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Feds Order More Weekend Inspections Of Nursing Homes To Catch Understaffing

Kaiser Health News:Marketplace - November 30, 2018

The federal government announced plans Friday to crack down on nursing homes with abnormally low weekend staffing by requiring more surprise inspections be done on Saturdays and Sundays.

The federal Centers for Medicare & Medicaid Services said it will identify nursing homes for which payroll records indicate low weekend staffing or that they operate without a registered nurse. Medicare will instruct state inspectors to focus on those potential violations during visits.

“Since nurse staffing is directly related to the quality of care that residents experience, CMS is very concerned about the risk to resident health and safety that these situations may present,” the agency said in a notification to state inspection offices.

The directive comes after a Kaiser Health News analysis found there are 11 percent fewer nurses providing direct care on weekends on average, and 8 percent fewer aides.

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Residents and their families frequently complain the residents have trouble getting basic help — such as assistance going to the bathroom — on weekends. One nursing home resident in upstate New York compared his facility to a weekend “ghost town” because of the paucity of workers.

Richard Mollot, executive director of the Long Term Care Community Coalition, an advocacy group in Manhattan, welcomed the new edict but said it was only necessary because state inspectors have not been properly enforcing the rules already on the books.

“The basic problem is the states don’t take this seriously,” Mollot said. “How many studies do we have to have, year after year, decade after decade, saying it all comes down to staffing, and there are very few citations for inadequate staffing and virtually all of them are identified as not causing any resident harm?”

CMS said it will identify potential violators by analyzing payroll records that nursing homes are now required to submit. Those records, which became public this year, showed lower staffing than what facilities had previously told inspectors during their visits, according to the KHN analysis.

“CMS takes very seriously our responsibility to protect the safety and quality of care for our beneficiaries,” CMS Administrator Seema Verma said in a statement.

The nursing home industry criticized the heightened scrutiny.

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“Unfortunately, today’s action by CMS will enforce policies that makes it even more difficult to meet regulatory requirements and hire staff,” said Dr. David Gifford, senior vice president of quality and regulatory affairs at the American Health Care Association, an industry trade group, in a written statement. “Rather than taking proactive steps to address the national workforce shortage long-term care facilities are facing, CMS seems to be focusing on a punitive approach that will penalize providers and make it harder to hire staff to meet the shared goal of increasing staffing.”

Currently, a tenth of inspections must occur during “off hours,” which can be either a weekend, or during a weekday before 8 a.m. or after 6 p.m. But for facilities that Medicare identifies as having lower weekend staffing, half of those off-hour inspections—or 5 percent of the total — must be performed on Saturdays or Sundays.

Medicare requires nursing homes to have a registered nurse on site for at least eight hours every day, but according to the payroll records, a quarter of nursing homes reported no registered nurses available at least one day during a three-month period. Since July, Medicare’s Nursing Home Compare website for consumers has highlighted homes that lack sufficient registered nurses and lowered their star ratings. Nursing Home Compare has downgraded ratings for 1,402 of 15,600 facilities for gaps in registered nurse staffing, records show.

The new directive instructs inspectors to more thoroughly evaluate staffing at facilities Medicare flags. The edict does not mean a flurry of sudden inspections. Instead, Medicare wants heightened focus on those nursing homes when inspectors come for their standard reviews, which take place roughly once a year for most facilities.

But what may appear to be staffing scarcities in payroll records may instead be clerical problems in which nurse hours are not properly recorded, say some nursing home officials.

Katie Smith Sloan, president of LeadingAge, an association of nonprofit providers of aging services, said in a statement that some homes are still struggling to adapt to the new data collection rules.

“We’ve been voicing our concerns to CMS and will continue to do so,” she said.

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

Government Investigation Finds Flaws In the FDA’s Orphan Drug Program

Kaiser Health News:Marketplace - November 30, 2018

The Food and Drug Administration has failed to ensure that drugs given prized rare-disease status meet the intent of a 35-year-old law, federal officials revealed in a report Friday.

The Government Accountability Office, which spent more than a year investigating the FDA’s orphan drug program, said “challenges continue” in the program that was created to spur development of drugs for diseases afflicting fewer than 200,000 patients.

This investigation examines the booming orphan drug business and how drugmakers have rushed into the marketplace with hundreds of drugs for rare diseases, helping patients while landing lucrative federal incentives and monopoly control for every drug that gets approved.

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The investigation began after a request from three high-profile Republican senators last year, in the wake of a KHN investigation. KHN found that the program was being manipulated by drugmakers to maximize profits and to protect niche markets for medicines being taken by millions.

The GAO uncovered inconsistent and often incomplete reviews early in the process of designating medicines as orphan drugs and recommended “executive action” to fix the system. In some cases, FDA reviewers failed to show they had checked how many patients could be treated by a drug being considered for orphan drug status; instead, they appeared to trust what drugmakers told them.

In response to GAO’s probe, the FDA issued a statement saying it agreed with the report recommendations regarding documentation and that the agency is “streamlining our processes.” The agency declined requests for interviews. In a comment included with the report, Matthew Bassett, assistant secretary for legislation at the Department of Health and Human Services, said HHS agreed with GAO’s recommendations.

John Dicken, director of the GAO’s health care team, said the focus of the report is “ensuring that the intent of the law is being met.”

The FDA’s rare-disease program began after Congress overwhelmingly passed the 1983 Orphan Drug Act to motivate pharmaceutical companies to develop drugs for people who lacked treatments for their conditions. Rare diseases had been ignored by drugmakers because treatments for them weren’t expected to be profitable. The law provides fee waivers, tax incentives for research and seven years of marketing exclusivity for any drug the FDA approves as an “orphan.”

The incentives, though, have proven to be more powerful and highly coveted than expected, said Avik Roy, president of the Foundation for Research on Equal Opportunity, a conservative think tank.

Many people are “starting to wonder whether or not the Orphan Drug Act over-corrected for the problem,” Roy said, noting that a third of all pharmaceutical spending in the U.S. will be on so-called rare-disease medicines in 2020.

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GAO analysts examined FDA records for 148 applications submitted by drugmakers for orphan drug approval in late 2017. FDA’s reviewers are supposed to apply two specific criteria — how many patients would be served and whether there is scientific evidence the drug will treat their disease.

In nearly 60 percent of the cases, the FDA reviewers did not capture regulatory history information, including “adverse actions” from other regulatory agencies. The FDA uses experienced reviewers, Dicken noted, who may already know the history of certain submitted drugs and not see the need to document it.

And 15 percent of the time FDA reviewers failed to independently verify patient estimates provided by the drugmaker.

Of the 148 records the GAO reviewed, 26 applications from manufacturers were granted orphan status even though the initial FDA staff review was missing information.

“It is tempting to think that perhaps those approvals were sort of granted routinely without sufficient scrutiny,” said Bernard Munos, senior fellow at FasterCures and the Milken Institute.

By contrast, early Orphan Drug Act advocate Abbey Meyers said she was not concerned about the lack of population estimates because many rare diseases lack population studies that show how common a disease is.

Rather, Meyers said, she’s “disappointed that there is no government-funded agency that is willing to finance” such research.

The GAO investigation began after Scott Gottlieb, who took over as FDA commissioner in May 2017, announced a “modernization” of the rare-disease program.

Critics have long complained that drugmakers game the FDA’s approval process for orphan drugs. In January 2017, the KHN investigation, which was co-published and aired by NPR, revealed that many orphan drugs aren’t entirely new and don’t always start as treatments for rare diseases.

The GAO report, while not analyzing the same years, found that 38.5 percent of orphan drug approvals from 2008 to 2017 were for drugs that had been previously approved either for mass-market or rare-disease use. About 71 percent of the drugs given orphan status were intended to treat diseases affecting fewer than 100,000 people.

KHN’s investigation found that popular mass-market drugs such as cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin and rheumatoid arthritis drug Humira, the best-selling medicine in the world, all won orphan approval yet were already on the market to treat common conditions.

In addition, more than 80 orphan drugs won FDA approval for more than one rare disease — or several — each one with its own bundle of rich incentives.

Genentech’s Avastin, a cancer treatment approved for mass-market use in 2004, won three more orphan-designated approvals this year for the treatment of three rare forms of cancer. It now has 11 approved orphan uses in all, and exclusive protections that keep generics at bay won’t run out until 2025.

Sens. Orrin Hatch (R-Utah), Chuck Grassley (R-Iowa) and Tom Cotton (R-Ark.) sent a letter in March 2017 asking the GAO to investigate the program and find out whether Congress’ original intent for it was still being followed.

“Despite the success of the Orphan Drug Act, 95 percent of rare diseases still have no treatment options,” Hatch said in a statement Friday. “I hope that my colleagues will utilize this [GAO] report as they work to strengthen the accomplishments of the Orphan Drug Act and encourage developers to continue their investment in this patient population.” The GAO report also mentioned concerns about prices, noting that “the ability to command high prices” was one reason the rare-disease market was growing so rapidly.

The average cost per patient for an orphan drug was $147,308 in 2017 compared with $30,708 for a mass-market drug, according to a 2018 EvaluatePharma report on the 100 top-selling drugs in the United States. Celgene’s chemotherapy drug Revlimid was the top-selling orphan with $5.4 billion in sales and $184,011 in revenue per patient.

“We have accepted culturally that it’s OK for a company to charge high prices for [orphan] drugs,” said Roy. “The end result is that a lot of these orphan drugs are $10 billion drugs, even though they are for rare diseases.”

From 2008 to 2017, more than half of the drugs granted orphan status were for cancer or blood disorders, according to the GAO report. And nearly two-thirds of drugs approved in the program were given expedited review processes, such as accelerated approval or fast-track designation.

Prior to announcing Gottlieb’s modernization plan, the FDA had a backlog of 138 drug applications for orphan status that had been waiting more than 120 days. The backlog was cleared in August 2017 after staff from across the agency stepped in to help.

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

HHS Secretary Azar Praises Release of State Relief and Empowerment Waiver Concepts

HHS Gov News - November 30, 2018

On Thursday, the Centers for Medicare & Medicaid Services (CMS) released four State Relief and Empowerment Waiver concepts that states can utilize, under Section 1332 of the Affordable Care Act (ACA), to design new approaches to make healthcare coverage more affordable and accessible in their communities.

HHS Secretary Alex Azar issued the following statement regarding the waiver concepts:

“The Trump Administration is committed to empowering states to think creatively about how to secure quality, affordable healthcare choices for their citizens. Part of that commitment is providing guidance on how states can use the waiver authorities within the ACA to open up more state-based, consumer-directed, fiscally sustainable healthcare options. The specific examples laid out today show how state governments can work with HHS to create more choices and greater flexibility in their health insurance markets, helping to bring down costs and expand access to care.”

Read the CMS fact sheet on State Relief and Empowerment Waiver concepts: https://www.cms.gov/CCIIO/Programs-and-Initiatives/State-Innovation-Waivers/Downloads/Waiver-Concepts-Fact-Sheet.pdf

Short On Federal Funding, Obamacare Enrollment Navigators Switch Tactics

Kaiser Health News:HealthReform - November 30, 2018

Enrollment is down sharply on the federal health insurance marketplace this fall, and the consumer assistance groups that help with sign-ups think they know why.

