the-signs-of-depression

Friday, October 28, 2016

FDA Faults 12 Hospitals For Failing To Disclose Injuries, Deaths Linked To Medical Devices

Federal regulators said 12 U.S. hospitals, including well-known medical centers in Los Angeles, Boston and New York, failed to promptly report patient deaths or injuries linked to medical devices.

The Food and Drug Administration publicly disclosed the violations in inspection reports this week amid growing scrutiny of its ability to identify device-related dangers and protect patients from harm.

Some of the reporting lapses were found at Massachusetts General Hospital in Boston, NewYork-Presbyterian Hospital and two hospitals in Los Angeles - the Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center.

Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said the violations pointed to a larger problem among hospitals nationwide in reporting patient harm tied to medical devices.

“We believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals,” Shuren wrote in an agency blog post this week. “Hospital staff often were not aware of, nor trained to comply with, all of the FDA's medical device reporting requirements.”

Under federal rules, hospitals must within 10 days report serious injuries potentially caused by devices to the manufacturer and notify both the manufacturer and the FDA about any deaths that may have resulted. Manufacturers are required to file reports to the FDA within 30 days of learning about an injury or death that may have been caused by a device.

Among the 17 hospitals reviewed, the FDA said six didn't properly report both patient deaths and injuries linked to devices within 10 days as required. Five other hospitals didn't report serious injuries in a timely manner, according to the FDA. The inspection at one hospital, NewYork-Presbyterian, focused only on a death.

NewYork-Presbyterian said it filed medical device reports “in accordance with FDA regulations” and none of the agency's findings related to the quality or safety of patient care.

It's hard to discern what devices were involved or other details in many of these cases because the inspection reports are brief and partly redacted by the FDA. The inspection reports indicate that in some cases hospitals reported events late and in others not at all.

At Massachusetts General, an FDA investigator found reporting delays of 10 months and 18 months in two separate patient deaths related to devices.

In a statement, hospital spokeswoman Terri Ogan said the FDA's findings all have been addressed. “Massachusetts General Hospital takes its reporting obligations very seriously and strives to comply with all requirements in a comprehensive and timely manner,” she said.

At Huntington Memorial Hospital in Pasadena, Calif., an FDA investigator found that a patient died from complications related to a multi-drug resistant infection and cardiac arrest following a procedure involving a duodenoscope, a long and flexible instrument put down a patient's throat.

According to FDA records, the hospital learned through test results that the patient's infection was likely related to 14 other confirmed infections caused by contaminated duodenoscopes. “However, this death was not reported to the FDA and the manufacturer by your facility,” the FDA inspector wrote in a December 2015 report.

A spokeswoman for Huntington Memorial, Eileen Neuwirth, said “we have taken steps to ensure rigorous compliance going forward.”

The FDA findings underscore concerns raised by a U.S. Senate report in January, which exposed reporting failures by hospitals as well as mistakes by device makers that contributed to multiple superbug outbreaks across the U.S. from contaminated duodenoscopes. The FDA's oversight of medical devices was also faulted in the report.

As many as 350 patients at 41 medical centers worldwide have been infected or exposed to contaminated duodenoscopes from 2010 to 2015, according to the FDA.

The agency initiated its investigation of hospitals' reporting in December 2015, a month before the Senate report was released. But the agency was already under fire by then for spotty oversight of duodenoscope manufacturers and other devices.

Shuren said in his blog post that the agency focused on hospitals where safety issues had occurred involving either duodenoscopes or power morcellators, a surgical tool used in hysterectomies. Morcellators are used to cut up benign growths called fibroids, but the FDA has warned about the device spreading cancerous tissue in the abdomen and pelvis. The investigators examined incidents involving other devices as well.

Other than publicly announcing the violations, Shuren said the agency didn't plan on taking further action against the hospitals. Instead, he said he wants to work with the hospital industry to improve monitoring of devices.

