Tuesday, 22 November 2016

An Average Patient In A Clinical Trial Isn't An Average Patient In Real Life. And That's A Problem.

Those who sign up for clinical trials tend to be younger, whiter and healthier than other cancer patients, which is causing a dissonance between the success of a drug in trials and its success in real life.

Monday, 14 November 2016

State Highlights: Legal Challenges Ahead For Expansion At Boston Children's; Virginia Gets Mediocre Grade On Dental Health

Outlets report on health news from Massachusetts, Virginia, Florida, Pennsylvania, Wisconsin, California, Ohio, Minnesota, Washington, Maryland and Texas.

2016 Version Of Washington's Quadrennial Guessing Game: Who Will Run HHS?

Stat takes a look at some of the people whose names are being mentioned for secretary of the Department of Health and Human Services and Modern Healthcare reports on the transition team.

Tuesday, 1 November 2016

Monday, 31 October 2016

Viewpoints: The DEA's Role In The Opioid Epidemic; What About 'Patient Zero'?

A selection of opinions and editorials from around the country.

State Highlights: N.H. Partnerships Benefit Patient Care; Wash. Children Hospitalized With Polio-Like Symptoms

Outlets report on health news from New Hampshire, Washington, California, Pennsylvania, Virginia, Ohio, Kansas, Arizona, Iowa and Florida.

Lack Of Mental Health Professionals Hampers Treatment Options For Children

Not a single state has what professional groups deem a sufficient number of child psychiatrists, The Washington Post reports. Also, a presidential task force makes recommendations to bring mental health care to the same level as physical care.

Health Leaders Turning An Eye Toward Physician Burnout But Solutions Are Hard To Find

In 2011, a survey of nearly 7,000 physicians by the American Medical Association and the Mayo Clinic found that just over 45 percent met criteria for burnout. Three years later, a follow-up survey found signs of burnout among nearly 55 percent of physicians, Modern Healthcare reports.

Millions Of Records Lost In 22 Major Health System Cybercrimes Over Past Year

Two surveys released this week find that hospitals must do a better job of guarding valuable health care data against hacking.

Two Massive Commercial Flops May Send Chilling Effect Through Biotech Industry

New cholesterol drugs that were expected to make billions failed to live up to their potential. And the disappointing sales has the new sector - which relies on the idea that the risky, expensive process of developing new drugs can one day pay off big - on edge. Meanwhile, the market is in flux after a dour earnings report from one of the largest pharmaceutical distributors in the U.S.

Insurers, Hospitals Clash Over Help Paying Obamacare Premiums

MADISON, Wis. - Having health insurance is vital for 21-year-old Mercedes Nimmer, who takes several expensive prescription drugs to manage multiple sclerosis. So Nimmer was thrilled to get health insurance last year through the Affordable Care Act's marketplace and qualify for a federal subsidy to substantially lower her cost.

Yet, the government assistance still left her with a $33 monthly premium, a hefty amount for Nimmer, who makes $11,000 a year as a part-time supply clerk.

Nimmer, though, doesn't have to worry about even that expense thanks to a United Way of Dane County program that has provided premium assistance to about 2,000 low-income people since 2014. The program, called HealthConnect, is funded by a 2013 gift of $2 million from UW Health, a large academic hospital system connected to the University of Wisconsin that also runs its own marketplace health plan.

“Oh my gosh, this is a big deal for me to get this help,” Nimmer said, noting the insurance is vital to cover her medications. The money she saves from the assistance program goes to help pay for gas to get to work, she said.

HealthConnect is one of several community-based programs across the United States helping thousands of lower-income Americans with their Obamacare marketplace premiums. Similar efforts operate in Texas, Oregon, Washington, North Carolina and South Carolina.

But premium assistance programs have come under fire from insurers. They argue that it is not fair for hospitals, other health providers and disease advocacy groups financed by providers to try to steer people who could be covered by Medicare or Medicaid into marketplace plans with higher reimbursement rates.

The federal government has banned hospitals from directly subsidizing patients' health insurance premiums. But America's Health Insurance Plans, the industry's lobbying group, wants the Obama administration to prohibit all premium assistance programs that are funded directly or indirectly by hospitals and other providers with a financial interest in the patient's care.

