Blood, Sweat And Workplace Wellness: Where To Draw The Line On Incentives

KFF Health News, September 24, 2018

Two recent court rulings have cast uncertainty over what is the appropriate limit for financial incentives that employers can offer workers to participate in programs that require clinical testing or disclosure of personal health data.

This article first appeared September 24, 2018 on Kaiser Health News.

By Julie Appleby

Workplace wellness programs that offer employees a financial carrot for undergoing health screenings, sticking to exercise regimens or improving their cholesterol levels have long been controversial.

Next year, they may become even more contentious. Two recent court rulings have cast uncertainty over what is the appropriate limit for financial incentives that employers can offer workers to participate in programs that require clinical testing or disclosure of personal health data. The dollar amount is subject to debate because it raises questions about when the incentives become so high that employees feel they don't have a choice about participating.

As a result, workers may find programs offer smaller incentives, consultants say. Also, programs might give employees options for qualifying for those incentives — a choice, for instance, between undergoing a medical exam or completing online health education modules.

About 4 in 10 employers participating in an informal survey by benefits firm Mercer said "they really were not sure what they would do," said Steven Noeldner, its senior consultant in total health management specialty practice. "Some are modifying … others are taking a wait-and-see-attitude."

Eighty-five percent of large employers offering health insurance included a wellness program designed to help people stop smoking, lose weight or take other healthful actions, according to a 2017 survey by the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.) Just over half of those included some type of medical screening. Rewards or incentives to participate vary. The most common are gift cards, fitness trackers or other merchandise, or discounts on what workers pay toward their health insurance coverage.

The Cleveland Clinic's version is more extensive than most, said Dr. Bruce Rogen, chief medical officer for the effort. He described it as a "population health program," with differing goals for workers who have chronic diseases like diabetes versus those who don't.

Full participation, which may mean losing weight, keeping blood sugar levels in check or hitting a gym at least 10 times a month, can save workers 30 percent in insurance premiums. That could be as much as $1,443 a year.

"Part of what makes the plan work is the fact we can offer that benefit discount," Rogen said.

That 30 percent amount is the ceiling set in a 2016 Equal Employment Opportunity Commission (EEOC) rule for what an employer can offer.

But it's also the point that leads critics to question when incentives become significant enough that employees no longer feel that participation is voluntary.

"You and I can look at the same incentive and you will find it's truly voluntary and I would say, given my financial circumstances, I feel I'm being compelled," said Tom Luetkemeyer, an attorney specializing in employment law at Hinshaw & Culbertson in Chicago.

Shortly after the EEOC's guidance was issued, the AARP challenged it in court, arguing that workers who did not want to provide medical information could feel coerced to do so because not participating would cost them substantial sums, ranging from hundreds to thousands of dollars.

In his first ruling, D.C. Circuit Court Judge John Bates noted that the EEOC had failed to provide justification for how it settled on that percentage. He also pointed out that 30 percent of a worker's health insurance costs could be "the equivalent of several months' worth of food for the average family, two months of child care in most states, and roughly two months' rent."

Bates ultimately ordered the 30 percent limit vacated as of Jan. 1, 2019, after the EEOC said it would not produce that justification or a new number until 2021.

Employers now putting together next year's health benefit programs don't have specific rules to follow.

The advice they are receiving from benefit consultants ranges widely, from "drop all incentives and penalties" to "stay the course."

Few expect employers will outright stop offering wellness programs because they hope the programs will hold down health costs by getting workers to take steps to improve their well-being. Critics, however, point out that studies show little evidence that workplace wellness programs achieve these goals.

The ruling does not affect some wellness program efforts, such as offering financial incentives for going to the gym or walking a certain number of steps per day. Substantial financial incentives to get people to quit tobacco are also not covered by the ruling, so long as there is no medical test required to check for nicotine use.

But "you can't fine them for not getting their weight down, because then you have to measure their weight and that becomes clinical," said Al Lewis, a frequent critic of workplace wellness programs who runs a company that offers an alternative.

Some employers say they will stick with their existing programs — even if they hit the 30 percent level — because the EEOC is unlikely to challenge those that stick with the rescinded percentage until new rules come out.

The Cleveland Clinic's Rogen, who credits the wellness program for holding medical costs almost flat for the past five years, said clinic officials plan to leave it at that level next year, despite the uncertainty.

Not all benefit consultants would agree with that choice.

"The way we interpret the ruling is that financial incentives that relate to physical exams, including questions about health history, would not be allowed starting Jan. 1," said Noeldner, of Mercer.

Others suggest that is taking the judge's ruling too far. After all, the Affordable Care Act provides a precedent for the 30 percent threshold — and the EEOC may well come back with a rule that reaffirms that amount. The ACA included a provision that raised the limit on health-contingent wellness incentives to that amount.

"People may be overreacting to this by saying with these rules null and void, we are out in the Wild West," said Todd Hlasney, senior vice president and director of health risk solutions at Lockton Companies, a benefits consultancy. "We are advising clients to be more conservative … but don't panic and say [you] can't do anything because of EEOC."

Woman Receiving Dental Exam Dentist

'Physicians Of The Mouth'? Dentists Absorb The Medical Billing Drill

KFF Health News, September 24, 2018

There's a growing trend in dental offices, as providers seek greater reimbursement for expensive services. Around the internet, firms have popped up claiming expertise in medical billing for dentists and offering courses and consulting services.

This article first appeared September 24, 2018 on Kaiser Health News.

By David Tuller

DUBLIN, Calif. — On a recent Friday morning, more than 30 dentists and dental staffers gathered in a conference room to learn an arcane new skill: how to bill medical insurers.

Pacing back and forth, the Florida dentist leading the two-day course advised the participants to stop thinking of themselves as tooth technicians and reposition themselves as "physicians of the mouth."

"There is a medical part of our practice and a dental part," said the presenter, Chris Farrugia, as audience members tapped on their keyboards or scribbled notes. "You have teeth, [and] you got the 'other stuff.' It's the other stuff that medical insurance pays for."

Faruggia's seminar is a sign of a growing trend in dental offices, as providers seek greater reimbursement for expensive services and patients balk at big bills. Around the internet, firms have popped up claiming expertise in medical billing for dentists and offering courses and consulting services.

The reason is simple: Medical insurance is generally much more generous in its coverage than dental insurance.

Unlike medical coverage, dental insurance is mostly geared to the healthy — something many people don't realize until they experience serious oral problems and get socked with unexpected costs. Standard dental insurance covers cleanings, fillings and other routine care. But major work like a crown or a bridge is often covered only at 50 percent and implants generally aren't covered at all. And dental insurance is usually capped at $1,000 or $1,500 per year.

As a result, people who require extensive reconstructive work often pay many thousands of dollars, or sometimes tens of thousands, in out-of-pocket expenses. Many other people, even with dental coverage, go without care because they cannot afford the large balances or co-pays for crowns, root canals and other major procedures.

Because of these differences in reimbursement, Farrugia told his seminar attendees, dentists should first consider what medical insurance might cover and then bill the dental plan for the rest.

For example, he said, dentists should seek medical coverage for the full head, neck and mouth exams they perform when they see a new patient, since the goal is to assess more than just the teeth. Medical insurers should also cover oral problems attributable to an underlying medical condition, such as diabetes or dry mouth, a common side effect of many medications, Farrugia said.

Besides sparing patients the pain of big bills, the strategy can also boost income for dentists, said Farrugia, who estimated that revenues for his practice rose almost 10 percent the first year he fully implemented medical billing. Patients, too, can learn to file claims for medical reimbursement if their dentists won't, he said.