“We feel certain there is a better way to work with hospitals to get the real-world information we need, and we should work with the hospital community to find that right path,” Shuren wrote.

Lawmakers, health policy experts and the FDA have proposed various reforms aimed at strengthening device surveillance, including tracking insurance claims data to supplement the injury reports and automating “adverse event” reports through electronic health records.

The issue may take on more urgency after federal authorities this month highlighted the infection risk from yet another commonly used device - heater-cooler units used in open-heart surgeries. The FDA is holding a public meeting Dec. 5 on improving hospital-based surveillance of devices.

According to the FDA, the hospitals that didn't report deaths as required were Advocate Lutheran General in Park Ridge, Ill.; Huntington Memorial Hospital; Reading Hospital and Medical Center in West Reading, Pa.; Allegheny General Hospital in Pittsburgh; NewYork-Presbyterian; and two in Boston - Brigham and Women's Hospital and Massachusetts General.

The agency said those that failed to report serious injuries in time were UCLA; Cedars-Sinai; Virginia Mason Medical Center in Seattle; UMass Memorial Medical Center in Worcester, Mass.; and Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

The FDA inspection for Advocate Lutheran General Hospital refers to 10 deaths related to a scope-related outbreak of carbapenem-resistant enterobacteriaceae, a superbug known as CRE. But a spokeswoman for the hospital said a “review of medical records in all 10 cases confirmed the cause of death was not linked to CRE.”

Dr. Leo Kelly, vice president of medical management at Advocate Lutheran, said in a statement the hospital will continue to work with the FDA and manufacturers “to ensure the safety and well-being of our patients.”

Many of the hospitals involved said they welcomed the agency's feedback and supported efforts to improve device oversight.

Cedars-Sinai said the FDA's findings related to its use of a surgical stapler in June 2015.

UCLA said it promptly reported scope-related cases to the FDA but the agency asked for duplicate reports through a separate system.

Suzanne Anderson, president of Virginia Mason Medical Center, said the FDA's recommendations on device reporting “will ultimately enhance patient safety across the country.”

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

Wednesday, October 26, 2016

States See Peer-Recovery Coaches As A Way To Break The Addiction Epidemic

PAWTUCKET, R.I. - Dustin French, 29, had four drug overdoses in the span of a year. “I was dead on arrival to the hospital,” he said of his last heroin overdose, which happened in April. “I woke up … and I didn't feel like myself. I could tell this time I was really dead.”

Now, he says, he's 100 days clean. He lives with his girlfriend. And he has three sons: an 8-year-old, a 2-year-old and a 1-year-old.

He credits his turnaround to a relationship he launched in the emergency department with a “peer recovery specialist” - someone who had herself struggled with addiction. She was there, he said, “when nobody else was.”

Stories like French's have led policymakers - here in Rhode Island and in other states - to embrace a road to recovery led by people who have traveled it. It's a growing effort to address the nation's burgeoning opioid epidemic.

Here's how the idea, still in its infancy, works: During overdose patients' emergency department stays, they are introduced to a “peer recovery coach.” Patients trust these coaches, with whom they share common experiences. Coaches then stay in touch after discharge, meeting patients regularly to help navigate the path toward sobriety and resolve issues such as housing, food stamp applications, court obligations or job searches.

The model is gaining traction because millions of Americans are estimated to abuse opioids, an epidemic that's behind billions of dollars in hospitalization costs. States want to train these workers, fund them and integrate them into the health system. Even so, they have to cross numerous logistical hurdles if they want the strategy to pay off.

So far, French has received active follow-up care, both from his coach and from AnchorED, the organization that operates Rhode Island's peer recovery program.

Now, he has a job cleaning kitchen equipment. He is studying for his commercial driver's license.

“Anything I needed, she was always there,” he said of his coach. “That program saved my life.”

