CA Bill Addresses Safety Concerns At Dialysis Clinics

KFF Health News, May 19, 2017

The California bill, SB 349, says that inadequate staffing is leading to hospitalizations, medical errors and “unnecessary and avoidable deaths.”

This article first appeared May 19, 2017 on Kaiser Health News.

By Anna Gorman

Saying they are concerned about safety in California’s dialysis clinics, a coalition of nurses, technicians, patients and union representatives is backing legislation that would require more staffing and oversight.

The bill, introduced by Sen. Ricardo Lara (D-Bell Gardens), would establish minimum staffing ratios, mandate a longer transition time between appointments and require annual inspections of the state’s 562 licensed dialysis clinics.

More than 63,000 Californians receive hemodialysis, which filters impurities from the blood of those with end-stage kidney disease. Demand for the procedure is growing statewide and nationwide as the population ages and more people suffer from chronic conditions that can lead to kidney failure, such as diabetes, hypertension and heart disease.

If the legislation passes, California would join several other states that have imposed minimum ratios for dialysis centers, including Utah, South Carolina and New Jersey.

The California bill, SB 349, says that inadequate staffing is leading to hospitalizations, medical errors and “unnecessary and avoidable deaths.”

In one case, three patients contracted an infection at a dialysis clinic in Los Angeles County after workers failed to clean and disinfect the machines properly, according to a report in the American Journal of Infection Control.

Patients undergoing dialysis are at risk for low blood pressure, fluid buildup or infections.

Problems can be overlooked if nurses don’t have enough time to devote to their patients and to transition between patients, said Megallan Handford, a registered nurse at a dialysis clinic in Fontana who helped draft the bill. Handford said nurses and technicians often have too many patients at once, making it difficult to ensure they are getting safe care. In some cases, patients left dialysis before they were ready, only to die in their cars, he said.

“We deal with short staffing day in and day out. … Enough is enough,” Handford said during a briefing at the offices of Service Employees International Union-United Healthcare Workers West (SEIU-UHW), which is sponsoring the bill and hopes to unionize dialysis workers. “We’re gonna do what it takes to change this industry.”

Lara agreed, saying oversight of the state’s growing dialysis business is overdue. “We need to keep a closer eye on the dialysis industry,” Lara said in an email.

Dialysis clinics in the state argue that the industry is already well-regulated and the bill would add unnecessary requirements.

Clinics already have a difficult time hiring enough workers and would need even more to satisfy the proposed staff-to-patient ratios, said Kristi Foy, assistant director of the California Dialysis Council, the statewide association of clinics. Besides, she said, there is no evidence that mandated ratios improve quality or patient satisfaction.

Foy added that while there have been “isolated problems,” California is outperforming other states in quality and patient satisfaction. She said a larger percentage of California clinics have high ratings from the federal government, based on factors such as complications, mortality rates and hospitalizations.

“There is no documented need for this bill,” Foy said. “We are very, very concerned that it will result in unintended consequences that will be bad for patients.”

In a survey of dialysis clinics in the state, the council determined that more than 100 of them would be at risk of closing if the bill passed, in part because of the inability to find staff, Foy said. Clinics in rural areas and those who treat large numbers of Medi-Cal patients are particularly vulnerable, she said.

If ratios are put into place, clinics won’t have flexibility when people call in sick or for night shifts that typically require lighter staffing, said Dr. Bryan Wong, a Berkeley-based nephrologist. That could force clinics to offer fewer appointments or turn patients away, he said.

“It would drive up the cost of care because the patient would have to be hospitalized to get their treatment.”

Dr. Randall Maxey, another nephrologist and clinic owner, said the bill is well-intentioned, but he believes the industry is already the “most regulated in the world.”

“If you pass legislation to put more regulations in … there is going to be less dialysis available for people in certain neighborhoods,” he said.

The dialysis industry is largely controlled by two for-profit corporations: DaVita Kidney Care and Fresenius Medical Care, which own nearly three-quarters of the clinics in California. As the demand for dialysis has grown around the country, both companies have acquired smaller dialysis providers.

Meanwhile, studies have shown poorer patient outcomes at for-profit dialysis clinics than at nonprofit facilities. One 2010 study found that mortality rates were higher for patients treated at sites belonging to for-profit chains than for those at nonprofit companies. Another study published the same year, based on data from 2003, showed that patients treated at nonprofit clinics spent fewer days in the hospital.

Supporters of the proposed legislation argue that companies such as DaVita and Fresenius put profits above patient safety.

“This is an industry that is incredibly profitable,” said Joan Allen, government relations advocate at SEIU-UHW. “There is a financial choice that the dialysis industry needs to make, and that is whether they are going to invest in patient safety and patient care or whether they would make a financial choice to reduce access.”

Spokesmen for both DaVita and Fresenius said they were part of a coalition opposing the legislation but declined to comment further.

The bill would require clinics to have one nurse per eight patients and one technician per three patients. The measure would require that patient appointments be at least 45 minutes apart, which supporters say gives staff time to thoroughly clean the equipment and ensure departing patients are safe.

The legislation would also mandate the state Department of Public Health to inspect dialysis centers annually. Lara said clinics are only inspected now about once every six years.

At the SEIU-UHW office in Commerce last week, dialysis technician Carlos Castillo explained why he supports the bill. Watching too many patients at once can be dangerous, he said, especially if one has an emergency. “Dialysis isn’t just about putting needles in patients,” he said. “You never know what will happen.”

Vince Gonzales, 54, who has been on dialysis for 20 years, recalled seeing a patient collapse in his chair and die.

“[Clinic staff] are so busy doing the things they are doing,” he said. “I always have that concern of, ‘Can you take care of me adequately?”

UnitedHealth Headquarters

UnitedHealth Doctored Medicare Records, Overbilled U.S. By $1 Billion, Feds Claim

KFF Health News, May 18, 2017

This week’s filing is the second time that the Justice Department has intervened to support a whistleblower suing UnitedHealth under the federal False Claims Act.