“In many cases these practices are harming patients and undermining the individual market by skewing the risk pool and driving up overall health care costs and premiums,” AHIP said in Sept. 22 letter to Andy Slavitt, the acting administrator of the Centers for Medicare & Medicaid Services. The letter notes specific concerns about plans assisting patients requiring kidney dialysis. It says one insurer saw its spending on those patients rise from $1.7 million in 2013 to $36.8 million in 2015 when the number of patients with serious kidney disease rose from 28 to 186.

AHIP officials also said patients could face consequences if the third-party groups stop paying premiums or the government determines patients are receiving a federal subsidy for which they are not eligible.

America's Health Insurance Plans wants the Obama administration to prohibit all premium assistance programs that are funded directly or indirectly by hospitals and other providers.

America's Health Insurance Plans wants the Obama administration to prohibit all premium assistance programs that are funded directly or indirectly by hospitals and other providers.

In response, CMS says it is considering new rules for third-party payment programs.

Nonetheless, insurers are taking action. Aetna, which announced this summer that it was scaling back its marketplace offerings, said that third-party groups steering patients to the individual market had contributed to an unhealthy mix of customers in its marketplace plans.

Blue Shield of California in July filed suit in a state court against CenCal Health, which manages the Medicaid program in Santa Barbara and San Louis Obispo counties. Blue Shield alleges that CenCal was avoiding millions of dollars in medical care claims by enrolling around 40 of its very ill members in Blue Shield's individual health plans and paying the premiums on their behalf. CenCal denied the allegations in lawsuit, saying it paid the patients' monthly Blue Shield insurance premiums so they could afford private insurance. It has since discontinued the practice.

UnitedHealthcare filed a lawsuit in federal court in July against kidney dialysis provider American Renal Associates, accusing it of encouraging patients in Florida and Ohio who were eligible for Medicaid or Medicare to move to the insurer's commercial plans to extract up to 20 times more than the $300 or so that the federal programs pay in reimbursements. American Renal Associates has said the suit is without merit.

The suit alleges that the patients' premiums were paid by the American Kidney Fund, an advocacy group for patients.

AHIP officials note that the fund is supported by dialysis providers who stand to benefit financially from patients gaining marketplace coverage over payments from Medicaid or Medicare.

The nonprofit American Kidney Fund has helped more than 6,400 people with their marketplace premiums. The fund's officials said it's not trying to steer people away from government coverage but trying to help those who otherwise couldn't afford coverage.

“It is critically important to emphasize that people with disabilities in general - and with end-stage renal disease in particular - should not be broadly excluded as a class from the insurance marketplace if they are unable to afford their health insurance premiums,” LaVarne Burton, the fund's CEO, said in a statement.

Some patient advocates, like those at HealthConnect in Wisconsin, say third-party payers have an important role in helping low-income customers afford their coverage. UW Health said in a statement that HealthConnect helps all providers, including UW Health, by reducing the number of uninsured patients and potentially helping people seek care earlier in their illness.

The program pays an average of $109 monthly per person in premium assistance. For every dollar spent, HealthConnect generates $2.26 in federal subsidies, said Krystal Webb, a spokeswoman for United Way of Dane County.

United Way said it structured HealthConnect to avoid a conflict of interest. Eligible people first buy their policy, which can be any of several silver-level plans on the federal marketplace. After that, they can apply for a HealthConnect subsidy. The program is administered by United Way, and UW Health plays no role in patients' choice of health plan, although its marketplace plan, Unity Health, refers people who may be eligible there.

Despite AHIP's concerns, some health insurers in Dane County say HealthConnect is filling a need, according to interviews with several plans. “We support United Way's HealthConnect efforts as a way to provide affordable insurance options to the residents of Dane County,” said a spokesman for Dean Health Plan, one of the larger marketplace plans in the county.

In Texarkana, Texas, Christus St. Michaels Health System donated $200,000 last year to an assistance program serving 138 people with marketplace coverage. The program is run by a local government agency called the Ark-Tex Council of Governments, and Christus has no control over who enrolls or what plan they choose.

“Our mission is to help the poor and this is certainly one of the ways to do that, and it gives people the opportunity to have health coverage when they normally wouldn't,” said Mike Hargrave, the hospital's manager of employee assistance and community outreach services. People with incomes between 100 and 150 percent of the federal poverty level (about $11,880 to $17,820 for an individual) are eligible.

Hargrave doesn't deny the hospital could benefit when more people gain insurance, but he notes other hospitals in the region benefit, too.

