Federal Experts' Advice On HPV Vaccine Could Leave Adults Confused

KFF Health News, August 8, 2019

Public health advocates say new HPV guidelines don't provide doctors and patients clear guidance about who in this expansive age group are good candidates. 

This article was first published on Thursday, August 8, 2019 in Kaiser Health News.

By Michelle Andrews

Vaccination decisions are usually pretty straightforward. People either meet the criteria for the vaccine based on their age or other factors or they don't. But when a federal panel recently recommended an update to the human papillomavirus (HPV) vaccine guidelines, it left a lot of uncertainty.

The panel recommended that men and women between ages 27 and 45 decide — in discussion with their health care providers — whether the HPV vaccine makes sense for them.

But some public health advocates criticize that advice because it doesn't provide doctors and patients clear guidance about who in this expansive age group are good candidates. They worry that many people may get immunized who won't benefit, adding needless cost to the health care system and possibly shortchanging people overseas, where the vaccine is in short supply.

"My concern is that there will be a whole lot of people or doctors recommending this vaccine," said Debbie Saslow, managing director of HPV and gynecological cancers for the American Cancer Society. "But I think that the benefit is so small and we just don't have guidance."

The human papillomavirus is the most common sexually transmitted infection in the United States; nearly everyone who's sexually active will get it at some point. People typically clear the virus on their own and often don't even realize they've been infected. But in some people, HPV remains in the body and may cause several types of cancer as well as genital warts.

Every year, HPV causes more than 33,000 cancers, including more than 90% of cervical cancers as well as cancers of the vagina, vulva, penis, anus and the area at the back of the throat called the oropharynx, according to the Centers for Disease Control and Prevention.

More than 40 types of HPV affect the genital area. Merck's Gardasil 9, the vaccine used in the United States, provides protection against nine types, which together are associated with the majority of HPV-related cancers and cause 90% of genital warts.

Because HPV is so common among people who are sexually active, the best time to vaccinate is before people start having sex and risk being exposed to the virus. The CDC's Advisory Committee on Immunization Practices recommends HPV vaccination for all 11- and 12-year-old girls and boys. Catch-up immunizations for young people outside that age window are recommended through age 21 for men and 26 for women (the proposed HPV vaccine update would change the catch-up vaccination guideline for men to align it with the age-26 cutoff for women).

In its June meeting, the immunization committee, which includes public health experts, recommended widening the vaccination window to include adults between 27 and 45.

But rather than give the thumbs-up for everyone in that age group, the panel said people should engage in "shared clinical decision-making" with their health care professional to decide if the vaccine is right for them.

"ACIP made this type of recommendation because most people in this age group are not likely to benefit from getting the vaccine," Kristen Nordlund, a spokeswoman for the CDC, wrote in an email.

The vaccine won't protect people against types of HPV to which they've already been exposed, and many sexually active people have been exposed to at least some HPV types by their late 20s.

That makes it tougher for the vaccine to have an impact in this age group. According to an economic modeling study presented at the ACIP meeting, under current guidelines that recommend immunization through age 26, 202 people would have to be vaccinated to prevent one case of HPV-related cancer. When the recommendations are broadened to include people through age 45, the number that would have to be vaccinated to prevent one case of cancer increases exponentially to 6,500.

However, it's unlikely that people in the older group have been exposed to all nine types of HPV the vaccine protects against.

"There's some sense that you can get some protection against some future cancers," said Dr. William Schaffner, professor of preventive medicine and infectious diseases at Vanderbilt University School of Medicine, who is the ACIP liaison for the National Foundation for Infectious Diseases.

Yet, patients — and their doctors — would be hard pressed to know if immunization would be beneficial.

"The problem is that no individual person is likely to know which individual type of HPV they've been exposed to," said Dr. Christopher Zahn, vice president of practice activities at the American College of Obstetricians and Gynecologists.

Vaccine experts have some suggestions about which people older than 26 might consider getting the three-shot series. They include people with multiple sex partners and those who are newly single and dating after being in a monogamous marriage or relationship.

Jennifer Sienko is in a better position than most people to evaluate whether to get the vaccine. She is co-director of the National HPV Vaccination Roundtable, a coalition of groups aimed at reducing HPV cancers that is hosted by the American Cancer Society.

But she was recently surprised when a new doctor asked the 40-year-old if she wanted the vaccine. She opted against it.

Sienko, who lives in Chicago, has been married to her second husband for three years, and that contributed to her decision. But perhaps, she said, it would have been different when she was single for a time.

"So there may have been a window where, had the vaccine been indicated for older women, perhaps between my marriages I would have looked into that," she said.

The CDC is reviewing the ACIP recommendation. If it approves the recommendation, experts hope the CDC will provide further guidance on determining who the vaccine is appropriate for.

If the CDC approves broadening the age for the vaccine in consultation with a health care provider, most insurers would cover the costs, which can run a few hundred dollars per dose. Under the Affordable Care Act's preventive coverage rules, patients generally won't have to pay anything out of pocket for it.

Michelle Andrews: andrews.khn@gmail.com, @mandrews110

Are Trump's Top Medicaid Regulators Ignoring Major Problems?

KFF Health News, August 7, 2019

The CEO of Centene, a company now entangled in a broader federal inquiry, met with Sen. Bob Casey to allay concerns that patients are being neglected.

The article was first published on Tuesday, August 6, 2019 in ProPublica and The Dallas Morning News.

By J. David McSwane, ProPublica, and Tom Benning, The Dallas Morning News.

The ranking member of the Senate health committee has complained for months about the Trump administration's failure to look into Medicaid contractors that have reaped big profits while sometimes failing to provide crucial patient services.

So last week, Sen. Bob Casey, D-Pa., called in the top boss of Centene, the nation's largest Medicaid managed care company. He wanted to question the company about reports that its Texas subsidiary denied life-sustaining care to sick and disabled children — in one case, leaving a baby in foster care to suffer a catastrophic brain injury.

The meeting with longtime Centene CEO Michael Neidorff did not go well, according to Casey.

"I thought they would try to persuade me that they were going to do better, but they didn't seem interested in that at all," Casey told ProPublica and The Dallas Morning News in an interview. "I just couldn't believe it."

Casey said the Centene official denied providing inadequate care and cast blame for failures on foster parents and nurses.

Centene declined to make Neidorff available for an interview and emailed a brief statement in response to questions about the meeting with Casey.

"Centene and its subsidiaries care deeply about each and every member we serve," the email read. "We work tirelessly to ensure we provide the appropriate level of care for our members."

Under Neidorff, Centene has grown from a tiny health network in the Midwest into a $60-billion-a-year health care empire, backed almost entirely with taxpayer money. The company cares for more than 8.5 million Medicaid patients.

The company came under criticism last year after an eight-part investigation published in the Morning News examined whether Centene and other Medicaid managed care companies were skimping on care to bolster profits. The series raised questions about Centene's Texas subsidiary, Superior HealthPlan, and its handling of the case of D'ashon Morris, a Texas toddler who was born with severe defects and was living in a foster home.

The series, titled "Pain & Profit," reported that D'ashon was denied 24/7 nursing care and suffered brain damage after a medical incident that occurred while he did not have his nurse around. (Read the full story here.)

The Morning News reported that state health officials had found the Centene subsidiary in violation of state and federal Medicaid rules and recommended the company face steep fines for what happened to the child. But top Texas health officials never assessed those fines, the Morning News reported.

D'ashon's adoptive mother sued the Centene subsidiary in Texas state court. That case is tied up in the Texas appeals court, where the Centene subsidiary has argued that the lawsuit should be dismissed because D'ashon and his mother are stifling the company's right to free speech.

During hearings in the state Capitol, Superior representatives denied that the company's refusal to provide 24/7 nursing was improper.

After his meeting with the Centene official, Casey sent a strongly worded letter to Seema Verma, a former health consultant appointed by President Donald Trump to run the Centers for Medicare and Medicaid Services.

