teams, called CDC Emergency Response Teams (CERT), that bring expanded expertise to contain an outbreak as quickly as possible.

The teams include not only epidemiologists but also scientists with backgrounds in a particular disease itself, such as Zika. Entomologists, vector technicians, communications specialists and public health scientists have been part of the Zika teams.

They rush to areas where the disease is reported and help with local efforts to identify other patients and health care workers who may have been in contact with an infected person. They also provide extra hands in the collection and analysis of blood samples. And, in the Salt Lake City case over the summer, two entomologists who are vector-borne disease specialists helped local authorities trap mosquitoes to see if they were transmitting Zika.

These medical SWAT teams have also deployed to Texas and the Miami area. Nearly 800 people have been diagnosed in Florida with Zika, at least 64 of them having been infected locally. The size of the teams varies.

Novosad said that she hopes people know "that we have these mechanisms in place" to send in experts to deal with these outbreaks. "That's why public health is there … and we do have a strong public health workforce."

CDC Plan For Outbreak

Zika, which can be transmitted by mosquito bites, sexual contact or from mother to fetus, typically causes mild symptoms, including a rash, fever, joint pain and bloodshot eyes. It has also in rare cases been associated with Guillain-Barre syndrome, which includes temporary muscle weakness and paralysis.

However, the effect that has brought the greatest concerns involves pregnant women. The infection sometimes causes microencephaly, a birth defect in which a baby's head is unusually small. That can result in developmental delays, intellectual disabilities, problems with balance and with swallowing, according to the CDC.

CDC officials developed a detailed, 57-page plan for handling Zika outbreaks, which called for epidemiologists to study outbreak patterns; doctors to interview and treat health care workers and other who may have been in contact with people who had the disease; entomologists to trap and study mosquitoes in the outbreak area; and communications officers to coordinate getting information out to the public.

The Zika plan drew from lessons in the Ebola outbreak, in which health care workers who contracted that deadly virus at first were not interviewed about their exposure to Ebola and precautions for their health and those of others not taken. That led to sharp criticism of the CDC. The agency broadened its teams of epidemiologists normally sent to investigate disease outbreaks to include other experts, such as the vector-born specialists sent in response to Zika.

Behind the scenes in Miami, the disease detectives are interviewing people, collecting data and trapping mosquitoes, all the while working not only to contain the disease but also to quell growing concerns about its reach, said Nordlund.

"Our teams have been well-received and helped contribute to the response. The states and local health departments have done a lot of work to get prepared for Zika and are putting in tremendous effort in the Zika response," the CDC's director, Dr. Thomas Frieden, said in an email.

The much-publicized logjam in Congress over emergency spending to fight Zika has not hampered the CDC efforts, Frieden said, but he added that a shortage of funding could impair response efforts going forward.

Frieden said money for the teams has come from $222 million in repurposed funds. The administration earlier this year redirected funding for Ebola research and prevention to help pay for its efforts on Zika.

"We're in peak mosquito season right now and if more states see local transmission, CDC's resources will be stretched thin as we help respond in multiple areas," Frieden wrote in the email. "But it's not too late, and we are hopeful that Congress will do the right thing, as they have with Ebola, for example."

An Urgent Call

The call from the Utah Department of Public Health to the CDC came in on July 12. "We were all on a plane July 13," said Novosad. "We took whatever plane that could get us there fastest."

Once there, Novosad said the first job was to identify all health care workers who had come into contact with the patient.

"We started by contacting the employees, and we administered surveys," she said. "I think people were just really interested in helping, given the unusual nature of this outbreak."

The team of epidemiologists talked to family members to see if any others were infected.

A lab team helped make sure all necessary blood samples had been taken and were accounted for. A communications group coordinated information among the teams. Each morning at 6 a.m., the entire crew assembled to talk with experts in Atlanta.

The team issued its report Tuesday. It did not name the man or his son. Although they did not determine how the son became ill, the investigators noted that he had close contact with his father, who had a very high virus level. The son had hugged and kissed his father, as well as assisted medical workers in caring for him. The report noted that health care workers and family members "should be aware that blood and body fluids of severely ill patients might be infectious."

Nordlund said she understands why people become unnerved and impatient when disease outbreaks occur.

People typically do not pay attention to the work of public health agencies when no immediate outbreaks are occurring, she said.

"When public health is doing its job, you don't see it," she said. When a crisis occurs, it's suddenly news, she said.