They don’t have the staff to help as many customers as before because the Trump administration slashed funding. The federal government is spending $10 million this year on navigators who help individuals enroll in coverage. The government spent $36 million in 2017 and $63 million in 2016.

“We don’t have the people to provide the enrollment assistance nor to do the outreach and marketing to let people know what’s happening,” said Jodi Ray at the University of South Florida, who has overseen Florida’s largest navigator program since 2014.

Ray’s program received $1.2 million in federal funding this year, down from $5 million a year ago. Florida leads the nation in enrollment in the Affordable Care Act marketplace plans.

With less money, Ray can afford to pay only 59 navigators across the state this year, down from 152 a year ago. With fewer navigators, much of the group’s counseling is done by phone instead of in person. That complicates their job, she said, because it is much easier to talk with and show marketplace customers in person when looking at dozens of health plans with different costs and benefits.

Open enrollment in the Obamacare plans began Nov. 1 and will run until Dec. 15 for the 39 states covered by the federal exchange, healthcare.gov. The other exchanges — run by states — typically extend until the end of December or into January.

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Obamacare plans are for people without workplace or government coverage.

Nationwide, navigator groups are scrambling to make up for the loss of federal funding to ensure they can help people make sense of their health insurance options.

  • In South Carolina, the Palmetto Project has transformed into the state’s first nonprofit insurance agency. Several of its former federally funded navigators are now licensed insurance agents. In their new role, they get paid a commission on their sales and don’t have to follow Trump administration rules that encourage navigators to talk to customers about short-term plans with limited benefits. The agents can also help customers enroll in Medicaid, Medicare and off-exchange plans.
  • The Community Council of Greater Dallas, which was funded last year to help with enrollment in 56 counties, has raised money from private donors to continue serving seven counties around Dallas. But it has 25 fewer navigators, so consumers seeking help must wait three days on average, compared with less than a day last year. Across Texas, 211 of 254 counties have no federally paid navigators.
  • In Wisconsin, the organization Covering Wisconsin has raised millions of dollars from cities, counties and local United Way chapters, as well as the state Medicaid agency, to make up for the federal cuts. Even still, it will be able to provide in-person assistance in only eight counties around Milwaukee and Madison. Twenty other counties are served by telephone.
  • The Kansas Association for the Medically Underserved is relying totally on volunteers to help consumers with in-person and telephone assistance. In the past year, the association was able to use government funding to pay about 20 navigators.

Nationally, nearly 800 counties served by the federal marketplace will not have any federally funded navigators this fall — up from 127 counties in 2016, according to the Kaiser Family Foundation. (KHN is an editorially independent program of the foundation.)

Federal officials said they were not providing funds for navigators in Iowa, Montana or New Hampshire because no organizations applied in those states.

Nearly 12 million people across the country — including nearly 9 million on the federal exchange — enrolled in Obamacare plans for 2018.

At the halfway point in the six-week enrollment period, 2.4 million people chose a plan for the 2019 coverage year on healthcare.gov, the federal health insurance exchange, according to data released Wednesday by the federal Centers for Medicare & Medicaid Services. That compares with nearly 2.8 million consumers who selected their coverage through the exchange during the first 25 days last year.

Among states with the largest enrollment drops: Pennsylvania (down 25 percent from last year), Missouri (down 25 percent) and Ohio (down 20 percent).

The annual enrollment tally is being closely followed in part because 2019 marks the first year since the marketplace plans began in 2014 that Americans won’t be fined for failing to have coverage.

But consumer experts think the lack of navigator funding could end up having a bigger impact on enrollment. Caroline Gómez-Tom, navigator program manager of Covering Wisconsin, said the end of the so-called individual mandate penalty has been a “non-issue” among people seeking coverage.

“Some folks mention it, but at the end of the day they still walk away with health coverage,” she said. “The ability to have coverage at affordable prices outweighs the penalty being gone because people still see health care insurance as important to have.”

Consumers generally have a greater choice of plans for 2019 as more companies enter the individual market and existing plans expand service areas. Plus, premiums are dropping in some areas, and where they are rising the rate of increase is among the lowest in several years.

Katrina McGivern, director of policy and public affairs for the Kansas Association for the Medically Underserved, said people in rural areas of the state will have the most difficulty getting help as a result of funding cuts.

After five years of experience, she said, she is hopeful that people are figuring out how to do it on their own. Still, she added, there are always “people who need assistance to get through it.”

Sales Reps May Be Wearing Out Their Welcome In The Operating Room

Kaiser Health News:Marketplace - November 30, 2018

In the operating room, surgical masks and matching scrubs can make it hard to tell who’s who — at least for outsiders.

Patients getting wheeled in might not realize that salespeople working on commission are frequently present and sometimes even advise the clinical team during surgery.

Who are these salespeople, and why are they there?

The answer to the first question is pretty easy. These sales reps typically work for medical device companies, such as Stryker, Medtronic or DePuy Synthes. Many surgeries, especially orthopedic trauma and cardiac procedures, require insertion of artificial joints or other hardware manufactured by these companies.

But as to why they’re present in the operating room, the answer depends on whom you ask.

Critics of the practice say that device reps attend surgeries to strengthen their relationships with particular surgeons and thereby persuade them to choose one brand of artificial hip joint or stent or pacemaker over a competitor’s.

The device reps say they observe surgeries because they are experts on particular devices and their accompanying toolkits, which often include hundreds of wrenches, screws and other hardware to aid in installation.

Sometimes, the device reps have observed more surgeries with a particular device than any one surgeon. That depth of experience can be helpful, the reps say, especially with the newest device model or upgrade.

“I can’t keep my socks together through the dryer. You can imagine trying to get 100 pans or 300 pans of instruments all set up correctly,” said Dr. Michael Christie of Nashville, an orthopedic surgeon who specializes in new hips.

Device reps have been attending surgeries for years, but that practice is coming under new scrutiny. As baby boomers age, there has been exponential growth in device-dependent procedures like total joint replacements. In addition, insurers are starting to crack down on health care costs, telling hospitals that they’ll pay only a fixed price, known as a “bundled payment,” for certain surgical procedures, such as hip or knee replacements.

That approach has forced hospitals to take a hard look at the price tags of the devices and the salespeople who are pushing the latest models. Hospitals are “starting to figure out what these reps make for a living. They feel like they’re making too much money, and I think that’s why they want them out,” said Brent Ford, a former sales rep who now works for Nashville-based HealthTrust, a firm that handles contracting and purchasing of supplies like hip implants for more than 1,600 U.S. hospitals.

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Medical device reps are more often business majors than biology buffs, but they train for the job as if they might have to conduct surgery themselves. At an educational center in Colorado, future reps learn how to saw off a hip bone and implant an artificial hip.

Their corporate training frequently involves cadavers, which helps reps develop the steel stomach required for the unsettling sights and sounds of an orthopedic operating room — like a surgeon loudly hammering a spike into a bone.

“Before we’re allowed to sell our products to surgeons, we have to know the anatomy of the body, go through tests of why physicians use these types of products and how we can assist in surgery,” says Chris Stewart, a former rep for Stryker, one of the largest device manufacturers.

Stewart now works for Ortho Sales Partners, a company that helps device manufacturers navigate relationships with hospitals.

Keeping those relationships strong is crucial, because hospitals don’t have to allow reps into their operating rooms. But if reps are allowed, there are rules: Reps can’t touch the patient or anything that’s sterile.

Big companies like Stryker have developed detailed policies for their own reps about how to behave in the operating room. And some hospitals, like hospital chain HCA’s flagship medical center in Nashville, have instituted even stricter rules — selling is banned in the OR and reps are only allowed to provide support for surgical cases.

But Stewart maintains reps still can be useful. Some help surgical assistants find a particular tiny component among the trays of ancillary tools. Some reps even deliver the tool trays to the hospital themselves, prior to the surgery. They want the procedure to run as smoothly as possible so that a busy surgeon will become a steady customer.

“Obviously, there’s a patient on the table being operated on, so that’s where the sense of urgency is,” Stewart said. “You have to become an expert in understanding how to be efficient with helping everyone in the OR making sure your implants are being utilized correctly.”

Keeping Up With Technology

It has become difficult for hospital staffs to keep pace with constant design changes for artificial joints or spinal rod systems, Stewart said.

The speed of innovation concerns some researchers, including Dr. Adriane Fugh-Berman, a Georgetown University medical doctor who studies the relationships between industry and physicians.

“What we need are skilled helpers in the operating room who are not making money off of the choices of the surgeons,” she said.

Fugh-Berman said she has come to believe that reps should be banned from operating rooms. Her biggest concern is safety, including the occasional violations of sterile protocol. As part of her research, she anonymously interviewed reps who said they’re instructed to always push the latest, most expensive products, even when the old version is more proven.

“The newest device is not necessarily the best device,” she said. “In fact, it may be the worst device.”

Cost Concerns

Yet safety issues are not what has worn out the welcome for some reps — it’s their potential influence on surgical costs. Their precise impact remains hard for hospitals to quantify, but hospital executives now have a new incentive to push back on the role of the rep because insurance reimbursement formulas have changed.

For example, in 2016 the government-run Medicare program began changing how it pays hospitals for a joint replacement — from a traditional billing-for-costs model to a fixed-dollar amount for each surgery. It’s a cost-control move, because joint replacement has become one of the most common reasons for inpatient hospitalization for Medicare patients.

Increasingly, hospitals are feeling the squeeze of these new payment caps.

“They’re looking at costs and saying, ‘I want to understand everything that drives cost in my OR,'” said Doug Jones, a former rep with DePuy who now works for HealthTrust to control surgical spending. “I think they’re becoming more aware that that rep is in there and saying, ‘Is there a cost associated with it?'”

HealthTrust hasn’t been telling administrators to kick out sales reps. But it has been suggesting hospitals reassess their role. The company, which is a subsidiary of for-profit hospital chain HCA, has studied particular devices, like pedicle screws, often used in spine procedures. They cost anywhere from $50 to $100 to manufacture, but a hospital might pay a thousand dollars apiece to keep them in stock. One basic spine procedure can involve several screws and rods, with the sales rep standing to make a 10 percent to 25 percent commission on the equipment used, according to HealthTrust’s market research.

And in many places, upselling occurs in the room, said HealthTrust’s Ford. He recalled seeing reps encouraging a surgeon preparing for a procedure to use a fancier device that wasn’t on the hospital’s discounted list.

Other HealthTrust clients are starting pilot projects on running operating rooms without company-sponsored reps and buying equipment directly from smaller firms, which often have devices that are nearly identical to the brand names.

But getting rid of the rep may have hidden costs, too.

Surgeon-Rep Relationships

Joint replacements have become so routine that an experienced surgical team can nearly operate in silence. When the surgeon says “neck” and reaches out his hand, an assistant places the piece in his hand without a moment’s delay.