In the letter, Casey called Centene's response to questions about D'ashon's case "callous."

He also asked Medicaid officials to dig further into Centene's business practices and to provide documentation on any response to the Morning News investigation.

"It's another indication that the regulatory approach here by the administration is, at best, suspect," Casey said.

A CMS spokesman said that Texas officials have shared with the agency an "action plan they intended to take to address the concerns raised," adding that CMS is in regular communication to ensure the state improves.

"CMS has received Sen. Casey's letter and will respond to his office directly," spokesman Brian Leshak said in an email.

Casey's position as the top Democrat on two Senate panels overseeing federal health programs gives him the standing to raise questions about the Medicaid managed care system.

It's not unusual for company officials facing a federal audit or investigation to meet with members of Congress to address concerns, but it is unusual for such meetings to spill into public view.

Casey said he sent the letter to CMS because of what he called Centene's "cold and clinical" defense of what happened in D'ashon's case. He said it gave him concern about how the company cares for other patients — and what, if anything, regulators are doing when things go wrong.

Last month, more than a year after the Morning News story was published, Centene officials provided Casey's office with a one-page rebuttal titled: "The Dallas Morning News got it wrong."

The company's explanations include that D'ashon's foster mother was a trained nurse. But, as the Morning News reported, she was on an approved vacation at the time of D'ashon's injury, and he had been placed in a different foster home.

The company also said D'ashon's foster mother should have restrained the baby, but the Morning News previously reported that Texas foster care officials confirmed restraints would have required a doctor's order, which she did not have.

"It was all blame shifting and pointing to other factors," Casey said of Centene's letter.

Casey said the meeting left him wondering why federal regulators weren't doing more.

"It might even be worse than asleep at the wheel," he said of CMS under Verma's watch.

"They may be awake at the wheel but choosing consciously to say, 'We're going the other direction.'"

Without commenting on specific cases, the CMS spokesman said the agency routinely monitors states and intervenes when necessary.

Problems with this privatized Medicaid model have grabbed headlines in other states, too. And advocates in those states said they haven't heard much from CMS, which they say is a shift from the Obama administration.

In Iowa, for instance, The Des Moines Register reported failures to provide care and chronicled patients who had been caught in that state's broken medical appeals system.

Rob Sand, Iowa's state auditor, wrote to state officials in June that two large managed care companies had "significantly harmed" two paraplegic patients by refusing to provide services they needed.

Mary Nelle Trefz, of Iowa's Child and Family Policy Center, said she's been shocked to hear nothing about that from CMS.

"I don't feel, or can't observe, or point to anything, where CMS has stepped in to provide that oversight and accountability," she said.

In March, California's state auditor found that millions of children in that state's privatized Medicaid system weren't being provided services that taxpayers had paid for. Auditor Elaine Howle blamed California health officials' "deficient oversight of the managed care plans."

Andy Schneider, a researcher at Georgetown's Center for Children and Families, and a former top adviser to CMS under the Obama administration, said these episodes come at an inconvenient time for the Trump administration, which is focused on reducing regulation and creating additional eligibility hurdles like work requirements.

CMS has taken a hands-off approach compared with the previous administration, he said.

"These are reports coming from reputable media sources," he said. "They're very concerning, they have to do with the operation of the program, they suggest that something is wrong."

Do you have any tips on what's happening inside CMS? Send them to david.mcswane@propublica.org.

Tom Benning is a reporter in the Washington bureau of the Dallas Morning News.

Drugmakers Master Rolling Out Their Own Generics To Stifle Competition

KFF Health News, August 5, 2019

Critics say authorized generics hurt long-term competition and often perversely increase costs, even in the short term.

This article was first published on Monday, August 5, 2019 in Kaiser Health News.

By Jay Hancock and Sydney Lupkin

When PDL BioPharma's $40 million blood-pressure medicine faced the threat of a generic rival this year, the company pulled out a little-known strategy that critics say helps keep drugs expensive and competition weak.

It launched its own generic version of Tekturna, a pill taken daily by thousands. PDL's "authorized" copycat hit the market in March, stealing momentum from the new rival and protecting sales even though Tekturna's patent ran out last year.

PDL's version sold for $187 a month versus $166 for the competing generic, made by Anchen Pharmaceuticals, according to Connecture, an information technology firm. PDL's brand-name Tekturna runs about $208 a month.

The plan is "to maximize profit at this point," Dominique Monnet, PDL's CEO, told stock analysts in March. With the boost of PDL's house generic, "the economics would still be very favorable to us" even against the generic rival and even if prescriptions plunged for the brand, he said.

Lawmakers who created the modern generic-drug industry in the 1980s never imagined anything like this — brand-pharma companies maximizing profits by appearing to compete with themselves.

But it goes on all the time. In fact, there are now nearly 1,200 authorized generics approved in the U.S., according to the Food and Drug Administration. While these might look like products that would push prices down, authorized generics can be as profitable as, if not more profitable than, brand-name drugs.

"Authorized generics are not generic drugs," Dr. Sumit Dutta, chief medical officer for drug-benefit manager OptumRx, told Congress in April. "The marketing and production of authorized generics is exclusively controlled and directed by brand-drug manufacturers. They do nothing to promote competition."

Last year, authorized generics appeared at the rate of about once a week. High-profile examples in recent years included Mylan's generic version of the EpiPen anti-allergy injector, introduced to soothe public outrage after the company raised the brand price 400%. In March, Eli Lilly said it would launch a less expensive generic of its Humalog insulin, whose branded list price has also soared.

Of all the ways drug companies try to protect sales as patents expire — changing doses, adding ingredients, seeking approval to treat new diseases — authorized generics are by far the most profitable, returning $50 for every dollar invested, research firm Cutting Edge Information calculated in 2015.

Brand-drug companies say authorized generics increase competition even if they're not an independent product.

This "reduces prices and results in significant cost savings," said Holly Campbell, spokeswoman for the Pharmaceutical Research and Manufacturers of America, or PhRMA, the brand-drug lobby. "Congress should reject attempts to delay, restrict or prohibit authorized generics."

But critics say authorized generics hurt long-term competition and often perversely increase costs, even in the short term.

Authorized generics don't just steal sales from existing generic rivals. Critics say they erode incentives to make generic drugs, partly by thwarting the intent of Congress to let one company temporarily have generic business to itself after a brand patent expires.

Tactics like this can "stave off generic competition and make sure that generics can't get much of a foothold when they do get to market," said Robin Feldman, a professor at the University of California Hastings College of the Law, who studies pharma policy. "That's the game. And drug companies have become masters at this."

Authorized copycats may help explain why relatively few true generics are reaching the market despite a surge in approvals, analysts say.

The 1984 Hatch-Waxman Act founded the modern generic business by establishing rules for safety and competition, including granting six months of market exclusivity to the first generic rival to each brand. The idea was to give the first mover a profitable head start to attack the established pill.

Few realized the law left room for brand companies to launch their own generics at the same time as or even earlier than rivals, often slightly lower in cost and nearly indistinguishable to patients and doctors from the brand as well as any independent generics.

PDL acquired Tekturna from Novartis via an affiliate in 2016 and soon learned that Anchen was planning a generic. It moved quickly to fight back.

PDL's authorized generic version of Tekturna "was timed to secure us the benefit of being first to market," before Anchen's version was even on the shelves, PDL's CEO, Monnet, told analysts. "We believe this provides [PDL] with a distinctive competitive advantage."

PDL was so confident the authorized generic, called aliskiren, would produce substantial revenue without much effort that it got rid of its Tekturna salesforce of 60 people.

"There's a lot of parts of the system that just automatically switch" to generics, whatever the source, said Maxim Jacobs, who follows PDL's stock for Edison Investment Research. So even if the authorized generic isn't much cheaper than the brand, "it's almost like a no-brainer" to roll one out, he said.

