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Updated: 13 hours 36 min ago

Podcast: KHN’s ‘What The Health?’ Drug Prices And Unicorns

July 19, 2018
Julie Rovner

Kaiser Health News

@jrovner

Read Julie's Stories Joanne Kenen

Politico

@JoanneKenen

Read Joanne's Stories Erin Mershon

STAT

@eemershon

Read Erin's Stories Margot Sanger-Katz

The New York Times

@sangerkatz

Read Margot's Stories

A trio of court actions provide news for this week’s “What the Health?’” panel.

A federal appeals court this week handed hospitals a setback in their effort to stop the Trump administration from cutting funding for a program that provides deep discounts on drugs. Physicians sued health insurer Anthem for its policy of retroactively declaring some emergency department claims not to be an emergency. And the Pennsylvania Supreme Court upheld the city of Philadelphia’s controversial tax on sweetened beverages.

Also this week, an interview with Jeff Goldsmith, health care futurist and consultant.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Margot Sanger-Katz of The New York Times, Joanne Kenen of Politico and Erin Mershon of STAT News.

Among the takeaways:

  • The fight over the “340B” hospital drug discount program largely pits pharmaceutical makers, who are required by law to give discounts to health facilities that serve low-income patients, against the hospitals and clinics that get the discounts. The court ruled that the hospitals’ challenge to the proposed cuts was premature, and hospitals have vowed to refile their lawsuit. But the fight has spawned a huge advertising effort aimed at policymakers in Washington, including bus stop posters from the program’s supporters featuring a unicorn.
  • Anthem has been heavily criticized for its policy of not paying emergency room bills if the patients should have known that they didn’t need emergency care. But it appears that the insurer has quietly pulled back from implementing the policy much of the time. That still didn’t stop emergency room doctors from suing Anthem this week in Georgia, however.
  • Could the Trump administration’s recent action to pull down some health care material from agency websites suggest that officials plan to make changes in some sexual discrimination regulations?
  • FDA Commissioner Scott Gottlieb stunned a Washington audience this week when he said officials are looking into whether beverages manufactured from plants, such as almonds and soy, can be labeled milk under FDA guidelines that say milk must come from animals that lactate. But perhaps that cow is already out of the barn.

Plus, for “extra credit,” the panelists recommend their favorite health stories of the week they think you should read, too:

Julie Rovner: The Atlantic’s “Illegal Abortion Will Mean Abortion By Mail,” by Olga Khazan

Joanne Kenen: Politico’s “Trump Promised Them Better, Cheaper Health Care. It’s Not Happening,” by Adam Cancryn

Erin Mershon: NPR and the Center for Public Integrity’s “Investigation: Patients’ Drug Options Under Medicaid Heavily Influenced By Drugmakers,” by Liz Essley Whyte, Joe Yerardi and Alison Kodjak

Margot Sanger-Katz: NPR and ProPublica’s “Health Insurers Are Vacuuming Up Details About You — And It Could Raise Your Rates,” by Marshall Allen

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

Facebook Live: The Marketing Plan That Fueled An Addiction Epidemic

July 13, 2018


Files from Fred’s basement: KHN senior correspondent Fred Schulte talks about a cache of files detailing Purdue Pharma’s early OxyContin marketing plan. These documents, which are more than 15 years old but still relevant now, offer insights into how these strategies contributed to the nation’s current opioid addiction epidemic.

Here’s the recent story he wrote on the topic. Click here to view the files.

For more in-depth conversations with KHN reporters, check out our Facebook video archive.

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

Retooled Vaccine Raises Hopes As A Lower-Cost Treatment For Type 1 Diabetes

July 13, 2018

For Hodalis Gaytan, 20, living with Type 1 diabetes means depending on an assortment of expensive medicines and devices to stay healthy. Test strips. Needles. A glucose meter. Insulin.

The increasing cost of Type 1 diabetes, one of the most common serious chronic diseases, has created heavy financial burdens for families and generated controversy, with insulin prices more than doubling in the past decade.

Without her parent’s insurance, “I would not be alive,” said Gaytan, a student at the University of Maryland.

The burden of treatment is why a small study that shows promise for a simpler, cheaper alternative treatment to Type 1 diabetes is being met with hope — but also with caution and skepticism.

The research, published June 21 in the journal Nature Partner Journal Vaccines, showed that an older generic vaccine may help lower the blood sugar level of patients with Type 1 diabetes, decreasing their need for insulin. The vaccine, BCG, is used in a number of countries to prevent tuberculosis and has long been known to stimulate the immune system as well. That vaccine is relatively cheap, costing about $157 per dose in the United States, according to the health care technology company Connecture.

In the study, participants with long-standing Type 1 diabetes were injected with two doses of Bacillus Calmette-Guerin tuberculosis vaccine — known as BCG — four weeks apart. Three of the patients were observed for eight years. Nine participants were followed for five years.

The blood sugar levels — known as A1c — of those followed for eight years dropped by more than 10 percent three years after the injection and were sustained for five more years.

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While the trial involved a tiny number of patients, the researchers — led by Dr. Denise Faustman, director of the Immunobiology Laboratory at Massachusetts General Hospital — are conducting a much larger Phase 2 trial of BCG to treat diabetes to see if the results hold up.

JDRF, a leading nonprofit organization that provides funding for research on Type 1 diabetes, and the American Diabetes Association issued a joint statement shortly after the new study was released, cautioning against misinterpreting the findings and stating that they “do not provide enough clinical evidence to support any recommended change in therapy at this time.” Both groups have partnered with drug manufacturers and device makers in the industry.

Still, Dr. Camillo Ricordi, director of the Diabetes Research Institute at the University of Miami, said he is “cautiously optimistic” about the findings, noting the “incredibly high price tag” for patients with diabetes. But he warned against generating “too much hype” among families before the treatment is proven to be effective.

Dr. Joseph Bellanti, professor emeritus of pediatrics and microbiology and immunology at Georgetown University Medical Center in Washington, D.C., was also encouraged by the studies’ findings. While he acknowledged the skepticism surrounding Faustman’s research, scrutiny is a necessary part of the scientific process, he said.

“We’re seeking the truth, and we want to make sure that the results and the interpretations are correct, Bellanti said, “and that requires healthy debate.”

Hodalis Gaytan was diagnosed with Type 1 diabetes six years ago after a routine physical. Without health insurance to pay for the expensive, lifesaving medicines, she says, she believes she would have died. (Courtesy of Hodalis Gaytan)

Faustman said her findings are important because they suggest that the vaccine could have positive effects in the treatment of diabetes, similar to what has been seen in previous research on other autoimmune diseases, like multiple sclerosis, that involve an immune system reaction against normal tissue.

“It also opens up a host of new possible treatment avenues,” Faustman said, adding that it could help in developing interventions for other groups suffering from chronic illnesses.

Type 1 diabetes, which typically is diagnosed in childhood, occurs when the immune system destroys the cells that produce insulin. People with Type 2 diabetes produce normal levels of this vital hormone, but their bodies don’t respond appropriately.

These findings surface as the country grapples with soaring insulin prices — a rise so significant it has prompted attorneys general in several states and at least one federal prosecutor to launch investigations targeting insulin makers Eli Lilly, Novo Nordisk, Sanofi and pharmacy benefit managers.

The United States already pays a steep price for its diabetes burden. According to the American Diabetes Association, the 24.7 million Americans living with the diagnosis last year spent $237 billion in direct medical costs.

For patients like Gaytan, the prospect of new medications to simplify and reduce the costs of her treatment is tantalizing. She injects herself with insulin and checks her blood sugar level about five times a day. And she attends therapy to help deal with the burden of living with a chronic condition, and worries about how she’ll afford it in the future.

“I know diabetics [whose] families pay for everything,” she said, adding they “just can’t afford it.”

According to Connecture, the list price for Apidra SoloStar — an injectable insulin product that Gaytan uses several times per day — increased from $33.24 per pen in early 2009 to $104.28 per pen in early 2018.

Faustman said her research has documented the mechanism by which the old vaccine reduces blood sugar levels. In the Phase 2 trial, she will attempt to replicate her findings by following 150 participants with the disease for five years. It will be at least another four years until results are published.

Ultimately, if BCG works to treat Type 1 diabetes, its current cheap price could rise, said Gerard Anderson, professor of health policy and management and medicine at Johns Hopkins University in Baltimore, who, like Kaiser Health News, receives money from the Laura and John Arnold Foundation. Though BCG is generic, pharmaceutical companies can raise the price by altering the drug and issuing a new patent.

Drugmakers are expert at retooling old drugs to treat new conditions, he said, adding: “It could result in no cost savings at all — and, in fact, a higher price.”

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

‘Like A Ghost Town’: Erratic Nursing Home Staffing Revealed Through New Records

July 13, 2018

ITHACA, N.Y. — Most nursing homes had fewer nurses and caretaking staff than they had reported to the government, according to new federal data, bolstering the long-held suspicions of many families that staffing levels were often inadequate.

The records for the first time reveal frequent and significant fluctuations in day-to-day staffing, with particularly large shortfalls on weekends. On the worst-staffed days at an average facility, the new data show, on-duty personnel cared for nearly twice as many residents as they did when the staffing roster was fullest.

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The data, analyzed by Kaiser Health News, come from daily payroll records Medicare only recently began gathering and publishing from more than 14,000 nursing homes, as required by the Affordable Care Act of 2010. Medicare previously had been rating each facility’s staffing levels based on the homes’ own unverified reports, making it possible to game the system.

The payroll records provide the strongest evidence that, over the past decade, the government’s five-star rating system for nursing homes often exaggerated staffing levels and rarely identified the periods of thin staffing that were common. Medicare is now relying on the new data to evaluate staffing, but the revamped star ratings still mask the erratic levels of people working from day to day.

At the Beechtree Center for Rehabilitation & Nursing here, Jay Vandemark, 47, who had a stroke last year, said he often roams the halls looking for an aide not already swamped with work when he needs help putting on his shirt.

Especially on weekends, he said, “it’s almost like a ghost town.”

Nearly 1.4 million people are cared for in skilled nursing facilities in the United States. When nursing homes are short-staffed, nurses and aides scramble to deliver meals, ferry bedbound residents to the bathroom and answer calls for pain medication. Essential medical tasks such as repositioning a patient to avert bedsores can be overlooked when workers are overburdened, sometimes leading to avoidable hospitalizations.

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“Volatility means there are gaps in care,” said David Stevenson, an associate professor of health policy at Vanderbilt University School of Medicine in Nashville, Tenn. “It’s not like the day-to-day life of nursing home residents and their needs vary substantially on a weekend and a weekday. They need to get dressed, to bathe and to eat every single day.”

Dr. David Gifford, a senior vice president at the American Health Care Association, a nursing home trade group, disagreed, saying there are legitimate reasons staffing varies. On weekends, for instance, there are fewer activities for residents and more family members around, he said.

“While staffing is important, what really matters is what the overall outcomes are,” he said.

While Medicare does not set a minimum resident-to-staff ratio, it does require the presence of a registered nurse for eight hours a day and a licensed nurse at all times.

The payroll records show that even facilities that Medicare rated positively for staffing levels on its Nursing Home Compare website, including Beechtree, were short nurses and aides on some days. On its best-staffed days, Beechtree had one aide for every eight residents, while on its lowest-staffed days the ratio was 1-to-18. Nursing levels also varied.

Jay Vandemark, who entered Beechtree after he suffered a stroke that immobilized his left side, complained that the center didn’t have enough workers on some shifts. “It’s almost like a ghost town,” he said. (Heather Ainsworth for The New York Times)

The Centers for Medicare & Medicaid Services, the federal agency that oversees nursing home inspections, said in a statement that it “is concerned and taking steps to address fluctuations in staffing levels” that have emerged from the new data. This month, it said it would lower ratings for nursing homes that had gone seven or more days without a registered nurse.

Beechtree’s payroll records showed similar staffing levels to those it had reported before. David Camerota, chief operating officer of Upstate Services Group, the for-profit chain that owns Beechtree, said in a statement that the facility has enough nurses and aides to properly care for its 120 residents. But, he said, like other nursing homes, Beechtree is in “a constant battle” to recruit and retain employees even as it has increased pay to be more competitive.

Camerota wrote that weekend staffing is a special challenge as employees are guaranteed every other weekend off. “This impacts our ability to have as many staff as we would really like to have,” he wrote.

New Rating Method Is Still Flawed

In April, the government started using daily payroll reports to calculate average staffing ratings, replacing the old method, which relied on homes to report staffing for the two weeks before an inspection. The homes sometimes anticipated when an inspection would happen and could staff up before it.

The new records show that on at least one day during the last three months of 2017 — the most recent period for which data were available — a quarter of facilities reported no registered nurses at work.

Medicare discouraged comparison of staffing under the two methods and said no one should expect them to “exactly match.” The agency said the methods measure different time periods and have different criteria for how to record hours that nurses worked. The nursing home industry also objected, with Gifford saying it was like comparing Fahrenheit and Celsius temperatures.

