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Must-Reads Of The Week From Brianna Labuskes

The Friday Breeze

Newsletter editor Brianna Labuskes, who reads everything on health care to compile our daily Morning Briefing, offers the best and most provocative stories for the weekend.

Welcome back to the Friday Breeze, where I can offer you a break from the Comey memos with a quick look at what you need to know about this week’s health care news.

Some recent abortion laws and legislative proposals in the states seem so strict they’re almost begging for a court challenge. And they are. Activists who think the Supreme Court is one Donald Trump-appointed justice away from overturning Roe v. Wade want to have a legal challenge in the pipeline ready to go. Others in the movement would rather focus on incremental changes, which is getting on the nerves of the more aggressive activists. “They’re standing in the way,” Rep. Steve King (R-Iowa) says in Politico’s story. “I’ve said, ‘Please lead, or get out of the way.’”

• Politico: Abortion Foes Seize On Chance To Overturn Roe

Tying performance and costs is a bit of a Hot Strategy these days, as everyone talks about ways to bring down health care spending. But Italy, which has been trying this approach for more than a decade, serves as a cautionary tale that, at least for drug prices, the efforts don’t really move the needle. Mostly because there’s a wide range of opinions on what exactly “success” looks like.

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And in a look ahead: President Donald Trump is planning a big speech on drug prices next week. But don’t get excited— no new policies are expected to be announced.

• The Wall Street Journal: Italy Serves Cautionary Lesson For New Trump Drug Plan

• Politico: Trump Plans First Major Speech On Drug Prices Next Week

There was a lot of movement on the opioid crisis again this week (nursing homes turning away patients who are recovering from addiction; Sen. Bernie Sanders (I-Vt.) wanting pharma execs to go to jail; and scientists working on a drug that could end addiction). But a deeper recurring theme was how ethics would play into combating the epidemic. What role does the industry that helped create the crisis play in fixing it? Does it matter that advocates who are lobbying for more spending are going to profit from that newly opened congressional wallet? It’s a tricky minefield to navigate.

• Stat: NIH Abruptly Changes Course On Industry Opioids Partnership After Ethics Flags Raised

• Politico: Patrick Kennedy Profits From Opioid-Addiction Firms

Dr. Ronny Jackson, Trump’s nominee for VA secretary, is eager to please, well-liked and ambitious, according to a telling background profile by The Washington Post. But notably absent from the heaping of bipartisan praise were endorsements on his ability to lead the sprawling, troubled agency.

• The Washington Post: ‘He Knows How To Read A Room Really, Really Well’: How White House Physician Ronny L. Jackson Became Trump’s Nominee To Lead VA
Use our content This story can be republished for free (details).

In the miscellaneous file for this week: There’s a disturbing pattern of leniency and forgiveness toward doctors who are accused of sexual assault, and not even the #MeToo movement seems to be changing it; livers like to be kept “warm and happy” instead of put on ice (which led to my favorite lede from the week about how livers are not beers that you pack in a cooler for your camping trip); nefarious profiteers are persuading women to get surgeries they might not need just because that makes them better plaintiffs; and what happens when the teaching hospitals that are supposed to train new doctors instead pass off their bad habits?

• The Associated Press: AP Investigation: #MeToo Has Little Impact On Medical World

• Stat: A ‘Breakthrough In Organ Preservation’ Raises Hopes For Transplants

• The New York Times: How Profiteers Lure Women Into Often-Unneeded Surgery

• Stat: Doctors May Learn Bad Habits At Teaching Hospitals With Safety Violations

And former first lady Barbara Bush’s decision to stop medical treatment and seek comfort care this week stirred a debate over the emotionally charged topic of end-of-life decisions.

Kaiser Health News: Barbara Bush’s End-Of-Life Decision Stirs Debate Over ‘Comfort Care

Have a great weekend, and maybe skip the salad? I know, such a hardship.

And let us know what you think of The Friday Breeze here.

Calif. Leads Nation In Pushing Back Against Trump Administration Health Policies

These days, when the federal government turns in one direction, California veers in the other — and in the case of health care, it’s a sharp swerve.

In the nation’s most populous state, lawmakers and other policymakers seemingly are not content simply to resist Republican efforts to dismantle the Affordable Care Act. They are fighting to expand health coverage with a series of steps they hope will culminate in universal coverage for all Californians — regardless of immigration status and despite potentially monumental price tags.

The Golden State embraced the health care law early and eagerly, and has more to lose than any other state if the ACA is dismantled: About 1.5 million Californians purchase coverage through the state’s Obamacare exchange, Covered California, and 3.8 million have signed up for Medicaid as a result of the program’s expansion under the law.

While other states are making efforts to preserve the ACA and expand coverage, California stands out by virtue of its ambition and size, economic clout, massive immigrant population and liberal bent.

Its health care resistance movement is broad and includes Attorney General Xavier Becerra, who has made a sport of suing the Trump administration. He is currently leading a coalition of 15 states, plus the District of Columbia, against a Texas-based lawsuit that seeks to strike down the ACA.

Even Covered California, the ACA marketplace, has jabbed at the feds. During the most recent enrollment period, which ended in January, it preserved its three-month sign-up window while the federal government cut the enrollment period in half for states that rely on the healthcare.gov exchange. Covered California also deployed a monster advertising budget of $45 million to encourage enrollment, while the federal government slashed its ad dollars to $10 million.

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California’s activism could be contagious, said Linda Blumberg, a fellow at the nonprofit research institution the Urban Institute.

“California has been in the forefront” on a lot of health policy issues, she said. To the extent that it is successful, she said, “that helps not only the state of California itself but other states as well.”

Since last year, the federal government has allowed some states to impose work requirements on Medicaid recipients; promoted temporary health plans that have fewer consumer protections than Obamacare insurance; and, most recently, adopted a rule allowing states to lower the percentage of premium dollars that insurers are required to spend on medical care.

In response, California lawmakers are debating bills that would prohibit work requirements in Medi-Cal, the state’s version of Medicaid; ban the sale of short-term plans in the state; and increase the percentage of insurance premiums that must go toward consumers’ care.

“Look at what we’ve done in women’s issues, climate change, protecting immigrants. … That’s just the kind of thing we do. Health is no different,” said state Sen. Ed Hernandez (D-West Covina), the head of the Senate Health Committee and author of several proposals.

Four pending bills in California would provide some consumers with state-funded financial help to supplement federal subsidies created by Obamacare. One such proposal could cost the state about $500 million initially.

“We continue to move forward and push the envelope, now more than ever,” state Sen. Ricardo Lara (D-Bell Gardens) told a room full of physicians recently in Sacramento. Lara, a candidate for state insurance commissioner, is carrying a bill that would offer full Medicaid benefits to a group that’s never been covered before: adults who are in the country illegally.

“We not only play defense, but we want to make sure we’re more proactive,” he said.

California’s efforts to cover unauthorized immigrants under Medi-Cal predate the Trump administration. Achieving it now would represent not only a significant expansion of coverage within the state, but also a direct challenge to the federal government, which has made a point of cracking down on immigrants.

Critics point out that this spirit of defiance does not represent all Californians.

“We have some crazy things happening here,” said Sally Pipes, president of the conservative Pacific Research Institute. “Nobody talks about how to pay for these. Well, you pay for it in increased taxes.”

Sara Rosenbaum, a professor at the Milken Institute School of Public Health at George Washington University, said it’s no secret that President Donald Trump doesn’t like California — and that the feeling is mutual.

While she believes his administration might try to punish the state for its defiance, California will nonetheless persist in its campaign to defend the ACA and expand coverage.

“I’m sure [federal officials] can try to do a million things to make the state’s life miserable,” she said. “They can jerk it around on the federal Medicaid payments. … But I just think this, too, shall pass.”

It’s not clear whether the pending legislative proposals will succeed. Assuming any of the bills make it through the legislature, their fate lies with Gov. Jerry Brown, a Democrat known for fiscal conservatism.

“If the past is any indication, it seems unlikely that bills with sizable and uncertain ongoing costs will move forward,” said Shannon McConville, a researcher at the Public Policy Institute of California.

California is not alone in resisting health care policies put forth by the Trump administration. Other states, including Maryland and New Jersey, may establish state-based penalties for not having insurance — a response to Congress’ decision to kill the federal Obamacare penalty starting in 2019.

But California’s approach, characteristically, is different.

“Rather than use the stick, use the carrot,” said Hernandez. His bill would target $500 million from the state’s general fund to help some income-eligible Californians pay their premiums or out-of-pocket medical costs. This assistance would supplement the federal financial aid for those on the Covered California exchange.

The Senate Health Committee approved the bill last week.

The Congressional Budget Office estimates that about 4 million people nationwide will become uninsured when the tax penalty for not having insurance goes away. In California, the number would be about 378,000, according to a recent Harvard University study.

Three other bills would offer state-based financial aid to different groups of consumers, including those who make too much money to qualify for federal tax credits but still struggle to pay their premiums.

The biggest potential budget-buster of them all is a proposal to establish a single-payer health system, which was pulled from consideration last year, largely because of its eye-popping price tag: $400 billion annually.

Advocates for universal health care aren’t giving up, though some have shifted their strategy to moving piecemeal toward universal health care in lieu of a massive single-payer bill.

“There are individual steps that we can still take to expand coverage to various populations that are falling through the cracks,” said Gerald Kominski, director of the UCLA Center for Health Policy Research.

One of those populations, and a large one, is immigrants living without authorization in the country.

Lara is not the only legislator with a proposal to extend full Medi-Cal coverage to income-eligible adult immigrants without legal status. State Assemblyman Joaquin Arambula (D-Fresno) has introduced a separate bill that would do the same. Arambula’s measure made it through the Assembly Health Committee on Tuesday, and Lara’s bill passed the Senate Health Committee earlier this month.

Of the nearly 3 million Californians without insurance, about 58 percent are currently ineligible for full Medi-Cal benefits or Covered California insurance because they’re not in the country legally.

California must “lead the nation in bold and inclusive polices” that support the health of all communities, said Arambula, who is an emergency room doctor.

In 2016, the state extended full Medi-Cal benefits to all children, and now more than 200,000 undocumented kids are enrolled. It’s not clear how much it would cost to cover undocumented adults, but last year, the state budgeted $279.5 million for the children. Adults are generally more expensive to cover.

All of these measures, successful or not, add up to a campaign of defiance.

“It’s a signal that California is willing to fight very hard, on multiple fronts … to protect certain values and policies,” McConville said. “This shows we’re not willing to go backwards on that.”