Monnet was unavailable for an interview, a spokesperson said. Anchen did not respond to requests for comment.

Oddly enough, authorized generics can be more profitable than the brand-name drug even if their list prices are much lower, OptumRX's Dutta told Congress. That's because they usually aren't subject to rebates that flow from the drugmaker to middlemen such as OptumRX and effectively lower a brand's revenue.

"These authorized generics often result in net prices higher than the brand drugs they replace," he told Congress. "Authorized generics are just another tactic for drug manufacturers to improve profitability."

The list price for the authorized generic of Humalog insulin is half the brand's — $137 versus $275. That apparent discount offered limited relief to uninsured patients paying cash and generated spirited headlines saying Lilly had lowered the price significantly.

But the move won't cost Lilly any money, said another senior pharmacy benefits executive who asked for anonymity to speak candidly about a vendor. After rebates, $137 is about what the drug giant nets for Humalog now, the executive said. And it's still far higher than what insulin costs in other countries.

"It's a parlor trick," the executive said. "They're bending to political pressure, but are they taking any money out of the system? They're not."

Lilly's Humalog generic, called insulin lispro, and Mylan's EpiPen copycat departed from the traditional playbook by launching well before patents for those brands expired. The companies were trying to calm outrage over rising prices rather than fend off generic rivals, analysts said.

Generic Humalog "was made available to help people paying full retail price for their insulin" because of coverage gaps or lack of insurance, said Lilly spokesman Greg Kueterman.

The mere threat of an authorized generic can also smother competition.

A 2013 Supreme Court ruling challenged deals in which brands blatantly paid rivals to keep generics off the market. So pharma firms came up with an alternative: They could would hold fire on an authorized clone if generic firms agreed to delay launching their products or gave some other concession, according to the Federal Trade Commission.

Both sides win. The brand stretches its monopoly beyond the life of the patent, while the generic firm avoids facing an authorized rival later on.

Authorized generics can generate outsize profits in yet another way: as a method to game Medicaid contracts that costs taxpayers hundreds of millions of dollars a year, according to investigators for the Health and Human Services Department.

Brand-pharma companies routinely "sell" authorized generics to a corporate affiliate at a sharp discount, establishing an artificial wholesale price, said Edwin Park, a research professor who studies Medicaid at the Georgetown University Center for Children and Families.

Because of complex discounting formulas, this strategy minimizes rebates the drugmakers owe to Medicaid, found HHS's Office of Inspector General.

Congress is eyeing bipartisan legislation to close that loophole, which the Congressional Budget Office estimates would save the federal government $3.15 billion over 10 years.

The next frontier in authorized generics involves harder-to-make biologic drugs, such as generic Humalog, which are made from components of living organisms, analysts say.

Such products tend to be expensive and highly profitable, producing especially strong incentives for brand companies to preserve their franchises.

Makers of valuable biologics such as arthritis drug Humira have avoided the kind of competition from generic-like "biosimilars" that exists in Europe, partly due to patent extensions and litigation settlements.

But once patents do expire, authorized biosimilars are likely to be an integral part of their profit-preservation tactics, analysts say. In February, Lilly asked regulators to clarify their stance on "branded biosimilars" — a clear indication of its interest.

The query is "part of a number of questions Lilly and others have posed" about shifting FDA treatment of biologics, said Lilly spokesman Kueterman.

Jay Hancock: jhancock@kff.org, @JayHancock1

Infusion Treatments For Low Iron Can Deplete Patients' Wallets

KFF Health News, August 2, 2019

Under Medicare, doctors are paid based on the average sales price of the prescribed drug, which critics say gives them an incentive to pick the more expensive option.

This article was first published on Friday, August 2, 2019 in Kaiser Health News.

By Shefali Luthra

Shannon Wood Rothenberg walked into her annual physical feeling fine. But more than a year later, she's still paying the price.

Routine bloodwork from the spring 2018 visit suggested anemia, of which she has a family history. Her doctor advised pills. After two months with no change, the doctor sent Rothenberg to a hematologist who could delve into the cause and infuse iron directly into her veins.

So last July, the 48-year-old public school teacher went twice to a cancer center operated by Saint Joseph Hospital in Denver, where she received infusions of Injectafer, an iron solution.

When the bill arrived in March, after prolonged negotiations between the hospital and her insurer, Rothenberg and her husband were floored.

The hospital had billed more than $14,000 per vial. Since her treatment was in-network, though, her insurance plan negotiated a much cheaper rate: about $1,600 per vial. She received two vials. Insurance paid a portion, but Rothenberg still owed the hospital $2,733, based on what was still unpaid in her family's $9,000 deductible.

"I have twins who are going to college next year. I'm already a bit freaked out about upcoming expenses," she said. "I don't have $2,700 sitting around."

About 9 million Americans on Medicare have gotten iron infusions each year since 2013, the first year for which data is available; that's almost one for every five people covered by the government insurance program for people over 65.

Anemia, the principal outgrowth of low iron levels, can cause headache, fatigue and irregular heartbeat. People with certain medical conditions, such as inflammatory bowel disease and kidney failure, are prone to low iron levels and anemia, which can be severe.

In other countries, doctors usually would not be so quick to resort to iron infusions — especially in healthy patients like Rothenberg, who have no underlying disease and no obvious symptoms.

"It would be extremely unlikely that IV iron would be administered" in Britain, said Richard Pollock, a health economist at the London-based Covalence Research Ltd. who studies iron products.

But one key difference between this country and others is that American physicians and hospitals can profit handsomely from infusions. Under Medicare, doctors are paid in part based on the average sales price of the prescribed drug, which critics say gives them an incentive to pick the newer, more expensive option.

For those with private insurance, hospitals and doctors can mark up prices even more. Intravenous infusions, generally administered in a hospital or clinic, also generate a "facility fee."

That creates a financial incentive to favor the most expensive infused treatments rather than pills or simple skin injections that patients can use readily at home.

Indeed, a Kaiser Health News analysis of Medicare claims found that Injectafer and Feraheme — the two newest (and priciest) infusions on the American market — made up more than half of IV iron infusions in 2017, up from fewer than one-third in 2014. Cheaper, older formulations — which can go for as little as a tenth of the cost — have seen their share of Medicare claims fall dramatically.

Situations like these, which drive up Medicare spending, are why the Trump administration has suggested changing how Medicare pays for intravenous drugs. The administration would tie reimbursements for some IV drugs to the price paid in countries that set drug prices at a national level, in part based on an estimate of their comparative value. This plan has generated sharp backlash from conservative lawmakers and the medical and pharmaceutical industries.

Physicians argue that they simply prescribe the most effective medication for patients, regardless of what the payment system would suggest.

But stories like Rothenberg's, expert research and the government's own Medicare claims data paint a different picture.

"When there's a financial incentive … that might move the physician away from the choice the patient would optimally make, we might be concerned," said Aditi Sen, a health economist at Johns Hopkins Bloomberg School of Public Health, who is researching how doctors prescribe and are paid for intravenous iron treatments.

The example of iron, she added, suggests "a clear financial incentive to prescribe more expensive drugs."

The Iron Market
 

Treatments for iron deficiency are nearly 100 years old. Geritol, a decades-old dietary iron supplement for "iron-poor tired blood," was among the first medicines widely marketed through TV ads in the 1950s and '60s.

The first federally approved iron infusion come to the U.S. market in 2000 — but these treatments have since surged in popularity. For one thing, infusions carry fewer side effects than do pills, which can cause constipation or nausea. And scientific advances have mitigated the risks of intravenous iron, although getting infusions still comes with inconvenience, some discomfort, and the risk of infection at the IV site and serious allergic reactions.

Now, five branded products dominate the American market for IV iron, and three have generic counterparts. They have different chemical formulations but by and large are considered mostly medically interchangeable.