The array of tools and components are often in the right place because a device rep made sure of it. Logistics is a big part of the job — delivering trays of instruments in the pre-dawn hours to be sterilized by the hospital, the “non-glorious side of being a rep,” Ford said.

The logistical role has essentially been filled by the manufacturers instead of hospitals in recent decades. And now surgeons may trust their reps more than anyone else in the room. They’re often the first call he or she makes when scheduling a case, to make sure the device will be ready to go.

“If that widget isn’t there the next day when I’m doing a case and I need the widget, we’re kind of at an impasse,” said Christie, the Nashville-based joint replacement surgeon.

Many experienced surgeons, like Christie, also have financial ties to manufacturers, collecting substantial royalties for helping design new implants. As of 2013, these payments are now disclosed publicly. Christie, for example, was paid $123,000 by DePuy in 2017.

An industry trade group spokesman defends the close relationship as a way to improve their products and provide hands-on training to surgeons. “Those are two areas where it’s key to maintain a close, collaborative relationship, with the appropriate ethical limitations,” said Dr. Terry Chang, associate general counsel for AdvaMed.

Filling A Personnel Gap

The overall result is that many clinicians are happy to have reps in the room.

“You say ‘sales rep,'” said Marley Duff, an operating room manager at TriStar Centennial Medical Center. “I look at them more being somebody that’s expertly trained in their field to provide support for the implants that they happen to sell.”

Reps can be especially helpful when a failing artificial joint needs to be removed and replaced, Duff said.

Hospitals are reluctant to remove reps, for fear of irritating surgeons, who typically don’t work directly for a particular hospital and could move their cases to another institution. Those hospitals experimenting with going “rep-less” have done so quietly and have had to hire additional staff to pick up the slack.

One of the first in the country to try, Loma Linda University Health in Loma Linda, Calif., boasted in 2015 of reducing costs for total knee and hip replacements by more than 50 percent by going rep-less.

But a hospital spokeswoman now says that the medical center has abandoned the effort, though she refused to discuss why.

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

Is Trump Pushing Health Insurance Innovation Or An ACA Rollback?

Kaiser Health News:HealthReform - November 29, 2018

On his first day in office, as part of his mission to dismantle the Affordable Care Act, President Donald Trump signed an order promising to give states flexibility “to create a more free and open healthcare market.”

The administration on Thursday released an official set of examples to help states flex these powers.

It is intended to roll back key elements of Obama-era requirements, which were designed to promote enrollment in ACA plans that cover a broad range of medical needs and meet uniform national standards.

Seema Verma, the Centers for Medicare & Medicaid Services administrator, said those strict rules were seen by many as burdensome, and “virtually impossible” for states to meet.

Instead, the Trump administration wants states to innovate in ways that could produce more lower-cost options, even if those alternatives do not provide the same level of financial or medical coverage as an ACA plan.

“I’m confident states will come up with ideas that will work better,” said Verma.

Still, coupled with other ongoing efforts by the Trump administration to gut Obamacare, policy experts predict the ideas would further foster a parallel market of cheaper, less robust coverage that could draw younger or healthier consumers, but drive up premiums for those who remain in ACA market plans.

“Invariably, the coverage is going to be more expensive for people who really need comprehensive coverage,” said Timothy Jost, a retired Washington and Lee University law professor who follows the ACA closely.

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One of the biggest changes signaled by the administration involves allowing states to revamp how federal subsidies are used. Currently, they are strictly targeted to lower-income Americans and are seen as key to bolstering enrollment in marketplace plans.

The Trump guidance would give states wider latitude to expand or narrow the income range eligible for subsidies, target them toward younger people or allow them to be used for less costly but skimpier types of insurance.

This would “potentially upend the subsidy structure,” said Sabrina Corlette, research professor at Georgetown University’s Health Policy Institute.

Another example would, for the first time, make federal subsidy money available to people who get job-based insurance, countering Obama-era rules that generally prohibited that. It would let states use federal dollars to fund accounts consumers could use to buy insurance or pay other health costs, such as deductibles or copayments. Employers or consumers could also add additional funds to these accounts.

Still, managing those accounts would be a large administrative expense for a state to oversee, said Corlette. “I don’t understand why a state would want to set it up,” she added.

Supporters say the examples unveiled Thursday would give consumers more control over how they choose to spend their health care dollars and the types of coverage they want to buy. They say it might also improve the markets, which are seeing declining enrollment as premiums rise.

“If states can provide larger subsidies to younger individuals to attract them to enroll, that will improve the market overall,” said Christopher Condeluci, a Washington, D.C., attorney who specializes in employee benefits and has served as the tax and benefits counsel to the U.S. Senate Finance Committee.

However, if many states follow the administration’s lead, critics say, it would bring back the days when insurance rules varied widely state by state. Consumers could end up buying skimpier plans that leave them vulnerable to high, unexpected medical bills.

While not prescriptive, the examples are designed to encourage states to innovate and apply for permission to offer more choices for consumers, so long as the proposals don’t cost taxpayers more and don’t reduce access to ACA plans, said Verma.

State proposals would still have to be affordable, comprehensive and not raise the federal deficit, she said. And CMS would pay particular attention to potential effects on low-income Americans, she added.

Reshaping The Individual Market

The administration’s examples focus on states’ health marketplaces, where insurance plans are designed for individuals who don’t get job-based coverage and small businesses. An estimated 14 million people buy their own coverage through those markets or through brokers.

Premiums in those markets have risen substantially since the law took effect in 2014, for a variety of reasons, including lower-than-expected enrollment by healthy people and actions taken by Congress and the Trump administration that removed the tax penalty for failing to have coverage, eliminated some payments to insurers and loosened restrictions on alternative types of insurance plans.

The administration’s examples add a new twist to a provision of the ACA, which gave states the option of seeking a federal waiver to develop alternative marketplace proposals.

To get one under Obamacare rules, however, states have to meet four “guardrails” established in 2015. These require states to ensure their proposals would provide equally comprehensive and affordable coverage, not result in fewer people enrolling or increased costs for taxpayers.

The examples, tapped by the administration as “waiver concepts,” build on the Trump administration guidance issued in late October to loosen those guardrails. That guidance, effective in 2020, says states have to provide access to affordable and comprehensive coverage, but will not be held to a strict tally of how many people actually enroll. So long as a state could show that equal numbers of people were buying some kind of coverage — either comprehensive ACA plans or less expensive but skimpier plans — it could pass the test.

That October announcement, and Thursday’s concepts, drew immediate criticism from ACA supporters, who said it encourages the use of subsidies to buy short-term plans, which aren’t as comprehensive as ACA coverage and can bar people with preexisting conditions.

Congressional Democrats sent a letter to top administration officials saying the process by which the changes are being made — meaning they are not following a formal rule-making process — are illegal.

“We believe this sub-regulatory guidance exceeds the Secretaries’ statutory authority,” wrote Ways & Means ranking member Richard Neal (D-Mass.) and Energy and Commerce ranking member Frank Pallone Jr. (D-N.J.). “It appears to be part of the Administration’s ideologically motivated efforts to sabotage the ACA.”

The Brookings Institution and other experts have raised similar questions and predicted a legal challenge.

“As soon as any state proceeds to go somewhere with this, there will be legal challenges,” said Jost, the law professor.

Verma pushed back against this warning, noting that the Obama administration also issued its guardrails as guidance, not a formal rule.

And, just as when the administration released its earlier guidance in October, Verma anticipated that critics would say the ideas would adversely affect people with preexisting medical conditions.

Those critics argue that anything that draws younger and healthier people out of the market will drive up costs for those who remain in ACA plans, including those with medical conditions who might be barred from buying an alternative policy, such as a short-term plan.

But Verma said that “nothing in this guidance would take away protections from people with preexisting conditions.”

Listen: Paying More For Your Health Insurance? Depends On Where You Live

Kaiser Health News:HealthReform - November 29, 2018
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Open enrollment is underway in the sixth year of the Affordable Care Act’s insurance marketplaces, with some regions of the country experiencing unexpected drops in premiums and others weathering higher prices.

In California, premiums for plans sold through the state’s health insurance exchange, Covered California, will rise an average of 8.7 percent next year, although individual rate increases — or decreases — depend on a variety of factors, including where you live, what plan you choose and your income. Many consumers can save money by switching plans.

While open enrollment lasts through Dec. 15 in states served by the federal health insurance exchange, healthcare.gov, Californians who purchase their own coverage from Covered California or the open market will have until Jan. 15 to sign up.

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Kaiser Health News senior correspondent Jordan Rau and Trudy Lieberman, contributing editor for the Columbia Journalism Review, appeared on the San Francisco public radio show “Your Call” to discuss why premiums are so expensive, how these insurance markets have succeeded and how they have fallen short, and what consumers should look for while shopping for next year’s plans.

Rau also discussed his recent reporting on premium changes around the country, with some areas like Memphis and Phoenix seeing more insurers selling policies and rates dropping.

Podcast: KHN’s ‘What The Health?’ Reading The Tea Leaves In Blue Wave’s Wake

Kaiser Health News:HealthReform - November 29, 2018
Mary Agnes Carey

Kaiser Health News

@MaryAgnesCarey

Read Mary Agnes' Stories Anna Edney

Bloomberg

@annaedney

Read Anna's Stories Alice Ollstein

Politico

@AliceOllstein

Read Alice's Stories Margot Sanger-Katz

The New York Times

@sangerkatz

Read Margot's Stories

This week, “What the Health?” panelists discuss, among other things, how the House Democrats’ leadership battle could affect the congressional health policy agenda.

The panelists are Mary Agnes Carey of Kaiser Health News, Margot Sanger-Katz of The New York Times, Alice Ollstein of Politico and Anna Edney of Bloomberg News.

As the post-election dust settles on Capitol Hill, the Democrats — soon to be in control of the House of Representatives — have begun the process of choosing their leadership team. How this shakes out will have a lot to do with how health policy agenda takes shape in the lower chamber.

House Democrats nominated Rep. Nancy Pelosi (D-Calif.) to retake the speaker’s gavel, but she still needs to win over more of her colleagues to secure the speaker post in January.

But all the action this week wasn’t focused on Congress. Food and Drug Administration Commissioner Scott Gottlieb unveiled a proposed overhaul of the FDA’s decades-old medical device approval process, and the Trump administration announced proposals it said would reduce Medicare prescription drug costs. Critics fear those changes could mean that some people with chronic diseases like AIDS or cancer might not have access to the drugs they need.