The insurance industry is also troubled by premium assistance programs funded by anonymous donors since they could be hospitals looking to protect their identity, said AHIP spokeswoman Clare Krusing.

For example, PremiumHealth.org, run by United Way of the Greater Triangle in North Carolina helps more than 850 people with incomes between 100 percent to 175 percent of the federal poverty level in Durham, Orange and Wake Counties.

An anonymous donor provided $1.2 million in funding for the program, said Melanie David-Jones, a senior vice president for United Way. She would not say why the donor wished to remain anonymous.

Noel Pitsenbarger, 48, of Durham, said the program made it possible for him to have health insurance this year by covering the $200-a-month premium for his Blue Cross Blue Shield of North Carolina policy. With insurance, he said, he got a colonoscopy, physical exam and help paying for several medications. And it saved him from having to pay a $1,000 bill after he cut his finger and had to go to the emergency room.

“It's been extremely beneficial,” he said.

Friday, 28 October 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, 26 October 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)

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)

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.”

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.

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.

Tuesday, 25 October 2016

Monday, 24 October 2016

Feds Find Doctor Listings Often Wrong In Medicare Advantage Directories

Provider directories for private Medicare Advantage plans are riddled with errors, according to the government's first in-depth review.

The results made public Monday, arriving amid the annual enrollment period through Dec. 7, validate gripes long made by seniors and consumer advocates. The level of errors still surprised regulators, said officials from the Centers for Medicare & Medicaid Services who disclosed their findings at an industry conference in Washington.

Incorrect information was found for almost half of the 5,832 doctors listed in directories for 54 Medicare Advantage plans checked last fall, they said. Only online directories were examined.

The government hopes that a new rule this year will help raise that bar because it requires Medicare Advantage plans to contact doctors and other providers every three months and update their online directories in “real time.”

CMS did not identify the names of insurers that were surveyed.

CMS' survey found the most error-prone listings involved doctors with multiple offices that did not serve health plan members at each location, said Christine Reinhard, a health insurance specialist in the CMS Division of Surveillance, Compliance and Marketing.

Explanations could be that the doctor was retired, worked at a different location or never worked at the address. Or maybe the doctor never had a contract with the Medicare health plan - a less likely possibility, according to officials.

The review also uncovered:

  • Wrong phone numbers for 521 doctors' offices.

  • Wrong addresses for 633 doctors' offices.

  • Error rates that exceeded 60 percent of the doctors surveyed for five Medicare Advantage plans.

CMS has not issued any fines but that could still occur, said Jeremy Willard, also a health insurance specialist in the CMS surveillance division. Inaccuracies found in the Medicare Advantage directories could lead to penalties up to $25,000 a day per beneficiary or bans on new enrollment and marketing.

Senior citizens rely on provider directories when choosing a health plan to identify in-network doctors. They also use them when seeking referrals to specialists.

directories“Errors jeopardize the beneficiary's ability to be connected with a needed provider,” Willard said.

CMS carried out the survey by randomly calling 108 doctors representing primary care, cardiology, ophthalmology and oncology for the Medicare Advantage companies. The highest error rates involved primary care physicians and cardiologists.

America's Health Insurance Plans, the industry trade group, said its companies work hard to make provider directories accurate and keep them up-to-date.

“That's what consumers need - and that's what we're committed to improving,” said spokesman David Merritt, acknowledging that plans needed to do better.

More than 17 million Americans, or nearly a third of Medicare beneficiaries, get coverage through Medicare Advantage plans.

Medicare Advantage plans and most exchange plans restrict coverage to a network of doctors, hospitals and other health care providers that can change during the year.

CMS is also surveying Medicare Advantage companies this fall, and officials hope to survey every company by 2018 when the three-year review will be completed.

Viewpoints: Obamacare Product Problems; Health Care's Costs And Disparities

A selection of opinions on health care from around the country.

Thursday, 13 October 2016

California Reforms Target Workers' Compensation Fraud

California is cracking down on graft in the state's system of medical care for injured workers with two bills recently signed into law by Gov. Jerry Brown.

The reforms will prohibit medical providers who are felons from billing for workers' compensation care and rein in a court-governed payment system that gave rise to hundreds of millions of dollars in unsanctioned treatment.

Lawmakers who introduced the bills cited an investigation by Reveal from The Center for Investigative Reporting that examined more than $1 billion in alleged fraud in the medical system for injured workers.