The Anchor bulletin board includes postings with information on job openings, educational opportunities and other support meetings and wellness programs the center offers - for instance, recovery programs focused on veterans, or yoga classes. (Shefali Luthra/KHN)

Rhode Island – where, since 2009, more than 1,000 people have died from painkiller or heroin overdoses - is taking a lead. This summer, the state committed to assigning a peer coach to every hospital emergency department and footing the bill. Other states, such as New York, New Jersey, Wisconsin, Maryland, Pennsylvania, Massachusetts and Delaware, are experimenting with ways to place and pay for peer coaches in their ERs, though programs vary in size and evolution. The National Governors Association has also come out in favor of the mode.

States hope to keep patients healthier and improve their own finances. The cost of a phone call with a peer coach, the logic goes, is less than that of a return trip to the ER. Many addiction patients are covered by Medicaid, the federal-state health plan for low-income people.

But it's a gamble to see whether lay people - whose main asset is that shared experience with patients - could be part of the secret sauce to curbing painkiller and heroin abuse. And challenges persist. These include getting more insurance plans to cover the service and devising payment structures in which they can easily do that; certifying and training peers; and the big one, finding definitive evidence that the peer coaches help.

“There is barely any research,” noted Dr. Manish Sapra, associate chief of clinical affairs, network hospitals and affiliates for Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center, which has a peer recovery pilot program. Despite growing interest, “there are no randomized controlled trials to show peer recovery efforts or peer support have as big an effect as what we're hoping.”

Intuitively, it makes sense. Peers who have navigated addiction are more relatable, experts said. They can spend an hour with patients, compared to the emergency doctor who, on a hectic Friday night, may only have a few minutes to discuss treatment. And, perhaps most importantly, they offer living proof that recovery is possible.

“When you're struggling through this issue - however you got there - you often feel like there's no hope, there's no end to this and you're alone,” said Dale Klatzker, president of The Providence Center, which operates AnchorED.

But if advocates want this model to stick, they need to prove peers provide more than just comfort. States want to know the service actually improves health outcomes for people with addiction. Insurers want to know they will save money if they cover this coaching model and the related services, such as helping clients in court or accompanying them to therapy.

That's why Maryland, which is working to expand its state-sponsored program, is starting to collect data on whether patients improve and what services the counselors help them get. The state hopes to track whether this intervention is cost-effective, by cutting the number of patients who return to the emergency room. Similar research is underway in Rhode Island and Massachusetts.

“Producing robust research to support [its] effectiveness … is critical,” said Colleen Barry, a professor of health policy at Johns Hopkins University, who co-directs its Center for Mental Health and Addiction Policy Research.

Donna Price, 57, has been a peer recovery specialist at Anchor for just over a year. She has been in recovery for heroin abuse for about 20 years, she said. Now, she's one of the coaches who visits overdose patients at local emergency departments. (Shefali Luthra/KHN)

And there are other hurdles. States have to figure out how to credential coaches. Some are developing certification programs that including training in motivational interviewing, navigating community resources, building rapport and understanding how addiction and recovery work.

Part of the challenge is ensuring counselors meet certain standards without making them seem less authentic and relatable to patients - like a junior clinician. Many hospitals also have strict rules about whether their employees can have a criminal background, which further limits the pool.

“We want to hire people with lived [addiction] experience, and the reality is most people with that will have a criminal record,” Dr. Sarah Wakeman, medical director of the substance use disorder initiative at Massachusetts General Hospital's Center for Community Health Improvement, which has piloted the model.

Recruiting is another issue. In Rhode Island, AnchorED employs about 22 peers to serve the state. Each has a caseload of maybe 40 clients at once. But that hardly meets the need, said George O'Toole, who manages the peer recovery program. And that's in a small state, with about a dozen hospitals. Other states trying to emulate the model have to scale up.

Consider New York. “Everything's at such a different scale. But [Rhode Island's] approach makes sense,” said Robert Kent, general counsel for New York State's Office of Alcoholism and Substance Abuse Services.