Among the takeaways from this week’s podcast:

  • House Democrats nominated Rep. Nancy Pelosi (D-Calif.) to retake the speaker’s gavel this week along with the rest of its leadership slate, Reps. Steny Hoyer of Maryland and Jim Clyburn of South Carolina. This is only the first step, though. The leadership positions will not be filled officially until January, when they are voted on by the full House. Although Pelosi is still wrangling for the support needed to earn her the required 218 votes, most insiders expect the Democrat’s leadership team to look much as it did the last time Democrats ruled the House chamber in 2010, when the Affordable Care Act became law. That means the House will likely be laser-focused on the necessary steps to protect the ACA. There may also be hearings on single-payer health insurance — a concept that is increasingly gaining interest and support within the caucus, and especially among some of its newest members.
  • In the background, the Texas lawsuit that could overturn the ACA’s protections for people with preexisting conditions is still pending. That decision could come any day. Keep in mind, though, that whatever the court rules, it is likely to be appealed immediately and move up the legal ladder. And, in the interim, House Democrats may still move forward with legislation to strengthen those ACA safeguards. Such a measure could get some GOP support because many Republicans seeking re-election this year said they wanted to ensure that patients with preexisting medical conditions would not lose coverage.
  • The FDA unveiled a proposed overhaul of its decades-old medical device approval system. Among its provisions, the plan includes steps to ensure that new medical devices reflect current safety and effectiveness features. Critics of the current system say it has failed to detect problems with some implants — like hip replacements that failed prematurely or surgical mesh that has been linked to pain and bleeding. The changes, if approved, could take years to implement and some might require congressional approval.
  • The Trump administration proposed a series of changes to reduce the number of prescription drugs that all Medicare drug plans must cover. The proposal focuses on drugs in six “protected classes” and involves medications such as antidepressants, antipsychotic medicines, cancer drugs and antiretrovirals to treat HIV/AIDS. Administration officials have said the proposal could cut costs for Medicare, but patient advocacy groups say it could reduce patients’ access for much-needed treatments. The proposed changes would not occur until 2020, and Congress could intervene to stop them. Send Us Your Medical Bill

    Do you have an exorbitant or baffling medical bill? Join the KHN and NPR’s Bill-of-the-Month Club and tell us about your experience. We’ll feature a new one each month.

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Also this week, Julie Rovner interviews KHN senior correspondent Jay Hancock, who investigated and wrote the latest “Bill of the Month” feature for Kaiser Health News and NPR. It’s about a single mother from Ohio who received a wrongful bill for her multiple sclerosis treatment. You can read the story here.

If you have a medical bill you would like NPR and KHN to investigate, you can submit it here.

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

Mary Agnes Carey: The New York Times’ “This City’s Overdose Deaths Have Plunged. Can Others Learn From It?” by Abby Goodnough

Margot Sanger-Katz: NPR’s “Rethinking Bed Rest for Pregnancy,” by Alison Kodjak

Anna Edney: The Washington Post’s “Overdoses, Bedsores, Broken Bones: What Happened When a Private-Equity Firm Sought to Care for Society’s Most Vulnerable,” by Peter Whoriskey and Dan Keating

Alice Ollstein: Wired.com’s “The Science Is Clear: Dirty Farm Water Is Making Us Sick,” by Elizabeth Shogren and Susie Neilson

To hear all our podcasts, click here.

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

HHS Announces Winners of Easy EHR Issue Reporting Challenge

HHS Gov News - November 29, 2018

As part of ongoing efforts to improve the safe use of health information technology (health IT) and electronic health records (EHRs), the U.S. Department of Health and Human Services announced today the winners of the Easy EHR Issue Reporting Challenge. Winners of this challenge created software tools that could help clinicians report EHR usability and safety issues faster, more efficiently, and in alignment with their regular clinical workflow.

“Helping reduce the burden of health IT continues to be a key area of focus at the Office of the National Coordinator for Health Information Technology (ONC) and we anticipate the winning submissions to the Easy EHR Issue Reporting Challenge will help with those efforts,” said Don Rucker, M.D., national coordinator for health information technology. “Once the winning submissions reach production, we expect to see how reporting safety issues can be less burdensome for healthcare providers.”

The winners include:

  • First place - James Madison Advisory Group. James Madison Advisory Group’s unique solution for reporting possible safety events launches through a system tray icon or hotkey on any Windows 8 or higher installation. Use of the tray icon or hotkey keeps the user from exiting the EHR workflow, regardless of the EHR platform. The tool exports in the HHS Agency for Healthcare Research and Quality (AHRQ) Common Formats XML and PDF, captures screenshots, and simplifies the report delivery process. The winning submission is awarded $45,000.
  • Second place – Pegwin. Pegwin provides a software platform that can create and send a safety or usability report in as few as three clicks. Using contextual menus and design intuitive to the user, the software makes completion of Common Formats reporting as automated as possible. The second place submission is awarded $25,000.
  • Third place – Jared Schwartz and team. Jared Schwartz and his team uses a browser plug-in to Google Chrome that can integrate with IT ticketing systems, enabling more consistent capture of safety issues. The user can also provide additional information immediately or save for a more convenient time. The third place submission is awarded $10,000.

“Improving the safety of health IT remains an important priority,” said Andy Gettinger, M.D., ONC chief clinical officer. “We believe that making it easier for end users to report will help in that goal.”

Many EHR users have indicated the need for more efficient and user-friendly mechanisms to facilitate reporting safety concerns quickly and easily, with little or no disruption to their clinical workflow.  The challenge submissions are intended to help EHR users identify, document, and report potential health IT safety issues when they occur. By promoting heath IT safety issue reporting, the industry will be in better position to determine root causes, provide feedback to EHR developers, and produce best practice guidance.

Additional information about the Easy EHR Issue Reporting Challenge is available at https://www.cccinnovationcenter.com/challenges/easy-ehr-issue-reporting-challenge/.

HHS Issues Draft Strategy to Reduce Health IT Burden

HHS Gov News - November 29, 2018

The U.S. Department of Health and Human Services (HHS) today issued a draft strategy designed to help reduce administrative and regulatory burden on clinicians caused by the use of health information technology (health IT) such as electronic health records (EHRs).

The draft Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs was led by the HHS Office of the National Coordinator for Health Information Technology (ONC), in partnership with the Centers for Medicare & Medicaid Services (CMS), and was required in the 21st Century Cures Act. The draft strategy reflects the input and feedback received by ONC and CMS from stakeholders, including clinicians, expressing concerns that EHR burden negatively affects the end user and ultimately the care delivery experience. This draft strategy includes recommendations that will allow physicians and other clinicians to provide effective care to their patients with a renewed sense of satisfaction for them and their patients.

“Usable, interoperable health IT was one of the first elements of the vision I laid out earlier this year for transforming our health system into one that pays for value,” said HHS Secretary Alex Azar. “With the significant growth in EHRs comes frustration caused, in many cases, by regulatory and administrative requirements stacked on top of one another. Addressing the challenge of health IT burden and making EHRs useful for patients and providers, as the solutions in this draft report aim to do, will help pave the way for value-based transformation.”

Stakeholders have indicated to ONC and CMS that when they use their EHRs, clinicians have to rely on checkboxes, templates, cut-and-paste functions, and other workarounds that hinder the intended benefits of EHRs. Clinicians have reported they are spending more time entering data into the EHR, leaving less time to interact with their patients. Required documentation guidelines have led to “note bloat,” making it harder to find relevant patient information and effectively coordinate a patient’s care.

“Information technology has automated processes in every industry except health care, where the introduction of EHRs resulted in additional burden on clinicians,” said Don Rucker, national coordinator for health information technology. “Health IT tools need to be intuitive and functional so that clinicians can focus on their patients and not documentation. This draft strategy identifies ways the government and private sector can alleviate burden. I look forward to input from the public to improve this strategy.”

“Over the past year, we hosted listening sessions, received written feedback, and heard from a wide range of clinical stakeholders about the current health IT systems and the requirements specifying documentation, reimbursement, and quality reporting that are burdensome and should be re-examined,” said Seema Verma, CMS administrator. “CMS has demonstrated through bold regulatory action the importance of reducing clinician burden.”  

Based on the input received by ONC and CMS, the draft strategy outlines three overarching goals designed to reduce clinician burden:

  1. Reduce the effort and time required to record health information in EHRs for clinicians;
  2. Reduce the effort and time required to meet regulatory reporting requirements for clinicians, hospitals, and health care organizations; and
  3. Improve the functionality and intuitiveness (ease of use) of EHRs.

The public comment period on the draft Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs ends on Monday January 28, 2019 at 11:59:59 PM ET.

“All of us share the responsibility to improve how we treat the nation’s patients, and we now have the opportunity to work together to find solutions to reduce burden associated with the use of EHRs so clinicians can spend more time with their patients,” said Rucker.

Watch: Why Infusion Drugs Come With Sticker Shock

Kaiser Health News:Insurance - November 29, 2018

Kaiser Health News Editor-in-Chief Elisabeth Rosenthal discusses the latest “Bill of the Month” installment on “CBS This Morning” on Wednesday. The story of an Ohio mom who faced an outrageous bill for a new medicine for multiple sclerosis is part of an ongoing crowdsourced investigation by KHN and NPR.

Under Trump, Number Of Uninsured Kids Rose For First Time This Decade

Kaiser Health News:HealthReform - November 29, 2018

After years of steady decline, the number of U.S. children without health insurance rose by 276,000 in 2017, according to a Georgetown University report released Thursday.

While not a big jump statistically — the share of uninsured kids rose to 5 percent in 2017 from 4.7 percent a year earlier — it is still striking. The uninsured rate typically remains stable or drops during times of economic growth. In September, the U.S. unemployment rate hit its lowest level since 1969.

“The nation is going backwards on insuring kids and it is likely to get worse,” said Joan Alker, co-author of the study and executive director of Georgetown’s Center for Children and Families.

Alker and other child health advocates place the blame for this change on the Trump administration and the Republican-controlled Congress, saying their policies and actions cast a pall on enrollment.

The number of children without coverage rose to 3.9 million in 2017 from about 3.6 million a year earlier, according to Census data analyzed by Georgetown.

The overall uninsured rate for people of all ages — which plummeted from 2013 to 2016 following the health law’s implementation — remained unchanged at 8.8 percent last year.

The share of children with employer-sponsored coverage rose modestly in 2017, but not by enough to make up for the drop in children enrolling in Medicaid or getting coverage from Obamacare insurance exchanges, Alker said.

While no states made any significant gains in lowering children’s uninsured rate, nine states experienced significant increases. The biggest occurred in South Dakota (up from 4.7 percent to 6.2 percent), Utah (up from 6 percent to 7.3 percent) and Texas (from 9.8 percent to 10.7 percent).

More than 1 in 5 uninsured children nationwide live in Texas — about 835,000 kids — by far the highest number of any state.

Florida had 325,000 uninsured children last year, as its uninsured rate for that age group rose 0.7 percentage points to 7.3 percent. California had 301,000 children without insurance, though its number remained virtually unchanged, relative to the previous year.

Other states with significant increases were Georgia, South Carolina, Ohio, Tennessee and Massachusetts.

The uninsured rates for children increased at nearly triple the rates in states that did not expand Medicaid under the Affordable Care Act, according to the report. Studies have shown that children whose parents are insured are more likely to have coverage.

The uninsured rate among Hispanic children was 7.8 percent, compared with 4.9 percent among whites and 4.6 percent among blacks overall. (Hispanics can be of any race.)