"There's not a huge amount of any difference in the efficacy of iron formulations," said Pollock. So, for value, "the question really does come down to cost."

Doctors are supposed to recommend infusions only if patients don't respond to iron pills or dietary changes.

Instead of steering patients toward "unnecessarily costly" infusions, he said, physicians should determine the underlying cause of low iron and treat that directly.

Injectafer, which Rothenberg received, is one of the most expensive infusions, retailing for more than $1,000 a vial — though hospitals can charge privately insured patients whatever they choose, resulting in her sky-high bill. Insurers then negotiate that hospital "list price" down.

An analysis of private insurance claims conducted by the Health Care Cost Institute, an independent research group funded by insurers, found that in 2017 private health plans on average paid $4,316 per visit if a patient received Injectafer infusions. Feraheme, the next most expensive infusion drug, cost private plans $3,087 per visit, while the other three on the market were considerably cheaper. Infed was $1,502, Venofer $825 and Ferrlecit $412, the institute found in its analysis for KHN.

The share of newer, pricier infusions has crept up in the private market as well as in Medicare. In 2017, 23% of privately billed iron infusion visits involved Injectafer or Feraheme, compared with 13% in 2015, according to the HCCI data.

Nobody told Rothenberg cheaper options might exist, or warned her about the price, she said. The hematologist who treated her did not respond directly to requests for comment.

But Alan Miller, the chief medical director of oncology for SCL Health (Saint Joseph's umbrella organization), told KHN that the hospital stopped using Injectafer in August 2018 — a month after Rothenberg's visit — because of the patient cost burden. The hospital now uses Venofer and Feraheme.

There are some other reasons that doctors might choose the more expensive drug, experts say — not all strictly medical.

Newer, more expensive drugs are more likely to be heavily marketed directly to doctors, said Stacie Dusetzina, an associate professor of health policy at Vanderbilt University.

Walid Gellad, an associate health policy professor at the University of Pittsburgh, said some formulations may be more convenient in terms of how many doses they require, or how long patients have to sit for an infusion. Doctors might use the product they have most of in stock. A certain patient might have a distinctive profile that makes one drug an obviously better fit.

None of those explanations sit particularly well with Rothenberg, whose iron levels are now fine — but who is paying off her $2,700 bill over two years in installments.

"If they had said, 'This is going to cost you $3,000,' I would have said, 'Oh, never mind,'" she said. "It's a big mental shift for me to say I'm supposed to weigh the costs against the health benefits. I'm not supposed to necessarily do what the doctor says."

Shefali Luthra: ShefaliL@kff.org, @Shefalil

The Talk Seniors Need To Have With Doctors Before Surgery

KFF Health News, August 1, 2019

It's a common complaint that surgeons don't help older adults and their families understand the impact of surgery in terms people can understand.

This article was first published on Wednesday, August 1, 2019 in Kaiser Health News.

By Judith Graham

The decision seemed straightforward. Bob McHenry's heart was failing, and doctors recommended two high-risk surgeries to restore blood flow. Without the procedures, McHenry, 82, would die.

The surgeon at a Boston teaching hospital ticked off the possible complications. Karen McHenry, the patient's daughter, remembers feeling there was no choice but to say "go ahead."

It's a scene she's replayed in her mind hundreds of times since, with regret.

On the operating table, Bob McHenry had a stroke. For several days, he was comatose. When he awoke, he couldn't swallow or speak and had significant cognitive impairment. Vascular dementia and further physical decline followed until the elderly man's death five years later.

Before her father's October 2012 surgery, "there was not any broad discussion of what his life might look like if things didn't go well," said Karen McHenry, 49, who writes a blog about caring for older parents. "We couldn't even imagine what ended up happening."

It's a common complaint: Surgeons don't help older adults and their families understand the impact of surgery in terms people can understand, even though older patients face a higher risk of complications after surgery. Nor do they routinely engage in "shared decision-making," which involves finding out what's most important to patients and discussing surgery's potential effect on their lives before setting a course for treatment.

Older patients, it turns out, often have different priorities than younger ones. More than longevity, in many cases, they value their ability to live independently and spend quality time with loved ones, according to Dr. Clifford Ko, professor of surgery at UCLA's David Geffen School of Medicine.

Now new standards meant to improve surgical care for older adults have been endorsed by the American College of Surgeons. All older patients should have the opportunity to discuss their health goals and goals for the procedure, as well as their expectations for their recovery and their quality of life after surgery, according to the standards.

Surgeons should review their advance directives — instructions for the care they want in the event of a life-threatening medical crisis — or offer patients without these documents the chance to complete them. Surrogate decision-makers authorized to act on a patient's behalf should be named in the medical record.

If a stay in intensive care is expected after surgery, that should be made clear, along with the patient's instructions on interventions such as feeding tubes, dialysis, blood transfusions, cardiopulmonary resuscitation and mechanical ventilation.

This is far cry from how "informed consent" usually works. Generally, surgeons explain to an older patient the physical problem, how surgery is meant to correct it and what complications are possible, backed by references to scientific studies.

"What we don't ask is: What does living well mean to you? What do you hope to be able to do in the next year? And what should I know about you to provide good care?" said Dr. Ronnie Rosenthal, a professor of surgery and geriatrics at Yale School of Medicine and co-leader of the Coalition for Quality in Geriatric Surgery Project.

Rosenthal tells of an 82-year-old patient with early-stage rectal cancer. The man had suffered a stroke 18 months earlier and had difficulty walking and swallowing. He lived with his wife, who had congestive heart failure, and had been hospitalized with pneumonia three times since his stroke.

Rosenthal explained to the man that if she operated to remove the cancer, he might land in the ICU with a breathing machine and then end up at a rehabilitation facility.

"No, I don't want that; I want to be home with my wife," Rosenthal recalled his saying.

The man declined the surgery. His wife died 18 months later, and he lived another six months before he had a fatal stroke.

Surgeons can help guide discussions that require complex decision-making by asking five questions, according to Dr. Zara Cooper, associate professor of surgery at Harvard Medical School:

How does your health affect your day-to-day life? When you think about your health, what's most important to you? What are you expecting to gain from this operation? What health conditions or treatments worry you most? And what abilities are so critical to you that you can't imagine living without them?

Cooper recalls an 88-year-old man seriously injured in a car crash arriving in the emergency room several years ago.

"When we started explaining to his family what his life would be like — that he would be highly functionally dependent and not able to live independently again — his wife said that would be absolutely devastating, especially if he couldn't ski," Cooper said. "We didn't even anticipate this was in the realm of what someone this age would want to do."

The family decided not to pursue treatment, and the patient died.

Sometimes surgeons make the misguided assumption that older patients want to follow recommendations rather than having input into medical decisions, said Dr. Clarence Braddock, professor of medicine at UCLA. In focus groups, 97% of seniors said "I prefer that my doctor offer me choices and ask my opinion," according to research Braddock published in 2012.

Yet in another study involving older adults, Braddock found that orthopedic surgeons rarely discussed the patient's role in decision-making (only 15% of the time) or assessed the patient's understanding of what surgery would entail (12% of the time).

At the University of Wisconsin-Madison, Dr. Margaret Schwarze, an associate professor of vascular surgery, has developed a tool called "best case/worst case" to help surgeons communicate more effectively with older patients.

"The idea is to tell the patient a story in terms they can understand," Schwarze said.

Instead of citing statistics on the risk of pneumonia or infection, for instance, a surgeon would explain what might happen if things went well or badly. Would the patient be in pain? Would she need nursing care? Would he be able to return home and do things he liked to do? Would she land in the ICU? Would he be able to walk on his own?

A similar range of possibilities is presented for a treatment alternative. Then the surgeon identifies the most likely outcomes for surgery and the alternative, based on the patient's circumstances.

"Going through a major operation when you're older is going to change your life," Schwarze said. "Our goal is to help older patients imagine what these changes might look like."

