Trump's Promise To Rein In Drug Prices Could Open Floodgate To Importation Laws

KFF Health News, March 22, 2017

Four former commissioners of the Food and Drug Administration argue that consumer drug importation remains too risky to permit.

This article first appeared March 22, 2017 on Kaiser Health News.

By Rachel Bluth

With prescription drug prices soaring and President Donald Trump vowing to take action, an old idea is gaining fresh traction: allowing Americans to buy medicines from foreign pharmacies at far lower prices. A new bill in Congress to allow the practice would modify previous safety standards and remove a barrier that proved insurmountable in past attempts to enable progress.

Congress came close to allowing importation through the Medicare Modernization Act in 2003, but added one firm precondition that has prove a nonstarter. The secretary of Health and Human Services had to guarantee that imported medications posed no additional risk to public safety and would save money.

"That is a fairly absolute standard and a high bar to cross," said Elizabeth Jungman, director of public health at the Pew Charitable Trusts. Such an exacting standard — guaranteeing that no imported prescriptions posed a threat — has kept any secretary of HHS from condoning it.

In an open letter to Congress, four former commissioners of the Food and Drug Administration argue consumer drug importation remains too risky to permit. "It could lead to a host of unintended consequences and undesirable effects, including serious harm stemming from the use of adulterated, substandard, or counterfeit drugs," they said in the letter distributed to media organizations. It was signed by Robert Califf, Margaret Hamburg, Mark McClellan and Andrew von Eschenbach, who headed the FDA at various times between 2002 through 2016.

The recent proposal, from Sen. Bernie Sanders (I-Vt.) and such Democrats as Cory Booker from New Jersey and Bob Casey from Pennsylvania, drops that requirement. Instead, it sets up a regulatory system where Canadian pharmacies who purchase their supply from manufacturers inspected by the Food and Drug Administration would be licensed to sell to customers across the border. The bill allows not only individuals but drug wholesalers and pharmacies to buy from Canada.

After two years, HHS could allow importation from other countries that meet standards comparable to those of the U.S.

(Another bill in Congress, proposed in January by John McCain (R-Ariz.) and Amy Klobuchar (D-Minn.) focuses solely on allowing individuals to purchase from such pharmacies.)

Trump has promised that "pricing for the American people will come way down." Last week, he had a high-profile meeting at the White House with Elijah Cummings, Peter Welch (D-Vt.) and the head of Johns Hopkins Hospital, Redonda Miller, to discuss allowing Medicare to negotiate prices on outpatient medicines. Cummings told reporters later that Trump said he supports Medicare price negotiation as well as the Sanders bill.

PhRMA, the drug industry's trade group, has denounced Sanders' proposal as it has others that enabled imports in the past.

"The bill lacks sufficient safety controls [and] would exacerbate threats to public health from counterfeit, adulterated or diverted medicines, and increase the burden on law enforcement to prevent unregulated medicines and other dangerous products from harming consumers," said PhRMA spokeswoman Nicole Longo.

Surveys indicate that up to 8 percent of Americans have bought medicines outside the U.S. even though the practice is technically illegal and imported pills are subject to confiscation.

Around 45 million Americans — 18 percent of the adult population — said last year they did not fill a prescription due to cost, according to an analysis of data from the Commonwealth Fund by Gabriel Levitt, president of PharmacyChecker.com, whose company helps Americans buy medications online by vetting overseas pharmacies and comparing prices for different drugs. Data compiled by the company comparing prices offered in Canada to those in New York, shows drugs are frequently three times or more as costly in the U.S. as over the border.

For example, a simple Proventil asthma inhaler costs $73.19 in the U.S. vs. $21.66 in Canada. Crestor, the cholesterol-lowering drug, is $6.82 per pill in the U.S. but $2.58 in Canada. Abilify, a psychiatric medicine, is $29.88 vs. $7.58, according to pharmacychecker.com.

Many previous bills to allow importation or to allow Medicare to negotiate prices for its beneficiaries have failed in the face of $1.9 billion in congressional lobbying by the pharmaceutical industry since 2003, according to Open Secrets. But Americans may be reaching a tipping point of intolerance. In polling just before the election by the Kaiser Family Foundation, 77 percent of Americans called drug prices "unreasonable" and well over half favored a variety of proposals to address them.

To address safety concerns, the Sanders bill institutes several new strategies. Canadian pharmacies that want to be registered to sell to Americans would have to pay a fee to pay for additional FDA monitoring. A General Accountability Office study would be required within 18 months of the final rule to address outcomes related to importation processes, drug safety, consumer savings and regulatory expenses.

Allowing people to legally import medications wouldn't totally solve the problem of high prescription drugs, advocates say, but would be a step in the right direction. Said Levitt: "The best way for Americans to afford their meds is to enact polices here to bring the prices down here."

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

Proposed changes could potentially saddle people on Medicaid with unaffordable medical bills, shortchange providers, and raise costs throughout the healthcare system.

GOP Bill's Unheralded Changes In Rules Could Undermine Health Of Neediest

KFF Health News, March 21, 2017

Proposed changes could potentially saddle people on Medicaid with unaffordable medical bills, shortchange providers, and raise costs throughout the healthcare system.

This article first appeared March 20, 2017 on Kaiser Health News.

By Emily Bazar

An under-the-radar provision in the Republican proposal to replace the Affordable Care Act would require the millions of Medicaid enrollees who signed up under the Obamacare expansion to renew their coverage every six months — twice as often as under current law.

That change would inevitably push many people out of coverage, at least temporarily, experts say, and help GOP leaders phase out Medicaid expansion — a key goal of the pending legislation.

"That's designed to move people off those rolls as soon as possible," said Ken Jacobs, chairman of the University of California, Berkeley, Center for Labor Research and Education.

