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Updated: 17 hours 23 min ago

Influential Leapfrog Group Jumps In To Rate 5,600 Surgery Centers

October 16, 2018

The influential Leapfrog Group, which grades nearly 2,000 U.S. hospitals, is launching a national survey to evaluate the safety and quality of up to 5,600 surgery centers that perform millions of outpatient procedures every year.

The group now issues hospitals an overall letter grade and evaluates how hospitals handle myriad problems, from infections to collapsed lungs to dangerous blood clots — helping patients decide where to seek care.

Simple Surgeries. Tragic Results.

The new surgery center effort will focus on staffing, surgical outcomes and patient experience in facilities that are performing increasingly complex procedures and seeing more aging patients. The grades will also cover surgery centers’ closest competitor, hospital outpatient departments.

Leah Binder, Leapfrog Group’s chief executive, said she wants to fill gaps in information about same-day surgery, which employers and health plans have embraced for its lower costs.

Employers, she said, “don’t have enough information on quality and safety of that care.”

Binder said a recent Kaiser Health News/USA Today Network investigation highlighted the need for independent information about surgery centers. The investigation found that since 2013, more than 260 patients died after care at centers that lacked appropriate lifesaving equipment, operated on very fragile patients or sent people home before they fully recovered.

“Your reporting did highlight the real lack of information from the federal government and the need for us to have an independent means of reporting,” Binder said. “People are going in for surgery, and our federal government doesn’t think it’s important to tell us how it’s going. Maybe that was OK 30 years ago, but now it’s not OK.”

The news report was based on inspection reports, lawsuits and data from many states that tally patient deaths but which refuse to note where they occurred. Seventeen other states collect no data on deaths at all.

The new Leapfrog plan will start with a survey of 250 centers in 2019 and include up to 5,600 surgery centers in 2020. At that point, it will publish data on the outcomes of specific procedures, like total knee replacements, across the hospital outpatient departments and surgery centers nationwide.

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The Leapfrog Group is funded by employers and health plans that cover the health care of the half of Americans who get health benefits through their job, Binder said. The organization was founded to shed light on health care quality and safety to help consumers pick high-value providers. It plans to disseminate the new surveys through its 40 business group members that steer millions in health spending.

Bill Prentice, chief executive of the Ambulatory Surgery Center Association, an industry trade group, said he supports the move toward greater transparency. However, he said the work to determine the specific measures is still underway, and “the devil is in the details.”

Ty Tippets, administrator of St. George Surgical Center in Utah, said he welcomes what Leapfrog is doing.

“Anytime [data] is gathered and provided in a transparent, easily accessed forum — it helps empower patients,” said Tippets, who recently testified before Congress about transparency in health care.

The Leapfrog Group announcement comes as Medicare is reviewing the data it will collect to gauge the quality of surgery centers.

The agency previously asked each surgery center to report its emergency transfer rate, or how often a patient 65 or older was sent from a center to the hospital. Yet the agency only required the centers to send data for half or more of its Medicare patients.

In the current rule-making period, Medicare declared the resulting data of little value, given the minimal differences among centers’ scores. The agency proposed dropping the measure, but has not yet finalized the proposal.

Going forward, Medicare has said it will use its own billing data to report the percent of surgery center patients who seek care at a hospital in the week after a procedure.

Medicare recently announced plans to shine more light on the performance of accreditors, which play a key role in granting or denying health facilities approvals to operate. A recent KHN investigation into accreditor performance in California — the only state where the private bodies’ inspection reports are public — showed repeated lapses in oversight.

A Medicare spokesman said new reports will show how well accreditors fare when state health officials inspect the same facilities.  In recent years, Medicare has found that accreditors overlooked the majority of problems that government officials uncovered.

In September, the White House Office of Management and Budget approved another health agency’s proposal to collect and report data about the “culture of safety” in surgery centers. The Agency for Healthcare Research and Quality will ask surgery center staff about issues such as whether staff feel comfortable speaking up about patient care concerns.

The plan says summary data — not facility-by-facility data — on the survey’s results will be reported publicly.

That effort would add to the overall information the public has about surgery centers, said Dr. Ashish Jha, a patient safety expert at Harvard’s School of Public Health.

“Places that do badly on safety culture surveys tend to have worse outcomes,” Jha said. “But you can’t bank on it.”

He said the most useful data for the public would cover actual events — such as deaths after surgery, admissions to the hospital or functional status and pain three months after surgery.

“Those are the things that actually matter,” he said.

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

Drugmakers Funnel Millions To Lawmakers; A Few Dozen Get $100,000-Plus

October 16, 2018

Explore The Database Campaign Contributions Tracker

Pharma Cash To Congress

By Elizabeth Lucas and Sydney Lupkin 2:00 AM EDT

A new Kaiser Health News database tracks campaign donations from drugmakers over the past 10 years.

Before the midterm elections heated up, dozens of drugmakers had already poured about $12 million into the war chests of hundreds of members of Congress.

Since the beginning of last year, 34 lawmakers have each received more than $100,000 from pharmaceutical companies. Two of those — Reps. Greg Walden of Oregon, a key Republican committee chairman, and Kevin McCarthy of California, the House Republican majority leader — each received more than $200,000, a new Kaiser Health News database shows.

As voters prepare to go to the polls, they can use a new database, “Pharma Cash to Congress,” tracking up to 10 years of pharmaceutical company contributions to any or all members of Congress, illuminating drugmakers’ efforts to influence legislation.

The drug industry ranks among lawmakers’ most generous patrons. In the past decade, Congress has received $79 million from 68 pharma political action committees, or PACs, run by employees of companies that make drugs treating everything from cancer to erectile dysfunction.

This story also ran on Daily Beast. This story can be republished for free (details). Drugmakers’ campaign contributions have reached record-breaking levels in recent years as skyrocketing drug prices have become a hot-button political issue. By June 30, 52 PACs funded by pharmaceutical companies and their trade organizations had given about $12 million to members of Congress for this election cycle. It is unclear whether drugmakers will top their previous 10-year record of $16 million, given during the 2016 election season.

While PAC contributions to candidates are limited, a larger donation frequently accompanies individual contributions from the company’s executives and other employees. It also sends a clear message to the recipient, campaign finance experts say, one they may remember when lobbyists come calling: There’s more where that came from.

The KHN analysis shows that pharmaceutical companies tend to play the field, giving to a wide swath of lawmakers on both sides of the aisle.

The drug industry favors power. Since the beginning of 2017, drugmakers contributed to 217 Republicans and 187 Democrats, giving only slightly more on average to Republicans, who currently control both chambers of Congress. This was also the case for Democrats during the 2010 election cycle, when they controlled Congress.

As with other industries, drugmakers tend to give more to lawmakers in leadership roles. For example, Rep. Paul Ryan, a Wisconsin Republican, became speaker of the House halfway through the 2016 election cycle, prompting drugmakers to pour $75,000 more into his war chest than they had the previous cycle.

Money also tends to flow to congressional committees with jurisdiction over pharmaceutical issues that can affect things like drug pricing and FDA approval. Walden, a nine-term Republican congressman, has watched his coffers swell with help from drugmaker PACs since he became chairman of the powerful House Committee on Energy and Commerce in early 2017.

With six months to go in the 2018 cycle, Walden had already raised an additional $71,000 over the 2016 cycle — or 11 times more than drugmakers gave him a decade ago.

Asked to comment on the increase in Walden’s contributions from drugmakers, Zach Hunter, his committee spokesman, called attention to Walden’s work to lower prescription drug prices and said “no member of Congress has done more” to end the opioid crisis.

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Pharmaceutical company PACs also gave to dozens of other members of committees, such as the Senate Committee on Health, Education, Labor and Pensions. And they appear to target congressional districts that are home to their headquarters and other facilities.

The PAC for Purdue Pharma, the embattled opioid manufacturer, gave to only a handful of members this cycle. However, it focused much of its giving on lawmakers from North Carolina, its headquarters for manufacturing and technical operations.

This election cycle, 28 percent of lawmakers did not receive any contributions from pharmaceutical PACs.

Under federal law, corporations cannot donate directly to political candidates. Exploiting a common loophole, they instead set up PACs, funded by money collected from employees. Those PACs then donate to campaigns, which are free to spend that money as they wish on necessities like advertising or campaign events.

Campaign contributions tell only part of the story. Drugmakers also spend millions of dollars lobbying members of Congress directly and give to patient advocacy groups, which provide patients to testify on Capitol Hill and organize social media campaigns on drugmakers’ behalf.

A previous investigation by Kaiser Health News, “Pre$cription for Power,” examined charitable giving by top drugmakers and found that 14 of them donated a combined $116 million to patient advocacy groups in 2015 alone.

To learn more about how Kaiser Health News built the Pre$cription for Power database, read our methodology.

And like other industries, pharmaceutical companies wield their political power in ways veiled from the public, giving to “dark money” groups and super PACs — independent groups barred from directly donating to or coordinating with campaigns — bent on swaying lawmaking.

Brendan Fischer, who directs federal reform programs at the Campaign Legal Center, cautioned that a campaign contribution from a corporate PAC does not directly translate into a vote in the drugmaker’s favor.

“Contributions help keep the door open for company lobbyists,” he said.

KHN data editor Elizabeth Lucas contributed to this story.

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

Pharma Cash To Congress

October 16, 2018

Every year, pharmaceutical companies contribute millions of dollars to U.S. senators and representatives as part of a multipronged effort to influence health care lawmaking and spending priorities. Use this tool to explore the sizable role drugmakers play in the campaign finance system, where many industries seek to influence Congress. Discover which lawmakers rake in the most money (or the least) and which pharma companies are the biggest contributors. Or use our search tool to look up members of Congress by name or home state, as well as dozens of drugmakers that KHN tracks.

Methodology

Kaiser Health News uses campaign finance reports from the Federal Election Commission (FEC) to track donations from political action committees (PACs) registered with the FEC by pharmaceutical companies. Totals include donations to the principal campaign committees and leadership PACs for current members of Congress. We include only donations to members for election cycles in which they hold office (even if they weren’t in office for the full cycle, in the case of special elections). Donations are assigned to the quarter in which they were given, regardless of when they are reported by the receiving committee or PAC. Exact amounts can change as amendments and refunds are reported; KHN will update the analysis quarterly. Occasionally, refunds are reported in a different cycle from the original contribution, resulting in a negative total for the cycle.

There is a legal limit to how much each PAC can give to a member of the Senate or House of Representatives: $5,000 per election (including primaries and general elections) and per committee, or $10,000 per cycle. Each cycle is two calendar years, e.g. Jan. 1, 2017-Dec. 31, 2018.

When calculating changes in contributions from one cycle to another, we compare the latest quarter in the current cycle to the same point in the previous cycle for all drugmakers and for members of the House, who run for re-election every two years. For senators, who run for re-election every six years, we compare the current cycle to the cycle six years prior. We use the ProPublica Congress API to gather some information about past and present members. We use both Open Secrets and CQ Political Moneyline to collect additional information about PACs and verify our work.