This article first appeared May 17, 2017 on Kaiser Health News.

By Fred Schulte

The Justice Department on Tuesday accused giant insurer UnitedHealth Group of overcharging the federal government by more than $1 billion through its Medicare Advantage plans.

In a 79-page lawsuit filed in Los Angeles, the Justice Department alleged that the insurer made patients appear sicker than they were in order to collect higher Medicare payments than it deserved. The government said it had “conservatively estimated” that the company “knowingly and improperly avoided repaying Medicare” for more than a billion dollars over the course of the decade-long scheme.

“To ensure that the program remains viable for all beneficiaries, the Justice Department remains tireless in its pursuit of Medicare fraud perpetrated by healthcare providers and insurers,” said acting U.S. Attorney Sandra R. Brown for the Central District of California, in a statement announcing the suit. “The primary goal of publicly funded healthcare programs like Medicare is to provide high-quality medical services to those in need — not to line the pockets of participants willing to abuse the system.”

Tuesday’s filing is the second time that the Justice Department has intervened to support a whistleblower suing UnitedHealth under the federal False Claims Act. Earlier this month, the government joined a similar case brought by California whistleblower James Swoben in 2009. Swoben, a medical data consultant, also alleges that UnitedHealth overbilled Medicare.

The case joined on Tuesday was first filed in 2011 by Benjamin Poehling, a former finance director for the UnitedHealth division that oversees Medicare Advantage Plans. Under the False Claims Act, private parties can sue on behalf of the federal government and receive a share of any money recovered.

UnitedHealth is the nation’s biggest Medicare Advantage operator covering about 3.6 million patients in 2016, when Medicare paid the company $56 billion, according to the complaint.

Medicare Advantage plans are private insurance plans offered as an alternative to traditional fee-for-service option.

Medicare pays the health plans using a complex formula called a risk score, which is supposed to pay higher rates for sicker patients than for people in good health. But waste and overspending tied to inflated risk scores has repeatedly been cited by government auditors, including the Government Accountability Office. A series of articles published in 2014 by the Center for Public Integrity concluded that improper payments linked to jacked-up risk scores have cost taxpayers tens of billions of dollars.

Tuesday’s court filing argues that UnitedHealth repeatedly ignored findings from its own auditors that risk scores were often inflated — and warnings by officials from the Centers for Medicare & Medicaid Services (CMS) — that it was responsible for ensuring the billings it submitted were accurate.

UnitedHealth denied wrongdoing and said it would contest the case.

“We are confident our company and our employees complied with the government’s Medicare Advantage program rules, and we have been transparent with CMS about our approach under its unclear policies,” UnitedHealth spokesman Matt Burns said in a statement.

Burns went on to say that the Justice Department “fundamentally misunderstands or is deliberately ignoring how the Medicare Advantage program works. We reject these claims and will contest them vigorously.”

A spokesman for CMS, which has recently faced congressional criticism for lax oversight of the program, declined comment.

Central to the government’s case is UnitedHealth’s aggressive effort, starting in 2005, to review millions of patient records to look for missed revenue. These reviews often uncovered payment errors, sometimes too much and sometimes too little. The Justice Department contends that UnitedHealth typically notified Medicare only when it was owed money.

UnitedHealth “turned a blind eye to the negative results of those reviews showing hundreds of thousands of unsupported diagnoses that it had previously submitted to Medicare, according to the suit.

Justice lawyers also argue that UnitedHealth executives knew as far back as 2007 that they could not produce medical records to validate about 1 in 3 medical conditions Medicare paid UnitedHealth’s California plans to cover. In 2009, federal auditors found about half the diagnoses were invalid at one of its plans.

The lawsuit cites more than a dozen examples of undocumented medical conditions, from chronic hepatitis to spinal cord injuries. At one medical group, auditors reviewed records of 126 patients diagnosed with spinal injuries. Only two were verified, according to the complaint.

The Justice Department contends that invalid diagnoses can cause huge losses to Medicare. For instance, UnitedHealth allegedly failed to notify the government of at least 100,000 diagnoses it knew were unsupported based on reviews in 2011 and 2012. Those cases alone generated $190 million in overpayments, according to the suit.

While Medicare Advantage has grown in popularity and now treats nearly 1 in 3 elderly and disabled Medicare patients, its inner workings have remained largely opaque.

CMS officials for years have refused to make public financial audits of Medicare Advantage insurers, even as they have released similar reviews of payments made to doctors, hospitals and other medical suppliers participating in traditional Medicare.

But Medicare Advantage audits obtained by the Center for Public Integrity through a court order in a Freedom of Information Act lawsuit show that payment errors — typically overpayments — are common.

All but two of 37 Medicare Advantage plans examined in a 2007 audit were overpaid — often by thousands of dollars per patient. Overall, just 60 percent of the medical conditions health plans were paid to cover could be verified. The 2007 audits are the only ones that have been made public.

CMS officials are conducting more of these audits, called Risk Adjustment Data Validation, or RADV. But results are years overdue.

Secret Sauce In Maine’s Successful High-Risk Pool: Enough Money

KFF Health News, May 17, 2017

Without using the so-called “invisible high-risk pool,” Anthem would have increased rates more than 20%, says the superintendent of Maine’s Bureau of Insurance. Instead, the rates went up less than two percent.

This article first appeared May 17, 2017 on Kaiser Health News.

By Patty Wight, Maine Public

As the GOP health care bill moves from the U.S. House of Representatives to the Senate, many consumers and lawmakers are especially worried that people with preexisting conditions won’t be able to find affordable health coverage.

There are a number of strategies under consideration, but one option touted by House Republicans borrows an idea that Maine used just before the Affordable Care Act went into effect. It’s called an “invisible high-risk pool” — invisible because people in it didn’t even know they were.