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Georgetown has been tracking these figures since 2008 when 7.6 million children — or about 10 percent of kids — lacked health coverage.

Because nearly all low-income children are eligible for Medicaid or the federal Children’s Health Insurance Program, known as CHIP, the challenge is making sure parents are aware of the programs, getting them enrolled and keeping them signed up as long as they are eligible, Alker said.

Congress let the CHIP program funding lapse for several months in 2017, putting states in a position of having to warn consumers that they would soon have to freeze enrollment. Congress restored federal funding in early in 2018.

In addition, low-income families were bombarded by news reports last year of Congress threatening to repeal the health law that expanded coverage to millions. In the past two years, the Trump administration has slashed funding to Obamacare navigators to help people sign up for coverage.

Alker also pointed to the Trump administration’s September proposal, known as the “public charge” rule, which could make it harder for legal immigrants to get green cards if they have received certain kinds of public assistance — including Medicaid, food stamps and housing subsidies. Green cards allow them to live and work permanently in the United States.

OLE Health, a large health provider based in Napa Valley, Calif., that serves many immigrants, said it has seen patients disenroll from Medicaid in the past year. CEO Alicia Hardy said many have dropped coverage over fears the help could jeopardize their immigration status.

“They are afraid of being deported,” she said.

All those events could have deterred families from getting their kids covered. “The welcome mat has been pulled back and as a result we see more uninsured children,” Alker said.

She said the easiest way to change the trend would be for more states to expand Medicaid under the health law. Fourteen states have yet to do so. Though the expansion largely affects adults, as parents enroll, their children are likely to follow.

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

Chronically Ill, Traumatically Billed: The $123,000 Medicine For MS

Kaiser Health News:Insurance - November 28, 2018

Shereese Hickson’s multiple sclerosis was flaring again. Spasms in her legs and other symptoms were getting worse.

She could still walk and take care of her son six years after doctors diagnosed the disease, which attacks the central nervous system. Earlier symptoms such as slurred speech and vision problems had resolved with treatment, but others lingered: she was tired and sometimes still fell.

This summer, a doctor switched her to Ocrevus, a drug approved in 2017 that delayed progression of the disease in clinical trials better than an older medicine did.

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Genentech, a South San Francisco-based subsidiary of Swiss pharma giant Roche, makes Ocrevus. It is one of several drugs for multiple sclerosis delivered intravenously in a hospital or clinic. Such medicines have become increasingly expensive as a group, priced in many cases at well over $80,000 a year. Hospitals delivering the drugs often take a cut by upcharging the drug or adding hefty fees for the infusion clinic.

Hickson received her first two Ocrevus infusions as an outpatient two weeks apart in July and August. And then the bill came.

Patient: Shereese Hickson, 39, single mother who worked as a health aide and trained as a medical coder, living in Girard, Ohio. Because her MS has left her too disabled to work, she is now on Medicare; she also has Medicaid for backup.

Total Bill: $123,019 for two Ocrevus infusions taken as an outpatient. CareSource, Hickson’s Medicare managed-care plan, paid a discounted $28,960. Hickson got a bill for about $3,620, the balance calculated as her share by the hospital after the insurance reimbursement.

Medical Service: Two Ocrevus infusions, each requiring several hours at the hospital.

Service Provider: Cleveland Clinic, a nonprofit, academic medical center in Ohio.

What Gives: Hickson researched Ocrevus online after her doctor prescribed the new medicine. “I’ve seen people’s testimonies about how great it is,” on YouTube, she said. “But I don’t think they really go into what it’s like receiving the bill.”

That was particularly shocking because, covered by government insurance for her disability, she’d never received a bill for MS medicine before.

“I have a 9-year-old son and my income is $770 a month,” said Hickson. “How am I supposed to support him and then you guys are asking me for $3,000?”

More From Our Bill Of The Month Series

Even in a world of soaring drug prices, multiple sclerosis medicines stand out. Over two decades ending in 2013, costs for MS medicines rose at annual rates five to seven times higher than those for prescription drugs generally, found a study by researchers at Oregon Health & Science University.

“There was no competition on price that was occurring,” said Daniel Hartung, the OHSU and Oregon State University professor who led the study. “It appeared to be the opposite. As newer drugs were brought to market, it promoted increased escalation in drug prices.”

With Ocrevus, Genentech did come up with a price that was slightly less than for rival drugs, but only after MS medicines were already extremely expensive. The drug launched last year at an annual list price of $65,000, about 25 percent lower than that of other MS drugs, Hartung said. MS drugs cost about $10,000 per year in the 1990s and about $30,000 a decade ago.

“We set the price of Ocrevus to reduce price as a barrier to treatment,” said Genentech spokeswoman Amanda Fallon.

It was also probably a response to bad publicity about expensive MS drugs, Hartung said. “Now companies are very aware at least of the optics of releasing drugs at higher and higher prices,” he said.

Patients starting Ocrevus get two initial infusions of 300 milligrams each and then 600 mg twice a year. Cleveland Clinic charged $117,089 for Hickson’s first two doses of Ocrevus — more than three times what hospitals typically pay for the drug, said John Hennessy, chief business development officer at WellRithms, a firm that analyzes medical bills for self-insured employers.

As is typical of government programs such as Medicare, the $28,960 reimbursement ultimately collected by the Cleveland Clinic was far less — but still substantial.

“We kind of got ourselves in a pickle here,” he said. “We’re more excited about the discount than we are about the actual price.”

Hickson’s nearly $3,620 bill represented the portion that Medicare patients often are expected to pay themselves.

Shereese Hickson, diagnosed with multiple sclerosis in 2012 and unable to work, supports herself and her son, Isaiah, on $770 a month.(Shane Wynn for KHN)

Last year, the Institute for Clinical and Economic Review, an independent nonprofit that evaluates medical treatments, completed a detailed study on MS medicines. It found that Ocrevus was one of three or four medicines that were most effective in reducing MS relapses and preventing MS from getting worse. But it also found that patient benefits from MS drugs “come at a high relative cost” to society.

At the same time, deciding which MS drug — there are about a dozen — would best suit patients is something of a shot in the dark: The science showing the comparative effectiveness of MS drugs is not as strong as it could be, researchers say.

“In general, there’s a real lack of head-to-head studies for many of these drugs,” said Hartung. The FDA has no required comparison standard for MS drugs, an agency spokeswoman said. Sometimes they’re rated against placebos. With everyone able to charge a high price, the companies have little incentive to see which works better and which worse.

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Resolution: After Hickson questioned the charges over the phone, the billing office told her to apply to the hospital for financial assistance. Hickson had to print a form, provide proof of her disabled status, mail it and wait.

Hospital officials told her in October she qualified for assistance based on her income through a state program funded by hospital contributions and federal money. Cleveland Clinic wiped out the $3,620 balance.

“I’m grateful that they approved me for that, but not everybody’s situation is like that,” she said. She was worried enough about being billed again for her next Ocrevus infusion that she considered switching back to her old medicine. But her doctor wants her to give it more time to gauge its effects.

The Takeaway: Always ask about charity care or financial assistance programs. Hospitals have different policies and wide discretion about how to apply them, but often do not even tell patients such programs exist.

Because health care costs are so high, you may be eligible even if you have a decent salary. Cleveland Clinic gives free care to everybody below a certain income, said spokeswoman Heather Phillips. But it wasn’t until Hickson called that the hospital agreed to erase the charge.

While there are multiple new drugs to treat serious chronic conditions, they have often not been tested against one another. Moreover, your doctor may have no idea about their relative prices. He or she should. For newer drugs, all options may well be very expensive.

Keep in mind that drugs which must be infused often come with facility fees and infusion charges, which can leave patients with hefty copayments for outpatient treatment. Ask about oral medicines or those you can self-inject at home.

NPR produced and edited the interview with Elisabeth Rosenthal for broadcast. Marlene Harris-Taylor, from member station Ideastream in Cleveland, provided audio reporting.

Do you have an exorbitant or baffling medical bill? Join the KHN and NPR Bill-of-the-Month Club and tell us about your experience.

KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation.

Allergy practice pays $125,000 to settle doctor’s disclosure of patient information to a reporter

HHS Gov News - November 27, 2018

Allergy Associates of Hartford, P.C. (Allergy Associates), has agreed to pay $125,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) and to adopt a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. Allergy Associates is a health care practice that specializes in treating individuals with allergies, and is comprised of three doctors at four locations across Connecticut.

In February 2015, a patient of Allergy Associates contacted a local television station to speak about a dispute that had occurred between the patient and an Allergy Associates’ doctor. The reporter subsequently contacted the doctor for comment and the doctor impermissibly disclosed the patient’s protected health information to the reporter.

OCR’s investigation found that the doctor’s discussion with the reporter demonstrated a reckless disregard for the patient’s privacy rights and that the disclosure occurred after the doctor was instructed by Allergy Associates’ Privacy Officer to either not respond to the media or respond with “no comment.” Additionally, OCR’s investigation revealed that Allergy Associates failed to take any disciplinary action against the doctor or take any corrective action following the impermissible disclosure to the media.

“When a patient complains about a medical practice, doctors cannot respond by disclosing private patient information to the media,” said OCR Director Roger Severino. “Because egregious disclosures can lead to substantial penalties, covered entities need to pay close attention to HIPAA’s privacy rules, especially when responding to press inquiries.”

In addition to the monetary settlement, Allergy Associates will undertake a corrective action plan that includes two years of monitoring their compliance with the HIPAA Rules. The resolution agreement and corrective action plan may be found on the OCR website at http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/allergyassociates/index.html

One Twin’s Difficult Birth Puts A Project Designed To Reduce C-Sections To The Test

Kaiser Health News:Marketplace - November 27, 2018

The tiny hand and forearm slipped out too early. Babies are not delivered shoulder first. Dr. Terri Marino, an obstetrician in the Boston area who specializes in high-risk deliveries, tucked it back inside the boy’s mother.

“He was trying to shake my hand and I was like, ‘I’m not having this — put your hand back in there,'” Marino would say later, after all 5 pounds, 1 ounce of the baby lay wailing under a heating lamp.

This is the story of how that baby, Bryce McDougall, tested the best efforts of more than a dozen medical staffers at South Shore Hospital in Weymouth, Mass., that day last summer.

Bryce’s birth also put to the test a new method of reducing cesarean sections developed at Dr. Atul Gawande’s Ariadne Labs, a “joint center for health systems innovation” at Brigham and Women’s Hospital and the Harvard T.H. Chan School of Public Health in Boston.

The story starts before Bryce’s birth, on the last day of August at about 9:30 in the morning.

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Melisa McDougall has just checked into South Shore, after a routine ultrasound. She’s in her 36th week, pregnant with twin boys. The doctors have warned Melisa that her placenta won’t hold out much longer. She’s propped up in bed, blond hair pulled into a neat bun, makeup still fresh, ordering a sandwich, when her regular obstetrician arrives.

“How are you?” asks Dr. Ruth Levesque, sweeping into the room and clapping her hands. “You’re going to have some babies today! Are you excited?”