The proposal to cut renewal time in half is among other changes that seem only procedural but could have a profound effect on Medicaid enrollees' health, pocketbooks and ability to get — and keep — coverage.

Another proposal would eliminate the ability of new Medicaid enrollees to request retroactive coverage for up to three months before the month they apply, which they can do under the current law — assuming they were eligible during that previous period.

Health care experts and advocates fear that could potentially saddle people on Medicaid with unaffordable medical bills, shortchange providers and raise costs throughout the health care system.

"These are changes to fundamental pieces of the Medicaid program," said Cathy Senderling-McDonald, deputy executive director of the County Welfare Directors Association of California in Sacramento, which represents human services directors from the state's 58 counties.

"They could result in people delaying their health care or having to pay out-of-pocket and not having any hope for reimbursement at all," she said.

But Michael Cannon, director of Health Policy Studies at the libertarian Cato Institute, said some of these changes would prevent fraud and keep ineligible people from obtaining benefits, thus saving taxpayer money.

"It's so hard to eliminate fraud in Medicaid, because someone always benefits from it," he said. "They don't want to give that up."

The expansion of Medicaid — the federal-state health care program for people with low incomes, known as Medi-Cal in California — would be phased out under the Republicans' plan starting in 2020.

The expansion, adopted by 31 states and the District of Columbia, added more than 11 million people to the rolls, including about 3.7 million in Medi-Cal. The federal government picks up a much higher proportion of the cost for this population than for traditional Medicaid enrollees.

In the GOP plan, people already covered under the expansion would continue to be funded by the federal government after Jan. 1, 2020, but if states opted to sign up new enrollees under the expansion criteria after that date, they wouldn't receive the more generous federal funding for them.

And those who remained in the program after 2020 but later lost eligibility would not draw the more generous federal funding for expansion enrollees if they became eligible again and re-enrolled at a later date.

In California, the potential loss of federal dollars caused by the rollback of the expansion would be massive. The state Legislative Analyst's Office estimated last month that the Golden State is slated to receive more than $17 billion from the federal government for the Medi-Cal expansion in 2017-18.

"We're talking about a big shift in costs to the state of California and potentially a major loss in coverage," said UC Berkeley's Jacobs.

The GOP legislation, which is scheduled for a vote on the House floor on Thursday, would impose the new renewal requirement on expansion enrollees starting Oct. 1.

"They're saying to states that do the expansion, 'We'll cover people who are continuously in the program, but we'll make it really hard for people to be continuously in the program,'" Jacobs said.

Wolf Faulkins, a resident of Mariposa, Calif., who enrolled in Medi-Cal in 2014 as a result of the expansion, said the proposed rule change regarding renewal would add one more layer to Medi-Cal's already considerable bureaucratic requirements, none of them logical or simple.

"If I were more of a senior citizen than I am now, I would be overwhelmed" by it, Faulkins, 61, said. "I would not be a happy camper." But he would complete the extra paperwork, he added, because his Medi-Cal coverage keeps him alive: Among other things, he has a heart condition and high blood pressure as well as knee and hand ailments.

Senderling-McDonald said the new paperwork will lead some enrollees to drop out for two reasons: Either they're no longer eligible, or they're eligible but the new bureaucratic hurdle stops them.

Faulkins agreed. Even though he would jump through the necessary hoops to keep his coverage, some others probably wouldn't, he guessed. "There are people who are just going to say, 'It's important, but it's too overwhelming. There's no one to advocate for me. There's no one to help me figure this out, " he said. "People are just going to get frustrated and say no."

The new renewal time frame has a precedent in California, which adopted a semiannual reporting requirement in 2003 for some enrollees that lasted about a decade. Though it was less cumbersome than the regular annual renewals, it nonetheless resulted in people dropping from the rolls, Senderling-McDonald said.

But the Cato Institute's Cannon believes six-month renewals are reasonable. "The savings from removing ineligible people would justify the paperwork involved," he said.

The paperwork imposed by these changes could be the least of the headaches for Medicaid beneficiaries.

Retroactive benefits, for example, are extremely valuable for new Medicaid enrollees who face medical bills during a gap in coverage, and losing them could cause financial pain.

"If they have had health expenses, like having to pay for a prescription out-of-pocket or a doctor's visit, or a woman goes into labor uninsured, they can say to the county, 'I had medical bills. Can you see if I was eligible during that time?'" said Senderling-McDonald.

Pregnant women are among the most frequent beneficiaries because they often don't know that they're pregnant right away, she added.

The GOP bill would end this, and would allow coverage to begin only the month in which enrollees apply. This provision would affect all Medicaid applicants and, like the change in renewal time, would begin Oct. 1.

Some experts believe the proposed change would increase medical debt for consumers hit with massive bills, and for providers who ultimately won't get paid for their services.

The three-month retroactive rule is "a big deal for hospitals as well as people, because it keeps them from being saddled with medical debt," said Judith Solomon, vice president for health policy at the Center on Budget and Policy Priorities in Washington, D.C.

Senderling-McDonald warned that as more consumers racked up medical debt, the cost of it would shift to other people. "If someone has to declare bankruptcy when they are hit with bills they can't pay, everybody else takes the hit for it," she said. "They're going to raise insurance rates or costs of care for everybody. People who have coverage through employers or the private market could see their rates go up."

Cannon agreed that providers will get hit with more unpaid bills, but said that this provision would save the federal government money. "States have taxing authority and can fund these benefits themselves if they want to," he said. "If they don't, that should tell us something — that they don't value these benefits that much."

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

A per-capita system would shift costs and financial risks to the states and could force them to cut benefits or eligibility.

On Medicaid Money, GOP Has Win-Or-Lose Proposition For States

KFF Health News, March 20, 2017

A per-capita system would shift costs and financial risks to the states and could force them to cut benefits or eligibility.