On its website, the California Dental Association explains that health insurance should cover costs that are "medically necessary" and lists more than a dozen categories of procedures that could qualify. Among them: treatment related to inflammation and infection, dental repair due to injury, certain periodontal surgery procedures and appliances for sleep apnea.

Kristine Grow, a spokeswoman for America's Health Insurance Plans, the industry trade association, did not dispute that some dental procedures could be covered by medical insurance. However, she cautioned that medical insurers were always on the lookout for abuse.

"Claims that are billed inappropriately or submitted fraudulently hurt everyone because they raise costs," Grow said. "It's important to note that procedures not related to an emergency event or trauma may not be medically necessary, and therefore would not be covered by medical insurance," she added.

Asked about the potential for abuse, Farrugia said: "There are unethical providers in all health care services, and dentistry is not immune to that. You will always have some that try to game the system."

Farrugia adopted medical billing several years ago after paying more than $100,000 for a CT scanner that produces 3-D images of the bone in the mouth and jaws.

"It occurred to me that this was a medical device," he said of the CT scanner. "I'm a licensed health care provider, I'm providing this within the scope of my license. They can't discriminate against me."

Once he investigated the matter, Farrugia discovered that medical insurance could be asked to cover not just CT scans but a wide range of services regularly performed by dentists. He buried himself in the arcana of coding, ultimately writing three workbooks for dentists about medical billing.

At first it was trial-and-error, and Farrugia learned that claims often get rejected if they do not cite a medically legitimate reason for the procedure as well as the appropriate code.

These days, Farrugia bills medical plans $744 for a CT scan (medical code: CPT 70486), receiving an average reimbursement of about $500. Medical plans generally require pre-authorization for non-emergency CT scans, he said, so his office staff had to learn how to explain why the scan was medically required — such as to assess bone quality.

The same procedure can be billed to a dental plan (dental code: D0367), but the average reimbursement is $125 — if the plan covers CT scans at all.

Others are following his example. Iowa dentist Richard Downs attended one of Farrugia's medical billing seminars last year in Chicago. "I'd never heard these things before," he said.

He said he recently sought and received prior authorization from a medical insurer for $60,000 to cover multiple implants and other costs for a woman whose dental woes stemmed from severe atrophy of the jaw and other medical problems.

During a break in the seminar, San Ramon, Calif., dentist Rashpal Deol said Farrugia's approach made sense. "We look at the soft tissues in the mouth, the muscles, the bone, the TM [temporomandibular] joint, and the head and neck area," he said. "You always check the lymph nodes, we do oral cancer screening, so that is a comprehensive medical exam."

Other seminar attendees also were enthusiastic, if a bit daunted. "People go to school to learn medical coding," said Kelly Bradshaw, a staff member at a Santa Rosa, Calif., dental practice. "To try to bridge that gap in order to help our patients is intimidating. You have to be open-minded to look at things in different ways."

Margaret Busch, an office manager for an Arizona dentist, said she planned to start medical billing as soon as she returned from the seminar.

"I've been making a list of people that we can go back and probably get money for," she said, mentioning patients who have had CT scans and those with dental problems related to medical conditions like diabetes.

"I think they'll be excited," she said.

As States Try To Rein In Drug Spending, Feds Slap Down One Bold Medicaid Move

KFF Health News, September 21, 2018

Massachusetts wanted to negotiate prices for about 1% of the highest-priced drugs and stop covering some of them. CMS rejected the proposal.

This article first appeared September 21, 2018 on Kaiser Health News.

By Martha Bebinger, WBUR

States serve as "laboratories of democracy," as U.S. Supreme Court Justice Louis Brandeis famously said. And states are also labs for health policy, launching all kinds of experiments lately to temper spending on pharmaceuticals.

No wonder. Drugs are among the fastest-rising health care costs for many consumers and are a key reason health care spending dominates many state budgets — crowding out roads, schools and other priorities.

Consider Vermont, California and Oregon, states that are beginning to implement drug price transparency laws. In Nevada, the push for transparency includes the markup charged by pharmacy benefit managers (PBMs). In May, Louisiana joined a growing list of states banning "gag rules" that prevent pharmacists from discussing drug prices with patients.

State-based experiments may carry even greater weight for Medicaid, the federal-state partnership that covers roughly 75 million low-income or disabled Americans.

Ohio is targeting the fees charged to its Medicaid program by PBMs. New York has established a Medicaid spending drug cap. In late June, Oklahoma's Medicaid program was approved by the federal Centers for Medicare & Medicaid Services to begin "value-based purchasing" for some newer, more expensive drugs: When drugs don't work, the state would pay less for them.

But around the same time, CMS denied a proposal from Massachusetts that was seen as the boldest attempt yet to control Medicaid drug spending.

Massachusetts planned to exclude expensive drugs that weren't proven to work better than existing alternatives. The state said Medicaid drug spending had doubled in five years. Massachusetts wanted to negotiate prices for about 1 percent of the highest-priced drugs and stop covering some of them. CMS rejected the proposal without much explanation, beyond saying Massachusetts couldn't do what it wanted and continue to receive the deep discounts drugmakers are required by law to give state Medicaid programs.

The Medicaid discounts were established in 1990 law based on a grand bargain that drugmakers say guaranteed coverage of all medicines approved by the Food and Drug Administration in exchange for favorable prices.

The New England Journal of Medicine dives into the CMS decision regarding Massachusetts and its implications for other state Medicaid programs in a commentary by Rachel Sachs, an associate professor of law at Washington University in St. Louis, and co-author Nicholas Bagley. They dispute the Trump administration's claim that Massachusetts' plan would violate the grand bargain.

We talked with Sachs about Massachusetts' proposal and the implications for the rest of the country. Her answers have been edited for length and clarity.

Q: Why do you think states, such as Massachusetts, should be allowed to exclude some drugs, a move the pharmaceutical industry has said would break the deal reached back in 1990?

In our view, there's a way to frame it where the bargain has been broken and Massachusetts is simply trying to restore the balance. The problem is that the meaning of FDA approval has changed significantly over the last almost 30 years. Now we have a lot more drugs that are being approved more quickly, on the basis of less evidence — smaller trials, using surrogate endpoints — where the state has real questions about whether these drugs work at all, not only whether they are good value for the money.

Q: You suggest that Massachusetts could make a reasonable case if it chose to challenge the CMS denial. How?

CMS did not explain why it didn't grant Massachusetts' waiver. It needs to give reasons for denying something that Massachusetts, in our view, has the legal ability to do. CMS' failure to give reasons in this case resembles their failure to give reasons in a number of other cases that have recently led courts to strike down actions by the Trump administration for failure to explain the actions that they were taking.

(Note: A spokeswoman for Health and Human Services in Massachusetts says the state is not going to challenge the CMS decision.)

Q: While CMS blocked the Massachusetts experiment, it has approved the value-based purchasing plan in Oklahoma, and New York has capped its Medicaid drug spending. Aren't those signs of flexibility for states?

In some ways, yes, and in other ways, no. New York passed a cap on state Medicaid pharmaceutical spending. But once the state hits that cap, it doesn't mean the state will stop paying for prescription drugs. It just means the state is empowered to negotiate with some of these companies and seek additional discounts. They didn't need CMS approval for this. New York doesn't have the ability to say "If you don't take this deal, we're not going to cover this product."

Oklahoma is pursuing outcomes-based pricing, which is of interest. It's the first state to express interest in doing so. However, there are a lot of observers who are skeptical that outcomes agreements of this kind will materially lower prices or if they just provide companies cover to charge higher prices in the first instance.

Q: So what options do you see ahead for states given what happened in Massachusetts with the Medicaid waiver?