Podcast: KHN’s ‘What The Health?’ Nothing In Health Care Ever Goes Away

Sarah Jane Tribble

Kaiser Health News

@sjtribble

Read Sarah Jane's Stories Joanne Kenen

Politico

@JoanneKenen

Read Joanne's Stories Margot Sanger-Katz

The New York Times

@sangerkatz

Read Margot's Stories Paige Winfield Cunningham

The Washington Post

@pw_cunningham

Read Paige's Stories

Congressional Republicans have struck a decidedly different tone when talking about the Affordable Care Act, and the Democrats have introduced a new Medicare expansion bill.

Meanwhile, states are talking about Medicaid expansion, and a federal court’s ruling on Maryland’s proposal to battle drug price-gouging sends shock waves nationwide. Both chambers of Congress have been busy introducing legislative fixes for the nation’s opioid epidemic with lawmakers promising that legislation will land this spring.

This week’s panelists for KHN’s “What the Health?” are Sarah Jane Tribble of Kaiser Health News, Joanne Kenen of Politico, Margot Sanger-Katz of The New York Times and Paige Winfield Cunningham of The Washington Post.

Among the takeaways from this week’s podcast:

  • In the upcoming election season, the tables may be turned: Democrats likely will spend more on health care ads than Republicans.
  • Democrats think that this congressional campaign season they can effectively target vulnerable Republicans by focusing on the GOP’s support for repealing and replacing the Affordable Care Act.
  • Republicans, on the other hand, predict they have a winning argument with their repeal of the unpopular requirement that people get insurance or pay a penalty. Campaigns likely will also point to the party’s efforts to encourage more flexible — but perhaps less protective — coverage options, such as association and short-term health plans.
  • Two Democratic senators, Jeff Merkley of Oregon and Chris Murphy of Connecticut, introduced a bill this week that would allow individuals who haven’t yet reached 65 and small businesses to buy into the Medicare program. It would also substantially increase subsidies for people buying ACA marketplace plans.
  • Democratic efforts to expand the population that can use Medicare could hit opposition from two key groups: health care providers, such as hospitals and doctors, who object to the lower reimbursement, and seniors, who may be afraid that resources could be stretched too thin.
  • Medicaid expansion advocates in some conservative states seek to follow Maine in getting the issue on the ballot, but those efforts in very conservative states, such as Utah and Idaho, face immense obstacles.
  • Despite a court last week throwing out Maryland’s new law on drug pricing, other states are moving forward on efforts to bring more transparency to what consumers are charged for their prescriptions.
  • Lawmakers are scurrying to push through Congress efforts to help fight the nation’s opioid epidemic. One measure, by Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.), is expected to be marked up next week. Rep. Greg Walden (R-Ore.), the head of the House Energy and Commerce Committee, says his panel will bring a bill to the floor by Memorial Day.
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Plus, for “extra credit,” the panelists recommend their favorite health stories of the week they think you should read, too.

Joanne Kenen: The New York Times’ “How Profiteers Lure Women Into Often-Unneeded Surgery,” by Matthew Goldstein and Jessica Silver-Greenberg

Margot Sanger-Katz: STAT.com’s “A ‘Breakthrough in Organ Preservation’: Study Shows Keeping Livers Warm Helps Preserve Them for Transplant,” by Eric Boodman

Paige Winfield Cunningham: The Washington Post’s “Science Hinted That Cancer Patients Could Take Less of a $148,000-a-Year Drug. Its Maker Tripled the Price of a Pill,” by Carolyn Y. Johnson

Sarah Jane Tribble: The Washington Post’s “‘One Last Time’: Barbara Bush Had Already Faced a Death More Painful Than Her Own,” by Steve Hendrix

Additional Reading

Sanger-Katz recommended two stories during the opioid discussion. Here are the links to those, too:

Reason’s “America’s War on Pain Pills Is Killing Addicts and Leaving Patients in Agony,” by Jacob Sullum

Harper’s “The Pain Refugees: The Forgotten Victims of America’s Opioid Crisis,” by Brian Goldstone

To hear all our podcasts, click here.

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

HHS provides states second installment of grant awards to combat opioid crisis

HHS Gov News - April 19, 2018

Today, the Department of Health and Human Services (HHS) is releasing the second year of funding to 50 states, four U.S. territories, and the free associated states of Palau and Micronesia, totaling $485 million to continue the Nation’s efforts to combat the opioid crisis.

“The Trump Administration is partnering with states and territories to accelerate the deployment of this historic level of resources provided by the Congress to fight the epidemic,” said HHS Secretary Alex Azar. “These funds will help support evidence-based efforts at the state level to prevent misuse of opioids in the first place, expand access to effective treatment options for people in need, and support recovery for those who have prevailed.”

The Opioid State Targeted Response (STR) grants, which were created by the 21st Century Cures Act, are administered by the Substance Abuse and Mental Health Services Administration (SAMHSA) within HHS.

Dr. Elinore F. McCance-Katz, Assistant Secretary for Mental Health and Substance Use said, “Within the first year, we have already seen states use the funding to support innovative models to connect Americans with the evidence-based programs and practices proven to help people who have opioid use disorders.”

Grantees have used first year funding to implement effective medication-assisted treatment, promote the use of naloxone and key prevention strategies, and build sustainable systems of recovery support services across the country. Prevention efforts include communications campaigns along with use of proven community-based strategies. People in recovery, friends, and family members with personal experience are helping enhance recovery support.

This funding is just one more step in implementing HHS’ comprehensive five-pronged strategy to address the opioid crisis. Within the next few months, SAMHSA will release details of a separate $1 billion grant funding opportunity for states, territories, and tribes hardest hit by the crisis. This new funding is expected to be awarded in September 2018.

People grappling with substance use disorders can find treatment resources at SAMHSA’s site: http://findtreatment.samhsa.gov or by calling SAMHSA’s National Helpline, 1-800-662-HELP. People who could use help determining which treatment provider is appropriate for their needs can find free guidance at https://store.samhsa.gov/product/Finding-Quality-Treatment-for-Substance-Use-Disorders/PEP18-TREATMENT-LOC.

More information on HHS work to combat the opioid crisis can be viewed at https://www.hhs.gov/opioids/

Details of the funding amounts for each state and territory:

Opioid State Targeted Response Grants Year Two Funding Table State Year 2 Authorized Amount (Total: $484,491,838) Alabama $7,967,873 Alaska $2,000,000 American Samoa $250,000 Arizona $12,171,518 Arkansas $3,901,295 California $44,749,771 Colorado $7,869,651 Connecticut $5,500,157 Delaware $2,000,000 District of Columbia $2,000,000 Federated States of Micronesia $250,000 Florida $27,150,403 Georgia $11,782,710 Hawaii $2,000,000 Idaho $2,000,000 Illinois $16,328,583 Indiana $10,925,992 Iowa $2,728,077 Kansas $3,114,402 Kentucky $10,528,093 Louisiana $8,167,971 Maine $2,039,029 Maryland $10,036,784 Massachusetts $11,742,924 Michigan $16,372,680 Minnesota $5,379,349 Mississippi $3,584,652 Missouri $10,015,898 Montana $2,000,000 Nebraska $2,000,000 Nevada $5,663,328 New Hampshire $3,128,366 New Jersey $12,995,621 New Mexico $4,792,551 New York $25,260,676 North Carolina $15,586,724 North Dakota $2,000,000 Northern Mariana $250,000 Ohio $26,060,502 Oklahoma $7,283,229 Oregon $6,564,425 Palau $250,000 Pennsylvania $26,507,559 Puerto Rico $4,811,962 Rhode Island $2,167,007 South Carolina $6,575,623 South Dakota $1,999,997 Tennessee $13,815,132 Texas $27,362,357 Utah $5,537,458 Vermont $2,000,000 Virgin Islands $250,000 Virginia $9,762,332 Washington $11,790,256 West Virginia $5,881,983 Wisconsin $7,636,938 Wyoming $2,000,000

Secretary Azar Announces Appointment of James Parker

HHS Gov News - April 19, 2018

Today, Health and Human Services Secretary Alex Azar announced that James Parker will serve as Senior Advisor to the Secretary for Health Reform and Director of the Office of Health Reform at HHS. Mr. Parker will lead the initiative to address the cost and availability of health insurance.

Upon this announcement, Secretary Azar said: “Jim Parker has spent his life working in the private sector to provide Americans access to quality, affordable health insurance. His knowledge and expertise will be vital to our work at HHS to ensure that Americans have access to insurance that meets their needs.”

This follows the recent announcement of Daniel M. Best to serve as Senior Advisor to the Secretary for Drug Pricing Reform and Brett Giroir, M.D., to serve as Senior Advisor to the Secretary for Mental Health and Opioid Policy, in addition to his duties as Assistant Secretary for Health.

These individuals will help advance three of Secretary Azar’s previously identified four initiatives for his transformation agenda: combating the opioid crisis; bringing down the high cost of prescription drugs; addressing the cost and availability of health insurance; and transforming our healthcare system to a value-based system. 

Biographical Information

An accomplished healthcare executive with broad leadership experience, James Parker has spent his career working to provide Americans with quality, affordable health insurance. He most recently served as Chief Executive Officer of MDwise, Inc., an Indiana Medicaid managed care organization with over 300,000 members and $1.4 billion in revenue. He also led the development of a provider-sponsored health plan and population health management capabilities within Indiana University Health, an Indianapolis-based integrated health system and served as co-chair of the Indiana University Health Population Health Management Services Organization. Mr. Parker previously spent 20 years with Anthem, Inc. in a number of senior leadership roles advancing initiatives to improve the quality and affordability of health insurance.

Readout of Deputy Secretary Hargan's Patient Advocacy Group Meeting

HHS Gov News - April 18, 2018

On Tuesday, Health and Human Services Deputy Secretary Eric Hargan held a meeting with attendees from patient advocacy groups. The attendees expressed their individual opinions and as a group exchanged information pertaining to the Department's priorities. The meeting included representatives and patients from the American Cancer Society, the American Heart Association, JDRF, the Leukemia and Lymphoma Society, the National Alliance on Mental Illness, and the National Health Council. Deputy Secretary Hargan was joined by two senior advisors Dan Best, HHS’s Senior Advisor to the Secretary for Drug Pricing Reform, and Dr. Brett Giroir, HHS’s Assistant Secretary for Health and Senior Advisor to the Secretary for Mental Health and Opioid Policy.

The gathering was part of Secretary Alex Azar’s efforts to ensure patients and their representatives have their voices heard as HHS implements President Trump’s important reforms to improve healthcare for all Americans.

Participants shared their perspectives on achieving HHS’s priorities: lowering the high price of prescription drugs, making health insurance and more accessible and affordable, creating a value-based healthcare system, and combating the opioid crisis.