This article first appeared March 20, 2017 on Kaiser Health News.

By Phil Galewitz

New England's bucolic countryside looks much the same on either side of the Connecticut River separating Vermont from New Hampshire.

But Medicaid beneficiaries are far better off in Vermont.

Vermont generously funds its Medicaid program. It provides better benefits, such as dental care, and pays doctors more than New Hampshire's program does. That brings more doctors into the program, giving enrollees more access to care.

New Hampshire has twice Vermont's population, but Vermont spends almost as much on Medicaid and covers more enrollees. Under the complicated formulas that set federal funding, Vermont's substantial investment helps it capture nearly as much aid from the government as New Hampshire gets.

States' policies differ about who or what to cover in Medicaid, and those decisions have led to historical variances in how much federal money they receive. House Republicans' effort to shrink federal Medicaid spending would lock in the differences in a way that favors those already spending high amounts per enrollee.

"Republicans are finding out why changing Medicaid is so hard and why the easiest thing to do is to do nothing given the substantial variation in federal spending across states," said John Holahan, a health policy expert with the nonpartisan Urban Institute.

Here's why.

Medicaid, the national health program for low-income people that covers about 1 in 5 Americans, is 60 percent funded by the federal government and 40 percent by states. Total spending in 2015 was about $532 billion, according to the latest official data.

Federal funding is open-ended, which means the government guarantees states it will pay a fixed rate of their Medicaid expenses as spending rises.

Those matching rates are tied to average personal incomes and favor the lowest-income states. Mississippi has the highest Federal Matching Assistance Percentage—76—while 14 wealthy states, including New York and California, get the minimum 50 percent from the federal government.

But state Medicaid spending varies significantly, too, and that influences how much federal money each receives to fund its program. State policies about how generous benefits should be and how much to pay doctors and hospitals account for those differences.

GOP leaders want to give states a set amount of money each year based on the number of Medicaid enrollees they had in 2016, a formula known as per-capita caps.

A per-capita system would benefit high-spending states already receiving relatively rich allotments from the government, the Urban Institute said in a paper last September.

According to its estimates, if the system were in effect this year, Vermont would receive $6,067 per enrollee—one of the highest allotments in the country—while New Hampshire would get the least, just $3,084 per enrollee.

Per-capita caps would limit the government's Medicaid spending because it would no longer be on the hook to help cover states' rising costs. But caps also would shift costs and financial risks to the states and could force them to cut benefits or eligibility to manage their budgets.

"It would present a huge problem," said Adam Fox, a spokesman for the Colorado Consumer Health Initiative, an advocacy group.

Under the GOP bill, federal Medicaid funding to states would be adjusted annually based on a state's enrollment and medical inflation. But that would not be enough to keep up with rising Medicaid spending per enrollee, which would force states to put up more of their money or scale back the program, the nonpartisan Congressional Budget Office said March 13.

Other analyses of the GOP plan have reached the same conclusion.

Since 1999, however, the average annual growth rate in Medicaid spending per enrollee has risen more slowly than medical inflation, according to MACPAC, the Medicaid and CHIP Payment and Access Commission, which advises Congress.

Republicans argue that overhauling federal Medicaid spending as they propose would hold down federal costs while giving states more leeway to run their programs as they see fit. "This incentive would help encourage efficiencies and accountability with taxpayer funds," House Speaker Paul Ryan wrote last June in his white paper, A Better Way.

Rep. Greg Walden (R-Ore.), chairman of the powerful House Energy and Commerce Committee, which has oversight of health care matters, sounded a similar note at a press conference in Washington, D.C., when the GOP plan was announced. "I think it's really important to empower states and to put Medicaid on a budget," he said.

But Fox argued the opposite would happen under a per-capita system — instead of gaining more control over their Medicaid programs, states would not be able to meet their needs because they'd have fewer dollars to decide how to spend, he said.

Bill Hammond, director of health policy for the nonpartisan Empire Center for Public Policy in New York, said House leaders' decision to tie future Medicaid funding to medical inflation could help mute concerns that funding wouldn't keep up with rising costs, but would not address the fairness issue of giving some states higher per-capita amounts than others.

"If a low-spending state decides it wants to spend more money on paying hospitals and doctors or adding more benefits, they would have a harder time doing that without breaking the federal cap," he said.

Medicaid advocates in New Hampshire are worried because their state has few alternatives to make up for a loss in federal funding. New Hampshire lacks an income or sales tax.

"There is a tremendous amount of fear among families here as Republicans try to dismantle the ACA," said Martha-Jean Madison, co-director of New Hampshire Family Voices.

Cholesterol Drug Prevents Heart Attacks, But It Doesn't Come Cheap

KFF Health News, March 17, 2017

Insurance plans initially reject about 75% of all requests for Repatha, although they eventually approve about half.

This article first appeared March 17, 2017 on Kaiser Health News.

By Liz Szabo

WASHINGTON — For the first time, research shows that a pricey new medication called Repatha not only dramatically lowers LDL cholesterol, the "bad cholesterol," it also reduces patients' risk of dying or being hospitalized.

Repatha, a man-made antibody also known as evolocumab, cut the combined risk of heart attack, stroke and cardiovascular-related death in patients with heart disease by 20 percent, a finding that could lead more people to take the drug, according to a study presented Friday at a meeting of the American College of Cardiology.

Some doctors hailed the results as major progress against heart disease. In an editorial in The New England Journal of Medicine, Dr. Robin Dullaart, a researcher at the University of Groningen in the Netherlands, called it a landmark study.

Others said they expected more from the $14,000-a-year drug. It was approved in 2015 without evidence that it prevents heart attacks, simply because its cholesterol reductions were so dramatic and promising.

Doctors often recommend that people keep their LDL levels under 100 milligrams per deciliter, and that people at very high risk reduce their LDL under 70.