Because of her father's experience, Karen McHenry was cautious when her mother, Marjorie McHenry, fell and broke five ribs in fall 2017. At the hospital, doctors diagnosed significant internal bleeding and a collapsed lung and recommended a complicated lung surgery.

"This time around, I knew what questions to ask, but it was still hard to get a helpful response from the surgeons," Karen said. "I have a vivid memory of the doctor saying, 'Well, I'm an awesome surgeon.' And I thought to myself, 'I'm sure you are, but my mom is 88 years old and frail. And I don't see how this is going to end well.'"

After consulting with the hospital's palliative care team and a heart-to-heart talk with her daughter, Marjorie McHenry decided against the surgery. Nearly three years later, she's mentally sharp, gets around with a walker and engages in lots of activities at her nursing home.

"We took the risk that Mom might have a shorter life but a higher quality of life without surgery," Karen said. "And we kind of won that gamble after having lost it with my dad."

Judith Graham: khn.navigatingaging@gmail.com, @judith_graham

Trump Administration Moves To Make Health Care Costs More Transparent

KFF Health News, July 31, 2019

Consumer advocates argue that transparency can help tackle rising healthcare costs. But the plan also has the potential to overwhelm patients with data.

This article was first published on Wednesday, July 31, 2019 in Kaiser Health News.

By Julie Appleby

Shopping around for the best deal on a medical X-ray or a new knee? The Trump administration has a plan for that.

On Monday, it proposed new rules that would provide consumers far more detail about the actual prices hospitals charge insurers. It comes amid growing calls from consumer advocates, who argue transparency can help tackle rising health care costs. But the plan also has the potential to overwhelm patients with data.

Under the proposal, hospitals would be required to post the prices they negotiate with every insurer for just about every service, drug and supply they provide to patients, starting Jan. 1, 2020.

The move follows an executive order issued by the president in June. It immediately drew sharp opposition from hospitals and insurers, who made it clear they plan to fight the proposal — all the way to court if necessary.

Final rules might differ from the proposal — and the courts will be asked to weigh in. But the move could help lift the secrecy that has long surrounded what patients, employers and insurers actually pay for medical services.

"As deductibles rise, patients have right to know the price of health care services so they can shop around for the best deal," said Seema Verma, administrator of the Centers for Medicare & Medicaid Services, who announced the proposal Monday.

The proposal, however, raises at least three questions:

Will consumers use it?
 

Some consumers will take advantage of price information, although maybe not many, said experts who have studied patient behavior.

The amounts would be different from what currently exists on websites run by some insurers, hospitals and private businesses because they would be actual negotiated prices, not area averages, estimates or hospital-set "charges," which are amounts set by hospitals and usually far higher than the negotiated rates.

Even so, "a lot of things can get in way of patients using the data," said Lovisa Gustafsson, assistant vice president at the Commonwealth Fund.

There may be only one hospital in town, for example, or patients might be reluctant to switch if they have a relationship with a specific hospital. Incentives to shop might be hampered, too, if a patient's share of the cost of a procedure or test is small. Finally, only a portion of medical care is "shoppable," meaning patients have time to look around and compare prices before they undergo the procedure or receive the treatment.

Still, when price data is available some patients — particularly those with high deductibles that haven't been met — will shop and choose a lower priced provider, said Gustafsson.

Experts point to consumer behavior in New Hampshire, which posts price information by insurer online. Only a small percentage took advantage of the online look-up tool, but those who did saved money, according to a recent study by Zach Brown, an assistant professor of economics at the University of Michigan.

Still, the new dataset proposed by the Trump administration might simply be too overwhelming for many consumers.

Although the proposal requires the information be presented so it can be searched online, it will be a huge dataset.

Start with the fact that each hospital has tens of thousands of charges, from room fees to suture costs to the price of each tablet of aspirin. Then multiply that by the number of insurers that contract with each hospital and the amount of data could be staggering.

Patients would need to know what tests, procedures, supplies and even drugs they might need for a given hospitalization, then add them up. For every hospital they are considering.

To help consumers, the proposal would also require hospitals to provide information on 300 "shoppable services" — say knee replacement — and include the price of all the related services that go with it rather than expecting patients to somehow try to add them up a la carte.

Will it lower prices?s
 

The short answer is maybe. But no one knows for sure.

"We've never had price transparency, so there is no evidence to point to exactly what it would do," said Gustafsson.

In retail, having price information from shopping websites like Amazon have helped drive prices down. But when the Danish government required concrete manufacturers to disclose negotiated prices, they went up, according to a study trotted out by skeptics of the price transparency approach.

But is health care like retail or cement?

On one hand, having actual price information can give self-insured employers and health insurers a stronger hand in negotiations, so they could demand better deals from hospitals. But it could also spur some hospitals to raise their prices if they think competitors are getting a better deal from insurers.

Business professor George Nation, who studies hospital pricing at Lehigh University, lands on the side of the argument that more price information can help lower prices, especially if employers and insurers use it to demand steeper discounts.

"This money is coming out of employers' pockets," he said. "They're going to say, why, if Hospital B can do this for $300, why are you charging me $600? Justify your charge."

While that won't work in areas with a strong hospital monopoly, it's a start, he said.

"You can't have price competition without knowing the price. And that's where we have been living."

Will it become law?
 

Again, the answer is maybe.

The proposal could be modified after the administration reviews public comments, which are due Sept. 27.

After it's finalized, there may well be a legal battle.

Hospitals and insurers didn't wait to take the first shots.

Shortly after the proposed rule was released late Monday, their trade organizations released sharply critical statements. They've long opposed efforts to reveal their negotiated prices, which they say are trade secrets.

The Trump plan will backfire, said that America's Health Insurance Plans: "Posting privately negotiated rates will make it harder to bargain for lower rates, creating a floor — not a ceiling — for the prices that hospitals would be willing to accept."

We'll see you in court, was the not too thinly veiled threat that came from the American Hospital Association, which said the proposal "misses the mark, exceeds the administration's legal authority and should be abandoned."

But Medicare administrator Verma was unfazed. When asked by reporters about the potential for a legal battle over the proposal, she said, "We're not afraid of that."

Still, on the legal front, it could get complex.

Currently, the administration is backing a lawsuit from 18 red states that are seeking to have the entire Affordable Care Act overturned, including, presumably, any authority it gives the administration to require hospitals to post prices.

Again, Verma was not worried: "If there are any changes to the ACA, we would work with Congress to keep what's working and get rid of what's not," she said at the press conference.

Nation said the attention the proposal is getting from industry backs his contention that there might must be something to it.

"The strength of the opposition is indication this may work to lower prices," he said.

Julie Appleby: jappleby@kff.org, @Julie_Appleby

Creator Of Brain Exam That Trump Aced Demands New Training For Testers

KFF Health News, July 29, 2019

The creator of MoCA says growing worries about the validity of test results have pressed him to require those who administer the test to pay for mandatory certification.

This article was first published on Monday, July 29, 2019 in Kaiser Health News.

By JoNel Aleccia

Last year, Dr. Ronny Jackson, then the White House physician, gave Donald Trump a standard test to detect early signs of dementia — and said the president had scored a perfect 30. “There is no indication whatsoever that he has any cognitive issues,” Jackson said at the time in front of TV cameras.

Trump’s team embraced the result, with Donald Jr. boasting on Twitter: “More #winning.” The publicity sparked a wave of interest in the screening tool. Much was written about what the test showed — or didn’t — about the president’s mental acuity. A media outlet even posted its questions online, suggesting readers could measure whether they were “fit to be U.S. president.”

Dr. Ziad Nasreddine, the creator of that test, the Montreal Cognitive Assessment, went with it. Within weeks, the Lebanese-Canadian neurologist and his colleagues were working on “mini-MoCA,” an online exam for anyone to take who was worried about his own cognitive decline. Nasreddine said at the time that he might charge the masses $1 or $2 per test.