But several prominent researchers said the contrast was not only fair but also warranted, since Medicare is using the new data for the same purpose as the old: to rate nursing homes on its website. “It’s a worthwhile comparison,” said David Grabowski, a professor of health care policy at Harvard Medical School.

Payroll records at Beechtree show that on its best-staffed days, it had one aide for every eight residents, but the ratio was 1-to-18 at the lowest staffing level. (Jordan Rau/KHN)

Of the more than 14,000 nursing homes submitting payroll records, 7 in 10 had lower staffing using the new method, with a 12 percent average decrease, the data show. And as numerous studies have found, homes with lower staffing tended to have more health code violations — another crucial measure of quality.

Even with more reliable data, Medicare’s five-star rating system still has shortcomings. Medicare still assigns stars by comparing a home to other facilities, essentially grading on a curve. As a result, many homes have kept their rating even though their payroll records showed lower staffing than before. Also, Medicare did not rate more than 1,000 facilities, either because of data anomalies or because they were too new to have a staffing history.

There is no consensus on optimal staffing levels. Medicare has rebuffed requests to set specific minimums, declaring in 2016 that it preferred that facilities “make thoughtful, informed staffing plans” based on the needs of residents.

Still, since 2014, health inspectors have cited 1 in 8 nursing homes for having too few nurses, federal records show.

With nurse assistants earning an average of $13.23 an hour in 2017, nursing homes compete for workers not only with better-paying employers like hospitals, but also with retailers. Understaffing leads predictably to higher turnover.

“They get burned out and they quit,” said Adam Chandler, whose mother lived at Beechtree until her death earlier this year. “It’s been constant turmoil, and it never ends.”

Medicare’s payroll records for the nursing homes showed that there were, on average, 11 percent fewer nurses providing direct care on weekends and 8 percent fewer aides. Staffing levels fluctuated substantially during the week as well, when an aide at a typical home might have to care for as few as nine residents or as many as 14.

(Story continues below.)

A Family Council Forms

Beechtree actually gets its best Medicare rating in the category of staffing, with four stars. (Its inspection citations and the frequency of declines in residents’ health dragged its overall star rating down to two of five.)

To Stan Hugo, a retired math teacher whose wife, Donna, 80, lives at Beechtree, staffing levels have long seemed inadequate. In 2017, he and a handful of other residents and family members became so dissatisfied that they formed a council to scrutinize the home’s operation. Medicare requires nursing home administrators to listen to such councils’ grievances and recommendations.

Related Stories Neglect Unchecked

Sandy Ferreira, who makes health care decisions for Effie Hamilton, a blind resident, said Hamilton broke her arm falling out of bed and has been hospitalized for dehydration and septic shock.

“Almost every problem we’ve had on the floor is one that could have been alleviated with enough and well-trained staff,” Ferreira said.

Beechtree declined to discuss individual residents but said it had investigated these complaints and did not find inadequate staffing on those days. Camerota also said that Medicare does not count assistants it hires to handle the simplest duties like making beds.

In recent months, Camerota said, Beechtree “has made major strides in listening to and addressing concerns related to staffing at the facility.”

Hugo agreed that Beechtree has increased daytime staffing during the week under the prodding of his council. On nights and weekends, he said, it still remained too low.

His wife has Alzheimer’s, uses a wheelchair and no longer talks. She enjoys music, and Hugo placed earphones on her head so she could listen to her favorite singers as he spoon-fed her lunch in the dining room on a recent Sunday.

As he does each day he visits, he counted each nursing assistant he saw tending residents, took a photograph of the official staffing log in the lobby and compared it to what he had observed. While he fed his wife, he noted two aides for the 40 residents on the floor — half what Medicare says is average at Beechtree.

“Weekends are terrible,” he said. While he’s regularly there overseeing his wife’s care, he wondered: “What about all these other residents? They don’t have people who come in.”

KHN’s coverage of these topics is supported by John A. Hartford Foundation and The SCAN Foundation

Tennessee-Based Pain Management Group To Close Clinics Amid Financial Turmoil

July 03, 2018

One of the largest pain management groups in the Southeast is closing multiple clinics amid worsening financial troubles and a federal criminal investigation that targeted its former chief executive.

This week, Tennessee-based Comprehensive Pain Specialists advised patients and employees about clinic closures, leaving patients scrambling to find new doctors willing to prescribe them opioids, according to a report on WSMV television.

Based in the Nashville area, CPS opened in 2005 and quickly grew into a powerhouse, which has treated as many as 48,000 pain patients a month, at more than 50 clinics in Tennessee and other states.

CPS did not respond to numerous requests for comment.

The doctor-owned company has endured a series of recent setbacks, including earlier clinic closures, pending lawsuits over alleged debts and the criminal case against former CEO John Davis.

In April, a federal grand jury in Tennessee indicted Davis on criminal kickback charges. He has pleaded not guilty. CPS also has faced nearly a dozen civil lawsuits from contractors alleging unpaid debts, including suits brought by two of its former doctors. A Justice Department official said the closure was not related to the criminal case against Davis.

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The shutdown of the clinics comes amid growing backlash against the use of opioids for treating chronic pain. The opioid crisis has cost the U.S. economy more than $1 trillion since 2001, estimates Altarum, an economic research firm. Since 1999, at least 200,000 people have died nationwide from overdoses, according to the Centers for Disease Control and Prevention.

According to the company’s website, CPS now operates 40 clinics in eight states: Arkansas, Illinois, Indiana, Kentucky, Mississippi, North Carolina, Ohio and Tennessee. Half are in Tennessee. The Tennessean reported Tuesday that all 21 clinics in the state would be closing by the end of the month.

CPS was the subject of a November 2017 investigation by Kaiser Health News that scrutinized its Medicare billings for urine drug testing. Medicare paid the company at least $11 million for urine screenings and related tests in 2014, when five of CPS’ medical professionals stood among the nation’s top such Medicare billers. One nurse practitioner at a CPS clinic in Cleveland, Tenn., generated $1.1 million in urine-test billing that year, according to Medicare records analyzed by KHN.

(Courtesy of Comprehensive Pain Specialists)

Peter Kroll, an anesthesiologist and one of CPS’ founders, said at the time that the tests were justified to monitor patients against risks of addiction or reduce chances the pills might be sold on the black market. Kroll, who is the company’s current CEO and medical director, billed Medicare $1.8 million for urine tests in 2015, agency records showed.

Kroll took charge of the business when Davis left the company abruptly last summer. He could not be reached for comment Tuesday.

Federal prosecutors charged Davis with accepting more than $750,000 in illegal bribes and kickbacks in a scheme that billed Medicare $4.6 million for durable medical equipment.

“As CEO, Davis oversaw the substantial expansion of CPS, recruiting new physicians and clinics to join CPS, as well as directing various aspects of the company’s overall treatment of patients,” prosecutors wrote in a May court filing.

Davis has pleaded not guilty. The U.S. attorney’s office has said in court filings that CPS and its employees are “victims” in the case.

The company also has been hit with civil suits. Anesthesiologist Donald E. Jones sued the company in May 2017, alleging that it failed to honor his employment contracts.

Jones said he joined the firm in 2012 to staff three Tennessee clinics at a salary of $30,000 a month plus a percentage of fees from laboratory and other services. Jones argued that he generated collections in excess of $9 million. In 2016, the clinics served 41,364 patients, the busiest of all the clinics, according to the suit.

But in April 2016, according to the suit, CPS quit paying him and in February 2017 the company began transferring his patients to other clinics and “making disparaging remarks” about him to patients.

CPS countered that Jones failed to deliver “safe and effective medical care, which CPS in court filings attributed to an “ongoing compensation dispute.” The suit is pending.

(Courtesy of Comprehensive Pain Specialists)

Pain specialist William Wagner also is suing the company. He said he relocated from New Mexico to open a CPS clinic in Anderson, S.C., lured by the promise of $30,000 a month in salary and a share of the profits from urine tests and other services.

Instead, according to Wagner, CPS failed to collect bills for services he rendered and then closed the clinic. CPS denies Wagner’s claims and says it fulfilled its obligations under the contract. In a counterclaim, CPS argues that Wagner owes it $190,000. The case is pending.

Several contractors, including companies that leased office space and medical software, also have taken CPS to court alleging unpaid bills and leases, according to court filings. The cases are pending.

Kroll told KHN last year that he and fellow anesthesiologist Steve Dickerson came up with the idea for CPS in August 2005, over a cup of coffee at a Nashville Starbucks. At the time, Tennessee was confronting an emerging opioid epidemic.

Kroll, raised in North Carolina, had moved to Nashville to launch a career in anesthesiology, a specialty he chose after watching his older brother die from an agonizing disease with little help from pain specialists.

Joined by two other doctors, Kroll and Dickerson opened with a single storefront in suburban Hendersonville. Dickerson, who was elected to the Tennessee Senate in 2012, remains at CPS, according to its website. Calls to Dickerson’s office were not returned.

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

Vulnerable Rural Hospitals Face Quandaries Over Questionable Billing Schemes

July 03, 2018

Two rural Missouri hospitals recently handed over their operations to a private company that promised to turn them around with a billing practice it calls “a lab outreach program.”

But the approach that company is using is drawing attention from lawmakers and Missouri’s auditor. It is similar to a tactic underway at 20 rural hospitals in Missouri, Kansas, Oklahoma, Florida and California.

Read KHN’s previous coverage of this topic: “Outsiders Swoop In Vowing To Rescue Rural Hospitals Short On Hope — And Money” by California Healthline senior correspondent Barbara Feder Ostrov.

Out-Of-Pocket Costs Put HIV Prevention Drug Out Of Reach For Many At Risk

July 03, 2018

Public health officials are expanding efforts to get the HIV prevention pill into the hands of those at risk, in a nationwide effort to curb infections. But the officials are hitting roadblocks — the drug’s price tag, which has surged in recent years, and changes in insurance coverage that put a heftier financial burden on patients.

Since brand-name Truvada was approved for HIV prevention six years ago, its average wholesale price has increased by about 45 percent. Now, the drug — which rakes in billions of dollars in annual global revenue for its manufacturer, Gilead Sciences — carries a list price of close to $2,000 for a 30-day supply.

Most insurers cover the pill, also known as pre-exposure prophylaxis, or PrEP. It has been shown to be more than 90 percent effective in HIV prevention when taken daily.

But patients can get stuck with out-of-pocket costs that make it unaffordable.

“If there is any example of the dysfunction in the American pharmaceutical system, it is this case,” said James Krellenstein, a member of the AIDS advocacy group ACT UP New York. “We have the most effective tool for ending the HIV epidemic, and one reason we’re unable to scale up is because it costs so [much] unnecessarily.”

As policymakers and the health system debate how to control ever-climbing drug prices, experts say this case underscores how patients are left holding the bag.

Private health plans are making patients responsible for a larger share of drug costs. And more are restricting use of the “copay coupons” pharmaceutical companies have used to shield patients from out-of-pocket expenses. Insurers say the drug companies use coupons to steer consumers toward pricier meds. One way health plans are limiting their use is by no longer allowing them to count toward patients’ deductibles.

“This is one more thing that is going to push people off their medications,” said Jim Pickett, a senior director at the AIDS Foundation of Chicago.

Jared Wile, who lives in Chicago, started taking PrEP about three years ago, when he was dating someone with HIV. Wile, who has a $2,750 deductible, used a coupon to obtain the drug. He never paid anything out-of-pocket, he said.

Gilead waives up to $4,800 in out-of-pocket expenses for commercially insured patients.

That changed for Wile this past May, when Wile learned the coupon no longer counted toward his deductible and that he would have to pay the full cost of the prescription — $1,600 per month — until he hit his deductible. Wile said he felt “blindsided” and stopped taking the medication.

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Gilead spokesman Ryan McKeel said the company has made extra efforts to help patients overcome financial barriers. He cited assistance programs for uninsured and underinsured people.

“We have designed our assistance programs with the intent that people can benefit from their full value, and we cannot control the actions or decisions of health insurers,” McKeel said in an emailed statement.

The federal Centers for Disease Control and Prevention estimates that more than 1 million people are at high risk of contracting HIV, but Gilead says only about 167,000 people currently take PrEP.

Beyond The Money Crunch

Price is one of many barriers — alongside patients’ lack of awareness and doctors’ hesitation to prescribe — that threaten to exacerbate the already stark disparities in PrEP use and HIV infection rates.

One major disparity is along geographic lines. The South, for example, accounts for over half of new HIV diagnoses but only about 30 percent of new PrEP users, according to data from AIDSVu, which maps HIV disease and PrEP use. HIV rates and PrEP use also vary by race and ethnicity.

“We are not necessarily seeing that those most at risk are the ones starting PrEP,” said Kristin Keglovitz Baker, chief operating officer of Howard Brown Health, a Chicago health center.

Gilead has recently gone all-in with advertising to reach people at risk, including print campaigns and TV ads that will air through the summer. Since 2012, it has spent $28 million to fund U.S. organizations that seek to raise awareness of HIV, McKeel, the company spokesman, said.

“We recognize that many people who are at high risk for HIV infection still face challenges in accessing Truvada for PrEP, and we are in regular dialogue with public health officials, advocates and physicians to better understand and, where possible, help to address these challenges,” he added.