In the new study, patients with heart disease who combined Repatha with a statin, the most commonly used cholesterol medication, decreased their LDL from 92 milligrams per deciliter to 30. Doctors have rarely seen cholesterol levels that low. Many doctors wondered if such low levels would be dangerous, causing memory problems or dementia due to a lack of cholesterol, said Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, who was not involved in the new research but has led clinical trials of PCSK9 inhibitors in the past.

Insurers have been reluctant to cover Repatha because of its price and uncertain benefits.

Insurance plans initially reject about 75% of all requests for Repatha, although they eventually approve half, said Dr. Joshua Ofman, senior vice president of global value and access at Amgen, the drug's manufacturer. Doctors make an average of five requests before getting the medication approved.

In an unusual move aimed at increasing coverage, Amgen on Friday offered a special deal to insurance companies: If they loosen restrictions on coverage, Amgen will refund the medication cost should patients have a heart attack or stroke while taking it.

Although about 5% of patients in the clinical trial had a heart attack or stroke, rates of those problems could be two to three times higher in the real world, where patients are often older and sicker than those in clinical trials, Ofman said.

The refunds would go to insurance companies, not patients, Ofman said. He said insurance companies would have to decide for themselves if they want to refund patients' out-of-pocket expenses.

The offer isn't completely unprecedented. Geisinger Health System offers refunds to members who are dissatisfied with their care.

Some health care experts weren't impressed by Amgen's offer.

The offer is "a fig leaf covering a massive price," said Dr. Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center in New York.

Insurance companies would lose money on the offer, Bach predicted, because they would have to pay to treat dozens of patients to prevent one heart attack or stroke.

The new study, which followed 27,000 patients for two years, found no safety risks.

While doctors said they were relieved that Repatha is safe, doctors such as David Rind said they had hoped the study would show that the injectable medication reduces heart attacks and other serious complications by 30 percent or more, given its success in early studies.

"This [result] is probably a little less than we had been hoping for," said Rind, chief medical officer at the Boston-based Institute for Clinical and Economic Review, which evaluates drugs' cost effectiveness. Rind also was not involved in the study.

The study's author, Dr. Marc Sabatine, said the "compelling reductions" in heart attacks, strokes and death suggest doctors should treat cholesterol much more aggressively, aiming to lower LDL levels as much as possible. His study focused on patients with underlying heart disease, most of whom had already had a heart attack.

The standard treatment for cholesterol, other than diet and exercise, is a generic statin, which costs $250 a year. Statins can cut LDL levels by up to half and reduce heart attack risk by 25 percent, Nissen said.

Some doctors are less impressed with the new study, which was funded by Amgen.

In the study, also published in The New England Journal of Medicine, 5.9 percent of patients who combined Repatha with a statin had a heart attack, stroke or died, compared with 7.4 percent of patients who took a statin plus a placebo.

"It's a small reduction for a super expensive drug," said Dr. John Mandrola, a cardiologist at Baptist Health in Louisville, Ky., and chief cardiology correspondent for Medscape, who wasn't involved in the study.

Yet Repatha's high cost could burden the U.S. health system, said Dr. Steve Miller, senior vice president and chief medical officer at Express Scripts, a pharmacy benefit manager. A similar drug to Repatha, called Praluent, costs about as much. Doctors don't know whether Praluent would also prevent heart attacks, Rind said.

Repatha and Praluent, which belong to a class called PCSK9 inhibitors, are especially expensive because they would be taken for such a long time. Unlike an antibiotic, which patients take for a few days or weeks, those prescribed Repatha would take it for the rest of their lives.

Given its price, doctors aren't likely to give Repatha to everyone with high cholesterol, said cardiologist Cam Patterson, chief operating officer at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, who wasn't involved in the study.

About 11 million Americans could be eligible for Repatha, according to Amgen. Repatha was approved for people with an inherited condition that causes high LDL levels or who have underlying heart disease but haven't been able to adequately lower their LDL with statins alone. About 70 million Americans have high cholesterol and 25 million take statins, Nissen said.

Repatha could be an important drug for some high-risk patients, in spite of the cost, he said.

"It would be hard for me to look a patient in the eye, if they've had a couple of heart attacks and is scared to death, and say it's not worth you taking this medication," Nissen said.

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

Obamacare Pushed Nonprofit Hospitals To Do Good Beyond Their Walls. Now What?

Obamacare Pushed Nonprofit Hospitals To Do Good Beyond Their Walls. Now What?

KFF Health News, March 16, 2017

Requiring a "community health needs assessment" was part of a package of rules included in the ACA to ensure that nonprofit hospitals justify the tax exemption they receive.

This article first appeared March 16, 2017 on Kaiser Health News.

By Shefali Luthra

For the past six years, Mardi Chadwick has run a violence prevention program at Boston's Brigham and Women's Hospital. The program's goal is to address broader, community-based health issues and social problems that make people ill or prone to repeated injury from gunshots, stabbings or environmental causes.

In Chadwick's view, this endeavor — almost from its inception — made a big difference in nearby neighborhoods. But its profile in the eyes of hospital administrators got a boost from an Affordable Care Act provision that required nonprofit hospitals to conduct triennial assessments of local health needs and devise strategies, updated yearly, to address them. Falling short would trigger a financial penalty.

"Everyone, all of a sudden, cares about the social determinants of health," she said. "Our expertise is being brought in. … We have a bigger seat at the table."

But will programs like this one continue to get such attention? As the GOP-controlled Congress works to scrap Obamacare, the answer is uncertain.

Requiring this "community health needs assessment" was part of a broader package of rules included in the health law to ensure that nonprofit hospitals justify the tax exemption they receive. Another directive was that these facilities establish public, written policies about financial assistance available for medically necessary and emergency care and that they comply with limits on what patients who qualify for the aid can be charged.