Health Spending Related To Opioid Treatment Rose More Than 1,300 Percent

KFF Health News, September 13, 2016

On average, insurers spend $3,435 a year on an individual patient, but for those with an opioid dependence or abuse diagnosis, that amount jumps to $19,333. Those numbers reflect what insurers actually paid.

This article first appeared September 12, 2016 on Kaiser Health News

By Julie Appleby

The nation's ongoing opioid problem comes with staggering physical and emotional costs to patients and families. But the dollar cost to the health system has been harder to peg. Now a new report shows a more than 1,300 percent rise in spending by health insurers in a four-year period on patients with a diagnosis of opioid dependence or abuse.

From 2011 to 2015, insurers' payments to hospitals, laboratories, treatment centers and other medical providers for these patients grew from $32 million to $446 million — a 1,375 percent increase.

While that's a small portion of the overall spending on medical care in the United States, the rapid rise is cause for concern, says Robin Gelburd, president of Fair Health, a nonprofit databank that provides cost information to the health industry and consumers.

"That really shows the stress on the health system and the impact on the individuals," said Gelburd.

The Fair Health study found a sharp difference in how much insurers spend on individual patients with such a diagnosis.

On average, insurers spend $3,435 a year on an individual patient, but for those with an opioid dependence or abuse diagnosis, that amount jumps to $19,333. Those numbers reflect what insurers actually paid. The report also includes data on what providers charged, amounts that are lowered by their contracts with insurers.

The study, set to be released Tuesday, builds on one Fair Health released in early August that found a 3,000 percent increase in the volume of insurance claims related to opioid dependence diagnoses between 2007 and 2014.

The latest study — part of a series — offers amounts associated with claims billed by providers and paid by insurers for the types of medical services used.

Both studies use de-identified claims data from insurers representing more than 150 million insured Americans who either have insurance through work or buy coverage on their own.

There have been other efforts by several researchers to quantify the cost of the opioid problem on the overall economy, estimated in the tens of billions of dollars. The new report adds to the available data "that it's not just the human cost associated with the opioid crisis that is enormous, but also that the economic costs are staggering," said Dr. Andrew Kolodny, senior scientist at Brandeis University. He did not work on the study.

The surge in spending on patients with opioid diagnoses is likely a combination of factors, the report notes. As media attention focuses on drug dependency, more people may be seeking treatment. At the same time, prescription and illegal use of narcotics may also be increasing.

The study found that emergency room visits and laboratory tests accounted for much of the spending.

Based on claims volume, the fastest-growing set of services in terms of utilization were for alcohol or drug therapy. Lab tests, including checks for barbiturate or opioid use, were not far behind.

Researchers did not use 2015 data for lab test costs, noting that a change in billing codes was made that increased the number of categories — and, in some cases, appear to generate higher payments by insurers. It is too early to estimate the long-term effects of the change, Gelburd said.

The report gives some examples of the changes, however. For example, one billing code for a test on opiate use commonly brought in a $31 payment from insurers prior to the change. The two billing codes that replaced it now are commonly paid at $78 and $156.

The new billing codes may reflect new technology in testing, said Gelburd. She said some observers speculate that the rapid increase in lab spending might reflect that, with more patients in therapy, the tests are being used to ensure they are taking their proper medications and not abusing narcotics.

But the spending might also reflect a growing use of very expensive urine and blood tests when less expensive ones would be sufficient, said Kolodny.

"I worry about profiteering," said Kolodny. "We do need tests, but not the expensive ones. A lot of clinics are making extra money off these lab tests."

The overall increase in spending across all types of medical services "is a societal issue," said Gelburd, who says policymakers need to ensure that changes are made to address the problem.

"Are medical school curricula adjusting to recognize the growing need for these services? Are insurers increasing the number of providers in their networks to ensure sufficient access? Are consumers being educated? It's an issue that has to be dealt with in all quadrants."

Lack Of Medicaid Expansion Hurts Rural Hospitals More Than Urban Facilities

KFF Health News, September 8, 2016

Rural hospitals have long argued they were hurt by the lack of Medicaid expansion, A study published in Health Affairs suggests they have a point.

This article first appeared September 7, 2016 on Kaiser Health News

By Shefali Luthra

It isn't news that in rural parts of the country, people have a harder time accessing good health care. But new evidence suggests opposition to a key part of the 2010 health overhaul could be adding to the gap.