Deputy Secretary Hargan thanked the participants for their insights and emphasized President Trump’s personal commitment to taking bold action to make health insurance and prescription drugs more affordable. He emphasized that HHS will maintain engagement with patient groups as the Department works to create a better healthcare system for every American.

 

Federal Appeals Court Puts Chill On Maryland Law To Fight Drug Price-Gouging

States continue to battle budget-busting prices of prescription drugs. But a federal court decision could limit the weapons available to them — underscoring the challenge states face as they, in the absence of federal action, go one-on-one against the powerful drug industry.

The 2-to-1 ruling Friday by the U.S. 4th Circuit Court of Appeals invalidated a Maryland law meant to limit “price-gouging” by makers of generic drugs. The measure was inspired by cases such as that of former Turing Pharmaceutical CEO Martin Shkreli, who raised one generic’s price 5,000 percent after buying the company.

The law, which had been hailed as a model for other states, is one of a number of state initiatives designed to combat rapidly rising drug prices. It gave the state attorney general power to intervene if a generic or off-patent drug’s price increased by 50 percent or more in a single year.

If dissatisfied with the company’s justification, the attorney general could have filed suit in state court. Manufacturers would have faced a fine of up to $10,000 and potentially have to reverse the price hike. The generics industry was fiercely critical of the law.

“We are evaluating all options with regard to next steps,” said Maryland Attorney General Brian Frosh in a statement. His office would not elaborate further.

The state could appeal to have the case heard “en banc,” meaning by the full 4th Circuit, with jurisdiction over five states.

Such appeals aren’t commonly granted, but this law could be a strong candidate, suggested Aaron Kesselheim, an associate professor at Harvard Medical School who researches drug-price regulation.

The Friday ruling looms large as other state legislatures grapple with ever-climbing drug prices.

Similar price-gouging legislation has been introduced in at least 13 states this year, though none of those measures became law, according to the National Conference of State Legislatures (NCSL). Three other bills failed to gain passage.

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The NCSL also cited the law in a March advisory for states seeking new approaches to regulating drug prices.

The court’s finding could have a chilling effect on such efforts, especially as more state legislatures wrap up business for 2018.

“A negative court ruling will put a damper or a pause on state activities,” said Richard Cauchi, NCSL’s health program director. “Unless this topic is your No. 1 priority of the year, your legislators are juggling multiple bills, multiple strategies. When bill three gets in trouble, they move to bill four.”

The appeals court held that Maryland’s law overstepped limits on how states can regulate commerce — specifically, a constitutional ban on states controlling business that takes place outside their borders. The majority ruling argues that since most generics manufacturers and drug wholesalers engage in trade outside Maryland, the state cannot control what prices they charge.

In a dissenting opinion, the panel’s third judge argued Maryland can regulate the drug prices charged within the state since the law is meant to affect only medications being sold to its own residents.

Kesselheim, in an article published last month in the journal JAMA, argued a similar point.

Regardless, striking down a law on constitutional grounds can be particularly discouraging, suggested Rachel Sachs, an associate law professor at Washington University in St. Louis who researches drug regulations.

“If it had been a rejection on vagueness grounds, that’s something you can cure with a more specific statute,” she said. “But the fact that they said this is unconstitutional poses real concern for other states.”

That’s important. While the federal government has talked a big game on bringing down drug prices, it has done little. Instead, states have taken the lead — spurred by the budget squeeze pricey prescriptions impose on their Medicaid programs and on state employee benefits packages.

But states have far fewer tools at their disposal than does Congress. Most state laws so far tackle only pieces of the problem — targeting a specific drug or particular practice, experts said.

“We’ll get more broad and better evolution on this issue if the federal government decides to take it seriously — which it hasn’t so far,” Kesselheim said.

To be fair, Maryland’s law is only one of a bevy of approaches.

Other states have focused on price transparency laws. In California, drug companies must disclose in advance if a price might increase by more than a set percent and that they justify the increase. Industry has sued to block the California law.

New York has limited what the state will pay for drugs, establishing a process to review if expensive drugs are priced out of step with their medical value.

A number of states have since 2017 passed laws regulating pharmacy benefit managers — the contractors who negotiate discounted drug coverage for insurance plans, but who rarely reveal what level of discount they actually pass on to consumers.

Experts expect that activity to continue, especially as escalating drug prices show little sign of letting up.

“The states are going to keep trying and experimenting,” Sachs added. “This is a problem that isn’t going away.”

Even efforts such as Maryland’s — which targeted price-gouging — will likely remain at the forefront.

“I don’t think this is the end of states trying to do something on price-gouging,” said Ellen Albritton, a senior policy analyst at the left-leaning advocacy group Families USA who consults with states on drug-pricing policy. “It’s such an issue that offends people’s sensibilities. It’s crazy people can do this.”

Congressional Advisers Urge Medicare Payments To Many Stand-Alone ERs Be Cut

The woman arrived at the emergency department gasping for air, her severe emphysema causing such shortness of breath that the physician who examined her put her on a ventilator immediately to help her breathe.

The patient lived across the street from the emergency department in suburban Denver, said Dr. David Friedenson, who cared for her that day a few years ago. The facility wasn’t physically located at a hospital but was affiliated with North Suburban Medical Center several miles away.

Free-standing emergency departments have been cropping up in recent years and now number more than 500, according to the Medicare Payment Advisory Commission (MedPAC), which reports to Congress. Often touted as more convenient, less crowded alternatives to hospitals, they often attract suburban walk-in patients with good insurance whose medical problems are less acute than those who visit an emergency room located in a hospital.

If a recent MedPAC proposal is adopted, however, some providers predict that these free-standing facilities could become scarcer. Propelling the effort are concerns that MedPAC’s payment for services at these facilities is higher than it should be since the patients who visit them are sometimes not as severely injured or ill as those at on-campus facilities.

The proposal would reduce Medicare payment rates by 30 percent for some services at hospital-affiliated free-standing emergency departments that are located within 6 miles of an on-campus hospital emergency department.

“There has been a growth in free-standing emergency departments in urban areas that does not seem to be addressing any particular access need for emergency care,” said James Mathews, executive director of MedPAC. The convenience of a neighborhood emergency department may even induce demand, he said, calling it an “if you build it, they will come” effect.

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Emergency care is more expensive than a visit to a primary care doctor or urgent care center, in part because emergency departments have to be on standby 24/7, with expensive equipment and personnel ready to handle serious car accidents, gunshot wounds and other trauma cases. Even though free-standing emergency departments have lower standby costs than hospital-based facilities, they typically receive the same Medicare rate for emergency services. The Medicare “facility fee” payments, which include some ancillary lab and imaging services but not reimbursement to physicians, are designed to help defray hospitals’ overhead costs.

The proposal would affect only payments for Medicare beneficiaries. But private insurers often consider Medicare payment policies when setting their rules.

According to a MedPAC analysis of five markets — Charlotte, N.C.; Cincinnati; Dallas; Denver; and Jacksonville, Fla. — 75 percent of the free-standing facilities were located within 6 miles of a hospital with an emergency department. The average drive time to the nearest hospital was 10 minutes.

Overall, the number of outpatient emergency department visits by Medicare beneficiaries increased 13.6 percent per capita from 2010 to 2015, compared with a 3.5 percent growth in physician visits, according to MedPAC. (The reported data doesn’t distinguish between conventional and free-standing emergency facility visits.)

“I think [the MedPAC proposal] is a move in the right direction,” said Dr. Renee Hsia, a professor of emergency medicine and health policy at the University of California-San Francisco who has written about free-standing emergency departments. “We have to understand there are limited resources, and the fixed costs for stand-alone EDs are lower.”

Hospital representatives say the proposal could cause some free-standing emergency departments to close their doors.

“We are deeply concerned that MedPAC’s recommendation has the potential to reduce patient access to care, particularly in vulnerable communities, following a year in which hospital EDs responded to record-setting natural disasters and flu infections,” Joanna Hiatt Kim, vice president for payment policy at the American Hospital Association, said in a statement.

Independent free-standing emergency departments that are not affiliated with a hospital would not be affected by the MedPAC proposal. These facilities, which make up about a third of all free-standing emergency facilities, aren’t clinically integrated with a hospital and can’t participate in the Medicare program.

The MedPAC proposal will be included in the group’s report to Congress in June.

Even though stand-alone emergency facilities might not routinely treat patients with serious trauma, they can provide lifesaving care, proponents say.

Friedenson said that for his emphysema patient, avoiding the 15- to 20-minute drive to the main hospital made a critical difference.

“By stopping at our emergency department, I truly think her life was saved,” he said.

Update from the Department of Health and Human Services

HHS Gov News - April 16, 2018

Today, the Department of Health and Human Services issued the following statement:

Earlier this evening the Secretary of Health and Human Services, Alex M. Azar II, was treated with intravenous antibiotics for a minor infection. Out of an abundance of caution he has been admitted to a hospital for observation.

Safety Violations Compound Pain Of Painkiller Shortages

Safety violations at a major compounding pharmacy are exacerbating hospital shortages of key painkillers, particularly in California where health officials have taken the “extraordinary” step of prohibiting sales from one of its plants.

In late March, California’s Board of Pharmacy barred the distribution of medications — including lidocaine and other local anesthetics — from a Texas factory belonging to the company, PharMEDium. The decision came after the pharmacy board had issued a cease-and-desist order against the plant in February, citing “an immediate threat to the public health or safety.”

In December, the Food and Drug Administration issued a damning inspection report on PharMEDium’s Tennessee plant that led the company to voluntarily cease production there.

There are two kinds of compounding pharmacies: ones that mix custom prescriptions for individual patients, from chemotherapy cocktails to thyroid drugs, and those like PharMEDium, which mass-produce ready-to-use IV bags, prefilled syringes and other sterile medical solutions for hospitals, surgery centers and other health care facilities.

PharMEDium, one of the nation’s largest compounding pharmacy companies, is owned by AmerisourceBergen and supplies medications to about 77 percent of hospitals nationwide.

Before the crackdown on PharMEDium, hospitals already were facing critical shortages of the injectable opioid painkillers Dilaudid, morphine and fentanyl, which started with manufacturing delays at pharmaceutical giant Pfizer. The shutdown at PharMEDium’s Tennessee plant, which makes those drugs, has intensified the shortage nationally.

Doctors, determined to spare their patients pain, consequently have turned to second-choice pain drugs and increased their use of local anesthetics such as lidocaine. But now, even those local anesthetics — lidocaine, ropivacaine and bupivacaine — are in short supply due to manufacturing problems and back orders, according to doctors and federal regulators.

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Shortages of both types of painkillers have hit California health care providers especially hard. They must contend with the state crackdown on PharMEDium’s Texas plant, which produces local anesthetics, and federal scrutiny of the Tennessee plant, which produces the injectable opioids. Some California hospitals have abandoned the company altogether.