Unfortunately, states are quite limited in what they're able to do on their own, in terms of controlling prescription drug costs — both costs that are borne by the state in its capacity as a public employer and its capacity as an insurer for the Medicaid population. and then more generally for the many citizens who are on private insurance plans throughout the state.

This is a real problem, this concern of federal pre-emption where states' ability to go beyond federal law is often limited. So what we're seeing now is more states like Massachusetts and Vermont taking action that forces the federal government to do something or say something. States are increasingly putting pressure on the federal government because they know that their ability to act on this problem of drug pricing is limited.

Despite Red Flags At Surgery Centers, Overseers Award Gold Seals

KFF Health News, September 20, 2018

California is the only state with more than 1,000 surgery centers that has given private accreditors a lead role in oversight. Those accreditors are typically paid by the same centers they evaluate.

This article first appeared September 20, 2018 on Kaiser Health News.

By Christina Jewett

At his surgery center near San Diego, Rodney Davis wore scrubs, was referred to as "Dr. Rod" and carried the title of director of surgery. But he was a physician assistant, not a doctor, who anesthetized patients and performed liposuction with little input from his supervising doctor, court records show.

So it was perhaps no surprise, in 2016, when an administrative judge stripped Davis of his license, concluding it was the only way to "protect the public." State officials also accused two former medical directors of Pacific Liposculpture of enabling Davis to act as a doctor.

One powerful authority in California took a different view. The state-approved private accreditation agency that oversees the center left its approval in place. So the center is still operating and Davis remains an owner and administrator, state records show.

California is the only state with more than 1,000 surgery centers that has given private accreditors a lead role in oversight. Those accreditors are typically paid by the same centers they evaluate.

That approach to oversight has created a troubling legacy of laxity, an investigation by Kaiser Health News shows. In case after case, as federal or state authorities waved red flags, state-approved accreditation agencies affixed gold seals of approval, according to a KHN review of hundreds of pages of doctors' disciplinary records, court files and accreditor reports — which are public only for California surgery centers.

One accreditation inspector called a doctor's anesthesia technique "impressive" just months before the state medical board accused her of "gross negligence" for putting patients in deep sedation without the training to save them if they stopped breathing. Another doctor who is fighting a medical board accusation of "gross negligence" over two patient deaths in 2014 and 2015 got his own surgery center approved by an accreditor in 2016.

In yet another case, Medicare officials declared a state of "immediate jeopardy" at a center that put an untrained receptionist in charge of disinfecting surgical scopes, a Medicare inspection report says. Its accreditor renewed its approval within a week.

Patient deaths after care in a California surgery center reached a 14-year high with 18 cases in 2016, though the total dipped to 14 the following year, according to state records based on reports filed by the centers. Since 2010, at least 102 patients have died after care in the state's surgery centers. Such facilities perform a variety of outpatient surgeries and now outnumber hospitals nationally.

State Sen. Jerry Hill, a San Francisco Bay Area Democrat, chairs the committee that oversees the state medical board, which reviews and approves the state's surgery center accreditation agencies every three years.

Briefed on the investigation's findings, Hill said this "definitely warrants a deeper examination into what's going on at the surgery centers and how the accreditation process is working today — and [whether it's] providing the patient protection I was hoping for when we established it."

'Impressive' Or Negligent?

California's oversight of surgery centers was upended about a decade ago when a physician's legal victory led the Department of Public Health to conclude it could no longer license doctor-owned surgery centers. The doctor had filed suit, challenging the requirement that he and his surgery center both maintain a license. He prevailed, putting state oversight of the doctor-owned centers in flux.

In 2011, state lawmakers came up with a solution, mandating that the state medical board approve the private accreditors that would be on the front lines of oversight. Today, five accreditors are allowed to both inspect surgery centers and to grant or deny surgery centers approval to operate. (Centers can also operate with just Medicare approval.)

State medical board officials denied a request for death reports that included centers' names, making a more comprehensive review of the centers or their accreditors difficult. Some of the same accreditation agencies that approve surgery centers, though, have been under fire with members of Congress after a Wall Street Journal report pinpointed gaps in their oversight of hospitals.

With the change in California, the state-approved accreditation agencies got a guaranteed source of income, since the centers each pay their accrediting agency about $15,000 every three years for their oversight role. In turn, the accreditors made a first-of-its kind concession: They agreed to make their inspection reports open to the public on a state website.

Those reports show that accreditors, at times, were at odds with other officials.

On May 1, 2012, the Institute for Medical Quality, or IMQ, a San Francisco-based accreditor, inspected Advanced Medical Spa in Rocklin, Calif. The inspectors were required to check whether the person administering anesthesia was "qualified and working within their scope of practice."

The inspector's note says the surgeon's wife, a pediatrician, was performing "conscious sedation" anesthesia and said her technique with the drug propofol was "impressive." The standard was marked as "met" and accreditation was awarded through 2015.

A month later, the state medical board launched an investigation of the pediatrician, Dr. Yessennia Candelaria, over complaints that she was handling anesthesia for plastic surgery procedures without "requisite training in anesthesia, including Propofol," the board's records show.

Investigators for the Medical Board of California found that before and after the accreditor's review, Candelaria was using propofol to put patients in a state of "deep sedation" even though she didn't have the "advanced airway" training in how to rescue them if their breathing shut down. Medical board authorities deemed the lapse "gross negligence" in an accusation filed in 2014 that also accused her of abusing controlled drugs. Her medical license was put on probation for seven years. Medical board authorities recently moved to revoke her license over unauthorized prescribing, and she has not yet filed a written response.

An attorney for Candelaria declined to comment and Candelaria did not respond to a request for comment.

In February 2013, IMQ revoked its approval of Advanced Medical Spa. The following month, Candelaria and her husband, Dr. Efrain Gonzalez, were arrested in a separate criminal case. Gonzalez was charged with 37 felony counts that included mayhem and conspiracy for allegedly disfiguring the women he operated on at the center. Candelaria was charged with 24 felony counts, including mayhem and grand theft by false pretense.

Gonzalez pleaded guilty to three felonies and was sentenced to three months of house arrest in the criminal case and surrendered his medical license. Charges were ultimately dismissed against Candelaria, who pleaded not guilty.

Victoria Samper, vice president of ambulatory programs with IMQ, said she could not comment on specific facilities. But she did note that California law allows doctors to practice outside of the field they initially train in. She also said if a doctor is doing so, an inspector would be expected to "drill down" into the physician's practices.

The medical board said in a statement that the private accreditor who dubbed Candelaria's technique "impressive" reviewed her work with a different patient than those cited in the board's accusation.

"If the Board becomes aware that there is an accreditation agency that is not following the law when accrediting outpatient surgery settings, the Board would look into it," the statement said.

Decertified, Yet Still Operating

Accreditation agencies have stood by eight California surgery centers facing the federal Medicare program's harshest consequence — "involuntary decertification." It's a rare sanction that amounts to being deemed unfit to care for seniors.

On March 22, 2016, California Department of Public of Health inspectors notified federal authorities about a state of "immediate jeopardy" at Digestive Diagnostic Center, a small endoscopy center south of San Francisco.

A state inspection report said the center had pressed its new receptionist into duty to disinfect medical devices that probe patients' colons — with no formal training. The center failed to protect patients and had "ineffective infection-control policies which did not address hiring … of qualified individuals," the report concluded.

Something else happened that day as well. The Accreditation Association for Ambulatory Health Care, or AAAHC, renewed its approval of the center, which the agency describes as a "widely recognized symbol of quality" to patients and health insurers.

Medicare involuntarily decertified the facility a month later, which meant the federal agency would no longer pay for seniors' care at the center. But with private accreditation still in place, private insurers would be likely to continue funding care there.

