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Updated: 22 hours 21 min ago

Postcard From Capitol Hill: Lawmakers Put Women’s Health Care In Its Place

July 19, 2017

The atmosphere at a House Appropriations Committee lunch meeting on women’s health midday Wednesday was predictably charged.

The Trump administration has proposed to defund Planned Parenthood and make severe cuts in other women’s health programs, such as Title X, a 40-year-old program that provides grants for family planning, and grants for teen pregnancy prevention.

Much of the male-dominated debate — over chili dogs and orange juice — was nominally about where women prefer to seek health care. But the central character was abortion.

Democratic representatives introduced several amendments related to women’s health, including one restoring teen pregnancy prevention grants and another striking language that would allow employers to exclude certain procedures from their health plans if they found them morally objectionable. All of the amendments failed in the Republican-controlled body.

Use Our ContentThis KHN story can be republished for free (details).

“No taxpayer dollars should be used to fund abortion, and I’ll fight any effort to dilute or get around that,” declared Rep. Martha Roby (R-Ala.), who prefaced her comments by calling herself “proudly pro-life.”

Federal funds are already prohibited for abortions under the Hyde Amendment, passed in 1976.

So the question of where women should be able to obtain health care has become an odd proxy for the abortion issue. According to Planned Parenthood, 60 percent of women who use their clinics consider it their main source for medical attention.

“We see community health centers as a more appropriate provider, and those are funded in the bill,” said Rep. Tom Cole (R-Okla.).

Rep. Evan Jenkins (R-W.Va.) agreed, saying women in his state — home to only one Planned Parenthood clinic — prefer to get their care at community health centers. “When we have an opportunity to defund Planned Parenthood and invest in community health centers, that’s good for West Virginia,” Jenkins said.

But money saved by defunding Planned Parenthood isn’t slated for community health centers, whose funding isn’t changing under the Trump administration’s proposed budget.

Rep. Barbara Lee (D-Calif.) pointed out: “We may disagree in terms of a woman’s right to choose abortions, but I hope we can agree that women should be able to make their own health care decisions.”

Fraud And Billing Mistakes Cost Medicare — And Taxpayers — Tens Of Billions Last Year

July 19, 2017

Federal health officials made more than $16 billion in improper payments to private Medicare Advantage health plans last year and need to crack down on billing errors by the insurers, a top congressional auditor testified Wednesday.

James Cosgrove, who directs health care reviews for the Government Accountability Office, told the House Ways and Means oversight subcommittee that the Medicare Advantage improper payment rate was 10 percent in 2016, which comes to $16.2 billion.

Adding in the overpayments for standard Medicare programs, the tally for last year approached $60 billion — which is almost twice as much as the National Institutes of Health spends on medical research each year.

“Fundamental changes are necessary” to improve how the federal Centers for Medicare and Medicaid Services ferrets out billing mistakes and recoups overpayments from health insurers, he said.

Medicare serves about 56 million people, both those 65 and older and disabled people of any age. About 19 million have chosen to enroll in Medicare Advantage plans as an alternative to standard Medicare.

Federal officials predict the Medicare Advantage option will grow further as massive numbers of baby boomers retire in coming years.

Standard Medicare has a similar problem making accurate payments to doctors, hospitals and other health care providers, according to statistics presented at the hearing. Standard Medicare’s payment error rate was cited at 11 percent, or $41 billion for 2016.

Use Our ContentThis KHN story can be republished for free (details).

Last week, Attorney General Jeff Sessions announced the arrest of 412 people, some 100 doctors among them, in a scattershot of health care fraud schemes that allegedly ripped off the government for about $1.3 billion, mostly from Medicare.

CMS official Jonathan Morse said that the “largest contributors” to billing mistakes in standard Medicare were claims from home health care and inpatient rehabilitation facilities.

Some lawmakers appeared frustrated that CMS cannot say for sure how much of the “improper payments” in both Medicare options are caused by fraud. The agency uses the term broadly to cover billing fraud, waste and abuse, as well as simply overcharges and underpayments.

“When trying to understand how much fraud is in Medicare, the answer is simply we don’t know,” subcommittee Chairman Vern Buchanan (R-Fla.) said.

