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Energy-Hog Hospitals: When They Start Thinking Green, They See Green

Kaiser Health News:Marketplace - August 16, 2018

Hospitals are energy hogs.

With their 24/7 lighting, heating and water needs, they use up to five times more energy than a fancy hotel.

Executives at some systems view their facilities like hotel managers, adding amenities, upscale new lobbies and larger parking garages in an effort to attract patients and increase revenue. But some hospitals are revamping with a different goal in mind: becoming more energy-efficient, which can also boost the bottom line.

“We’re saving $1 [million] to $3 million a year in hard cash,” said Jeff Thompson, the former CEO of Gundersen Health System in La Crosse, Wis., the first hospital system in the U.S. to produce more energy than it consumed back in 2014. As an added benefit, he said, “we’re polluting a lot less.”

The health care sector — one of the nation’s largest industries — is responsible for nearly 10 percent of all greenhouse gas emissions — hundreds of millions of tons worth of carbon each year. Hospitals make up more than one-third of those emissions, according to a paper by researchers at Northeastern University and Yale.

Increasingly, though, health systems are paying attention:

  • Gundersen Health System in Wisconsin employs wind, wood chips, landfill-produced methane gas — and even cow manure — to generate power, reporting more than a 95 percent drop in its emissions of carbon monoxide, particulate matter and mercury from 2008 to 2016.
  • Boston Medical Center analyzed its hospital for duplicative and underused space, then downsized while increasing patient capacity. Among other changes, it now has a gas-fired 2-megawatt cogeneration plant that traps and reuses heat, saving money and emissions, while supplying 41 percent of the hospital’s needs and acting as a backup for essential services if the municipal power grid goes out.
  • Theda Clark Medical Center in Wisconsin is saving nearly $800,000 a year — 30 percent of its energy costs — after making changes that included retrofitting lights, insulating pipes, taking the lights out of vending machines and turning off air exchangers in parts of its building after hours.
  • Kaiser Permanente aims to be “carbon-neutral” by 2020, mainly by incorporating solar energy at up to 100 of its hospitals and other facilities. One already in use — at its Richmond (Calif.) Medical Center — is credited with reducing electric bills by about $140,000 a year. (Kaiser Health News is not affiliated with Kaiser Permanente.)
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While the environmental benefits are important, “what I’ve seen over the years is cost reductions are the prime motivator,” said Patrick Kallerman, research manager at the Bay Area Council Economic Institute, which released a report this spring outlining ways the hospital industry can help states such as California reach environmental goals by becoming more efficient.

Some of its recommendations are simple: replacing old lighting and windows. Others are more complex: powering down heating and cooling in areas not being used and updating ventilation standards first set back in Florence Nightingale’s day. Such tight standards “might not be necessary,” Kallerman said. Loosening them could help save money and energy.

When Bob Biggio was hired in 2011 to oversee Boston Medical Center’s facilities, hospital leaders were about to launch a broad redesign. Yet the hospital was also facing serious financial struggles. He put the move on hold while analyzing how the hospital was using its existing space, looking for unused or duplicative areas.

“My first impression with data I had gathered was our campus was about 400,000 square feet bigger than it needed to be, said Biggio. “A square foot you never have to build is most efficient of all.”

The new design is smaller but more efficient, handling 20 percent higher patient volume and eliminating the need for ambulance transportation between far-flung areas of the campus. It also cut power consumption by 42 percent from a 2011 baseline.

While the hospital sunk a lot of money into the renovation, the center was able to sell off some of its land to help offset the costs, leading to about a five-year return on investment, Biggio said.

“We are a safety-net hospital with a large Medicaid population,” he said. “So this is the last place people expect to see the type of investments and progress we’ve made.”

But how to sell that in the C-suite?

The environmental argument wasn’t how Thompson convinced executives at Gundersen.

“At no point did I mention climate change or polar bears,” said Thompson.

Instead, he focused on the organization’s mission to improve health — and the potential cost savings.

“There are multiple examples — at Gundersen and other places — where, if we’re thoughtful, we can improve the local economy, lower the cost of health care and decrease the pollution that is making people sick,” he said.

But hospitals’ energy efficiency efforts vary, with only about 10 percent attempting changes as dramatic as those done at Gundersen, estimated Alex Thorpe, a hospital energy expert at Optum Advisory Services, a consulting firm owned by UnitedHealth Group.

“About 50 percent are in the middle,” he added, perhaps because these investments are weighed against other capital needs.

“If you have a well-known doctor that wants a new cutting-edge piece of equipment, then it can be hard to make the business case [for investing in alternative energy],” said Thorpe.

Of the more than 5,000 hospitals in the country, about 1,100 are members of Practice Greenhealth, a nonprofit that promotes environmental stewardship. Fewer than 300 hospitals qualify as Energy Star facilities, an Environmental Protection Agency program that recognizes buildings that rank in the top quartile for energy conservation among their peers.

Greenhealth estimates its members average about a million dollars a year in savings, but it all depends what steps they take.

There are modest savings from such things as reducing the heating and air conditioning in operating rooms during hours they are not in use, with median annual cost savings of $45,398, a report from the group notes. Other energy reduction efforts net another median $53,599 in annual savings, while swapping older lighting for new LED bulbs in operating rooms saves another $3,329.

Individually, those savings are not even rounding errors in most hospitals’ total expenses, which are measured in the millions of dollars.

Still, within facility expenses, energy use accounts for 51 percent of spending, so even modest cuts are “significant,” said Kara Brooks, sustainability program manager for the American Society for Healthcare Engineering.

Ultimately, that may affect what hospitals charge insurers and patients.

“If hospitals can lower peak demand through energy efficiency efforts, that will directly impact their pricing,” said Thorpe.

HHS awards $125 million to support community health center quality improvement

HHS Gov News - August 15, 2018

Today, the U.S. Department of Health and Human Services (HHS) announced $125 million in Quality Improvement grant awards to 1,352 community health centers across all U.S. states, territories and the District of Columbia. Funded by the Health Resources and Services Administration (HRSA), health centers will use these funds to continue to improve quality, efficiency, and the effectiveness of healthcare delivery in the communities they serve. This announcement comes during National Health Center Week, the annual celebration that highlights the critical role community health centers play in providing high-quality, affordable, primary healthcare.

“Community health centers provide coordinated, comprehensive, and patient-centered care to millions of Americans,” said HHS Deputy Secretary Eric Hargan. “They have a track record of delivering quality care at significantly lower cost, and are vital partners in our movement toward a health system that delivers quality, affordable, value-based health care for all Americans.”

HRSA’s Quality Improvement grant awards promote continued community health center improvements in the following categories: Expanding access to comprehensive care, improving care quality and outcomes, increasing comprehensive care delivery in a cost-effective way, addressing health disparities, advancing the use of health information technology, and delivering patient-centered care.

Community health centers that exceed national clinical quality benchmarks, like Healthy People 2020 goals, receive special designation as National Quality Leaders. The top 30 percent of community health centers that achieve the best overall clinical performance receive designation as Health Center Quality Leaders.

“Quality, value-based care is a priority of the U.S. Department of Health and Human Services and HRSA-funded health centers serve as leaders in quality healthcare in the U.S.,” said HRSA Administrator George Sigounas, MS, Ph.D. “Nearly all HRSA-funded health centers demonstrated improvement in one or more clinical quality measures from the year prior, and these funds will support health centers’ work to improve the quality of care they deliver every day in their communities around the country.”

HRSA also released new data compiled from health centers through its Uniform Data System (UDS) reporting, providing an update on health centers’ provision of primary healthcare services. In 2017, more than 27 million people (approximately 1 in 12 U.S. residents) relied on a HRSA-supported health center for affordable, accessible primary healthcare including:

  • One in nine children 17 years or younger;
  • One in five rural residents;
  • One in three people living in poverty; and
  • More than 355,000 U.S. veterans.

For more than 50 years, health centers have delivered affordable, accessible, quality, and cost-effective primary healthcare services to patients. Today, nearly 1,400 health centers operate more than 11,000 service delivery sites nationwide.

For a list of FY 2018 Quality Improvement Awards recipients, visit: https://bphc.hrsa.gov/programopportunities/fundingopportunities/qualityimprovement/index.html

To learn more about HRSA’s Health Center Program, visit: http://bphc.hrsa.gov/about.

To locate a HRSA-funded health center, visit: http://findahealthcenter.hrsa.gov.

Financial Ties That Bind: Studies Often Fall Short On Conflict-Of-Interest Disclosures

Kaiser Health News:Marketplace - August 15, 2018

Papers in medical journals go through rigorous peer review and meticulous data analysis.

Yet many of these articles are missing a key piece of information: the financial ties of the authors.

Nearly two-thirds of the 100 physicians who rake in the most money from 10 device manufacturers failed to disclose a conflict of interest in their academic writing in 2016, according to a study published Wednesday in JAMA Surgery.

The omission can have real-life impact for patients when their doctors rely on such research to make medical decisions, potentially without knowing the authors’ potential conflicts of interest.

“The issue is anytime there’s a new technology, people get really excited about it,” said lead researcher Dr. Mehraneh Jafari. “Whoever is reading the data on it needs to have the most information.”

The study sought to “assess the credibility and accuracy” of conflict-of-interest statements — also known as COIs — in such journal articles, wrote the researchers.

They did this by sampling 10 large surgical and medical device manufacturers. This list includes Medtronic, Stryker Corp., Intuitive Surgical, Covidien, Edwards Lifesciences Corp., Ethicon, Olympus Corp., W.L. Gore & Associates, LifeCell Corp. and Baxter Healthcare.

The researchers also pinpointed the 10 physicians who received the highest compensation from each company. They then searched for articles published by these physicians between Jan. 1 and Dec. 31, 2016, and reviewed the full text of each article for COI disclosure.

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According to their findings, those 10 companies paid more than $12 million in 2015 to the 100 doctors included in the study. The median payment to these physicians was $95,993.

Jafari, a surgeon at the University of California-Irvine, said the disclosures aren’t necessarily omitted in bad faith, but standards for disclosure vary from one conference or publication to another.

“It’s not necessarily because surgeons are trying to hide conflicts of interest, but because the system is broken,” she added. “People don’t understand what the rules are and there’s no one clearing it up.”

It’s a problem because even the appearance of conflict can cast doubt on research, she said.

“We work very hard on our research, it’s difficult to conduct, we’re proud of what we do, and the papers we write might change patient outcomes for the better,” Jafari said. “We don’t want there to be the appearance of bias.”

The researchers concluded that the only way to make sure doctors are upfront about all potential conflicts is to have a universal process for full disclosure for every financial relationship in every paper.

A separate commentary letter by Dr. Greg Sacks and Dr. Joe Hines in the same issue of JAMA Surgery suggested, though, that the study might have used too high a standard to determine conflicts of interest. For instance, it cited the case of one doctor who disclosed the relationship he had with one device maker he was writing about, but not another one because he didn’t think it was a conflict.

Still, it reiterated the need to revise current disclosure procedures: “Given the enormous sums of money invested by industry into physician relationships, enforcing accurate disclosure … is a critical step to ensuring the integrity and reputation of our fields.”

The financial ties between medical device manufacturers and providers go well beyond academic research and ivory towers.

As many as 94 percent of doctors, according to research published in the New England Journal of Medicine, report getting some kind of benefit from the industry. These benefits can range from a fancy dinner or cocktail party with a sales representative to new equipment for students to use in the classroom to payments for being consultants.

With the passage of the Physician Payments Sunshine Act, which became law as part of the Affordable Care Act, medical product manufacturers are required to report to the Centers for Medicare & Medicaid Services payments made to physicians and teaching hospitals, among other things.

These payments are tracked in a federal database, which researchers used for this study. The database also offers patients a way to see their physicians’ financial relationships with these companies.