Dr. Michael Bishop, a former California medical board member, said the case exposes a gap in state oversight if a center falls below one overseer's standard but meets another's. "You want no one to have easier [approval] process than any other one," he said. "That's quite egregious."

Kevin Calisher, president of the surgery center management firm Calisher & Associates, said his company took over management of the center in 2017, and that he could not comment on Medicare's findings.

AAAHC said in a statement that it could not discuss individual facilities.

The medical board's statement said Medicare is not required to notify the board when it decertifies a surgical center. "Now that this situation has been brought to the Board's attention, however, the Board will be looking into the matter," the statement said.

The Case Of 'Doctor' Davis

On April 9, 2015, an inspector from AAAHC arrived to perform an initial inspection of Pacific Liposculpture, which had been operating since 2011.

The inspectors' checklist included a review of complaints filed against the center by a state "licensure board." Davis had already been publicly accused by the state physician assistant board of engaging in the unlawful practice of medicine and gross negligence for failing to appropriately care for patients who experienced complications.

The inspector checked the box for "substantial compliance" and awarded the center approval through April 2018.

That decision was "enraging actually, outrageous," said Todd Glanz, a San Diego-area attorney. He represents a patient, Cecilia O'Neill, who went to the center for liposuction a few weeks after it was accredited.

O'Neill returned a few days after her May 28, 2015, procedure, complaining of pain, dizziness and signs of infection, her lawsuit alleges. But she claims her condition got worse. On June 9, 2015, she went to an emergency room, where she was told she had sepsis and needed emergency surgery followed by a stay in the ICU, according to her lawsuit.

Glanz said O'Neill was left with a hospital bill of nearly $200,000 and ongoing disfigurement. Davis and Dr. Harrison Robbins, the facility's former medical director and other owner, have denied wrongdoing and are fighting the ongoing lawsuit.

The following year, in February 2016, Davis faced an eight-day administrative hearing over whether he should keep his license as a physician assistant. A central issue was whether he truly worked under a doctor's supervision, as the law requires, or hired a figurehead who would exert little control.

One 2010 email discussed in court was by Davis, saying he hoped his new supervising physician, Dr. Jerrell Borup, would not be "another clumsy physician getting in the way."

His attorney presented experts and argued that he should keep his license. At its conclusion, the administrative judge revoked his license and reached a searing conclusion.

Davis "purposefully and intentionally set out to create a business arrangement that looked legitimate on paper," Judge Susan Boyle wrote, "but allowed him to manipulate the system and run a liposuction business without the interference of a physician."

The two former medical directors of the center were accused by the Medical Board of California of "aiding and abetting" Davis' unlicensed practice of medicine. Neither doctor actively supervised Davis, who performed all the procedures, the accusations say.

Davis has denied wrongdoing in each proceeding and declined to comment for this report through an attorney. One of the former medical directors, Borup, surrendered his license in 2016. The other, Dr. Harrison Robbins, is fighting the medical board's similar case against him. The controversy did not deter AAAHC, which earlier this year approved the center through April 2021.

Robert Frank, a San Diego attorney who represented Davis and Robbins, said Robbins has retired and the public should have no concerns about Davis' ongoing administrative role at Pacific Liposculpture.

"[Davis] knows the business, he knows the procedure and he knows he's being watched and scrutinized" during the ongoing legal case, Frank said.

Davis contested his license revocation but lost that case in Sacramento Superior Court. He's now challenging that decision in appeals court.

Betsy Imholz, former director of special projects for Consumers Union, who reviewed the findings for this report, said the case was shocking. "There are huge gaps in California law, clearly," she said.

Two Deaths — And Then A Green Light

The families of two women in their 40s sued Diamond Surgery Center in Encino, Calif., and its surgeon, alleging wrongdoing in their 2014 and 2015 deaths.

The incidents did not stop the facility from getting accreditation in 2017 from the Chicago-based Joint Commission, the nation's most prominent accreditor.

Oneyda Mata, 40, was the first to die, on March 29, 2014. According to her autopsy, she called 911 from her car, struggling to breathe. Although her liposuction at the surgery center was 22 days earlier, the autopsy lists Diamond Surgery Center as the "place of injury" in her death from a blood clot lodged in her lung.

Dr. Roya Dardashti admitted no fault, but reached a $200,000 settlement in the family's lawsuit. The sum became public only because the family filed legal records saying Dardashti failed to make some payments.

MaryCruz Elizalde, 42, was the second to die, on Dec. 10, 2015. She was in recovery after a tummy tuck and liposuction at Diamond Surgery Center when she went into cardiac arrest and was taken to a hospital. Her autopsy says she died from internal bleeding and shock "as a consequence of complications of surgery."

Elizalde's partner's lawsuit alleged that an unlicensed anesthesia provider at the center was involved in her care. The case was voluntarily dismissed after the partner was imprisoned in an unrelated fraud case.

State law bars doctors from operating in an unapproved facility at levels of anesthesia that rob people of their "life-preserving" reflexes.

Whether the facility operated outside of that limit or erred in either woman's care wasn't noted when the center got its initial approval to operate in 2017.

With a slightly different, new name, Diamond Surgical Institute, the same location and same lead doctor, the facility now appears to have full accreditation on the state's website for surgery centers.

Joint Commission spokeswoman Katherine Bronk said the center was awarded "limited temporary accreditation" in 2017 and 2018 after "limited" inspections. Those limited inspections did not include a check of patient medical records because they're designed for facilities "not actively caring for patients."

Bronk said in an email that past problems might not affect an accreditation decision.

"If the surgery center had not been following the law but made compliance with the law part of its corrective action plan, it would not necessarily be denied accreditation," she wrote. "As a private accreditor, our goal is to help organizations identify deficiencies in care and correct them as quickly and sustainably as possible."

Dardashti did not respond to calls or email requests for an interview. The medical board declined to say whether it has received a report of a patient death from the facility since 2014, saying the information is "confidential."

State law requires accreditors to perform a "reasonable investigation" of a surgery center's past, which includes a check to see if its doctors have a license, which Dardashti did. The checks should go deeper, said Imholz, of Consumers Union.

"If past is prologue, we should be looking at what the key players, owners and doctors involved, what they have in their records," she said. "It's relevant; it should be looked at."

Senators Unveil Legislation To Protect Patients Against Surprise Medical Bills

KFF Health News, September 19, 2018

Federal law does not prohibit balance billing in self-funded health plans, which 61% of privately insured employees have.

This article first appeared September 19, 2018 on Kaiser Health News.

By Rachel Bluth

With frustration growing among Americans who are being charged exorbitant prices for medical treatment, a bipartisan group of senators Tuesday unveiled a plan to protect patients from surprise bills and high charges from hospitals or doctors who are not in their insurance networks.

The draft legislation, which sponsors said is designed to prevent medical bankruptcies, targets three key consumer concerns:

  • Treatment for an emergency by a doctor who is not part of the patient's insurance network at a hospital that is also outside that network. The patients would be required to pay out-of-pocket the amount required by their insurance plan. The hospital or doctor could not bill the patient for the remainder of the bill, a practice known as "balance billing." The hospital and doctor could seek additional payments from the patient's insurer under state regulations or through a formula established in the legislation.
  • Treatment by an out-of-network doctor or other provider at a hospital that is in the patient's insurance network. Patients would pay only what is required by their plans. Again, the doctors could seek more payments from the plans based on formulas set up by state rules or through the federal formula.
  • Mandated notification to emergency patients, once they are stabilized, that they could run up excess charges if they are in an out-of-network hospital. The patients would be required to sign a statement acknowledging that they had been told their insurance might not cover their expenses, and they could seek treatment elsewhere.