Reviewing more than a dozen prosecutions and analyzing state data, the investigation found that alleged scams affected more than 100,000 injured workers. Many were monolingual Latinos who were targeted in aggressive marketing efforts in Southern California. They encountered everything from kickback-fueled spinal surgeries to fraudulent providers to $1,600 tubes of pain cream.

Alleged scammers included felons and doctors banned from billing Medicare for malfeasance. Many fraud defendants exploited a feature of California's workers' compensations system that let them file a “lien,” or a demand for payment, for services after insurers refused to pay. They included therapies like shock wave pain treatments or unwanted drugs, such as the pricey pain creams.

The new laws would ban certain medical providers with troubled pasts from treating injured workers and also aim to limit the avalanche of liens that clog the docket in two dozen workers' compensation courts throughout the state.

Christine Baker, director of the Department of Industrial Relations, which administers workers' compensation, said she hopes the laws improve care for people who seek help for an on-the-job injury.

“I think both abuses and fraudulent activities prey on the most vulnerable populations and we're hopeful that appropriate treatment will be provided to workers when needed,” Baker said. The laws “should reduce costs, because a lot of costs are tied to fraudulent activity, and that frees up dollars for the injured workers.”

The investigative series identified several medical providers with criminal convictions that precluded them from treating Medicare or Medicaid patients. Some, like Dr. Thomas Heric, went on to treat California's injured workers. Several years after making the move, Heric was indicted again for allegedly fraudulent reports he wrote about injured workers' sleep patterns.

One of the new laws - introduced by Assemblymen Adam Gray (D-Merced) and Tom Daly (D-Anaheim) - bans such providers from treating California's injured workers. The law requires the director of California's Department of Industrial Relations to send providers who might be suspended a notice. The providers can request a hearing, where a final decision would be made.

“It shocked me that we needed to do these things,” Gray said. “But we are happy to get some of these simple changes made and signed by the governor.”

The Reveal investigation also focused on the widespread use of liens filed in workers' compensation courts. Many providers accused of fraud rendered unapproved medical care that insurers did not deem appropriate or medically necessary. Denied payment, many medical firms went to court and filed a lien or sold the right to demand the money to a collections firm.

Kim Reeder of Sherman Oaks, Calif., requested a copy of her workers' compensation medical records and she said she discovered bills for transportation and language-interpreting services she never used. (Christina Jewett/Courtesy of Reveal)

Kim Reeder of Sherman Oaks, Calif., requested a copy of her workers' compensation medical records and she said she discovered bills for transportation and language-interpreting services she never used. (Christina Jewett/Courtesy of Reveal)

Workers compensation insurers often haggle over providers' charges; many pay settlements and thus boost employers' insurance costs.

State officials concluded in August that providers charged or convicted of fraud had filed $600 million in liens in workers' compensation courts from 2011 to 2015.

Injured workers like Denise Rivera, of Riverside, were shocked to learn that sums nearing $100,000 were billed on their cases, even though they seldom felt they got the care they needed. Another worker, Kim Reeder, was troubled when reviewing bills for her care to discover charges for services she never used and expensive pain creams she didn't want.

And employers, like Suzie Kim, felt defeated as mounting liens led to soaring workers' compensation insurance rates. Her family's Los Angeles-based janitorial business - which once employed 350 workers - collapsed under the pressure of questionable liens, many by medical providers who faced fraud charges.

“It just surprises me it took this long,” Kim said. “But I think this is a step in the right direction and I hope they follow up with it.”

The other new law introduced by state Sen. Tony Mendoza (D-Artesia) requires medical providers, such as doctors, acupuncturists and chiropractors, to cite the legal authority they are relying on to file a lien. It is meant to quickly dispatch with liens related to unapproved care or injuries not deemed work-related.

The law also bans providers who are charged with medical fraud from collecting on liens until the case is concluded. The law will also limit the lucrative business of rendering medical care and selling the right to bill for it to collections firms. According to a Senate committee's analysis of the new law, the practice leads to workers to getting “substandard, profit-driven care.”

This story was also published by Reveal from The Center for Investigative Reporting, a nonprofit news organization based in the San Francisco Bay Area. Christina Jewett, formerly of Reveal, is now a senior correspondent at Kaiser Health News.