“I think the better and more information that patients and the public have, the better information they can have for their own care and what providers they turn to,” said Matt Wetzel, vice president and assistant general counsel for AdvaMed, the trade association of medical device manufacturers.

And the financial support is often a good thing, Jafari said.

The industry money that goes into the academic end of medicine comes out in the form of better training, better product development and better-prepared surgeons, she added.

Wetzel agreed. “The partnership is really a benefit to patients at the end of the day, but having that context around that relationship is important.”

Listen: Why Young Doctors Appear To Be Embracing Single-Payer

Kaiser Health News:Marketplace - August 15, 2018

Kaiser Health News correspondent Shefali Luthra talks with Susan Rinkunas, news editor for Tonic, about how a new generation of doctors within the American Medical Association hope to change the organization’s long-held opposition to such ideas as universal health care or single-payer systems. Luthra notes that some of the demographic and political shifts taking place within the profession mirror changes in the population at large.

You can read Luthra’s recent Kaiser Health News story on the topic here.

States Leverage Federal Funds To Help Insurers Lower Premiums

[UPDATED at 3:45 p.m. ET]

When Tracy Deis decided in 2016 to transition from a full-time job to part-time contract work, the loss of her employer’s health insurance was not a major worry because she knew she could get coverage through the marketplace set up by the Affordable Care Act.

But price was a big concern.

“The ACA made it possible to make the switch in my life,” said Deis, 48, who lives in Minneapolis. But she quickly added, “I was really worried about the cost.”

Her anxiety was understandable. In Minnesota, the average cost of insurance in the state-run exchange soared 57 percent in 2017, after a 40 percent rise in 2016.

Tracy Deis of Minneapolis was worried about the cost of an ACA marketplace plan. But Minnesota’s effort to help insurers cover some patients’ high bills is curbing premiums. (Courtesy of Carmen Carda)

Amid a public outcry, the legislature last year took several steps to stabilize its individual insurance marketplace.

Among those moves, lawmakers launched a “reinsurance” program. The program helps pay the costs insurers incur for people with high medical bills. In turn, the companies — knowing that these “outlier” expenses will be covered — can lower premiums. Alaska had launched a similar program in 2016.

The Alaska and Minnesota models have now become touchstones for other states eager to prevent startling premium increases in the individual insurance marketplace.

Critically, much of the money comes from the federal government. A provision in the ACA allows states to experiment with their marketplaces as long as they honor ACA requirements and don’t cost the federal government more money. (Federal reinsurance funding for high-cost patients reduces premium subsidies, which are fully paid by the federal government.)

Notably, even as the Trump administration has blocked other provisions of the ACA and pushed Congress to repeal the law, it has encouraged states to establish reinsurance programs and seek federal funding.

In Alaska, lawmakers used only state funds to cut an anticipated 43 percent premium increase to 7 percent in 2017. As the program continued in 2018 with $58 million in federal funds, the lone insurer in the state, Premera Blue Cross Blue Shield, lowered premiums by an average 22.4 percent. And on Aug. 2, Premera announced it had asked the state if it could reduce premiums by an average 3.9 percent in 2019.

Alaska’s program, unlike other states’, covers all the costs for people with 33 high-cost conditions. In 2017, about half of all expenses for enrollees in the exchange were for people with one or more of those conditions.

“We have unique issues here,” said Jim Grazko, president of Premera Blue Cross Blue Shield of Alaska. “Without the reinsurance program, things would be untenable in the individual market.”

The federal Department of Health and Human Services approved Minnesota’s waiver request for a 2018 reinsurance program, with $131 million in funding. The program covers medical bills between $50,000 and $250,000 for marketplace customers.

It worked. Premium rates declined by 13 percent in 2018 compared with 2017 and are projected to drop again in 2019 by 5 to 8 percent, according to Eileen Smith, a spokeswoman for the Minnesota Council of Health Plans.

That was good news for Deis. Her monthly premium this year is $317, down from $355 in 2017. She’s in a plan that includes the doctors she wanted and is happy with her coverage, although it has a deductible of $7,050.

“I wouldn’t mind if my premiums came down again for 2019,” she said. “Every little bit helps.”

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Pushing Premiums Down

Oregon also launched a federally approved reinsurance program in 2018. And last month, the Trump administration notified Wisconsin and Maine that their requests for reinsurance program funding had been approved.

Four other states — Idaho, Louisiana, Maryland and New Jersey — are seeking federal approval for reinsurance programs enacted this year. All hope to have plans in place for 2019.

Eric Cioppa, Maine’s insurance commissioner, estimates his state’s reinsurance program will reduce premiums in 2019 by an average 9 percent compared to what they would have been without the program.

“Reinsurance is possibly the best proven mechanism to restrain premium increases and keep health insurance affordable,” said Trish Riley, executive director of the National Academy for State Health Policy in Portland, Maine. “The biggest plus is that it’s a tool with support across the political spectrum.”

That includes some deep conservatives, such as Wisconsin Gov. Scott Walker, a Republican and longtime critic of Obamacare. He strongly supports the reinsurance program and touts it on the campaign trail as he seeks a third term.

Wisconsin’s program establishes a $200 million fund — $166 million of it federal money — to pay about 50 percent of the costs for individuals with medical expenses between $50,000 and $200,000.

The state’s insurance department estimates the program will yield premiums in 2019 that will be 11 percent lower on average than they would have been without reinsurance. Premiums rose 44 percent in 2018, leading 25,000 people to drop coverage.

Amy Brooks, who buys insurance on the health law’s marketplace and underwent brain surgery this year, said she supports Wisconsin’s plan to use reinsurance to help hold down premium costs. “Anything that keeps the costs down is a huge help because I could need this coverage for some time.” (Courtesy of Amy Brooks)

For Amy Brooks, of Madison, Wis., the initiative is especially timely. Brooks, 48, who pays $150 a month for subsidized coverage in an ACA plan because her job didn’t come with insurance, was diagnosed in April with a benign brain tumor that required surgery.

She lost her job after the diagnosis and said having insurance coverage “takes a gigantic weight off my shoulder. I would have gone bankrupt. … Anything that keeps the costs down is a huge help because I could need this coverage for some time.”

No Panacea

Insurance analysts say that state-based reinsurance programs are a potent mechanism to lower premiums, but not a panacea.

The programs don’t address underlying medical costs, for example. And if money for the programs is not sustained — or increased — over time, reinsurance can yield a one-time decline in premiums over a year or two.

“Reinsurance programs can meaningfully reduce premiums,” said Matthew Fiedler, a health policy researcher at the Brookings Institution in Washington, D.C. But, he said, other steps would also be needed to offset the effects of changes recently implemented by the administration.

The every-state-for-itself approach also frustrates insurers and consumer advocates.

“A sustained federal approach would be much preferable and what we’d like to see,” said Kris Haltmeyer, vice president for legislative and regulatory policy at the Blue Cross Blue Shield Association, which represents 36 Blues plans nationwide.

After Republicans in Congress failed to repeal and replace the ACA in 2017, Sens. Patty Murray (D-Wash.) and Lamar Alexander (R-Tenn.) launched a bipartisan effort to stabilize the ACA marketplaces. A prominent part of their plan was a $30 billion reinsurance pool — $10 billion a year.

The effort failed in March amid discord over an unrelated abortion measure in the bill.

Voters To Settle Dispute Over Ambulance Employee Break Times

Kaiser Health News:Marketplace - August 15, 2018

If private-ambulance workers take a break from work, even for 10 minutes, it can mean the difference between life and death.

So, they routinely accept emergency calls during their meal and rest breaks — just as firefighters, policemen and other public emergency workers do.

But labor laws guarantee most California workers uninterrupted breaks, and multiple lawsuits are challenging whether private ambulance companies have the right to interrupt their employees’ breaks.

In November, voters will resolve the issue. Proposition 11 — a measure backed and funded by American Medical Response (AMR), California’s largest private ambulance company — would require private-ambulance employees to remain on call during their breaks.

“If a dispatcher calls and the closest ambulance is only a few blocks away, they’ll be reachable and ready to respond,” said Marie Brichetto, spokeswoman for the campaign advocating the ballot measure. “In times of emergency, seconds will make a difference.”

Proposition 11 also would require private ambulance companies to provide their employees with mental health coverage and training to respond to natural disasters, mass shootings and other emergencies.

The ballot measure would apply to the state’s estimated 17,000 private ambulance employees, including dispatchers, emergency medical technicians (EMTs) and paramedics, who answer about three-quarters of the state’s emergency calls, according to a report by the state Legislative Analyst’s Office. The initiative doesn’t affect public ambulance workers because the labor codes governing rest and meal breaks apply only to private-sector workers.

Opponents of the measure, including a California lawmaker who works part time as an EMT, call it a “misleading” effort by the industry to save money on staffing — and get out of potentially bank-breaking lawsuits.

The initiative isn’t about public safety, but rather “trying to extract machine-level work from human beings,” said Mike Diaz, an AMR employee in Antelope Valley and president of the International Association of EMTs and Paramedics Local 77.

For AMR, “the most efficient ambulance crew is one that is on a call for every hour of your 24-hour shift,” he said. “We’re not machines. We need rest.”

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The initiative grew out of a 2016 state Supreme Court ruling in Augustus v. ABM Security, which found that a California security company had failed to meet its legal obligation to provide breaks because its workers had to remain on call.

Given the similarities between the private security and ambulance industries, the case is likely to be applied to private EMTs and paramedics, the analyst’s report concluded.

AMR is already facing at least two lawsuits from employees who say they were denied breaks.

If the ambulance companies lose in court, they can no longer assume their employees are available during their breaks and would have to increase staffing — which could cost the industry around $100 million a year, the report said.

Proposition 11 is the industry’s effort to avoid that. The ballot measure also includes a provision that would effectively nullify the pending lawsuits.

So far, AMR is the only donor on either side of the measure. The company has poured about $3.6 million into a committee to support the measure, and the committee has used about $3 million of that, mostly to get the measure on the ballot. AMR declined to comment for this article and referred inquiries to Brichetto, the Proposition 11 campaign spokeswoman.

Some ambulance companies have offered muted support for the measure, while others have remained silent.

Edward Guzman, CEO and general manager of the nonprofit Sierra Ambulance Company in eastern Madera County, said he supports Proposition 11. But he acknowledged there are some private companies that overwork their employees.

“Some of the urban providers … were running their people into the ground and not providing adequate rest or breaks,” he said. “There are players that will continue to do that because they don’t want to add extra units into the mix.”

This summer, Sierra added an additional ambulance and paramedics to its daytime rotation to respond to higher demand, and employees have a strong collective bargaining agreement that protects them from overwork or abuse, Guzman said.

Still, he fears that his smaller company could get slammed with lawsuits if Proposition 11 doesn’t pass. The measure protects Sierra “from unnecessary and expensive litigation,” he said.

County officials across the state cannot take political positions, but some worry that if the measure fails and lawsuits against the companies succeed, the cost of hiring more ambulance workers could be passed on to them. Some counties hire private ambulance companies to supplement local fire departments and public ambulances.

“Somebody’s gonna have to pay for that,” said Cathy Chidester, director of Emergency Medical Services for Los Angeles County. “That [cost is] going to go back to the general public.”

Opposition to the ballot measure is largely unorganized but includes some unionized emergency response workers and lawyers representing the plaintiffs who are suing AMR. They argue that the proposition won’t change how private-ambulance employees operate, because their first instinct is to help people in distress.

“If I see something happen in front of me while I’m having my meal or rest break, I’m gonna respond. That’s our duty. That’s our calling,” said state Assemblyman Freddie Rodriguez (D-Pomona), who works part time as an EMT. “We’re not gonna sit there and watch somebody die just because we’re eating.”