“We’re having to be very creative,” said Dr. Aimee Moulin, an emergency doctor at the University of California-Davis Health System who is president of the California chapter of the American College of Emergency Physicians.

“There are times when we’re not able to achieve that amount of anesthesia that we would like,” Moulin said. When that happens, she often turns to a second-choice drug that might not be as effective.

Dr. Rita Agarwal, who practices at Stanford University’s Lucile Packard Children’s Hospital, said the facility has a sufficient supply of local anesthetics to cope with the injectable opioid shortages. But if that changes, doctors may have to cancel elective surgeries, she said.

“If we can’t provide patients with adequate pain relief, then it’s sort of barbaric to do the surgery,” said Agarwal, who is also a professor of anesthesiology at Stanford.

In the meantime, her team is using more drugs like Demerol or remifentanil, which are not ideal in many cases because they have side effects or are short-acting.

“It’s unbelievably frustrating,” Agarwal said. “The solutions are [being] snatched away from us.”

California’s concern about PharMEDium dates to at least 2016, when the state warned the company about drugs “lacking in quality or strength” and fined it for failing to notify state officials about a product recall, according to public records obtained by California Healthline.

Then, the California Board of Pharmacy’s temporary cease-and-desist order, issued Feb. 27, faulted PharMEDium’s Sugar Land, Texas, plant for 14 violations, including flawed expiration dating and improper labeling. Virginia Herold, the board’s executive officer, called the action an “extraordinary authority” that it doesn’t use frequently.

In late March, the board decided not to renew the plant’s license. The agency is not aware of any patient harm that may be related to the plant’s failures, Herold said.

PharMEDium spokeswoman Lauren Esposito said the company is committed to resolving the matter.

“We look forward to renewing our California licenses and resuming shipment of our products into the state of California as soon as the board feels that its observations have been satisfactorily addressed,” she said.

California’s crackdown could make waves economically and symbolically, because of the size of its market and the message it sends to other states, said Dave Thomas, a principal with LDT Health Solutions, a consulting firm for compounding pharmacies.

“This can get pretty hairy for PharMEDium pretty fast,” he said.

At the federal level, the FDA’s December report on PharMEDium’s Memphis, Tenn., plant listed a litany of deficiencies.

The report said the plant, which supplies injectable opioids to hospitals around the country, wasn’t doing enough to ensure medications were sterile before shipping them.

The FDA also reprimanded the company for poor employee training and failure to report and thoroughly investigate a case in which a patient became unconscious after receiving an injection of morphine produced by PharMEDium.

In the industry’s defense, said Thomas, the consultant, FDA inspectors can be inconsistent and deficiencies cited at compounding plants can depend on the person writing the report.

Government officials have stepped up scrutiny of compounding pharmacies since 2012, when contaminated drugs from the New England Compounding Center led to a national meningitis outbreak that killed 64 people and sickened 793 patients. The incident led to an eight-year prison sentence for the compounder’s supervising pharmacist, and a 2013 federal law that created new requirements for the pharmacies.

PharMEDium doesn’t know when the Memphis plant will start production again, Esposito said.

“We are actively working to address the items noted by FDA during the inspection and will resume … activities when we have determined our own readiness,” she said.

Because the Memphis plant is still offline, shortages of injectable opioids have worsened, according to a large California medical system.

“It’s been a struggle” to maintain an adequate stock of the medications since the plant stopped producing, said Donald Kaplan, a pharmacy director at Kaiser Permanente in Southern California. (California Healthline is produced by Kaiser Health News, which is not affiliated with Kaiser Permanente.)

Opioid supplies have dwindled so dramatically that Kaiser is shipping medications from one hospital to others that are in short supply, sometimes multiple times per week, he said.

In recent years, some hospitals have sought alternatives to PharMEDium because of quality problems, according to the California Hospital Association.

That’s the case with Mayers Memorial Hospital District in Shasta County, whose chief clinical officer Keith Earnest said it hasn’t used PharMEDium’s products in five years.

“I am glad they are finally no longer allowed to ship to California,” he said. “It has been a long time coming.”

Great Weekend Reads From KHN

The Friday Breeze

Newsletter editor Brianna Labuskes, who reads everything on health care to compile our daily Morning Briefing, offers the best and most provocative stories for the weekend.

Happy Friday! Welcome back to The Friday Breeze, where I (KHN’s newsletter editor) wade through hundreds of health articles from the week so you don’t have to.

Health certainly was not at the top of mind for this week’s news cycle (what with the House speaker announcing he would not seek re-election and a raid here or there), but there were still some stories that are worth the read. Here’s what you need to know.

Following on the heels of Minnesota’s success, states are starting to eye publicly funded reinsurance pools (which essentially protect insurers when they’re hit with an unexpectedly high claim) as an answer to stabilizing the health law marketplace. But in the era of tight budgets, states have only so much money to throw at the problem. Also, a comprehensive look at where exchanges stand after the past couple topsy-turvy months.

The growing popularity of retail clinics and urgent care centers (as well as low pay and long hours for the physicians themselves) are nudging the traditional primary care doctor toward extinction. Physicians are worried all these mergers and movement in the industry are a slippery slope. What’s next, asks one: “Are Aetna patients going to be mandated to go to a CVS MinuteClinic?”

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Over in pharmaceutical land, the once-powerful industry’s rare defeat in the “doughnut hole” battle with Congress doesn’t speak well of its current clout on the Hill. And, believe it or not, there are some arguing that certain drug prices are too low.

In the war on opioids, you won’t get far without hearing about naloxone. It’s been a lifesaver for thousands, and the surgeon general just last week urged Americans to start carrying it. But it has its flaws, it’s expensive and, right now, there aren’t any realistic alternatives. Scientists want to change that.
Use our content This story can be republished for free (details).
And drug distributors are about to be summoned to Congress in a move some are likening to the tobacco executive hearings in the 1990s.

There were a few things out of the states to keep an eye on from this week: the California bill that would let the state set certain health prices (like hospital stays); how beliefs on single-payer are coming to define the California gubernatorial race (in a microcosm of the Democratic Party); and the fact that not one patient has utilized D.C.’s aid-in-dying law.

In the miscellaneous file of smart, funny or insightful reads from the week: a heartbreaking dive into the crisis facing black women and their babies; juicy takeaways from a book on Theranos (including how staffers would “get disappeared” by the company’s mysterious No. 2); the thousands of vacancies the VA just can’t seem to fill (because there aren’t enough HR people to do the hiring); and the lawyer who’s at the center of the battle over young immigrants seeking abortions.

Have a fantastic weekend (but not too fantastic, because apparently one extra glass of wine a day takes 30 minutes off your life). And make sure to let us know what you think of the Friday Breeze.

Podcast: KHN’s ‘What The Health?’ It’s Nerd Week

Julie Rovner

Kaiser Health News

@jrovner

Read Julie's Stories Stephanie Armour

The Wall Street Journal

@StephArmour1

Read Stephanie's Stories Sarah Kliff

Vox.com

@sarahkliff

Read Sarah's Stories Paige Winfield Cunningham

The Washington Post

@pw_cunningham

Read Paige's Stories

The Trump administration this week issued the rules governing next year’s Affordable Care Act insurance marketplaces, and they make some potentially large changes that could result in higher premiums and fewer benefits.

Meanwhile, states are going different ways in addressing the health insurance markets in their states in response to the federal activity. And House Speaker Paul Ryan announced his retirement — leaving an intellectual void among House Republicans when it comes to health care.

This week’s panelists for KHN’s “What the Health?” are:

  • Julie Rovner of Kaiser Health News
  • Stephanie Armour of The Wall Street Journal
  • Sarah Kliff of Vox.com
  • Paige Winfield Cunningham of The Washington Post

Among the takeaways from this week’s podcast:

  • The federal rules for the ACA’s marketplaces could dramatically alter how state regulators determine what plan benefits must be covered.
  • Those rules also change some conditions allowing people to qualify for exemptions to the requirement to have coverage — and they make those exemptions retroactive to 2017. So, some people who opted not to buy insurance and paid a penalty for 2017 may be able to file for refunds from the government.
  • Insurance companies are concerned about a number of the new provisions, including those that might drive healthy consumers away from the marketplaces and alter how insurers are compensated for having unusually high numbers of expensive customers.
  • An announcement from the White House this week said the administration is hoping to extend the work requirements that some states are seeking for Medicaid to other safety-net programs.
  • California and Maryland are among the states looking at ways to shore up their individual insurance markets in light of the changes being made at the federal level. Email Sign-Up

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‘Bill of the Month’

This month, NPR’s Alison Kodjak talks about a case of two CT scans — identical, except one cost 33 times more than the other.

Send Us Your Medical Bill

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

Submit Your Bill

If you want to submit a bill for the Bill of the Month series, here is the form.

And if you have an emergency room bill you’d like to share for this Vox.com project, here’s that form.

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

Julie Rovner: Vox.com, “Toe Ointment, a $937 Bill, and a Hard Truth About American Health Care,” by Sarah Kliff.

Stephanie Armour: Axios.com, “The Drug Pricing Contract Express Scripts Doesn’t Want You to See,” by Bob Herman.

Sarah Kliff: Vox.com, “Why Scott Gottlieb Is the One Trump Official Everybody Seems to Like,” by Julia Belluz, German Lopez and Dylan Scott.

Paige Winfield Cunningham: Kaiser Health News, “How A Drugmaker Turned The Abortion Pill Into A Rare-Disease Profit Machine,” by Sarah Jane Tribble.

To hear all our podcasts, click here.

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

FDA Launches Criminal Investigation Into Unauthorized Herpes Vaccine Research

The Food and Drug Administration has launched a criminal investigation into research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine, Kaiser Health News has learned.

SIU professor William Halford, who died in June, injected participants with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that is routinely performed by the FDA or an institutional review board.

According to four people with knowledge about the inquiry, the FDA’s Office of Criminal Investigations is looking into whether anyone from SIU or Halford’s former company, Rational Vaccines, violated FDA regulations by helping Halford conduct unauthorized research. The probe is also looking at anyone else outside the company or university who might have been complicit, according to the sources who asked not to be identified because of the sensitivity of the matter.

KHN Investigation

A researcher’s quest to find a new herpes vaccine raises questions of safety and academic and corporate governance. KHN’s Marisa Taylor investigates.

Get All Related Stories

The FDA rarely prosecutes research violations, usually choosing to administratively sanction or ban researchers or companies from future clinical trials, legal experts said. Even so, the agency is empowered to pursue as a crime the unauthorized development of vaccines and drugs — and sometimes goes after such cases to send a message.

