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Monthly Archives: December 2017

Trump Administration Relaxes Financial Penalties Against Nursing Homes

The Trump administration — reversing guidelines put in place under President Barack Obama — is scaling back the use of fines against nursing homes that harm residents or place them in grave risk of injury.

The shift in the Medicare program’s penalty protocols was requested by the nursing home industry. The American Health Care Association, the industry’s main trade group, has complained that under Obama, inspectors focused excessively on catching wrongdoing rather than helping nursing homes improve.

“It is critical that we have relief,” Mark Parkinson, the groupâ€s president, wrote in a letter to then-President-elect Donald Trump in December 2016.

Since 2013, nearlyņ,500 nursing homes — 4 of every 10 — have been cited at least once for a serious violation, federal records show. Medicare has fined two-thirds of those homes. Common citations include failing to protect residents from avoidable accidents, neglect, mistreatment and bedsores.

The new guidelines discourage regulators from levying fines in some situations, even when they have resulted in a resident’s death. The guidelines will also probably result in lower fines for many facilities.

The change in policy aligns with Trump’s promise to reduce bureaucracy, regulation and government intervention in business.

Dr. Kate Goodrich, director of clinical standards and quality at the Centers for Medicare & Medicaid Services (CMS), said in a statement that unnecessary regulation was the main concern that health care providers raised with officials.

“Rather than spending quality time with their patients, the providers are spending time complying with regulations that get in the way of caring for their patients and doesn’t increase the quality of care they provide,” Goodrich said.

But advocates for nursing-home residents say the revised penalties are weakening a valuable patient-safety tool.

“They’ve pretty much emasculated enforcement, which was already weak,” said Toby Edelman, a senior attorney at the Center for Medicare Advocacy.

Medicare has different ways of applying penalties. It can impose a specific fine for a particular violation. It can assess a fine for each day that a nursing home was in violation. Or it can deny payments for new admissions.

The average fine in recent years has been $33,453, but 531 nursing homes amassed combined federal fines above $100,000, records show. In 2016, Congress increased the fines to factor in several years of inflation that had not been accounted for previously.

The new rules have been instituted gradually throughout the year.

In October, CMS discouraged its regional offices from levying fines, even in the most serious health violations, if the error was a “one-time mistake.” The centers said that intentional disregard for residents’ health and safety or systemic errors should still merit fines.

A July memo from CMS discouraged the directors of state agencies that survey nursing homes from issuing daily fines for violations that began before an inspection, favoring one-time fines instead. Daily fines remain the recommended approach for major violations discovered during an inspection.

Dr. David Gifford, the American Health Care Association’s senior vice president for quality, said daily fines were intended to prompt quick remedies but were pointless when applied to past errors that had already been fixed by the time inspectors discovered them.

“What was happening is you were seeing massive fines accumulating because they were applying them on a per-day basis retrospectively,” Gifford said.

But the change means that some nursing homes could be sheltered from fines above the maximum per-instance fine of $20,965, even for egregious mistakes.

In September 2016, for instance, health inspectors faulted Lincoln Manor, a nursing home in Decatur, Ill., for failing to monitor and treat the wound of a patient whose implanted pain-medication pump gradually slipped over eight days through a ruptured suture and protruded from her abdomen. The patient died.

CMS fined Lincoln Manor $282,954, including $10,ጛ a day for 28 days, from the time the nursing home noticed the problem with the wound until supervisors had retrained nurses to avoid similar errors. An administrative law judge called the penalties “quite modest” given the “appalling” care.

The fines were issued before the new guidelines took effect; if the agency had issued a one-time fine, the maximum would have been less than $21,000.

Lincoln Manor closed in September. Its owner could not be reached for comment, and his lawyer did not respond to an interview request.

Advocates for nursing home residents say that relaxing penalties threatens to undo progress at deterring wrongdoing. Janet Wells, a consultant for California Advocates for Nursing Home Reform, said the changes come as “some egregious violations and injuries to residents are being penalized — finally — at a level that gets the industry’s attention and isn’t just the cost of doing business.”

In November, the Trump administration exempted nursing homes that violate eight new safety rules from penalties for 18 months. Homes must still follow the rules, which are intended, among other things, to reduce the overuse of psychotropic drugs and to ensure that every home has adequate resources to assist residents with major psychological problems.

Rodney Whitlock, a health policy consultant and former Republican Senate staffer, said health inspectors “are out there looking for opportunities to show that the nursing homes are not living up to some extremely tight standards.” He said while the motivation for tough regulation was understandable, “the fines don’t make it easier to hire people and doesnt make it easier to stay in business.

In June, CMS rescinded another Obama administration action that banned nursing homes from pre-emptively requiring residents to submit to arbitration to settle disputes rather than going to court.