The first of the twins — Brady — is head-down, ready for a normal vaginal delivery. But brother Bryce is horizontal at the top of Melisa’s uterus.

That’s one reason Melisa is a candidate for a C-section. Babies do not come out sideways. And there’s another reason most doctors would not consider a vaginal delivery in Melisa’s case, Levesque says. Four years ago, she delivered the twins’ sister by cesarean.

“[Melisa] has a scar on her uterus,” Levesque explains, “so there’s a risk of uterine rupture — very rare, but there’s always a possibility.”

And that possibility may be greater for Melisa because she’s 37 and having twins. But the McDougalls hope to have vaginal deliveries for both boys.

“I just feel like it’s better for the kids — better for the babies,” Melisa says.

Melisa McDougall hears comforting words from her nurse at South Shore Hospital in Weymouth, Mass. Part of the focus of the Team Birth Project is on facilitating communication among parents, nurses and doctors.(Jesse Costa/WBUR)

How The ‘Team Birth Project’ Came To Be

Avoiding C-sections is also better for many moms. With cesareans, there’s a longer recovery period, a greater risk of infection and an association with injury and death. And most C-sections are not medically necessary, said Dr. Neel Shah, who directs the Delivery Decisions Initiative at Ariadne Labs.

“We’re fairly confident that, when you look nationally, the plurality — if not the majority — of C-sections are probably avoidable,” said Shah.

Those avoidable C-sections are the focus of the Team Birth Project, designed by Shah with input from roughly 50 doctors, nurses, midwives, doulas, public health specialists and consumer advocates who focus on childbirth. South Shore Hospital is one of the pilot sites for the project.

In describing the collaboration, Shah begins with an acknowledgement: Childbirth is complicated. You’ve got two patients — the mother and the baby — and an ad hoc, often shifting team that at a minimum includes the mom, a nurse and a doctor.

“So you’ve got three people who have to come together and become a very high-performing team in a really short period of time, for one of the most important moments in a person’s life,” Shah said.

And this team has to perform at its best during an unpredictable event: labor.

Shah says doctors and nurses generally agree about three things: when a mom is in active labor; when a mom can definitely try for a vaginal delivery; and when she must have a C-section.

“And then there’s this huge gray zone,” Shah said. “And actually, everything about the Team Birth Project is about solving for the gray.”

To avoid unnecessary C-sections when what to do isn’t clear, this hospital, in conjunction with Ariadne, has changed the way labor and delivery is handled from start to finish.

First, women aren’t admitted until they are in active labor. Secondly, the mom’s preferences — such as whether she’d like an epidural or not, whether she wants to have “skin-to-skin contact” with the baby immediately after birth — help guide the members of the labor team. The team members map the delivery plan — including mom’s preferences and the medical team’s guidance — on a whiteboard, like the one in Melisa’s room.

For the births of Bryce and Brady McDougall, the white erasable planning board gets a lot of use.

Under “Team,” Levesque and registered nurse Patty Newbitt write their names. Melisa and Shaun McDougall are also listed as equal partners. The names of other family members or nurses may be added and erased as labor progresses. Shah’s idea is that this team will “huddle” regularly throughout the labor to discuss the evolving birth plan.

The birth plan itself is divided into three separate elements on the board: Maternal (the mom), Fetal (the baby) and Progress (in terms of how the labor is progressing). A mom with high blood pressure, for instance, may need special attention — and that would be noted on the board — but she could still have a normal labor and vaginal delivery.

The whiteboard in Melisa McDougall’s hospital room details the birth plan, including her preferences and the medical team’s guidance.(Jesse Costa/WBUR)

Good Communication Throughout Labor And Delivery Is Key

Dr. Kimberly Dever, who chairs the OB-GYN department at South Shore, highlights a section of the whiteboard called “Next Assessment.”

That category is included on the board, Dever said, “because one of the things I often heard from patients is that they didn’t know what was going to happen next. Now they know.”

Asking the mom — and the couple — about their preferences for the delivery is crucial, too, Levesque said.

“It forces us to stop and to think about everything with the patient,” she explained. “It makes us verbalize our thought process, which I think is good.”

Shaun McDougall walks across the room to get a closer look at the whiteboard.

“Honestly, it seems like common sense,” he says. “I would always think the nurses would have something like this, but to have it out where mom and dad can see it — I think it’s pretty cool.”

With Melisa McDougall’s plan in place, everyone settles in, to wait. About four hours later, Melisa isn’t yet feeling contractions. Levesque breaks the water sac around Brady.

“Looks nice and clear,” Levesque reports. “Hey bud, come on and hang out with us,” she says to the baby.

“So, you’re going to keep leaking fluid until you leak babies,” the doctor explains to Melisa. “Whenever you start getting uncomfortable, we’ll get you an epidural at that point.”

Levesque moves to the board and adds updates: Melisa is 4 centimeters dilated; her waters broke at 13:26; the next assessment will be after she gets an epidural.

The medical team insisted ahead of time that Melisa agree to be numbed from the waist down if she wants to deliver Bryce — the second twin — vaginally. Melisa agreed. The obstetricians may need to rotate the baby in her uterus, find a foot and pull Bryce out, causing pain most women would not tolerate.

One of those doctors — Marino — peeks into the room and waves.

“Just came to say hi,” says Marino, who has more experience than most obstetricians in delivering babies positioned like Bryce. Along with Levesque, Marino has been seeing Melisa regularly through office visits.

Shaun McDougall asks the physicians if they’ll pose for a picture with his wife.

“Can we make funny faces?” asks Levesque.

“I want you to,” says Shaun. “You guys are like her favorite people on the planet.”

As the hours tick by, there’s a shift change, and registered nurse Barbara Fatemi joins the McDougall team. She checks Melisa’s pain level regularly to determine when she’s ready for the epidural.

Melisa says she isn’t feeling much, but adds that she has a high tolerance for pain. Shaun tells Fatemi he sees the strain on his wife’s face. Fatemi acts on Shaun’s assessment, and calls an anesthesiologist to prepare the epidural, something Shaun later says reinforces his feeling that they’re a team.

Levesque soon arrives for the promised “next assessment.” Melisa is now 10 centimeters dilated and ready to deliver — but she must hold on until nurses can get her into an operating room.

The OR will be the right place if the second baby, Bryce, doesn’t shift his position, and the doctor needs to do a last-minute cesarean.

“I’ll see you in a few minutes. No pushing without me, OK?” Levesque says over her shoulder as she heads to the OR to prep.

“I’ll try,” Melisa says, weakly. In a minute, nurses are rolling her down the hall, following Levesque.

Almost five years ago, two women who were wheeled into this hospital’s operating rooms during childbirth died after undergoing C-sections. Though state investigators found no evidence of substandard care, Dever, the head of obstetrics, said the hospital scrutinized everything.

“When you have something like that happen, that expedites your efforts,” she said. “Exponentially.”

Now, Dever said, she sees an opportunity, through the Team Birth Project, to model changes that could help women far and wide.

“I would love women everywhere to be able to come in and have a safe birth and healthy baby,” she said. “That’s why I’m doing it.”

‘They Did Not Flinch’

Dever is about to see her pilot study of the Team Birth Project pushed to new limits by little Bryce McDougall. First, though, Melisa must deliver Bryce’s twin brother, Brady. Even his birth, the one that was expected to be easier, is more difficult than anticipated.

Bent nearly in half, her face beet red, Melisa strains for five pushes. She throws up, then gets back to laboring. And suddenly, there he is.

“Oh my goodness Brady, oh Brady,” wails Shaun. He follows a nurse holding his son over to a warmer.

Marino takes Shaun’s place next to Levesque, who has reached inside Melisa to get the next twin. Levesque’s mission is to grab Bryce’s feet and guide him out. But everything feels like fingers, not toes.

That’s a hand,” she murmurs. “That’s a hand, too.”

Marino rolls an ultrasound across Melisa’s belly, hoping the scan will show a foot. But Bryce’s feet are out of sight and out of reach.

Marino has had more experience than most obstetricians with transverse babies and this procedure, known as a breech extraction; she asks to try. She reaches into Melisa’s uterus while Levesque moves to Melisa’s right side and uses her forearm to shift Bryce and push him down. Dever has come into the room, and takes over the ultrasound. At least six doctors and nurses encircle Melisa, whose face is taut. Shaun frowns.

“Babe, you OK?” he asks.

Melisa nods. Bryce’s heart rate is steady. But there’s still no sign of a foot. One little hand slips out and Marino nudges it back in.

“Open the table,” says Marino, her voice strained.

It’s open and ready, her colleagues say, referring to the array of sterile surgical instruments that Marino may soon need, to begin a C-section.

For 36 seconds, this room with more than a dozen adults grows oddly quiet. Everyone is watching Marino twist her arm this way and that, determined to find Bryce’s feet. Levesque leans hard into Melisa’s belly. Shaun bites his lip. Then Marino yanks at something — and her gloved hand emerges, clenching baby Bryce by his two teeny legs.

“Oh babe, here he comes, here he comes — Woo!” squeals Shaun.

Shaun is overcome with emotion again. Melisa manages an exhausted giggle. Baby Bryce keeps everyone waiting a few more seconds and then howls.

Levesque tends to Melisa, and Marino comes around to congratulate the new mom.

“He was fighting you, huh?” Melisa says, and laughs.

“I think I found at least five hands,” says Levesque.

Outside the OR, Levesque and Marino look relieved and elated. Both agree that most doctors would have delivered Bryce by C-section. But at South Shore, the McDougalls found a hospital that has challenged itself to perform fewer C-sections, and a doctor with experience in these unusual deliveries — one who knew and respected the parents’ preference.

“They specifically wanted to have a vaginal delivery of both babies,” Marino says — and that was on her mind during the difficult moments.

Bryce was fine, says Marino, so the deciding factor for her was that Shaun and Melisa did not panic.

“They did not flinch — they were like, ‘Keep going,'” Marino recalls. “Sometimes the patient will say ‘stop,’ and then you have to stop.”

The babies’ father says he came close to requesting that, in the very last minute before Bryce was born.

“That part with the arm — it was pretty aggressive,” Shaun says.

But in that moment, he adds, the feeling that he and Melisa were part of the team made a difference.

“It made us more comfortable,” Shaun says, and that comfort translated to trust. “We trusted the decisions they were making.”

Melisa says she’s grateful for the vaginal delivery.

“I did not want to have a natural birth and a C-section,” she says. “That would be a brutal recovery.”

Instead, 30 minutes after Bryce’s birth, Melisa is nursing Brady and talking with family members on FaceTime.

Next Assessment For The Team Birth Project

South Shore began using the Team Birth approach in April. Three other hospitals are also pilot sites: Saint Francis in Tulsa, Okla.; EvergreenHealth in Kirkland, Wash.; and Overlake in Redmond, Wash. The test period runs for two years. In the first four months at South Shore, the hospital’s primary, low-risk C-section rate dropped from 31 percent to 27 percent — about four fewer C-sections each month.