Rodriguez and other opponents say the Proposition 11 campaign’s emphasis on public safety masks its true intentions: to maximize private companies’ profit margins.

“It’s a little misleading,” Diaz said.

EMT and paramedic workloads vary greatly depending on the county and employers. Diaz, who works in the Antelope Valley region of Los Angeles County, said his area is chronically understaffed. But Dandy Mendoza and Esther Nungaray, who work for American Ambulance in Fresno County, said they take an average of six to seven calls during a 12-hour shift — a number they consider reasonable.

“I don’t really have a strong opinion because I really like my job. I show up to take care of people,” Mendoza said. “I try to stay out of politics.”

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

Feds Urge States To Encourage Cheaper Plans Off The Exchanges

For those who make too much money to qualify for health insurance subsidies on the individual market, there may be no Goldilocks moment when shopping for a plan. No choice is just right.

A policy with an affordable premium may come with a deductible that’s too high. If the copayments for physician visits are reasonable, the plan may not include their preferred doctors.

These consumers need better options, and in early August federal officials offered a strategy to help bring down costs for them.

The guidance is from the Centers for Medicare & Medicaid Services, which oversees the insurance marketplaces set up by the Affordable Care Act. CMS is encouraging states to allow the sale of plans outside of those exchanges that don’t incorporate a surcharge insurers started tacking on last year.

Many insurers added the premium surcharges last fall to plans sold on the individual market. It was a response to the Trump administration’s announcement that it would no longer pay the companies for the “cost-sharing reduction” subsidies required under the health law. The subsidies help cover deductibles and other out-of-pocket costs for lower-income consumers who buy marketplace plans.

Insurers typically added the cost to silver-level plans because those are the type of plans that consumers have to buy in order to receive the cost-sharing subsidies. “Silver loading,” as it’s called, added an estimated 10 percent to the cost of those plans, according to the Congressional Budget Office.

People who qualified for federal premium subsidies — those with incomes up to 400 percent of the federal poverty level (about $48,000 for one person or $100,000 for a family of four) — were shielded from the surcharge because their subsidies increased to cover the cost.

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But people with higher incomes faced higher premiums. The new guidance is geared to help them.

“It encourages states to encourage silver loading only on the exchange,” said Aviva Aron-Dine, vice president for health policy at the Center on Budget and Policy Priorities.

But some analysts say they’re unsure if the new federal policy will make a difference since states have already implemented similar strategies.

Many states moved last fall to limit silver loading to plans sold on the exchanges, while allowing or, in the case of California, requiring, very similar plans to be sold off the exchanges without the extra premium charge.

Yet CMS’ endorsement of the strategy removes doubts states may have had, said David Anderson, a research associate at Duke University’s Margolis Center for Health Policy who has tracked the issue.

Eighty-three percent of people who bought a plan during the open-enrollment period for 2018 qualified for premium tax credits. The average monthly premium per subsidized enrollee was $639; after accounting for premium tax credits, however, enrollees owed just $89 on average. That amount was 16 percent lower than the monthly premium the year before.

For people who don’t qualify for premium tax credits, the picture is very different. The average monthly premium for 2018 was $522. That total was 28 percent higher than the previous year’s total of $407, according to an analysis by the Center on Budget and Policy Priorities of CMS enrollment data.

In general, federal rules require that insurers charge the same rates for identical qualified health plans that are sold on and off the exchanges. The CMS guidance suggests that the unloaded plans could be tweaked slightly in terms of cost sharing or other variables so that they are not identical to those on the marketplaces.

Tracing what type of coverage is purchased off the exchange is difficult because there is no centralized source. Consumers can buy plans directly from insurers, or they may use a broker or an online web portal. According to one such portal, eHealth, 28 percent of unsubsidized consumers on its site bought silver plans in 2018, while 42 percent bought bronze plans, whose coverage is less generous than silver plans and typically have lower premiums. Conversely, on the exchanges nearly two-thirds of people bought silver plans in 2018 while 29 percent bought bronze plans, according to federal data.

If fewer insurers add the CSR load to silver plans sold off the exchange, those plans may be more affordable next year than they were in 2018, said Cynthia Cox, director of health reform and private insurance at the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

“This makes silver plans an option for [unsubsidized] people who wanted to buy a silver plan but might have been pushed off onto a bronze plan,” she said.

Consumers who want to consider off-exchange plans have to find them first. Some experts suggest checking with insurers that are selling on the marketplace in an area, because it’s possible that they’ll also be selling plans off the exchange.

But that’s not a given. A health insurance broker can help people find and evaluate plans sold off the exchange. But experts urge consumers to stay on their toes and make sure they understand whether the plans they’re considering provide comprehensive coverage.

Starting in October, insurers can offer short-term plans with limited benefits that last up to a year.

“Differentiating between the two may not be easy, and the off-exchange unsubsidized market is the target market for short-term plans,” said Anderson.

Please visit khn.org/columnists to send comments or ideas for future topics for the Insuring Your Health column.

‘No One Is Ever Really Ready’: Aid-In-Dying Patient Chooses His Last Day

Kaiser Health News:States - August 14, 2018

In the end, it wasn’t easy for Aaron McQ to decide when to die.

The 50-year-old Seattle man — a former world traveler, triathlete and cyclist — learned he had leukemia five years ago, followed by an even grimmer diagnosis in 2016: a rare form of amyotrophic lateral sclerosis, or ALS.

An interior and urban designer who legally changed his given name, McQ had been in pain and physical decline for years. Then the disease threatened to shut down his ability to swallow and breathe.

“It’s like waking up every morning in quicksand,” McQ said. “It’s terrifying.”

Last fall, McQ decided to use Washington state’s 2009 Death With Dignity law to end his suffering. The practice, approved in seven states and the District of Columbia, allows people with a projected six months or less to live to obtain lethal drugs to end their lives.

Although the option was legal, actually carrying it out was difficult for McQ, who agreed to discuss his deliberations with Kaiser Health News. He said he hoped to shed light on an often secretive and misunderstood practice.

“How does anyone get their head around dying?” he said, sitting in a wheelchair in his Seattle apartment in late January.

Aaron McQ speaks during an interview in his Seattle apartment in January. “No one is ever really ready to die,” McQ said. “There will always be a reason not to.”(Dan DeLong for KHN)

More than 3,000 people in the U.S. have chosen such deaths since Oregon’s law was enacted in 1997, according to state reports. Even as similar statutes have expanded to more venues — including, this year, Hawaii — it has remained controversial.

California’s End of Life Option Act, which took effect in 2016, was suspended for three weeks this spring after a court challenge, leaving hundreds of dying patients briefly in limbo.

Supporters say the practice gives patients control over their own fate in the face of a terminal illness. Detractors — including religious groups, disability rights advocates and some doctors — argue that such laws could put pressure on vulnerable people and that proper palliative care can ease end-of-life suffering.

Thin and wan, with silver hair and piercing blue eyes, McQ still could have passed for the photographer’s model he once was. But McQ’s legs shook involuntarily beneath his dark jeans and his voice was hoarse with pain during a three-hour effort to tell his story.

Last November, doctors told McQ he had six months or less to live. The choice, he said, became not death over a healthy life, but a “certain outcome” now over a prolonged, painful — and “unknowable” — end.

“I’m not wanting to die,” he said. “I’m very much alive, yet I’m suffering. And I would rather have it not be a surprise.”

In late December, a friend picked up a prescription for 100 tablets of the powerful sedative secobarbital. For weeks, the bottle holding the lethal dose sat on a shelf in his kitchen.

“I was not relaxed or confident until I had it in my cupboard,” McQ said.

At the time, he intended to take the drug in late February. Or maybe mid-March. He had wanted to get past Christmas, so he didn’t ruin anyone’s holiday. Then his sister and her family came for a visit. Then there was a friend’s birthday and another friend’s wedding.

“No one is ever really ready to die,” McQ said. “There will always be a reason not to.”

In late December, a friend picked up Aaron McQ’s prescription for 100 tablets of the powerful sedative secobarbital. For weeks, the bottle holding the lethal dose sat on a shelf in his kitchen.(Dan DeLong for KHN)

Many people who opt for medical aid-in-dying are so sick that they take the drugs as soon as they can, impatiently enduring state-mandated waiting periods to obtain the prescriptions

Data from Oregon show that the median time from first request to death is 48 days, or about seven weeks. But it has ranged from two weeks to more than 2.7 years, records show.

Neurodegenerative diseases like ALS are particularly difficult, said Dr. Lonny Shavelson, a Berkeley, Calif., physician who has supervised nearly 90 aid-in-dying deaths in that state and advised more than 600 patients since 2016.

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“It’s a very complicated decision week to week,” he said. “How do you decide? When do you decide? We don’t let them make that decision alone.”

Philosophically, McQ had been a supporter of aid-in-dying for years. He was the final caregiver for his grandmother, Milly, who he said begged for death to end pain at the end of her life.

By late spring, McQ’s own struggle was worse, said Karen Robinson, McQ’s health care proxy and friend of two decades. He was admitted to home hospice care, but continued to decline. When a nurse recommended that McQ transfer to a hospice facility to control his growing pain, he decided he’d rather die at home.

Aaron McQ and his friend Karen Robinson go boating on Seattle’s Portage Bay in 2013, before he fell ill with leukemia and a rare form of ALS, or amyotrophic lateral sclerosis.(Courtesy of Karen Robinson)

“There was part of him that was hoping there were some other alternative,” Robinson said.

McQ considered several dates — and then changed his mind, partly because of the pressure that such a choice imposed.

“I don’t want to talk about it because I don’t want to feel like, now you gotta,” he said.

Along with the pain, the risk of losing the physical ability to administer the medication himself, a legal requirement, was growing.

“I talked with him about losing his window of opportunity,” said Gretchen DeRoche, a volunteer with the group End of Life Washington, who said she has supervised hundreds of aid-in-dying deaths.

Finally, McQ chose the day: April 10. Robinson came over early in the afternoon, as she had often done, to drink coffee and talk — but not about his impending death.

“There was a part of him that didn’t want it to be like this is the day,” she said.

DeRoche arrived exactly at 5:30 p.m., per McQ’s instructions. At 6 p.m., McQ took anti-nausea medication. Because the lethal drugs are so bitter, there is some chance patients won’t keep them down.

Four close friends gathered, along with Robinson. They sorted through McQ’s CDs, trying to find appropriate music.

“He put on Marianne Faithfull. She’s amazing, but, it was too much,” Robinson said. “Then he put on James Taylor for, like, 15 seconds. It was ‘You’ve Got a Friend.’ I vetoed that. I said, ‘Aaron, you cannot do that if you want us to hold it together.’”

DeRoche went into a bedroom to open the 100 capsules of 100-milligram secobarbital, one at a time, a tedious process. Then she mixed the drug with coconut water and some vodka.

Just then, McQ started to cry, DeRoche said. “I think he was just kind of mourning the loss of the life he had expected to live.”

After that, he said he was ready. McQ asked everyone but DeRoche to leave the room. She told him he could still change his mind.

“I said, as I do to everyone: ‘If you take this medication, you’re going to go to sleep and you are not going to wake up,’” she recalled.

McQ drank half the drug mixture, paused and drank water. Then he swallowed the rest.

His friends returned, but remained silent.

“They just all gathered around him, each one touching him,” DeRoche said.

Very quickly, just before 7:30 p.m., it was over.

“It was just like one fluid motion,” DeRoche said. “He drank the medication, he went to sleep and he died in six minutes. I think we were all a little surprised he was gone that fast.”

The friends stayed until a funeral home worker arrived.

“Once we got him into the vehicle, she asked, ‘What kind of music does he like?’” Robinson recalled. “It was just such a sweet, human thing for her to say. He was driving away, listening to jazz.”