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

TV Ads Must Trumpet Drug Prices, Trump Administration Says. Pharma Tries A Plan B.

October 15, 2018


[UPDATED at 6:45 p.m. ET]

The Trump administration proposed Monday that drugmakers reveal the list prices of their medicines in television ads, effectively setting the stage for months or possibly years of battle with the powerful industry.

The proposal, released late in the day, would require pharmaceutical companies to include in its television advertising the price of any drug that cost more than $35 a month. The price should be listed at the end of the advertisement in “a legible manner,” the rule states. It goes on to explain that the price should be presented against a contrasting background in a way that is easy to read.

Related Story More Stories On Drug Costs

Health and Human Services Secretary Alex Azar, nodding to an industry proposal announced earlier in the day, said voluntary moves are not enough.

“We will not wait for an industry with so many conflicting and perverse incentives to reform itself,” Azar told the audience gathered at the National Academy of Sciences in Washington, D.C.

If approved, the proposed rule has no government enforcement mechanism that would force the companies to comply. Rather, it depends on shaming, noting that federal regulators would post a list of companies violating the rule. It would depend on the private sector to police itself with litigation.

“It is noteworthy that the government is unwilling to take enforcement action,” said Rachel Sachs, an associate professor of law at Washington University at St. Louis and expert in drug-pricing regulation. The rule might never be finalized, she added.

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“It will take many months if not years for this regulation to be implemented and free from the cloud of litigation that will follow it. And the administration knows that,” Sachs said.

Earlier Monday, the pharmaceutical industry trade group went on the offensive in anticipation of Azar’s speech by announcing its own plans.

“Putting list prices in isolation in the advertisements themselves would be misleading or confusing,” argued Stephen Ubl, CEO of the Pharmaceutical Researchers and Manufacturers of America, or PhRMA, the major trade group for branded drugs.

Instead, Ubl, whose trade group represents the largest pharmaceutical manufacturers on the globe, promised that pharma companies would direct consumers to websites that include a drug’s list price and estimates of what people can expect to pay, which can vary widely depending on coverage.

Drug manufacturers would voluntarily opt in to this disclosure starting next spring, he said. Ubl remained strongly critical of the White House proposal.

The Trump administration’s proposal comes weeks before midterm elections in which health care is a top voter concern. Polling from the Kaiser Family Foundation suggests most voters support forcing price transparency in drug advertisements. (Kaiser Health News is an editorially independent program of the foundation.)

The White House’s plan, which was teased in President Donald Trump’s blueprint this summer, has won praise from insurance groups and the American Medical Association.

Sens. Chuck Grassley (R-Iowa) and Dick Durbin (D-Ill.) also proposed the plan in the Senate last month, but it failed to garner enough support.

Experts pointed out a host of complications, suggesting that neither PhRMA’s approach nor the White House’s would fully explain to consumers what they’ll actually pay for drugs.

On Monday, Grassley applauded Azar’s announcement, saying it was a “common-sense way to lower prices.”

But Dale Cooke, a consultant who works with drug companies trying to meet Food and Drug Administration requirements for advertising, warned there is no reason to believe posting prices would help drive down prices.

“No one has ever explained to me why this would work,” Cooke said. “What’s the mechanism by which this results in lower drug prices?”

Even more, it could be confusing for patients, Cooke said. The proposed rule seemed to acknowledge this danger, he said, noting, “On the other hand, consumers, intimidated and confused by high list prices, may be deterred from contacting their physicians about drugs or medical conditions.”

A drug’s list price — the metric HHS wants to emphasize — often bears little relationship to what a patient pays at the drugstore. Insurance plans and pharmacy benefit managers often negotiate cheaper prices than the list price. Some patients qualify for other discounts. And often patients pay only what their copay or deductible requires at any given time.

Other consumers could be stuck paying the full cost, depending on how their insurance plan is designed, or if they don’t have coverage.

“The system is very opaque, very complicated and, importantly, there isn’t a huge relationship between list prices for drugs and what patients will expect to pay out-of-pocket,” said Adrienne Faerber, a lecturer at the Dartmouth Institute for Health Policy and Clinical Practice who researches drug marketing.

But the industry’s strategy, she said, also appeared lacking.

Under PhRMA’s plan, drugmakers would not standardize how they display their information. Where consumers go could vary on Pfizer’s website versus Merck’s to learn about the list price and the range of out-of-pocket costs. That, Faerber argued, would make it difficult for people to unearth relevant information.

PhRMA also announced it is partnering with patient advocacy groups to create a “patient affordability platform,” which could help patients search for costs and insurance coverage options.

Ubl cast their proposal as a way to address more effectively the government and public concern about drug price transparency.

Pharmaceutical manufacturers rely heavily on national advertising and together represent the third-highest spender in national television advertising, according to Michael Leszega, a manager of market intelligence at consulting firm Magna.

At certain times of day, pharmaceutical ads make up more than 40 percent of TV advertisements. And those commercials stand out because they are generally longer, with a long list of side effects and warnings the pharmaceutical industry must tag on at the end.

Those disclaimers highlight another challenge for the administration: legal action.

The rule notes its legal justification was based on the responsibility of the Centers for Medicare & Medicaid Services to ensure the health coverage programs that it administers — Medicare and Medicaid — must be operated in a manner that “minimizes reasonable expenditures.”

Sachs noted that the argument may be weak because most drugs are marketed to a wider audience than Medicare and Medicaid beneficiaries.

A body of Supreme Court decisions dictate how disclaimers and disclosures can be required, said constitutional law expert Robert Corn-Revere. He filed a “friend of the court” brief in a 2011 U.S. Supreme Court case related to commercial speech and the pharmaceutical industry.

Generally, the administration’s requirement must meet the standards of being purely factual, noncontroversial and not burdensome, Corn-Revere said.

On the question of whether requiring drug prices be listed in advertising violates the First Amendment’s free-speech guarantee, Corn-Revere said it “all comes down to the specifics.”

Ubl, when asked earlier about legal action, didn’t rule out the possibility. “We believe there are substantial statutory and constitutional principles that arise” from requiring list-price disclosure, Ubl said, adding: “We do have concerns about that approach.”

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

‘Grossly Unfair’? Widower Takes Ban On Military Injury Claims To Supreme Court

October 11, 2018

Walter Daniel, a former Coast Guard officer, filed a wrongful death lawsuit after his wife died following childbirth at a military hospital in 2015, but it was dismissed based on a 68-year-old federal ruling. After two failed appeals, he petitioned the U.S. Supreme Court to allow active-duty service members to seek legal damages for medical malpractice harm the same way civilians can.(Heidi de Marco/KHN)

This story also ran on The Seattle Times. This story can be republished for free (details). More than four years after Navy Lt. Rebekah Daniel bled to death within hours of childbirth at a Washington state military hospital, her husband still doesn’t know exactly how — or why — it happened.

Walter Daniel, a former Coast Guard officer, demanded explanations from officials at the Naval Hospital Bremerton, where his wife, known as “Moani,” died on March 9, 2014.

He says he got none. No results from a formal review of the incident, no details about how the low-risk pregnancy of a healthy 33-year-old woman — a labor and delivery nurse herself — ended in tragedy, leaving their newborn daughter, Victoria, now 4, without a mom.

“There was no timeline, no records of what steps were taken,” recalled Daniel, 39, sitting in his Seattle lawyer’s high-rise office last month. “I’ve had no answers.”

Daniel, who now lives in Dublin, Calif., filed a wrongful death lawsuit in 2015, but it was dismissed, as were subsequent appeals.

The dismissals were based not on the facts of the case but on what’s known as the Feres doctrine, a 68-year-old federal ruling that bars active-duty military members from suing the federal government for injuries.

This week, Daniel is taking his quest for answers to the U.S. Supreme Court.

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Through his lawyer, he petitioned the high court on Thursday to amend the 1950 ruling, creating an exception that would allow service members to sue for medical malpractice the same way civilians can.

The military health system, with 54 hospitals and 377 medical clinics, serves about 9.4 million beneficiaries, including nearly 1.4 million active-duty members.

“I don’t want this to happen to any other family,” Daniel said.

The Supreme Court hasn’t considered the Feres doctrine in more than 30 years, since the 1987 case U.S. v. Johnson, where the justices ruled 5-4 to uphold the ruling. That decision drew a scathing dissent from Justice Antonin Scalia, who declared the rule should be scrapped.

Feres [v. United States] was wrongly decided and heartily deserves the widespread, almost universal criticism it has received,” Scalia famously wrote.

Since then, however, the court has refused to accept at least two petitions that would have allowed reconsideration of Feres. And chances are slim now. Of the 7,000 to 8,000 cases submitted to the Supreme Court each term, only about 80 are accepted.

But Daniel and his lawyer, Andrew Hoyal of the Luvera law firm in Seattle, insist that the circumstances of Moani Daniel’s death warrant new scrutiny.

“We thought if we’re ever going to take a shot at the Feres doctrine, this is the case to do it,” Hoyal said. “It was clear negligence. It was an awful situation. And every civilian in the country would be able to bring a lawsuit to get accountability, except for members of the service.

“She was treated differently because she had lieutenant’s bars.”

Walter Daniel, a former Coast Guard officer, holds a photograph of his wife, Navy Lt. Rebekah Daniel, known as “Moani.” She died hours after giving birth to their daughter, Victoria, at the Naval Hospital Bremerton. Daniel says he received no details about how the low-risk pregnancy of his healthy 33-year-old wife, a labor and delivery nurse, ended in tragedy.(Heidi de Marco/KHN)

 

Walter Daniel plays with daughter Victoria near their apartment in Dublin, Calif., on Sept. 27, 2018.(Heidi de Marco/KHN)

A photo of Walter and Moani Daniel sits in the living room of the Daniels’ apartment. More than four years after Moani bled to death following childbirth at a Washington state military hospital, Daniel still doesn’t know exactly how or why it happened. (Heidi de Marco/KHN)

Daniel disputes the findings of a Navy autopsy that concluded Rebekah Daniel died of “natural” causes possibly linked to an amniotic fluid embolism, a rare, hard-to-prove complication of childbirth.

Daniel claims that his wife — who worked in the maternity unit where she delivered her baby — died from botched medical care that failed to stop her from hemorrhaging nearly a third of the blood in her body.

“It was utter chaos,” he recalled. “I remember multiple towels and sponges like they were trying to soak up the blood … but it kept coming.”

Doctors failed to perform vital tests, to employ an obstetrical balloon — a standard device used to halt postpartum hemorrhage — and to start massive blood transfusions until too late, court documents claim.

Just four hours after the birth of her 8-pound, 7-ounce daughter, Moani Daniel was dead.

“I was in shock,” recalled Walter Daniel.

Capt. Jeffrey Bitterman, commanding officer of Naval Hospital Bremerton, said in an email that the circumstances of Moani Daniel’s death were “thoroughly examined in a quality review process.” The results of the review cannot be publicly released, he said, declining further comment because of pending litigation.

However, in a press release promoting the “Aloha Moani” 5K run organized in Daniel’s honor, Navy officials publicly said she died “due to a rare complication of childbirth.”