Tuesday, 11 October 2016

Hospitals Say They're Being Slammed By Drug Price Hikes

Hospitals are getting slammed by drug price hikes that often have nothing to do with improving patient health, a new report has found.

Inpatient drug spending increased by 23.4 percent annually from 2013 to 2015, compared with 9.9 percent annual increases on retail drug spending during the same period, according to a new report by National Opinion Research Center (NORC) at the University of Chicago, which was commissioned by the American Hospital Association and the Federation of American Hospitals. Spending was driven by increases in drug unit prices rather than an increase in the volume of drugs used, they found.

“It would be one thing if price increases were associated with clear and important clinical improvements, but they're not,” Chip Kahn, CEO of the federation, said Tuesday in a press briefing.

The price hikes driving the spending increases “appear to be random and inconsistent from one year to the next,” the researchers wrote. About half of the drug price hikes in the report occurred in drugs with no generic competitors.

“Drugs that were around for decades - almost a century, sometimes - caught us off guard,” said Scott Knoer, chief pharmacy officer of the Cleveland Clinic, referring to price hikes for drugs such as nitroprusside, which increased 672 percent per unit from 2013 to 2015, according to the report. “For a long time, old generic drug prices were so stable we didn't even think about that,” said Knoer, who participated in the press briefing.

The brand name version of nitroprusside, Nitropress, was originally approved in 1981 to treat cardiovascular patients. Today, it's made by just one company, Valeant Pharmaceuticals, which bought it in early 2015, and pushed the price to $790.46 per unit from $150 per unit, according to the report. The price hike has been the subject of Congressional attention.

Nitroprusside cost hospitals almost $95 million in 2015 up from $48.3 million the year before, according to the report.

“We understand the value of innovation,” said Rick Pollack, the American Hospital Association's president and CEO. “However an unaffordable drug is not a lifesaving drug and a price increase resulting from market manipulation is simply wrong.”

The Pharmaceutical Research and Manufacturers of America (PhRMA) said the report misses the big picture by honing in on the drugs in the report, and it leaves out the fact that hospitals mark up drug prices when they bill patients.

“Focusing on a set of unrepresentative, older and off-patent medicines at a time when new generic drug applications had a record backlog gives a distorted portrayal of medicine spending,” said PhRMA spokesperson Holly Campbell.

The Generic Pharmaceutical Association was not available for comment.

The report included a national web-based survey with responses from 712 community hospitals from April through June of 2016. Researchers then weighted these responses to come up with estimates for 4,369 community hospitals in the United States. The analysis also included aggregate data for 28 drugs from two group-purchasing organizations, or GPOs, which buy drugs in bulk to negotiate better costs. The two GPOs represent 1,400 community hospitals.

More than 90 percent of survey respondents said drug price hikes had a “moderate or severe” impact on their budgets. What's more, Medicare reimbursements often don't reflect increased inpatient drug costs because the reimbursements are based on price indexes, and drug prices are rising too fast for the indexes to keep up.

“The bottom line is if you spend several million dollars more on drugs, it's just accounting. You're going to spend several million dollars less on other things,” Knoer said, adding that although this is not a problem for Cleveland Clinic, some hospitals aren't able to hire has many nurses or can't invest in the latest screening technologies as a result of increased drug spending.

David Vandewater, president and CEO of Ardent Health, which includes 14 hospitals, pointed out that hospital closures seem to be more common than ever before. And although greedy drug companies aren't 100 percent at fault, they may share some of the blame for this trend, he said.

When companies hike drug prices, hospitals lose money on insured patients, but make money on uninsured or out-of-network patients because they can legally charge a markup for drugs, said Gerard Anderson, a health policy and management professor at Johns Hopkins Bloomberg School of Public Health. Drugs are regularly marked up at least 500 percent, so if the drug price is higher, so is the profit.

“It's not a total loss to them when prices go up because charged payers make up some of the difference,” Anderson said. He was not involved in the report or on the press call.

Ultimately, even healthy individuals wind up paying the price for out-of-control drug costs, in the form of higher premiums and copays, increased deductibles and higher taxes, Knoer said on the press call.

“If these kinds of increases took place in the sale of gasoline in the U.S., you'd be paying $30 a gallon,” Vandewater said. “And if that was the case, the federal government or somebody would decide enough is enough.”

KHN's coverageof prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation, and coverage related to aging & improving care of older adults is supported by The John A. Hartford Foundation.