McQ’s friends gathered June 30 in Seattle for a “happy memories celebration” of his life, Robinson said. She and a few others kayaked out into Lake Washington and left McQ’s ashes in the water, along with rose petals.

In the months since her friend’s death, Robinson has reflected on McQ’s decision to die. It was probably what he expected, she said, but not anything that he desired.

“It’s really tough to be alive and then not be alive because of your choice,” she said.

“If he had his wish, he would have died in his sleep.” 

Medicaid Officials Target Home Health Aides’ Union Dues

Kaiser Health News:States - August 13, 2018

Medicaid home care aides — hourly workers who help the elderly and disabled with daily tasks like eating, getting dressed and bathing — are emerging as the latest target in the ongoing power struggle between conservatives and organized labor.

About half a million of these workers belong to the Service Employees International Union, a public-sector union that represents almost 1.9 million workers in the United States and Canada. The union is an influential donor to liberal politicians and boasted strong ties to the Obama administration.

A proposed rule from the federal Centers for Medicare & Medicaid Services would prohibit home health aides paid directly by Medicaid from having their union dues automatically deducted from their paychecks, though it doesn’t name the fees explicitly.

Blocking these direct Medicaid payments means the workers — especially those who don’t work in a single, centralized office, or don’t have a credit card or a bank account — are far less likely to pay dues, diminishing the union’s potential influence.

CMS’ language affects only “individual providers” — that is, those who aren’t employed by the private, for-profit agencies that dominate this industry. Individual providers, who are technically state employees, are far more likely to be unionized.

The directive, which would overturn an Obama administration policy put in place to ease the collection of union dues and pay for other fees, such as health benefits, could take effect by the end of this year. A month-long comment period, ending Monday, has attracted more than 3,300 responses.

“This is just another way to make life more difficult for public-sector unions,” said Jake Rosenfeld, an associate professor of sociology at Washington University in St. Louis, who studies unions and their influence.

The proposed rule comes on the heels of June’s landmark Supreme Court ruling, in which a 5-4 majority held that public-sector workers don’t have to pay unions for the cost of collective bargaining, calling it a violation of their free speech.

That decision expanded on the Supreme Court’s 2014 ruling in Harris v. Quinn, in which the high court found that home care workers must explicitly state their desire to be in a union before the organization can collect dues. But because these workers are not attached to a single office or meeting point, organizing them into a collective unit poses a distinct challenge; collecting membership dues, even more so.

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As union membership has waned in other sectors, organized labor has doubled down on home care, lobbying liberal governors to declare thousands of workers as state employees, rendering them eligible to organize and engage in collective bargaining.

The median annual salary for home health aides in 2017 was $23,100, with about 67 percent turnover in 2017. The federal Bureau for Labor Statistics projects that demand for home care will increase by as much as 41 percent from 2016 to 2026, as more Americans age.

Both SEIU and the National Employment Law Project, an advocacy group, said that, if the rule takes effect, they expect to file a lawsuit seeking to reverse the decision. And a spokesperson for California Attorney General Xavier Becerra, who has frequently clashed with the White House, said the state will “take any action necessary” to blunt its impact.

In states where home care workers are unionized, the group can have the state withhold membership fees from their paycheck and transfer them directly to the union. Workers must actively choose to join the union.

In California, where most home care workers don’t work for private agencies, about 250,000 belong to the state SEIU chapter.

“They’ll effectively lose their voice on the job and their ability to advocate,” said Laphonza Butler, president of SEIU Local 2015, the California branch of the union.

Beyond California, home care aides have unionized in states including Connecticut, Massachusetts, Minnesota, Illinois, Oregon, Vermont and Washington.

The government is arguing that federal law does not allow states to divert Medicaid dollars to pay for a home care worker’s other benefits, such as health care or job training.

“The law provides that Medicaid providers must be paid directly and cannot have part of their payments diverted to third parties outside of a few very specific exceptions,” said Tim Hill, acting director for CMS’ Center for Medicaid and CHIP Services, in a statement.

Supporters of the rule, such as the National Federation of Independent Businesses, argue it stops powerful unions from using taxpayer dollars to pad their lobbying budget.

But it’s a controversial take. Critics said CMS’ argument inappropriately casts workers’ paychecks as government property, instead of as their own money. And they said it leaves vulnerable workers — arguably, the backbone of elderly care — unable to fend for themselves.

“When a state pays a worker, and the worker pays the union, it’s the worker’s money going into the union,” said Benjamin Sachs, a professor at Harvard Law School who studies labor law. “CMS doesn’t have the authority to decide.”

Some conservatives suggested that limiting union membership is less about home care policy and more about curtailing a powerful liberal lobbying force.

“There have been steps taken in underlying law and practice to provide extra favors to public sector unions. They are as much political bodies as they are representatives,” argued Thomas Miller, a resident fellow at the conservative American Enterprise Institute.

But labor advocates warned the consequences could be steep, and not just for home care workers.

Surveys from the National Employment Law Project suggest that unionized home care workers stay in their jobs longer when represented by unions, partially because they can negotiate better pay and benefits. Higher pay also makes the job more appealing, especially as need grows.

That, many experts argued, means patients also benefit.

“We can be putting more money into making these good quality jobs. The shortages and turnover we are facing —it is not rocket science what is causing that,” said Caitlin Connolly, who runs the National Employment Law Project’s campaign to increase home care wages. “If we made these quality jobs, we would be able to ensure that people had access to quality care.”

Readout of Secretary Azar’s ALEC Speech and Louisiana Healthcare Leaders Roundtable

HHS Gov News - August 10, 2018

On Thursday, Health and Human Services Secretary Alex Azar delivered remarks at the 45th American Legislative Exchange Council Annual Meeting in New Orleans, Louisiana. His remarks focused on the Trump Administration’s commitment to working with and challenging states to improve healthcare. Here is a key excerpt from his speech:

“From administering Medicaid programs to providing mental health services, retiree healthcare, and public health programs, states have a major role to play in running America’s healthcare system. But we don’t just want you administering our system as it stands today. This administration believes states should play a vital role in driving American healthcare forward.”

To read the full remarks, please visit: https://www.hhs.gov/about/leadership/secretary/speeches/2018-speeches/remarks-on-state-healthcare-innovation.html.

Later in the day, Secretary Azar and Adam Boehler, Director of the Center for Medicare & Medicaid Innovation and Senior Advisor for Value-Based Transformation and Innovation, visited the “O Bar” at Ochsner Medical Center to learn about their work to integrate technology into patients’ care.

They also held a roundtable discussion with Louisiana healthcare leaders to discuss one of the priorities that Secretary Azar has identified for HHS: transforming America’s healthcare system into one that pays for value.

At the roundtable, Secretary Azar and Mr. Boehler outlined their vision for this transformation, focusing on four areas:

  • Maximizing the promise of health IT, including through promoting interoperability and patient control of data.
  • Boosting transparency around price and quality.
  • Pioneering bold new models in Medicare and Medicaid.
  • Removing government burdens and barriers, especially those impeding care coordination.

At the roundtable, healthcare leaders discussed the challenges and successes they have had working with the federal government on daily basis. Other topics discussed by individual leaders included: President Trump’s American Patients First drug pricing blueprint, including HHS’s announcement this week of new tools for Medicare plans to negotiate with drug companies; the possibilities presented by telemedicine; the important role played by federally qualified health centers; innovations to help patients access their own healthcare data; and the future of Accountable Care Organizations.

Secretary Azar and Mr. Boehler stressed the department’s commitment to reforming regulations that could be impeding value-based, coordinated care, and President Trump’s commitment to ensuring all Americans have access to better healthcare at a lower cost.

Trump Administration Sinks Teeth Into Paring Down Drug Prices, On 5 Key Points

Kaiser Health News:Marketplace - August 10, 2018

Three months after President Donald Trump announced his blueprint to bring down drug prices, administration officials have begun putting some teeth behind the rhetoric.

Many details have yet to be announced. But experts who pay close attention to federal drug policy and Medicare rules say the administration is preparing to incrementally roll out a multipronged plan that tasks the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration with promoting competition, attacking the complicated drug rebate system and introducing tactics to lower what the government pays for drugs.

Mark McClellan, director of the Duke-Margolis Center for Health Policy in Durham, N.C., and a former CMS administrator, said that although none of the initial steps has “fundamentally transformed drug prices,” there is “a lot going on inside the administration.”

Two HHS officials who are rolling out the plan, Dan Best and John O’Brien, described their efforts to Kaiser Health News not as a public relations strategy but a push to reform the system.

“This administration is trying to go after root causes” of high drug prices, said Wells Fargo analyst David Maris.

But others are not so optimistic.

Ameet Sarpatwari, an instructor in medicine at Harvard Medical School in Boston, said policies the administration has rolled out thus far “alone will not translate into meaningful cost savings for most Americans.”

Broadly, the strategy falls under a handful of steps:

1. Attacking The Rebates

Health and Human Services Secretary Alex Azar has said Americans “do not have a real market for prescription drugs” because drug middlemen and insurers get a wide range of hidden rebates from drugmakers, but those savings may not be passed on to consumers or Medicare. In July, the administration submitted a proposed rule that could change the way rebates are handled.

Details of the proposal have not been made public. But O’Brien, a deputy assistant secretary at HHS, explained during a recent conference on federal drug spending sponsored by the Pew Charitable Trust: “You don’t have to use market power to get rebates, you can use market power to obtain discounts, to actually lower the price of the drug on the front end.”

Umer Raffat, an investment analyst with EverCore ISI, said “it’s not clear [that drug prices are going down]” but the “rebate structure is changing.”

2. Bringing More Negotiation To Medicare

This week, CMS Administrator Seema Verma announced that Medicare Advantage insurers can use a step-therapy approach to negotiate better prices for Part B drugs — those administered in hospitals and doctors’ offices. These private plans will be allowed to require patients to first select the least expensive drug before stepping up to more costly drugs if the original medications aren’t working.

The administration is also looking at ways to introduce more competition into Part B drug purchasing. That idea was mentioned deep inside the annual Medicare outpatient payment rule released last month.

Peter Bach, director of Memorial Sloan Kettering’s Center for Health Policy and Outcomes in New York, pointed to the possible introduction of a competitive purchasing program in which a firm negotiates with drugmakers to buy their drugs and then sells them to the doctors and hospitals that will administer the medications. Bach said that helps ensure that hospitals and doctors can’t make more money by prescribing more expensive drugs.

Currently, Medicare pays the average sales price plus 6 percent to doctors or hospitals when they purchase drugs, a pricing mechanism that can benefit the providers if the drug costs go up. If there were a third party buying the drugs, it would “have a huge effect,” Bach said.

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3. Paying For Value

Trump’s blueprint calls for CMS to encourage “value-based care” to lower drug prices, shifting from paying a set fee for drugs to basing payments on how well the patient does on them.

Louisiana’s Medicaid program could show the way. The state is working with CMS to explore a subscription-based model to pay for hepatitis C medicines. Louisiana would pay a fixed price to a drug manufacturer that would then get unlimited access to treat patients enrolled in Louisiana’s Medicaid program or in prison.

The program would move “from a big payment upfront to paying less over time based on actual outcomes,” said McClellan, who also serves on the boards of health care giant Johnson & Johnson and insurer Cigna.

CMS also approved a Medicaid waiver from Oklahoma in June. Medicaid programs are allowed to negotiate drug prices. Oklahoma’s plan would expand that to negotiate additional prescription price reductions based on value-based purchasing agreements.

Still, CMS’ recent rejection of a related Massachusetts proposal makes it difficult to believe negotiating drug prices will really happen, said Sara Rosenbaum, a professor of health law and policy at George Washington University.

That proposal would have allowed Massachusetts’ Medicaid program to choose drugs based on cost and how well the medicines work.