But price is also an impediment for publicly funded programs, which have limited budgets and are now shelling out more cash for the prevention effort.

“If it was only pennies … we would be throwing it around,” said Joey Mattingly, an assistant professor at the University of Maryland School of Pharmacy. “Because of how costly it is, we have to control it.”

Some states — California and Florida among them — have launched PrEP assistance programs that can help patients cover the cost of the medication, along with required lab work and medical visits.

Beyond these state-based programs, some public health departments and HIV service organizations are hiring PrEP navigators to help patients navigate the maze of copays and deductibles, and to improve recruitment and retention of new PrEP users.

Washington, D.C.’s health department has doubled down on prevention, and Truvada is key in that effort, said Michael Kharfen, the department’s senior deputy director for HIV/AIDS, Hepatitis, STD and TB Administration.

Insurance usually covers PrEP, and patient assistance programs should fill any financial gaps, he said. But when that isn’t feasible, the department steps in, distributing free Truvada starter packs to at-risk patients.

Kharfen said the city has in the past three years spent almost a million dollars just on Truvada pills, which it purchases at a discounted rate through the federal 340B program, which benefits certain health care providers that treat low-income people. And because of new publicity efforts, he expects the department will need to buy and distribute more pills — posing a conundrum.

Treating more people is net positive, he said. But “how do we sustain this?”

Medicaid programs generally cover PrEP, so they confront a similar situation. Outreach efforts lead to more beneficiaries who take the drug, but that, in turn, could subject the states’ Medicaid budgets to financial hardship.

States are spending millions of dollars on the drug. California’s Medicaid program, for example, spent about $50 million in 2017 and expects the costs to continue climbing. But officials said the expense is offset by long-term savings in preventing new HIV cases.

Massachusetts’ Medicaid program spent about $22 million on Truvada that same year — about $18,000 per beneficiary, according to a spokeswoman for the agency’s Executive Office of Health and Human Services. Those figures don’t account for rebates the state receives from Gilead, which are undisclosed and considered proprietary information.

A Complex Solution, And No Competition

PrEP is only one part of HIV prevention, so help paying for the pill is only one piece of the puzzle.

Patients also need regular HIV testing and medical care, which add to the cost borne both by patients and the health system. Some experts warn that Truvada’s high price point could financially undermine such broad prevention efforts.

Competition could help.

A generic version of the drug, manufactured by Teva Pharmaceuticals, is available abroad and gained approval for use last year from the federal Food and Drug Administration. When it becomes available in the United States, it could bring down prices, though it’s unclear when that will happen. Gilead’s own forecasts reflect that expectation, showing declines in future revenue from Truvada.

“When generics enter, brands lose market share,” said David Howard, a health economist and professor at Emory University, who previously worked in the pharmaceutical industry.

For now, though, Truvada is the only PrEP option available in the U.S., he said. “From a company standpoint … their best strategy is to make as much money as they can.”

KHN’s coverage of these topics is supported by Laura and John Arnold Foundation and Blue Shield of California Foundation

More Nurse Practitioners Now Pursue Residency Programs To Hone Skills

July 03, 2018

The patient at the clinic was in his 40s and had lost both his legs to Type 1 diabetes. He had mental health and substance abuse problems and was taking large amounts of opioids to manage pain. He was assigned to Nichole Mitchell, who in 2014 was a newly minted nurse practitioner in her first week of a one-year postgraduate residency program at the Community Health Center clinic in Middletown, Conn.

In a regular clinical appointment, “I would have been given 20 minutes with him, and would have been without the support or knowledge of how to treat pain or Type 1 diabetes,” she said.

But her residency program gives the nurse practitioners extra time to assess patients, allowing her to come up with a plan for the man’s care, she said, with a doctor at her side to whom she could put all her questions.

A few years later, Mitchell is still at that clinic and now mentors nurse practitioner residents. She has developed a specialty in caring for patients with HIV and hepatitis C, as well as transgender health care.

The residency program “gives you the space to explore things you’re interested in in family practice,” Mitchell said. “There’s no way I could have gotten that training without the residency.”

Mitchell is part of a growing cadre of nurse practitioners — typically, registered nurses who have completed a master’s degree in nursing — who tack on up to a year of clinical and other training, often in primary care.

Residencies may be at federally qualified health centers, Veterans Affairs medical centers or private practices and hospital systems. Patients run the gamut, but many are low-income and have complicated needs.

Proponents say the programs help prepare new nurse practitioners to deal with the growing number of patients with complex health issues. But detractors say that a standard training program already provides adequate preparation to handle patients with serious health care needs. Nurse practitioners who choose not to do a residency, as the vast majority of the 23,000 who graduate each year do not, are well qualified to provide good patient care, they say.

As many communities, especially rural ones, struggle to attract medical providers, it’s increasingly likely that patients will see a nurse practitioner rather than a medical doctor when they need care. In 2016, nurse practitioners made up a quarter of primary care providers in rural areas and 23 percent in non-rural areas, up from 17.6 and 15.9 percent, respectively, in 2008, according to a study in the June issue of Health Affairs.

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Depending on the state, they may practice independently of physicians or with varying degrees of oversight. Research has shown that nurse practitioners generally provide care that’s comparable to that of doctors in terms of quality, safety and effectiveness.

But their training differs. Unlike the three-year residency programs that doctors must generally complete after medical school in order to practice medicine, nurse practitioner residency programs, sometimes called fellowships, are completely voluntary. Like medical school residents, though, the nurse practitioner residents work for a fraction of what they would make at a regular job, typically about half to three-quarters of a normal salary.

Advocates say it’s worth it.

“It’s a very difficult transition to go from excellent nurse practitioner training to full scope-of-practice provider,” said Margaret Flinter, a nurse practitioner who is senior vice president and clinical director of Community Health Center, a network of community health centers in Connecticut.

“My experience was that too often, too many junior NPs found it a difficult transition, and we lost people, maybe forever, based on the intensity and readiness for seeing people” at our centers.

Flinter started the first nurse practitioner residency program in 2007. There are now more than 50 postgraduate primary care residency programs nationwide, she said. Mentored clinical training is a key part of the programs, but they typically also include formal lectures and clinical rotations in other specialties.

Not everyone is as gung-ho about the need for nurse practitioner residency programs, though.

“There’s a lot of debate within the community,” said Joyce Knestrick, president of the American Association of Nurse Practitioners. Knestrick practices in Wheeling, W.Va., a rural area about an hour’s drive from Pittsburgh. She said that there could be a benefit if a nurse practitioner wanted to switch from primary care to work in a cardiology practice, for example. But otherwise she’s not sold on the idea.

A position statement from the Nurse Practitioner Roundtable, a group of professional organizations of which AANP is a member, offered this assessment: “Forty years of patient outcomes and clinical research demonstrates that nurse practitioners consistently provide high quality, competent care. Additional post-graduate preparation is not required or necessary for entry into practice.”

“We already have good outcomes to show that our current educational system has been effective,” Knestrick said. “So I’m not really sure what the benefit is for residencies.”

Top Policy Expert’s Ties To Giant Drugmaker Often Go Unstated

June 29, 2018

When Dr. Mark McClellan sat for an in-depth 30-minute question-and-answer session at an April health policy forum, the audience was filled with top researchers, advocates and Capitol Hill staffers eager to hear what insight the former head of the Food and Drug Administration would dispense.

He did not disappoint.

In response to a question about how competition might drive down the cost of new drugs made from living cells, McClellan said, “That is a great example of where more clarity from FDA about what exactly is required could potentially open up more biosimilar competition.”

McClellan is director of the Margolis Center for Health Policy at Duke University, the academic position by which he’s commonly identified. But he frequently has not disclosed another position he’s held since late 2013: He earned $285,000 last year on the board of pharmaceutical giant Johnson & Johnson, a company accused of blocking the sale of Pfizer’s Inflectra biosimilar, which competes against J&J’s blockbuster Remicade, a rheumatoid arthritis drug.

According to corporate financial filings, McClellan has been compensated with more than $1 million in cash and stock awards since taking that post.

McClellan also receives compensation as a member of the advisory board of privately held Alignment Healthcare, which employs doctors and provides chronic-care management for Medicare Advantage plans in three states. Alignment Healthcare declined to disclose his compensation.

The issue of conflicts of interest has become more pressing in recent years as drug prices soar and health care companies reach out to the academic and policy community for advice — often with generous payments attached, ethics experts say.

Sen. Claire McCaskill (D-Mo.) introduced a bill in June that would require drugmakers to report payments to patient advocacy groups and professional societies. If passed, it would toughen the Sunshine Act, which requires pharmaceutical companies to report payments to teaching hospitals and physicians, detailing how much was paid annually to doctors for travel, speaking and food.

As a board member to these for-profit health care companies, McClellan has a fiduciary obligation “not to injure them” when writing articles and speaking, said Stephen Bainbridge, law professor at UCLA.

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And while there is no legal requirement to disclose board memberships when writing for journals or speaking, Bainbridge and other experts agreed there is an ethical obligation.

“There’s certainly a potential conflict of interest there,” Bainbridge said, adding that while serving on the board of Johnson & Johnson “you are dealing with an enormous company that has fingers in a lot of different pies.”

McClellan said in an emailed statement that he provides specific disclosures on topics on which his interests might give the appearance of conflict, including in medical journals and at speaking engagements.

“My board memberships are public information and are broadly known within the field, and I stand by the independence and integrity of all my work,” McClellan said.

Ellen de Graffenreid, director of communications at the Duke-Margolis Center, said it was “clear that Dr. McClellan disclosed his position on the Johnson & Johnson Board when a potential conflict of interest existed — that is, when the publication mentions drugs or devices that may intersect with J&J’s business.” She said that while he serves on the J&J board, he “does not advocate for any positions on behalf the company.”

McClellan is a prolific writer and speaker about how the U.S. health care system operates. He left his work at the Brookings Institution to become the founding director of Duke-Margolis in 2015. He ran the FDA from 2002 to 2004 and served as administrator of the U.S. Centers for Medicare & Medicaid Services from 2004 to 2006 before joining Brookings.

In a majority of the articles McClellan wrote for the Journal of the American Medical Association, he did not disclose his corporate connections when he filled out forms concerning potential conflicts of interest. Of 15 papers he wrote since 2013, McClellan disclosed his relationship with Johnson & Johnson three times.

Johnson & Johnson is a Fortune 500 health care giant, with more than $76 billion in annual sales and a range of products including pharmaceuticals, medical devices and consumer products that include brand names Aveeno, Tylenol and Neutrogena.

“I don’t think there’s any reason to cover up or ignore those [corporate] relationships,” said Arthur Caplan, a professor of bioethics at New York University School of Medicine. “In general … I would say disclose more.”

Journals, conferences and policy forums generally ask contributors to list their potential conflicts of interest — financial relationships that might in some way sway their opinion or color the audience’s perception of information they relay. But the experts themselves decide which connections to list.

At the April forum addressing high drug prices, which was hosted by Kaiser Permanente’s Institute for Health Policy, neither the forum’s agenda, nor the speaker’s introduction at the event mentioned McClellan’s Johnson & Johnson role. (Kaiser Health News is not affiliated with Kaiser Permanente.)

Kaiser Permanente’s John Nelson said speakers at the forums typically have extensive backgrounds and “thus we only provide abbreviated biographies when introducing them.” Kaiser Permanente declined to say whether they knew of McClellan’s corporate roles.

Dr. Jerry Avorn, a professor of medicine at Harvard Medical School, said he favors disclosure of corporate roles and thinks “many [people] would argue that it should be for the reader and not the author” to determine whether there is a conflict of interest.

The question of when to disclose industry or nonprofit funding has been debated for decades, said Dr. Sandro Galea, who wrote about conflicts of interest and schools of public health last year in JAMA.

“There are public and private actors and both importantly shape the environment in which we are in,” Galea said, adding that it has been “relatively standard practice” for those in academia to determine for themselves whether there is a conflict to disclose.

Bioethics professor Caplan said he could understand why some authors would choose not to disclose a board membership in every article, particularly if the article wasn’t directly related to the company or its products. Caplan serves as an unpaid chair of a compassionate use advisory committee based at New York University and funded by Janssen, which is a division of Johnson & Johnson.

“Just because you have a connection to a company, in my opinion, you don’t necessarily generate a conflict for everything that you do,” Caplan said. “We have to get more sophisticated” about conflicts of interest, though he advocates personally for full disclosure.

Elite medical journals, including JAMA and the New England Journal of Medicine, have streamlined the conflicts of interest question by using a standard disclosure form created by the International Committee of Medical Journal Editors.

JAMA media relations manager Deanna Bellandi declined to release McClellan’s ICMJE forms and said, “We publish what authors provide.”

The New England Journal of Medicine publishes the ICMJE forms with its manuscripts. McClellan disclosed his role at Johnson & Johnson in a 2015 letter to NEJM about the 21st Century Cures Act, a sweeping law that increases funding for disease research and alters the regulatory system for drugs and medical devices. But he did not disclose any corporate roles in two recent articles for NEJM Catalyst, a separate publication that requires authors to fill out a separate disclosure form. Those 2017 articles focused on payment reform and private-sector entrepreneurship in health care.