The finding comes from a study published Wednesday in the journal Health Affairs, which analyzes how the states' decisions on implementing the federal health law's expansion of Medicaid, a federal-state insurance program for low-income people, may be influencing rural hospitals' financial stability. Nineteen states opted not to join the expansion.

Rural hospitals have long argued they were hurt by the lack of Medicaid expansion, which leaves many of their patients without insurance coverage and strains the hospitals' ability to better serve the public. The study suggests they have a point.

Specifically, the researchers, from the University of North Carolina Chapel Hill, found that rural hospitals saw an improved chance of turning a profit if they were in a state that expanded Medicaid — while in city-based hospitals, there was no improvement to overall profitability. Across the board, hospitals earned more if they were in a state where more people had coverage and saw declines in the level of uncompensated care they gave.

To put it another way: All hospitals generally fared better under the larger Medicaid program, but there's more at stake for rural hospitals when the state expands coverage.

The study looked at how expanding Medicaid affected hospital revenue, how many Medicaid patients they discharged, levels of uncompensated care the hospitals provided and how well the institutions did financially overall. It compared those effects in rural versus urban areas, across more than 14,000 annual cost reports from hospitals between January 2011 and December 2014, or a year after eligible states could have expanded their Medicaid programs.

In states expanding Medicaid, rural hospitals saw a greater increase in Medicaid revenue than urban hospitals did. City-based facilities save a higher percentage than rural hospitals with the reduction in uncompensated care, though that change "did not translate into improved operating margins for urban hospitals," the study notes.

How much these differences matter, though, remains up in the air.

"There is a disparity in the impact of Medicaid expansion, and probably the [law] overall," said Brystana Kaufman, a doctoral candidate at the university's department of health policy and management and the study's first author. "There needs to be more exploration into why we're seeing this."

One likely factor: Rural hospitals serve more low-income people — who weren't eligible for insurance before, but who got covered after the health law took effect. And rural hospitals are historically more likely to operate at a loss than are urban ones. So the chance to see increased revenue is greater than in a city-based hospital.

That said, these are preliminary figures, looking at barely a year's worth of evidence when it comes to the Medicaid expansion. But the effect merits further scrutiny, experts said.

It's important because hospital finances matter for consumers, too. In rural communities, hospitals are often among the largest employers, and the main source of health care. Financial duress can affect what kind of services the facility offers.

"If you're [a hospital] in a state that did expand Medicaid, obviously you're going to be experiencing lower amounts of uninsured. Your bad debts and charity care have gone down," said Brock Slabach, senior vice president at the National Rural Health Association. He was not involved in the study, although he is familiar with the research team's work. "Has [that expense] gone to nothing? No. But it has helped."

That's especially true for rural hospitals, Kaufman said, because they have narrower profit margins than do urban ones. Any squeeze on the budget "is going to be more influential" and may limit a hospital's offerings or quality.

Hospitals are "still really trying to anticipate and assess the shakeout from all the changes that are happening," said Kristin Reiter, an associate professor at UNC-Chapel Hill's Department of Health Policy and Management and another study author.

Meanwhile, rural hospitals are already facing financial strains, Slabach said. More than 70 have shut down since 2010. Still more are at risk of closure. Many endangered hospitals are in non-expansion states.

How Medicaid affects rural and urban hospitals could influence other debates, the study authors said. For instance, the health law also is expected to cut so-called disproportionate health spending payments – cash infusions that support hospitals that treat low-income people, often in rural areas.

Those cuts haven't taken effect yet, but the researchers suggest, the paper could make a case for indefinitely postponing them.

"The hospitals rely on that funding to address uncompensated care," Kaufman said. In rural states that declined the expansion, uncompensated medical treatment poses a significant financial hurdle for hospitals.

But others cautioned against drawing hard conclusions yet. It's unclear how meaningful the rural-urban difference will be, especially over time, said Doug Staiger, a professor of economics at Dartmouth who has researched rural health access but was not involved with this study.

"I'd be really cautious interpreting," he said.

Plus, Slabach added, researchers must examine how the findings actually affect consumers.

And, it's possible the effects seen here aren't just thanks to Medicaid, said George "Mark" Holmes, an associate professor at UNC and director of the university's North Carolina Rural Health Research and Policy Analysis Program. Expansion states may have taken other steps meant to help hospitals and consumers. If so, it's worth figuring out what those are.