In this case, human-subject violations would be deemed especially serious given Halford was not a medical doctor and had injected people with his experimental vaccine without any routine oversight, experts said.

“Since the research appears to be an effort to totally evade FDA oversight and is egregious, it makes sense the FDA would investigate it as a criminal matter,” said Patricia Zettler, a former FDA lawyer who was told of the criminal investigation by KHN. “There is a deterrent effect for others who might consider this a very brazen way to get out of human subject and FDA requirements.”

The FDA declined to comment. Rational Vaccines did not respond to requests for comment. An SIU spokeswoman said, without elaboration, “The government is investigating and we are cooperating.”

Any resulting criminal prosecution from the investigation could have political ramifications.

Rational Vaccines was co-founded with Hollywood filmmaker Agustín Fernández III and the company received millions of dollars in private investment from investors after the Caribbean trial, including from billionaire Peter Thiel.

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Thiel, who for months has refused to respond to questions from KHN, contributed to President Donald Trump’s campaign and is a high-profile critic of the FDA. Thiel is part of a larger libertarian movement to roll back FDA regulations to speed up medical innovation.

The sources familiar with the inquiry said the FDA’s Office of Criminal Investigations, which has dozens of offices across the country, began to aggressively pursue the case weeks ago.

The investigators have interviewed witnesses across the country, asking them to identify Halford’s associates, and have described his actions as possible violations of human-subject guidelines and of FDA regulations, the sources told KHN.

The investigators also have expressed interest in whether Halford’s former associates at the university or other researchers and medical professionals outside the university might have helped or known about his conduct, the sources said. They also have raised questions about the company’s knowledge of the violations.

Rational Vaccines helped oversee the Caribbean trial, but the 2013 hotel injections took place before the company was formed.

Under a Supreme Court ruling, a corporate official may be prosecuted for a criminal misdemeanor offense under the Federal Food, Drug and Cosmetic Act even without proof that the official acted with intent or actual knowledge of the offense.

Initially, university officials and Rational Vaccines publicly defended Halford’s research. Rational Vaccines has said it considered the 2016 trial a success — though it is unclear what data it used to support that claim.

After KHN’s investigation revealed that Halford injected people in the United States, not just in the Caribbean, Rational Vaccines took down its website, although it had vowed to continue research.

SIU, a state university with a medical school in Springfield, Ill., initially said it bore no responsibility for the experiments because Halford conducted the research independently and overseas.

After Kaiser Health News raised questions about Halford’s practices, the Department of Health and Human Services asked the university to determine whether his activities violated the institution’s pledge to HHS to follow human-subject safety protocols for all research. SIU’s medical school receives about $ 9 million a year in federal research dollars.

SIU has since acknowledged that Halford’s conduct violated university rules and U.S. laws. University officials have denied knowing about his misconduct, an assertion that FDA investigators are still probing, the sources said.

Halford’s actions already raised unusual legal questions because the FDA would not ordinarily have jurisdiction over clinical trials when they occur overseas and the researchers have not sought FDA approval.

It’s also unclear where Halford manufactured the vaccine.

If it was manufactured in the United States, the FDA likely has jurisdiction, said Zettler, a law professor at Georgia State University.

The OCI often goes after such cases of contaminated food, counterfeit or off-label pharmaceuticals. The office was created in the wake of a 1988 scandal in which pharmaceutical executives bribed FDA officials in exchange for speeding up generic drug approvals.

While rare, the OCI occasionally pursues research abuses as a crime. A GlaxoSmithKline researcher, for instance, pleaded guilty in 2010 to charges related to her fabrication of data in a study of children taking the antidepressant Paxil. GlaxoSmithKline later agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability in the case.

Medical Marijuana’s ‘Catch-22’: Federal Limits On Research Hinder Patients’ Relief

By the time Ann Marie Owen turned to marijuana to treat her pain, she was struggling to walk and talk. She also hallucinated.

For four years, her doctor prescribed the 61-year-old a wide range of opioids for her transverse myelitis, a debilitating disease that caused pain, muscle weakness and paralysis.

The drugs not only failed to ease her symptoms, they hooked her.

When her home state of New York legalized marijuana for the treatment of select medical ailments, Owens decided it was time to swap pills for pot. But her doctors refused to help.

“Even though medical marijuana is legal, none of my doctors were willing to talk to me about it,” she said. “They just kept telling me to take opioids.”

While 29 states have legalized marijuana to treat pain and other ailments, the growing number of Americans like Owen who use marijuana and the doctors who treat them are caught in the middle of a conflict in federal and state laws — a predicament that is only worsened by thin scientific data.

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Because the federal government classifies marijuana a Schedule 1 drug — by definition a substance with no currently accepted medical use and a high potential for abuse — research on marijuana or its active ingredients is highly restricted and even discouraged in some cases.

Underscoring the federal government’s position, Health and Human Services Secretary Alex Azar recently pronounced that there was “no such thing as medical marijuana.”

Scientists say that stance prevents them from conducting the high-quality research required for FDA approval, even as some early research indicates marijuana might be a promising alterative to opioids or other medicines.

Patients and physicians, meanwhile, lack guidance when making decisions about medical treatment for an array of serious conditions.

“We have the federal government and the state governments driving a hundred miles an hour in the opposite direction when they should be coming together to obtain more scientific data,” said Dr. Orrin Devinsky, who is researching the effects of cannabidiol, an active ingredient of marijuana, on epilepsy. “It’s like saying in 1960, ‘We’re not going to the moon because no one agrees how to get there.’”

Ann Marie Owen walks with her husband, Bruce, near their home in Port Ewen, N.Y., on Feb. 19. (Allyse Pulliam for KHN)

The problem stems partly from the fact that the federal government’s restrictive marijuana research policies have not been overhauled in more than 40 years, researchers say.

Only one federal government contractor grows marijuana for federally funded research. Researchers complain the pot grown by the contractor at the University of Mississippi is inadequate for high-quality studies.

The marijuana, which comes in a micronized powder form, is less potent than the pot offered at dispensaries, researchers say. It also differs from other products offered at dispensaries, such as so-called edibles that are eaten like snacks. The difference makes it difficult to compare the real-life effects of the marijuana compounds.

Researchers also face time-consuming and costly hurdles in completing the complicated federal application process for using marijuana in long-term clinical trials.

“It’s public policy before science,” said Dr. Chinazo Cunningham, a primary care doctor who is the lead investigator on one of the few federally funded studies exploring marijuana as a treatment for pain. “The federal government’s policies really make it much more difficult.”

Cunningham, who received a five-year, $3.8 million federal grant, will not be administering marijuana directly to participants. Instead, she will follow 250 HIV-positive and HIV-negative adults with chronic pain who use opioids and have been certified to get medical marijuana from a dispensary.

“It’s a catch-22,” said Cunningham, who is with the Albert Einstein College of Medicine. “We’re going to be looking at all of these issues — age, disease, level of pain — but when we’re done, there’s the danger that people are going to say ‘Oh, it’s anecdotal’ or that it’s inherently flawed because it’s not a randomized trial.’’

Without clear answers, hospitals, doctors and patients are left to their own devices, which can result in poor treatment and needless suffering.

Hospitals and other medical facilities have to decide what to do with newly hospitalized patients who normally take medical marijuana at home.

Some have a “don’t ask, don’t tell” approach, said Devinsky, who sometimes advises his patients to use it. Others ban its use and substitute opioids or other prescriptions.

Young adults, for instance, have had to stop taking cannabidiol compounds for their epilepsy because they’re in federally funded group homes, said Devinsky, the director of NYU Langone’s Comprehensive Epilepsy Center.

“These kids end up getting seizures again,” he said. “This whole situation has created a hodgepodge of insanity.”

The Trump administration, however, has resisted policy changes.

Last year, the Drug Enforcement Administration had been gearing up to allow facilities other than the University of Mississippi to grow pot for research. But after the DEA received 26 applications from other growers, Attorney General Jeff Sessions halted the initiative.

The Department of Veterans Affairs also recently announced it would not fund studies of using marijuana compounds to treat ailments such as pain.

The DEA and HHS have cited concerns about medical supervision, addiction and a lack of “well-controlled studies proving efficacy.”

Patients, meanwhile, forge ahead.

Ann Marie Owen prepares to take oral medical marijuana at home. The retired university administrative assistant credits marijuana for weaning her off opioids. (Allyse Pulliam for KHN)

While experts say they don’t know exactly how many older Americans rely on marijuana for medicinal purposes, the number of Americans 65 and older who say they are using the drug skyrocketed 250 percent from 2006 to 2013.

Some patients turn to friends, patient advocacy groups or online support groups for information.

Owen, for one, kept searching for a doctor and eventually found a neurologist willing to certify her to use marijuana and advise her on what to take.

“It’s saved my life,” said the retired university administrative assistant who credited marijuana for weaning her off opioids. “It not only helps my pain, but I can think, walk and talk again.”

Mary Jo, a Minnesotan, was afraid of being identified as a medical marijuana user, even though she now helps friends navigate the process and it’s legal in her home state.

“There’s still a stigma,” said Mary Jo, who found it effective for treating her pain from a nerve condition. “Nobody helps you figure it out, so you kind of play around with it on your own.”

Still, doctors and scientists worry about the implications of such experimentation.

In a sweeping report last year, the National Academies of Sciences, Engineering and Medicine called on the federal government to support better research, decrying the “lack of definitive evidence on using medical marijuana.”

The national academies’ committee reviewed more than 10,000 scientific abstracts related to the topic. It made 100 conclusions based on its review, including finding evidence that marijuana relieves pain and chemotherapy-induced nausea. But it found “inadequate information” to support or refute effects on Parkinson’s disease.

Yet those who find that medical marijuana helps them can become fierce advocates no matter what their doctors say.

Caryl Barrett, a 54-year-old who lives in Georgia, said she decided to travel out of state to Colorado to treat her pain from her transverse myelitis and the autoimmune disease neurosarcoidosis.

“I realized it worked and I decided to bring it back with me,” she said. “I broke federal law.”

Georgia, meanwhile, permitted limited medicinal use of marijuana but did not set up dispensaries. As a result, patients resort to ordering it online or driving to another state to get it.

The conflict in the law makes her uneasy. But Barrett, who had been on opioids for a decade, said she feels so strongly about it working that “if someone wants to arrest me, bring it on.”

Others experience mixed results.

Melodie Beckham, who had metastatic lung cancer, tried medical marijuana for 13 days in a clinical trial at Connecticut Hospice before deciding to quit.