“They have been very good and quite careful with their [Medicaid] program and so why not let them try this?” Rosenbaum said.

4. Tackling Foreign Drug Costs

Pharmaceutical makers often sell their drugs at substantially lower prices in many foreign countries than they do in the United States. Trump emphasized in May that “it’s time to end the global freeloading once and for all,” saying U.S. consumers were paying part of the cost of the medicines that patients in other countries use.

He directed U.S. Trade Representative Robert Lighthizer to address the situation. Lighthizer’s office declined to comment.

When Sen. Todd Young (R-Ind.) asked during a Senate health committee hearing in June whether trade agreements with other countries should be used to “level the playing field,” Azar’s response was swift: “We absolutely believe we should be using our trade agreements to get them to pay more even as we have our job to pay less.”

Avalere Health President Matt Brow, who has been involved in talks with the administration, said it’s clear the focus on overseas pricing isn’t going away and the administration is “talking a lot about how to get the president what he wants.”

5. Increasing Competition

FDA Commissioner Scott Gottlieb has become the Trump administration’s lead proponent for increasing competition among drugmakers.

Competition resonates with Americans “because people see it every day in their experience in Costco and other places,” said Rena Conti, an assistant professor at the University of Chicago.

Gottlieb has announced plans to bolster the use of generic drugs and an “action plan” to encourage the development of biosimilars, which are copycat versions of expensive biologic drugs made from living organisms.

And to combat anti-competitive behavior in the market, Gottlieb said the FDA has passed along information to the Federal Trade Commission and hinted at potential action to come: “I think we’ve handed them some pretty good facts.”

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

Clinicians Who Learn Of A Patient’s Opioid Death Modestly Cut Back On Prescriptions

Kaiser Health News:Marketplace - August 10, 2018

Physicians and other medical providers modestly reduced the volume of opioids they prescribed after being told one of their patients had died of an overdose, according to research published Thursday.

“You can hear a lot of statistics about the crisis,” said Jason Doctor, lead author of the study, published Thursday in the journal Science. “But it always feels like it is happening elsewhere if you are not aware of any deaths in your own practice.”

The research included more than 800 clinicians — doctors, nurse practitioners, physician assistants and dentists — comparing those who received a letter from the medical examiner about a patient’s death and those who didn’t. The ones who knew about the overdose death cut the overall volume of opioids they prescribed by almost 10 percent over three months, while those who didn’t know prescribed roughly the same amount as before.

The study shows that awareness and education can change prescribing behavior, said Doctor, lead author and associate professor at University of Southern California’s Price School of Public Policy. The modest size of the reduction among those who were notified of a death suggests “that clinicians exercised greater caution with opioids rather than abandoning use,” according to the study.

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The providers in the study who were informed about patients’ deaths were also 7 percent less likely to start new patients on opioids.

The letter did not blame providers for the deaths but showed that authorities were paying attention, according to the study.

“We were providing them with important information and also giving them a way to make things better by changing prescribing,” Doctor said. “Anyone who got the letter could continue to prescribe as much as they wanted, but we found that they didn’t. They became more judicious prescribers.”

Over 19,000 people died from prescription opioids in 2016, roughly double the number 14 years earlier, according to the National Institute on Drug Abuse. Most of that increase occurred from 2002 to 2011, and the numbers have been relatively stable since then, according to the NIDA.

Meanwhile, prescriptions of opioids are declining, and health officials are seeking ways to accelerate the trend.

The study did not measure whether the letters from the medical examiner or the changes in prescribing patterns had any effect on patient deaths.

Across the country, physicians have been accused of overprescribing opioids and have even faced charges related to patient overdose deaths. In an effort to better track prescribing patterns, states have started prescription drug monitoring databases.

The CDC recommends that providers avoid opioids if possible, but if they are necessary, they should start with the lowest effective dose.

KHN's coverage in California is supported in part by Blue Shield of California Foundation.

Medicare To Overhaul ACOs But Critics Fear Less Participation

Accountable care organizations were among the key initiatives of the Affordable Care Act, designed to help control soaring Medicare costs.

ACOs were expected to save the government nearly $5 billion by 2019, according to the Congressional Budget Office.

It hasn’t come anywhere close.

On Thursday, the Trump administration proposed an overhaul to the program, which was designed to encourage doctors and hospitals to work together to coordinate care by reducing unnecessary tests, procedures and hospitalizations. The move could dramatically scale back the number of participating health providers.

Administration officials say ACOs have led to higher Medicare spending.

The announcement was just the latest in a steady drumbeat of moves by Trump administration officials to unwind health policies set in place by the Obama administration.

Medicare ACOs began in 2012 and today enroll more than 10 million beneficiaries. If they provide care for less than certain cost targets — while meeting quality of care standards — then they get to share in any of the savings. Commercial insurers and Medicaid have also adopted ACOs in the past decade.

About 82 percent of the 561 Medicare ACOs are set up so that they are not at risk of losing money from Medicare. They can share in any savings they achieve. The rest are in a model where they can gain a higher share of savings, but also risk paying back money to Medicare if they do not meet their savings targets. Those ACOs have been more successful in saving money, Medicare officials said.

The Medicare program said it would phase out its no-risk model beginning in 2020.

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A recent industry-sponsored survey showed 70 percent of ACOs would rather quit than assume such financial risk.

Seema Verma, administrator of the Centers for Medicare & Medicaid Services, said it’s wrong to have ACOs that can only make profits but not risk any losses. “We want to put the accountability back into Accountable Care Organizations,” she said during a briefing with reporters.

Existing ACOs will have one year to switch to a model accepting financial risk. New ACOs will have two years.

Currently, ACOs have up to six years to shift to a model where they share in financial risk.

These and other proposed changes would save Medicare $2.2 billion over the next decade, Verma said.

The proposal drew rare praise from a former Obama administration official. Andy Slavitt, who once headed CMS, tweeted: “CMS is proposing changes to Medicare pay for value (ACO) models. … At first look, they look positive to me.”

CMS estimated that its new policy would lead to a drop of about 100 ACOs by 2027.

Industry observers say that prediction seems modest at best.

“That does not seem too realistic,” said Ross White, manager of the Center for Healthcare Regulatory Insight at KPMG, a large consulting firm. “This is going to come as quite a shock to a lot of current participants, although the administration has been sending these signals for several months. … It definitely seems like they are trying to ratchet down and squeeze the dollar savings out and not have participants in it for the wrong reasons.”

Clif Gaus, the CEO of the National Association of ACOs, blasted the proposal, saying it will “upend the ACO movement” and introduces “many untested and troubling policies.”

CMS is “pulling the rug out from ACOs by redoing the program in a short time frame,” he said.

He added that the “likely outcome will be that many ACOs quit the program, divest their care coordination resources and return to payment models that emphasize volume over value.”

Tom Nickels, executive vice president of the American Hospital Association, also criticized the new ACO rules. “The proposed rule fails to account for the fact that building a successful ACO, let alone one that is able to take on financial risk, is no small task; it requires significant investments of time, effort and finances.”

Under the new plan, CMS also wants to require doctors in ACOs to inform their patients that they are in an ACO. That has not occurred previously, because unlike HMOs, ACOs do not restrict which providers they can see.

Verma, who has repeatedly said unleashing the free market principles will help control costs and improve quality, said ACOs are driving more hospitals and doctors into mergers, which leads to higher costs.

“We want to work with ACOS that are serious about delivering value. We can no longer run a program that is losing money for taxpayers,” she said.

Podcast: KHN’s ‘What The Health?’ Coming Soon: ‘Long-Term Short-Term’ Plans

Julie Rovner

Kaiser Health News

@jrovner

Read Julie's Stories Anna Edney

Bloomberg

@annaedney

Read Anna's Stories Kimberly Leonard

Washington Examiner

@leonardkl

Read Kimberly's Stories Margot Sanger-Katz

The New York Times

@sangerkatz

Read Margot's Stories

The Trump administration’s new rule allowing “short-term” insurance plans to be used for up to three years has touched off a big reaction in health policy circles. Supporters of the change say those who can no longer afford comprehensive health insurance will have the ability to purchase lesser but cheaper plans. But opponents worry that consumers who fail to read the fine print will end up with plans that won’t cover care they need.

Reaction is similarly divided over an administration rule change that will make it easier for managed-care plans participating in Medicare to negotiate the price of drugs provided in doctors’ offices or hospitals. Insurance groups call it a small but positive step; patient groups worry it will make it harder for those with serious medical problems to get the medication their doctors recommend.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Anna Edney of Bloomberg News, Margot Sanger-Katz of The New York Times and Kimberly Leonard of the Washington Examiner.

Among the takeaways from this week’s podcast:

  • The Trump administration says its promotion of short-term health plans is designed to help people who don’t get government subsidies find more affordable health coverage and will provide some help to people who are not going to buy a plan on the federal health insurance marketplaces anyway. But the policies tend to limit many types of care, such as maternity expenses, prescription drugs and mental health issues.
  • In addition to concerns that these plans will destabilize the Affordable Care Act marketplaces, some consumer advocates say people looking at the plans don’t realize the extent to which they lack patient protections. For example, one may not cover hospital expenses if a patient is admitted over a weekend or pay for care needed for injuries if the patient was drunk.
  • As part of the administration’s effort to meet President Donald Trump’s promise to curb prescription costs, federal officials announced this week that private Medicare Advantage plans can require patients being prescribed drugs from a doctor or in a hospital to first try the cheapest drug options. But some patient advocates object, saying consumers and their doctors should be able to decide what is the best therapy.
  • The federal indictment announced this week against Rep. Chris Collins (R-N.Y.) renews questions about why a member of Congress with a large role in a biotech company was allowed to be a member of a House committee that oversees health issues. After the indictment, House Speaker Paul Ryan stripped Collins of his seat on the Energy and Commerce Committee.
  • New York Gov. Andrew Cuomo, a Democrat, surprised many people with his announcement that insurers would not be able to factor in to premium prices the expectation that fewer people will buy marketplace plans because the health law’s coverage penalties expire in 2019.

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

Julie Rovner: NPR’s “Doctors With Disabilities Push For Culture Change In Medicine,” by Elana Gordon

Anna Edney: The Atlantic’s “Women More Likely to Survive Heart Attacks If Treated by Female Doctors,” by Ed Yong

Margot Sanger-Katz: ProPublica’s “The Shadow Rulers of the VA,” by Isaac Arnsdorf

Kimberly Leonard: The Washington Post’s “A Huge Clinical Trial Collapses, and Research on Alcohol Remains Befuddling,” by Joel Achenbach

To hear all our podcasts, click here.

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

Lax Oversight Leaves Surgery Center Regulators And Patients In The Dark

Kaiser Health News:Marketplace - August 09, 2018

The first man died in April 2014. Another died later that month. Then on July 18 of that year, a woman was rushed to a hospital where she was told she was lucky to be alive.

They all went to the same Little Rock, Ark., surgery center for a colonoscopy, among the safest procedures a patient can have. And each stopped breathing soon afterward, court records say, sustaining the same type of brain damage seen in a drowning victim.

Simple Surgeries. Tragic Results. As Surgery Centers Boom, Patients Are Paying With Their Lives

An investigation by Kaiser Health News and the USA TODAY Network discovers that more than 260 patients have died since 2013 after in-and-out procedures at surgery centers across the country. More than a dozen — some as young as 2 — have perished after routine operations, such as colonoscopies and tonsillectomies.

Read The Investigation

What happened at Kanis Endoscopy Center prompted no review by officials in Arkansas, which, like 16 other states, has no mandate to report patient deaths after surgery center care. So no facility oversight authority has examined whether the deaths were a statistical anomaly or cause for alarm.