"Our proposal protects patients in those emergency situations where current law does not, so that they don't receive a surprise bill that is basically uncapped by anything but a sense of shame," Sen. Bill Cassidy (R-La.) said in his announcement about the legislation.

Kevin Lucia, a senior research professor at Georgetown University's Center on Health Insurance Reforms who had not yet read the draft legislation, said the measure was aimed at a big problem.

"Balance billing is ripe for a federal solution," he said. States regulate only some health plans and that "leaves open a vast number of people that aren't covered by those laws."

Federal law regulates health plans offered by many larger companies and unions that are "self-funded." Sixty-one percent of privately insured employees get their insurance this way. Those plans pay claims out of their own funds, rather than buying an insurance policy. Federal law does not prohibit balance billing in these plans.

Related: Send Us Your Medical Bill

Cassidy's office said, however, that this legislation would plug that gap.

In addition to Cassidy, the legislation is being offered by Sens. Michael Bennet (D-Colo.), Chuck Grassley (R-Iowa), Tom Carper (D-Del.), Todd Young (R-Ind.) and Claire McCaskill (D-Mo.).

Cassidy's announcement cited two recent articles from Kaiser Health News and NPR's "Bill of the Month" series, including a $17,850 urine test and a $109,000 bill after a heart attack.

In a statement to Kaiser Health News, Bennet said, "In Colorado, we hear from patients facing unexpected bills with astronomical costs even when they've received a service from an in-network provider. That's why Senator Cassidy and I are leading a bipartisan group of senators to address this all-too-common byproduct of limited price transparency."

Emergency rooms and out-of-network hospitals aren't the only sources of balance bills, Lucia said. He mentioned that both ground and air ambulances can leave patients responsible for surprisingly high costs as well.

Lucia said he was encouraged that both Democrats and Republicans signed on to the draft legislation.

"Any effort at the federal level is encouraging because this has been a challenging issue at the state level to make progress on," Lucia said.

New Medicare Advantage Tool To Lower Drug Prices Puts Crimp In Patients' Choices

KFF Health News, September 17, 2018

Starting next year, Medicare Advantage plans will be able to add restrictions on expensive, injectable drugs administered by doctors to treat cancer, rheumatoid arthritis, macular degeneration and other serious diseases. Under the new rules, these private Medicare insurance plans could require patients to try cheaper drugs first. If those are not effective, then the patients could receive the more expensive medication prescribed by their doctors.

This article first appeared September 17, 2018 on Kaiser Health News.

By Susan Jaffe

Starting next year, Medicare Advantage plans will be able to add restrictions on expensive, injectable drugs administered by doctors to treat cancer, rheumatoid arthritis, macular degeneration and other serious diseases.

Under the new rules, these private Medicare insurance plans could require patients to try cheaper drugs first. If those are not effective, then the patients could receive the more expensive medication prescribed by their doctors.

Insurers use such "step therapy" to control drug costs in the employer-based insurance market as well as in Medicare's stand-alone Part D prescription drug benefit, which generally covers medicine purchased at retail pharmacies or through the mail. The new option allows Advantage plans — an alternative to traditional, government-run Medicare — to extend that cost-control strategy to these physician-administered drugs.

In traditional Medicare, which covers 40 million older or disabled adults, those medications given by doctors are covered under Medicare Part B, which includes outpatient services, and step therapy is not allowed.

About 20 million people have private Medicare Advantage policies, which include coverage for Part D and Part B medications.

Some physicians and patient advocates are concerned that the pursuit of lower Part B drug prices could endanger very sick Medicare Advantage patients if they can't be treated promptly with the medicine that was their doctor’s first choice.

Critics of the new policy, part of the administration’s efforts to fulfill President Donald Trump's promise to cut drug prices, say it lacks some crucial details, including how to determine when a less expensive drug isn't effective.

"Do you have to lose vision before you are allowed to use” medication approved by the Food and Drug Administration, asked Richard O'Neal, vice president for market access for Regeneron, which makes Eylea, a medicine that is injected into the eye to treat macular degeneration. In 2016, Medicare paid $2.2 billion for Eylea prescriptions for patients in traditional Medicare, more than any other Part B drug, according to government data.

Medicare Advantage insurers spend about $12 billion on Part B drugs, compared to the $25.7 billion traditional Medicare spent in 2016 on such drugs. Insurers that adopt the step therapy policy can apply it only to new prescriptions — medicine a patient hasn't received in the past 108 days.

The change in policy gives insurers a new bargaining tool: Pharmaceutical makers may want to compete by cutting prices to get their product on the plans’ list of preferred lists, allowing patients to receive the medicines without step therapy pre-conditions. That "strengthens their negotiating position with the manufacturers," Medicare chief Seema Verma said when she unveiled the policy last month.

It could also save patients money since they usually pay a portion of the Part B prescription cost. In addition, Medicare is requiring plans to share the savings with enrollees.

"Competition is a big factor in price concessions," said Daniel Nam, executive director of federal programs at America's Health Insurance Plans, an industry trade group. But insurers haven't had much leverage to negotiate lower prices for these drugs without strategies like step therapy, he said.

Federal health officials told insurers in a memo last month that they could substitute a less expensive Part B drug to treat a medical condition the FDA has not approved it for, if insurers can document that it is safe and effective. Yet coverage for a Part D drug is usually denied for a condition that doesn’t have FDA approval, according to the Center for Medicare Advocacy, which helps beneficiaries with appeals.

Several representatives of medical specialty groups recently met with Alex Azar, the secretary of the Department of Health and Human Services, to express their concerns.

Dr. Stephen Grubbs, vice president of clinical affairs at the American Society of Clinical Oncology, was among them. He said Azar told then the new step therapy policy would not have a big impact on cancer treatment.

Patients and their physicians who encounter problems getting specific Part B drugs can appeal using the “process that we have throughout the Medicare Advantage program and Part D plans," advised Verma.

Under this system, if patients don't want to follow their insurance plans' requirements to try a less expensive medication first, they can request an exception to step therapy.

"They need their doctor's support," said Francine Chuchanis, director of entitlement rights at Direction Home, an Area Agencies on Aging organization that serves older adults and people with disabilities in northeastern Ohio. The physician must tell the plan why its restrictions should be lifted and provide extensive documentation.

The plans have 24 hours to respond to an expedited exception request and 72 hours for a regular one. During this time, "people are going without their drugs," said Sarah Jane Blake, a Medicare counselor for New York’s StateWide Senior Action Council.

However, Dr. David Daikh, president of the American College of Rheumatology, said plans frequently do not meet the 72-hour deadline.

"We raised this point with the secretary and his staff," he said. "They replied that they felt that there would not be a backlog for this program."

If a plan denies the exemption, patients can file a "reconsideration" appeal. During this process, patients still can't get their medicine unless they pay for it out-of-pocket.

Only a tiny fraction of Medicare Advantage beneficiaries filed a reconsideration appeal last year. Of the 3,498 cases that were decided, just 1 in 10 beneficiaries won decisions fully or partially in their favor, according to Medicare statistics.

"That's disheartening to say the least," said Blake, but she wasn't surprised. "Beneficiaries are intimidated by the hoops they have to go through and often give up trying to purchase the drugs prescribed for them."

Is 'Precision Medicine' The Answer To Cancer? Not Precisely.

KFF Health News, September 13, 2018

Doctors and hospitals love to talk about the patients they’ve saved with precision medicine. But the patients who succumb to advanced cancer despite the advanced testing still vastly outnumber the rare successes.