Experts who contributed to the development of the Team Birth Project are eager to see whether other hospitals can lower their rates of C-section and keep them down.

“Once you get past the early adopters, how do you demonstrate the benefits for others that aren’t willing to change?” asked Gene Declercq, a professor of community health sciences at Boston University School of Public Health.

Declercq noted that a few insurers are beginning to force that question, refusing to include in their networks hospitals that have high C-section rates, or high rates of other unnecessary, if not harmful, care.

The federal government has set a target rate for hospitals: No more than 23.9 percent of first-time, low-risk mothers should be delivered by C-section. The U.S. average in 2016 was 25.7 percent.

The target was put in place because research has shown that if a woman’s first delivery is a C-section, her subsequent deliveries are highly likely to be C-sections, too — raising her (and her baby’s) risk for complications and even death.

Declercq said the project’s focus on communication in the labor and delivery room makes sense because many physicians decide when to perform a cesarean based on clinical habit or the culture of their hospital.

“If you can impact that decision-making process, you can perhaps change the culture that might lead to unnecessary cesareans,” said Declercq.

This story is part of a reporting partnership with WBUR, NPR and Kaiser Health News.

KHN’s coverage of these topics is supported by Heising-Simons Foundation and The David and Lucile Packard Foundation

In Health Insurance Wastelands, Rosier Options Crop Up For 2019

Kaiser Health News:HealthReform - November 23, 2018

In recent years, places such as Memphis and Phoenix had withered into health insurance wastelands as insurers fled and premiums skyrocketed in the insurance marketplaces set up by the Affordable Care Act. But today, as in many parts of the country, these two cities are experiencing something unprecedented: Premiums are sinking and choices are sprouting.

In the newly competitive market in Memphis, the cheapest midlevel “silver” plan for next year will cost $498 a month for a 40-year-old, a 17 percent decrease. Four insurers are selling policies in Phoenix, which then-presidential candidate Donald Trump highlighted in 2016 as proof of “the madness of Obamacare” as all but one insurer left the region.

Janice Johnson, a 63-year-old retiree in Arizona’s Maricopa County, which includes Phoenix, said her premium for a high-deductible bronze plan will be $207 instead of $270 because she is switching carriers.

“When you’re on a fixed income, that makes a difference,” said Johnson, who receives a government subsidy to help cover her premium. “I’ll know more than a year from now if I’m going to stick with this company, but I’m going to give them a chance, and I’m pretty excited by that.”

Across all 50 states, premiums for the average “benchmark” silver plan, which the government uses to set subsidies, are dropping nearly 1 percent. And more than half of the counties that use the federal healthcare.gov exchange are experiencing an average 10 percent price decrease for their cheapest plan.

In most places, the declines are not enough to erase the price hikes that have accrued since the creation in 2014 of the health care exchanges for people who don’t get insurance through an employer or the government.

Instead, experts said, next year’s price cuts help to correct the huge increases that jittery insurers set for 2018 plans to protect themselves from anticipated Republican assaults on the markets. Although Congress came up one vote shy of repealing the law, Trump and Republicans in Congress did strip away structural underpinnings that pushed customers to buy plans and helped insurers pay for some of their low-income customers’ copayments and deductibles. Insurers responded with 32 percent average increases.

“Insurers overshot last year,” said Chris Sloan, a director at Avalere, a health care consulting company in Washington, D.C. “We are nowhere close to erasing that increase. This is still a really expensive market with poor benefits when it comes to deductibles and cost.”

For 2019, the average benchmark silver premium will be 75 percent higher than it was in 2014, according to data from the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

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When Republicans failed to kill the health law last year, they inadvertently may have made it stronger. Insurers banked hefty profits this year, and new companies are moving in.

All these factors were especially influential in Tennessee, where the average benchmark premium is dropping 26 percent, according to a government analysis. That is more than in any other state.

In 2018, 78 of 95 Tennessee counties had just one insurer. That monopoly allowed the insurer to set the prices of its plans without fear of competition, said David Anderson, a researcher at the Duke-Margolis Center for Health Policy in Durham, N.C. “They were massively overpriced,” he said.

But for the coming year, 49 Tennessee counties will have more than one insurer, with a few — like Shelby County, where Memphis is located — having four companies competing. There, Cigna dropped the price of its lowest-cost silver plan by 15 percent. Nonetheless, it was underbid by Ambetter of Tennessee, which is owned by the managed-care insurer Centene Corp.

“We’re finally at the point where the market is stabilized,” said Bobby Huffaker, the CEO of American Exchange, an insurance brokerage firm based in Tennessee. “From the beginning, every underwriter, and the people who were the architects, they knew it would take several years for the market to mature.”

Still, the cheapest Memphis silver premium is nearly three times what it was in 2014, the first year of the marketplaces. A family of four with 40-year-old parents will be paying $19,119 for all of next year unless they qualify for a government subsidy.

“The unsubsidized are leaving,” said Sabrina Corlette, a professor at Georgetown University’s Health Policy Institute. “They are finding these premiums unaffordable.”

The landscape in Phoenix is greatly improved from when Trump visited after the federal government announced a 116 percent premium increase for 2017, as the number of insurers dropped from eight to one.

But now, three new insurers are entering Maricopa County. Ambetter, the only insurer this year, dropped its lowest price for a silver plan for next year by 12 percent and still offers the cheapest such plan.

Ambetter’s plan is still 114 percent above the least expensive silver plan in the first year of the exchanges. And none of the insurers are offering as broad and flexible a choice of doctors and hospitals as consumers had back then, said Michael Malasnik, a local broker.

Since the start of the exchanges, he said, insurers have “raised their rates by multiples, and they’ve figured out you have to be a very narrow network.”

Each plan for 2019 contains trade-offs. He said only Bright Health’s plan includes Phoenix Children’s Hospital. Ambetter’s plan includes the most popular hospital and doctor groups, but they are not as conveniently located for people living in the southeastern corner of the county, making other insurers’ plans appealing.

“Geography is the name of the game this year,” Malasnik said.

Theresa and John Flood(Courtesy of Theresa Flood)

Theresa Flood, a preschool teacher who lives outside Phoenix, said none of the plans she considered accepted her doctors, who include a specialist for her spine problems — she has had four surgeries — and a neurologist who monitors a cyst and benign tumor in her brain.

“I have to establish care with a whole new spine doctor and establish care with a whole new neurologist if I want to follow up on these things,” Flood, 59, said. “You’re going from established care to who in the heck am I going to see?”

The plan she chose would have been too expensive except that she and her husband, John, a pastor, qualified for a $1,263-a-month subsidy that will drop the cost to $207 a month. That bronze plan from Ambetter carries a $6,550-per-person deductible, so she expects she’ll still have to pay for her doctors on her own unless she needs extensive medical attention.

“It’s gone from being able to have a plan that you could sort of afford and got some benefit from, to putting up with what you can afford and hoping nothing happens that you actually have to use your insurance,” she said. “At this point, I’ll take what I can get.”

HHS Activates Aid for Uninsured Californians in Need of Medications Lost in Wildfires

HHS Gov News - November 21, 2018

Uninsured citizens in California’s Butte, Los Angeles and Ventura counties are eligible for no-cost replacements of critical medications lost or damaged by the current wildfires in those counties. This relief comes from the Emergency Prescription Assistance Program (EPAP), managed by the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR).

“EPAP provides vital assistance to people without insurance who rely upon certain prescription medicines and equipment to protect their health after disasters,” said HHS Assistant Secretary for Preparedness and Response Robert Kadlec, M.D. “I encourage citizens in impacted areas of California who qualify for this assistance to take advantage of it.”

At no cost to uninsured patients, those needing certain prescription medications during an emergency can obtain a 30-day supply at any EPAP participating pharmacy through Dec. 31, 2018. Most prescription drugs are covered under the program.

Uninsured patients also may use EPAP to replace specific medical supplies or medical equipment, such as canes and walkers, damaged or lost as a direct result of the wildfires or as a secondary result of loss or damage caused while in transit to an emergency shelter.

More than 72,000 pharmacies participate nationwide, including more than 200 in California. EPAP provides an efficient mechanism for enrolled pharmacies to process claims for prescription medication, specific medical supplies, and some forms of durable medical equipment for eligible individuals in a federally identified disaster area. All pharmacies in the United States are eligible to participate. Pharmacies in the California can call 888-571-8182, toll-free, to be added to the program.

Uninsured California residents affected by the current wildfires can call 855-793-7470, to learn if their medication or specific durable medical equipment is covered by EPAP and to find a participating pharmacy or visit www.phe.gov/epap.

HHS is providing additional assistance to the state. Secretary Alex Azar declared a public health emergency in California on Nov. 13, 2018, authorizing flexibilities for CMS beneficiaries and providers retroactive to Nov. 8, 2018.

The Centers for Medicare & Medicaid Services (CMS) has temporarily waived or modified certain Medicare and Medicaid requirements to give healthcare providers, facilities and suppliers the flexibility needed to provide continued access to care during the wildfire emergency. In addition to issuing broad waivers, CMS can grant provider-specific requests for hospitals and other California healthcare facilities as needed.

HHS deployed approximately 60 medical and public health staff, including doctors, nurses, and paramedics from the National Disaster Medical System and behavioral health experts who are working alongside local professionals to provide care in shelters, as well as regional emergency coordinators (RECs) and environmental health experts who are coordinating with state and local health authorities and emergency response officials. Additional personnel from the U.S. Public Health Service Commissioned Corps are on alert to provide medical care or additional public health support if needed.

The Substance Abuse and Mental Health Services Administration’s Disaster Distress Helpline is available to assist residents in the impacted areas in coping with the stress of the wildfires. The Disaster Distress Helpline provides immediate 24/7, 365-days-a-year crisis counseling and support to people experiencing emotional distress related to natural or human-caused disasters. This toll-free, multilingual, and confidential crisis support service is available to all residents in the United States and its territories. Stress, anxiety, and other depression-like symptoms are common reactions in disasters. Call 1-800-985-5990 toll free or text TalkWithUs to 66746 to connect with a trained crisis counselor.

SAMHSA also has resources available to assist residents with the behavioral health impacts of disasters, including tips for parents and educators on talking with children after traumatic events. Children respond to trauma in many different ways, and the tips cover signs of stress reactions in different age groups and how to help.

The Centers for Disease Control and Prevention (CDC) is working with the California Department of Public Health and other partners on public information materials to help residents and responders protect their lungs from the effects of wildfire smoke.

HHS and state partners are encouraging people in the way of wildfire smoke to listen to local authorities and take precautions to protect their health. CDC cautions that children, pregnant women, older adults, and people with existing respiratory or cardiovascular illnesses are especially susceptible to the effects of smoke. CDC recommends that if told to do so, residents stay indoors and keep air as clean as possible by shutting windows and doors, setting air conditioning systems to the “re-circulate” setting, and operating air cleaners equipped with a high-efficiency particulate air (HEPA) filter documented not to produce excess ozone.