When completing the standard ICMJE disclosure form, an author fills out a series of sections. Section 3 notes: “You should disclose interactions with ANY entity that could be considered broadly relevant to the work.” And it tells the author to report “all sources of revenue paid (or promised to be paid) directly to you or your institution on your behalf over the 36 months prior to submission of the work.”

The Duke-Margolis Center and McClellan have been at the forefront of discussions on the merits of using real-world evidence, a somewhat controversial topic that could alter the way drugs are regulated and approved. The idea is that once a drug is on the market, the patients’ experience might in part supplant rigorous and expensive clinical trials.

Johnson & Johnson, whose executives are open proponents of the use of real-world evidence, did not respond to requests for comment.

McClellan did not disclose his J&J board membership in a 2017 white paper about real-world evidence, which was funded in part by the FDA. In September 2017, McClellan’s role at J&J was not disclosed during a public event done in coordination with the FDA. In December, Duke-Margolis announced a Real-World Evidence Collaborative, which is funded by pharmaceutical companies including Johnson & Johnson.

In May, a $4.2 million FDA grant was reposted for bids after concerns that Duke-Margolis was the sole bidder listed on the grant. The grant focuses on the drug approval process and research initiatives in the 21st Century Cures Act, including the potential benefits of using real-world evidence to analyze whether a drug works instead of rigorous and expensive clinical trials.

“Billions of dollars ride on the evidence that the FDA will accept for whether or not a drug is safe and effective,” said Avorn, whose center does similar research on drug pricing.

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

Doling Out Pain Pills Post-Surgery: An Ingrown Toenail Not The Same As A Bypass

June 22, 2018

What’s the right painkiller prescription to send home with a patient after gallbladder surgery or a cesarean section?

That question is front and center as conventional approaches to pain control in the United States have led to what some see as a culture of overprescribing, helping spur the nation’s epidemic of opioid overuse and abuse.

The answer isn’t clear-cut.

Surgeon Marty Makary wondered why and what could be done.

So, Makary, a researcher and a professor of surgery and health policy at Johns Hopkins School of Medicine in Baltimore, took an innovative approach toward developing guidelines: matching the right number of opioid painkillers to specific procedures.

After all, most doctors usually make this decision based on one-size-fits-all recommendations, or what they learned long ago in med school.

Even Makary admitted that for most of his career he “gave [painkillers] out like candy.”

In December, he gathered a group of surgeons, nurses, patients and other leaders, asking them: What should we be prescribing for operation X?”

The answer was illuminating.

“No one should have 50 tabs sitting in their medicine cabinet” for acute pain, says Dr. Marty Makary, who’s leading an effort to curb overprescribing by offering procedure-specific guidelines for opioid painkillers. (Courtesy of Johns Hopkins Medicine)

“The head of the hospital’s pain services said, ‘You’re the surgeon, what do you think?’” recalled Makary.

Makary didn’t know. Nor did the resident. And the nurse practitioner, who often is the one who most closely follows up with patients, said it varies.

“Wow,” recalls Makary of that day when they first considered appropriate limits. “We’re the experts, the heads of this and that, and we don’t know.”

After a quick couple of weeks of intense discussion, Makary’s group reached consensus and gave its blessing to guidelines setting maximum numbers of opioid-containing pills for 20 different common surgical situations, from relatively minor procedures to coronary bypass surgery.

“We’re in a crisis,” said Makary, explaining why the group didn’t go a more traditional route and publish its findings in a medical journal first, which could take months.

Sometimes the right number of opioids is zero, concluded the group.

Indeed, it recommends no opioids for patients heading home after uncomplicated labor and delivery, or after cardiac catheterization, a procedure in which a thin, hollow tube is inserted into the heart through a blood vessel to check for blockages.

For certain types of knee surgery, such as arthroscopic meniscectomy, the guidelines recommend no more than 12 pills upon discharge, while a patient going home after an open hysterectomy could require as many as 20.

Optimally, “no one should be given more than five or 10 opioid tablets after a cesarean section,” Makary said.

Oh, and for cardiac bypass surgery? No more than 30 pills.

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But What About The Pain?

Tens of thousands of Americans are dependent upon opioid medications. An increasing number are dying from overdoses, both from prescription medication and street drugs.

Knowing that, Makary, as well as other surgeons, hospitals and organizations, are taking steps to change how they practice medicine.

After all, many experts view the use of opioid prescription painkillers after surgery as a gateway to long-term use or dependence. A study published last year in the journal JAMA Surgery found that persistent use of opioids was “one of the most common complications after elective surgery.”

In that study, University of Michigan researchers found that 6 percent of people who had never taken opioids but received them after surgery were still taking the medications three to six months later.

With about 50 million surgeries that occur in the U.S. each year, “there are millions who may become newly dependent,” said Chad Brummett, the study’s lead author and an associate professor of anesthesiology at the University of Michigan Medical School.

Smokers, and those diagnosed with certain conditions such as depression, anxiety or chronic pain before their operations, were most at risk of long-term use.

Each refill or additional week of use makes for a greater risk of misuse, other studies have shown.

Additional research points to another reason for concern. If patients don’t take all the pills they are prescribed following an operation, those pills can be stolen or diverted to other people, who then run the risk of becoming dependent.

Still, there is debate in medical circles about just how effective recommendations and guidelines will be in stemming the epidemic.

For one thing, some experts worry that if the fight against opioids focuses only on safe prescribing at the expense of seeking alternatives, it may miss the bigger picture.

“Are there better methods than opioids in the first place?” asks Lewis Nelson, chair of emergency medicine at Rutgers New Jersey Medical School. “Could you put a lidocaine patch over the wound or is there a better way to immobilize a joint?”

Studies have shown that sometimes a combination of ibuprofen and acetaminophen can be just as good as or better than opioids.

Alternatives should always be considered first, agreed Makary.

Another concern is that guidelines for prescribing relief — even those aimed at short-duration, acute pain, such as that following surgery — have carryover effects on patients with long-term pain. Advocates say all the attention around prescribing limits have made it difficult for chronic pain patients to get the medications they need.

Some people even apply these concerns to recommendations about the treatment of acute pain.

“It’s important for a physician to have the ability, if they feel there’s a medical necessity, to write a prescription for a longer duration,” said Steven Santos, president of the American Academy of Pain Medicine. “It’s challenging to lump all patients into one basket.”

A Different Focus: Duration

Lawmakers — desperate to address overdose problems that are destroying families and communities — have gone where they usually don’t: setting specific rules for doctors.

Legislatures in more than a dozen states, including New Jersey, Massachusetts and New York, have set restrictions, often on the number of days’ worth of pills prescribed for acute pain.

“States said that since physicians haven’t self-regulated, we’re going to do it for them,” said Nelson at Rutgers.

Congress, too, is getting involved, holding a flurry of hearings this spring, and considering legislation that would, among other things, set limits on prescribing opioids for acute pain. The recently passed federal spending bill includes $3 billion in new funding to help states and local governments with opioid prevention, treatment and law enforcement efforts.

To be sure, the medical profession has also responded to the crisis — with medical societies and other expert groups offering a growing number of standards for prescribing opioids.

Some are fairly generic, recommending the lowest dose for the shortest period of time for acute pain. Some are more prescriptive.

None is meant to address the needs of chronic pain patients or those with cancer.

And state rules vary. New Jersey’s, for example, says patients with acute pain should, initially, get no more than a five-day supply, while Massachusetts sets the cap at seven days for a patient prescribed opiates for the first time.

The Centers for Disease Control and Prevention recommends three days.

Makary and some other experts say that, while well-intentioned, such durational rules are too blunt.

A day’s worth of pills can vary, depending on how often the doctor instructs patients to take them. Under many of the state rules, patients could still head home with more than 50 pills.

“No one should have 50 tabs sitting in their medicine cabinet” for acute pain, said Makary.

Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management, supports guidelines but wants states to take their rules a step further.

“I don’t think the way the states are going at this makes much sense because the issue with overprescribing was quantity, yet they’re passing laws around duration,” he said.

Instead, the laws should require that “if physicians are going to prescribe more than three days, they have to warn the patients that this is an addictive drug and that taking it every day for as little as five days may cause them to become physiologically dependent,” Kolodny said.

That would create a disincentive to prescribing more than three days’ worth of opioid painkillers, he added, and lead to more informed patients among those who need a longer supply.

Rutgers’ Nelson, who sat on the CDC panel that developed recommendations, said durational rules — like those adopted by the states — can be effective.

“I personally think three days is enough,” said Nelson. “That doesn’t mean pain goes away in three days, but most people get better within three to five days.”

That said, Nelson called the Hopkins’ approach an “excellent idea” and one he has tried to do. “It’s a lot harder than it sounds because of the large number of procedures and the diversity of patient needs,” he said.

To get around overprescribing — or setting one-size-fits-all guidelines — physicians at Dartmouth-Hitchcock Medical Center have a developed their own data-based approach.

Dr. Richard Barth, the chief of general surgery at Dartmouth, and colleagues studied 333 patients discharged from the hospital following six common surgeries that included bariatric procedures; operations on the stomach, liver, colon and pancreas; and hernia repair.

Surveying the patients, they asked how many opioid pills they went home with, how many they actually took, how many went unused and how much pain they experienced.

The data helped them land on a way to recommend a specific number of pills. “If they took none the day before discharge, then over 85 percent of patients did not take any when they went home,” said Barth.

Dartmouth-Hitchcock now uses that data as a recommended starting point for physicians.

Under the guidelines, patients taking no opioid pain pills the day before discharge go home with none. Those who take one to three pills get 15, an amount Barth’s study found satisfied 85 percent of patients, and those who took four or more get 30 pills.

“We came out with a very easy to implement and remember guideline,” said Barth. “We actually called patients and asked them how many [pills] they used. That’s what differentiates us from other places.”

Brummett, at Michigan, says the Opioid Prescribing Engagement Network, a collaboration of hospitals, insurers, physicians and others in his state, has used similar data methods to come up with procedure-specific guidelines.

“We’ve taken a data-driven approach,” he said. “We believe patient-reported outcomes are a better way to guide than expert consensus.”

For his part, Makary admitted it is harder to develop guidelines like those at Hopkins and Dartmouth, but he said the effort is vital.

“It’s mind-boggling to me” that so many opioid-prescribing guidelines do not specify the procedure, said Makary. “An ingrown toenail is not the same as cardiac bypass surgery.”

That ‘Living Will’ You Signed? At The ER, It Could Be Open To Interpretation.

June 14, 2018
Navigating Aging

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“Don’t resuscitate this patient; he has a living will,” the nurse told Dr. Monica Williams-Murphy, handing her a document.

Williams-Murphy looked at the sheet bearing the signature of the unconscious 78-year-old man, who’d been rushed from a nursing home to the emergency room. “Do everything possible,” it read, with a check approving cardiopulmonary resuscitation.

The nurse’s mistake was based on a misguided belief that living wills automatically include “do not resuscitate” (DNR) orders. Working quickly, Williams-Murphy revived the patient, who had a urinary tract infection and recovered after a few days in the hospital.

Unfortunately, misunderstandings involving documents meant to guide end-of-life decision-making are “surprisingly common,” said Williams-Murphy, medical director of advance-care planning and end-of-life education for Huntsville Hospital Health System in Alabama.

But health systems and state regulators don’t systematically track mix-ups of this kind, and they receive little attention amid the push to encourage older adults to document their end-of-life preferences, experts acknowledge. As a result, information about the potential for patient harm is scarce.

A new report out of Pennsylvania, which has the nation’s most robust system for monitoring patient safety events, treats mix-ups involving end-of-life documents as medical errors — a novel approach. It found that in 2016, Pennsylvania health care facilities reported nearly 100 events relating to patients’ “code status” — their wish to be resuscitated or not, should their hearts stop beating and they stop breathing. In 29 cases, patients were resuscitated against their wishes. In two cases, patients weren’t resuscitated despite making it clear they wanted this to happen.

The rest of the cases were “near misses” — problems caught before they had a chance to cause permanent harm.

Most likely, this is an undercount, said Regina Hoffman, executive director of the Pennsylvania Patient Safety Authority, adding that she was unaware of similar data from any other state.

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Asked to describe a near miss, Hoffman, co-author of the report, said: “Perhaps I’m a patient who’s come to the hospital for elective surgery and I have a DNR (do not resuscitate) order in my [medical] chart. After surgery, I develop a serious infection and a resident [physician] finds my DNR order. He assumes this means I’ve declined all kinds of treatment, until a colleague explains that this isn’t the case.”

The problem, Hoffman explained, is that doctors and nurses receive little, if any, training in understanding and interpreting living wills, DNR orders and Physician Orders for Life-Sustaining Treatment (POLST) forms, either on the job or in medical or nursing school.

Communication breakdowns and a pressure-cooker environment in emergency departments, where life-or-death decisions often have to be made within minutes, also contribute to misunderstandings, other experts said.