Meanwhile, the counselors also need to be established in their own recovery and be willing to work in the program, which can be emotionally taxing and time-consuming.

And then patients don't always buy in, warned Dr. Gary Bubly, medical director for the Miriam Hospital Emergency Department in Providence. His department has “heavily used” peer coaches. The symptoms of withdrawal can be so unpleasant that, even after an overdose, patients may reject any treatment path.

But the potential outweighs these complications, advocates said. “If there is one thing I can look at in my career and say, 'That was a good thing,' - this will be it,” said Rebecca Boss, Rhode Island's acting director of behavioral healthcare, developmental disabilities and hospitals. She helped develop the program.

Take French, the AnchorED patient. He calls these early recovery months transformative.

“These people understand addiction, and they're going to meet you where you're at. Whether you're using or not - they're going to help you.”

Despite Health Care Costs Actually Slowing Down, Americans Still Feeling The Pinch

Although the rise in health insurance premiums moderated from 2010 to 2015, compared with the previous five years, wages did not keep pace with the increases so it still feels like a burden to many Americans.

State Highlights: Even With More Residency Slots, Fla. Still Faces Doc Shortage; Mental Health, Drug Abuse Driving Up E.R. Visits In N.J.

Outlets report on health news from Florida, New Jersey, Colorado, Virginia, California, Georgia, Ohio, Maryland, New Hampshire and Washington.

Clinton Took More Conciliatory Tone With Health Care Industry In Paid Speeches

On the campaign trail, Democratic presidential candidate Hillary Clinton has sharply criticized the health care industry, accusing pharmaceutical companies of profiteering and vowing to control skyrocketing costs.

But Clinton's tone was often more conciliatory before her presidential campaign when she addressed medical companies and trade groups as part of her brief but lucrative career delivering speeches for pay.

Elements of the speeches, some of which were delivered behind closed doors, were revealed in a hacked email that WikiLeaks made public in recent weeks.

“I know how critical the role that you play is,” Clinton told the Advanced Medical Technology Association, a medical device trade group, in a 2014 speech. She avoided a direct question about a 2.3 percent tax on medical devices that was intended to fund the Affordable Care Act but was suspended until the end of 2017 after intense industry lobbying.

That appearance, for which Clinton was paid $225,000, was one of 15 paid speeches she gave to health care industry audiences, drawing a total of $3.5 million in fees. Overall, between the end of her tenure as secretary of state in February 2013 and the start of her 2016 White House bid, Clinton was paid about $21.6 million in speaking fees, according to her federal financial disclosure forms.

The health care speeches, largely overshadowed by the political storm over Clinton's paid presentations to big banks, provide another example of an industry with much at stake during the next administration adding to the personal wealth of the woman who is now the Democratic presidential nominee.

Clinton campaign spokeswoman Julie Wood said that the candidate has a long record of “standing up to special interests in health care,” noting that the industry waged an aggressive push against her efforts as first lady in the early 1990s to overhaul the system.

“In this campaign, she has put forward proposals to hold drug companies accountable and ensure they put patients before profits and strengthen scrutiny of insurance companies,” Wood said. “She's called out drug companies by name when they try to jack up prices with no apparent justification, like Mylan and the EpiPen, or exploit tax loopholes to shift profits overseas, like Pfizer's proposed inversion, or insurance company mergers that threaten to raise prices and restrict choice.”

Transcripts and excerpts of Clinton's paid remarks show a cautious speaker treading delicately between flattering her hosts and avoiding compromises on policy that might complicate a presidential run in a time of public antipathy toward the drug industry and rising insurance costs.

One internal email published by WikiLeaks that gained attention this month, for showing an aide flagging politically dicey comments Clinton made to financial institutions, also compiled Clinton's potentially controversial remarks on issues such as single-payer health care, universal coverage, medical devices and pharmaceutical price controls.