Walter and Moani Daniel, who met in Hawaii, had been married nearly a decade when she became pregnant in 2013. Moani Daniel had a son, Damien, now 19, from a previous marriage.

Moani Daniel loved her job, but she had submitted her resignation to the Navy months earlier and was set to leave the service in April 2014. Walter Daniel had accepted a job in Northern California, where he had moved with Damien to get him settled in school.

The day after his wife’s death, Walter Daniel returned to her empty apartment.

“She had all this stuff for the baby set up,” he recalled. “I’m like, ‘What the hell just happened?’ It was like a nightmare.’”

The Feres doctrine holds that active-duty members of the military cannot sue under the Federal Tort Claims Act for harm “incident to service.” The justices wanted to ensure that Congress would not be “burdened with private bills on behalf of military and naval personnel.”

They reasoned then that the military provides comprehensive relief for injuries or death of service members and their families — and that there’s no parallel with private liability because the relationship between the government and its armed forces is distinct. Later, the court insisted that a primary reason for barring such lawsuits is to maintain military discipline.

But the decision, particularly the definition of “incident to service,” has been debated fiercely for years by scholars and, at least twice, in bills before Congress.

The rule, however, has been interpreted to include not just military duty, but virtually any activity of an active-duty service member, said Richard Custin, a clinical professor of business law and ethics at the University of San Diego.

“It’s just grossly unfair,” he said. “Childbirth is not a military activity. It’s clearly not ‘incident to service.’”

Custin and other critics claim the Feres doctrine strips military members of a constitutional right to seek redress for grievances, while also allowing military hospitals and doctors to escape scrutiny for negligent care.

Military hospitals reported 545 so-called sentinel events — medical omissions or errors — from 2014 to 2017, according to Defense Health Agency data. In 2014, Naval Hospital Bremerton reported at least one case of postpartum hemorrhage or hysterectomy.

But such reports aren’t public, so Daniel doesn’t know whether his wife’s case was included in those records. A 2014 review of military health care found the rate of postpartum hemorrhage was consistently higher in military hospitals than the national average, Hoyal noted.

“What they do in the medical arena is no different than what civilian hospitals do and they should be held to the same standards as civilian hospitals and civilian doctors,” Hoyal said.

Officials with the Department of Defense declined interview requests regarding the Feres ruling.

In an email, however, an agency spokeswoman said that overturning the rule would “destroy the premise” of no-fault workers’ compensation available in the military and elsewhere. It would also “create an unsustainable inequity” between military members allowed to sue and others, such as those injured in combat, who couldn’t.

And, rather than improving military health care, overturning Feres would “compromise its effectiveness,” the agency said, noting: “No medical system is perfect.”

Custin, the law professor, said he sympathizes with Daniel, but isn’t optimistic that the court will view the case differently than other medical malpractice claims.

“What this attorney needs to do is somehow distinguish Daniel from the long line of victims that have been maligned by Feres,” he said.

Walter Daniel has been raising daughter Victoria as a single dad for four years. After the death of his wife, Moani, he left the Coast Guard and returned to college to study to become a high school teacher.(Heidi de Marco/KHN)

Hoyal intends to argue that the Supreme Court’s rulings regarding Feres have been inconsistent and irreconcilable. In decisions that followed Feres, the court rejected its own “parallel liability” argument, said Hoyal. And it has never ruled that medical decisions like those at stake in Daniel’s case would undermine military discipline.

“In short, the legal landscape has undergone a sea change since 1950,” Hoyal’s petition states. “Theories once central to Feres no longer matter. Rationales not considered in Feres are now central.”

Such an argument may well sway an increasingly conservative Supreme Court that now includes justices loyal to Scalia’s views — as well as progressives inclined to support workers’ rights, said Dwight Stirling, chief executive of the Center for Law and Military Policy, a Southern California think tank.

“The Feres doctrine does not divide the court members on your standard ideological grounds,” he said. “It tends to scramble the typical calculus.”

Walter Daniel hopes so. After raising Victoria as a single dad for four years, he left the Coast Guard, recently remarried and returned to college to study to become a high school teacher. Even as his life moves on, he said, he hopes Moani Daniel’s case will provide justice for others.

“It’s not about the Daniel family, it’s about those thousands of service members throughout the world who are affected by this rule,” he said. “That’s what our fight is for.”

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

Doctors Give Medicare’s Proposal To Pay For Telemedicine Poor Prognosis

October 10, 2018

The Trump administration wants Medicare for the first time to embrace telemedicine across the country by paying doctors $14 for a five-minute “check-in” phone call with their patients.

But many physicians say the proposed reimbursement will cover a service they already do for free. And the Medicare reimbursement — intended to motivate doctors to communicate with patients outside the office — could have a chilling effect on patients because they would be required to pay a 20 percent cost-sharing charge.

Medicare said the call would be used to help patients determine whether they need to come in for an appointment. But doctors and consultants said the virtual sessions could cover a broad array of services, including monitoring patients starting a new medicine or those trying to manage chronic illnesses, such as diabetes. The Medicare Payment Advisory Commission, which provides guidance to Congress, panned the proposal last month, saying it could lead to excess spending without benefiting patients.

“Direct-to-consumer telehealth services … appear to expand access, but at a potentially significant cost and without evidence of improved quality,” the commission’s chairman, Dr. Francis Crosson, said in a letter to the Centers for Medicare & Medicaid Services (CMS). “Due to their greater convenience, these services are at risk of misuse by patients or provider.”

Congress has shied away from expanding the use of telemedicine in Medicare — even as it has become commonplace among private insurers — because of concerns about higher spending. Budget hawks worry that rather than replace comparatively expensive in-person visits, extra telemedicine billings would add to them.

Lack of coverage — except in rare circumstances — means fewer than 1 percent of the 50 million Medicare beneficiaries use telemedicine services each year.

Federal law forbids Medicare from paying for telemedicine services that replace in-person office visits, except in certain rural areas. That’s why CMS called the new benefit a check-in using “virtual” or “communications technology,” said Jacob Harper, who specializes in health issues at the law firm Morgan, Lewis & Bockius.

In addition to the check-in call, CMS has proposed starting to pay physicians to review photos that patients text or email to them to evaluate skin and eye problems, as well as and other conditions. It also has proposed paying physicians an unspecified fee for consulting electronically or by phone with other doctors.

“Innovative technology that enables remote services can expand access to care and create more opportunities for patients to access personalized care management as well as connect with their physicians quickly,” said CMS Administrator Seema Verma when announcing the proposal.

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CMS said it hopes to enact the changes in 2019. Officials will announce their final rule after evaluating public comments on the plan.

Verma and other CMS officials say they believe the change would end up saving Medicare money by reducing unnecessary office visits and catching health problems early, before they become more costly to treat.

But in its detailed proposal, CMS acknowledges the telehealth service will increase Medicare costs. CMS said the telehealth will result in “fewer than 1 million visits in the first year but will eventually result in more than 19 million visits per year, ultimately increasing payments under the [Medicare physician pay schedule] by about 0.2 percent,” or eventually about $180 million per year. Because the change must be budget-neutral, CMS is paying for this by decreasing some other Medicare physician payments.

CMS doesn’t expect rapid adoption of the telehealth service, partly because doctors can get paid from $35 to $150 for an in-person visit. “Because of the low payment rate relative to that for an office visit, we are assuming that usage of these services will be relatively low,” CMS said in its proposal.

The virtual check-in can be conducted by physicians or nurse practitioners or physician assistants working with a doctor.

Only patients who have established relationships with a doctor would be eligible for the service. Doctors also would not be allowed to bill for the check-in service if it stems directly from an in-person visit or is followed by an appointment with the doctor, according to the CMS proposal.

Dr. Michael Munger, a family physician in Overland Park, Kan., and president of the American Academy of Family Physicians, said many doctors routinely check on patients by phone. Still, he applauded the effort to increase physician pay.

“Anytime you can tie payment to what many of us are already doing is good,” he said.

Mercy, a large hospital system in St. Louis, has been offering telehealth services even without reimbursement because it helps patients access care and lowers costs in the long run, said Dr. J. Gavin Helton, president of clinical integration at Mercy Virtual.

“We are already on this path, and this will help to continue to grow our programs and make them financially sustainable,” he said.

Still, Helton said the “check-in” fee from Medicare won’t be enough to motivate providers to start telehealth services.

He said the new reimbursement signals that Medicare wants to pay for services to keep patients well rather than just treat them while they are sick.

Other physicians were more skeptical, particularly while Medicare has also proposed reducing some fees for in-person office visits.

In a letter to CMS, Dr. Amy Messier, a family medicine doctor in Wilmington, N.C., raised concerns about the effect this could have on patients’ expenses.

“I worry about implementation of this from the patient perspective now that we are charging patients for this previously free service and they have to pay their portion of the charge,” she said.

“Patients will be less likely to engage their physician outside of the office visit and more likely to seek care face-to-face at more expense, when perhaps that visit could have been avoided with a phone call which they will no longer make because it comes with a charge,” she said.

Dr. Todd Czartoski, chief executive of telehealth at Providence St. Joseph Health in Renton, Wash., predicts most doctors won’t use the proposed telehealth service.

“It’s still easier for a doctor to go room to room with patients lined up,” he said. “It’s a step in the right direction, but I don’t think it will open the floodgates for virtual care.”

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

The Feds’ Termination Of A Tiny Contract Inflames Bitter Fight Over Fetal Tissue

October 08, 2018

Federal health officials announced late last month they had terminated their contract with a company that supplies human fetal tissue for medical research and were checking that similar contracts, as well as studies conducted with that tissue, comply with federal law.

The seemingly innocuous release about a tiny government contract, which came out as Americans focused on Judge Brett Kavanaugh’s nomination to the Supreme Court, belied the big stakes and contentious issue behind it. Government officials are considering pulling federal funding for a decades-old form of research that has yielded a number of medical advances, including the polio vaccine.

The Department of Health and Human Services has faced mounting pressure from conservative lawmakers and abortion opponents, who strongly supported President Donald Trump’s candidacy, to halt the use of tissue obtained from aborted fetuses.

“The federal government must find ethical alternatives as soon as possible, and should end all association with those who participate in any trafficking or procurement of aborted baby organs,” 45 leaders from groups, including Susan B. Anthony List and the Family Research Council, wrote in a recent letter to HHS.

But a letter to congressional leaders, signed by 64 medical and scientific institutions including the American Academy of Pediatrics and Johns Hopkins University, said interfering in fetal tissue research would be “devastating.” The letter cited its impact in understanding viruses like Zika and HIV, as well as ongoing clinical trials to find treatments for spinal cord injuries.

“Fetal tissue research has been critical for scientific and medical advances that have saved the lives of millions of people,” they wrote.

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The supplier whose contract was terminated, a California-based company called Advanced Bioscience Resources, came under fire in 2015 when it was identified in videos that surreptitiously captured Planned Parenthood officials discussing how fetal tissue is provided to researchers.