Research by Dr. Ferdinando Mirarchi, medical director of the department of emergency medicine at the University of Pittsburgh Medical Center Hamot in Erie, Pa., suggests that the potential for confusion surrounding end-of-life documents is widespread. In various studies, he has asked medical providers how they would respond to hypothetical situations involving patients with critical and terminal illnesses.

In one study, for instance, he described a 46-year-old woman brought to the ER with a heart attack and suddenly goes into cardiac arrest. Although she’s otherwise healthy, she has a living will refusing all potentially lifesaving medical interventions. What would you do, he asked more than 700 physicians in an internet survey?

Only 43 percent of those doctors said they would intervene to save her life — a troubling figure, Mirarchi said. Since this patient didn’t have a terminal condition, her living will didn’t apply to the situation at hand and every physician should have been willing to offer aggressive treatment, he explained.

In another study, Mirarchi described a 70-year-old man with diabetes and cardiac disease who had a POLST form indicating he didn’t want cardiopulmonary resuscitation but agreeing to a limited set of other medical interventions, including defibrillation (shocking his heart with an electrical current). Yet 75 percent of 223 emergency physicians surveyed said they wouldn’t have pursued defibrillation if the patient had a cardiac arrest.

One issue here: Physicians assumed that defibrillation is part of cardiopulmonary resuscitation. That’s a mistake: They’re separate interventions. Another issue: Physicians are often unsure what patients really want when one part of a POLST form says “do nothing” (declining CPR) and another part says “do something” (permitting other interventions).

Mirarchi’s work involves hypotheticals, not real-life situations. But it highlights significant practical confusion about end-of-life documents, said Dr. Scott Halpern, director of the Palliative and Advanced Illness Research Center at the University of Pennsylvania’s Perelman School of Medicine.

Attention to these problems is important, but shouldn’t be overblown, cautioned Dr. Arthur Derse, director of the center for bioethics and medical humanities at the Medical College of Wisconsin. “Are there errors of misunderstanding or miscommunication? Yes. But you’re more likely to have your wishes followed with one of these documents than without one,” he said.

Make sure you have ongoing discussions about your end-of-life preferences with your physician, surrogate decision-maker, if you have one, and family, especially when your health status changes, Derse advised. Without these conversations, documents can be difficult to interpret.
Use Our Content This story can be republished for free (details).
Here are some basics about end-of-life documents:

Living wills. A living will expresses your preferences for end-of-life care but is not a binding medical order. Instead, medical staff will interpret it based on the situation at hand, with input from your family and your surrogate decision-maker.

Living wills become activated only when a person is terminally ill and unconscious or in a permanent vegetative state. A terminal illness is one from which a person is not expected to recover, even with treatment — for instance, advanced metastatic cancer.

Bouts of illness that can be treated — such as an exacerbation of heart failure — are “critical” not “terminal” illness and should not activate a living will. To be activated, one or two physicians have to certify that your living will should go into effect, depending on the state where you live.

DNRs. Do-not-resuscitate orders are binding medical orders, signed by a physician. A DNR order applies specifically to cardiopulmonary resuscitation (CPR) and directs medical personnel not to administer chest compressions, usually accompanied by mouth-to-mouth resuscitation, if someone stops breathing or their heart stops beating.

The section of a living will specifying that you don’t want CPR is a statement of a preference, not a DNR order.

A DNR order applies only to a person who has gone into cardiac arrest. It does not mean that this person has refused other types of medical assistance, such as mechanical ventilation, defibrillation following CPR, intubation (the insertion of a breathing tube down a patient’s throat), medical tests or intravenous antibiotics, among other measures.

Even so, DNR orders are often wrongly equated with “do not treat” at all, according to a 2011 review in the Journal of General Internal Medicine.

POLST forms. A POLST form is a set of medical orders for a seriously ill or frail patient who could die within a year, signed by a physician, physician assistant or nurse practitioner.

These forms, which vary by state, are meant to be prepared after a detailed conversation about a patient’s prognosis, goals and values, and the potential benefits and harms of various treatment options.

Problems have emerged with POLST’s increased use. Some nursing homes are asking all patients to sign POLST forms, even those admitted for short-term rehabilitation or whose probable life expectancy exceeds a year, according to a recent article authored by Charlie Sabatino, director of the American Bar Association Commission on Law and Aging. Also, medical providers’ conversations with patients can be cursory, not comprehensive, and forms often aren’t updated when a patient’s medical condition changes, as recommended.

“The POLST form is still relatively new and there’s education that needs to be done,” said Amy Vandenbroucke, executive director of the National POLST Paradigm, an organization that promotes the use of POLST forms across the U.S. In a policy statement issued last year and updated in April, it stated that completion of POLST forms should always be voluntary, made with a patient’s or surrogate decision-maker’s knowledge and consent, and offered only to people whose physician would not be surprised if they die within a year.

KHN’s coverage of these topics is supported by John A. Hartford Foundation, Gordon and Betty Moore Foundation and The SCAN Foundation

How America Got Hooked On A Deadly Drug

June 13, 2018

(Maria Fabrizio for KHN)

This story also ran on Daily Beast. This story can be republished for free (details). Purdue Pharma left almost nothing to chance in its whirlwind marketing of its new painkiller OxyContin.

From 1996 to 2002, Purdue pursued nearly every avenue in the drug supply and prescription sales chain — a strategy now cast as reckless and illegal in more than 1,500 federal civil lawsuits from communities in Florida to Wisconsin to California that allege the drug has fueled a national epidemic of addiction.

Read The Documents

Click here to dive into Purdue’s internal budget documents from 1996 through 2002, a 2001 sales bonus program and more.

Kaiser Health News is releasing years of Purdue’s internal budget documents and other records to offer readers a chance to evaluate how the privately held Connecticut company spent hundreds of millions of dollars to launch and promote the drug, a trove of information made publicly available here for the first time.

All of these internal Purdue records were obtained from a Florida attorney general’s office investigation of Purdue’s sales efforts that ended late in 2002.

I have had copies of those records in my basement for years. I was a reporter at the South Florida Sun-Sentinel, which, along with the Orlando Sentinel, won a court battle to force the attorney general to release the company files in 2003. At the time, the Sun-Sentinel was writing extensively about a growing tide of deaths from prescription drugs such as OxyContin.

We drew on the marketing files to write two articles, including one that exposed possible deceptive marketing of the drug. Now, given the disastrous arc of prescription drug abuse over the past decade and the stream of suits being filed — more than a dozen on some days — it seemed time for me to share these seminal documents that reveal the breadth and detail of Purdue’s efforts.

Asked by Kaiser Health News for comment on the OxyContin marketing files and the suits against the company, Purdue Pharma spokesman Robert Josephson issued a statement that reads in part:

“Suggesting activities that last occurred more than 16 years ago, for which the company accepted responsibility, helped contribute to today’s complex and multi-faceted opioid crisis is deeply flawed. The bulk of opioid prescriptions are not, and have never been, for OxyContin, which represents less than 2% of current opioid prescriptions.”

Purdue first marketed OxyContin for cancer pain but planned to expand that use to meet its multimillion-dollar sales goals.(John Ewing/Portland Press Herald via Getty Images)

The marketing files show that about 75 percent of more than $400 million in promotional spending occurred after the start of 2000, the year Purdue officials told Congress they learned of growing OxyContin abuse and drug-related deaths from media reports and regulators. These internal Purdue marketing records show the drugmaker financed activities across nearly every quarter of medicine, from awarding grants to health care groups that set standards for opioid use to reminding reluctant pharmacists how they could profit from stocking OxyContin pills on their shelves.

Purdue bought more than $18 million worth of advertising in major medical journals that cheerily touted OxyContin. Some of the ads, federal officials said in 2003, “grossly overstated” the drug’s safety.

The Purdue records show that the company poured more than $8 million into a website and venture called “Partners Against Pain,” which helped connect patients to doctors willing to treat their pain, presumably with OxyContin or other opioids.

It made and distributed 14,000 copies of a video that claimed opioids caused addiction in fewer than 1 percent of patients, a claim Food and Drug Administration officials later said “has not been substantiated.”

Purdue hoped to grow into one of the nation’s top 10 drug companies, both in sales and “image or professional standing,” according to the documents; OxyContin was the means to that end.

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Purdue first marketed the drug for cancer pain but planned to expand that use to meet its multimillion-dollar sales goals. In 1998, the market for treating cancer with opioids stood at $261 million, compared with $1.3 billion for treating other types of pain, the Purdue reports note.

Purdue’s OxyContin sales objectives were clearly stated in the earliest marketing plan in the records, for 1996. It sought $25 million in sales and to generate 205,000 prescriptions. By the next year, its goals had tripled: $77.9 million in sales and to generate 600,000 prescriptions.

Purdue bombarded doctors and other health workers with literature and sales calls. Records show that in 1997 the company budgeted $300,000 for mailings to doctors who prescribed opioids liberally, based on sales data that drug companies purchase. The mailers recommended OxyContin for “pain syndromes,” including osteoarthritis and back pain. It added $75,000 for mailings “to keep in touch with our best customers for OxyContin to ensure they continue prescribing it.”

Sales agents made thousands of visits to general practice doctors and others who had little training or experience using potent opioids, according to a 2003 Government Accountability Office audit. The OxyContin slogan in 1999 was: “The One to Start With and the One to Stay With.” OxyContin earned Purdue about $2.8 billion in revenue from the start of 1996 through June 2001, according to the Justice Department.

In May 2000, Purdue’s hope to conquer the arthritis market hit a snag when the FDA criticized an ad for OxyContin in the New England Journal of Medicine. The FDA said the ad, which Purdue Pharma agreed to stop using, overstated the drug’s benefits for treating all types of arthritis without pointing out risks.

News reports of abuse and overdose deaths also were surfacing. Purdue’s 2001 marketing document noted that OxyContin had “experienced significant challenges” the year before because of abuse and unlawful diversion in Maine, Ohio, Virginia, Louisiana and Florida.

OxyContin pills contain oxycodone, an opioid as potent as morphine and maybe more so. Abusers quickly figured out they could crush the pills and snort or inject the dust

In response, Purdue’s 2001 marketing budget included funding to help doctors recognize patients who were in need of “substance abuse counseling” and do more to “prevent abuse and diversion.” It added $1.2 million in spending for what it called “anti-diversion” efforts in 2002, according to the internal records.

Potent Sales Force

In 2002, The Florida attorney general’s office was one of the first law enforcement agencies to investigate Purdue. The state ended its probe after Purdue agreed to pay Florida $2 million to help fund a data system to monitor narcotics prescriptions. It did not admit to any wrongdoing in the settlement.

Yet handwritten notes of a state investigator’s interview with a former Purdue sales manager for West Virginia and western Pennsylvania named Bill Gergely, then 58, suggested otherwise. The notes were part of the documents released by the state.

Gergely, who worked for the company from 1972 until 2000, said Purdue executives told sales staff at a launch meeting that OxyContin “was non-habit forming,” according to the undated investigator’s notes. Gergely said Purdue gave its sales force material — some of which was not approved by the FDA — for “education,” the notes show. He told the investigator that Purdue had a bonus system and paid well; the last year he worked for Purdue, Gergely earned $238,000.

(Story continues below.)

As Purdue charged ahead with OxyContin, prescription pills overtook illegal drugs like heroin and cocaine as killers in Florida, according to medical examiner files. In May 2002, the South Florida Sun-Sentinel documented nearly 400 pill deaths in three South Florida counties the previous two years, based on an examination of autopsy and police records.

Half the deaths involved drugs that contained oxycodone, according to medical examiner records. But it was not always clear in these records that it was OxyContin because oxycodone was an ingredient in many other narcotic pills. In 70 of the deaths, however, police or medical examiner records specifically identified OxyContin as one of the drugs. Though some people who died bought pills on a thriving black market, many were under the care of doctors for what appeared, at least at some point, to be legitimate injuries, according to medical examiner files.

Purdue did not challenge the accuracy of the newspaper’s reporting. It countered that the articles “did a disservice” to the company and patients who take their medicine “according to the directions of their doctors.” While the company said its executives “deeply regret the tragic consequences that have resulted from the misuse and abuse of our pain medicine … advances in the treatment of pain should not be limited or reversed because some people illegally divert, abuse or misuse these drugs.”

To its sales force, the internal Purdue records show, Purdue blamed bad press for cutting into sales. “The media’s attention to abuse and diversion of OxyContin tablets has provided state Medicaid plans and some HMOs, concerned about the effect the product is having on their budget, an excuse to look for ways to limit the prescribing of OxyContin tablets,” the 2002 marketing document said.

But five years after its legal battle with Florida officials, Purdue made a startling admission in federal court in Virginia. The company pleaded guilty in 2007 to felony charges of “misbranding” OxyContin “with the intent to defraud or mislead.” The company paid $600 million in fines and other penalties. Among the deceptions it confessed to was directing its salespeople to tell doctors the drug was less addictive than other opioids.