Yet he added that “it doesn’t take a big percentage [of fraud] to get a giant number” of dollars.

CMS official Morse did little to clear up any confusion over billing mistakes. In his written testimony, he said that improper payments are “most often payments for which there is no or insufficient supporting documentation to determine whether the service … was medically necessary.”

In his testimony, GAO official Cosgrove focused on the Medicare Advantage program. He took aim at a little-known government audit process called Risk Adjustment Data Validation, or RADV. These audits require health plans to submit a sample of patient records for review.

Cosgrove said that the RADV audits take too long to complete and failed to focus on health plans with the greatest potential for recovery of overcharges. He also said that CMS officials had not done enough to make sure the payment data they use are accurate. As a result, “the soundness of billions of dollars in Medicare expenditures remains unsubstantiated,” according to written testimony.

The GAO, the watchdog arm of Congress, has previously criticized CMS for its failure to ferret out overcharges in Medicare Advantage. In an April report, GAO found that CMS has spent about $117 million on the Medicare Advantage audits since 2010 but recouped just under $14 million in total.

Payment errors and overcharges by Medicare Advantage plans were the subject of a lengthy investigation by Kaiser Health News and the Center for Public Integrity. Federal officials have struggled for years to weed out billing irregularities by Medicare Advantage plans, according to CMS records obtained through a Freedom of Information Act lawsuit filed by the Center for Public Integrity.

The investigation found that Medicare Advantage payment errors result mostly from flaws in a billing formula called a risk score. Congress expected risk scores would pay higher amounts for sicker patients and less for people in good health when it began phasing in the billing scales in 2004.

But since then, a wide range of CMS audits and other reviews have found that Medicare wastes billions of tax dollars annually because some health plans inflate risk scores by exaggerating how sick their patients are. One CMS memo made public through the FOIA lawsuit referred to risk-based payments as essentially an “honor system,” with few audits to curtail fraud and abuse.

Even when RADV audits have detected widespread overpayments, CMS officials have failed to recoup money after years of haggling with the health plans.

In January, Kaiser Health News reported that Medicare had potentially overpaid five Medicare Advantage health plans by $128 million in 2007, but under pressure from the insurance industry collected just $3.4 million and settled the cases.

Morse testified on Wednesday that CMS is still in the process of completing appeals of RADV audits from 2007. He said that payment errors have been calculated for 2011 and that reviews for 2012 and 2013 were underway.

These results are years behind schedule, according to CMS documents, which show the results were expected in early 2014. In the past, officials have said that they expected to collect as much as $370 million from the 2011 audits.

Morse said on Wednesday he didn’t know when the 2011 audit results would be released. “Hopefully soon,” he said after the hearing. “I actually don’t know.”

KHN’s coverage related to aging & improving care of older adults is supported by The John A. Hartford Foundation.

Latinos Left Out Of Clinical Trials … And Possible Cures

July 19, 2017

Two decades ago, Luis Antonio Cabrera received devastating news: He likely had only three months to live.

The Puerto Rican truck driver, then 50, had attributed his growing leg pain to spending so many hours on the road. The real culprit was a malignant tumor in his left kidney that was pressing on nerves from his lower spine.

His initial treatment involved removing the organ, a complex surgery that, by itself, proved insufficient, as the cancerous cells had already spread to his lungs. Therefore, his primary care physician in Puerto Rico contacted doctors at the National Institutes of Health (NIH), in Bethesda, Md., and managed to enroll Cabrera in a medical study to test an innovative therapy: transplanting blood stem cells to destroy the cancer cells.

Today, at 70, Cabrera, a father of five and grandparent who moved to West Virginia with his wife to be closer to NIH, feels strong and healthy. “I come to do tests every six months — I’m like a patient at large,” he said.

This KHN story also ran in USA Today. It can be republished for free (details).

However, Cabrera is one of a relatively small number of Hispanics who participate in clinical trials. “Only less than 8 percent of enrollees are Hispanic, even though Hispanics comprise 17 percent of the population,” said Dr. Eliseo Pérez-Stable, director of NIH’s National Institute on Minority Health and Health Disparities.