"Medicaid expansion is not a random event. That's very important to consider here," said Holmes, another author of the study. "These are states that have decided to do it. There could be other elements" at play.

Getting Doctor Lists Right

KFF Health News, September 6, 2016

Under a new California law, insurance companies — and health care providers — must comply with requirements to keep physician directories updated at least every quarter.

This article first appeared September 6, 2016 on Kaiser Health News

By Emily Bazar

SACRAMENTO, Calif. — State Sen. Ed Hernandez and his wife, Diane, are optometrists.

Diane handles some insurance matters for their practice, and she recently told him that a health plan had emailed to request more information: It wanted confirmation that they were both participating providers, he says.

"I didn't say anything because I was afraid she'd be mad at me," says Hernandez, D-West Covina.

That's because the additional paperwork was probably his doing.

Hernandez, who chairs the California Senate Health Committee, is author of a newly enacted state law that aims to improve provider directories, long riddled with out-of-date and inaccurate information.

Under the law, insurance companies — and health care providers like the Hernandezes — must comply with new requirements to keep directories updated at least every quarter.

The law, which took effect July 1, also provides patients with some firepower to fight surprise medical bills that result from directory errors.

The law's reach is broad: It applies to Covered California and private market plans, as well as Medi-Cal managed care and most job-based insurance policies.

The inaccuracy of directories, Hernandez says, "has been and … seems to continue to be a problem that needs to be rectified."

Several other states, from Georgia to Maryland, have passed similar legislation or are considering doing so, says Claire McAndrew, private insurance program director for Families USA, a national health care consumer advocacy group. In some states, insurance commissioners have adopted new rules through the regulatory process.

But California's law "is the most comprehensive," she says. "The level of detail in California goes beyond any other state." Federal officials also instituted a rule this year requiring directories be updated monthly for all plans sold on the 37 state marketplaces run by the federal government.

And they set new rules for Medicare Advantage plans, requiring that the companies contact doctors every three months and update their online directories within 30 days. A recent study in the journal Health Affairs found that provider directories for some health plans sold through Covered California and in the private market are so inaccurate that they create a "disheartening" situation for consumers trying to find doctors.

That finding was confirmed this month when the state Department of Managed Health Care (DMHC) announced that Anthem Blue Cross and Blue Shield of California — which were previously fined for inaccuracies in their Covered California provider directories — still had "disappointing" directory problems.

"We are optimistic and hopeful that the law … will help," says department director Shelley Rouillard.

Among the law's new rules:

Health plans must update their printed directories at least every quarter and their online directories at least every week if providers report changes.
Provider directories must be posted online and be available to anyone, not just enrollees. Print directories must be available upon request.
The directories must "prominently" display directions for consumers who want to report inaccuracies. Upon receiving complaints, plans have 30 business days to makes changes, if necessary.
Providers must inform plans within five business days if they are no longer accepting new patients — or, alternately, if they will start accepting them.
Health plans can delay payments to providers who fail to respond to attempts to verify information.

The California law also gives consumers recourse. Let's say you use a provider directory to find a doctor but you're billed the out-of-network price because the directory was wrong. In that case, health plans must reimburse you the amount beyond what you would have paid to see an in-network doctor.

If you find yourself in this situation, first take your complaint to your plan, advises DMHC's Rouillard. You will have at least 180 days from the date you received the bill to file a grievance.

"You'll probably have to make a case" to the plan, Rouillard says. "You should explain what you did, when you looked at the directory, and that you relied on that information."

Documentation could help your case.

That's something to consider when you're searching for a provider in the first place. It wouldn't hurt to save a screen shot from the online directory showing the doctor is in-network, or take detailed notes if you call your plan's customer service line.

"Keep copies of everything, and note the date, time and name of anyone you speak to," says Nancy Kincaid, spokeswoman for the state Department of Insurance.

Plans have 30 days to investigate and respond to your complaint. If the situation isn't resolved to your satisfaction, your next step is to take your grievance to your health plan's regulator.

Since the law went into effect, the DMHC has helped one consumer get reimbursed as a result of this law.

But, "I'm hoping consumers don't have to go through process. I'm hoping the directories are accurate," Hernandez says.

It might take time to get there, as health plans implement the new requirements — as well as others that will take effect in the coming months — and work with providers to update the information.

"This is so early and there are so many errors," Rouillard says.

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