The videos were part of a controversial sting operation by activists who alleged Planned Parenthood was unlawfully profiting from the sale of fetal tissue, including to Advanced Bioscience Resources. Planned Parenthood officials condemned the videos, which they said were deceptively edited. After its own investigation, a Texas grand jury declined to indict anyone from Planned Parenthood, instead indicting two of the activists responsible for the videos.

HHS vowed to look into the research “in light of the serious regulatory, moral, and ethical considerations.”

The announcement also comes weeks before Election Day, giving Republicans an opportunity to employ a potent talking point — their rigid opposition to Planned Parenthood — as they urge their supporters to vote.

Here’s what you need to know to understand the debate.

Where does fetal tissue come from, and how is it used in research?

Tissue from human fetuses is frequently used to make cell cultures, which allow researchers to examine biological processes in a laboratory setting.

The tissue comes from elective abortions, with the written consent of the woman donating the tissue. Health facilities where the abortion occurred may provide it directly to researchers or transfer it to a supplier, such as Advanced Bioscience Resources.

It is unclear how many suppliers there are. A 2015 report from the Congressional Research Service identified just a few known suppliers, citing a New York Times story that said many researchers go to just two companies: Advanced Bioscience Resources and another California-based company called StemExpress.

Researchers have used fetal tissue to study genetic diseases and development disorders like Down syndrome, as well as to test the toxicity of medications taken by pregnant women and the efficacy of vaccines. The measles vaccine, for example, was developed with the help of fetal tissue.

Fetal tissue also has been transplanted into patients in attempts to treat various disorders, injuries and illnesses, including Parkinson’s disease.

Why is HHS reviewing compliance with federal law? Isn’t this research legal?

It is legal to conduct research using fetal tissue, subject to laws and regulations addressing issues such as consent from the woman undergoing the abortion. Researchers in the United States have used fetal tissue since the 1930s, and the federal government has funded such research since the 1950s, according to the Congressional Research Service.

Things get thorny when it comes to acquiring the tissue. A 1993 law made it illegal “to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the transfer affects interstate commerce.” In other words, you can neither sell nor purchase fetal tissue in the United States.

But the ban comes with a caveat: Companies that supply researchers with fetal tissue can charge to cover their costs for things like storage, preservation and transportation.

Republican lawmakers and abortion opponents have accused Advanced Bioscience Resources, as well as StemExpress and another supplier that has since gone out of business, of inflating their costs to turn a profit.

After the release of the sting videos in 2015, House and Senate Republicans launched lengthy investigations into fetal tissue acquisition and research, culminating in a pair of reports that accused the suppliers, Planned Parenthood and a handful of its affiliates of illegal sales and purchases.

In late 2016, Republican lawmakers asked the Justice Department to investigate the matter, and several news outlets reported last December that it appeared to be doing so. (The Justice Department typically does not confirm the existence of ongoing investigations.)

So, why is HHS doing this now?

In August, the conservative news outlet CNSNews.com reported the Food and Drug Administration had signed a one-year, nearly $16,000 contract with Advanced Bioscience Resources to acquire fetal tissue for transplantation in mice in federal research labs.

It was not the government’s first contract with the supplier. Records show the FDA contracted with Advanced Bioscience Resources in 2015 and 2016.

In September, 85 House Republicans sent a letter to Scott Gottlieb, the head of the FDA, noting that lawmakers had found evidence the supplier may have violated federal law during their investigations.

“We urge you to cancel this contract immediately and utilize alternative, modern scientific techniques that do not contribute to the trafficking in baby body parts,” the lawmakers wrote. 

Has fetal tissue research been an issue in the past?

Yes. In 1988, in fact, HHS banned funding for research on fetal tissue transplantation while an advisory panel reviewed the issue. While divided in their views on abortion, most panel members supported the conclusion that, since abortion was legal and the research could yield significant medical discoveries, this research was “acceptable public policy.”

The George H.W. Bush administration rejected the panel’s conclusion, concerned the research would create incentives for women to have abortions, and the ban stood until President Bill Clinton eliminated it in 1993, shortly after being sworn in.

Democrats in Congress seized on the safeguards recommended by the panel and soon passed the 1993 law that, among other things, banned the sale and purchase of fetal tissue.

A similar fight over stem cells erupted in 2001, when President George W. Bush severely restricted research on embryonic stem cells, which are taken from human embryos donated by couples undergoing in vitro fertilization. President Barack Obama later lifted the restrictions.

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

Medicare Advantage Plans Shift Their Financial Risk To Doctors

October 08, 2018

STUART, Fla. — Dr. Christopher Rao jumped out of his office chair. He’d just learned an elderly patient at high risk of falling was resisting his advice to go to an inpatient rehabilitation facility following a hip fracture.

He strode into the exam room where Priscilla Finamore was crying about having to leave her home and husband, Freddy.

“Look, I would feel the same way if I was you and did not want to go to a nursing home, to a strange place,” Rao told her in September, holding her hand. “But the reality is, if you slip at home even a little, it could end up in a bad, bad way.”

After a few minutes of coaxing, Finamore, 89, relented and agreed to go into rehab.

Keeping patients healthy and out of the hospital is a goal for any physician. For Rao, a family doctor in this retiree-rich city 100 miles north of Miami, it’s also a wise financial strategy.

Rao works for WellMed, a physician-management company whose doctors treat more than 350,000 Medicare patients at primary care clinics in Florida and Texas. Instead of being reimbursed for each patient visit, WellMed gets a fixed monthly payment from private Medicare Advantage plans to cover virtually all of their members’ health needs, including drugs and physician, hospital, mental health and rehabilitation services.

If they can stay under budget, the physician companies profit. If not, they lose money.

Dr. Christopher Rao, a family doctor at WellMed in Stuart, Fla., comforts Priscilla Finamore about seeking inpatient rehabilitation care.(Phil Galewitz/KHN)

This model — known as “full-risk” or “global risk” — is increasingly used by Medicare plans such as Humana and UnitedHealthcare to shift their financial exposure from costly patients to WellMed and other physician-management companies. It gives the doctors’ groups more money upfront and control over patient care.

As a result, they go to extraordinary lengths to keep their members healthy and avoid expensive hospital stays.

WellMed, along with similar fast-growing companies such as Miami-based ChenMed, Boston-based Iora Health and Chicago-based Oak Street Health, say they provide patients significantly more time with their doctors, same-day or next-day appointments and health coaches. These doctors generally work on salary.

ChenMed doctors encourage their Medicare patients to visit their clinic every month — for no charge and with free door-to-door transportation — to stay on top of preventive care and better manage chronic conditions. If patients are not feeling well after-hours, ChenMed even will send a paramedic to their home.

“We can be much more creative in how we meet patient needs,” said Iora CEO Rushika Fernandopulle. “By taking risk, we never have to ask … ‘Do we get paid for this or not?’”

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A Way To ‘Provide Less Care’

Some patient advocates, pointing to similar experiments that failed in the 1990s, fear “global risk” could lead doctors to skimp on care — particularly for expensive services such as CT tests and surgical procedures.

“At the end of the day, this is a way to keep costs down and provide less care,” said Judith Stein, executive director of the Center for Medicare Advocacy.

Dr. Brant Mittler, a Texas cardiologist and trial attorney who has followed the issue, said Medicare Advantage members should be suspicious.

“Patients don’t know that decisions made on their behalf are often financially based. There may be pressure on doctors to cut corners to save money and that may not be in the best interests of a patient’s health,” he said.

The insurers and physician groups disagree. They said limiting necessary care would only exacerbate a patient’s health problems and cost the doctors’ group more money.

Noting that Medicare members stay with Humana an average of eight years, Roy Beveridge, the insurer’s chief medical officer, said the plan would be unwise to skimp on care because that would eventually leave the company with sicker patients and longer hospitalizations.

“It makes even less sense for physicians at financial risk to skimp on care because patients are typically with their physicians much longer than they are with a health plan,” he said.

A study that examined care at ChenMed, published last month in the American Journal of Managed Care, found health costs were 28 percent lower among patients who had more than double the number of typical visits with their primary physician. The study was conducted by researchers at ChenMed and the University of Miami.

To offer more personal care, ChenMed doctors typically see only about a dozen patients per day — about half as many as is usual for a doctor who gets paid for each individual service.

Medicare beneficiaries, who can choose a private health plan during the open-enrollment period that runs from Oct. 15 to Dec. 7, generally have no idea if their health plan has ceded control of their care to these large doctors’ groups.

After choosing a Medicare Advantage plan, they generally sign up for a medical group that is part of their health plan’s network, often because doctors are close to where they live or because the doctors offer extra benefits such as free transportation to appointments.

Eloy Gonzalez, 71, of Miami, said that before switching to ChenMed a couple of years ago his doctors always seemed to be in a hurry when he saw them. He’s happy with his ChenMed physicians.

On a recent visit, he spent nearly 20 minutes with Dr. Juana Sofia Recabarren-Velarde talking about keeping his blood pressure and lung condition under control. She also showed him exercises to manage back and shoulder pain.

“If she thinks she needs to see me once a month to monitor my blood pressure and see if anything else is happening, it’s OK with me,” said Gonzalez, who pays nothing for the office visits or generic drugs under his Humana Medicare Advantage plan with ChenMed.

A Growth Spurt

Nearly one-third of the 57 million Medicare beneficiaries are covered by private Medicare Advantage plans — an alternative to government-run Medicare — and federal officials have estimated that the proportion will rise to 41 percent over the next decade. The government pays these plans to provide medical services to their members.

The “global risk” system has been used in South Florida and Southern California since the late 1990s and nearly half of Medicare Advantage members in those regions get care in the model. The use has spread further in the past two years as large physician companies have become more common, and about 10 percent of Medicare Advantage plan members across the nation are in them now, health consultants say.

In addition, new information technology allows these groups to better track their patients. With mixed results, Medicare Advantage insurers for years offered doctors bonuses to meet certain quality care standards, such as getting members vaccinated against the flu or controlling diabetes and other chronic diseases.

Under the “global risk” arrangements, the health plans give the physician companies the bulk of their Medicare funding when they take on the mantle of being financially responsible for all patient care.

For the doctors’ groups, the arrangement means they get paid a large amount of money upfront for patient care and don’t have to worry about billing or having to get insurers to always preapprove treatments.

Because the “global risk” arrangements are designed to reduce plans’ costs, they potentially allow the companies to lower premiums and attract more customers, said Mark Fendrick, director of the University of Michigan’s Center for Value-Based Insurance Design.

“I see this trend continuing to grow as clinicians will be accountable for the first time for the care they provide,” he said.

Historical Lessons

But Ana Gupte, a securities analyst with Leerink Partners in New York, noted providers can also lose money if not successful.

That’s what happened in the late 1990s when some physician-management companies such as FPA Medical Management and PhyMatrix took on financial risk from insurers only to later go bankrupt, interrupting care to thousands of patients.

Health insurers say they now trust only doctors’ groups that have shown they can handle the financial risk. They also retain varying levels of control. Insurers set benefits, handle member complaints and review which doctors are allowed in its network.