The Maine pool earned higher marks than most state high-risk pools because it had a key ingredient: enough money.

“The problem is that in order to do the Maine model — which I’ve heard many House people say that is what they’re aiming for — it would take $15 billion in the first year, and that is not in the House bill,” Sen. Susan Collins (R-Maine) told Politico. “There is actually $3 billion specifically designated for high-risk pools in the first year.”

Here’s how the Maine model worked: When a resident applied for health insurance, they had to fill out a questionnaire. If they had certain medical conditions known to be costly, their application was flagged for the high-risk pool. To consumers, it was seamless: They paid regular premiums and got the same sort of coverage as any other enrollee in their chosen health plan.

What was different was how their medical bills were paid. The state set up a nonprofit entity — the Maine Guaranteed Access Reinsurance Association, or MGARA. Mitchell Stein, an independent health policy consultant, explained that the money to pay for these high-cost patients came from two sources: the insurance policy premiums paid by patients within that high-risk pool and a $4-a-month surcharge on all policyholders in the state.

This “invisible high-risk pool” was just one part of a larger health reform law in Maine, Stein said, and that makes a straight-up assessment of how well the strategy worked difficult. But it’s “a great theory,” he said, “and can be an appropriate way to handle these things.”

Eric Cioppa, superintendent of Maine’s Bureau of Insurance, agrees with Stein. “In Maine, for the period of time it was operating, it worked very well,” Cioppa said.

It was active from 2012 through 2013, as 2014 marked the advent of the Affordable Care Act’s marketplace insurance exchanges. Though in effect only for a brief period, Cioppa said, the invisible high-risk pool did keep costs down in the individual market, where Anthem was the largest insurer.

Without the invisible high-risk pool, Cioppa said, Anthem would have increased rates more than 20 percent, based on estimates the insurer had to make. Instead, the rates went up less than 2 percent.

But Steve Butterfield, policy director of the Maine-based advocacy group Consumers for Affordable Health Care, cautioned that one crucial component that made Maine’s high-risk pool work was that it was well-funded. The strategy proposed in the House Republicans’ American Health Care Act is not, he said.

“An analysis that was done on what this program would need showed that it would need $15 billion to $20 billion per year to have any kind of reasonable impact on premiums,” Butterfield said.

The GOP bill does allocate about $15 billion to $20 billion — but that is supposed to last almost a full decade, not per year.

“One of our concerns,” Butterfield said, “is if the feds are going to put this in place and only kick in a token amount of money, is it going to be up to the states to pick up the slack and pay into this thing to make it work?”

Furthermore, Butterfield said, as the law stands now, under the Affordable Care Act, there’s no need for high-risk pools of any sort. The idea to use invisible high-risk pools is a solution to a problem that the GOP health care bill creates. Right now people can buy insurance regardless of their health status, whether or not they have a preexisting condition. It’s the GOP bill that would allow states to opt out of that Obamacare rule.

“I don’t understand,” Butterfield said, “why it would be a good idea to, on the one hand, say, ‘Well, we’re worried about preexisting conditions, so we’re going to throw not enough money at a problem we’re creating. At the same time, we’re going to allow insurance companies to charge sick people more.’ ”

And the invisible high-risk pool, said consultant Stein, is just one small proposal within the larger health bill.

“There’s nothing inherently wrong with it,” Stein said, “but it doesn’t really fix all the other problems of the bill.”

Which, he said, include cuts to Medicaid and potential changes to what are, under Obamacare, guaranteed “essential benefits.”

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

Houston Hospital Checking To See If Patients’ Cupboards Are Bare

KFF Health News, May 15, 2017

Starting in fall 2015, clinicians at Houston-based Memorial Hermann Health System began to examine the food struggles among patients at four medical sites.

This article first appeared May 15, 2017 on Kaiser Health News.

By Charlotte Huff

Sherry King had lost her job as a dental assistant and was stretching her food, sometimes going without any fresh fruit or vegetables. But the suburban Houston resident didn’t reach out for any help — even from her own relatives, whom she didn’t want to worry.

Then she switched to a new doctor late last year. “They asked me, ‘Do I have enough food? Do I have access to nutritious food?’ ” the 51-year-old recalled. “When they asked me that, it made me cry.” That prompted the medical practice to take note of her situation, and a clinician soon introduced King to several local food banks that carry fresh produce and some meat, such as chicken.

Nearly 1 in 8 Americans live with some degree of food insecurity, according to the most recent data from the U.S. Department of Agriculture.

Increasingly, doctors and nurses are realizing that they need to ask directly about food stress, said John Weidman, deputy executive director at The Food Trust, a Philadelphia-based nonprofit organization seeking to improve food access. “This is not naturally going to come up in conversations.” Otherwise, he said, patients with a near-bare cupboard might buy cheaper but unhealthful food or skimp on prescriptions or other medical care to avoid going hungry.

Starting in fall 2015, clinicians at Houston-based Memorial Hermann Health System began to examine the food struggles among patients at four medical sites, including the physician practice where King gets care, as well as emergency rooms and 10 school-based clinics in areas with high rates of poverty. They’ve asked patients two questions: Did you run out of food in the prior month, or did you think that you would? Depending upon the location surveyed, 11 percent to 30 percent said they did.

There’s been “some surprise at the numbers,” said Carol Paret, the system’s chief community health officer and a senior vice president. “That’s one of the things that the doctors have realized — you can’t tell this just by looking at somebody.”

This summer, clinicians at Memorial Hermann will expand their effort across the 15-hospital system, routinely asking hospitalized patients, along with patients seeking care at roughly 225 physician practices affiliated with Memorial Hermann, about their food supply, Paret said.

In the process, preconceptions are being debunked, Paret said. Even obese patients might be coping with food shortages or loading up on high-calorie foods during the limited stretches when it’s available, she said. Senior citizens barely eking by on a fixed income might wear their nicer clothes for an outing to the doctor’s office, creating the perception they’re doing fine financially.