That means not only do Hispanics have less access to experimental cutting-edge treatments but researchers have less data on how a drug works in that population. Studies have shown that different ethnic groups might respond differently to treatments. The lack of patients from minority groups is an endemic problem in clinical trials; minorities typically are represented at a very low rate.

“Studies should represent the demographics of the country,” said Dr. Jonca Bull, an assistant commissioner on minority health at the Food and Drug Administration. “We need to close that gap so we can better understand how a particular drug or therapy works in different communities.”

Two Pioneering Initiatives

One of the few studies focused 100 percent on the Hispanic community has been the The Hispanic Community Health Study of Latinos, led by the National Heart, Lung and Blood Institute. This study has been analyzing a group of more than 16,000 Hispanics of different backgrounds in five cities since 2006, helping researchers learn more about the incidence of conditions such as diabetes, cholesterol, smoking and depression within the community.

In addition, an NIH-led initiative of the 21st Century Cures Act, a law in force since December, is compiling a database of about 1 million potential volunteers for medical studies, with a goal of including thousands of Hispanics.

There are many reasons why Latinos do not enroll in these studies, Perez-Stable said: lack of information, disparities in access to health care and not being fluent in English are among main factors. Dr. Otis Brawley, chief medical officer with the American Cancer Society (ACS), said Latino families are open to participating in clinical trials, especially to help treat a sick son or daughter, but they need advice from a doctor to navigate the process.

Federal officials aim to augment these numbers. In March, the FDA launched a campaign to educate Hispanics about medical studies. “Primary care physicians have to be the champions. … In addition, the community health centers can help, because they are places of care that people trust,” said Bull.

As of July 5, there were 94,545 ongoing clinical trials in the United States, according to the NIH’s official website, clinicaltrials.gov. As in Cabrera’s case, the primary physician usually helps a patient find a medical study, although the advent of the internet in recent decades has meant a growing number of patients discover trials themselves online. To participate, the person must meet the researchers’ criteria for eligibility: age, gender or condition. Often, the center conducting the study covers related costs of drugs, treatments and tests.

For Brenda Aldana, receiving care at Holy Cross Hospital in Silver Spring, Md., made all the difference.

Luis Antonio Cabrera, 70, during his appointment at the NIH Clinical Center in Bethesda, Md., in June.
Two decades ago, he was told he likely had only three months to live, due to a kidney cancer. He
was enrolled in a clinical trial that saved his life. (Paula Andalo/KHN)

Aldana, 34, arrived in the United States from Zacatecoluca, El Salvador, nine years ago. During her first year in the U.S., she began to feel tired and her hair began to fall out. She initially thought those were symptoms of the stress of starting a new life in a new country, but while visiting her sister in Frederick, Md., Aldana fainted. It turned out she was suffering more than nerves: She had a pulmonary embolism. Within two weeks of tests, she was diagnosed with lupus, a debilitating chronic condition with a high incidence among Latinas.

Resources

Those interviewed agreed that Latinos should ask their doctors if a condition or illness experienced by themselves or a loved one could make them eligible for a medical study. “Do not be afraid,” said Luis Antonio Cabrera, a patient who felt lucky to participate in a clinical trial. “Even if you do not speak English, there are interpreters who will help.”

Among websites to search for information about clinical studies:

“At Holy Cross, the doctors told me that they were going to help me get into a medical program for a medication to treat arthritis [caused by her lupus],” said Aldana, who has three children, ages 17, 6 and 5.

Aldana travels from Olney, Md., to the NIH Clinical Center once a month to receive intravenous medication.

These days, “Hispanics receive less quality medical care, so it’s important for them to be more involved in clinical trials,” said Brawley, noting that enrolling in a clinical trial gives patients access to a high-quality physician they might not otherwise see.

“In a medical study, instead of having the opinion of a single doctor, you’ll get the opinion of a group of highly qualified doctors who can say, ‘This is good for people like you,'” Brawley said. The American Cancer Society has an information service to help patients find clinical trials that match their medical condition. This service is also available in Spanish.