Martin Graf, a partner with consulting firm Oliver Wyman, said the old financial arrangements failed because provider groups did not manage the risks facing their patients.

“Now they know physician groups must be vigilant about their patients — whether they are in the office or not,” he said. “Everyone is aware of the failure of the past.”

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

Patient Advocacy Or Political Ploy? Union, Industry Square Off Over Dialysis Initiative

October 05, 2018

This year, California dialysis clinics — and their profits — are in a powerful union’s crosshairs.

On Nov. 6, the Service Employees International Union-United Healthcare Workers West union hopes to deliver a stinging blow with a ballot measure designed to limit clinic profits.

Proposition 8, or the “Fair Pricing for Dialysis Act,” would cap dialysis clinic profits at 115 percent of the costs of patient care, with revenue above that amount to be rebated primarily to insurers. Medicare and other government programs, which pay significantly lower prices for dialysis, would not receive rebates.

It’s been a costly campaign, suggesting high stakes for both sides. The union, which sponsored the initiative and represents over 150,000 nurses and other health care workers in California, so far has invested nearly $17 million in the effort.

Two leading national for-profit dialysis companies, DaVita and Fresenius Medical Care, dominate California’s market and are fighting back hard, contributing more than $40 million and $22 million respectively to defeat the measure. Overall, dialysis companies have raised more than $72 million to oppose the initiative.

In California, close to 70,000 patients need regular dialysis, which essentially performs the function of kidneys for patients whose own kidneys are failing. DaVita and Fresenius control 70 percent of the nation’s market. Between them, they reported more than $4 billion in operating profits last year.

Proponents say the initiative would spur clinics to reduce executive salaries, increase investment in patient care and lower the prices for patients with private insurance.

“It will allow these companies to make good profits, but not the obscene profits they make now,” said Steve Trossman, a spokesman for the union and the “Yes on 8” campaign.

Opponents argue the issue is too complicated to be decided at the polls and that it could reduce patients’ access to care, causing the vast majority of clinics to lose money and forcing many to shut down.

Fresenius and Davita referred questions on the initiative to the “No” campaign. But in an earnings call last month, DaVita CEO Kent Thiry said the passage of the initiative in California would have mostly “unsustainable” effects on dialysis centers.

A win for the union, known as SEIU-UHW, could encourage similar efforts elsewhere, said Laurel Lucia, director of the health care program at the Center for Labor Research and Education at the University of California-Berkeley.

“The initiative addresses a national problem,” she said. “If the policy is implemented successfully here, it wouldn’t be surprising if it spread to other states.”

Similar measures pushed by the union in Ohio and Arizona did not make the ballots for this November’s election.

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The initiative is part of the union’s wide-ranging campaign to force changes in the dialysis industry. In August, California legislators approved a bill promoted by the union that would have effectively capped reimbursement rates for dialysis clinics. While that was perceived as a solid victory for SEIU-UHW, Democratic Gov. Jerry Brown vetoed the measure last month.

A few years ago, SEIU-UHW began organizing among dialysis clinic workers, raising concerns about poor sanitation, high infection rates, understaffing, exorbitant prices for those covered by private insurance and other problems. The union ramped up its efforts on the ballot measure after legislative attempts to address some of the issues stalled last year.

Since 2012, the union has spent tens of millions of dollars on multiple state and local ballot initiatives in California relating to a wide range of health care issues, including access to affordable insurance, hospital and clinic funding, and training for in-home supportive services.

In 2013, for instance, SEIU-UHW launched ballot measures in California targeting hospital pricing and executive pay, and opponents accused the union of abusing the ballot process to force compliance with its demands.

According to Thad Kousser, a professor at the University of California-San Diego and an expert in the legislative process, the strategy of using ballot measures for political leverage is standard practice and not unique to SEIU-UHW. Even if the dialysis initiative is defeated, Kousser said, the effort will likely provide the union with a bargaining edge in future negotiations.

“It strengthens the union’s hand for future bargaining, even if it doesn’t win now,” Kousser said.

The union says it uses ballot measures to improve health conditions for all state residents, not just its members. “We made a decision as a union a number of years ago that in order to be successful, we couldn’t just be worried about our own members and our own narrow interests and have blinders,” Trossman said.

Nonsense, say critics.

“The spin from the SEIU-UHW is that the union is crusading for a healthier California, not trying yet again to get leverage over health-care employers,” declared an editorial last year in the San Diego Union-Tribune. “Californians with failing kidneys have enough worries. They should not be political pawns.”

The “No on 8” campaign, citing findings from the Centers for Medicare & Medicaid Services, notes that California’s clinics rate higher than those in other states on quality-of-care measures, such as avoiding unnecessary transfusions, preventing infections and maintaining proper blood levels of calcium levels.

“The ‘Yes on 8’ people talk about a crisis in dialysis and that’s not even close to being the truth,” said Kathy Fairbanks, spokeswoman for the “No” campaign.

But other research, such as a 2014 study of Medicare beneficiaries nationwide, found that patients treated at for-profit clinics had higher hospitalization rates than those in not-for-profit centers.

In June, a Colorado jury found DaVita liable for the deaths of three patients who suffered cardiac arrests following dialysis treatment, ordering the company to pay almost $400 million in damages. Witnesses had accused DaVita of failing to provide sufficient warning to doctors about the possible risks of a medication commonly used during dialysis. The company said at the time it would appeal. In 2016, Fresenius agreed to pay $250 million to resolve thousands of lawsuits involving the same medication.

In the heated battle over next month’s ballot measure, both sides have lined up many dozens of endorsements from community and statewide organizations. Proponents have strong labor and Democratic Party support. The California Medical Association, and some other medical groups, along with many veterans’ and business organizations, back the “No” campaign, arguing that the change would put dialysis patients at risk.

The “No” campaign has spent millions on television and online ads as the election nears. The “Yes” campaign has also launched an aggressive ad campaign.

Not all dialysis patients support the bill. Dialysis patient DeWayne Cox, a 55-year-old independent filmmaker and Uber driver in Sherman Oaks, said his opposition goes against his natural inclination to support labor. But he fears the mandated changes would force clinics to close and make it harder for patients like him to get dialysis.

“The thing is, I come from a union family, I believe in unions, but in this case I question their [SEIU-UHW’s] motives,” Cox said.

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

In The Battle To Control Drug Costs, Old Patent Laws Get New Life

October 05, 2018

In the drug pricing battle, progressive lawmakers such as Sen. Bernie Sanders (I-Vt.) and patients’ rights activists rarely find themselves in step with the health industry’s big players.

But in a twist, these usually at-odds actors are championing similar tactics to tame prescription drug prices.

The strategies involve repurposing two obscure and rarely deployed workarounds in patent law that, in different ways, empower the federal government to take back patents and license them to other companies. The first is known as “march-in rights.” The second is generally referred to as Section 1498 because of its location in the U.S. Code.

Sanders has in recent years pointed to these steps as useful tools in the drug-pricing debate.

As an indicator of how high the stakes have become, these ideas also are finding traction among some major health industry players — most notably, two large trade groups that represent health plans and the “middlemen” companies that negotiate drug coverage.

“It used to be the case that everyone played nicely with one another, and now as prices have gone up, the knives have come out,” said Jacob Sherkow, a law professor at New York University who focuses on intellectual property and the pharmaceutical industry.

The push for march-in rights gained momentum this past summer, when activists launched a campaign challenging the patent for Truvada, the HIV treatment by Gilead Sciences that has been shown to reduce the risks of contracting HIV when taken daily as a preventive.

Initially, patient advocates focused mainly on shaming insurance companies into providing better coverage of that pill, also known as pre-exposure prophylaxis, or PrEP, because it is taken before someone is exposed to the virus. But they soon found themselves targeting a frustration that insurance happened to share: the drug’s list price.

James Krellenstein, co-founder of the PrEP4All Collaboration, an advocacy group, was part of that campaign. Health plans had put barriers in place to limit access to the drug, he said. But they, too, were worried about Truvada’s escalating price.

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“You can’t scale up to a level you need to unless we deal with the pricing problem,” he said.

Now, as insurers signal they might adopt an approach similar to that of the campaign, he voiced skepticism. On the one hand, the support could benefit their cause. At the same time, “they have their interests, and that’s not the interests of public health,” Krellenstein said.

Still, in Washington, the influence of groups like America’s Health Insurance Plans (AHIP), which is the largest trade association for health insurers, and the Pharmaceutical Care Management Association (PCMA), which represents those middlemen companies known as pharmacy benefit managers (PBMs), could add political credibility to these long-shot ideas.

President Donald Trump has said curbing prescription drug costs is a high priority. But, as congressional action seems increasingly unlikely, these two approaches offer another possible path forward.

They are “already part of a law that is intact. … An option the administration can take now,” said Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.

AHIP says the Department of Health and Human Services should lean on a federal statute that lets the government take over drug patents and grant them to other manufacturers, as long as it adequately compensates the original patent holder.

Meanwhile, PCMA is pressing the administration to use the “march-in rights” championed by HIV activists. Provided under the 1980 Bayh-Dole Act, they empower the government to rescind a drug’s patent and let other companies develop versions of it. This applies only if government funding helped develop a drug, and it can be invoked only in specific circumstances, including a threat to public health or safety.

“Everybody is feeling the heat, and I think that is the reason you’re seeing this interest in using the tools that exist,” said Amy Kapczynski, professor at Yale Law School who has written extensively about drug patents.

But opposition is strong among drugmakers.

“Policies should spur competition and new innovations to meet patient needs, not disincentivize them such as the use of 1498 and march-in could do,” said Priscilla VanDerVeer, a spokeswoman for the Pharmaceutical Researchers and Manufacturers of America, or PhRMA, a trade and lobbying group.

Gilead, which manufactures Truvada, has a similar stance.

“We believe that there is no rationale or precedent for the government to exercise march-in or other [intellectual property] rights related to Truvada for PrEP,” said Ryan McKeel, a spokesman for Gilead. The company’s other efforts to make the drug “available for health and safety needs,” he added, “clearly satisfy” the company’s legal requirements.

And the potential for march-in authority is still theoretical. It has never been used, despite at least five petitions to the National Institutes of Health, three of which cited high drug prices.

Section 1498 was used to negotiate lower drug prices in the 1960s and ’70s, but has since faded. In 2001, during the nation’s anthrax scare, the Department of Health and Human Services threatened to invoke it to procure more of the antibiotic used to treat the deadly bacterial disease, according to contemporaneous reports. Last year, Louisiana’s health secretary unsuccessfully tried to use it to ease the toll pricey hepatitis C medications exerted on the state’s Medicaid program.

NIH Director Francis Collins remains skeptical, repeatedly saying that a drug’s price doesn’t constitute a health or safety concern within the agency’s jurisdiction.

HHS Secretary Alex Azar, speaking at a June Senate hearing, described march-in, also known as “compulsory licensing,” as a “socialist” approach.

But health pans and other payers, increasingly squeezed by fast-climbing prices, are undeterred — touting this kind of intervention as a “market-based solution.”