Amid “the hidden pockets of poverty” in suburbia, someone who has been laid off might put every dollar into keeping their house and car, with little left to fill the refrigerator, Weidman said. The suburban practice where King is treated — staffed by more than 50 physicians and physician residents — is located southwest of Houston in Sugar Land, Texas. The median household income for the surrounding ZIP code is $92,000 annually, nearly twice the statewide median of $53,200.

Before asking patients about food insecurity, most of the doctors and nurses would likely have predicted that no more than 2 percent qualified, said Dr. Laura Armstrong, a family physician in the practice, Physicians at Sugar Creek. “Then it ended up being 11 percent, which was, I think, fairly shocking to most of us.”

Armstrong said she was taken aback upon learning that those without sufficient food included some patients who had jobs with insurance, as well as numerous seniors. The rates were even higher at the other locations that Memorial Hermann surveyed, including 30 percent at the school-based health clinics and 22 percent among the uninsured or otherwise vulnerable patients getting primary care in the system’s emergency rooms.

When feasible, Armstrong will switch patients who are experiencing food problems to a more affordable medication. In the case of diabetic patients, she might postpone adding a second or third drug, to see if some help with nutritious food might stabilize their blood sugars without the additional medication cost.

Some are trying to stay fed on astoundingly tight budgets. One patient, who has rescheduled a cancer biopsy because of finances, told Armstrong she has $26 available for food each week.

The practice has hired a community health worker to connect patients with food banks and brainstorm how to get better nutrition on a slim wallet. It also has planted a vegetable garden, so patients can literally grab some okra or collard greens on the way home, Armstrong said.

It’s easier for doctors and nurses to ask about food worries if they feel as if they can offer some options, said Chinwe Onyekere, associate administrator for Lankenau Medical Center, a 370-bed hospital just outside of Philadelphia. Since 2013, medical school student volunteers there have paired up with patients who report food difficulties on a social needs survey. (Food is the most common problem cited, surpassing transportation or housing needs.)

The students help eligible patients sign up for food stamps. Through an initiative with The Food Trust, Lankenau clinicians also can “prescribe” patients with diabetes and other chronic conditions coupons for produce at more than two dozen farmers markets, Onyekere said. The coupons are tracked through the electronic medical record system; to date, roughly one-third had been redeemed.

Since her food struggles were already on the table, King confessed to her doctor this spring that she had delayed filling two prescriptions, including a hormonal drug she takes since undergoing breast cancer treatment several years ago. That week, her grocery bill had been unexpectedly high. By the time King sought care, she wasn’t feeling well, and her doctor blamed it on having missed medication for several days.

King has since learned she can visit a food bank every week, alternating between sites, rather than every other week. If the practice had never asked, she believes she’d still be limping along with processed food and little else some days. “That’s something you don’t talk to your doctor about,” she said. “You don’t tell your doctor ‘I’m running out of food the last 10 days of the month.’ ”

Trump Says He Knows About Health Care, But Some Of His Facts Seem Alternative

KFF Health News, May 15, 2017

“He seems to think it’s like a life insurance policy, which you can buy at a certain age and it keeps you at a fixed premium dollar forever,” says the health economist who ran Medicare under President George H.W. Bush.

This article first appeared May 15, 2017 on Kaiser Health News.

By Julie Rovner

Lost in all the coverage of the firing of FBI Director James Comey last week were a pair of in-depth interviews President Donald Trump gave that included lengthy comments on health care — one with Time magazine and the other with The Economist.

He acknowledged to Time interviewers that health care was not an area of expertise in his previous job. “It was just not high on my list,” he said. But he added that “in a short period of time I understood everything there was to know about health care.”

Not really.

Among the president’s more questionable claims was his description of the House-passed health bill as “You’re going to have absolute coverage.”

The last full estimate from the Congressional Budget Office predicted that a previous version of the bill would result in 24 million fewer people with insurance after 10 years.

Trump also told The Economist that “we’re getting rid of the state lines,” a reference to allowing health insurers to sell across state lines. Not only is that not in the GOP bill, many experts agree such a policy would not work to increase competition.

Possibly the most curious comment was this one, also in The Economist interview: “[T]his was not supposed to be the way insurance works. Insurance is, you’re 20 years old, you just graduated from college, and you start paying $15 a month for the rest of your life and by the time you’re 70, and you really need it, you’re still paying the same amount and that’s really insurance.”

“He seems to think it’s like a life insurance policy, which you can buy at a certain age and it keeps you at a fixed premium dollar forever,” said Gail Wilensky, a health economist who ran the Medicare and Medicaid programs under President George H.W. Bush. Except “you can’t buy health insurance that way,” Wilensky said. “Even if you stay continuously insured, that’s just not how it works.”

On the other hand, Wilensky said, it might not matter all that much how well a president understands the intricacies of health policy. “It matters whether he thinks it’s important,” she said. The president she worked for was much more comfortable on issues of foreign relations and defense. “It wasn’t that he didn’t care” about health, she said. “He just didn’t know that area the way he knew other areas.”

Jonathan Oberlander, a health policy professor at the University of North Carolina-Chapel Hill, points out that a deep understanding of a subject by itself is not enough to produce policy change.

“Bill Clinton thought he knew health policy, and look at how that turned out,” he said, referring to the collapse of his health reform plan in Congress in 1994. Still, “ignorance surely doesn’t help,” he added.

David Blumenthal, president of the Commonwealth Fund and co-author of a book on presidents and health care, agreed with both Wilensky and Oberlander.

“A president has to know enough to sell the plan” to Congress and the public, he said. “But presidents can make mistakes by getting too deep in the details.” He pointed to not only Clinton but also President Jimmy Carter as chief executives who got mired in the small print of health policy.