The difference between Clinton's tone as a candidate and her paid remarks to the industry is evident when it comes to her comments on how drugmakers deal with the burden of paying high U.S. taxes and issues of costs.

In 2014, Clinton seemed sympathetic to the struggles of the drug industry when she appeared alongside Jim Greenwood, chief executive of the Biotechnology Innovation Organization (BIO), a trade association that includes large drugmakers such as Pfizer and Gilead Sciences.

“I don't want to see biotech companies or pharma companies moving out of our country simply because of some kind of tax - perceived tax disadvantage and potential tax advantage somewhere else,” she said, according to an excerpt included in the email released by WikiLeaks.

The group paid Clinton $335,000 for the speech, according to her disclosure form.

But as a candidate, Clinton has attacked the industry on several fronts. Her campaign website, for instance, singled out the now-defunct proposed merger of Pfizer and Allergan - which would have allowed Pfizer to avoid taxes by moving its headquarters to Ireland - for “eroding the U.S. tax base.” And Clinton sent biotechnology stocks tumbling last year when she rebuked “price gouging” by the specialty drug market, tweeting a link to an article about Turing Pharmaceuticals and then-chief executive Martin Shkreli.

Greenwood, the BIO executive who sat with her in 2014, criticized Clinton's jab, saying at the group's convention two years later that “even a lone tweet by a candidate for high office can have unintended, market-moving consequences.”

BIO did not respond to requests for comment.

Clinton resisted the idea of drug price controls during a 2014 dinner with the Drug, Chemical and Associated Technologies Association, at a venue the moderator described as being “filled with individuals from the pharmaceutical industry.” She was paid $250,000 for the speech, the content of which has previously not been reported.

“Well, I have to start by saying I don't think we proposed price controls,” Clinton said in reference to her efforts in the 1990s, according to the WikiLeaks email. “We proposed more competition, more transparency, state exchanges, if those sound familiar, to entice greater negotiation over price.”

In her 2014 appearance before the Advanced Medical Technology Association, Clinton addressed the group's conference in Chicago and participated in a question-and-answer session with the group's chief executive, Stephen Ubl, according to a news release from the group.

Ubl has since become chief executive of the industry's largest trade association, Pharmaceutical Research and Manufacturers of America, and has been critical of Clinton's negative comments about the industry during the campaign.

A spokeswoman for the association, Wanda Moebius, said asking Clinton to speak was in keeping with the group's outreach to important policymakers “to address our members on key issues of the day and to share their policy perspectives.”

The speech excerpts show that Clinton has consistently supported the Affordable Care Act. She applauds government-provided health care but is cautious about applying those lessons to the U.S. market.

Clinton expressed resignation to the current private insurance market in a 2013 address to the Economic Club of Grand Rapids - whose board includes the president of Blue Cross Blue Shield Michigan.

“People are entitled to make a profit,” she said.

Despite Clinton's criticism, the pharmaceutical and health products industry is the 10th-largest industry among her campaign contributors, giving about $11.6 million to her campaign and outside groups supporting her, according to the Center for Responsive Politics, which analyzes Federal Election Commission data. Hospitals and nursing homes have donated $3.8 million. Republican nominee Donald Trump has received $1.5 million from health professionals.

Although Clinton has campaigned on improving the Affordable Care Act, she also has accepted speaking fees from groups that opposed aspects of the health law, including the National Association of Convenience Stores and Fuel Retailing and the Society for Human Resource Management.

Elizabeth Lucas contributed to this report.

Thoughts On Mental Health, Medicare And Other Issues

Opinion and editorial writers offer their thoughts on a range of health policy topics.

Tuesday, October 25, 2016

State Highlights: Minn. Nurses Settlement Could Give Hospitals More Labor-Relations Muscle; Legal Fees Grow In Kansas Planned Parenthood Case

Outlets report on health news from Minnesota, Kansas, Maine, Massachusetts, Georgia, Florida, New Hampshire, Ohio and California.