John Vasquez, 21, of San Antonio, Texas, needed only internet access and a cellphone to find the medical study that could change his life. In September 2015, while on his way to his brother’s football game, he lost feeling in his leg, arm and right part of his face. “I thought I was having a stroke,” he said.

He had aplastic anemia, a potentially deadly rare blood disorder that was destroying his red and white cells, and platelets, which aid the body’s clotting mechanism.

In a Facebook group for people with severe blood conditions, he was advised to contact the NIH, which sent him a kit for blood tests. After analyzing his clinical history, they told him he was eligible to participate in a medical study, which opened the gates to an innovative transplant that could change the course of his disease. Temporarily living with a sister in Maryland, he is scheduled for a bone marrow transplant on Aug. 1. His donor: his 14-year-old brother.

Congress Squares Off Over Drug Pricing And A Controversial Drug Discount Program

July 18, 2017

House Democrats are calling foul on Republican assertions that cuts to a little-known discount drug program will eventually reduce skyrocketing drug prices.

At a hearing Tuesday, Rep. Diana DeGette (D-Colo.) said high drug prices should be investigated separately from the focus on oversight of the drug discount program, known as 340B.

“I think we need an investigation, a robust investigation, and a series of hearings that explore in-depth the reasons for exorbitant cost of drugs and why the prices continue to rise,” DeGette said.

Use Our ContentThis KHN story can be republished for free (details).

Last week, Health and Human Services Secretary Tom Price proposed steep cuts in what Medicare reimburses some hospitals for outpatient drugs under the 340B program. In a release, Price said such cuts would be “a significant step toward fulfilling President [Donald] Trump’s promise to address rising drug prices.”

DeGette countered Tuesday that the proposal “would do nothing” to address high drug prices and said making that connection “seems more like fantasy than reality.”

Also on Tuesday, there were other hints at Trump Administration efforts to address drug pricing. Food and Drug Administration Commissioner Scott Gottlieb talked in a public meeting about lowering drug prices on a different front — saying that the agency needs to increase generic drug competition.

Trump routinely criticized high drug prices on the campaign trail last year and promised to take action during his presidency. In June, a leaked draft of an executive order on drug prices, first reported by The New York Times, spoke of facilitating more drug competition but also targeted the 340B program. That strategy immediately drew criticism from Sen. Al Franken (D-Minn.), who said scaling back the program would drive up what hospital patients pay for drugs and force Americans “to choose between health and other basic life necessities, like putting food on the table and a roof overhead for the family.”

The federal 340B program requires pharmaceutical manufacturers to provide outpatient drugs at a significant discount to hospitals and clinics that serve a largely low-income population.

After buying the discounted drugs, the hospitals and clinics can bill Medicare or other insurers at their regular rate, pocketing the difference.

About 40 percent of hospitals nationwide participate in the program and, as House members pointed out Tuesday, the program has grown dramatically in recent years to become a significant force in the pharmaceutical marketplace. The Medicare Payment Advisory Commission estimated that hospitals and other participating entities spent more than $7 billion to buy 340B drugs in 2013, three times the amount spent in 2005.

Advocates of the program say the discounts — and the money hospitals make on payments from Medicare — are necessary to combat skyrocketing drug prices.

But federal reports in recent years from the Medicare advisory board, as well as the Government Accountability Office and the Office of Inspector General, have raised concerns about oversight and abuse of the 340B program.

Rep. Joe Barton (R-Texas) noted “this is a difficult hearing” because while the program was created with good intent, its complexity makes it challenging to understand. For example, hospitals and clinics aren’t required to pass any discounts they receive on to patients — they can direct the money to their general fund.

Looking at his colleagues, Barton said: “We all support the program but it has grown topsy-turvy. We need to put the best minds on this.”

Republican lawmakers are not the only ones raising concerns about 340B oversight. The Pharmaceutical Research and Manufacturers of America, which represents drugmakers, advocates ensuring hospitals are “good stewards” of the money they gain from the program’s discounts.

Peggy Tighe, who represents hospitals in the 340B program as a principal at the D.C. law firm Powers, said “PhRMA has done a particularly good job of getting the attention of the administration …. They haven’t let up on 340B.”