Ann Marie Owen prepares to take oral medical marijuana at home in Port Ewen, N.Y., on Feb. 19, 2018. The retired university administrative assistant credits marijuana for weaning her off opioids. (Allyse Pulliam for KHN)

“She was hopeful that it would help her relax and just kind of enjoy those days,” said her daughter, Laura Beckham.

Instead, it seemed to make her mother, who died in July at age 69, “a little more agitated or more paranoid.”

The marijuana “didn’t seem effective,” nor did it keep her mother from hitting her pain pump to get extra doses of an opioid, her daughter said.

The researchers running the trial at Connecticut Hospice spent two years getting necessary approvals from the Food and Drug Administration, the National Institute on Drug Abuse (NIDA) and the DEA.

Started in May, the trial has enrolled only seven of the 66 patients it plans to sign up because many patients were too sick, too close to death or simply couldn’t swallow the pills. So far, the trial has shown “mixed results,” said James Prota, director of pharmacy for the hospice.

Researchers point out they are still exploring the basics when it comes to marijuana’s effects on older adults or the terminally ill.

“We just have no data on how many older adults are using medical marijuana, what they are using it for and most importantly what are the outcomes,” said Brian Kaskie, a professor at the University of Iowa’s College of Public Health. “It’s all anecdotal.”

Kaskie, who specializes in public policy and the aging, received grants from the state of Colorado and the Chicago-based Retirement Research Foundation to survey the use of medical marijuana by older Americans.

In many quarters, there’s a growing appetite for solid information, he said.

“When I first started this, my colleagues joked we were going to find all the aging hippies who listen to the Grateful Dead,” said Kaskie, who has been studying medicinal marijuana for years. “Now, they’re starting to realize this is a legitimate area of research.”

Twenty researchers received marijuana from the federal program last year, which was more than any previous year since 2010, according to NIDA statistics.

In a recent funding announcement, the National Institutes of Health requested grant applications to study the effects of marijuana and other drugs on older adults and pain.

NIH, however, continues to funnel much of its funding into studying the adverse effects of marijuana, researchers said.

Although NIH acknowledged in one of the announcements that some research supports “possible benefits” of marijuana, it emphasized “there have not been adequate large controlled trials to support these claims.”

HHS sponsors its largest exercise for moving patients with highly infectious diseases

HHS Gov News - April 10, 2018

The largest patient movement exercise in U.S. Department of Health and Human Services’ history began today to test the nationwide ability to move patients with highly infectious diseases safely and securely to regional treatment centers.

“Saving lives during crises requires preparation and training,” explained HHS Assistant Secretary for Preparedness and Response Robert Kadlec, M.D. “A tremendous amount of coordination, synchronization, and skill is needed to move patients with highly infectious diseases safely. We have to protect the patients and the healthcare workers caring for those patients. This type of exercise helps ensure that everyone involved is ready for that level of complexity.” 

Coordinated by the HHS Office of the Assistant Secretary for Preparedness and Response, more than 50 organizations will participate, including the Department of State, Department of Transportation, the Regional Ebola Treatment Centers, local and state health and emergency management agencies, hospitals, airport authorities, and non-government organizations.

Throughout the exercise, participants react as if the incident is real. They must take the necessary actions and employ the appropriate resources to manage and protect the patients, the workforce and the environment and safely transport the patients.

The exercise focuses on moving seven people acting as patients with Ebola symptoms in different regions of the country. The patients, including one pediatric patient, first present themselves at one of the following healthcare facilities: CHI St. Luke's Health-The Woodlands Hospital in The Woodlands, Texas; Medical University of South Carolina in Charleston, South Carolina; Norman Regional Hospital in Norman, Oklahoma; St. Alphonsus Regional Medical Center in Boise, Idaho, and St. Luke’s Regional Medical Center in Boise, Idaho.

At each facility, healthcare workers will collect and ship samples for diagnostic tests to state laboratories, which in turn will practice running the necessary laboratory tests to diagnose the patients with Ebola. As part of the exercise, each patient will receive a positive diagnosis. Using appropriate isolation techniques and personal protective equipment, health care workers then must take steps to have six of the patients transported by air to designated Regional Ebola Treatment Centers. These patients will be placed into mobile biocontainment units for these flights. The pediatric patient will be placed into protective equipment and transported by ground ambulance.

The treatment centers that will receive the patients are Cedars-Sinai Medical Center in Los Angeles, California; Emory University Hospital in Atlanta, Georgia; Providence Sacred Heart Medical Center in Spokane, Washington; and University of Texas Medical Branch in Galveston, Texas. The pediatric patient will be transported to Texas Children’s Hospital West Campus in Houston, Texas.

The participating airports are Boise Airport in Boise, Idaho; Charleston International Airport in Charleston, South Carolina; DeKalb-Peachtree Airport in Atlanta, Georgia; Ellington Field Airport in Houston, Texas; Los Angeles International Airport in Los Angeles, California; Spokane International Airport in Spokane, Washington; and Will Rogers World Airport in Oklahoma City, Oklahoma. Upon arrival, local emergency responders will transfer the patients to ground ambulances for transportation from the airports to the treatment centers.

HHS and the Department of State previously collaborated on exercises to move Americans acting as Ebola patients from West African countries to Ebola treatment centers in the United States. In public health emergencies or disasters, the U.S. government orchestrates the return of Americans to the United States, including Americans who are sick or injured.

This exercise runs through April 12. Participants will gather on April 13 to assess the exercise, compare actions across the country, and share best practices for moving patients with highly infectious diseases.


Note to editors: Video sound bites from Dr. Kadlec are available for download at https://www.dropbox.com/sh/ktvdv44y7z68ly7/AAAf2H_JzzY8i-tzREY6VfaAa?dl=0.

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. Within HHS, ASPR’s mission is to save lives and protect Americans from 21st century health security threats. ASPR leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. To learn more about preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, www.phe.gov.

How A Drugmaker Turned The Abortion Pill Into A Rare-Disease Profit Machine

Even though the $550 yellow pills sold as Korlym have a controversial origin as the abortion pill, Leslie Edwin says they “gave me life.”

The 40-year-old Georgia resident lives with Cushing’s syndrome, a potentially deadly condition that causes high levels of the hormone cortisol to wreak havoc on a body. When first diagnosed, she said, she gained about 100 pounds, her blood sugars were “out of control,” and she suffered acne, the inability to sleep and constant anxiety.

“I wouldn’t leave the house,” Edwin said of her first bout with the condition. “I quit my job after a certain point. I just couldn’t keep being in front of people.”

That’s when Edwin endured surgeries, including one to remove her pituitary gland. She went into remission, but then, in 2016, her weight shot up 30 pounds and the anxious feelings returned. Her doctors prescribed Korlym.

The drug’s active ingredient is mifepristone, once called RU-486 and better known as the abortion pill because it causes a miscarriage when taken early in a pregnancy. Nearly two decades ago, Danco Laboratories won approval to market Mifeprex in the U.S. as the abortion drug, with tight restrictions on use. Corcept Therapeutics, a Silicon Valley-based drug company, began marketing Korlym six years ago as a specialty drug for about 10,000 rare-disease patients such as Edwin.

The difference in price between Korlym and Mifeprex is striking, even though the ingredients are the same: One 200-milligram pill to prompt an abortion costs about $80. In contrast, a 300-milligram pill prescribed for Cushing’s runs about $550 before discounts. Patients wanting an abortion take only one pill. People with Cushing’s often take up to three pills a day for months or years.

Dr. Joseph Belanoff, chief executive of the drug’s maker, Corcept, said Korlym’s average cost per patient is $180,000 annually and concedes that “we have an expensive drug. There’s no getting around that.”

The story of Korlym highlights how America’s drug development system can turn an old drug into a new one that treats relatively
few — but often very desperate — patients.

When the Food and Drug Administration approved Korlym in 2012, it was designated as an orphan drug, giving Corcept seven years of market exclusivity as well as other economic incentives. Congress approved orphan drug incentives to encourage the development of medicines for rare diseases that affect fewer than 200,000 patients. Since the drug’s approval, Korlym’s price has risen about 150 percent, and last year the company’s revenue nearly doubled to $159.2 million. (Korlym is the company’s only product and treats about 1,000 patients in the U.S.)

“You can hike that drug [price] 50 percent or 80 percent, and if there is backlash you can walk it back,” said Dr. Joshua Liao, an associate medical director at University of Washington Medicine.

Corcept has steadily increased the price with little backlash.

Belanoff said the profits from Korlym pay for the company’s past spending on the drug’s research and development as well as its effort to create new drugs. The company last month reported an encouraging Phase 2 trial update on Korlym’s successor, relacorilant, a drug that could treat Cushing’s without the side effects for some women of endometrial thickening and possible vaginal bleeding.

The company’s pipeline is also full of potential oncology drugs that hold the promise of using molecules to influence the cortisol receptors, with wide-ranging effects in the body. Korlym in combination with another drug is being tested for the treatment of metastatic triple-negative breast cancer, which tends to be more aggressive than other types of breast cancer. And relacorilant is in the very early stages of testing to treat castration-resistant prostate cancer.

While many of the second-generation drugs are not related to Korlym structurally, Korlym did “provide the funding. … If there had not been orphan-drug pricing and the [Orphan Drug] Act, you would have to look for a different way to develop those drugs,” Belanoff said.

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Korlym came to market in 2012 with an average wholesale price of $223.20 per pill before discounts, according to the health care technology firm Connecture. Corcept boosted the price $20 to $50 each year. By December 2017, each pill had an average wholesale price of $549.60 before any discounts or rebates were negotiated for patients.

Alan Leong, senior research analyst and owner of BioWatch, who follows Corcept, said he thought the company might fail at one point but noted that Belanoff “played the odds” with Korlym and won.

So far, incrementally increasing Korlym’s price while adding patients has paid off. Corcept’s stock soared 27.4 percent in January before Teva Pharmaceutical Industries announced it had filed an application for a generic version on the drug. Teva declined to comment for this story.

Belanoff said he would like to know where Teva obtained enough doses of Korlym to successfully test a generic: “We have a single pharmacy and a single manufacturer and the medicine has to be [FedEx’ed] to the patient.”

Talking to analysts last month, Corcept Chief Financial Officer Charlie Robb said the impact of Teva’s generic filing for the next few years is “nothing but litigation, which we can comfortably afford.”

Corcept’s executives expect revenues to keep climbing, reaching $275 million to $300 million in 2018 — an expectation that has not changed despite Teva’s announcement.

A ‘Pioneering Substance’

Cushing’s syndrome happens when the body produces too much of the powerful hormone cortisol, which normally helps keep the cardiovascular system functioning well and allows the body to turn proteins, carbohydrates and fats into energy. But too much cortisol can be destructive. It can cause cognitive difficulties, depression, fatigue, high blood pressure, bone loss and, in some cases, Type 2 diabetes. Those affected by the syndrome can develop a fatty hump between their shoulders and a rounded face. Without treatment, patients can die of a variety of complications, including sepsis after the hormone compromises the immune system.