A Kaiser Health News and USA Today Network and investigation found that surgery centers operate under such an uneven mix of rules across U.S. states that fatalities or serious injuries can result in no warning to government officials, much less to potential patients. The gaps in oversight enable centers hit with federal regulators’ toughest sanctions to keep operating, according to interviews, a review of hundreds of pages of court filings and government records obtained under open records laws. No rule stops a doctor exiled by a hospital for misconduct from opening a surgery center down the street.

Even the high-profile death of comedian Joan Rivers — who passed away in 2014 following a routine procedure at a Manhattan surgery center — failed to appear in Medicare’s public tally of patients rushed to a hospital.

When Faye Watkins, 63, walked into Kanis Endoscopy in Arkansas, she was unaware that there had been two deaths after care there within the previous three months, she said. She was in the fog of anesthesia when it struck her that something was amiss. She said she heard men say her blood pressure was falling.

“I said [to myself], ‘Lord, if it’s time for me to go, take me. But I’m not ready,’” Watkins recalled. Her next memory was waking up in a hospital with her chest sore from CPR.

The KHN/USA Today examination raises questions about the need for more robust oversight of surgery centers, where public access to important information, such as surgical outcome data, tends to be more limited than what’s available about hospitals. The gap persists even as the nation’s 5,600 surgery centers have surpassed hospitals in number and taken on increasingly complex procedures.

“It’s disgraceful that there’s so little information” about what happens in surgery centers, said Leah Binder, chief executive of the Leapfrog Group, an employer consortium that surveys more than 2,000 hospitals a year.

Scrutinizing unexpected deaths is the norm for U.S. hospitals. The Joint Commission, their leading accreditation body, recommends that members send the accreditor reports of unexpected deaths so that lessons from one tragedy might prevent another. The top surgery center accreditation body has no similar guideline.

Bill Prentice, executive director of the Ambulatory Surgery Center Association, an organization that represents the centers in policymaking discussions, said the centers safely perform millions of procedures, from tonsillectomies to knee replacements, each year.

Prentice said he supports giving patients access to data that could compare surgery centers with hospital outpatient departments.

“We shouldn’t have a patchwork system where one state asks for one thing and others ask for others,” Prentice said. “What consumers want is consistency.”

A memorial of cards and flowers lies outside Joan Rivers’ apartment in New York City in 2014 following the comedian’s death. Rivers passed away after a routine procedure at a Manhattan surgery center.(DVT/Star Max/GC Images)

Colorado requires surgery centers to report deaths and some major injuries to the state health department, and the agency posts summaries of incidents online for consumers. Several other states — including Pennsylvania, Florida and New Jersey — require incident reports but don’t reveal to the public where they happened.

In at least 17 states, health facility officials confirmed they have no way to know that a patient died because surgery centers have no duty to report. So just as in Arkansas, surgery centers had no mandate to notify an official over cases outlined in lawsuits, including a 33-year-old Missouri man who died after finger surgery, a 66-year-old Georgia woman who died after an eye procedure or a 60-year-old in Oklahoma who died soon after a total hip replacement.

Even in Colorado, a leader in transparency, the outcome of a 2017 jury trial raised questions about the depth of the oversight. Robbin Smith was paralyzed from the waist down after an epidural pain injection at the Surgery Center at Lone Tree in 2013, according to her lawsuit against the center.

Smith’s attorneys cited Medicare rules that say the center’s own governing body has a duty to keep patients safe. Each center must appoint a body that is legally responsible for the center’s operations.

Smith’s legal team argued that the center should have upheld its duty by ensuring that its doctors did not use the drug Kenalog — an injectable steroid — for epidural injections. The drugmaker had changed the label in 2011 to warn against using it that way due to the risk of paralysis.

The center’s governing body never discussed proper usage of the drug prior to Smith’s care, trial testimony shows, and there’s no sign that state or private facility overseers examined the board’s actions before Smith’s injury.

The surgery center’s lawyer argued that the doctor — not the facility — was responsible for choosing Kenalog for Smith’s treatment. The doctor denied wrongdoing and reached a confidential settlement with Smith before her case against the center went to trial.

Jurors ultimately ruled against the center, awarding Smith $14.9 million. The center has filed a motion for a new trial.

Robbin Smith’s legal team argued that the center should have ensured that its doctors did not use the drug Kenalog — an injectable steroid — for epidural injections. The drugmaker had changed the label in 2011 to warn against using it that way due to the risk of paralysis. (Austin Humphreys/The Coloradoan)

Jurors ultimately ruled against the Surgery Center at Lone Tree, awarding Robbin Smith $14.9 million. The center has filed a motion for a new trial. (Courtesy of Robbin Smith)

Public Reports Flawed

The federal government posts on its “Hospital Compare” website far more data about hospitals than surgery centers, and available hospital data cover several types of surgical complications and mortality rates for certain conditions. Some hospitals’ quality measures, like infection rates or patient satisfaction scores, reflect the experience of every patient in the hospital.

The same Medicare website displays different data for surgery centers — and for some key measures, the reported results cover only a fraction of patients. Medicare allows surgery centers to report data for as few as half of just their Medicare patients, ignoring most patients under age 65 who do not yet qualify for Medicare.

In practice, that has allowed surgery centers to report as many hospital transfers as they choose — unless more than half of their patients leave by ambulance.

Yet a person examining the data on the Medicare website would see no explanation about the limits of the information. They would see a national transfer rate that’s less than half the rate reported in medical research.

State records, ambulance records and Medicare’s own inspection reports highlight the apparent disconnect. They show that dozens of centers reporting zero transfers in Medicare’s public data do, in fact, send patients to hospitals.

For example, Memphis-based Urocenter, which specializes in urological procedures, reported to state officials 45 transfers combined in 2014 and 2015. Its public report on the Medicare website for those years showed zero transfers.

When a reporter noted the discrepancy, Urocenter’s administrator responded in an email that the facility “put in place corrective measures … and have provided [Medicare] with the corrected information.”

The Medicare data also show zero transfers in 2014 from Yorkville Endoscopy. The Manhattan surgery center transferred Joan Rivers, 81, to a hospital after complications from a vocal cords procedure that year. Rivers died a week later.

An attorney for Yorkville Endoscopy said all transfers meeting the government’s standards were reported.

After reviewing the reporting rules, Cheryl Damberg, a Rand Corp. researcher who has worked on hospital quality-reporting tools for the federal government, said the 50 percent rule leaves the public with little useful information.

“It seems like this can totally be gamed,” Damberg said. “From a consumer standing, the data [for surgery centers] doesn’t have a lot of utility at this point.”

Bill Prentice, executive director of the Ambulatory Surgery Center Association, said he supports giving patients access to data that could compare surgery centers with hospital outpatient departments.(Courtesy of Ambulatory Surgery Center Association)

Medicare officials said in an interview that the agency allows limited reporting so the requirements do not overburden surgery centers.

Yet industry leaders have told Medicare they want to report more data. In letters to Medicare during 2016 and 2017 rule-making periods, the ASC Quality Collaboration, a group of surgery center leaders, urged Medicare to collect reports on every patient transfer to expand transparency and accountability.

Medicare made a very different move in July, proposing to stop collecting surgery center-to-hospital transfer data and seven other measures of quality. The agency said it still plans to report on incidents gleaned from its own records, like visits to the hospital seven days after certain surgery center procedures.

Medicare said in the proposed rule that the transfer measure appears to be “topped out,” meaning there is a tiny difference in transfer rates reported by the centers.

Dr. Ashish Jha, a senior associate dean at Harvard’s School of Public Health, said calling the data “topped out” is puzzling since Medicare is not sampling all of the patients.

“Getting rid of [the transfer measure] doesn’t make a lot of sense to me,” he said.

Prentice, of the surgery center association, lauded the proposal in a press release as recognizing the “outstanding” work of surgery centers in preventing harm. In an interview, he conceded that he was “parroting” Medicare’s sentiment and said he hopes the industry will find a way to report meaningful quality data.

“I want us to fill that gap,” Prentice said. “We need to be robustly reporting data to [Medicare] and the world on quality of care.”

Cluster Of Cases In Arkansas

Medicare’s rules for surgery centers require them to track unusual events, analyze them internally and try to learn from them. But after two deaths and a close call after procedures at Kanis Endoscopy Center, no outside official went in to see if patients remained at risk.

Medicare spokesman Tony Salters confirmed that, lacking a consumer complaint, no state or federal official was notified of the events and no special review occurred.

In April 2014, Rev. Ronald Smith died at a hospital after visiting Kanis Endoscopy Center for a colonoscopy.(Courtesy of Deborah Smith)

Yet what happened in a stretch of three months was far from routine. In April 2014, Rev. Ronald Smith, 63, died at a hospital after visiting Kanis for a colonoscopy. His family later alleged in a lawsuit that Smith’s sleep apnea and heart disease made him “extremely high risk” for undergoing anesthesia at the center, rather than at a hospital.

Smith was close to death at the Little Rock hospital when, coincidentally, an Arkansas health official began a routine inspection of the center on behalf of Medicare, records show. The lack of public information makes it impossible to determine precisely what happened in Smith’s case.

Medicare spokesman Bob Moos said state recertification inspectors come in every four to seven years and review all cases in the previous year in which a surgery center patient was transferred to a hospital. When the state inspector visited Kanis, “nothing on the hospital transfer log raised a red flag for her to investigate,” the spokesman said.

Officials would not describe what was on the transfer log or which cases were on it or confirm that Smith’s name had been included on it.

A Kanis spokesperson said it would violate patient confidentiality to comment on what the staff showed the inspector. Arkansas Department of Health spokeswoman Meg Mirivel provided no details, saying state law prohibits releasing information about hospital or surgery center investigations.

The state official’s inspection report does not mention any patient transfers. It does say the center was operating outside of industry norms by performing colonoscopies without an additional nurse in the room. The center pledged to health officials that it would add a nurse to the endoscopy suites.

The extra set of hands can be critical in case of an airway failure, said Dr. John Dombrowski, an anesthesiologist and a board officer with the American Society of Anesthesiologists.

“When you have an airway problem, you’ve got minutes,” he said. “When you have more hands on deck, you’re better able to save somebody.”

About three hours after the inspector left Kanis, another ambulance was speeding to the center.

It remains unclear if having another medical professional present would have helped save Clarence Creggett, 83, who also stopped breathing at the center after his colonoscopy, according to his family’s lawsuit. He died in a hospital nine days later, the family alleged.

Creggett’s family also filed a lawsuit, alleging that he was at “extremely high risk” as a surgery center patient, given his age and history of respiratory problems, including asthma.

Watkins, who survived after she stopped breathing, according to her lawsuit, said she only learned about the deaths of Smith and Creggett through gossip at her bank and hair salon. “My eyes got big then,” Watkins said. “That’s how I actually found out.”

Attorney Lamar Porter filed lawsuits in Pulaski County, Ark., on behalf of Watkins and the families of Smith and Creggett. The suit alleged that Dr. Alonzo Williams, who performed all three procedures, failed to properly screen the patients. The suits also claim that the nurse anesthetists did not administer the anesthesia appropriately.

“I said [to myself], ‘Lord, if it’s time for me to go, take me. But I’m not ready,’” Faye Watkins recalled thinking during her procedure at Kanis Endoscopy in Arkansas.(Robert Huston for KHN/USA Today)

The endoscopy center denied wrongdoing in court filings, and the suits ultimately ended with confidential settlements. Suzette Siegler, director of Kanis, stated in a letter that the center “strives to provide the very best care possible.”

The anesthetists also denied fault or negligence in legal filings. Dustin Wixson, the nurse anesthetist on the Creggett case, said the death was the only one in his 14-year career.

Williams denied wrongdoing in court filings for each case. He did not respond to requests for comment. Siegler’s letter stated that he was dismissed from the lawsuits before they settled and has “practiced for over 35 years with an unassailable reputation nationally. He was appointed by three separate Arkansas Governors to [the] Arkansas State Medical Board.”