The rule that Price proposed last week would cut what hospitals are paid for drugs from the Medicare Part B program, which covers outpatient drugs including those delivered through infusion.

Currently, Medicare pays hospitals an average sales price plus 6 percent for most of the Part B drugs they purchase. The administration’s proposal is to cut that to average sales price minus 22.5 percent.

340B Health, a coalition that represents hospitals, immediately responded to the proposal saying the cuts would be “devastating” to hospitals and would “lead to cuts in patient services.”

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

Calif. Hits Nerve By Singling Out Cardiac Surgeons With Higher Patient Death Rates

July 17, 2017

Michael Koumjian, a heart surgeon for nearly three decades, said he considered treating the sickest patients a badge of honor. The San Diego doctor was frequently called upon to operate on those who had multiple illnesses or who’d undergone CPR before arriving at the hospital.

Recently, however, Koumjian received some unwelcome recognition: He was identified in a public database of California heart surgeons as one of seven with a higher-than-average death rate for patients who underwent a common bypass procedure.

“If you are willing to give people a shot and their only chance is surgery, then you are going to have more deaths and be criticized,” said Koumjian, whose risk-adjusted death rate was 7.5 per 100 surgeries in 2014-15. “The surgeons that worry about their stats just don’t take those cases.”

Now, Koumjian said he is reconsidering taking such complicated cases because he can’t afford to continue being labeled a “bad surgeon.”

This story also ran in the Los Angeles Times. It can be republished for free (details).

California is one of a handful of states — including New York, Pennsylvania and New Jersey — that publicly reports surgeons’ names and risk-adjusted death rates on a procedure known as the “isolated coronary artery bypass graft.” The practice is controversial: Proponents argue transparency improves quality and informs consumers. Critics say it deters surgeons from accepting complex cases and can unfairly tarnish doctors’ records.

“This is a hotly debated issue,” said Ralph Brindis, a cardiologist and professor at UC-San Francisco who chairs the advisory panel for the state report. “But to me, the pros of public reporting outweigh the negatives. I think consumers deserve to have a right to that information.”

Prompted by a state law, the Office of Statewide Health Planning and Development began issuing the reports in 2003 and produces them every two years. Outcomes from the bypass procedure had long been used as one of several measures of hospital quality. But that marked the first time physician names were attached — and the bypass is still the only procedure for which such physician-specific reports are released publicly in California.

California’s law was sponsored by consumer advocates, who argued that publicly listing the names of outlier surgeons in New York had appeared to bring about a significant drop in death rates from the bypass procedure. State officials say it has worked here as well: The rate declined from 2.91 to 1.97 deaths per 100 surgeries from 2003 to 2014.

“Providing the results back to the surgeons, facilities and the public overall results in higher quality performance for everybody,” said Holly Hoegh, manager of the clinical data unit at the state’s health planning and development office.

Since the state began issuing the reports, the number of surgeons with significantly higher death rates than the state average has ranged from six to 12, and none has made the list twice. The most recent report, released in May, is based on surgeries performed in 2013 and 2014.

In this year’s report, the seven surgeons with above-average death rates — out of 271 surgeons listed — include several veterans in the field. Among them were Daniel Pellegrini, chief of inpatient quality at Kaiser Permanente San Francisco and John M. Robertson, director of thoracic and cardiovascular surgery at Providence Saint John’s Health Center in Santa Monica. Most defended their records, arguing that some of the deaths shouldn’t have been counted or that the death rates didn’t represent the totality of their careers. (Kaiser Health News, which produces California Healthline, is not affiliated with Kaiser Permanente.)

“For the lion’s share of my career, my numbers were good and I’m very proud of them,” said Pellegrini. “I don’t think this is reflective of my work overall. I do think that’s reflective that I was willing to take on tough cases.”

During the two years covered in the report, Pellegrini performed 69 surgeries and four patients died. That brought his risk-adjusted rate to 11.48 deaths per 100, above the state average of 2.13 per 100 in that period.

Pellegrini said he supports public reporting, but he argues the calculations don’t fully take the varying complexity of the cases into account and that a couple of bad outcomes can skew the rates.