At the same time, however, Blumenthal said that a president has “to lay out principles and parameters that the Congress knows if they meet he will sign the bill.” And while Trump has done that, “I don’t think he’s been entirely consistent with what he’s said, so it’s not clear how much the Congress is being guided by his principles,” he said.

One health issue Trump is clearly not ignorant about is his power to stop paying insurance companies who are providing help to some low-income policyholders in the health insurance exchanges. The “cost-sharing reductions” are the subject of a lawsuit that was appealed by the Obama administration, and Trump could, in fact, stop the payments by dropping the appeal.

Insurers say uncertainty about whether they will get that money is a key reason they are asking for higher rates or dropping out of markets.

Trump did not help allay that uncertainty. He told The Economist that “we don’t have to subsidize it. You know if I ever stop wanting to pay the subsidies, which I will.”

CMS Gives States Until 2022 To Meet Medicaid Standards Of Care

KFF Health News, May 11, 2017

Federal standards requiring states find ways of delivering care to Medicaid enrollees in home and community-based settings will take effect in 2022 instead of 2019, CMS announced this week.

This article first appeared May 11, 2017 on Kaiser Health News.

By Phil Galewitz

The Trump administration has given states three extra years to carry out plans for helping elderly and disabled people receive Medicaid services without being forced to go into nursing homes.

Federal standards requiring states find ways of delivering care to Medicaid enrollees in home and community-based settings will take effect in 2022 instead of 2019, the Centers for Medicare & Medicaid Services announced this week.

The standards were set by an Obama administration rule adopted in 2014 that governs where more than 3 million Medicaid enrollees get care.

Among other things, the rule requires states to provide opportunities for enrollees to engage in community life, control their own money and seek employment in competitive settings. It also ensures that enrollees in group homes and other residential settings get more privacy and housing choices that include places where non-disabled people live.

Matt Salo, executive director of the National Association of Medicaid Directors, applauded the delay.

“We have long been on record saying that the regulation was hopelessly unrealistic in its time frame,” he said. “Delaying it actually helps consumers because the underlying regulation was going to push too many changes too fast into a system that wasn’t ready.”

The Obama administration’s 2014 rule was an effort to create a federal standard to improve the quality of care that the disabled receive outside institutions.

Some states had tried ― and struggled ― to make changes on their own, partly due to a lack of funding and political difficulties of changing deeply-entrenched relationships with providers.

Some had, for instance, forced providers to change longstanding operations at group homes and so-called sheltered workshops such as Goodwill Industries where disabled people often work apart from other employees, performing menial tasks for less than minimum wage.

Helping disabled people find work in places where they are not segregated costs states more money, said Gary Blumenthal, CEO of the Association of Developmental Disabilities Providers.

The delay in implementing the federal rule is “a victory for the status quo and for states reluctant to embrace the [new standards],” he said.

States spent several years fighting the new rules during the Obama administration and that slowed their planning, said Elizabeth Priaulx, senior legal specialist with the National Disability Rights Network. She noted states were under pressure from nursing homes and for-profit group homes to resist the changes.

“It is unfortunate the delay had to occur,” but many states were not ready, she said.

The new rule also directs states and providers to reconfigure existing community settings such as group homes to ensure that people will have more privacy. “Without these dollars it’s difficult to change the system,” Blumenthal said.

Funds Already Shifting

In 2014, state Medicaid programs for the first time spent more on long-term care in home and community-based settings than on nursing homes. But there was great variation: Mississippi spent about 25 percent of its long-term care dollars on home and community care while Oregon and other states spent nearly 80 percent.

Camille Dobson, deputy executive director of the National Association of States United for Aging and Disability, said the delay was important for states worried about losing federal funding if they didn’t meet the new standards.

“It was very likely that most of the states would not have been in compliance by March 2019 and so CMS would [have been] faced with taking money away from programs that help people stay in their homes rather than go to nursing facilities,” Dobson said.

The administration’s announcement of the delay came less than a week after the House passed the American Health Care Act, which would take $880 billion over 10 years out of the Medicaid program. It was expected after Health and Human Services Secretary Tom Price in March invited states to apply for waivers from federal Medicaid rules that he said were too onerous to help improve the program.

So far, Tennessee is the only state that has received final approval from CMS for its implementation plan. States still face a 2019 deadline to gain approval for their implementation plans.

Kathy Carmody, CEO of The Institute on Public Policy for People with Disabilities in Illinois, said there is concern the Trump administration may not just delay the rule’s implementation, but eventually eliminate it altogether.

“We are disappointed,” she said, noting that Illinois ranks last or near last on several measures of care for people receiving home and community-based services. That includes having about half of its disabled Medicaid enrollees in residential care settings with seven or eight other disabled people and less than 6 percent of its disabled enrollees in competitive employment, she said.

“We were really hoping the rule would be a push from the federal government to help us evolve into the 21st century and get out of the mid-1980s where we are stuck,” Carmody said.

Grassley, Chaffetz Send Fiery Response To HHS Memo They Say Chills Whistleblowing

KFF Health News, May 10, 2017

The Congressmen are blasting a memo from HHS Secretary Tom Price’s chief of staff, which instructed employees not to have “any communications” with members of Congress or their staffs without first consulting the department.

This article first appeared May 08, 2017 on Kaiser Health News.

By Rachel Bluth

Two influential Republican congressmen are blasting a Department of Health and Human Services memo to division heads as a “potentially illegal and unconstitutional” infringement on whistleblowers’ rights to call attention to waste, fraud and abuse in the executive branch.

The May 3 memo from HHS Secretary Tom Price’s chief of staff, Lance Leggitt, instructed employees not to have “any communications” with members of Congress or their staffs without first consulting the department’s assistant secretary for legislation. Leggitt’s memo said he was only restating a long-standing policy on congressional relations and gave eight examples of contacts needing approval, including requests for calls, briefings, hearings and oversight.