Crackdowns That Don’t Stick

Medicare inspectors have a harsh sanction they mete out sparingly after serious safety lapses: involuntary decertification. It means the federal government won’t pay for seniors’ care at a health facility.

Such actions cut off a major source of patients and payments to hospitals and tend to make headlines. Hospitals that were involuntarily decertified in recent years closed for good, had to reopen as a clinic or reorganized before seeing another patient.

But surgery centers hit by such penalties have hardly skipped a beat.

Medicare pulled its certification from Cascade Cosmetic Surgery Center in Orem, Utah, on Dec. 28, 2014, after state inspectors said the center failed to meet basic standards mandated by federal regulations.

Medicare requires a surgery center to have a governing body that has formal meetings and takes legal responsibility for providing “quality health care in a safe environment.” According to the inspection report, the Utah center’s owner, Dr. Trenton Jones, told the inspector “he was the governing body and that he did not keep minutes of his thoughts.”

The inspection also said the center did not meet Medicare’s infection-control rules, such as putting a licensed professional in charge, determining what kind of bacteria infected patients or logging antibiotic use.

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In some states, licensing officials would follow Medicare’s lead and revoke their approval. But in Utah, any licensed surgeon can operate in a one-operating-room surgery center without state approval, said Tom Hudachko, spokesman for the Utah Department of Health.

That meant Cascade was open for business — five days after Medicare pulled its approval — when Sandy Lee Walters, a 37-year-old real estate agent and mother of three, flew to Utah from Hawaii for breast reduction, tummy tuck and liposuction surgeries. The procedures took nearly nine hours, from 2:30 p.m. to 11:20 p.m., court records show.

Five days later, Walters died after a blood clot lodged in her lung. Her autopsy report notes “recent surgery” as a “significant contributing condition” in her death.

A lawsuit filed by her family alleged that Walters was at high risk for a blood clot because of her recent air travel and the extent of the surgery, yet she was not prescribed a “sequential” compression device or clot-busting medication. The suit is ongoing.

Walters’ eldest daughter testified in a deposition that her brother treasures a blanket his grandmother made from his mother’s blue jeans. “We all have a little piece of us missing,” the teen testified.

Three months after Walters’ death, a 55-year-old woman went to the same surgery center to have her breast implants removed. Within a week, the woman was found to have infections so severe that her nipples had to be removed in subsequent surgeries. In 2017, the woman filed a lawsuit alleging malpractice by Jones and the center. The suit is ongoing.

Cascade, Jones and his attorneys did not return calls or emails seeking comment. In both lawsuits, Cascade and Jones denied the allegations, according to court documents.

In California, eight centers that Medicare decertified over health violations have continued to operate on patients, with the blessing of private accreditation agencies hired by the centers to perform inspections. They include a center that was operating without a lifesaving drug in the crash cart and a facility where managers pressed an unqualified receptionist into duty disinfecting scopes used inside the body.

A Medicare official said accreditation bodies are notified when the agency pulls an approval, but officials do not control the private body’s decisions.

George Nelson lost his wife, Jeanette Nelson, in 2015 after complications from surgery at the Innovations Surgery Center in Rockville, Md.(Camille Fine/USA TODAY)

Owners In Charge

Hospitals have committees and administrators focused on making sure doctors’ skills are sharp and their insurance is in place. Surgery centers have similar rules, but the oversight is lacking when a controversial doctor is also the facility owner.

Dr. Paul Mackoul, a Maryland gynecological surgeon, lost his hospital privileges in 2001 after a medical staff committee at Washington Hospital Center reviewed his “competence or conduct,” according to Washington, D.C., Board of Medicine records. Mackoul criticized the decision, saying he never had a chance to defend himself.

Mackoul has faced 14 lawsuits since 1991 alleging substandard obstetrics and gynecological care, according to court records. Women have accused him of leaving them infertile, incontinent or with perforated bowels. Mackoul said in an email that settlements were paid on his behalf in four cases, two were decided in his favor at trial, one case is pending and the others were dismissed or resulted in no payment on his behalf.

Despite losing privileges at Washington Hospital Center, Mackoul and his wife, who is also a gynecologist, co-own and operate Innovations Surgery Center in Rockville, Md. The facility is Medicare-approved, based on the recommendation of an accreditation body.

An insurer’s lawsuit shows that in early 2015, Mackoul’s malpractice policy did not cover him to perform cancer surgery. Most hospital executives would not allow a physician to perform procedures that aren’t covered, according to interviews with hospital administration experts.

Mackoul, his wife and the facility administrator served as the governing board at Innovations, according to court records and Mackoul. He also said he has privileges at one Maryland hospital.

In February 2015, Jeanette Nelson, 73, a soprano gospel singer, turned to Mackoul for care after she had been diagnosed with uterine cancer.

He performed her hysterectomy without incident. Mackoul saw her again a month later to install a catheter in her chest that would better deliver chemotherapy drugs to her bloodstream. Nelson died in a hospital later that same day, her autopsy report says.

The autopsy report states that blood built up in Nelson’s chest wall and caused her lung to collapse, but the source of the blood was “not definitively identified.” However, the report concluded that her death was the result of “a complication of attempted treatment for her” cancer.

Nelson’s family alleged in a lawsuit that Mackoul punctured a vein as he installed the catheter, and his mistake caused internal bleeding that proved fatal.

Jeanette and George Nelson were married in 1966 on Belle Isle in Detroit. (Courtesy of George Nelson)

Jeanette Nelson celebrates Mother’s Day in 2007 with sons George Everett Nelson (left), now 49, and Dwayne Elliot Nelson, now 47. (Courtesy of George Everett Nelson)

George Nelson said he was devastated by the loss of his wife of 48 years, who was both devoutly religious and fascinated with murder-mystery detective shows. Before her death, the couple was looking forward to her graduation from a master’s program in cybersecurity policy.

After his wife’s passing, he said: “I didn’t care if I would have died.”

In an email, Mackoul said Jeanette Nelson’s death was related to a “major cardiac episode” and that experts he retained found no shortcomings with his care. He denied wrongdoing in the lawsuit, which reached a confidential settlement.

“Unfortunately, even under the best of circumstances and in the very best of hands, a patient can experience the most catastrophic event,” Mackoul said in an email.

Mackoul’s malpractice insurer sued him over the wrongful death case, revealing in court records that he had not been covered to perform cancer surgeries. Mackoul said in an email that the port procedure is not specifically a cancer surgery, though he was not aware of the clause at the time and was self-insured. He denied negligence in court filings, and the case reached a confidential settlement.

The question remains whether the center’s governing board was independent enough to perform the typical doctor-oversight practices, said Dr. Jonathan Burroughs, a faculty member of the American College of Healthcare Executives. And it’s a question that applies to an untold number of surgery centers.

“When push comes to shove,” he said, “the board has to make decisions in the best interest of the community and good patient care.”

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

Pharmacy-Made Pain Creams Flagged On Fears Of Medicare Fraud And Risk

Kaiser Health News:Marketplace - August 09, 2018

Medicare pays hundreds of millions of dollars each year for prescription creams, gels and lotions made-to-order by pharmacies — mainly as pain treatments. But a new report finds that officials are concerned about possible fraud and patient safety risks from products made at nearly a quarter of the pharmacies that fill the bulk of those prescriptions.

“Although some of this billing may be legitimate, all of these pharmacies warrant further scrutiny,” concludes the report from the Office of the Inspector General for the Department of Health and Human Services.

In total, 547 pharmacies — nearly 23 percent of those that submit most of the bills to Medicare for making these creams — hit one or more of five red-flag markers set by investigators. Those included what the researchers called “extremely high” prices; large percentages of Medicare members getting identical drugs — 16 of the pharmacies billed for identical drugs for 200 or more customers; “greatly increased” year-over-year billing — 20 pharmacies increased their billing by more than 10,000 percent; or having a single medical provider writing more than 131 prescriptions. More than half of those pharmacies hit two or more measures — and 10 hit all five.

One Oregon pharmacy, for example, submitted claims for 91 percent of its customers. A pharmacy in New York submitted 5,342 prescriptions ordered by one podiatrist, while a Florida pharmacy saw its Medicare billing for such treatments go from $7,468 in 2015 to $1.8 million the following year.

Many of the pharmacies are clustered in four cities: Detroit, Houston, Los Angeles and New York.

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The report comes amid ongoing concern by Medicare officials about these custom-made — or compounded — drugs. In addition to questions like those raised in the report about overuse and pricing, safety has been a key issue in recent years. A meningitis outbreak in 2012 was linked to a Massachusetts pharmacy that did not maintain sterile conditions and sold tainted made-to-order injections that killed 64 Americans.

When done safely, pharmacy-made compounded drugs provide a legitimate option for patients whose medical needs can’t be met by commercially available products mass-produced by pharmaceutical companies. For example, a patient who can’t swallow a commercially available prescription pill might get a liquid version of a drug.

State boards of pharmacy generally oversee compounding pharmacies, and the drugs they produce are not considered approved by the Food and Drug Administration.

The new report focuses on concerns with compounded topical medications.

Medicare spending for such treatments has skyrocketed, rising more than 2,350 percent, from $13.2 million in 2010 to $323.5 million in 2016. Price hikes and an increase in the number of prescriptions written drove the increase, the report said.

It is not the first time the inspector general has looked at compounded drugs. A 2016 report found that overall spending on all types of compounded drugs — not just topical medications — rose sharply. The U.S. Postal Service inspector general and the Department of Defense also have raised concerns about rising spending and possible fraud for compounded drugs.

In response to those previous reports, the International Academy of Compounding Pharmacists, the industry’s trade group, has said that legitimately compounded drugs “can dramatically improve a patient’s quality of life,” noting that proper billing controls need to be in place. The inspector general’s report in 2016, it added, found that “such controls are not in place.”

This report, which the compounding trade group has not yet reviewed, focuses on topical drugs and a subset of the 15,290 pharmacies that provide at least one such prescription each year. It looked at billing records from the 2,388 pharmacies that do at least 10 such prescriptions a year — providing 93 percent of all compounded topical drugs paid for by Medicare.

Most of the prescriptions were for pain treatment, made from ingredients such as lidocaine, an anesthetic, or diclofenac sodium, an anti-inflammatory drug.

On average, those compounds were more expensive than non-compounded drugs with the same ingredients.

For example, Medicare paid an average of $751 per tube of compounded lidocaine, and $1,506 for the diclofenac, according to the inspector general’s report. Non-compounded tubes of those drugs averaged $445 and $128, respectively.

FDA Commissioner Scott Gottlieb recently outlined new efforts his agency is taking to oversee compounded drugs in the wake of legislation passed by Congress following the meningitis outbreak.

“The FDA is inspecting compounding facilities to assess whether drugs that are essentially copies of FDA-approved drugs are being compounded for patients” who could otherwise take a product sold commercially, he said in a statement issued on June 28.

Gottlieb also said the FDA plans to make more information available to patients and their doctors about compounded topical pain creams, including information about their effectiveness and any potential safety risks.

Not being effective is a safety risk, noted Miriam Anderson, a researcher with the inspector general’s office who helped write the report.

The report urged the Centers for Medicare & Medicaid Services to clarify some of its policies to emphasize that insurers can limit the use of compounded drugs by requiring prior authorization or other steps. The agency concurred with the recommendations, according to the report, including the need to “follow up on pharmacies with questionable Part D billing and the prescribers associated with these pharmacies.”

Anderson said the inspector general’s office is continuing to probe the issue.

“We will investigate a number of leads on specific pharmacies and prescribers who were identified as having these questionable patterns,” she said. “Whenever we see that kind of increase in spending, it raises concern about fraud, waste and abuse.”