We publish nearly 11,000 pages of regulation every year,” the agency’s administrator, Seema Verma, said in a speech in October. That paperwork is “taking doctors away from what matters most: patients.”

Janine Finck-Boyle, director of health regulations and policy at LeadingAge, a group of nonprofit nursing homes and other entities that care for older people, said the groupâ€s members had been struggling to cope with regulations.

“If you’re a 50-bed rural facility out West or in the Dakotas,” she said, “you don’t have the resources to get everything done from A to Z.”

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Sickle Cell Patients, Families And Doctors Face A ‘Fight For Everything’

CHICAGO — The day before his 30th birthday, Marqus Valentine was in a panic. “I was so scared for midnight to come rolling around because subconsciously I was like, ‘This is it. Tomorrow’s my last day on Earth,’” he said.

Valentine has sickle cell disease, an inherited blood disorder, and his doctors had warned him throughout his life that he was not likely to make it to 30.

That birthday passed without event, and so have four more. Still, Valentine’s disease has left him severely disabled and ill. “Instead of 34, I feel like I’m 68, just with all the stuff I’ve been through,” he said.

He uses a portable oxygen tank, needs a hip replacement and sleeps in a hospital bed on the first floor of his parents’ house — he is in too much pain to make it up the stairs to his bedroom. And an early death still looms: œI could wake up in the morning, brush my teeth, eat breakfast and by the time afternoon comes rolling around, I could possibly be dead.”

Like many people with sickle cell, Valentine has watched as one successful advocacy campaign after another brought attention and resources to other disorders, including breast cancer, HIV, cystic fibrosis and Lou Gehrig’s disease (amyotrophic lateral sclerosis or ALS). But little is heard about sickle cell. With drug development and other treatments, outcomes for the vast majority of diseases have improved over the past few decades, while life expectancy for sickle cell patients has declined.

To sickle cell patients and their families — most of whom are African-American — efforts to fight the disease appear slow, underfunded, ineffective or too limited in scope, perpetuating disparities that have existed for more than a century.

“You feel like the baldheaded stepchild that no one cares about,” Valentine said from his bed at Edward Hospital in Naperville, Ill., where he was recovering from one of his bimonthly blood transfusions. A catheter dangled from his neck. “What about us? We’re here too.”

Sickle cell disease affects an estimated 100,000 people in the United States, causing chronic pain, multi-organ failure and stroke. With annual costs to treat the disease soaring past $1 billion, new efforts are afoot to improve the lot of patients. But each of these developments faces limitations and obstacles:

  • In July, the FDA approved the first new drug to treat sickle cell in two decades. Yet specialists say the drug, Endari, will likely have limited benefit, and insurers are already balking at covering it. Physicians associations are working to disseminate guidelines to improve care and reduce discrimination against sickle cell patients, who often are assumed to be drug addicts when they come to emergency rooms in severe pain. Still, there has been so little research on sickle cell that it is difficult even to write evidence-based protocols.
  • Legislation in Congress to fund research and treatment, stalled since 2009, is finally moving out of committee. But the bill would provide only $4 million — less than half its original funding level.

Meanwhile, most sickle cell patients struggle to access even the most basic care.

“It’s appalling. This country ought to be ashamed of itself,” said Valentine’s mother, Francesca Valentine, who has been a registered nurse for over 35 years and, with Marqus and the rest of the family, has become an activist for sickle cell patients. “I am baffled that in 2017, we’re still not treating the disease based on science, and we still deal with racism and stigma and inaccurate information.”

Francesca Valentine, a sickle cell mother and advocate, sits in her home in Lisle, Ill. (Jenny Gold/Kaiser Health News)

The Fight For Medicine

Francesca Valentine is gearing up for a fight with her insurance company over Endari, the new FDA-approved drug, which will likely be on the market in January. Endari is a highly refined version of a nutritional supplement called L-Glutamine, which has been shown to relax the stiff, sickle-shaped red blood cells of people with the disease. It’s the first of a number of new drugs in the pipeline and will cost about $3,300 per month for the average adult.

But many insurers plan to restrict how the drug covered.

Several, including the Valentines’ Blue Cross Blue Shield’s Federal Employee Program, will cover Endari only if patients have “failed first” at other treatments, including blood transfusions and hydroxyurea (the only other drug available to treat sickle cell) — even though in studies Endari appeared to be of benefit when given in conjunction with other treatments.

At least one insurer, Cigna, which covers 15 million people, says it will not cover Endari at all because it is a nutritional supplement.

If insurance doesn’t cover the drug for her son, Francesca Valentine said she and her husband would both need second jobs. Because Marqus is disabled, he is on his mothers insurance plan, which she gets through her job at the Department of Veterans Affairs. If necessary, she plans to challenge her insurer by writing letters explaining the science. “It’s like this disease has to fight for everything. We should not have to fight for everything,” she said.