This article first appeared September 13, 2018 on Kaiser Health News.

By Liz Szabo

Facing incurable breast cancer at age 55, MaryAnne DiCanto put her faith in "precision medicine" — in which doctors try to match patients with drugs that target the genetic mutations in their tumors. She underwent repeated biopsies to identify therapies that might help.

"She believed in it wholeheartedly," said her husband, Scott Primiano of Amityville, N.Y., a flood-insurance broker. "You live on hope for so long, it's hard to let go."

Around this point in the average news story, readers would learn how DiCanto — mother to a blended family of five — took a chance on an experimental drug that no one expected to work.

She would be the scrappy protagonist whose determination to "keep fighting" enabled her to beat the odds — allowing us to celebrate the triumph of modern science and worry a bit less about our own mortality.

But there's a serious problem with talking about precision medicine for cancer this way.

It misleads the public.

In spite of DiCanto's high hopes, none of it helped. DiCanto died last year at age 59.

Doctors and hospitals love to talk about the patients they've saved with precision medicine, and reporters love to write about them. But the people who die — patients like DiCanto, who succumb to advanced cancer despite the advanced testing — still vastly outnumber the rare successes.

"There are very few instances in which we can look at a genomic test and pick a drug off the shelf and say, 'That will work,'" said Dr. Nikhil Wagle, a cancer specialist at Boston's Dana-Farber Cancer Institute who helped develop precision-medicine tests. "That's our goal in the long run, but in 2018 we're not there yet."

Reflecting on his family's experience with "precision" treatment, Primiano said, "You think it's going to be more precise, like a laser versus a shotgun. But it's still a shotgun."

There has been real progress, of course.

Testing for genetic mutations has become the standard of care in lung cancer, melanoma and a handful of other tumor types. But the number of people with advanced cancer eligible for these approaches is just 9 percent to 15 percent, experts estimate. These targeted therapies help about half of patients who try them, said Dr. Vinay Prasad, an associate professor at Oregon Health and Science University.

Targeted therapies tend to be less successful in patients like DiCanto, who have exhausted all standard treatments. In a large study published last year in Cancer Discovery, precision medicine failed to help 93 percent of the 1,000 patients who signed up for the study.

At the most recent meeting of the American Society of Clinical Oncology — the largest cancer meeting in the world — researchers presented four precision-medicine studies. Two were total failures. The other two weren't much better, failing to shrink tumors 92 percent and 95 percent of the time.

The studies received almost no news coverage.

Some experts, including Dr. David Hyman of New York's Memorial Sloan Kettering Cancer Center, say that such testing should be available to everyone with advanced cancer, because no one can predict which individual might have a rare mutation that can be targeted with a new or experimental drug. When patients respond to these drugs, they tend to do very well, and some survive much longer than expected.

But Hyman acknowledged that many people who pursue precision medicine will be disappointed, because testing won't lead to a new treatment. Precision medicine "is not addressing the needs of the majority of cancer patients," he said.

Many of the doctors I interview as a health care reporter are uncomfortable talking about patients who don't survive.

While acknowledging that not all patients are helped by tumor sequencing, they quickly pivot to talking about people they've saved. They rush past the disappointing present and fast-forward to a future in which every patient gets the treatment she or he needs. If you don't listen carefully, you could easily be led to believe those future cures are already here.

There are very few instances in which we can look at a genomic test and pick a drug off the shelf and say, 'That will work.'

Dr. Nikhil Wagle, cancer specialist at Boston's Dana-Farber Cancer Institute

Hospitals promote their precision-medicine programs by showcasing the stories of long-term survivors. Companies such as Foundation Medicine, Caris Life Sciences and Guardant Health — which sell the tests that look for cancer mutations — highlight only the best-case scenarios on their websites. In drug company marketing, patients are cheerleaders for the latest treatment fad.

Against this backdrop of hope and desperation, how are patients supposed to make informed decisions?

DiCanto gave precision medicine everything she had, including biopsies from her lungs and liver, where her cancer had spread. Over 2½ years, her doctor sent seven blood and tissue samples to specialized labs for "next-generation sequencing," which can quickly scan hundreds of genes. The tests aim to locate a cancer's Achilles' heel — a genetic vulnerability that can be targeted with a drug.

DiCanto's first genomic test matched her to a newly approved drug she would have tried anyway, Primiano said. When it stopped working, she had another biopsy.

That time, tests matched her to a different drug approved for breast cancer. But it proved so toxic that it "nearly killed her," Primiano said.

Additional tests matched DiCanto to drugs available only in clinical trials. Eligibility criteria for clinical trials are notoriously strict, however, and often exclude people who've been heavily treated with other medications. DiCanto wasn't eligible for any of them. Even when patients are eligible for trials, many turn them down. They're just too frail and sick to travel to the metropolitan areas where most trials are run.

Although DiCanto benefited from standard cancer treatments, none of the targeted therapies recommended through genetic testing extended her life, Primiano said.

"She didn't give up," Primiano said. "Her body gave up. Her body just couldn't take it anymore."

Primiano said patients should remember that precision medicine is in its infancy. Although scientists have identified tens of thousands of genetic "variations" — changes from normal DNA that could play a role in cancer — doctors have only a few dozen drugs with which to target them. In the majority of cases, genetic mutations are of "unknown significance"; they're essentially useless, because scientists don't know if they affect how patients respond to drugs.

Even when drugs are a good match for a specific mutation, they don't always work. A targeted therapy that works in melanoma, for example, doesn't help people with colorectal cancer — even when patients have the exact same mutation, said Wagle, a member of the medical advisory board for Living Beyond Breast Cancer, a patient advocacy group in which DiCanto was active.

Paying for tests and treatment poses its own hurdles. Insurers often tell patients that next-generation sequencing is unproven. Even when insurers agree to cover the testing, they won't necessarily cover nonstandard or experimental treatments that sequencing companies recommend.

Primiano, a insurance broker, said his family was able to handle the costs: $500,000 out-of-pocket on his wife's cancer care over 13 years. But managing his wife's cancer "was a full-time job — doing the research, finding the clinical trials, dealing with the insurance companies, managing the money."

He worries about people with fewer resources, especially patients tempted to drain their savings account to pay for a treatment with little to no chance of working.

The very words "precision medicine" suggest a high rate of success, Primiano said. While its successes should be celebrated, its failures must be acknowledged and tallied, reminding us how much is left to learn. When patients and their families have so much on the line, they deserve to understand what they're paying for.

"Let's not pretend this is something it isn't," Primiano said. "I'm not saying we shouldn't try it. I just don't want people to have false hope."

Insurer To Purdue Pharma: We Won't Pay For OxyContin Anymore

KFF Health News, September 13, 2018

This move could reduce fraudulent prescriptions to street dealers or drug-seeking people with active addictions and cut down on costly hospital stays for overdoses.

This article first appeared September 13, 2018 on Kaiser Health News.

By Blake Farmer, Nashville Public Radio

The largest insurer in Tennessee has announced it will no longer cover prescriptions for what was once a blockbuster pain reliever. It's the latest insurance company to turn against OxyContin, whose maker, Purdue Pharma, faces dozens of lawsuits related to its high-pressure sales tactics around the country and contribution to the opioid crisis. Last fall, Cigna and Florida Blue both dropped coverage of the drug.

Top officials at BlueCross BlueShield of Tennessee say newer abuse-deterrent opioids work better, and starting in January, the insurer covering 3.4 million Tennesseans will pay for those opioids made by other pharmaceutical companies instead.

"We felt it was time to move to those products and remove Oxycontin from the formulary, which does still continue to have a higher street value," said Natalie Tate, the insurer's vice president of pharmacy.