Robertson said in a written statement that he had three very “complex and challenging” cases involving patients who came to the hospital with “extraordinary complications and additional unrelated conditions.” They were among five deaths out of 71 patients during the reporting period, giving him an adjusted rate of 9.75 per 100 surgeries.

“While I appreciate independent oversight, it’s important for consumers to realize that two years of data do not illustrate overall results,” Robertson said. “Every single patient is different.”

The rates are calculated based on a nationally recognized method that includes deaths occurring during hospitalization, regardless of how long the stay, or anytime within 30 days after the surgery, regardless of the venue. All licensed hospitals must report the data to the state.

State officials said that providing surgeons’ names can help consumers make choices about who they want to operate on them, assuming it’s not an emergency.

“It is important for patients to be involved in their own health care, and we are trying to work more and more on getting this information in an easy-to-use format for the man on the street,” said Hoegh, of the state’s health planning and development office.

No minimum number of surgeries is needed to calculate a rate, but the results must be statistically significant and are risk-adjusted to account for varying levels of illness or frailty among patients, Hoegh said.

She acknowledged that “a risk model can never capture all the risk” and said her office is always trying to improve its approach.

Surgeons sometimes file appeals — arguing, for example, that the risk was improperly calculated or that the death was unrelated to the surgery. The appeals can result in adjustments to a rate, Hoegh said.

Despite the controversy it generates, the public reporting is supported by the California Society of Thoracic Surgeons, the professional association representing the surgeons. No one wants to be on the list, but “transparency is always a good thing,” said Junaid Khan, president of the society and director of cardiovascular surgery at Alta Bates Summit Medical Center in the Bay Area.

“The purpose of the list is not to be punitive,” said Khan. “It’s not to embarrass anybody. It is to help improve quality.”

Khan added that he believes outcomes of other heart procedures, such as angioplasty, should also be publicly reported.

Consumers Union, which sponsored the bill that led to the cardiac surgeon reports, supports expanding doctor-specific reporting to include a variety of other procedures — for example, birth outcomes, which could be valuable for expectant parents as they look for a doctor.

“Consumers are really hungry for physician-specific information,” said Betsy Imholz, the advocacy group’s special projects director. And, she added, “care that people receive actually improves once the data is made public.”

But efforts to expand reporting by name are likely to hit opposition. Officials in Massachusetts, who had been reporting bypass outcomes for individual doctors, stopped doing it in 2013. Surgeons supported reporting to improve outcomes, but they were concerned that they were being identified publicly as outliers when they really were just taking on difficult cases, said Daniel Engelman, president of the Massachusetts Society of Thoracic Surgeons.

“Cardiac surgeons said, ‘Enough is enough. We can’t risk being in the papers as outliers,’” Engelman said.

Engelman said the surgeons cited research from New York showing that public reporting may have led surgeons to turn away high-risk patients. Hoegh said research has not uncovered any such evidence in California.

In addition to Koumjian, Robertson and Pellegrini, the physicians in California with higher-than-average rates were Philip Faraci, Eli R. Capouya, Alexander R. Marmureanu, Yousef M. Odeh. Capouya declined to comment.

Faraci, 75, said his rate (8.34 per 100) was based on four deaths out of 33 surgeries, not enough to calculate death rates, he said. Faraci, who is semi-retired, said he wasn’t too worried about the rating, though. “I have been in practice for over 30 years and I have never been published as a below-average surgeon before,” he said.

Odeh, 45, performed 10 surgeries and had two deaths while at Presbyterian Intercommunity Hospital in Whittier, resulting in a mortality rate of 26.17 per 100. “It was my first job out of residency, and I didn’t have much guidance,” Odeh said. “That’s a recipe for disaster.”

Odeh said those two years don’t reflect his skills as a surgeon, adding that he has done hundreds of surgeries since then without incident.

Marmureanu, who operates at several Los Angeles-area hospitals, had a mortality rate of 18.04 based on three deaths among 22 cases. “I do the most complicated cases in town,” he said, adding that one of the patients died later after being hit by a car.

“Hospital patients don’t care” about the report. he said. “Nobody pays attention to this data other than journalists.”

KHN’s coverage in California is funded in part by Blue Shield of California Foundation.

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