These requirements add to the ongoing controversy about whether all nonprofit hospitals do enough to deserve a tax break. People on one side of the issue view the assessment rule, for instance, as an undue, unfunded burden while others say it doesn't do enough. So far, though, the community health assessment requirement hasn't exactly been a hot topic in the repeal-and-replace debate and was not addressed by the House Republicans' health plan unveiled March 6.

Sen. Chuck Grassley (R-Iowa), who has long urged that more scrutiny be applied to nonprofit hospitals' tax status, championed the provision. His spokeswoman said he will continue to advocate that it remains in effect in whatever new health policy plans emerge. Regardless, the financial uncertainty of any overhaul of the health law could undermine some hospitals' efforts.

The decades-old nonprofit tax status, granted by the Internal Revenue Service to institutions that meet the "community benefit" standard, spares hospitals from paying federal taxes and is collectively worth billions of dollars. Nonprofit hospitals have generally cited the uncompensated or "charity" care they provide, as well as initiatives they undertake to promote public health, as sufficient proof that they earn their tax exemption. But for-profit hospitals, which do pay taxes, cry foul, saying they make similar contributions.

The new requirements overall were meant to hold nonprofits to a higher standard — and penalize those that didn't deliver. Under the law, hospitals that fail to complete the assessment and implementation strategy face a $50,000 fine — which can seem small next to their overall operating budgets. But down the line, the penalties can accumulate and ultimately could jeopardize their valuable tax exemption.

Meanwhile, federal data show that as recently as 2011 nonprofit hospitals targeted less than 10 percent of their operating expenses to benefit the community — this includes charity care, unreimbursed costs from Medicaid and other government programs and medical research and education. Less than 1 percent went to community health improvement services like Chadwick's.

Advocates hoped the health law would change this. The idea was to push nonprofit hospitals to invest more in public health initiatives that do not directly earn them money — giving such programs more value on the balance sheet. But it's hard to gauge whether that's happened.

"You can find hospitals that have done this. But … are we seeing a real shift in the hospital community? Or are these a few hospitals that are outliers?" said Gary Young, director of the Center for Health Policy and Healthcare Research at Northeastern University. "We've asked them to make a sea change in how they're doing things. And that can't happen overnight."

Part of the problem, analysts say, is that the underlying idea — reaching into the community to help people navigate the social and economic factors that can influence health — goes beyond what hospitals have traditionally viewed as their mission. Despite the potential for long-term payoff, administrators tend to focus on the immediate questions: How many beds are full? What medical services are being provided? How are they doing with their operating budget?

"It's a new world out there in terms of the hospital not being the center of the universe," said Lawrence Massa, president of the Minnesota Hospital Association, the state's hospital trade group, which has been tracking hospital response to the health assessment requirement.

Initially, they found the money nonprofit hospitals put toward "community needs" went up after the assessment requirement: from about $355 million in 2011 to $459 million in 2013, according to an analysis by the association. (The needs assessment requirement took effect in between, for the tax year starting after March 2012.) But the increase leveled off in 2014 — the most recent year for which data are available.

Massa's conclusion: Caring for the health of people before they come into the hospital is unfamiliar territory. Not everyone took naturally to it. "We saw some communities that embraced this, and did a nice job. … In other communities, there's been friction between public health and the acute setting — and lack of understanding."

With continued time and sustained emphasis, that could have changed, said Sara Rosenbaum, a professor of health law and policy at George Washington University.

But now? Even if the community benefit requirements remain intact, she and others fear this accountability effort could take a hit. Repeal of the health care law is likely to create fresh financial challenges for hospitals. For instance, although the House GOP's American Health Care Act would restore some of the uncompensated-care funding cuts hospitals absorbed under the ACA, the coverage changes proposed in Republicans' plan could mean tens of millions more uninsured people.

That scenario, policy experts and trade groups say, would increase the amount of free care nonprofit hospitals provide, creating new budget pressures that could lead them to tamp down on efforts to promote community health work.

"We could be right back in a situation where there is a fair amount of charity care, and that could become a large component of how hospitals are justifying their nonprofit status," said Ken Fawcett, a physician who runs a community health worker initiative at Spectrum Health in Grand Rapids, Mich.

Meanwhile, the health assessment's impact has been evident at Boston-based Massachusetts General Hospital. There, administrators used it to devise an intervention strategy around drug abuse — partnering, for instance, with local schools and community organizations, and hiring former addicts to help patients navigate recovery.

"There's no question the Affordable Care Act required us to bump up our game," said Joan Quinlan, its vice president for community health. If people lose coverage, she added, hospitals will increasingly argue that's enough reason for a tax break. It could stifle efforts to promote more substantial community benefit.

"If the ranks of the uninsured or underinsured grow, then charity care will increase. And the ability to do some of these more creative downstream efforts will be hampered," she said. "There might be heightened awareness. But if there aren't resources to address them, it's going to be hard."

Trump's Choice For FDA Chief, By the Numbers

KFF Health News, March 15, 2017

Scott Gottlieb's career has included two previous stints at the FDA, practicing as a physician, and writer/editor roles at prestigious medical journals.

This article first appeared March 15, 2017 on Kaiser Health News.

By Sydney Lupkin

President Donald Trump's pick to lead the Food and Drug Administration has deep ties to the pharmaceutical industry as a consultant, investor and board member. Scott Gottlieb, 44, also has worn many hats in a career that included two previous stints at the FDA, practicing as a physician, and writer/editor roles at prestigious medical journals.

"It seems like the main question is, 'Which Gottlieb are we going to get?'" said Dr. Robert Califf, who stepped down from his position as the commissioner of the Food and Drug Administration in January.

Here's a look at Gottlieb's career, by the numbers:

188 Companies

New Enterprise Associates, the venture capital firm where Gottlieb is a partner, is currently or has been invested in 188 health care companies.