A nurse removes the catheter from sickle cell patient Marqus Valentine’s neck, following a blood transfusion at Edward Hospital in Naperville, Ill. (Jenny Gold/Kaiser Health News)

Marqus Valentine prepares to take his evening medications, including hydroxyurea, until recently the only FDA-approved drug for sickle cell disease. (Jenny Gold/Kaiser Health News)

While the Valentines and many other sickle cell families have high hopes for Endari, doctors already question whether it will mark a significant improvement in care.

“We have one treatment option, so it’s lovely to have a second treatment option, but I don’t think this will change the world of sickle cell,” said Sophie Lanzkron, who directs the adult sickle cell clinic at Johns Hopkins Medicine. “It’s not a game changer.”

And because Endari is a powder that must be taken twice a day, Lanzkron worries it will be an inconvenience for patients, leading to poor compliance.

As it stands, few patients even receive the current standard of care: hydroxyurea. The chemotherapy drug, approved for sickle cell treatment in 1998, is considered safe and costs less than $100 per month.

About 3 in 4 sickle cell patients who could benefit from hydroxyurea are not being treated with it, according to a study published in񎧟 in the Journal of the American Medical Association.

“We should be prescribing it to everybody whoâ€s eligible, and everyone who’s eligible should be taking it,” Lanzkron said.

Some patients do not want to take it because of side effects such as hair loss, skin changes and nausea, but many others lack access to doctors who understand how to prescribe the drug.

“What amazed me are the number of people in their 30s who have never seen a hematologist, said Julie Kanter, who runs the sickle cell program at the Medical University of South Carolina in Charleston. Many hematologists do not treat sickle cell patients, and a 2014 survey found that just 20 percent of family physicians are comfortable caring for them, mainly due to a lack of training on the complex disease.

œIn general, 80 percent of the patients are not well cared for, are not on the right medications and have not been screened for the right issues,” said Kanter.

Francesca Valentine has been advocating for her son Marqus, who has sickle cell disease, since he was born. (Jenny Gold/Kaiser Health News)

The Fight For Informed Care

Instead, these patients often go to emergency rooms in severe pain, as the misshapen red blood cells clog the vessels and cut off oxygen to joints and organs.

It feels like you want to die almost. You just want the pain to stop — nothing but pure, unfiltered pain,” Marqus Valentine described. “Your mind starts to race, your brain cannot process it. And it just doesn’t stop. It does not stop until someone intervenes and you get medication.”

But emergency room doctors rarely understand how to treat these crises, and many patients are misdiagnosed and inappropriately sent home, said Patricia Kavanagh, a pediatrician and emergency department physician at Boston Medical Center. “What we learn about sickle cell disease in med school is usually covered in 20 minutes.”

Nearly 40 percent of sickle cell patients have to be readmitted to the hospital within 30 days — more than for any other diagnosis, according to the federal government’s Agency for Healthcare Research and Quality.

Kavanagh brought protocols established by national experts for sickle cell treatment to her own emergency room, but says ER doctors are “coming late to the table.”

In 2014, the National Heart, Lung, and Blood Institute, part of the National Institutes of Health, put out guidelines for physicians, and 11 national organizations endorsed the protocols — not the American College of Emergency Physicians (ACEP), however.

Recently, Kavanagh has been working with ACEP to get more emergency departments to adopt the guidelines and to triage sickle cell patients faster, so they don’t have to wait for care in a crisis or get misdiagnosed.

But protocols are only as good as the science behind them, and “the evidence for most of the guidelines is not strong,” because there have not been enough studies on the disease, said Rosalyn Stewart, a Johns Hopkins physician who is an investigator on a federal grant to improve care for people with sickle cell.

“In the totality of health care, the research that has been devoted to sickle cell has been very small compared to other diseases with the same frequency,” she said.

The Fight For Funding

Sickle cell funding pales in comparison to other diseases. Cystic fibrosis, which affects 30,000 people in the U.S., for example, gets seven to 11 times more funding per patient than sickle cell disease, according to a 2013 study in the journal Blood.  The ALS challenge in 2014 raised $115 million for approximately 20,000 patients in the U.S.

There are some new studies in the works, including eight funded by the Patient-Centered Outcomes Research Institute, but many questions remain unanswered.

One major problem is that no national data registry exists for sickle cell disease, unlike most other diseases, said Mary Hulihan, director of the sickle cell program at the Centers for Disease Control and Prevention.

Marqus Valentine sits on the edge of his hospital bed, following a blood transfusion at Edward Hospital in Naperville, Ill. (Jenny Gold/Kaiser Health News)

“It means we don’t know what is happening to the patients. We don’t have even basic information like how many people in the U.S. have sickle cell disease or where they are getting their health care or what their health care utilization looks like,” said Hulihan. â€The most basic questions you would like to have answered cannot be answered at a national level for this condition. It makes things very difficult.”