OxyContin was reformulated in 2010 to make the drug harder to misuse — but it's still possible to crush or liquefy in order to snort or inject it.

The latest long-acting opioids that BlueCross BlueShield of Tennessee is going to start covering — Xtampza and Morphabond — are still more difficult to misuse, according to the company and some pharmaceutical experts.

Motives Questioned

In a page-long response a reporter's query, a Purdue Pharma spokesman pointed out that no opioid drug is "abuse proof" or less addictive, accusing BCBST of financial motives that remove choices for many patients.

"We believe that patients should have access to FDA-approved products with abuse-deterrent properties," Purdue's Robert Josephson wrote in an email. "The recent decision by BlueCross BlueShield of Tennessee limits prescribers' options to help address the opioid crisis."

In response, BCBST's Tate argued that ditching one of the most recognized names in opioids is not designed to save money, though it could in a roundabout way.

This move could reduce fraudulent prescriptions to street dealers or drug-seeking people with active addictions and cut down on costly hospital stays for overdoses, said pain consultant and pharmacist Jeff Fudin, an adjunct professor at Albany College in New York.

"It's a smart idea to use dosage forms that have proven to have been better abuse-deterrent formulations," he said. "In the long run, it actually will cost them a whole lot less money."

Fudin said he's often at odds with insurers over their decisions about which drugs to cover, but he applauds this decision, which he expects more insurers to follow.

Alternative Therapies

Practicing pain physicians in Tennessee — who regularly battle with insurance companies — also approve of the change, though they said OxyContin was already falling out of favor. And they argue trading one opioid for slightly safer ones doesn't address a larger gripe that physicians have with insurers over paying for other, non-addictive types of treatment.

"We will have denials and prior authorizations on a muscle relaxer, and we will have no issue getting an opioid through the insurance company," said Dr. Stephanie Vanterpool, an anesthesiologist at the University of Tennessee and the president-elect of the Tennessee Pain Society.

"The physicians or the doctor's offices jump through hoops to get the better medication for the patients," said Vanterpool. "And when I say better medication, I mean the medication that's treating the cause of the pain, not just the medication that's covering up the pain."

BlueCross BlueShield of Tennessee is adding some alternative pain therapies in the coming year, according to its announcement last week. But Vanterpool would like to see a philosophical about-face.

Not to say OxyContin won't be sorely missed by some patients.

"There are plenty of people who benefit from that drug," said Terri Lewis, a patient advocate and rehabilitation specialist from Cookeville, Tenn.

She's suspicious of BCBST's motives since the insurer may be blamed for its role in the opioid crisis. Embattled Purdue Pharma could be a convenient scapegoat.

"Maybe this is a good decision," Lewis said. "But it smells like a political decision."

And this would be just the latest decision inserting politics into a nuanced medical problem.

A Blessing In Disguise?

The Tennessee legislature instituted some of the tightest opioid prescribing regulations in the country this year — a three-day limit for most people who aren't already on opioids. And even long-term pain patients are having trouble getting refills.

John Venable of Kingsport, Tenn., was shown the door by his pain clinic in July after more than a decade on oxycodone — a generic, short-acting version of OxyContin.

"I just felt like I was in a hopeless state, like, 'there is no help for John,'" he recalled.

At their worst, he said his headaches get so debilitating "that death would be a relief." Despite his dread, he's noticed something surprising over the last few months without opioids — his crippling headaches haven't gotten that much worse, if at all.

"It very well might be a blessing in disguise," Venable said.

The retired builder and one-time pastor said he prays that those losing OxyContin also will get to use the moment as an opportunity, though he knows many can't cut ties with opioids. And he worries some will turn to more dangerous drugs off the street or even contemplate ending their own lives.

Experts point out that the number of opioid prescriptions has already been falling around the country. And in Tennessee, BCBS has experienced a 26 percent drop in opioid prescription claims over three years.

But restricting legal access to opioids hasn't turned back the rise in overdose deaths, which hit a record in Tennessee and nationwide last year.

In Trump's First Year, Nation's Uninsured Rate Unchanged

KFF Health News, September 13, 2018

An estimated 8.8% of the population, or about 28.5 million people, did not have health insurance coverage at any point in 2017.

This article first appeared September 12, 2018 on Kaiser Health News.

By Phil Galewitz

Despite Republican resistance to the federal health law, the percentage of Americans without health insurance in 2017 remained the same as during the last year of the Obama administration, according to a closely watched report from the Census Bureau released Wednesday.

However, the uninsured rate did rise in 14 states. It was not immediately clear why, because the states varied dramatically by location, politics and whether they had expanded Medicaid under the federal health law. Those states included Texas, Florida, Vermont, Minnesota and Oregon.

The uninsured rate fell in three states: California, New York and Louisiana.

An estimated 8.8 percent of the population, or about 28.5 million people, did not have health insurance coverage at any point in 2017. That was slightly higher than the 28.1 million in 2016, but did not affect the uninsured rate. The difference was not statistically significant, according to the Census report.

About 17 percent of Americans were uninsured in 2010, the year the Affordable Care Act was enacted.

The Census numbers are considered the gold standard for tracking who has insurance because the survey samples are so large.

Census of Uninsured

Analysts credit the health law with helping drive down the number of uninsured. But also a factor: The proportion of people without insurance typically falls as unemployment rates decline. That's because more people can get health coverage at work or can better afford buying insurance on their own.

The nation's unemployment rate has generally been falling since before 2011 and was 4.1 percent for the last quarter of 2017, the lowest level since before the Great Recession began in December 2007.

Critics of the health law said the report emphasized its deficiencies. "Today's report is another reminder that Obamacare has priced insurance out of the reach of millions of working families," Marie Fishpaw and Doug Badger of the Heritage Foundation said in a statement. "Despite a growing economy and very low unemployment rate, the uninsured rate remains virtually unchanged."

But the law's supporters instead saw the glass as half full.

"These numbers show the resilience of the Affordable Care Act," said Judith Solomon, senior fellow at the Center on Budget and Policy Priorities. She said people still value the coverage they receive from the health law even as it's been under attack by President Donald Trump and Republicans who want to repeal it. "It's good news because the numbers show the strength of the ACA but bad news in that we have not seen further progress."

Solomon expressed concern, though, about the large number of states seeing uninsured rates increase.

Uninsured rates last year ranged from a high of more than 17 percent in Texas to low of just under 3 percent in Massachusetts.

West Virginia had one of the sharpest increases in uninsured.

About 14 percent of the state's residents were uninsured in 2013 before the ACA's premium subsidies and Medicaid expansion began. That rate fell by nearly two-thirds by 2016. Last year, however, West Virginia's uninsured rate crept up 0.8 percentage points to 6.1 percent, according to the Census report.

Carol Bush, 58, of Elkins, W.Va., expects to lose coverage Oct. 1 because her job is ending.

It's an unfortunate irony: Elkins has served for the past three years as a navigator helping people in her community find coverage in the health law marketplaces. Federal officials have largely scrapped that program.

The Trump administration cut funding by more than 80 percent during the past two years, saying it had no proof that navigators were helping people find coverage. Only if consumers signed up in the presence of the navigator was a session considered a success.

Bush had coverage through the University of West Virginia, which has a navigator contract that ends at the end of this month. Without employer coverage, Bush said, the cheapest insurance she could find would be about $1,100 a month. She won't qualify for a federal subsidy to lower her premium because of her family's income. Her husband is insured through Medicare.

Although she said she has strongly considered going without insurance because of the cost, she knows she needs it.

"In all honesty, I've always had some kind of health insurance, and the thought of being without it worries me," she said. "I can't risk getting seriously ill and incurring enormous debt at this point in my life. Peace of mind has a value too."