Mifepristone, the active ingredient in Korlym, helps Cushing’s patients by blocking the body’s ability to process cortisol. It induces an abortion by blocking the body’s receptor for progesterone, which causes the uterine wall to break down.

When the FDA approved Korlym for a specific set of Cushing’s patients, the agency required a “TERMINATION OF PREGNANCY” warning box at the top of the label.

In 2016, Leslie Edwin takes a selfie while vacationing in Cuba. At that time, Edwin was managing her symptoms with daily doses of Korlym. (Courtesy of Leslie Edwin)

In 2012, Leslie Edwin walks down the aisle as a bridesmaid. Edwin says she wasn’t taking medication to treat her Cushing’s syndrome and describes this period as “when things got really bad.” (Courtesy of Leslie Edwin)

Dr. Constantine Stratakis, a senior investigator and scientific director at the National Institute of Child Health and Human Development who specializes in treating people with Cushing’s syndrome, calls mifepristone a “pioneering substance” because it “has a lot of crossover” to other receptors in the body.

That means the drug has a lot of potential uses. Belanoff and Dr. Alan Schatzberg, a Stanford University psychiatrist and scientist, co-founded Corcept in 1998 to explore whether mifepristone could help treat major depression. In 2002, Schatzberg said the drug “may be the equivalent of shock treatments in a pill.”

But clinical trials didn’t back up the claim. Schatzberg rotated off the board and left the company in 2007, saying the company “went in a different direction.” A congressional investigation also questioned whether Schatzberg had conflicts of interest as the government’s principal investigator overseeing clinical trials and a co-founder of Corcept, which had awarded him stock options.

In response to the congressional investigation, Stanford said Schatzberg was fully compliant with its internal conflict-of-interest policy.

Leong of BioWatch recalls the transition to Cushing’s research as a difficult time for Corcept. But after the “psychiatric depression program shut down, [Belanoff] stuck to it,” Leong said.

Social Contract

Corcept’s “Hail Mary” moment came in 2007. The company filed an application to see whether mifepristone might work for Cushing’s patients. (Cushing’s affects about 20,000 people in the U.S., but Corcept executives say the condition often goes undiagnosed.)

Developing the drug cost about $300 million, Belanoff estimates, and involved long-term toxicology tests to ensure that patients could safely take higher doses for months or years. As an orphan drug, a portion of Korlym’s research and development costs could be written off. For example, Corcept reported in 2013 that it had $19.7 million in federal tax credits.

And while Korlym’s annual costs pale against other specialty drugs, which run as high as $750,000 a year, the climbing price tag and increasing number of patients do affect the health care system.

“It’s like an unseen cost and then down the road this is a huge cost burden,” said the University of Washington’s Liao.

Most patients are covered by private insurance, Belanoff said, but Medicare and Medicaid are paying for the drug as well. According to Medicare Part D data, 52 Korlym patients cost Medicare $2.6 million in 2013. Two years later in 2015, 115 beneficiaries filed claims of $11.4 million.

In Georgia, Leslie Edwin is on private insurance and describes herself as being in “a really high tax bracket” yet she never paid more than $25 a month through Corcept’s patient assistance program called SPARK (the Support Program for Access and Reimbursement for Korlym).

“Across the board, it would be very difficult to find any patient that pays the full price,” said Edwin, who volunteers as president of the nonprofit patient advocacy group Cushing’s Support and Research Foundation. The small organization, which reported $50,000 in contributions and grants in 2015, notes on its website that Corcept as well as Novartis Oncology provide financial support to the organization. Edwin is not paid, and the group’s federal tax filing details that the majority of its expenses go to distributing a quarterly newsletter, contacting members and patients “to promote mission,” and providing referrals to doctors.

Belanoff said he believes Corcept has a “social contract” to take care of patients and pledged that any patient who is prescribed Korlym will get it regardless of insurance coverage or costs.

“We were starting with a notorious drug, and the growth has been steady from a very low base over time,” Belanoff said, emphasizing that the “single most important thing” is that the drug works very well.

Dr. Sherwin D’Souza at St. Luke’s Boise Medical Center in Idaho prescribed Korlym for the first time last year to Vonda Huddleston, knowing the company would provide financial assistance until Huddleston could get insurance to pay for surgery.

Huddleston, though, recalled being concerned about the price and what it would cost her out-of-pocket. The company provided her first two months’ worth for free and asked her to call back when she was enrolled for insurance.

“They were so eager to get me on this medication,” she said.

C-SPAN: FDA Commissioner Scott Gottlieb Talks To KHN

Kaiser Health News reporter Sarah Jane Tribble sat down with Dr. Scott Gottlieb, commissioner of the Food and Drug Administration, on C-SPAN’s “Newsmakers” program, which aired Sunday. Tribble was joined by Bloomberg correspondent Anna Edney. The conversation ranged from how the nation should combat the opioid epidemic to reining in drug prices. Gottlieb said competition in the drug market remains key to lowering prices.

A Tale Of Two CT Scanners — One Richer, One Poorer


Benjamin Hynden, a financial adviser in Fort Myers, Fla., hadn’t been feeling well for a few weeks last fall. He’d had pain and discomfort in his abdomen.

In October, he finally made an appointment to see his doctor about it. “It wasn’t severe,” he said. “It was just kind of bothersome. It just kind of annoyed me during the day.”

The internist, Dr. John Ardesia, checked him out and referred him for a CT scan at a nearby imaging center. The radiologist didn’t see anything wrong on the images, and Ardesia didn’t recommend any treatment.

A few weeks later, Hynden, who has a high-deductible health insurance policy with Cigna, got a bill for $268. He paid it and moved on.

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But three months later, in mid-January, Hynden was still feeling lousy. He called up Ardesia’s office again. This time, the doctor wasn’t available. A nurse practitioner, concerned that Hynden might be suffering from appendicitis, advised him to go to the hospital right away.

“I was a little worried,” Hynden recalled. “When he told me to go to the ER, I felt compelled to take his advice.”

Hynden arrived later that morning at Gulf Coast Medical Center, one of several hospitals owned by Lee Health in the Fort Myers area. The triage nurse told him the problem wasn’t his appendix, but she suggested he stick around for some additional tests — including another CT scan — just to be safe.

“It was the exact same machine. It was the exact same test,” Hynden said.

The results were also the same as the October scan: Hynden was sent home without a definitive diagnosis.

And then the bill came.

Patient: Benjamin Hynden, 29, a financial adviser in Fort Myers, Fla.

Total Bill: $10,174.75, including $8,897 for a CT scan of the abdomen

Service Provider: Gulf Coast Medical Center, owned by Lee Health, the dominant health care system in southwest Florida.

(Story continues below.)

Medical Procedure: A computed tomography scan, commonly known as a CT or CAT scan, uses X-rays to create cross-sectional images of the body. Hynden got his October scan at Summerlin Imaging Center, a standalone facility in Fort Myers that offers a range of diagnostic tests, including X-rays, MRI and CT scans.

Rick Davis, co-owner of Summerlin, said his center is small and independent, so he doesn’t have much bargaining power. That means insurance companies pretty much dictate what he can charge for a scan. In Hynden’s case that was $268, including the cost of a radiologist to read the images.

Ultimately, what Medicare decides to pay for a scan sets the standard. “The Medicare fee schedule is what all the other companies use as their guideline,” Davis said. “It’s basically the bible. It’s what everyone goes by.”

Benjamin Hynden was surprised when he received a bill for a CT scan that was 33 times higher than a scan he received months before at an imaging clinic. (Alison Kodjak/NPR)

Summerlin’s office manager, Kimberly Papiska, said that the maximum the center ever bills for a CT scan is $1,200, but that the rates insurance companies pay are usually less than $300.

Hynden was shocked when he got the second CT scan in January, and the listed price was $8,897 — 33 times what he paid for the first test.

Gulf Coast Medical Center is part of his Cigna insurance plan’s approved network of providers. But even with Cigna’s negotiated discount, Hynden was on the hook for $3,394.49 for the scan. The additional ER costs added another $261.76 to that bill.

What Gives: We called Gulf Coast Medical Center and its parent company, Lee Health, to understand why they billed nearly $9,000 for a single test. No one at the health center or hospital would agree to an interview.

Lee Health spokeswoman Mary Briggs responded with an emailed statement: “Generally that it is not unusual for the cost of providing a CT scan in an emergency department to be higher than in an imaging center. Emergency department charges reflect the high cost of maintaining the staffing, medical expertise, equipment, and infrastructure, on a 24/7-basis, necessary for any possible health care need — from a minor injury to a gunshot wound or heart attack to a mass casualty event.”

Do the hospital’s costs and preparations justify a list price that’s so much higher than the nearby imaging center’s tab? We asked some experts in medical billing and management for their thoughts.

Emergency rooms often charge people with insurance a lot of money to make up for the free care they provide to uninsured patients, said Bunny Ellerin, director of the Healthcare and Pharmaceutical Management program at Columbia Business School in New York. “Often those people are what they call in the lingo ‘frequent flyers,'” Ellerin said. “They come back over and over again.”

She said hospitals also try to get as much money as they can out of private insurance companies to offset lower reimbursements from Medicare and Medicaid.

Even in that context, the price of Hynden’s CT scan was off the charts.

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Healthcare Bluebook, a health care pricing tool, says the range for an abdominal CT scan with contrast, like Hynden had, in Fort Myers is between $477 and about $3,700. It pegs a fair price at $595.

The higher price from Gulf Coast Medical Center and its parent company could be a result of their enormous pricing power in Fort Myers, said Gerard Anderson, a professor of health policy and management at Johns Hopkins University.

Lee Health owns the four major hospitals in the Fort Myers area, as well as a children’s hospital and a rehabilitation hospital, according to its website. It also owns several physician practices in the area. When you drive around Fort Myers, the blue-green Lee Health logo appears on buildings everywhere.

“Anybody who’s in Fort Myers is going to want to get care at these hospitals. So by having a dominant position, they have great bargaining power,” Anderson said. “So they can raise their rates, and they still do OK.”

Anderson said his research shows hospital consolidation has been driving prices higher and higher in recent years. And because more and more people, like Hynden, have high-deductible insurance plans, they’re more likely to be on the hook for huge bills.

So Lee Health and other dominant hospital systems mark up most of their services on their master price lists — the list that prices a CT scan at Lee Health at $8,897. Anderson calls those lists “fairy-tale prices” because almost no one actually pays them.