8 Boards Of Directors

Gottlieb serves or served on eight boards of directors, according to his LinkedIn profile. The firms include pharmaceutical companies Gradalis and Tolero Pharmaceuticals, which are developing cancer treatments, among other things; and Glytec, which offers glycemic management tools for patients with diabetes.

8 Drug And Device Companies

Eight pharmaceutical companies disclosed payments to Gottlieb in 2015, according to the open payments database: Vertex Pharmaceuticals, GlaxoSmithKline, Daiichi, Valeant, Pfizer, Millennium, SI-BONE and E.R. Squibb & Sons. Payments included travel to Philadelphia, San Francisco and London.

9 Recusals

In a memo, Gottlieb wrote that he had a consulting relationship with nine health care companies before his stint as the FDA's deputy commissioner for medical and scientific affairs during the George W. Bush administration. Those ties disqualified him from dealing with matters concerning those companies for at least a year. The firms included Eli Lilly, Roche and Sanofi-Aventis.

The recusals generated some headlines during the avian flu scare because Gottlieb had to recuse himself from some of the planning efforts around vaccines.

7 Years

Starting in 1997, Gottlieb spent seven years as a staff writer for BMJ, the British Medical Journal. BMJ is one of the top medical journals in the world. And he was an editor at the Pulse section of JAMA, the Journal of the American Medical Association, from 1996 to 2001.

Gottlieb also spent the past seven years as an adviser to drugmaker GlaxoSmithKline's product investment board, according to his LinkedIn page.

33 Years Old

Gottlieb was 33 when he got the No. 2 job at the FDA in 2005. He had done a short stint at the agency a few years earlier, but was considered a controversial pick because of his ties to Wall Street. He stayed until 2007.

"He has done a lot of thinking about how FDA should be managed — his operational sophistication is going to be a great asset," said former FDA attorney Coleen Klasmeier, who worked with Gottlieb and co-authored articles with him. "He also has very strong relationships among career FDA personnel and will be able to hit the ground running on a range of important initiatives."

18 Times Before Congress

Gottlieb testified before Congress as an expert witness 18 times. He has spoken about drug prices, revamping the FDA approval process and the vaccine supply.

"Most people watching at the FDA would breathe a sigh of relief," Dr. Joshua Sharfstein, who served as the FDA's principal deputy commissioner until 2011, said of Gottlieb's impending nomination. He added that Gottlieb is "not someone who has expressed antagonism to the core principles of the agency."

36,000 Twitter Followers

More than 36,000 people follow Gottlieb on Twitter, though he follows only 845 people, as of Tuesday. He has tweeted at least 10,400 times, lately about different strains of the flu.

72 Percent

Almost three-fourths of the 53 drug companies surveyed by Mizuho said they'd prefer Gottlieb to head the FDA.

$414,000

Pharmaceutical companies paid Gottlieb nearly $414,000 from 2013 through 2015, according to federal open payments data, for speeches, consulting, travel and meals.

That included $65,780 from a pharmaceutical company to promote a controversial cystic fibrosis drug called Kalydeco. Only one other doctor received more money toward promoting the drug.

The drug's price tag was controversial because the nonprofit Cystic Fibrosis Foundation kicked in $150 million toward finding a cure for the fatal disease and got a rich $3.3 billion payday for selling its rights to royalties for the drug. Vertex Pharmaceuticals priced Kalydeco at more than $300,000 a year.

Nearly $30,000

Gottlieb has contributed nearly $30,000 toward Republican political campaigns and joint fundraising committees from 2005 to 2014. He has donated toward the presidential runs of Mitt Romney and Sen. John McCain. He also donated more than once to Speaker Paul Ryan.

Gottlieb contributed the most money toward Republican Sen. Ben Sasse of Nebraska, spending $2,600 in the primary and $2,600 again in the general election in 2013. Sasse was a vocal anti-Trump supporter, penning an open letter in February 2016 about how he could not support Trump, who was "dividing" the nation, in his view.

"But have you noticed how Mr. Trump uses the word 'Reign' — like he thinks he's running for King?" Sasse asked in the post.

Programs to circumvent litigation by offering prompt disclosure, apology and compensation for mistakes as an alternative to malpractice suits are becoming more popular.

Two Words Can Soothe Patients Who Have Been Harmed

KFF Health News, March 15, 2017

Programs to circumvent litigation by offering prompt disclosure, apology and compensation for mistakes as an alternative to malpractice suits are becoming more popular.

This article first appeared March 15, 2017 on Kaiser Health News.

By Sandra G. Boodman

When Donna Helen Crisp, a 59-year-old nursing professor, entered a North Carolina teaching hospital for a routine hysterectomy in 2007, she expected to come home the next day.

Instead, Crisp spent weeks in a coma and underwent five surgeries to correct a near-fatal cascade of medical errors that left her with permanent injuries. Desperate for an explanation, Crisp, who is also a lawyer, said she repeatedly encountered a white wall of silence: The hospital and her surgeon refused to say little more than "things didn't go well." Crisp spent years piecing together what happened. "I decided I was going to find out even if it takes the rest of my life," she said.

Jack Gentry said he "went into the hospital a patient and came out a victim." In 2013, the retired Baltimore police officer suffered a catastrophic spinal cord injury during disk replacement surgery at MedStar Union Memorial Hospital that left him a quadriplegic.

But unlike Crisp, Gentry and his wife, a nurse, were immediately told what had gone wrong by his surgeon, who apologized for the error. The hospital covered Gentry's rehabilitation and other major expenses and paid an undisclosed amount in compensation, all without litigation.

"When hospitals mess up, they need to do the right thing," Gentry said. "MedStar did."