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

As An Investor In Biotech Stock, Republican Chris Collins May Have Overshared

Kaiser Health News:Marketplace - August 08, 2018

Rep. Chris Collins never stopped telling friends and family about his involvement with Innate Immunotherapeutics, a small Australian biotech company.

The New York Republican sat on Innate’s board and had invested millions in the company. His son owned Innate shares. So did numerous friends as well as Tom Price, a fellow congressman who became secretary of Health and Human Services in 2017.

“I talk about it all the time,” Collins once said of Innate to CNN.

He talked one time too many, according to federal prosecutors who on Wednesday charged him and two others with violating insider trading laws.

Collins leaked sensitive information about a failed clinical trial last year that quickly reached seven people who were able to dump Innate shares before the bad news got out, according to an indictment filed Wednesday in U.S. District Court for the Southern District of New York.

“Congressman Collins had a legal obligation to keep that information secret until made available to the public,” said Geoffrey Berman, U.S. attorney for the district. “Instead, he decided to commit a crime. He placed his family and friends above the public good.”

Collins, who pleaded not guilty, will “mount a vigorous defense to clear his good name,” his lawyers said in a prepared statement, noting that he didn’t sell any of his own Innate shares.

The indictment may be the first time a sitting member of Congress has been prosecuted for allegedly tipping inside stock information to others, ethics experts said.

“I’m not familiar with another instance,” said Donna Nagy, an Indiana University law professor and congressional ethics authority.

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House Speaker Paul Ryan removed Collins from the powerful Energy and Commerce Committee on Wednesday and called for a new investigation by the House Ethics Committee. Last year, the panel began looking at evidence that Collins had previously “shared material, nonpublic information” on Innate.

Innate’s stock plunged to nearly zero in June 2017 after the company disclosed that its leading drug, intended to treat multiple sclerosis, had failed a key clinical test.

The news erased millions of dollars in wealth for Collins and many in his hometown of Buffalo and elsewhere whom he had recruited as investors. Innate shareholders included Buffalo business people, doctors, lobbyists and donors to his campaigns, Kaiser Health News reported last year.

A Politico reporter overheard Collins bragging on the phone in early 2017 “about how many “millionaires I’ve made in Buffalo” apropos of Innate stock.

Collins had recommended Innate stock to Price while the former HHS secretary was still a congressman from Georgia. The two participated in an unusual, “private placement” in 2016 that awarded them Innate shares at a discount to the market price.

Unlike others, Price avoided the collapse in Innate stock because conflict-of-interest rules forced him to sell when he took over the reins at HHS in early 2017.

Sen. Ron Wyden, an Oregon Democrat who last year questioned the propriety of Collins’ and Price’s Innate investments, said the indictment shows “insiders getting special deals while working Americans are left in the dust.”

There was no indication in Wednesday’s indictment that Price, who resigned a few months later after Politico revealed he was taking private, chartered flights at taxpayer cost, was privy to inside information.

But seven people close to Collins were tipped off, prosecutors said, using the information to sell before the company announced the disappointing drug results. A few minutes after hearing from Innate’s CEO via email that the trial was a “clinical failure,” Collins called his son, Cameron, with the news, according to the indictment.

Cameron Collins quickly told four people, including his girlfriend and his girlfriend’s father, who told two others, according to a civil complaint filed Wednesday by the Securities and Exchange Commission. Shareholders receiving inside information and selling Innate shares were able to avoid total losses of $768,600, prosecutors said.

Innate shares plunged from 55 cents to a nickel after the company announced the clinical failure.

The government charged Chris Collins, his son and his son’s girlfriend’s father with 13 counts of securities fraud, wire fraud and false statements relating to the alleged scheme. Cameron Collins and Stephen Zarsky, the girlfriend’s father, also pleaded not guilty on Wednesday.

Trump Administration Gives Medicare New Tools to Negotiate Lower Drug Prices for Patients

HHS Gov News - August 08, 2018

Today, delivering on proposals in President Trump’s American Patients First blueprint, HHS announced that Medicare Advantage plans will be able to use tools employed by private-sector insurers to negotiate lower prescription drug prices for patients.

HHS Secretary Alex Azar issued the following statement:

“President Trump promised better Medicare negotiation and lower drug prices for the American people. Today, we are taking an important step in delivering on that promise. By allowing Medicare Advantage plans to negotiate for physician-administered drugs like private-sector insurers already do, we can drive down prices for some of the most expensive drugs seniors use.

“As soon as next year, drug prices can start coming down for many of the 20 million seniors on Medicare Advantage, with more than half of the savings going to patients. Consumers will always retain the power to choose the plan that works for them: If they don’t like their plan, they don’t have to keep it.

“We look forward to seeing the results of this step toward tougher negotiation within Medicare, and will continue efforts to expand negotiation tools throughout our programs.”

Further Background

What is the policy HHS announced today?

The Centers for Medicare & Medicaid Services is rescinding a policy regarding Medicare Part B drugs that discouraged Medicare Advantage plans from using tools that are widely used in private insurance plans to negotiate lower prices from pharmaceutical companies.

Specifically, patients will now be able to choose Medicare Advantage plans that require enrollees to try certain more cost-effective drugs first (known as “step therapy”). Plans will also be able to cross-manage between the drugs covered by different parts of Medicare, allowing them to pay for the most appropriate, most affordable drugs, regardless of whether patients receive them in a doctor’s office (Part B) or at a pharmacy (Part D).

These negotiating tools will offer plans the same power that private-sector insurers have to drive down the price of prescription drugs and force manufacturers to compete on price, while maintaining patients’ rights to appeal decisions, choose another plan, or enroll in Medicare fee-for-service instead.

What is the problem that’s being addressed?

As President Trump has made clear, American drug prices are too high. Government programs for our seniors often pay higher prices than necessary for drugs, because they lack the tools they need to negotiate discounts. For many physician-administered drugs covered by Medicare Part B, private insurance plans negotiate discounts of 15 to 20 percent or more, while Medicare essentially pays full price.

This step to strengthen negotiation in Medicare is one piece of HHS’s ongoing efforts to implement the President’s American Patients First blueprint. As Secretary Azar said in introducing the blueprint at the White House in May, “Our blueprint brings the latest negotiation tools to our government programs and expands private-sector negotiation to parts of Medicare that have never had negotiation.”

Who will benefit from this change?

More than 20 million Americans are enrolled in Medicare Advantage plans, representing 33 percent of Medicare enrollees. In 2017, Medicare Advantage plans spent $11.9 billion on Medicare Part B drugs, the category where plans will now have more power to drive down prices.

How will patients see the benefit of these savings?

Plans will be required to pass on to patients more than half of the savings generated from tougher negotiation. Savings can be realized for enrollees through lower coinsurance amounts and through rewards programs, which provide patients with benefits such as gift cards.

Beginning in 2020, plans will be able to pass on savings to patients through lower premiums. (Premiums have already been set for 2019 Medicare Advantage plans.)

How soon can patients see savings?

Medicare Advantage plans can begin using these tools as part of their 2019 policies, meaning savings could be generated and passed on to patients as soon as next year. Plans have limited time to implement the tools for next year, however, and it is expected that more plans will adopt the tools over time.

How will this protect patients’ access to drugs?

High drug prices and the associated cost-sharing can be a significant barrier to patients’ access to drugs, which is why President Trump has made bringing down prices such a priority.

Each year, beneficiaries have the opportunity to choose which Medicare Advantage plan is right for them, or whether they would prefer Medicare fee-for-service, which covers all medically necessary drugs at a fixed price. Plans will be allowed only to apply step therapy to new prescriptions or prescriptions where the patient is not actively receiving the affected medication. On top of that, for the first time in 2019, beneficiaries will be able to change their Medicare Advantage plan or switch to fee-for-service through March 31.

If a beneficiary chooses a plan that incorporates step therapy and needs a drug subject to it, but feels they need access to it without trying an alternative drug, they can ask their plan for an exception, which will be reviewed as expeditiously as the beneficiary’s health condition requires (generally within 72 hours).

Medicare Advantage plans will be required to couple Part B step therapy with patient-centered care coordination services for beneficiaries as part of a drug management care coordination program. Care coordination must include discussing medication options with beneficiaries, providing beneficiaries with educational material and information about their medications, and implementing adherence strategies to their medication regimen.

How does this fit into President Trump’s drug-pricing blueprint?

President Trump and Secretary Azar laid out tougher negotiation as one of the four key strategies for putting American patients first and lowering drug prices. In particular, the blueprint highlighted the importance of bringing competition to Medicare Part B, which CMS is doing today.
This policy change to Medicare Advantage will bring new negotiating power to Medicare faster than other policies may have, but it is just part of a broader vision to ensure that the latest, successful negotiation tools are applied throughout the Medicare program to bring down prices for seniors.

Read more at CMS.gov: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2018-Press-releases-items/2018-08-07.html.

HHS Secretary Azar Statement on Passing of Former HHS Secretary Margaret Heckler

HHS Gov News - August 08, 2018

HHS Secretary Alex Azar issued the following statement regarding the passing of Margaret Heckler, who served as Secretary of Health and Human Services from 1983 to 1985:

“It is with great sadness that I have learned of the death of Margaret Heckler, former secretary of Health and Human Services. Secretary Heckler lived a full life in devotion to serving her country.

Over 30 years ago, under her leadership, HHS took on a task that laid the foundation for improving the health of millions of Americans. In 1985, Heckler created the Task Force on Black and Minority Health, charging it with researching and analyzing ‘the impact of a broad range of behavioral, societal and healthcare issues on the current departmental program areas.’ She wanted a full, inclusive picture of our nation’s health.

The Heckler Report revealed a large ‘disparity in the burden of death and illness experience’ across the American people, especially among black, Hispanic, Asian, and American Indian populations. In the opening pages of the report, Secretary Heckler expressed a principle that has lasted at HHS to this day. The stubborn disparities in American health, she said, were ‘an affront both to our ideals and to the ongoing genius of American medicine.’ In response to the report’s findings, HHS established the Office of Minority Health in 1987.

In 1984, Secretary Heckler called a press conference to highlight the emergence of the HIV/AIDS epidemic, publicly launching a battle that continues to this day. She was joined at the press conference by Dr. Robert Gallo, one of the discoverers of HIV/AIDS and a close research partner of our current CDC director, Dr. Robert Redfield.

Prior to her time at HHS, Heckler served eight terms in the U.S. House of Representatives, representing the former 10th congressional district in southeastern Massachusetts. Following her time at HHS, she served as U.S. Ambassador to Ireland from 1985 to 1989.

Secretary Margaret Hecker’s boldness in taking on health disparities and HIV/AIDS is a proud legacy of our department, and I hope everyone at HHS and all Americans remain committed to the ideals she espoused of creating a healthier America for everyone.”

GOP Congressman Chris Collins Indicted On Insider Trading Charges

Kaiser Health News:Marketplace - August 08, 2018

Rep. Chris Collins (R-N.Y.) was indicted Wednesday on federal insider trading charges. Prosecutors alleged that he used information he received while on the board of an Australian biotechnology firm, Innate Immunotherapeutics, to tip off his son and others to sell the company’s stock before a damaging report on the company’s lack of success with a drug to treat multiple sclerosis.

The Associated Press has a story about the indictment and the complaint filed by the Securities and Exchange Commission.

Here’s a look at Kaiser Health News’ earlier coverage of Collins’ relationship with the company:

Congressman’s Ties To Foreign Biotech Draw Criticism

Report: Congressional Ethics Office Probing Rep. Chris Collins’ Aussie Investment

Rep. Chris Collins’ Australian Stock Bet Looks Bleaker

Trump’s HHS Nominee Got A Sweetheart Deal From A Foreign Biotech Firm

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