Three Purdue Pharma executives pleaded guilty to misdemeanor criminal charges for their roles in the marketing scheme. The three men paid a total of $34 million in fines and penalties, court records show. Accepting Purdue’s plea deal, U.S. District Judge James P. Jones noted that federal prosecutors believed the Purdue case of 2007 would send a “strong deterrent message to the pharmaceutical industry.”

A Costly Reckoning?

Ten years on, the 1,500-plus lawsuits, filed mostly on behalf of cities, counties and states, could prove to be a costly reckoning for the opioid industry. The suits are demanding payback from Purdue and other drugmakers for the sky-high costs of treating addiction and other compensation, much as the litigation against Big Tobacco in the late 1990s.

Other drug makers named as defendants in most of the suits include those that Purdue considered to be its top competitors in the pain sector: Janssen Pharmaceuticals, Teva Pharmaceutical Industries, Endo International PLC and Mallinckrodt PLC.

Federal officials estimate the economic cost of opioid abuse topped $500 billion in 2015 alone. Since 1999, at least 200,000 people have died in the U.S. from these overdoses, according to the Centers for Disease Control and Prevention. More than 52,000 of those died in 2015 alone, more than were killed in car crashes and gun homicides combined, the suits contend.

A case filed in April by Baltimore County in Maryland makes an argument common to many of the suits:

“From the mid-’90s to the present, manufacturing defendants aggressively marketed and falsely promoted liberal opioid prescribing as presenting little to no risk of addiction, even when used long term for chronic pain. They infiltrated academic medicine and regulatory agencies to convince doctors that treating chronic pain with long-term opioids was evidence-based medicine when, in fact, it was not.

“Huge profits resulted from these efforts — as did the present addiction and overdose crisis.”

Purdue has not yet filed a response to the allegations in the suit.

Other drug manufacturers “emulated Purdue’s false marketing strategy” and sold billions of dollars of prescription opioids “as safe and efficacious for long term use, knowing full well that they were not,” Wisconsin’s Oneida County alleges in its November 2017 federal court suit. Purdue also has not yet filed a response to the allegations in this suit.

But Purdue spokesman Josephson told KHN: “We share public officials’ concern about the opioid crisis, and we are committed to working collaboratively toward meaningful solutions. We vigorously deny these allegations and look forward to the opportunity to present our defense.”

One California doctor who was sentenced to 25 years in prison for overprescribing OxyContin is also suing Purdue. Masoud Bamdad alleges that the company’s representatives made sales calls and gave him “deceitful, misleading and over-hyped information,” which he relied on to prescribe the drug, in some cases with deadly consequences for his patients, according to the suit, which is pending. Purdue has asked that the case be stayed while judges decide if it should be consolidated with others filed against the company. In February, Purdue announced that it would no longer promote opioids to doctors.

(Story continues below.)

Because the lawsuits from across the U.S. contain similar allegations, many of them have been consolidated in Ohio – as a multi-district litigation. Some days, federal court dockets log a dozen or more new cases. Many of the suits run a hundred pages or more and allege that deceptive opioid marketing schemes continue to this day.

The manufacturers, in a joint court motion late last year, contend that opioids “serve a critical public health role in providing relief to patients suffering from pain that is often debilitating” and that they are being wrongly blamed.

They also point out that the FDA approved all of their products as “safe and effective.”

This month, the manufacturers filed motions to dismiss several of the cases, arguing that the county governments lack a legal basis for their claims. In seeking to blame the drugmakers, these lawsuits ignore “the criminal acts of third parties, the crucial role of health care providers, and the thorny public policy questions surrounding the problem of opioid abuse,” reads a motion to dismiss a case filed by Monroe County, Mich., against Purdue Pharma and other drug companies.

Dan Polster, the federal judge handling the cases, told an overflow crowd in his courtroom that the opioid epidemic has become so severe, that it is cutting the average life expectancy of Americans.

“I’m pretty ashamed that this has occurred while I have been around,” he said in January, adding “I think we all should be.”

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

Medicare Takes Aim At Boomerang Hospitalizations Of Nursing Home Patients

June 13, 2018

“Oh my God, we dropped her!” Sandra Snipes said she heard the nursing home aides yell as she fell to the floor. She landed on her right side where her hip had recently been replaced.

She cried out in pain. A hospital clinician later discovered her hip was dislocated.

That was not the only injury Snipes, then 61, said she suffered in 2011 at Richmond Pines Healthcare & Rehabilitation Center in Hamlet, N.C. Nurses allegedly had been injecting her twice a day with a potent blood thinner despite written instructions to stop.

“She said, ‘I just feel so tired,’” her daughter, Laura Clark, said in an interview. “The nurses were saying she’s depressed and wasn’t doing her exercises. I said no, something is wrong.”

Her children also discovered that Snipes’ surgical wound had become infected and infested with insects. Just 11 days after she arrived at the nursing home to heal from her hip surgery, she was back in the hospital.

The fall and these other alleged lapses in care led Clark and the family to file a lawsuit against the nursing home. Richmond Pines declined to discuss the case beyond saying it disputed the allegations at the time. The home agreed in 2017 to pay Snipes’ family $1.4 million to settle their lawsuit.

While the confluence of complications in Snipes’ case was extreme, return trips from nursing homes to hospitals are far from unusual.

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With hospitals pushing patients out the door earlier, nursing homes are deluged with increasingly frail patients. But many homes, with their sometimes-skeletal medical staffing, often fail to handle post-hospital complications — or create new problems by not heeding or receiving accurate hospital and physician instructions.

Patients, caught in the middle, may suffer. One in 5 Medicare patients sent from the hospital to a nursing home boomerang back within 30 days, often for potentially preventable conditions such as dehydration, infections and medication errors, federal records show. Such rehospitalizations occur 27 percent more frequently than for the Medicare population at large.

Nursing homes have been unintentionally rewarded by decades of colliding government payment policies, which gave both hospitals and nursing homes financial incentives for the transfers. That has left the most vulnerable patients often ping-ponging between institutions, wreaking havoc with patients’ care.

(Story continues below)

“There’s this saying in nursing homes, and it’s really unfortunate: ‘When in doubt, ship them out,’” said David Grabowski, a professor of health care policy at Harvard Medical School. “It’s a short-run, cost-minimizing strategy, but it ends up costing the system and the individual a lot more.”

In recent years, the government has begun to tackle the problem. In 2013, Medicare began fining hospitals for high readmission rates in an attempt to curtail premature discharges and to encourage hospitals to refer patients to nursing homes with good track records.

Starting this October, the government will address the other side of the equation, giving nursing homes bonuses or penalties based on their Medicare rehospitalization rates. The goal is to accelerate early signs of progress: The rate of potentially avoidable readmissions dropped to 10.8 percent in 2016 from 12.4 percent in 2011, according to Congress’ Medicare Payment Advisory Commission.

“We’re better, but not well,” Grabowski said. “There’s still a high rate of inappropriate readmissions.”

The revolving door is an unintended byproduct of long-standing payment policies. Medicare pays hospitals a set rate to care for a patient depending on the average time it takes to treat a patient with a given diagnosis. That means that hospitals effectively profit by earlier discharge and lose money by keeping patients longer, even though an elderly patient may require a few extra days.

But nursing homes have to hospitalize patients. For one thing, keeping patients out of hospitals requires frequent examinations and speedy laboratory tests — all of which add costs to nursing homes.

Plus, most nursing home residents are covered by Medicaid, the state-federal program for the poor that is usually the lowest-paying form of insurance. If a nursing home sends a Medicaid resident to the hospital, she usually returns with up to 100 days covered by Medicare, which pays more. On top of all that, in some states, Medicaid pays a “bed-hold” fee when a patient is hospitalized.

None of this is good for the patients. Nursing home residents often return from the hospital more confused or with a new infection, said Dr. David Gifford, a senior vice president of quality and regulatory affairs at the American Health Care Association, a nursing home trade group.

“And they never quite get back to normal,” he said.

‘She Looked Like A Wet Washcloth’

Communication lapses between physicians and nursing homes is one recurring cause of rehospitalizations. Elaine Essa had been taking thyroid medication ever since that gland was removed when she was a teenager. Essa, 82, was living at a nursing home in Lancaster, Calif., in 2013 when a bout of pneumonia sent her to the hospital.

When she returned to the nursing home — now named Wellsprings Post-Acute Care Center — her doctor omitted a crucial instruction from her admission order: to resume the thyroid medication, according to a lawsuit filed by her family. The nursing home telephoned Essa’s doctor to order the medication, but he never called them back, the suit said.

Deborah Ann Favorite holds a photograph of her mother, Elaine Essa. The nursing home and Essa’s primary care practice settled a lawsuit brought by the family. (Heidi de Marco/KHN)

Without the medication, Essa’s appetite diminished, her weight increased and her energy vanished — all indications of a thyroid imbalance, said the family’s attorney, Ben Yeroushalmi, discussing the lawsuit. Her doctors from Garrison Family Medical Group never visited her, sending instead their nurse practitioner. He, like the nursing home employees, did not grasp the cause of her decline, although her thyroid condition was prominently noted in her medical records, the lawsuit said.

Three months after her return from the hospital, “she looked like a wet washcloth. She had no color in her face,” said Donna Jo Duncan, a daughter, in a deposition. Duncan said she demanded the home’s nurses check her mother’s blood pressure. When they did, a supervisor ran over and said, “Call an ambulance right away,” Duncan said in the deposition.

At the hospital, a physician said tests showed “zero” thyroid hormone levels, Deborah Ann Favorite, a daughter, recalled in an interview. She testified in her deposition that the doctor told her, “I can’t believe that this woman is still alive.”

Essa died the next month. The nursing home and the medical practice settled the case for confidential amounts. Cynthia Schein, an attorney for the home, declined to discuss the case beyond saying it was “settled to everyone’s satisfaction.” The suit is still ongoing against one other doctor, who did not respond to requests for comment.

Dangers In Discouraging Hospitalization

Out of the nation’s 15,630 nursing homes, one-fifth send 25 percent or more of their patients back to the hospital, according to a Kaiser Health News analysis of data on Medicare’s Nursing Home Compare website. On the other end of the spectrum, the fifth of homes with the lowest readmission rates return fewer than 17 percent of residents to the hospital.

Get The Data

Safely Home Or Back To The Hospital?

Download the data to see how skilled nursing homes in the U.S. performed on two metrics of quality.

Many health policy experts say that spread shows how much improvement is possible. But patient advocates fear the campaign against hospitalizing nursing home patients may backfire, especially when Medicare begins linking readmission rates to its payments.

“We’re always worried the bad nursing homes are going to get the message ‘Don’t send anyone to the hospital,’” said Tony Chicotel, a staff attorney at California Advocates for Nursing Home Reform, a nonprofit based in San Francisco.

Richmond Pines, where Sandra Snipes stayed, has a higher-than-average rehospitalization rate of 25 percent, according to federal records. But the family’s lawyer, Kyle Nutt, said the lawsuit claimed the nurses initially resisted sending Snipes back, insisting she was “just drowsy.”

After Snipes was rehospitalized, her blood thinner was discontinued, her hip was reset, and she was discharged to a different nursing home, according to the family’s lawsuit. But her hospital trips were not over: When she showed signs of recurrent infection, the second home sent her to yet another hospital, the lawsuit alleged.

Ultimately, the lawsuit claimed that doctors removed her prosthetic hip and more than a liter of infected blood clots and tissues. Nutt said if Richmond Pines’ nurses had “caught the over-administration of the blood thinner right off the bat, we don’t think any of this would have happened.”

Snipes returned home but was never able to walk again, according to the lawsuit. Her husband, William, cared for her until she died in 2015, her daughter, Clark, said.

“She didn’t want to go back into the nursing home,” Clark said. “She was terrified.”

KHN’s coverage of these topics is supported by John A. Hartford Foundation and Gordon and Betty Moore Foundation

Outsiders Swoop In Vowing To Rescue Rural Hospitals Short On Hope — And Money

June 04, 2018

CEDARVILLE, Calif. — Beau Gertz faced a crowd of worried locals at this town’s senior center, hoping to sell them on his vision for their long-beloved — but now bankrupt — hospital.

In worn blue jeans and an untucked shirt, the bearded entrepreneur from Denver pledged at this town hall meeting in March to revive the Surprise Valley Community Hospital — a place many in the audience counted on to set their broken bones, stitch up cattle-tagging cuts and tend to aging loved ones.

Gertz said that if they vote June 5 to let him buy their tiny public hospital, he will retain such vital services. Better still, he said, he’d like to open a “wellness center” to attract well-heeled outsiders — one that would offer telehealth, addiction treatment, physical therapy, genetic testing, intravenous vitamin infusions, even massage. Cedarville’s failing hospital, now at least $4 million in debt, would not just bounce back but thrive, he said.

Gertz, 34, a former weightlifter who runs clinical-lab and nutraceutical companies, unveiled his plan to pay for it: He’d use the 26-bed hospital to bill insurers for lab tests regardless of where patients lived. Through telemedicine technology, doctors working for Surprise Valley could order tests for people who’d never set foot there.

To some of the 100 or so people at the meeting that night, Gertz’s plan offered hope. To others, it sounded suspiciously familiar: Just months before, another out-of-towner had proposed a similar deal — only to disappear.