The 10-sentence memo drew an incensed reply from Sen. Chuck Grassley (R-Iowa) and Rep. Jason Chaffetz (R-Utah), the chairmen, respectively, of the Senate Judiciary Committee and the House Committee on Oversight and Government Reform. They asked Price to clarify in writing Leggitt’s communication as soon as possible.

Their complaint was that the memo contained no exception for lawful, protected communications with Congress.

“In its current form, employees are likely to interpret it as a prohibition, and will not necessarily understand their rights,” they wrote in their letter to Price.

“Protecting whistleblowers who courageously speak out is not a partisan issue — it is critical to the functioning of our government,” added the lawmakers.

Grassley and Chaffetz warned that the memo could violate federal employees’ constitutional rights to petition the government, as well as violate other laws protecting government employees from reprisals for speaking with members of Congress.

Two experts on good government practices agreed with the congressmen’s viewpoint.

Liz Hempowicz, policy counsel at the Project on Government Oversight, said the memo’s failure to remind employees of their rights as potential whistleblowers made it illegal.

“If they don’t know they have that right, it’s essentially taking it away from them,” she said.

Thomas Scully, who served as administrator for the Centers for Medicare & Medicaid under President George W. Bush, said the Trump administration isn’t the first to try to coordinate congressional relations, but using a formal memo to do so surprised him.

Congress regularly seeks information from staffers in HHS — and other agencies — and certain employees often go to Capitol Hill to give technical briefings, testify or request more budget money, he said. “People should be able to go to the Hill whenever they need to, but if you’re up there pushing an agenda that’s different than the president’s, they’re going to get reined in one way or another,” he said. “You shouldn’t be up there as a free agent.”

Grassley and Chaffetz instructed Price to provide all documents and communications about Leggitt’s directive to their committees by May 18.

President Donald Trump has not yet named a nominee to head the HHS Office of Assistant Secretary for Legislation. Until then, employees complying with the memo will go through the acting assistant secretary, Barbara Clark.

Leggitt’s memo isn’t the first to stir controversy in HHS this month. Some media outlets reported last week that another directive ordered television monitors to be switched from CNN to Fox at the Food and Drug Administration’s main campus. Some details were disputed by an FDA spokesperson, and The Wall Street Journal reported the switch was temporary. The FDA is part of HHS.

Nearly 1 In 3 Recent FDA Drug Approvals Followed By Major Safety Actions

KFF Health News, May 10, 2017

Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a “black box” warning on side effects or warranted a safety announcement, researchers say.

This article first appeared May 10, 2017 on Kaiser Health News.

By Sydney Lupkin

The Food and Drug Administration is under pressure from the Trump administration to approve drugs faster, but researchers at the Yale School of Medicine found that nearly a third of those approved from 2001 through 2010 had major safety issues years after they were widely available to patients.

Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a “black box” warning on side effects or warranted a safety announcement about new risks to the public, Yale professor Dr. Joseph Ross and his colleagues reported in JAMA on Tuesday. The study included safety actions through Feb. 28.

“While the administration pushes for less regulation and faster approvals, those decisions have consequences,” Ross said. The Yale researchers’ previous studies concluded that the FDA approves drugs faster than its counterpart agency in Europe, and that the majority of pivotal trials in drug approvals involved fewer than 1,000 patients and lasted six months or less.

It took a median time period of 4.2 years after the drugs were approved for these safety concerns to come to light, and issues were more common among psychiatric drugs, biologic drugs, drugs that were granted “accelerated approval” and drugs that were approved near the regulatory deadline for approval.

Drugs ushered through the FDA’s accelerated approval process were among those that had higher rates of safety interventions. These approvals typically rely on surrogate endpoints, meaning that researchers measured something other than survival, such as tumor size, to determine whether the drugs worked.

“This [finding on surrogate endpoints] has the greatest relationship to policy today,” Ross said. “In the 21st Century Cures Act, there’s a push to have the FDA move to further support the use of surrogate markers … [but] they’re more likely to have concerns in the post-market setting.”

Former President Barack Obama signed the act into law on Dec. 13. Among other things, it offers ways to speed drug approval by pushing the FDA to consider different kinds of evidence beyond the three phases of traditional clinical trials. The new process has made some researchers worry that it will open the door for more unsafe approvals.

“I’m actually sympathetic to the idea that there are ways in which the FDA can be more streamlined and do a quicker job,” said Dr. Vinay Prasad, a hematologist-oncologist and professor at Oregon Health and Sciences University who did not work on the study. “The one place you don’t want to cut a corner is safety and efficacy prior to coming to market.”

Given criticism of the FDA’s mostly voluntary system for reporting new drug- and device-related health problems, it’s possible there are more unknown adverse side effects of which neither the FDA nor the general public is aware. The reports are not verified, and critics say this system is underutilized and filled with incomplete and late information. The FDA also monitors other available studies and reports to determine whether it needs to take action on a particular drug.

FDA spokeswoman Angela Hoague said the agency is reviewing Ross’ findings.

“In general, the FDA does not comment on specific studies, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health,” she said.

Regardless, some observers may find the proportion of safety concerns alarming and others may be breathing a sigh of relief that it’s not higher, Ross said.

“That’s the million-dollar question: What’s the right amount? What’s the appropriate level of safety concerns to have identified only once the product is out of the gate?” said Dr. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness. He did not work on the study.

Surprisingly, drugs approved in under 200 days were less likely to have safety issues, which the authors speculate could be because “some approval packages provide clearer evidence of safety, allowing for more rapid regulatory approval.”

The study included market withdrawals of three drugs: the anti-inflammatory drug Bextra, a drug called Zelnorm that treats irritable bowel syndrome and the psoriasis drug Raptiva. Bextra and Zelnorm were withdrawn over cardiovascular risk, and Raptiva was withdrawn because of increased risk of a rare and fatal infection that damages material in the brain.