For patients and their families killed or maimed by medical errors, Crisp's experience — in which doctors clam up and hospitals deny wrongdoing and aggressively defend their care — remains standard operating procedure in most institutions.

But spurred by concerns about the "deny and defend" model — including its cost, lack of transparency and the perpetuation of errors — programs to circumvent litigation by offering prompt disclosure, apology and compensation for mistakes as an alternative to malpractice suits are becoming more popular. Researchers at Johns Hopkins University in Baltimore recently estimated that medical mistakes kill 251,000 Americans annually, which would make them the third-leading cause of death. Traditionally, the only way for patients to find out what went wrong has been to sue.

A blueprint for the approach used in Gentry's case is being promoted by the federal Agency for Healthcare Research and Quality. Called CANDOR, an acronym for Communication and Optimal Resolution, the approach is modeled on a long-standing program pioneered at the University of Michigan. It was tested in 14 hospitals around the country, including MedStar's Washington Hospital Center and Georgetown University Hospital.

Although they differ, these programs — which typically feature prompt investigation of errors whose findings are shared with the victims, as well as an apology and compensation for injuries — are operating at the University of Illinois at Chicago, Stanford and eight hospitals and outpatient groups in Massachusetts. Despite fears that the new approach would encourage lawsuits, the opposite has proved true. In Michigan, the number of lawsuits was cut nearly in half, and the hospital system saved about $2 million in litigation costs in the first year after the new model was adopted in 2001.

"The whole point of this isn't to drop malpractice costs, it's to drive patient safety," said Richard Boothman, the University of Michigan Health System's executive director of clinical safety and chief risk officer, who launched the program after a career defending doctors and hospitals. "We need to hard-wire as quickly as possible the lessons of these cases."

In most hospitals, Boothman said, patient safety experts do not routinely talk to risk managers who handle malpractice claims. As a result, valuable information about preventing errors is lost.

In The Dark
Most patients never learn they are victims of a medical error. A landmark 1991 Harvard study found that only 2 percent of people harmed by errors file a lawsuit. Those who do face daunting odds: Patients lose 80 percent of malpractice cases. Huge litigation costs, combined with laws that have reduced damage awards in many states, have left many unable to find an attorney because plaintiffs' lawyers are paid on contingency. Malpractice cases typically take three or more years to resolve. In the interim, many injured people struggle to pay for care.

Litigation "is a tortuous process for patients and health care workers," said Beth Daley Ullem, who spent five years seeking answers about the 2003 death of her newborn son from a Chicago hospital that denied any wrongdoing.

"We later learned that this had happened to a family before us and another seven months after," said Daley Ullem, a former McKinsey & Co. consultant whose ruptured uterus went untreated for an hour. She said she received a $4 million settlement before trial, which she offered to give back to the hospital to fund safety improvements. The hospital refused.

Disclosure efforts also face stiff resistance from doctors, insurers and lawyers, including defense attorneys for whom speedier resolution means fewer billable hours.

Despite laws in most states that prevent apologies from being used against doctors in lawsuits, many worry that it will make patients more likely to file suit, said Thomas Gallagher, a University of Washington professor of medicine who has written extensively about disclosure. A recent study found that 77 percent of 300 primary-care doctors would not fully disclose a delayed breast cancer diagnosis to a patient.

Doug Wojcieszak — who founded an Illinois-based disclosure advocacy group called "Sorry Works!" — said one Iowa doctor told him that if he started apologizing when things went wrong, "he'd be doing nothing else all day long."

Insurers are also leery, said Brian Atchinson, president of Physician Insurers Association of America, the trade association for liability insurers, which was involved in the development of CANDOR. "Some states are more conducive to this than others," he said. "But there are those who don't believe the benefits outweigh the risks."

Lawyer Joanne Doroshow, director of the Center for Justice & Democracy at New York Law School, expressed worry that disclosure programs may take advantage of vulnerable patients who are not represented by a lawyer. "The hospitals are in control of it, and it's still in their interest to try and limit compensation to patients," she said.

Jeffrey Catalano, a Massachusetts plaintiffs' lawyer who is president of the state bar and a participant in that state's disclosure program, says that patients should be represented early in the process. "I think if there's a good attorney present, there's no way a client is going to be shortchanged," he said. "Good attorneys know this: Medical malpractice cases are hard to take to trial. If a client can get $1 now rather than risking getting nothing [at trial] for the prospect of $1.50 later, it may be better to take the $1 now."

Doing The Right Thing
The country's first disclosure program began 30 years ago with a doctor's desire to do the right thing.

Pulmonologist Steve Kraman, newly named as chief of staff for what is now the Lexington Veterans Affairs Medical Center in Kentucky, said he faced a problem in 1987: how to handle the death of a middle-aged woman caused by an "undeniable error," a massive overdose of potassium.

"If we had said nothing, [the family] never would have known a thing," said Kraman, who was also the hospital's risk manager. "We never would have gotten sued. But I just didn't feel that was right." So he suggested to the hospital's lawyer that they come clean to the patient's two adult daughters, from whom she was estranged.

"I sat down and told them exactly what happened, that we were responsible for it, that they should hire a lawyer and we were going to negotiate a payment," he recalled. Two months later, the family was paid $250,000.

From then on, Kraman said, all cases involving errors were handled similarly. "We paid out for things that nobody could have sued for in their wildest dreams," said Kraman, who is now a professor at the University of Kentucky. Some patients declined the cash, he said, because they feared it would "ruin their relationship with the doctor." Kraman said he refused to pay a dime in cases where no injury could be proved. "That just alienates doctors and nurses who feel like you're throwing them under the bus."

Kraman said he had several advantages: Doctors were employed and insured by the VA system. Payments, which averaged $16,000, were made from the U.S. Treasury, not the hospital coffers. And the program had the support of the hospital's director and lawyer as well as the U.S. attorney for Kentucky.