Outsiders “come in and promise the moon,” said Jeanne Goldman, 72, a retired businesswoman. “The [hospital’s] board is just so desperate with all the debt, and they pray this angel’s going to come along and fix it. If this was a shoe store in Surprise Valley, I could care less, but it’s a hospital.”

Goldman says the hospital’s board is just so desperate with all the debt that they “pray this angel’s going to come along and fix it.” (Heidi de Marco/KHN)

About 100 people attended the town hall meeting hosted by Beau Gertz. (Heidi de Marco/KHN)

(Heidi de Marco/KHN)

Looking For Salvation

The woes of Surprise Valley Community Hospital reflect an increasingly brutal environment for America’s rural hospitals, which are disappearing by the dozens amid declining populations, economic troubles, corporate consolidation and, sometimes, self-inflicted wounds.

Nationwide, 83 of 2,375 rural hospitals have closed since 2010, according to the North Carolina Rural Health Research Program. These often-remote hospitals — some with 10, 15, 25 beds — have been targeted by management companies or potential buyers who promise much but often deliver little while lining their own pockets, according to allegations in court cases, a Missouri state audit and media reports.

Enticed by such outsiders, some struggling rural hospitals around the country have embraced lab billing for faraway patients as a rescue plan. That’s because Medicare and commercial insurers tend to pay more for tests to sustain endangered rural hospitals compared with urban hospitals and especially outpatient labs. In general, this kind of remote billing is controversial and legally murky, and it recently has resulted in allegations of fraud in several states, according to government documents and media reports.

Surprise Valley’s hospital has 22 skilled nursing beds, one acute bed and three “swing” beds that can be used as needs arise. (Heidi de Marco/KHN)

(Heidi de Marco/KHN)

Rural hospital boards, however, tend not to have expertise in the health care business. The president of Surprise Valley Community’s board, for instance, is a rancher. Another board member owns a local motel; a third, a construction company. That lack of experience “leaves them vulnerable in many cases,” said Terry Hill of the nonprofit National Rural Health Resource Center, based in Duluth, Minn.

Seeking to distinguish himself from other would-be rescuers who ran into legal trouble, Gertz described his proposal to residents as perfectly legal — a legitimate use of telemedicine, essentially remote treatment via electronic communication such as video. “If you do it correctly,” he said in an interview with Kaiser Health News, “there is a nice profit margin. There [are] extra visits you can get from telemedicine but … it has to be billed correctly and it can’t be abused.”

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Gertz runs several companies — founded within the last four years —including two labs, SeroDynamics and Cadira Labs, as well as a wellness company called CadiraMD.

He pledged in court documents to buy the bankrupt hospital for $4 million and cover its debts, saying he had lined up a $4 billion New York company as a financial backer. Kaiser Health News was unable to locate the company under the name Gertz cited, Next Genesis Development Group. He did not respond to emails seeking clarification on the issue.

Gertz, who acknowledged that he had never before run a hospital, was asked at the same gathering whether he had disclosed his “financials” to the hospital board. “As a private entity, I don’t have to show my financials and I have not provided my financials to the board,” he replied.

It was not clear whether board members had ever asked. Surprise Valley Health Care District board President John Erquiaga declined to comment.

Cedarville, a hamlet of about 514 residents, is in one of California’s poorest counties, with a median income of roughly $30,000. The closest hospital with an emergency room is about 25 miles away over a mountain pass. (Heidi de Marco/KHN)

(Heidi de Marco/KHN)

A Sad Decline

Surrounded by the Warner and Modoc mountains and forests in California’s northeastern corner, Surprise Valley is home to four small communities. The largest is Cedarville, population 514, at last count.

The valley, covered in sagebrush and greasewood, is part of Modoc County, one of California’s poorest, with a median income of about $30,000. The closest hospital with an emergency room is roughly 25 miles away, over a mountain pass.

One of hundreds of rural hospitals built with help from the 1946 federal Hill-Burton Act, the Surprise Valley hospital opened in 1952 to serve a thriving ranching community. But it has struggled since, closing in 1981, reopening as a health clinic in 1985, then reconverting to a hospital in 1986.

A county grand jury report in 2014-15 found that “mismanagement of the [hospital district] has been evident for at least the past five years.”

By last summer, those in charge didn’t seem up to the task of running a modern hospital. By then, it was hardly a hospital at all. Crushed by debt, it primarily offered nursing home care, an emergency room, a volunteer ambulance service and just one acute care bed, with three others available if needed.

Surprise Valley Community Hospital (Heidi de Marco/KHN)

Besides its ER and volunteer-staffed ambulance service, Surprise Valley’s hospital in recent years has functioned mostly as a nursing home, saddled with crushing debt. (Heidi de Marco/KHN)

(Heidi de Marco/KHN)

When state inspectors arrived last June, they found chaos. The hospital’s chief nursing officer resigned during the inspection. Staffers reported unpaid checks to vendors hidden in drawers. Inspectors learned that the hospital had sent home temporary nurses because it couldn’t pay them, according to their report.

The hospital’s then-chief administrator, Richard Cornwell — who staffers said had instructed them to hide the checks, according to the report — had taken a leave of absence and was nowhere to be found. Cornwell, a health care accountant from Montana, was later fired and replaced with the hospital’s lab director, who in turn resigned, according to public records. Reached by Kaiser Health News, Cornwell declined to comment.

Federal regulators suspended Medicare and Medicaid payments to the hospital — a rarely invoked financial penalty — over concerns about patient care. Those payments have since been reinstated, but a follow-up state inspection in November 2017 identified more patient care concerns.

Jean Bilodeaux, 74, a journalist who lives in Cedarville says members of the hospital board “blew up” at her when she raised important questions about the hospital’s finances in stories she wrote for the Modoc County Record, a weekly newspaper. (Heidi de Marco/KHN)

Infighting ensued, with some residents fiercely committed to keeping the hospital open and others favoring closure, perhaps replacing it with a small clinic. Local journalist Jean Bilodeaux, 74, said board members often kept the public in the dark, failing to show up for their own meetings and sometimes making decisions outside public view.

When Bilodeaux raised questions about the hospital’s finances in the Modoc County Record, a weekly newspaper, she recalled, board members “started screaming at me,” she said. Now “I don’t even step foot in that hospital.”

Ben Zandstra, 65, a pastor in Cedarville, said that while Cornwell was in charge, he too got a chilly reception at the hospital, where he had long played guitar for patients on Christmas Eve. “I became persona non grata. It’s the most divisive thing I’ve seen in the years I’ve lived here.”

Ben Zandstra, pastor of the Surprise Valley Community Church in Cedarville, says the hospital’s administrators made clear he was no longer welcome at the hospital after he voiced concerns. (Heidi de Marco/KHN)

A White Knight, Vanished

Even residents who say they have experienced poor care at Surprise Valley Community believe its continued existence in some form is crucial — for its 50 or so jobs, for its ER, and because it puts the region on the map.

Eric Shpilman, 61, a retired probation officer, said his now-deceased wife received “unspeakable” treatment at Surprise Valley. But to shut it down? “It would take out the heart of Surprise Valley, the heart out of Cedarville.”

Last summer, the board turned to an outside management company for help.

Jorge Perez, CEO of Kansas City-based EmpowerHMS — which promises on its website to “rescue rural hospitals” — agreed to take over Surprise Valley’s debt and operate the hospital for three years, according to a management agreement with the board.

Eric Shpilman, a retired probation officer who lives in Fort Bidwell, Calif., works at a ranch in Cedarville. “If the hospital closes, it’s irreplaceable,” says Shpilman, who says his wife received “unspeakable” treatment at the hospital before she died. (Heidi de Marco/KHN)

In the two months after EmpowerHMS took over management, Surprise Valley’s revenue more than doubled, according to financial documents provided by the hospital.

Then, according to hospital officials’ public statements, the company stopped making the promised payments, and they haven’t been able to contact EmpowerHMS or Perez since. In January, when Surprise Valley filed for bankruptcy, documents filed in court said EmpowerHMS had “abandoned” the hospital.

Around the time Perez took over, he and companies with which he was involved were dogged by allegations of improper laboratory billing at facilities in Mississippi, Florida, Oklahoma and Missouri, according to ongoing lawsuits by insurers and others, a state audit and media reports. Missouri’s attorney general in May opened an investigation into one of the hospitals Perez managed, and Sen. Claire McCaskill (D-Mo.) recently called for a federal investigation into lab billing practices at one of the hospitals.

Medicare rules and commercial insurance contracts, with some exceptions, require people to be treated on an inpatient or outpatient basis by the hospitals that are billing for their lab tests. But insurers have alleged in court documents that hospitals Perez was involved with billed for tests — to the tune of at least $175 million — on patients never seen at those facilities. Perez has maintained that what he is doing is legal and that it generates revenue that rural hospitals desperately need, according to Side Effects Public Media.

Experts say insurers are catching on to voluminous billing by hospitals in communities that typically have generated a tiny number of tests. At one Sonoma County district hospital not associated with Perez, an insurer recently demanded repayment for $13.5 million in suspect billings, forcing the hospital to suspend the lucrative program and put itself up for sale.

Lab tests for out-of-town patients have “been a growing scheme in the last year, slightly longer,” said Karen Weintraub, executive vice president of Healthcare Fraud Shield, which consults for insurers. “There’s an incentive to bill for things not necessary or even services not rendered. It also may not be proper based on contracts with insurers. The dollars are getting large.”

Some residents were aware of controversy surrounding Perez and his companies and said they tried to warn the hospital district board. “All they wanted to hear was, ‘We will pay the bills,’” Bilodeaux said.

Neither Perez nor EmpowerHMS returned requests for comment. However, Michael Murtha, president of the National Alliance of Rural Hospitals, said in an email that he was responding on behalf of Perez, who chairs the coalition’s board.

“The mission to rescue rural hospitals and set them on a path of sustainability is a difficult undertaking, and it would be a disservice to their communities to preclude struggling facilities from availing themselves of every legal and regulatory means to generate badly needed revenue,” Murtha wrote, in part.

“Such pioneering efforts are not always welcomed by those who have benefited from the status quo,” he said.

Regarding Perez’s role at Surprise Valley, Murtha wrote that Perez tried to help save the facility by “effectively” donating over $250,000 but then discovered it faced “more challenges than had been initially realized.” Murtha said Perez worked to attract others who might be better able to help the hospital.

Businessman Beau Gertz faced a tough crowd of worried locals at a recent board meeting in Cedarville, hoping to sell his vision for their beloved but bankrupt hospital. (Heidi de Marco/KHN)

The Surprise Valley Health Care District held its meeting at the local church on March 28, 2018. (Heidi de Marco/KHN)

The Surprise Valley Health Care District is a public facility and supported by taxes on homeowners. Residents raised concerns at public meetings that they would personally be on the hook for thousands of dollars per household to pay off the hospital’s debt. (Heidi de Marco/KHN)

A New Savior?

One of those “others” in Perez’s orbit was Gertz, the Denver entrepreneur, who arrived in Surprise Valley several months ago.

The Denver executive told residents and Kaiser Health News that he operated a lab that previously performed tests for hospitals owned or managed by Perez’s companies. At one hospital board meeting, Gertz also said he had handled marketing for Perez companies for 1½ years.

However, he said he had parted ways with Perez after learning of his controversial dealings in other states, and Gertz said Perez now owes him more than $14 million. (Gertz and his companies have not been named as defendants in lawsuits reviewed by Kaiser Health News involving Perez and his companies.)

“I come in with a certain guilt by association,” he told the Modoc County Board of Supervisors in April, according to a recording of the meeting. But Gertz sought to assuage any concerns, telling the supervisors he had a “passion” for rural life. He’d grown up on a farm, he said, where he “hung out with the chickens” and cleaned the stables every morning.

Gertz said his plan was different from Perez’s and legal because the hospital and one of his Denver labs, SeroDynamics, had become one business. With the hospital board’s approval earlier this year, he loaned the district $2.5 million for it to buy SeroDynamics — effectively an advance on the hospital’s purchase price of $4 million, according to bankruptcy court documents. SeroDynamics’ website now proclaims the lab a “wholly-owned subsidiary” of the Surprise Valley hospital, with “national reach.”

Robert Michel, a clinical laboratory management consultant who learned of the terms of the transaction from a reporter, offered a critical assessment. “The essence of this arrangement is to use the hospital’s existing managed-care contracts with generous payment terms for lab tests as a vehicle to bill for claims in other states,” said Michel, editor-in-chief of a trade magazine for the lab industry. This arrangement “should ring all sorts of bells” for the hospital board, he said.

Cedarville (Heidi de Marco/KHN)

For now, Gertz has said, dollars are flowing in. According to the journalist Jean Bilodeaux, Gertz phoned in to a Surprise Valley hospital board meeting last month to report that the lab billing so far had netted about $300,000. According to bankruptcy court documents, 80 percent of the profits will go to his companies, 20 percent to the hospital.

Those are terms some in Surprise Valley are willing to live with.