“The trends of drug prices in this country suggest that we all collectively need to find new approaches — including new approaches that are available under existing law — to try to change this trend,” said Mark Hamelburg, AHIP’s senior vice president of federal programs.

Kaiser Permanente, the health system and insurance provider, called for leveraging Section 1498 in a public comment submitted to HHS about its strategy to bring down drug prices. In a similar filing, Humana, a major insurer, pointed to “existing law [that] allows for actions around patents,” singling out march-in rights.

Humana did not respond to requests for comment. Both PCMA and Kaiser Permanente declined to comment beyond their statements. (Kaiser Health News is not affiliated with Kaiser Permanente.)

Nonetheless, experts say there are serious sticking points.

Neither of these legal provisions would be a sweeping solution. And both require administration buy-in.

“They’re only as effective as the government’s willingness to pursue them,” said Robin Feldman, a law professor at the University of California-Hastings.

Simply taking a patent doesn’t bring down prices, either. There are other ways manufacturers gain favorable market positioning for specific drugs, said Rachel Sachs, an associate law professor at Washington University in St. Louis who tracks drug-pricing laws.

And creating an opening for generics is only one step. Another drugmaker would still need to create a competing product, gain approval and make it available. Then, theoretically, market competition can kick in.

Finally, there’s no guarantee such savings would benefit consumers, argued Nicholson Price, an assistant professor at the University of Michigan Law School. Insurance plans or PBMs could simply bargain greater discounts on drugs and pocket the money. (AHIP says any savings should be passed on.)

That’s the fundamental question, Krellenstein said.

“Is this going to be more armor in the fighting [between payers and drug companies]?” he said. “Or is it actually going to be a dramatic reform that actually results in real changes, that actually makes it easier for Americans to access the medications they need?”

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

Drugmakers Play The Patent Game To Lock In Prices, Block Competitors

October 02, 2018

David Herzberg was alarmed when he heard that Richard Sackler, former chairman of opioid giant Purdue Pharma, was listed as an inventor on a new patent for an opioid addiction treatment.

Patent No. 9861628 is for a fast-dissolving wafer containing buprenorphine, a generic drug that has been around since the 1970s. Herzberg, a historian who focuses on the opioid epidemic and the history of prescription drugs, said he fears the patent could keep prices high and make it more difficult for poor addicts to get treatment.

“It’s hard not to have that reaction of, like … these vultures,” said Herzberg, an associate professor at the University at Buffalo.

James Doyle, vice president and general counsel of Rhodes Pharmaceuticals, the Purdue subsidiary that holds the patent, said in an email statement that the company does not have a developed or approved product and “therefore no money has been made from this technology.”

“The invention behind the buprenorphine patent in question was developed more than a dozen years ago,” he wrote. “If a product is developed under this patent, it will not be commercialized for profit.”

Yet, the patenting of a small change in how an existing drug is made or taken by patients is part of a tried-and-true pharmaceutical industry strategy of enveloping products with a series of protective patents.

Drug companies typically have less than 10 years of exclusive rights once a drug hits the marketplace. They can extend their monopolies by layering in secondary patents, using tactics critics call “evergreening” or “product-hopping.”

Lisa Larrimore Ouellette, a patent law expert at Stanford University, said the pharmaceutical industry gets a greater financial return from its patent strategy than that of any other industry.

AztraZeneca in 2001 famously fended off generic versions of its blockbuster heartburn medicine Prilosec by patenting a tweaked version of the drug and calling it Nexium. When Abbott Laboratories faced multiple generic lawsuits over its big moneymaker Tricor, a decades-old cholesterol drug, it lowered the dosage and changed it from a tablet to a capsule to win a new patent.

And Forest Laboratories stopped selling its Alzheimer’s disease drug Namenda in 2014 after reformulating and patenting Namenda XR to be taken once a day instead of twice.

Another common strategy is to create what Food and Drug Administration Commissioner Scott Gottlieb calls “patent thickets,” claiming multiple patents for a single drug to build protection from competitors. AbbVie’s rheumatoid arthritis drug Humira has gained more than 100 patents, for example.

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The U.S. Patent and Trademark Office awards patents when an innovation meets the minimum threshold of being new and non-obvious. Secondary patents are routinely granted to established drugs when an improvement is made, such as making it a once-a-day pill instead of twice a day, said Kristina Acri, an economist and international intellectual property expert at the Fraser Institute and Colorado College.

“Is there a better way? Maybe, but that’s not what we’re doing,” Acri said.

The controversial patent that Sackler and five co-inventors obtained is widely known as a “continuation patent.” (The original patent application for the wafer was filed in August 2007.)

Continuation patents do not necessarily extend the patent life of a drug, but they can have other uses. In 2016, Rhodes filed a lawsuit against Indivior alleging patent infringement.

Indivior, formerly part of Reckitt Benckiser, sells a film version of the popular addiction treatment drug Suboxone that is placed under the tongue — an oral medicine similar to what Rhodes has patented. Indivior’s comes in a lime flavor.

Indivior’s film, which federal regulators approved in 2010, dominates the market with a 54 percent average market share, according to the company’s most recent financial report. And the company has vigorously fought rivals, including filing lawsuits against firms such as Teva Pharmaceutical Industries, which sought approval to manufacture generic versions. Indivior declined to comment.

The Rhodes Pharmaceuticals version would be a wafer that melts quickly in the mouth. The inventors list potential flavors including mint, raspberry, licorice, orange and caramel, according to the patent.

For opioid historian Herzberg, the patent battles between companies like Rhodes and Indivior are “absolute madness.”

Decisions on what is available on the market to treat addicts should be based on what is the best way to treat the people who have the problem, he said.

Patent battles, Herzberg said, are “not how you want drug policy getting made.”

Attempts to change the patent system have intensified over the past decade as prices of prescription drugs continue to climb.

In 2011, President Barack Obama signed the America Invents Act, which included the creation of the Patent Trial and Appeal Board. The PTAB is an alternative to using the cumbersome U.S. court system to challenge weak patents. Generic drug manufacturers have used the board’s “inter partes review” process and overturned 43 percent of the patents they challenged, according to recent research.

Critics of the administrative process, including the pharmaceutical industry trade group PhRMA, said it creates “significant business uncertainty for biopharmaceutical companies.” Often companies have to defend their products twice — both in the courts as well as before the PTAB, said Nicole Longo, PhRMA’s director of public affairs.

Drug giant Allergan attempted to overcome the PTAB’s review process by arguing that the patent couldn’t be challenged at the review board because they sold the patent to the St. Regis Mohawk Tribe, which had sovereign immunity. A federal appeals court ruled this summer that Allergan could not shield its patents from the PTAB review this way.

This year, several members of Congress proposed bills that would unwind or limit changes made by the America Invents Act, though nothing is likely to happen before the midterm elections. The STRONGER Patents Act, introduced in both the House and Senate, would weaken the PTAB board by aligning its claims standards with what has been established by court rulings.

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

Feds Settle Huge Whistleblower Suit Over Medicare Advantage Fraud

October 01, 2018

One of the nation’s largest dialysis providers will pay $270 million to settle a whistleblower’s allegation that it helped Medicare Advantage insurance plans cheat the government for several years.

The settlement by HealthCare Partners Holdings LLC, part of giant dialysis company DaVita Inc., is believed to be the largest to date involving allegations that some Medicare Advantage plans exaggerate how sick their patients are to inflate government payments. DaVita, which is headquartered in El Segundo, Calif., did not admit fault.

“This settlement demonstrates our tireless commitment to rooting out fraud that drains too many taxpayer dollars from public health programs like Medicare,” said U.S. Attorney Nick Hanna in announcing the settlement Monday.

Medicare Advantage plans, which now enroll more than 1 in 3 seniors nationwide, have faced growing government scrutiny in recent years over their billing practices. At least a half-dozen whistleblowers have filed lawsuits accusing the insurers of boosting payments by overstating how sick patients are. In May 2017, two Florida Medicare Advantage insurers agreed to pay nearly $32 million to settle a similar lawsuit.

The DaVita settlement cites improper medical coding by HealthCare Partners from early 2007 through the end of 2014. The company, according to the settlement agreement, submitted “unsupported” diagnostic codes that allowed the health plans to receive higher payments than they were due. Officials did not identify the health plans that overcharged as a result.

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One such “unsupported” code was for a spinal condition known as spinal enthesopathy that was improperly diagnosed in patients in Florida, Nevada and California from Nov. 1, 2011, to Dec. 31, 2014, according to the settlement. The agreement did not say how much health plans took in from the unsupported codes.

The company also contracted with a Nevada firm from 2010 through January 2016 that sent health care providers to visit patients in their homes, a controversial practice that critics have long held is done largely to inflate Medicare payments. These house calls also generated “unsupported or undocumented” diagnostic codes, according to the settlement.

Officials said that DaVita disclosed the practices to the government. It acquired HealthCare Partners, a large California-based doctors’ group, in 2012. They said the government agreed to a “favorable resolution” of the allegations payment because of the self-disclosure.

In a statement, DaVita said the settlement “reflects close cooperation with the government to address practices largely originating with HealthCare Partners.” DaVita said the settlement will be paid with escrow funds set aside by the former owners.

“This case involved illegal conduct in which patients’ medical conditions were improperly reported and were not corrected after further review — all for the purpose of boosting the bottom line,” reads the government’s statement.

The settlement also resolves allegations made by whistleblower James Swoben that HealthCare Partners knew that many of the diagnostic codes were unsupported, but failed to report them. The company reported only cases in which it deserved higher reimbursement, while ignoring codes that would slash payments, a practice known as “one-way” chart reviews.

Swoben, a former employee of a company that did business with DaVita, will receive just over $10 million for the settlement of the “one-way” allegations, under the federal False Claims Act, which rewards whistleblowers who expose fraud.

White Coats As Superhero Capes: Med Students Swoop In To Save Health Care

October 01, 2018

NEW YORK — Each wall of the library reading room at the New York Academy of Medicine is lined with tall wooden bookshelves holding leather-bound medical tomes. Atop the shelves perch busts — seemingly all white, all male — lit by two large brass chandeliers. Floor-to-ceiling windows overlook New York City’s Central Park and Fifth Avenue.

This setting, which speaks to medicine’s staid past, recently became the backdrop for plotting medicine’s future.

On a gray Sunday in September, 150 medical and nursing students dragged themselves in before 9 a.m. to learn how to meld their chosen professional careers with societal and political activism.

“As doctors, we will have this tremendous opportunity to talk to people every day,” said Miriam Callahan, a second-year student at Columbia University medical school. “We’ll have the ability to organize with them, to bring people together.”

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While doctors have traditionally been branded a mostly conservative group, there is growing evidence that young doctors-to-be are leaning leftward. This year, the American Medical Association student caucus persuaded the organization to drop its decades-long opposition to single-payer health care and instead study the concept, for example.

The conference at the academy, which was organized by medical students and sponsored by the New York City Department of Health’s Center for Health Equity along with four New York medical schools, sought to help students navigate that path. It featured a panel discussion and speeches by public health workers and doctors, including Dr. Abdul El-Sayed, a physician who mounted an unsuccessful progressive campaign this year for governor of Michigan.