Now Nasreddine has changed course. He says growing worries about the validity of test results — and possible liability for errors — have pressed him to require those who administer the test to pay for mandatory certification to make sure the results are accurate.

Further examination of the results called into question even perfect scores.

“I’ve seen so much variability, which might make us reconsider some of the decisions made based on the MoCA score,” said Nasreddine, who has reviewed hundreds of exams administered to patients in recent years.

Training and certification have been voluntary for years. But starting Sept. 1, most clinicians who administer the MoCA will be required to complete a one-hour, $125 online course, said Nasreddine, who holds the copyright to the test.

Nasreddine, director of the MoCA Clinic and Institute in Quebec, Canada, wouldn’t speculate about whether Trump’s test was accurate. Officials with the White House and the Navy, where Jackson is a rear admiral, did not respond to questions about the issue. Jackson did not reply to an email seeking comment.

The move to require certification — and particularly to charge for it — sparked outrage among geriatricians like Dr. Eric Widera of the University of California-San Francisco. He accused Nasreddine of creating a “pay to play” scenario that profits from a growing need and the test’s ubiquitous use.

“It raises huge red flags,” Widera said. “This is a growing issue, the monetization of tools that we promoted as the standard.”

It’s a controversial change for an exam that is used by doctors and other health professionals in nearly 200 countries to screen people for potential problems with memory and thinking.

In the U.S., the MoCA is a go-to tool used in about 8,000 visits each year to the 31 Alzheimer’s Disease Research Centers funded by the National Institute on Aging. The 30-question test assesses various cognitive domains through exercises that include drawing a cube, drawing a clock with hands set at a specific time, naming certain animals, memorizing a series of words and calculating numbers in a certain way.

Until now, the MoCA screen has been free for clinicians, making it a cheap, easy way to tell if someone should proceed to the more detailed evaluations used to make an actual diagnosis of dementia.

After Sept. 1, 2020 — a year after the training requirement begins — access to the test will be restricted to certified users, Nasreddine said. Only medical students, residents and fellows, and neuropsychologists will be exempt. Two-year recertification is optional and will be offered at half the original cost. Group rates will be available for institutions and government bodies to make the training affordable.

Still, Widera said he worries that requiring MoCA certification will deter nonspecialists from testing for early signs of dementia.

Studies estimate that somewhere between about 500,000 and 1 million Americans age 65 or older will develop Alzheimer’s disease this year.

Nasreddine said he has seen testing errors after reviewing hundreds of MoCA exams given by doctors and others who didn’t properly follow a four-page list of directions.

A MoCA score of 26 or higher is generally considered normal, while a score of 18 to 25 can indicate mild cognitive impairment, and 10 to 17 can indicate moderate impairment. A score of less than 10 indicates severe impairment.

On some tests, scores varied by as much as 5 points in the same patient over a few weeks, Nasreddine said.

“That is a lot of points out of 30,” he said. “If it’s within the same month, it’s not because the disease changed that quickly.”

Widera and others acknowledged that errors can occur in administering and interpreting the MoCA or any tool.

“There may be operator error,” he said. “That’s true for everything we do in medicine. Nobody licenses us every two years to use a stethoscope.”

Nasreddine said he and his team have been threatened with lawsuits — though it appears no cases have been filed — by people who said they were harmed by the results of tests given by health professionals who lack specialized dementia training.

“One man, they stripped him of his legal rights, put him in the nursing home — all … because he scored 15 or 20 on the MoCA test,” said Nasreddine, who in addition to running a memory clinic is an assistant clinical professor at McGill University and the University of Sherbrooke in Canada.

A nurse who had been having mild attention problems lost her job “because the psychiatrist who ran the test on her was not trained and didn’t do it well,” Nasreddine said, adding: “They’re blaming us.”

Regular users of the MoCA likened the controversy over the exam to the recent fate of another cognitive screening tool, the Mini-Mental State Examination.

That test, known as the MMSE, was used widely for 30 years before its authors began enforcing copyright protection and then granted an exclusive license to a third-party firm. A licensed version of the MMSE is now sold for $89 for a package of 50 tests.

The parallel upset experts like Dr. Louise Aronson, a UCSF professor of geriatrics and author of the best-selling book “Elderhood: Redefining Aging, Transforming Medicine, Reimagining Life.”

“First we gave up the #MMSE and now we will renounce the #MOCA,” Aronson tweeted on June 28. “Lessons in putting profit ahead of patients and #healthcare. Disappointing is the most polite word I can think of.”

Nasreddine said he has received many emails from MoCA users happy with the mandatory certification, adding that “the purpose of the training is to make the test more reliable and valid.”

JoNel Aleccia: jaleccia@kff.org, @JoNel_Aleccia

Doctor Alexa Will See You Now: Is Amazon Primed To Come To Your Rescue?

KFF Health News, July 29, 2019

Alexa could help doctors diagnose mental illness, autism, concussions and Parkinson's disease, or even detect when you're having a heart attack.

This article was first published on Monday, July 29, 2019 in Kaiser Health News.

By Janet Rae-Dupree

Now that it's upending the way you play music, cook, shop, hear the news and check the weather, the friendly voice emanating from your Amazon Alexa-enabled smart speaker is poised to wriggle its way into all things health care.

Amazon has big ambitions for its devices. It thinks Alexa, the virtual assistant inside them, could help doctors diagnose mental illness, autism, concussions and Parkinson's disease. It even hopes Alexa will detect when you're having a heart attack.

At present, Alexa can perform a handful of health care-related tasks: "She" can track blood glucose levels, describe symptoms, access post-surgical care instructions, monitor home prescription deliveries and make same-day appointments at the nearest urgent care center.

Amazon has partnered with numerous health care companies, including several in California, to let consumers and employees use Alexa for health care purposes. Workers at Cigna Corp. can manage their health improvement goals and earn wellness incentives with Alexa. And Alexa helps people who use Omron Healthcare's blood pressure monitor, HeartGuide, track their readings.

But a flood of new opportunities are emerging since Alexa won permission to use protected patient health records controlled under the U.S. privacy law known as the Health Insurance Portability and Accountability Act (HIPAA).

Before, Alexa had been limited to providing generic responses about medical conditions. Now that it can transmit private patient information, Amazon has extended its Alexa Skills Kit, the software development tools used to add functions. Soon, the virtual assistant will be able to send and receive individualized patient records, allowing health care companies to create services for consumers to use at home.

Amazon's efforts in this domain are important because, with its 100 million smart devices in use worldwide, it could radically change the way consumers get health information and even treatment — and not just tech-savvy consumers. Analysts expect 55% of U.S. households will have smart speakers by 2022.

Some of Alexa's new skills depend on a little-understood feature of the devices: They listen to every sound around them. They have to in order to be ready to respond to a request, like "Alexa, how many tablespoons in a half-pint?" or "Put carrots on the shopping list."

University of Washington researchers recently published a study in which they taught Alexa and two other devices — an iPhone 5s and a Samsung Galaxy S4 — to listen for so-called agonal breathing, the distinct gasping sounds that are an early warning sign in about half of all cardiac arrests. These devices correctly identified agonal breathing in 97% of instances, while registering a false positive only 0.2% of the time.

Earlier research had shown that a machine learning system could recognize cardiac arrest during 911 emergency calls more accurately and far faster than human dispatchers could.

Amazon, which declined to comment for this article, holds a patent on an acoustic technology that recognizes and could act on significant audio interruptions. Combined with patented technology from the University of Washington that differentiates coughs and sneezes from other background noises, for example, Alexa could discern when someone is ill and suggest solutions.

Because Amazon also holds patents on monitoring blood flow and heart rate through an Alexa-enabled camera, Alexa could send vitals to a doctor's office before you head to your appointment and continue to monitor your condition after you get home.