Still, it’s important to keep in mind that the post-approval safety issues cover the spectrum from relatively minor to serious, Alexander said. A good next step would be to dig into the extremely serious safety problems, determine whether the FDA could have flagged them sooner and how they might have been missed, he said.

Alexander commended the researchers, saying their study “underscores the importance of surveillance” after a drug has been launched. This helps researchers find new problems — and new benefits — associated with a drug.

“All too often, patients and clinicians mistakenly view FDA approval as [an] indication that a product is fully safe and effective,” he said. “Nothing could be further from the truth. We learn tremendous amounts about a product only once it’s on the market and only after use among a broad population.”

Why Blue States Might Ditch Beloved Obamacare Protections

KFF Health News, May 9, 2017

Opt-out provisions could accelerate the unraveling of Obamacare, even in places that fully embraced the landmark law.

This article first appeared May 09, 2017 on Kaiser Health News.

By Chad Terhune and Barbara Feder Ostrov  

Under the Republican health bill, it’s up to states whether to dismantle key parts of the Affordable Care Act.

Red, or GOP-leaning, states are sure to be interested in rolling back the law’s coverage requirements and freeing insurers to charge people more when they have preexisting conditions.

As strange as it sounds, deep-blue, heavily Democratic states supportive of Obamacare, including California and New York, may be forced to do the same, according to experts, regulators and consumer advocates.

The American Health Care Act, which narrowly passed the House on Thursday and now heads to the Senate, would significantly cut the federal subsidies on which many Americans rely to buy coverage. Unless the legislation fails or changes substantially, many consumers across the country could see the amount they pay every year for premiums increase by thousands of dollars, making coverage effectively unaffordable.

Few, if any, states would be able to fund subsidies on their own. To keep insurers in the market and bring costs down, state leaders might feel compelled to seek exemptions from rules that require health plans to provide 10 “essential health benefits” and prohibit them from charging higher rates for sicker consumers. The new GOP health care bill would allow such waivers.

“With the skimpier subsidies, states are going to be under enormous pressure to apply for these waivers,” said Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms.

These opt-out provisions could accelerate the unraveling of Obamacare, even in places that fully embraced the landmark law.

“Certainly the Californias and New Yorks of the world will do what they can to hold onto the ACA protections. But when confronted with insurer exits and big price hikes, many states with the best of intentions may feel they have little choice but to get a waiver,” Corlette said.

The idea of opting out is unfathomable to many liberals who fought so hard to win the consumer protections in the Affordable Care Act. They’re hoping the Senate will dump the bill or, in its quest for more moderate votes, at least make the premium tax credits more generous or eliminate the waivers.

Republican leaders insist the current health law isn’t worth saving because it has left consumers with double-digit rate hikes, onerous deductibles and little or no competition in some states, as insurers exit the marketplaces.

Rep. Kevin Brady (R-Texas), chairman of the House Ways and Means committee, said the GOP health bill grants states the flexibility they need to remove the “crushing mandates” that have led to “Obamacare plans you don’t want and can’t afford.”

House Speaker Paul Ryan (R-Wis.) struck a similar note in urging his colleagues to pass the bill. “Let’s make it easier for people to afford their insurance. … Let’s return power from Washington to the states,” he said on the House floor Thursday.

Consumer advocates in North Carolina, Colorado and other states are taking the threat of waivers seriously.

“No state is safe from such a waiver,” said Brendan Riley, a health policy analyst at the North Carolina Justice Center, an advocacy group focused on economic and social issues.

North Carolina would be one of the states hit hardest by the House bill, according to an analysis by the left-leaning Center on Budget and Policy Priorities. The state’s average premiums and out-of-pocket costs would rise by $7,549 annually.

Nationally, the average tax credit for enrollees in the online marketplaces would be 41 percent lower under the American Health Care Act by 2022, according to a study by the Kaiser Family Foundation. (Kaiser Health News, which produces California Healthline, is an editorially independent program of the foundation.)

The GOP bill also ends the penalty for not having coverage, which experts say might increase premiums as fewer healthy people sign up, leaving health plans with a higher proportion of sick patients.

All this could put the focus back on which benefits are deemed essential in health insurance — an all-too-familiar battle in statehouses before the ACA set a nationwide standard.

The health law now requires all plans sold on the individual and small-group markets to cover the 10 essential health benefits, including hospitalization, prescription drugs and mental health treatment. It has made coverage more comprehensive and prevented insurers from selling bare-bones plans that had cheaper premiums but often exposed consumers to huge medical bills after they sought care.

Before the ACA, coverage for maternity care, prescription drugs and substance abuse treatment often wasn’t available. State lawmakers were hesitant to approve new benefit mandates for fear of raising premiums.

Washington state Insurance Commissioner Mike Kreidler, a Democrat, said he sees a political fight over benefits on the horizon if the GOP bill advances.

“I certainly think there’s going to be political pressure applied to make adjustments [in essential health benefits],” he said. “I’d be vociferously and violently opposed to those changes.”

Adela Flores-Brennan, executive director of the Colorado Consumer Health Initiative, said she too has faith that her state’s Democratic governor and insurance commissioner would uphold essential benefits and protections for people with preexisting conditions.

But she and other patient advocates said that resolve may be tested by the lack of competition in some areas, which insurers could use as a bargaining chip for more leeway on regulations.

For instance, Flores-Brennan noted that industry giant Anthem is the sole company on the state’s insurance exchange in 14 Colorado counties. She said she worries the company could threaten to pull out if the state doesn’t opt for weaker standards.

California would be loath to cut benefits. If you’re selling a policy to a young adult without maternity care, that’s nuts.

John Baackes, CEO of L.A. Care
Health Plan

Even in California, a liberal bastion that enthusiastically implemented Obamacare, the law’s supporters are bracing for a fight over the waivers.

“As premiums go higher, it will create pressure on us to undercut the standards we have,” said Beth Capell, a lobbyist for the consumer advocacy group Health Access California.