The Advocacy in Medicine Conference, held Sept. 23 in New York City, trained medical students to push progressive issues. On the agenda: combating gun violence, promoting single-payer and treating refugees.(Rachel Bluth/KHN)

Dressed in blazers and dress shirts reflecting their professional identity, some also donned Planned Parenthood Buttons or Democratic Socialists of America pins. The agenda had a clear progressive bent, with workshops on LGBTQ+ health, gun violence, abortion access and criminal justice reform.

Attendees gave each other advice about how to advocate for single-payer, for example. Don’t talk about socialism, focus on the inefficiency and inequality you see, some said. Forget the “decrepit old physicians only worried about money,” their minds will never change, advised others.

Some participants were motivated by a humanitarian streak. Others were galvanized by the conditions they saw at free clinics, where they work as part of their medical education, or by a goal to increase national student engagement on issues like gun violence.

All were struggling with what they perceived as the responsibility that comes with a white coat and grappling with their place in a health care system they saw as broken.

Keven Cabrera, a fourth-year medical student at the Zucker School of Medicine at Hofstra University/Northwell, said this notion became real to him when he and some of his classmates participated this year in the March for Our Lives, a rally against gun violence.

Accustomed to the student position at the bottom of the medical hierarchy, he was taken aback by how much the white coat, even a short one that marks a student instead of a full-fledged attending doctor, afforded him respect in the community.

“We were all surprised by how much our voices counted,” Cabrera said.

About 150 medical students from eight schools gather at the New York Academy of Medicine to discuss how to advocate for their patients as they enter the medical field.(Rachel Bluth/KHN)

Everyone came to the table with the general agreement that health care for all was a moral necessity and abortion access was a fundamental right.

So they discussed how best to move these ideas forward. How do you get better reproductive education into a conservative medical school syllabus? How can you organize other students to protest, call legislators and show up for marches?

In one noisy room after lunch, students crowded around tables where doctors with experience lobbying on behalf of Physicians for a National Health Program led role-playing conversations to demonstrate how best to communicate with congressional staff or state assembly members. They also learned how to use the stories of patients they saw on a daily basis to work within the system to advocate for single-payer health care.

The students fretted — at least a bit — about how activism could help or hinder their professional success. A group sat in a semicircle listening to a doctor tell his story of being arrested at a protest.

Students asked about how civil disobedience could affect their residency placements, or get them marked as agitators within their departments. Then another chimed in: “Would you even want to be in a residency program where they would disqualify you for a protest arrest?”

Buried In Congress’ Opioid Bill Is Protection For Personal Drug Imports

September 27, 2018

WASHINGTON — The final version of the massive opioid bill Congress released Wednesday would grant the Food and Drug Administration new powers to crack down on drug imports, but it also includes a provision — nearly killed in the Senate — to shield people who are just trying to buy cheaper, needed prescription medication from other countries.

Broadly, the bill seeks to enlist the FDA in combating the opioid crisis by mandating that the agency take steps to accelerate development of non-opioid painkillers and to limit the supplies of the drugs, both illegal and legitimate, that claimed the lives of more than 49,000 people last year.

Among those steps, the bill expands the FDA’s power to “debar” people “from importing or offering for import into the United States a drug” if they are violating any of a number of regulations, including importing “mislabeled” medications, which includes any from overseas.

In the original House version of the bill, there was also a provision that defined those importers to exclude regular people who were importing personal prescriptions from foreign countries. That definition had been cut without explanation from the Senate’s version of the bill.

Congressional staffers who spoke on background to describe internal negotiations said the senators eliminated the protection because they believed it was unnecessary. The FDA already has discretion to look the other way on personal imports and told lawmakers it has no intention of changing the policy, staffers said.

Still, advocates for importation of cheaper drugs raised a red flag, noting that policies are not permanent and could be changed at any time absent legislation.

“I believe pharma lobbyists tried to piggyback language onto this bill to give FDA greater authority to stop importation of lower-cost, non-controlled medicines — ones having nothing to do with the opioid crisis, whether wholesale or personal,” said Gabriel Levitt, the president of PharmacyChecker.com, which serves as a clearinghouse for people trying to buy prescriptions from regulated foreign pharmacies. “If that’s the case, then they did not get everything they wanted.”

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PhRMA, the lobbying arm of the pharmaceutical industry, could not immediately respond to questions about the shifts in the bill, but praised the overall goal of the broader measure.

“We applaud Congress for producing bipartisan, bicameral legislation that is a comprehensive approach to combating the opioid addiction crisis,” spokeswoman Priscilla VanderVeer said in a statement. “We look forward to the final legislation moving swiftly through the House and Senate and then on to the President’s desk to be signed into law.”

Indeed, the definition appears to have been added back to help forestall any controversy that might have interfered with swift passage of a measure that lawmakers hope to tout for the rest of campaign season. The bill is expected to be passed by the House this week and the Senate next week.

While lawmakers who at first removed the language may have seen it as unnecessary, advocates saw it, if not as a major victory, at least as a significant step in recognizing the legitimacy of importing medication from places where it is less expensive.

“That this language was put back in the bill is very helpful because now personal drug importation has greater recognition under law as different from illegal wholesale importation and worthy of protection,” said Levitt. “For those people who rely on lower-cost personal imports from pharmacies in Canada and other countries, this is very good.”

Millions of Americans every year seek prescriptions from overseas and Canada. Many millions more don’t take or thin out their prescribed medications, often because of costs. According to the Centers for Disease Control and Prevention, almost 8 percent of Americans do not take their medication as prescribed, and more than 15 percent seek cheaper alternatives from their doctor.

The consequences of non-adherence are on a par with the opioid crisis. The failure of people to take medication properly kills about 125,000 every year and costs the health care system between $100 billion and $289 billion, according to studies.

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

KHN Conversation On Overtreatment

September 27, 2018
Special Reports

Treatment Overkill

Mar 13

In this series Kaiser Health News investigates the causes and consequences of medical overtreatment, both for patients and the health care system.

From duplicate blood tests to unnecessary knee replacements, millions of American undergo screenings, scans and treatments that offer little or no benefit every year. Doctors have estimated that 21 percent of medical care is unnecessary — a problem that costs the health care system at least $210 billion a year. Such “overtreatment” isn’t just expensive. It can harm patients.

Kaiser Health News senior correspondent Liz Szabo moderated a discussion a panel of experts to explore overtreatment.

Our panelists were:

  • Dr. Louise Davies,  An associate professor of  otolaryngology – head and neck surgery in The Dartmouth Institute for Health Policy & Clinical Practice
  • Dr. Saurabh Jha, an associate professor of radiology at the University of Pennsylvania
  • Dr. Barry Kramer, director of the division of cancer prevention at the National Cancer Institute
  • Dr. Jacqueline Kruser, a pulmonologist and critical care physician at Northwestern University Feinberg School of Medicine
  • Dr. Ranit Mishori, professor of family medicine at the Georgetown University School of Medicine.

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

Putting Oversized Health Care Costs Upfront — On T-Shirts

September 26, 2018

If only patients knew how expensive medical procedures are and how wildly prices vary by hospital, they could be smart shoppers and lower the cost of health care for everybody.

At least that’s what policy experts and health insurers keep saying as they promote “consumer-directed” health care and cost-comparison websites.

None of it has had much effect. Now, exasperated Maryland officials are presenting hospital cost information in a way they believe Americans might understand: on a T-shirt.

“We tried to focus it on a level most consumers are at,” said Ben Steffen, executive director of the Maryland Health Care Commission, which created the campaign. “It is an opportunity to wear a billboard in certain public settings” to get people to ask questions, he said.

You can get a black shirt that says “HIP REPLACEMENT $30,067” in big type from the commission’s WearTheCost.org website. Or one that says “HYSTERECTOMY $16,138.” Other shirts feature prices for a knee replacement or baby delivery.

“I sent an email to all my colleagues in the health-policy wonk world and said, ‘I just got your holiday gift,’” said Dr. Ateev Mehrotra, a Harvard Medical School professor who has studied medical price transparency and patient responses.

Social media for the campaign points people to the WearTheCost.org website, which shows huge differences in what the same procedures cost at different Maryland hospitals.

The hysterectomy expense of $16,138 on the T-shirt is just an average. In recent years, the operation cost as much as $20,635 at Johns Hopkins Hospital in Baltimore and as little as $12,798 at Anne Arundel Medical Center in Annapolis.

Hopkins was also the most expensive hospital in which to have a baby, at $14,578, compared with the average Maryland cost of $11,590.

“Our teams treat the most complex cases in the region,” making them more expensive, said Hopkins spokesman Ken Willis. Hopkins supports publishing data to help patients make informed decisions, he added, but he said the Wear the Cost site “does not yet achieve that goal.”

The website’s price quotes apply to commercial insurance rates and include hospital care as well as non-hospital spending, such as doctors’ fees and prescription drugs.

The reported expenses are adjusted so that “it would take account of differences in case severity,” Steffen said.

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Hospital-to-hospital results vary sharply even under Maryland’s health care finance system, which regulates what hospitals are paid. One reason is that hospitals make money from their mistakes. Those with high rates of avoidable complications, such as infections or drug reactions, end up delivering more care, for which they charge.

Wear the Cost’s software tries to measure this, flagging avoidable problems and calculating the expense. Potentially avoidable complications added $2,271 to the cost of a hysterectomy at Johns Hopkins.

Such costs were even higher at Baltimore’s Saint Agnes Hospital, adding $5,481 to a hysterectomy’s total cost of $18,433. (The hospital did not respond to requests for comment.)

A $4 million federal grant financed the Wear the Cost campaign, which was led by the commission’s analysis director, Linda Bartnyska, who died of breast cancer in August.

Economists like to note that health care lacks many attributes needed for a minimally functioning market, including customers who understand the product and know what it costs.

The price transparency movement was supposed to help fix that. If patients give more business to lower-cost institutions with fewer complications, the thinking goes, hospitals will work harder to contain costs and improve outcomes, slowing the increase in insurance premiums and government health expenses.

“The hope is that, over time, consumers will come to expect that prices are available … and use them regularly in making decisions about where to get care,” said Sarah Litton of Altarum, a research and consulting firm that worked on the campaign with the Maryland commission.

But it’s an uphill fight. Nobody checks hospital prices when they have a heart attack or get in a car crash, so Wear the Cost, which has given away more T-shirts than it has sold, focuses on elective procedures that people can shop for in advance. Even these patients, though, tend to go to wherever doctors suggest. Since insurance usually pays everything for in-network hospitals once out-of-pocket spending limits are met, they have little incentive to shop around when considering pricey procedures. The patient’s portion is likely to be similar whether a joint replacement is $25,000 or $50,000.

Federal authorities recently required hospitals to start posting their charges online, but these bear little relationship to what most patients and their insurers pay.

Just 3 percent of adults under age 65 compared costs between medical providers before getting care, found a 2017 survey led by Mehrotra.