"It opens possibilities to deliver care at a distance," said Dr. Sandhya Pruthi, lead investigator for several breast cancer prevention trials at the Mayo Clinic, which has been on the front lines of using voice assistants in health care. "Think about people living in small towns who aren't always getting access to care and knowing when to get health care," she said. "Could this be an opportunity, if someone had symptoms, to say, 'It's time for this to get checked out'?"

A growing number of clinics, hospitals, home health care providers and insurers have begun experimenting with products using Alexa:

  • Livongo, a Mountain View, Calif.-based startup focused on managing chronic diseases, sells an Alexa-connected blood glucose monitor that can help diabetes patients track their condition.
     
  • Home health care provider Libertana Home Health, based in Sherman Oaks, Calif., created an Alexa skill that lets elderly or frail residents connect with caregivers, set up reminders about medications, report their weight and blood pressure, and schedule appointments.
     
  • Cedars-Sinai Medical Center in Los Angeles put Amazon devices loaded with a plug-in called Aiva into more than 100 rooms to connect patients with staff and to provide hands-free television controls. Unlike a static call button, the voice-controlled device can tell nurses why a patient needs help and can then tell the patient the status of their request.
     
  • Boston Children's Hospital, which offered the first Alexa health care software with an educational tool called Kids MD, now uses Alexa to share post-surgical recovery data between a patient's home and the hospital.

Many medical technology companies are tantalized by the possibilities offered by Alexa and similar technologies for an aging population. A wearable device could transmit information about falls or an uneven gait. Alexa could potentially combat loneliness. It is learning how to make conversation.

"Alexa can couple a practical interaction around health care with an interaction that can engage the patient, even delight the patient," said elder care advocate Laurie Orlov.

It and other voice assistants might also help bring some relief to doctors and other medical practitioners who commonly complain that entering medical information into electronic health records is too time-consuming and detracts from effective interactions with patients.

This technology could work in the background to take notes on doctor-patient meetings, even suggesting possible treatments. Several startup companies are working on such applications.

One such company is Suki, based in Redwood City, Calif., which bills itself as "Alexa for doctors." Its artificial intelligence software listens in on interactions between doctors and patients to write up medical notes automatically.

Amazon devices will need to excel at conversational artificial intelligence, capable of relating an earlier phrase to a subsequent one, if it is to remain dominant in homes.

In a 2018 interview on Amazon's corporate blog, Rohit Prasad, a company vice president who is head scientist for Amazon Alexa, described Alexa's anticipated evolution using "federated learning" that lets algorithms make themselves smarter by incorporating input from a wide variety of sources.

"With these advances, we will see Alexa become more contextually aware in how she recognizes, understands and responds to requests from users," Prasad said.

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

GOP Senators Distance Themselves From Grassley And Trump's Efforts To Cut Drug Prices

KFF Health News, July 26, 2019

Even some Republicans who supported legislation in committee warned they may not back the sweeping package in a full Senate vote. They object in particular to a provision that would cap drug prices paid by Medicare based on the rate of inflation.

This article was published by Kaiser Health News on Thursday, July 25, 2019.

By Emmarie Huetteman

The fight between policymakers intent on lowering prescription drug prices and the drugmakers who keep raising them intensified Thursday, as a slew of Republican senators threatened to side with manufacturers against legislation supported by their own committee chairman and president.

After months of closed-door meetings and high-profile hearings, the Senate Finance Committee voted 19-9 to advance legislation introduced by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) to rein in drug costs in the Medicare and Medicaid programs.

But even some Republicans who supported it warned they may not back the sweeping package of proposals in a full Senate vote. They object in particular to a provision that would cap drug prices paid by Medicare based on the rate of inflation.

Other obstacles have piled up. Wyden announced that Democrats, who provided most of the bill's support in committee, would not allow a Senate vote without the Republicans agreeing to hold votes on cementing insurance protections for people with preexisting conditions. Democrats have complained for months that GOP efforts to kill the Affordable Care Act will leave people with these medical problems without any recourse to get affordable health care. Democrats also want to empower federal health officials to negotiate drug prices.

Here are the three major problems revealed in Thursday's hearing.

Many Senate Republicans disagree with President Donald Trump about how to lower drug prices.

Some of Trump's efforts to reduce Americans' drug costs took a beating Thursday. They were criticized — by members of his own party — for putting too much power in the hands of government.

Despite urging from White House and federal health officials to support the legislation, 13 of the committee's 15 Republicans voted to remove its controversial proposal to prevent drug prices from rising faster than inflation under Medicare. Their attempt failed, barely.

Medicaid already uses this strategy, requiring drugmakers to pay the government a rebate if the prices it pays outpace inflation, and Medicaid tends to pay lower prices on drugs than Medicare. The HHS inspector general has said Medicare could collect billions of dollars from the drug industry if it did the same. But many Republicans strongly oppose any government interference in private markets or price setting.

Sen. Patrick Toomey (R-Pa.), who introduced the amendment to remove the proposal, said it wasn't necessary because seniors would be protected from paying too much by another proposal in the bill to cap out-of-pocket expenses.

"It's my view that we should not use this sledgehammer of a universal price control, imported from Medicaid, to deal with that relatively narrow problem and to disrupt a program that's working very well," Toomey said, mentioning Medicare's popularity.

Grassley said the inflation caps would help relieve taxpayers from covering Medicare's skyrocketing drug costs.

And having played a key role in 2003 creating Medicare's prescription drug program, called Medicare Part D, he took issue with the idea that his latest bill would harm the program: "I wrote it, so you ought to know that I want to protect it," Grassley said.

Most of the Republicans also backed an amendment to block a proposal being considered by the Trump administration to tie drug prices here to those paid in other developed nations, which narrowly failed. While Grassley said he, too, opposes the administration's proposal, he did not want the issue to hold up his own bill and so voted against the amendment.

Grassley also said he is not comfortable with empowering federal health officials to negotiate drug prices, as Wyden said he would like to see considered. But Grassley noted that the issue isn't going away: Trump campaigned on the idea, which White House officials have been discussing with House Democratic leaders as part of a plan expected to be released in September.

But that may not be enough, Grassley suggested: "I don't think that you're going to get 60 votes in the United States Senate."

Critics in Congress are using some of the same misleading arguments as drugmakers.

Smelling trouble, pharmaceutical executives met with Trump at the White House on Wednesday evening to voice their opposition to the Grassley-Wyden bill.

In a statement after their meeting, PhRMA, the industry's lobbying group, called it "the wrong approach to lowering drug prices" and said it "imposes harmful price controls in Medicare Part D."

PhRMA claimed the bill would "siphon more than $150 billion from researching and developing new medicines." (Experts say most innovation now happens at academic institutions, not pharmaceutical companies.) It said the Medicare Payment Advisory Commission, a panel that advises Congress, had found "it will only benefit 2% of Medicare patients starting in 2022." (A Bloomberg Law reporter said a commission official told her it had not analyzed the bill.) The lobbying group asserted the bill would "result in money going to the federal treasury instead of seniors." (The money collected by the new rebates would go into the Supplemental Medical Insurance trust fund, which pays for health services for Medicare beneficiaries.)

The flaws in PhRMA's claims did not stop critics from echoing some of them. Sen. Robert Menendez (D-N.J.), whose state is home to several drugmakers, said the bill's savings should go to patients and not into "some fund" where patients would not see it. (He nonetheless voted to advance the bill.)

And Republicans decried the bill's "price controls" — even as Grassley and Wyden explained that the inflation caps would do nothing to the list prices set by drugmakers, only slow price increases once they were on the market.

In one exchange, Sen. John Cornyn (R-Texas) questioned Phillip Swagel, the director of the Congressional Budget Office, about who would pay more under the legislation's inflation caps. "If you cut the subsidy," he said, referring to what the government pays drugmakers, "doesn't somebody else's cost have to go up?"