Shenandoah Community Health Center, a federally funded health clinic in Martinsburg, W.Va., has started to see an increase in uninsured patients the past year, although it's still below levels it saw before the health law's coverage expansion began in 2014, said CEO Michael Hassing. Hassing said he believes many patients have dropped coverage, thinking the ACA's individual mandate was repealed.

"Folks say, 'I don't need to have it anymore,' and they let it go," he said.

While the GOP failed last year to repeal the law, Congress was able to strip out one of its key features — the individual penalty for not having coverage. The vote last December eliminated that penalty starting in 2019 — meaning Americans are still required this year to have health coverage or face the consequences on their 2018 taxes.

Unwitting Patients, Copycat Comments Play Hidden Role In Federal Rule-Making

KFF Health News, September 11, 2018

The pattern identified in the 340B comments suggests the system can easily be manipulated. Patients may be especially vulnerable to being used.

This article first appeared September 11, 2018 on Kaiser Health News.

By Sarah Jane Tribble

A proposal to sharply cut a drug discount program that many hospitals rely on drew some 1,400 comments when the Trump administration announced its plan last year. Hundreds appeared to come from patients across the country — pleas from average Americans whose treatments for diseases such as cancer depend on costly medicines.

But a review of the responses found that some individuals were not aware they apparently had become part of an organized campaign to oppose what's known as the "340B" program. Some had no memory of signing anything, much less sending their opinions about it.

Of the 1,406 comments that specifically mentioned 340B — part of several thousand comments submitted on a broad proposal to revise medical payment systems — about half included the same or similar wording and were submitted anonymously, an analysis by Kaiser Health News found. Those comments lamented "abuse" of the drug discounts, faulted hospitals for being "greedy" and used phrasing such as "quality, affordable, and accessible."

Two that were duplicated hundreds of times made the very same grammatical mistake.

They "are clearly related," said Robert Leonard, a forensic linguistic expert at Hofstra University whose team analyzed the submissions for KHN.

In fact, the wording in the duplicate comments tracks language in a formal letter submitted to regulators by a nonprofit trade group, the Community Oncology Alliance, which receives funding from pharmaceutical companies.

Cancer survivor Janice Choiniere's name is on a public comment saying reform of the 340B program will help "those suffering from this insidious disease." But when reached by phone, the 69-year-old Florida resident said she had "no idea" what the program is and didn't recall signing a petition.

"My first thought is, I don't fill out and send in responses casually," Choiniere said. "I'm hoping nobody lifted my information."

The quarter-century-old federal program requires pharmaceutical companies to sell certain drugs at steep discounts to eligible hospitals and clinics, which don't have to share their savings with patients. Critics, including Republican lawmakers, have questioned what the facilities do with the money. Doctors in private practice, who are not eligible for the reduced rates, have warned that the program's continued growth makes it susceptible to exploitation.

The administration's plan, finalized in November, reduced by $1.6 billion annually what the Centers for Medicare & Medicaid Services pays for the targeted drugs. In late July, the agency proposed expanding those payment cuts.

As with any proposed rule, the purpose of requesting public comments is to help lawmakers and regulators consider the potential effects of their actions. But the pattern identified in the 340B comments, which were posted online by CMS, suggests the system can easily be manipulated. Patients may be especially vulnerable to being used.

"It feels like inappropriate influence," said Peter Ubel, a physician and behavioral scientist at Duke University's Fuqua School of Business. "When you have a life-threatening illness, you need to know you can trust your physician to care about your interests ahead of their own."

KHN reached 10 individuals whose names appeared in the comments — either as a signature on a personal note or on a petition also signed by others. All were patients, former patients or caregivers seen at private practices connected to the Community Oncology Alliance.

Two patients confirmed they had written notes, although they couldn't say when. Several said they must have signed or written something amid the paperwork handed to them at a doctor's office during appointments or in follow-up correspondence. A few drew mental blanks.

The name of an 84-year-old melanoma patient shows as an online signature in an individual public comment that described the program's reform as a matter of "life or death." But the Florida man, who asked not to be identified, had little recollection of writing it. His wife remembered that he signed something at his doctor's office "out front on a clipboard" before getting his biweekly cancer treatment.

"If my doctor wanted me to sign something, I would sign it for him," the man said. He "saved my life."

Julie Yarbrough, whose husband received treatment at New England Cancer Specialists in Maine, remembered signing a petition "at the [doctor's] check-in area" about hospitals abusing 340B discounts. She was the only individual contacted who had a basic understanding of the program.

The patients reached by KHN sought care at either New England Cancer Specialists, which has three locations in Maine, or Florida Cancer Specialists, which runs nearly 100 treatment centers in that state. Data posted on the federal website regulations.gov show that more than 60 percent of the 340B-specific comments originated in Florida.

"We do a good job of educating patients and letting them know how to get involved," said Michael Diaz, director of patient advocacy for Florida Cancer Specialists and vice president on the Community Oncology Alliance's executive committee. "They need to be able to contribute and give their opinion."

Steve D'Amato, executive director of New England Cancer Specialists and an Alliance board member, mentioned patients' support in a letter accompanying a petition posted multiple times to the government portal Oct. 10. The petition included the trade group's website; D'Amato noted that "patient signatures obtained in just 2 days" were attached.

When asked recently about patients who didn't recall signing something, D'Amato said he did not have the petition in front of him and referred all questions to the Alliance's executive director, Ted Okon. In an interview, Okon denied that the organization had any role in soliciting patient comments.

"We didn't do anything with patient petitions," said Okon, although talking points and material were sent to practices nationwide for them to use when submitting comments. "This is what we do in terms of advocating."

Susannah Rose, scientific director of research in the Cleveland Clinic's patient experience office, said there is "always a worry about coercion" when doctors make a request of patients, but more so when oncologists do the asking.

"Cancer patients often feel very much in the hands of their oncologists, and they are often suffering from significant distress," said Rose, who serves on the ethics committee of the American Society of Clinical Oncology.

The Washington-based Alliance represents private oncology practices as well as about 50 corporate members, according to its website. Formed in 2003 when Congress approved Medicare's prescription drug program, it was a leading critic of a controversial 2016 proposal to change how CMS paid for some drugs in Medicare. The group's revenue nearly quadrupled that year, to $16.3 million from $4.4 million in 2015, according to federal tax filings. The proposal never became reality.

Pharmaceutical giants Sanofi, Pfizer, Eli Lilly, Bristol-Myers Squibb and Merck each confirmed paying annual dues of $75,000 to the Alliance. The five companies also paid it nearly $1 million between 2014 and 2017 for research papers, conferences, filming and patient education, according to corporate transparency reports.

Walgreens and PhRMA, the pharmaceutical industry trade group, also confirmed membership but did not disclose how much they pay in dues. Okon said corporate membership fees range from $25,000 to $75,000 annually while individual oncologists and their practices pay "usually on the order of a thousand dollars, two thousand dollars."

Drug manufacturers do not influence the Alliance's position on 340B, he said, noting in an email that "correlation is not causality."

After the comment period ended, CMS slashed 340B payments to hospitals by $1.6 billion annually. Medicare had been paying hospitals 6 percent above a drug's average sales price; it now pays them 22.5 percent less than the average sales price.

CMS Administrator Seema Verma and Eric Hargan, deputy secretary of the Health and Human Services Department, emphasized that public comments played into their decision. In the 1,133-page final rule, they said they shared the concern that current Medicare payments "are well in excess of the overhead and acquisition costs" for drugs bought under the program.

"We thank the commenters for their support," they wrote.

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