Congress has not passed funding or a directive for such a registry, said Hulihan, so instead the CDC Foundation has obtained limited funding from pharmaceutical companies to collect data — and only in California and Georgia. There is no funding to expand the program to other states.

So far, Congress has taken little action. In 2004, it provided $10 million per year in funding for sickle cell research, surveillance and treatment as part of the American Jobs Creation Act, but those funds expired in 2009.

Since then, Rep. Danny Davis (D-Ill.) has been trying to get a reauthorization passed, with little success. “Sickle cell does not have the priority in this country that it had in the 쌨s, when I started working on it,” said Davis. â€Congress has been cutting everything that wasn’t nailed down.”

Family photos hang on the wall of the Valentines’ home in Lisle, Ill. (Jenny Gold/Kaiser Health News)

Even with all the delays and setbacks, experts and patients alike remain hopeful that the treatment of sickle cell disease can gain momentum and attention.

“Things are happening that have never happened before. I’ve been around sickle cell for a while, and never before have you seen this kind of buzz,” said Derek Robertson, president of the Maryland Sickle Cell Disease Association. Robertson, whose brother died in 1977 from the disease, said he would like to see sickle cell take its turn on the national stage.

“I would like to see the NBA have a day where they talk about sickle cell or wear a color. I don’t realistically expect sickle cell to be like breast cancer, but we could have more. I donâ€t know if LeBron James knows about sickle cell disease.”

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Children’s Insurance, Other Health Programs Funded — For Now — In Bill

The bill passed by Congress late Thursday to keep most of the federal government funded for another month also provided a temporary reprieve to a number of health programs in danger of running out of money, most notably the Childrenâs Health Insurance Program, or CHIP.

Funding for CHIP technically expired Oct. 1. States have been operating their programs with leftover funds provided by the Department of Health and Human Services since then. But nearly half of the states were projected to run out of money entirely by the end of January, putting health coverage for nearly 2 million children at risk by that point.

The funding provided by Congress for CHIP — $2.85 billion — is for six months, but it is back-dated to Oct. 1, so it will run out at the end of March 2018. The program covers 9 million children across the country.

This week, Alabama announced it would curtail enrollment and renewals starting Jan. 1, and start disenrolling children currently in the program Feb. 1. On Friday, the state posted a notice on its website that those plans were now canceled. Several other states, including Colorado, Virginia and Utah, have begun the process of notifying families that their coverage could end unless Congress acts.

The funding bill also provided a temporary reprieve for a raft of other health programs that were running out of money, most notably the nation’s community health centers, which provide basic primary care to 27 million Americans. Many centers are already freezing hiring, laying off staff and closing sites due to the uncertain funding stream from Washington.

Other health programs that were set to expire but have been funded, for now, include the National Health Service Corps, which places health practitioners in medically underserved areas, and the teaching health centers program, which trains medical residents in community health centers.

Backers of CHIP complain that short-term funding fixes are disruptive to the program.

“By failing to extend long-term funding for the Children’s Health Insurance Program, Congress falls far short of the reassurance and relief families deserve,” said a statement from the American Academy of Pediatrics.

A coalition of children’s groups, including the Children’s Defense Fund and the March of Dimes, agreed, saying the short-term funding “only causes more chaos and confusion on the ground.”

Both Republicans and Democrats strongly support CHIP, which was created in a 1997 budget bill. What they disagree on is whether its funding — expected to be roughly $8 billion over the next 10 years — should be paid for by cutting other health programs. The House in November passed a five-year renewal that would finance CHIP primarily by reducing the Affordable Care Act’s Prevention and Public Health Fund and by raising some peopleâ€s Medicare premiums. Democrats question why CHIP needs to have its funding offset while Republicans are adding $1.4 trillion to the deficit through their tax cut bill.

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Viewpoints: Obamacare Is Not Repealed; Puerto Rico’s Water Needs; Keeping Humanity In Medicine

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State Highlights: Calif.’s Sutter Health Gets Hit With $18K Fine Over Lobbying Violations; Colo. Governor Names Interim Insurance Commissioner

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Research Roundup: Victims Of Bullying; Court-Ordered Addiction Treatment; And Cervical Pessaries

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HHS And Texas Reach Accord For $25B Medicaid Funding For Hospitals

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Under Fire For Alleged Role It Played In Opioid Crisis, Purdue Tries To Change The Narrative

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Life-Threatening Complications For Women Giving Birth Have More Than Doubled In Past 20 Years

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In Response To Criticism, CMS Revises Methodology For Hospital Star Ratings

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