"In this case, the out-of-pocket spending would go down. The premiums would go down. The federal spending would go down," Swagel replied. "The drug manufacturer, they would see lower price increases than they might have seen without this provision."

"So they would have to eat that cost?" Cornyn asked.

"We would see them, as you put it, eating some of that cost, and they might change their overall pricing as well," Swagel said.

Saying there was "sufficient uncertainty" about how the caps would work, Cornyn then asked to be added as a co-sponsor of the amendment opposing that change.

Democrats, who unanimously voted to advance the bill, may still kill it.

Wyden opened with an unusual declaration as he discussed the legislation he and Grassley had spent months crafting: If Republican leaders do not allow votes on amendments that would protect preexisting conditions and empower federal health officials to negotiate drug prices, Democrats will oppose moving forward on it.

In short, he threatened his own bill.

"We're certainly not going to sit quietly by while protections for preexisting conditions are wiped out," Wyden said. "We're not going to sit by while opportunities for seniors to use their bargaining power in Medicare are frittered away."

Democrats slammed Republicans during the 2018 midterm election for not doing enough to protect those with preexisting conditions, especially since Republican attorneys general have sued to void the entire Affordable Care Act. It looks like Democrats are warming up that argument for 2020.

During one tense exchange Thursday, Sen. Bob Casey (D-Pa.) fired back at Cornyn for claiming Republicans have a plan to protect patients should the ACA be thrown out.

"How the hell can you say that you support protections when you have all the power and a bill did not pass that would support the Affordable Care Act?" Casey said. "You've had eight years of bellyaching about it, and you haven't done a damn thing about it."

As the hearing went on, Democrats praised the bipartisan legislation at hand but listed other proposals they would like to see, including the revival of the Trump administration's now-defunct rebate rule. That would have forced the pharmacy benefit managers who negotiate drug prices for government health plans to refund some of those discounts to customers. (Grassley, for his part, asked Wyden to work with him on incorporating the proposal into their legislation.)

Still, Grassley referred to the opposition among his own Republican colleagues as his "most vexing problem." At one point, when Sen. John Thune (R-S.D.) gently suggested that stripping out the inflation caps would leave them with "a big, bipartisan margin on this bill coming out of here," Grassley didn't miss a beat.

"It could get us a unanimous vote in this committee, but it would also leave the taxpayers with $50 billion more cost," he said before calling on the next senator.

On A Mission To Help People Control Diabetes — And Save Money On Insulin

KFF Health News, July 25, 2019

A Tennessee couple has dedicated the last years of their working lives to helping people with Type 2 diabetes control and even reverse the condition with diet and exercise.

By Blake Farmer, Nashville Public Radio

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

In a former church parsonage in Grundy County, Tenn., Karen Wickham ladled out her lentil stew as people arrived for an evening health education class.

Wickham and her husband, Steve, are white-haired, semi-retired nurses who have dedicated the last years of their working lives to helping people with Type 2 diabetes control and even reverse the condition with diet and exercise.

Wendy Norris is in the group, and she has brought along her father and daughter. Since her diagnosis several years ago, Norris said, her doctor prescribed insulin shots and told her to watch what she ate.

She recalled thinking at the time, "Well, what does that mean?"

The Wickhams have set out to answer that question in Tennessee's Grundy County, which ranks lowest on the scale of residents' health. Grundy's population of 13,000 has the shortest life expectancy in the state and an elevated rate of diabetes (16% of adults), which can eventually result in blindness, kidney failure or amputations.

Norris said trying to overhaul her diet by herself was confusing and difficult. And when things didn't change, the doctor just kept increasing her dosage of insulin.

But then Norris lost her health insurance. The injectable insulin cost her hundreds of dollars a month — money she simply didn't have.

"I felt like I was stuck having to take three or four shots a day [for] the rest of my life," she said. She enrolled in one of the six-week seminars the Wickhams offer and is seeing results in how many shots she needs: "I've got it down to one already."

With slide presentations, the Wickhams explain the difference between sucrose and glucose, and the science behind the fact that certain foods, like potatoes, spike blood sugar, while sweet potatoes don't. They preach eating as much fiber as a stomach can stand, and dropping almost every kind of sweetened beverage.

And they demonstrate ways to burn all those calories. Steve even invented the "Beersheba Boogie" — after the Grundy town of Beersheba Springs — asking participants to raise their knees and pump their fists while marching in place.

Support for Hard changes
 

All the workshop participants have to find a way to get active at home or in a rugged state park nearby because there's no gym anywhere in the county. There's not a proper grocery store anywhere nearby either, so healthy cooking can become a real chore.

These communitywide obstacles reveal why it can be a struggle for people to maintain their health in rural America. But the Wickhams are working to overcome those barriers.

During one education session, as participants shared their latest health stats, Steve called out: "Her blood sugar is going down! Give her a hand."

If it sounds like a revival meeting, it kind of is. Steve and Karen Wickham say they are compelled in this work by their Christian faith as Seventh-day Adventists — a denomination known for a focus on health. They first moved to Grundy County to take care of ailing parents, and once settled in their scenic mountain retreat, they grew disturbed by the suffering they saw in their neighbors.

"I think God holds us responsible for living in the middle of this people and doing nothing," Steve Wickham said.

Many people think of Type 2 diabetes as practically incurable, though it has long been known that the condition can be reversed with weight loss and exercise. But research shows people need lots of help to change their lifestyle, and they rarely get it.

"I had taken care of diabetic patients for so long, and I knew the progression," Karen said. "If you truly want the people to get better, you have to treat it with lifestyle interventions."

Those changes can be hard to start and even harder to maintain.

"Nobody, actually, will make all of the lifestyle changes that we recommend," Steve said. "But if you're making the kind of choices that lead you to a healthier lifestyle, then you get better."

A more hopeful message
 

Along with their lifestyle counseling, the Wickhams always give a disclaimer, advising people to consult with their doctors. They also acknowledge that their seminars are not yet "evidence-based" or backed by peer-reviewed scientific literature.

But there are studies showing that people with blood sugar levels in the "prediabetes" range can get back to normal blood sugar by losing 5% of their body weight.

And weight loss and exercise have already been shown to lower hemoglobin A1c levels, a test physicians use to monitor a patient's blood sugar over two to three months.

In addition, new research from Dr. Roy Taylor of Newcastle University in England shows promise for true remission.

"Doctors tell their patients, 'You've got a lifelong condition. We know it's going to steadily get worse.' Then they turn around and their patients aren't losing weight or doing exercise, but they've given them this utterly depressing message," he said.

Taylor's research finds that by losing 30 pounds or so, Type 2 diabetes can be reversed in the early stages.

Ultimately, Taylor hopes, better nutrition will become the preferred response to high blood sugar in the next decade.

"I think the main headwinds [against progress] are just conceptual ones — of scientists and doctors believing this is an irreversible condition because of what we've seen," he said.

Even the American Diabetes Association has been changing its views. The advocacy group has a new position on reversal:

"If a patient wishes to aim for remission of Type 2 diabetes, particularly within six years of diagnosis, evidence-based weight management programs are often successful."

Dr. John Buse, chief of endocrinology at the University of North Carolina medical school, helped write the new position on reversal.

"We've known, literally since the 17th century, that diet is the key to managing diabetes," he said.

But it's hard to write a prescription for a lifestyle change.

"Doctors don't have the time to do it well, so we have often used the sort of short shrift," he said. "'Eat less carbohydrates and walk every day' … that has basically no impact."

The Wickhams are doing their part to add to the scientific data, tracking the blood sugar of the participants in their program. And the anecdotal, short-term evidence they've gathered is resonating far beyond Grundy County. They've been traveling more and more lately.

The couple just sold their retirement home so they can say "yes" to all the invitations they've received, mostly from Seventh-day Adventist groups, to present their program to other communities around the country.

Blake Farmer, Nashville Public Radio: bfarmer@wpln.org, @flakebarmer

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