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“Everybody who’s taken a look at it agrees — including the CFO of the organization — that it’s a fairy-tale thing, but it does have relevance,” Anderson said.

The relevance is that insurance companies typically negotiate what they’ll pay at discounted rates from list prices.

So from the master price of $8,897, Cigna negotiated Hynden’s bill down to $5,516.14 — a discount of almost 40 percent. Then Cigna paid $2,864.08, leaving Hynden to pay the rest.

“If it wasn’t for that CT scan, I don’t think this whole thing would have been so difficult and so blatantly obvious that they’re extremely overcharging for that service,” Hynden said.

Resolution: Hynden never got a definitive diagnosis from the CT scans. Several weeks after his second test, however, he went to a nearby urgent care center, also run by Lee Health, and underwent an ultrasound on his abdomen. That test, which cost about $175, revealed some benign cysts that he said his doctor said are likely to go away on their own.

The Takeaway: Tests and services are almost always going to be more expensive in an emergency room or hospital setting. If your doctor suggests you go to an ER, it might be worth asking whether an urgent care or walk-in clinic would suffice.

Sources: Explanations of Benefits provided by Benjamin Hynden and interviews.

This is a monthly feature from Kaiser Health News and NPR that will dissect and explain real medical bills in order to shed light on U.S. health care prices and to help patients learn how to be more active in managing costs. Do you have a medical bill that you’d like us to see and scrutinize? Submit it here and tell us the story behind it.

Secretary Azar Announces Appointments for the Department of Health and Human Services

HHS Gov News - April 07, 2018

Assistant Secretary for Public Affairs –Judy Stecker began her tenure yesterday as the Assistant Secretary for Public Affairs. Stecker came to the Department from the American Enterprise Institute (AEI), where she served as Executive Director of Media Relations and Strategic Marketing. At AEI, she was responsible for developing strategic media and marketing plans, implementing and evaluating publicity tools, brand management and crisis communications. Prior to joining AEI, Stecker served as Senior Media Associate for Broadcast Services at the Heritage Foundation. Before that, she was Director of Communications for the Foundation for Defense of Democracies and Director of Communications for Vets for Freedom.

Principal Deputy Assistant Secretary for Public Affairs – Jeff Rosenberg began his tenure last week as the Principal Deputy Assistant Secretary for Public Affairs. Rosenberg has more than 30 years of providing high-level strategic communications guidance to government agencies and leading nonprofit organizations and foundations. Before joining the Department, he most recently served as an Executive Vice President at Crosby Marketing Communications, directing major integrated communications programs. Prior to this position, Rosenberg served as the President and Owner of Rosenberg Communications, his own firm, a full-service communications practice. Additionally, during President George H. W. Bush’s Administration, Mr. Rosenberg previously served at the Department as Director of Communications, Acting Associate Commissioner for Head Start, and Special Assistant to the Commissioner, Administration for Children, Youth, and Families.

Acting Assistant Secretary for Administration – HHS Deputy General Counsel Heather Flick has been named the acting Assistant Secretary for Administration – a role she will fill until a new Assistant Secretary for Administration is named. Flick started with the Department as part of the beachhead team as Deputy General Counsel, was promoted to Principal Deputy General Counsel; she served as Acting General Counsel until the General Counsel Robert Charrow was confirmed by the Senate. Before her service with the Department, Flick was of counsel with Dhillon Law Group in San Francisco and owner of The Flick Group practicing corporate law, specializing in mergers and acquisitions, licensing, employment law, IP protection and arbitration.

Deputy Administrator and Director of the Centers for Medicare & Medicaid Innovation (CMMI) – Adam Boehler joins the Department next week in the role of Deputy Administrator and Director of CMMI. Boehler is the former CEO and founder of Landmark Health – a company focused on delivering medical services to the most chronically ill patients. Boehler is the founder of Avalon Health Solutions – a leading provider of laboratory benefit management services in the country. Boehler was a board member and founder of TrellisRx, a built-for-purpose company that partners with health systems to fund, build, and operate specialty pharmacies. Additionally, Boehler was an Operating Partner at Francisco Partners a leading global private equity firm focused on healthcare technology and services investing, including both the incubation of built-for-purpose companies and execution of transactions involving established, high-growth businesses.

Senior Advisor to the Secretary for Drug Pricing Reform – Dan Best began his tenure this week as the Senior Advisor to the Secretary for Drug Pricing Reform. A highly accomplished, healthcare industry executive, Best is an expert on both the pharmaceutical landscape and the Medicare Part D program. He recently served as the Corporate Vice President of Industry Relations for CVSHealth’s Medicare Part D business. Prior to working at CVS, Best spent 12 years at Pfizer Pharmaceuticals.

Health and Human Services and the Department of Justice Return $2.6 Billion in Taxpayer Savings from Efforts to Fight Healthcare Fraud

HHS Gov News - April 07, 2018

Health and Human Services Secretary Alex Azar and Attorney General Jeff Sessions today released a fiscal year (FY) 2017 Health Care Fraud and Abuse Control Program report showing that for every dollar the federal government spent on healthcare related fraud and abuse investigations in the last three years, the government recovered $4. Additionally, the report shows that the departments’ FY 2017 Takedown event was the single largest healthcare fraud enforcement operation in history.

In FY 2017, the government’s healthcare fraud prevention and enforcement efforts recovered $2.6 billion in taxpayer dollars from individuals and entities attempting to defraud the federal government and Medicare and Medicaid beneficiaries. Some of these fraudulent practices include:

  • Providers operating “pill mills” out of their medical offices.
  • Providers submitting false claims to Medicare for ambulance transportation services.
  • Clinics submitting false claims to Medicare and Medicaid for physical and occupational therapy.
  • Drug companies paying kickbacks to providers to prescribe their drugs, and pharmacies soliciting and receiving kickbacks from pharmaceutical companies for promoting their drugs.
  • Companies misrepresenting capabilities of their electronic health record software to customers.

“Today’s report highlights the success of HHS and DOJ’s joint fraud-fighting efforts,” said HHS Secretary Azar. “By holding individuals and entities accountable for defrauding our federal health programs, we are protecting the programs’ beneficiaries, safeguarding billions in taxpayer dollars, and, in the case of pill mills, helping stem the tide of our nation’s opioid epidemic.”

“Taxpayers work hard every day to help fund government programs for our fellow Americans,” Attorney General Sessions said. “But too many trusted medical professionals like doctors, nurses and pharmacists have chosen to violate their oaths and exploit this generosity to line their pockets, sometimes for millions of dollars.  At the Department of Justice, we have taken historic new actions to incarcerate these criminals and recover stolen funds, including executing the largest healthcare fraud enforcement action in American history.  These achievements are important, but the department's work is not finished. We will keep up this pace and continue to prosecute fraudsters so that we can give financial relief to taxpayers.”

The departments of Justice (DOJ) and Health and Human Services (HHS), through the Health Care Fraud Prevention and Enforcement Action Team (HEAT) effort, use data analytics and surveillance to crack down on, prevent and prosecute healthcare fraud. While the program continues to be very successful, the return on investment fluctuates from year to year, in part because cases resulting in large settlements take multiple years to complete. Additionally, there has been a reduction in large monetary settlements as many of the large pharmaceutical manufacturers have entered into Corporate Integrity Agreements with the HHS Office of the Inspector General to establish protections against fraudulent activities.

With teams comprised of law enforcement agents, prosecutors, attorneys, auditors, evaluators and other staff, last year DOJ opened 967 new criminal healthcare fraud investigations of which federal prosecutors filed criminal charges in 439 cases involving 720 defendants.  A total of 639 defendants were convicted of healthcare fraud related crimes. In FY 2017, the DOJ and HHS joint Medicare Fraud Strike Force filed 253 indictments and charges against 478 defendants who allegedly billed federal healthcare programs more than $2.3 billion. The Strike Force obtained more than 290 guilty pleas, litigated 33 jury trials and won guilty verdicts against 40 defendants. The Fraud Strike Force secured prison sentences for more than 300 defendants, with an average sentence of 50 months. Since its inception in 2007, Strike Force prosecutors filed more than 1,660 cases charging more than 3,490 defendants who collectively billed the Medicare program more than $13 billion.

Beyond criminal prosecution, the HHS Office of Inspector General (OIG) remains vigilant in excluding providers and suppliers who committed fraud or engaged in the abuse or neglect of patients in federal health programs. A total of 3,244 individuals and entities were excluded in FY 2017. Others were excluded as a result of licensure revocations. These exclusions help to safeguard beneficiaries from future harm that could otherwise be inflicted by such convicted individuals or entities. HHS can also suspend Medicare payments to providers during investigations of credible allegations of fraud.  During FY 2017, there were 551 related payment suspensions.  More than 4 million claims are reviewed by Medicare each day; resulting in more than one billion claims processed annually for timely payments to healthcare providers and suppliers. Given the volume of claims processed by Medicare each day and the significant cost associated with conducting medical review of an individual claim, the Centers for Medicare and Medicaid Services uses automated edits to help prevent improper payments without the need for manual intervention.  The National Correct Coding Initiative consists of edits designed to reduce improper payments in Medicare Part B, and this program saved Medicare $186.9 million during the first nine months of FY 2017.

As the opioid epidemic continues to devastate communities and families across the nation, both DOJ and HHS are responding with new approaches. One out of every three beneficiaries received prescription opioids through Medicare Part D in 2016. Additionally, 401 prescribers were found to have questionable prescribing patterns for beneficiaries at serious risk of opioid misuse or overdose, based on an OIG analysis. Last July, DOJ and HHS announced the largest ever healthcare fraud enforcement action, involving 412 charged defendants across 41 federal districts, including 115 doctors, nurses and other licensed medical professionals, for their alleged participation in healthcare schemes involving approximately $1.3 billion in false billings. Of those charged, more than 120 defendants, including doctors, were charged for their roles in prescribing and distributing opioids and other dangerous narcotics.

In August, Attorney General Sessions announced the formation of the Opioid Fraud and Abuse Detection Unit, a new DOJ pilot program that will use data to help combat and prosecute individuals and entities involved in illegal activities that fuel the crisis. As part of that task force, the department funded 12 experienced assistant United States attorneys for a three-year term to focus solely on investigating and prosecuting healthcare fraud related to prescription opioids, including pill mill schemes and pharmacies that unlawfully divert or dispense prescription opioids for illegitimate purposes. Those prosecutors have already charged several with unlawful distribution of opioids, and their continued success is crucial in combatting this deadly epidemic.

For more details on the Health Care Fraud and Abuse Control Program and today’s report, visit: https://oig.hhs.gov/publications/docs/hcfac/FY2017-hcfac.pdf

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