In California, premiums and out-of-pocket costs would rise by $2,779, on average, under the House bill, according to the analysis by the Center on Budget and Policy Priorities.

“California policymakers will once again hear what we heard year after year before the ACA: ‘Some coverage is better than no coverage. More limited benefits are better than nothing,’” Capell said.

John Baackes, the chief executive of L.A. Care Health Plan, with about 26,000 enrollees in the California exchange, said state leaders would exhaust every other option before slashing coverage.

“California would be loath to cut benefits,” Baackes said. “If you’re selling a policy to a young adult without maternity care, that’s nuts.”

No matter the state, red or blue, experts anticipate vigorous debate over these waivers because consumer protections under Obamacare have become more popular.

Wisconsin Gov. Scott Walker, a Republican, experienced that firsthand last week when he suggested his state may opt out of the ACA’s preexisting condition rules — and then immediately backtracked amid strong opposition.

Michael Miller, director of strategic policy for Community Catalyst, a Boston-based national consumer group, said waiver requests won’t necessarily proceed “quietly even in the red states. … People have heart disease and cancer and asthma in those states, too.”

Medicare Failed To Investigate Suspicious Infection Cases From 96 Hospitals

KFF Health News, May 9, 2017

The lapse was discovered as by an OIG study designed to address concerns over whether hospitals are “gaming” a system in which it falls to the hospitals to report patient-infection rates.

This article first appeared May 09, 2017 on Kaiser Health News.

By Christina Jewett

Almost 100 hospitals reported suspicious data on dangerous infections to Medicare officials, but the agency did not follow up or examine any of the cases in depth, according to a report by the Health and Human Services inspector general’s office.

Most hospitals report how many infections strike patients during treatment, meaning the infections are likely contracted inside the facility. Each year, Medicare is supposed to review up to 200 cases in which hospitals report suspicious infection-tracking results.

The IG said Medicare should have done an in-depth review of 96 hospitals that submitted “aberrant data patterns” in 2013 and 2014. Such patterns could include a rapid change in results, improbably low infection rates or assertions that infections nearly always struck before patients arrived at the hospital.

The IG’s study, released Thursday, was designed to address concerns over whether hospitals are “gaming” a system in which it falls to the hospitals to report patient-infection rates and, in turn, the facilities can see a bonus or a penalty worth millions of dollars. The bonuses and penalties are part of Medicare’s Inpatient Quality Reporting program, which is meant to reward hospitals for low infection rates and give consumers access to the information at the agency’s Hospital Compare website.

The report zeroes in on a persistent concern about deadly infections that patients develop as a result of being in the hospital. A recent British Medical Journal report identified medical errors as the third-leading cause of death in the U.S. Hospital infections particularly threaten senior citizens with weakened immune systems.

Rigorous review of hospital-reported data is important to protect patients, said Lisa McGiffert, director of the Consumers Union’s Safe Patient Project.

“There’s a certain amount of blind faith that the hospitals are going to tell the truth,” McGiffert said. “It’s a bit much to expect that if they have a bad record they’re going to ’fess up to it.”

Yet there are no uniform standards for reviewing the data that hospitals report, said Dr. Peter Pronovost, senior vice president for patient safety and quality at Johns Hopkins Medicine.

“There are greater requirements for what a company says about a washing machine’s performance than there is for a hospital on quality of care, and this needs to change,” Pronovost said. “We require auditing of financial data, but we don’t require auditing of [health care] quality data, and what that implies is that dollars are more important than deaths.”

In 2015, Medicare and the Centers for Disease Control and Prevention issued a joint statement cautioning against efforts to manipulate the infection data. The report said CDC officials heard “anecdotal” reports of hospitals declining to test apparently infected patients — so there would be no infection to report. They also warned against overtesting, which helps hospitals assert that patients came into the hospital with a preexisting infection, thus avoiding a penalty.

In double-checking hospital-reported data from 2013 and 2014, Medicare reviewed the results from 400 randomly selected hospitals, about 10 percent of the nation’s more than 4,000 hospitals. Officials also examined the data from 49 “targeted” hospitals that had previously underreported infections or had a low score on a prior year’s review.

All told, only six hospitals failed the review, which included a look at patients’ medical records and tissue sample analyses. Those hospitals were subject to a 0.6 percent reduction in their Medicare payments. Medicare did not specify which six hospitals failed the data review, but it did identify dozens of hospitals that received a pay reduction based on their reports on the quality of care.

The new IG report recommended that Medicare “make better use of analytics to ensure the integrity of hospital-reported quality data.” A response letter from Centers for Medicare & Medicaid Services Administrator Seema Verma says Medicare concurs with the finding and will “continue to evaluate the use of better analytics … as feasible, based on [Medicare’s] operational capabilities.”

Questions about truth in reporting hospital infections have percolated for years, as reports have trickled out from states that double-check data.

In Colorado, one-third of the central-line infections that state reviewers found in 2012 were not reported to the state by hospitals, as required. Central lines are inserted into a patient’s vein to deliver nutrients, fluids or medicine. Two years later, though, reviewers found that only 2 percent of central-line infections were not reported.

In Connecticut, a 2010 analysis of three months of cases found that hospitals reported about half — 23 out of 48 — of the central-line infections that made patients sick. Reviewers took a second look in 2012 and found improved reporting — about a quarter of the cases were unreported, according to the state public health department.

New York state officials have a rigorous data-checking system that they described in a report on 2015 infection rates. In 2014, they targeted hospitals that were reporting low rates of infections and urged self-audits that found underreporting rates of nearly 11 percent.

Not all states double-check the data, though, which Pronovost said underscores the problem with data tracking the quality of health care. He said common oversight standards, like the accounting standards that apply to publicly traded corporations, would make sense in health care, given that patients make life-or-death decisions based on quality ratings assigned to hospitals.

“You’d think, given the stakes, you’d have more confidence that the data is reliable,” he said.

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