The next step, for Gertz, is taking ownership of Surprise Valley’s entire operation. For the 1,500 district residents, voting no on Tuesday almost certainly means closure, leaving taxpayers with potentially more debt, including any money they may owe Gertz.

That is good enough reason to go with the Denver entrepreneur, said acting hospital administrator Bill Bostic.

“He’s got something we haven’t got — which is money,” Bostic said.

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

Another Cause Of Doctor Burnout: Being Forced To Give Immigrants Unequal Care

May 31, 2018

One patient’s death changed the course of Dr. Lilia Cervantes’ career.

The patient, Cervantes said, was a woman from Mexico with kidney failure who repeatedly visited the emergency room for more than three years. In that time, her heart had stopped more than once, and her ribs were fractured from CPR.

The woman finally decided to stop treatment because the stress was too much for her and her two young children. She died soon afterward, Cervantes said.

Kidney failure, or end-stage renal disease, is treatable with routine dialysis every two to three days. Without regular dialysis, which removes toxins from the blood, the condition is life-threatening: Patients’ lungs can fill up with fluid, and they’re at risk of cardiac arrest if their potassium level gets too high.

But Cervantes’ patient was undocumented. She didn’t have access to government insurance, so she had to show up at the hospital in a state of emergency to receive dialysis.

Cervantes, an internal medicine specialist and a professor of medicine at University of Colorado in Denver, said the woman’s death inspired her to focus more on research.

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“I decided to transition so I could begin to put the evidence together to change access to care throughout the country,” she said.

Cervantes said emergency dialysis can be harmful to patients: The risk of death for someone receiving dialysis only on an emergency basis is 14 times higher than someone getting standard care, she found in research published in February.

Cervantes’ newest study, published recently in the Annals of Internal Medicine, shows these cyclical emergencies harm health care providers, too. “It’s very, very distressing,” she said. “We not only see the suffering in patients, but also in their families.”

There are an estimated 6,500 undocumented immigrants in the U.S. with end-stage kidney disease. Many of them can’t afford private insurance and are barred from Medicare or Medicaid. Treatment of these patients varies widely from state to state, and in many places the only way they can get dialysis is in the emergency room.

Cervantes and her colleagues interviewed 50 health care providers in Denver and Houston and identified common concerns among them. The researchers found that providing undocumented patients with suboptimal care because of their immigration status contributes to professional burnout and moral distress.

“Clinicians are physically and emotionally exhausted from this type of care,” she said.

Cervantes said the relationships clinicians build with their regular patients conflicts with the treatment they have to provide, which might include denying care to a visibly ill patient because their condition was not critical enough to warrant emergency treatment.

“You may get to know a patient and their family really well,” she said. Providers may go to a patient’s restaurant, or to family gatherings such as barbacoas (similar to barbecues) or quinceañeras (milestone parties for 15-year-old girls).

“Then the following week, you might be doing CPR on this same patient because they maybe didn’t come in soon enough, or maybe ate something that was too high in potassium,” she said.

Other providers, Cervantes said, report detaching from their patients because of the suffering they witness. “I’ve known people that have transitioned to different parts of the hospital because this is difficult,” she said.

Melissa Anderson, a nephrologist and assistant professor at the Indiana University School of Medicine in Indianapolis who was not involved in Cervantes’ study, said Cervantes research matches her own experience. She said that when she worked at a safety-net hospital in Indianapolis, patients would come to the ER when they felt sick. But some hospitals would not provide dialysis until their potassium was dangerously high.

To avoid being turned away when their potassium level was too low, she said, patients in the waiting room would drink orange juice, which contains potassium, putting themselves at risk of cardiac arrest.

“That’s Russian roulette,” Anderson said. “That was hard for all of us to watch.”

Anderson eventually stopped working at that hospital and, like Cervantes, has worked on research and advocacy efforts to change how undocumented immigrants with kidney failure are treated.

“I practically had to take a class in immigration to understand what’s going on,” she said. “Physicians just don’t understand it, and we shouldn’t have to.”

Providers in Cervantes’ study also worried that these avoidable emergencies strain hospital resources — clogging emergency departments when undocumented patients could simply receive dialysis outside the hospital — and about the cost: Emergency-only hemodialysis costs nearly four times as much as standard dialysis, according to a 2007 study from researchers at Baylor College of Medicine.

Those costs are often covered by taxpayers through emergency Medicaid, which pays for emergency treatment for low-income individuals without insurance. In a study published in Clinical Nephrology last year, Anderson and her colleagues found that at one hospital in Indianapolis, the state paid significantly more for emergency-only dialysis than it did for more routine care.

Areeba Jawed, a nephrologist in Detroit who has performed survey research into this issue, said many providers don’t understand how much undocumented immigrants actually contribute to society, while receiving few of the societal benefits.

“A lot of people don’t know that undocumented immigrants do pay taxes,” she said. “There’s a lot of misinformation.”

“I think there are better options,” said Jawed, who has treated undocumented patients both in Detroit and Indianapolis.

As a workaround, some hospitals simply provide charity care to cover regular dialysis for undocumented patients. But Cervantes argues that a better solution is a policy fix. States are allowed by the federal government to define what qualifies as an emergency.

“Several states, like Arizona, New York and Washington, have modified their emergency Medicaid programs to include standard dialysis for undocumented immigrants,” she said.

Illinois covers routine dialysis and even passed a law allowing undocumented immigrants to receive kidney transplants, she noted.

“Ideally, we could come up with federal language and make this the national treatment strategy for undocumented immigrants,” Cervantes said.

Ultimately, Cervantes said, providers don’t want to treat undocumented patients differently.

“At the end of the day, clinicians become providers because they want to provide care for all patients,” she said.

This story is part of a partnership that includes Side Effects Public MediaNPR and Kaiser Health News.

Watch: Beyond Puerto Rico’s Grim Statistics, Stories Of Lives And Deaths

May 30, 2018

In an interview with Judy Woodruff on “PBS NewsHour” Tuesday, Kaiser Health News senior correspondent Sarah Varney discussed the updated estimates that more than 4,600 people died as a result of Hurricane Maria. Varney and “PBS NewsHour” producer Jason Kane are on assignment in Puerto Rico this week to continue reporting on the aftermath of the devastating Sept. 20 storm.

Cameras On Preemies Let Family In, Keep Germs Out

May 29, 2018

Hospitals around the country have been upgrading their neonatal intensive care units to include personal webcams for each tiny patient. It’s a convenience for parents — and reduces worries about visitors bringing in germs.

The neonatal intensive care unit at St. Thomas Midtown in Nashville is the latest hospital to join the webcam wave, among facilities around the country from big cities to towns that are installing cameras over each infant.

At St. Thomas, Sherri Anderson has 20 years of experience as a neonatal nurse, watching parents run themselves ragged trying to be at the hospital every waking hour, sometimes commuting long distances.

“The parents go through a lot — emotionally, spiritually, physically,” Anderson said. “It’s very taxing, and sometimes they just need to go home and just recover.”

The $1,200 cameras — which St. Thomas paid for through a special fundraiser — come from a company called Natus Medical. They provide a close-up shot that anyone in the world can log on to see — using a password.

Jill Brothers had twin boys born at 27 weeks, requiring a two-month stay in the NICU. Her husband, who plays professional baseball, was away for spring training most of that time, but he could get on the computer and watch the boys’ progress.

“This has been a crucial element to just being a part and feeling like you’re involved with their growth,” she said. “There’s lots of other people in the family that have been able to log on and see the boys and see them [in] real time, which is great.”

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Brothers still came to the hospital every day, but she found herself checking the web stream when she was up in the middle of the night — to watch the boys breathing.

“I really just felt like it was safe and comfortable,” she said.

Parents’ peace of mind is only one aim, though. St. Thomas NICU nursing director Donna Darnell said the new cameras could cut down on germs sneaking into the unit from other relatives stopping by.

“There are times throughout the year that we worry about a lot of visitors. Flu season is the best example,” Darnell said.

Even during normal times, access for family and friends is highly restricted because of germs — and the cameras give many more people the opportunity to see the tiny patients.

While baby Duke Brothers stayed in the NICU, his parents could watch over him via webcam. (Blake Farmer/WPLN)((Blake Farmer/WPLN))

In the little research that has been done, parents have loved the video access. Doctors also are OK with it, but a study published in the American Journal of Perinatology found that some nurses have misgivings about being watched all day and all night.

One of the study’s authors, Dr. Gene Dempsey from the University College Cork in Ireland, helped conduct the survey and said nurses worry they will get even more after-hours calls, wanting an explanation for what’s on screen. But, he said, that doesn’t seem to happen.

“In fact some of the workers [in hospitals with these cameras] suggested that the interaction at parent level — in terms of phone calls in the evening and at nighttime — are less when the system is in place,” he said.

Dempsey’s own hospital is launching a webcam system in the next few weeks and he has made a point of getting nurses on board.

“What we’re probably going to do, and we’ve had much discussion with the nursing staff initially, is that this would be a phased-in process,” he said.

Dempsey said they’ll start with “virtual visitation hours.” At St. Thomas, the nursing director decided to turn off the livestreams whenever a nurse is working with a child — a compromise that seems to have everyone smiling for the camera.

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

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.

Pfizer Settles Kickback Case Related To Copay Assistance For $24M

May 24, 2018
Explore The Database

Pre$cription For Power

Apr 6

Investigating the relationships between patient advocacy groups and Big Pharma

Pfizer will pay the government nearly $24 million as part of a settlement to resolve allegations that it funneled money through a foundation resulting in illegal kickbacks.

The company is not admitting wrongdoing or liability as part of its agreement with the Department of Justice.

According to the settlement, from 2012 through 2016, Pfizer made donations to the Patient Access Network (PAN) Foundation, a copay assistance nonprofit organization, and then used a specialty pharmacy to steer Medicare patients taking its drugs toward the foundation to cover their copays.

“Pfizer knew that the third-party foundation was using Pfizer’s money to cover the copays of patients taking Pfizer drugs, thus generating more revenue for Pfizer and masking the effect of Pfizer’s price increases,” said U.S. Attorney Andrew Lelling, citing the settlement. “The Anti-Kickback Statute exists to protect Medicare, and the taxpayers who fund it, from schemes like these.”

Drugmakers can’t directly offer copay assistance to Medicare or Medicaid beneficiaries under federal law. The concern is that covering such out-of-pocket costs for expensive drugs still leaves taxpayers with the bill for the remainder of the costs. Congress didn’t want beneficiaries to be shielded from price increases, allowing drugmakers to increase prices without risking that patients will switch to cheaper alternatives.

Pfizer spokeswoman Sally Beatty stressed that the company takes compliance “very seriously.” The company continues to donate to charities that offer assistance with copays. This story also ran on USA Today. This story can be republished for free (details).

“The Company believes all individuals deserve access to medicines prescribed by their physicians,” she said in a statement provided to Kaiser Health News. “Pfizer continues to believe these programs help patients lead healthier lives.”

Joel Hay, a health policy and economics professor at the University of Southern California, disagrees. “In essence, [copay programs give] the drug companies free rein to jack the price up to whatever they want,” he said. “You totally dilute any effort on the part of the doctor or consumer to think carefully about whether these drugs are worth their cost.”

Pfizer gave the PAN Foundation $16.9 million in 2015, according to Kaiser Health News’ Pre$cription for Power database, which covers contributions from drugmakers to patient groups in 2015 but will expand over time. Asked why the settlement was only $7 million more than what Pfizer gave the PAN Foundation in 2015, the Department of Justice said its policy was not to comment on settlement amounts.

The chemotherapy drugs at the center of the alleged scheme were Sutent, which treats kidney cancer and other cancerous tumors, and Inlyta, which also treats kidney cancer.

Sutent cost Medicare Part D $183 million in 2016 before rebates, or about $47,000 per patient. Medicare’s spending for each unit of this drug had increased by 80 percent since the illegal conduct allegedly began in 2012. Inlyta cost Medicare about $73 million in 2016, or about $57,000 per patient. Medicare spent 34 percent more on each unit of the drug in 2016 than it did in 2012.

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Tikosyn, a Pfizer drug to treat an irregular heartbeat, was also part of the alleged scheme, according to the settlement. The drugmaker raised the list price of 40 Tikosyn capsules from $220 to $317 in the final three months of 2015. It cost Medicare $107 million in 2016 before rebates.

Planning a price increase, Pfizer worked with the PAN Foundation to “create and finance a fund” for Medicare patients with a specific irregular heartbeat, the settlement says. “For the next nine months, Tikosyn patients accounted for virtually all of the beneficiaries of PAN’s fund.”

Hay said the DOJ action is “long overdue.” Pfizer is one of many drug companies engaging in such behavior with various copay assistance nonprofits, he said, and the DOJ should have been aggressive about it “years if not decades earlier.”

“The basic fact is it’s illegal under the False Claims Act,” he said.

PAN Foundation President and CEO Daniel Klein said the foundation learned about the DOJ settlement Thursday.

“While PAN has received contributions from Pfizer, we endeavor to operate our patient assistance programs independent of any influence by donors,” he said. “Without the assistance PAN provides, many thousands of underinsured patients would be unable to afford their critical medications.”

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

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