HHS, through its Office of the Assistant Secretary for Preparedness and Response (ASPR), leads the federal government’s public health and medical response and recovery support for states and territories after disasters. HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. ASPR’s mission is to save lives and protect Americans from 21st century health security threats.

Information on disaster health and HHS actions is available on www.phe.gov/emergency. Public Service Announcements with wildfire health tips are available on https://www.cdc.gov/disasters/psa/index.html.

HHS Deputy Secretary Hargan Announces DSIIS Participants and First Meeting Date

HHS Gov News - November 21, 2018

Today, Health and Human Services Deputy Secretary Eric Hargan announced the initial core participants of the Deputy Secretary’s Innovation and Investment Summit (DSIIS) and December 18, 2018 as the date of the first meeting. As announced on September 19, 2018, the DSIIS will be a yearlong collaboration between healthcare innovation and investment professionals and HHS personnel who will meet quarterly to discuss the innovation and investment landscape within the healthcare sector, emerging opportunities, and the government’s role in facilitating more investment and accelerated innovation.

“Collaboration between HHS and private sector investors and innovators is critical to advancing new solutions and evolving healthcare in America,” said Deputy Secretary Hargan. “We believe this will produce new approaches that will improve the health and well-being of the American people. As the healthcare community innovates, HHS must also be innovative in how we engage with that community.”

HHS received over 250 nominations of highly qualified, prospective DSIIS core participants from all of the healthcare subsectors.  Each nominee was evaluated based on areas of educational focus, executive or other organizational leadership experience, private equity experience, venture capital experience, lending experience within the healthcare sector, and applicable experience, expertise, knowledge and leadership in innovation and investment in the healthcare sector.

The following experienced leaders in digital health, life sciences, medical devices, payor organizations, provider organizations, and health technology investing and innovation have been selected as initial DSIIS core participants.

Anna Haghgooie-Managing Director, Sandbox Industries

Annie Lamont-Managing Director, Oak HC/FT

Anthony Davis-Co-Founder and President, Linden Partners

Barry Uphoff-Founder and Managing Partner, Martis Capital

Bill Geary-Co-Founder and Partner, Flare Capital

Brian Thompson-CEO, UnitedHealthcare Medicare & Retirement

Dean Harrison-President and CEO, Northwestern Memorial HealthCare

Ezra Perlman-Co-President, Francisco Partners

Jim Rogers-Chair, Department of Business Development, Mayo Clinic

Matt Hermann-Senior Managing Director, Ascension Ventures

Mo Makhzoumi-Head of Global Health, New Enterprise Associates

Robbert Vorhoff-Managing Director and Global Head of Healthcare, General Atlantic

Scott Hilinski–Managing Director, Nautic Partners

Stephen Kraus-Partner, Bessemer Ventures

Todd Fruchterman-President/GM, 3M

This group will not be recommending or giving any direction on healthcare innovation and investments made by HHS.  This group will collaborate with HHS in an open discussion over the coming year to compare perspectives, analyze the most promising opportunities, and identify barriers related to innovation and investment in healthcare.  As previously announced, HHS will also bring in participants with subject matter expertise to provide additional perspectives during more focused discussions.

FAQs are available here: 

https://www.hhs.gov/about/leadership/eric-d-hargan/dsiis-faq/index.html

Additional information on DSIIS is available here:

https://www.hhs.gov/about/news/2018/09/19/hhs-deputy-secretary-hargan-announces-collaboration-accelerate-innovation-and-investment-healthcare.html

Attention, Marketplace Shoppers: Don’t Delay On 2019 Enrollment

Kaiser Health News:HealthReform - November 21, 2018

Don’t procrastinate. Most consumers who buy their own insurance on the federal health insurance marketplace face a Dec. 15 deadline. Advocates are reminding these customers that if they miss the deadline, they may not have a plan that starts in January 2019.

Despite repeated efforts by Republicans to repeal the Affordable Care Act, it remains the law of the land, and subsidies that help bring down premiums and reduce cost sharing are still available to help people afford plans sold on the marketplaces, also called exchanges. Those plans still must provide comprehensive benefits and limit out-of-pocket costs for consumers. If you buy an exchange plan, insurers can’t turn you down or charge you more if you have a preexisting medical condition.

But Republicans did push through a major change in the law that takes effect in 2019: Consumers will no longer owe a fine if they don’t have health insurance. It’s not yet clear if that has tamped down interest, but data released by federal officials showed that the number of people who had signed up during the first two weeks of open enrollment was down by about 20 percent from a year ago.

If you’re shopping for coverage off the exchange, you’ll probably encounter ads for short-term policies, which the Trump administration is promoting and for which it has loosened the requirements. Those plans generally have lower premiums, but they are riskier buys if you get sick, advocates say. More on those plans later.

If you want to enroll in a marketplace plan, now’s the time to get cracking. Enrollment, which began Nov. 1, will close on Dec. 15 in about two-thirds of states, which use the federal exchange.

Some people who live in states that run their own marketplaces may have extra time to sign up. California’s open-enrollment period doesn’t end until Jan. 15, for example, and in New York open enrollment runs through Jan. 31. In addition, people who’ve been affected by the wildfires in California may qualify for a special enrollment period that gives them even more time, according to a spokesperson for Covered California, the state’s marketplace.

Although you may have more plans to choose from for 2019, there will likely be fewer enrollment pros on hand to help you pick the one that’s right for you. Here are some tips that may help.

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Review All Your Plan Options

If you’re already enrolled in a marketplace plan and don’t take steps to sign up during open enrollment, chances are the marketplace will automatically re-enroll you in your current plan or another one that is similar for 2019. Don’t let that happen.

Even if you like the coverage you have, it’s critical to study the details. Your plan may have essentially the same name, but there’s no guarantee that the premium, deductible and other specifics — like the list of approved hospitals and doctors — will be the same. Check to make sure it still meets your needs.

Many people will have more insurers to choose from for next year. Fifty-eight percent of enrollees will have a choice of at least three insurers in 2019, compared with 48 percent who did so this year, according to an analysis by the Kaiser Family Foundation. (KHN is an editorially independent program of the foundation.) Meanwhile, the share of enrollees with just one marketplace insurer in their area will drop to 17 percent in 2019 from 26 percent this year.

Premiums will edge down slightly for many people next year. The changes vary widely by region, but the monthly unsubsidized premium for the second-lowest-priced silver plan, called the benchmark plan because its cost is used to set the level of federal premium support, will drop by an average 1.5 percent in states that use healthcare.gov, according to the Centers for Medicare & Medicaid Services. For a 27-year-old nonsmoker, that will mean a $6 difference ($412 dropping to $406).

(Silver plans are the most popular type of marketplace plan, picking up 70 percent of the cost of covered benefits, on average. Bronze plans are less generous, paying for 60 percent, while gold plans, at 80 percent, pay a greater share of the costs.)

Keep The Benchmark Plan In Sight

Premium tax credits are available for people with incomes between 100 and 400 percent of the federal poverty level ($12,140 to $48,560 for one person, or $25,100 to $100,400 for a family of four). With more insurers competing for your business and premiums heading down in some areas, the benchmark plan may change in 2019.

If you have the benchmark plan or another one with an even cheaper premium this year, be sure to check out the benchmark plan for next year.

“If you don’t stay with [the] benchmark plan, you could get sticker shock on your premium next year,” said Sabrina Corlette, research professor at Georgetown University’s Center on Health Insurance Reforms.

That’s because your subsidy will be reduced in line with the lower benchmark plan premium, and you’ll have to cover the difference if you don’t switch plans.

Estimate Your Income Carefully

If you’re ineligible for premium tax credits because your 2018 income is too high but you think it may dip below the 400 percent poverty threshold next year, it’s a good idea to sign up for a marketplace plan rather than buy a plan outside the exchange, said Karen Pollitz, a senior fellow at the Kaiser Family Foundation.

“People in marketplace plans whose income drops into subsidy territory are eligible for a special enrollment period to sign up for a subsidized plan,” Pollitz said. “If you’re enrolled in a plan off the exchange, you won’t have that option.”

About 80 percent of people who enroll in marketplace plans qualify for premium tax credits.

To avoid giving people more in advance premium tax credits than they’re eligible for, the marketplace typically asks for additional documentation to verify income when people project that their earnings will be lower than government data sources show.

This sign-up season, the marketplaces are asking for more information from people on the other end of the income spectrum. People with incomes below 100 percent of the federal poverty level aren’t eligible for subsidies. (Lawmakers who wrote the ACA expected these low-income people to qualify for Medicaid, but some states have not expanded their programs under the health law.)

For 2019 coverage, customers who estimate their income will reach or exceed that 100 percent mark, which would qualify them for premium tax credits, will generally be asked to provide additional income information if the marketplace’s data show that their income is below that standard.

The change is supposed to help avoid fraud, but inaccurate estimates may not be intentional, said Tara Straw, senior policy analyst at the Center on Budget and Policy Priorities.

“People in that income range who are often cobbling together income from part-time jobs may not have a great estimation of what their income may be for the coming year,” she said.

Update The Marketplace With Your Personal And Plan Information

Make sure to update your income and family information in your marketplace account. Otherwise, the marketplace may make an error in calculating the amount of your premium contribution, and you could be on the hook to repay excess subsidies at the end of the year.

If, while shopping for a plan, you get a notice that you’ve been automatically re-enrolled, don’t assume the marketplace will cancel that plan when you sign up for something else. Tell the marketplace that you want to terminate that plan, or you may end up owing a month’s premium for both plans while you get it sorted out, said Straw.

Complicated Coverage Questions? Get Help Now

This year, the federal government cut funding for navigators — those groups and individuals helping people sign up for coverage on the marketplaces — to $10 million, continuing a steady whittling away of support for that program from more than $60 million two years ago.

“My advice is ‘Don’t procrastinate,’ because there is less one-on-one help available in most states,” said Corlette.

If you live in a state that runs its own marketplace, you may have an easier time finding in-person help with coverage questions. Those exchanges are generally spending significantly more on outreach and assistance than the federally facilitated exchange, according to an analysis by researchers at Georgetown University and published by the Commonwealth Fund.

You may be able to find published answers to questions on your own with Georgetown’s Navigator Resource Guide or the marketplace FAQs published by the Kaiser Family Foundation.

Approach Short-Term Plans With Extreme Caution

To make more affordable health insurance options available, the Trump administration issued a rule in August that eases restrictions on short-term plans that are less comprehensive than ACA-compliant plans. These plans generally don’t cover preexisting conditions nor benefits like maternity care or prescription drugs. They can be renewed for up to three years, but that will be at the insurer’s discretion.

Because they offer much skimpier coverage than comprehensive plans that comply with the health law, short-term plans are generally cheaper.

Any plan offered through a state exchange must comply with the ACA. But people shopping online may see noncompliant coverage featured on other sites and find it hard to distinguish ACA-compliant plans from short-term and other types of limited coverage, such as health care-sharing ministries and fixed-indemnity plans, said Corlette, who has examined these offerings.

“It’s a mishmash of stuff that falls outside of the ACA,” Corlette said.

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