“To date, price transparency initiatives that have been rigorously assessed have had little to no impact on prices in the health care system,” Mehrotra said. “The reason so far is few people are using those websites.”

Still, maybe the point of programs like Wear the Cost “is to shame” expensive hospitals, to say, ‘What the heck is going on here?’” Mehrotra said. “’Why are you 50 percent more’” than the hospital across town?

Podcast: KHN’s ‘What The Health?’ Health On The Hill

September 20, 2018
Julie Rovner

Kaiser Health News

@jrovner

Read Julie's Stories Rebecca Adams

CQ Roll Call

@RebeccaAdamsDC

Read Rebecca's Stories Joanne Kenen

Politico

@JoanneKenen

Read Joanne's Stories Margot Sanger-Katz

The New York Times

@sangerkatz

Read Margot's Stories

As the start of the fiscal year draws near — along with pivotal midterm elections — Congress is picking up its pace on legislation. This week alone the Senate passed a comprehensive bill aimed at curbing the opioid epidemic and a nearly final bill to fund the Department of Health and Human Services.

Meanwhile, a bipartisan group of senators unveiled draft legislation aimed at helping patients who receive “surprise” medical bills after inadvertently receiving medical care outside their insurance carrier’s network.

This week’s panelists are Julie Rovner of Kaiser Health News, Rebecca Adams of CQ Roll Call, Margot Sanger-Katz of The New York Times and Joanne Kenen of Politico.

On Sept. 27, the podcast will tape in front of a live audience at the Texas Tribune Festival in Austin, Texas. Details are here. Also on Sept. 27, KHN is hosting a live event to discuss medical overtreatment and its health consequences. More information on that event is here.

Among the takeaways from this week’s podcast:

  • Legislation to combat the opioid epidemic is expected to move through Congress quickly because both Republicans and Democrats are eager to show voters they are addressing what is a nationwide public health crisis.
  • That opioid package won’t provide a solution to one of the most vexing problems of the epidemic: The majority of deaths come from the use of an extremely powerful drug, fentanyl, that is often mixed with illegal opioids.
  • For the first time in years, Congress is likely to pass a bill to fund HHS before the start of the fiscal year on Oct. 1. The bill is known for triggering “culture war” debates, especially on issues dealing with abortion, but lawmakers have largely avoided that this year.
  • Opponents of abortion sought to use the HHS appropriations bill to defund Planned Parenthood. But both Republicans and Democrats worked to stop any poison pills that might have held up the bill. Also, the bill needs 60 votes to pass the Senate, so Democrats had to be accommodated in order to get it through.
  • Sen. Bill Cassidy (R-La.) headed a bipartisan group of senators who unveiled a bill this week that would squelch surprise medical bills that patients get from out-of-network hospitals or doctors, a process known as “balance billing.” The initiative isn’t expected to pass this year, but it is an issue that Cassidy will likely bring up again next year when the new Congress meets.

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

Julie Rovner: Politico’s “Obamacare Lawsuit Boosts Democrats in State AG Races,” by Alice Ollstein

Rebecca Adams: The Wall Street Journal’s “Behind Your Rising Health-Care Bills: Secret Hospital Deals That Squelch Competition,” by Anna Wilde Mathews

Joanne Kenen: The New York Times’ “23andMe Said He Would Lose His Mind. Ancestry Said The Opposite. Which Was Right?” by Laura Hercher

Margot Sanger-Katz: The New York Times’ “Manchin Counts on Health Care to Stave Off Republican Tide in West Virginia,” by Trip Gabriel

To hear all our podcasts, click here.

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

Despite Red Flags At Surgery Centers, Overseers Award Gold Seals

September 20, 2018

(Maria Fabrizio for KHN)

Use Our Content This story can be republished for free (details). 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.”

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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.”

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

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

September 13, 2018

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 3.5 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.

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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.

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

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

Doctor To The Stars Disciplined Over Use Of Controversial Menopause Therapy 

September 12, 2018

In a conversation with Sarah “Fergie” Ferguson, the Duchess of York, that aired on the Oprah Winfrey Network, Dr. Prudence Hall said age isn’t what determines health and vitality. “It’s about how healthy your hormones are,” she said. Hormone therapy means “we don’t have to grow old and grow ill,” she said. Hall was disciplined late last month by the Medical Board of California. (Screen grab from “Dr. Prudence Hall | Finding Sarah | Oprah Winfrey Network” on YouTube)

A Santa Monica doctor who touted a controversial menopause therapy on the Oprah Winfrey Network and received testimonials for her work from such celebrity patients as model Cindy Crawford and actress-author Suzanne Somers has been disciplined by California’s medical board for gross negligence.

This story also ran on People.com. This story can be republished for free (details). In a settlement approved late last month, the Medical Board of California put Dr. Prudence Hall on probation for four years, faulting her for being “unaware” of potential risks posed by the plant-based hormones — including cancer — and failing to monitor her patients properly.

Hall used numerous hormones to treat two women, according to the board, missing an aggressive uterine cancer in one patient and treating the other based on an “incorrect diagnosis in a manner such that [Hall] stood to gain financially.”

“My jaw was on the floor. This is just egregious,” said Dr. Jen Gunter, a San Francisco Bay Area OB-GYN who reviewed the medical board’s report. “You hear about all these self-described functional medicine doctors providing these treatments. Never in my wildest dreams did I think it would be in this ballpark.”

A statement issued by Hall’s publicist Monday did not address the specifics of the board’s findings but generally defended the doctor’s results and commitment to patients.

“Dr. Hall continues to devote her career and life to helping patients achieve optimal health and wellness,” the statement said.

“She utilizes advances in modern medicine plus proven natural therapies. Safely incorporating results of the latest medical research has allowed her to achieve exceptional results for her patients.”

The statement added that Hall “joins respected physicians worldwide who are also using” this type of hormone therapy.

The hormone therapies prescribed by Hall are supposedly customized to individual patients’ needs and are generally not approved by the Food and Drug Administration. They are known as “bioidentical” because their molecular structure is the same as the natural hormones found in a woman’s body, including estrogen and progesterone.

Hall has claimed to have treated more than 40,000 patients with them over 30 years. Under the terms of her settlement with the board, she is no longer allowed to promote herself as a specialist in hormone therapy, an OB-GYN or an endocrinologist, and she must submit her medical practice to oversight by an outside physician who will report to the board. She is allowed to continue treating women for menopause management and other health issues.

Her case stands as a possible warning to many other physicians and providers who have embraced such unproven hormone treatments. Popularized by testimonials from celebrity women, these made-to-order hormones are used by up to 2.5 million women in the United States, according to one study.

Representatives for Crawford and Somers said they chose not to comment at this time.

Hall has been hailed by supporters as a “pioneer” in this type of personalized bioidentical hormone therapy, appearing on national television and infomercials and promoting such treatments as a virtual fountain of youth.

“It’s not about age; it’s about how healthy your hormones are,” Hall told Sarah Ferguson, the Duchess of York, in a conversation on the Oprah Winfrey Network in 2011. “It’s new to think we don’t have to grow old and grow ill.”

In her appearances, Hall offers an appealing message to women entering their 50s and 60s who are looking for “natural” relief from hot flashes, night sweats, loss of libido, aging skin or other concerns.

The hormone treatments she provides are “like water to a plant,” Hall told Somers on an episode of Somers’ television program, “The Suzanne Show.” “How could water be bad for a plant? … Hormones do not cause cancer.”

Dr. David Gorski, a surgical oncologist, professor of surgery at Wayne State University School of Medicine and a longtime critic of unproven alternative medicine, rejected Hall’s analogy. “I’m not a gardener by any stretch of the imagination,” he said, “but even I know that too much water can kill a plant.”

Many other clinicians and researchers say there’s no evidence to back up the claims by Hall and other doctors that these customized treatments are more effective or safer or that they act any differently in the body than FDA-approved hormone replacement therapies.

Some bioidentical hormones, unlike the ones primarily used by Hall, are FDA-approved. They are manufactured in pharmaceutical plants using standard formulas and have been shown to relieve menopausal symptoms — though they have not been tested in large, long-term trials — according to a report in Harvard Women’s Health Watch.

The customized therapies used by Hall and other doctors are mixed in compounding pharmacies and generally are not tested for safety and efficacy, according to Harvard Women’s Health Watch and other reports.

Compounded bioidenticals are big business. In 2013, U.S. sales of these products were estimated in one study at $845 million, compared with a $3.7 billion market for traditional, FDA-approved hormone replacement medications.

“There’s a definite concern that for some women they may be dangerous,” said Dr. Janet Pregler, director of the Iris Cantor-UCLA Women’s Health Center. “Often these [hormones] are presented as risk-free, when we as physicians know that nothing you put in your body is risk-free.”

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Women flocked to bioidentical hormone treatment after the Women’s Health Initiative, a massive federally funded study on a widely used hormone replacement therapy for menopausal women, was halted prematurely in 2002 over concerns about an elevated risk of breast cancer, heart disease and stroke.

Hall, according to medical board investigators, put a patient with a family history of uterine cancer on a regimen of bioidentical hormones after the woman complained of “zero libido” and menstrual migraines. She also prescribed iodine and two adrenal hormone supplements. The patient started to bleed — a potential warning sign of uterine cancer — but Hall prescribed her more hormones, according to the medical board.

Ultimately, the patient developed a cancerous mass in her uterus — but board investigators alleged that Hall failed to detect it, after performing ultrasounds on the patient that she was not certified to analyze. She charged the patient $7,000 over three years for the treatment, according to the board.

In the two cases for which she was disciplined — which occurred between 2011 and 2015 — the medical board found that Hall treated women who were not yet in menopause but whom she incorrectly diagnosed as being in perimenopause. Those are the years immediately before menopause that can create uncomfortable symptoms such as hot flashes and low libido. Their lab tests showed hormone values within normal limits, the board said.

The second patient had numerous other conditions including diabetes and a history of psychiatric disorders, according to the board. The board said Hall diagnosed the patient with hypothyroidism when no clinical evidence supported such a diagnosis — and that later aberrations that surfaced in lab testing had actually been caused by the physician’s treatment.

Hall presented herself to patients as a specialist in “hormone balance,” or endocrinology,” but does not have any post-medical school training by an accredited fellowship in either medical or reproductive endocrinology, according to the board.

It’s not the first time California’s medical board has disciplined a doctor for prescribing such bioidentical hormones. In 2009, the board put Dr. Michael Platt of Rancho Mirage on five years’ probation after charging him with negligence and incompetence for his treatments of several patients. The doctor, author of “The Miracle of Bio-identical Hormones,” later was forced to surrender his license.

Experts say such doctors take advantage of patients’ vulnerability as they age.

“We all fear getting older and loss of sexuality, and the way society makes women feel, women are more vulnerable to it, for sure,” said Gunter, the Bay Area OB-GYN. “I don’t blame the patients for going to the doctor and putting trust in them. I blame the doctors for saying this can somehow help them.”

Sheila Cosgrove Baylis of People magazine contributed to this report.

KHN’s coverage of these topics is supported by California Health Care Foundation and The David and Lucile Packard Foundation

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

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