"This has to be done from the top down" or it won't work, Kraman said. "The message has to be 'This is how we do business.'"

When Boothman arrived at the University of Michigan in 2001 — after two decades defending doctors, including an orthopedic surgeon who had been sued 21 times — he decided to try a similar approach. That included encouraging staff to report errors and bad outcomes; reports jumped from 2,400 a year to more than 34,000.

"You have to normalize honesty," Boothman said, "to create a culture of continuous improvement." Applying the lessons gleaned from those errors, he said, has helped make care safer.

"Litigating a case for three years and telling everybody, 'Don't talk about it and don't change anything,' is immoral and counterproductive," he added. "I don't serve my organization well by defending care we shouldn't be defending."

"Today we're often at the bedside as soon as things happen," he said. Patients and their families are interviewed as part of the hospital's investigation of the facts, something that does not happen in traditional litigation.

Like Kraman, Boothman said he worries that some hospitals are using disclosure to cherry-pick small or unwinnable cases, not as a standard approach.

A Test Case
Orthopedic surgeon P. Justin Tortolani remembers with sickening clarity the moment he realized that a device he was installing had gone too far, penetrating Jack Gentry's spine. The 60-year-old retired police officer, who once had hiked the entire Appalachian Trail, was instantly paralyzed from the neck down.

"You can't really believe it's happening," said Tortolani, Union Memorial's director of spine surgery. Summoning his years of training, the surgeon formulated a plan and steeled himself to tell Teresa Gentry what had happened. It was the first of many conversations about the accident that he would have with the family.

"We didn't want to go through litigation, we didn't need to go through litigation," said Larry Smith, MedStar's vice president for risk management. MedStar uses CANDOR in about a dozen cases with substantial damages annually.

MedStar executives "told me what had happened, why it happened, that it was directly or indirectly their fault and that whatever I needed I should ask for," Gentry recalled. MedStar paid for five months of inpatient rehab — Gentry's insurance would have covered only two weeks — modifications to the couple's home, a $45,000 wheelchair and a new wheelchair-accessible van. It provided a case manager, a home-care nurse and $15,000 for incidental medical expenses.

"Because of the nature of Jack's injury, we would have had to mortgage everything to pay for his care" otherwise, Teresa Gentry said.

Early on, Gentry said, his older brother, a Baltimore malpractice lawyer, expressed bafflement at MedStar's approach. "He said as long as we were getting what we needed, to just go with it," Gentry recalled.

At the end of two years, the case was settled with a confidential payment negotiated by lawyers for the couple, MedStar and the device manufacturer.

"I felt like it would take care of Jack for the rest of his life," said Teresa Gentry, adding that the couple had been prepared to file a lawsuit if an agreement could not be reached. "Did I get enough to pay for everybody's pain and suffering and trauma? No."

"I was very skeptical in the beginning of this whole process," she recalled, but she said she believes it has worked well, as does her husband.

Tortolani said he feels "remorse, guilt and sorrow for Jack and his family. This shakes you to your core," he said. MedStar officials have been "unbelievably supportive," Tortolani said, and he remains deeply grateful to the Gentrys. "My relationship with Jack has never been stronger."

Donna Helen Crisp says she thinks she would have been less traumatized had the North Carolina hospital and her surgeon not stonewalled her. "I would have been deeply depressed that I had such a bad experience, but I could have moved on with my life," said Crisp, who has written a book about her experience entitled "Anatomy of Medical Errors: the Patient in Room 2." Being denied the truth left her with "no way to put it into perspective."

Deciphering CBO's Estimates On The GOP Health Bill

KFF Health News, March 14, 2017

CBO estimates that 95 percent of people getting Medicaid through the health law's expansion would lose that enhanced federal funding.

This article first appeared March 13, 2017 on Kaiser Health News.

By Julie Rovner

The Congressional Budget Office is out with its estimate of what effects the Republican health bill, "The American Health Care Act," would have on the nation's health care system and how much it would cost the federal government. The GOP plan is designed to partially repeal and replace the Affordable Care Act passed during the Obama administration.

Here are some of the CBO highlights:

• $337 billion reduction in the deficit. That's CBO's estimate over the next decade, taking into account both decreased government spending in the form of less help to individuals to purchase insurance and lower payments to states for the Medicaid program. It also includes decreased revenue from the repeal of the taxes imposed by the ACA to pay for the new benefits.

• 24 million more people without insurance in a decade. The federal budget experts estimate that people will lose insurance and that the drop will kick in quickly. In 2018, they say 14 million more people would join the ranks of the uninsured. It would reach the 24 million by 2026, when "an estimated 52 million people would be uninsured, compared with 28 million who would lack insurance that year under current law."

• 15 to 20 percent increase in 2018 premiums, but relief would follow. Monthly costs for insurance would go up at first, due to the elimination of the requirement for most people to have insurance or else pay a tax penalty. After 2018, CBO estimates that average premiums would actually drop by 10 percent by 2026 compared to current law. That is because the lower prices for younger people would encourage more to sign up. By contrast, the law would "substantially [raise] premiums for older people."

• $880 billion drop in federal Medicaid spending over the decade. That comes primarily by imposing, for the first time, a cap on federal contributions to the program for those with low incomes.

• 14 million fewer Medicaid enrollees by 2026. That's 17 percent fewer than projected under current law. The projection includes people who are currently eligible and would lose coverage, as well as people who might have become eligible if more states, as expected, expanded coverage under the ACA. CBO projects that is unlikely to happen now.

• 95 percent of people who are getting Medicaid through the health law's expansion would lose that enhanced federal funding. The CBO estimates that only 5 percent of enrollees in the expansion program would remain eligible for the higher federal payments by 2024, since the bill would phase out those payments to states as patients cycle in and out of eligibility.

• 15 percent of Planned Parenthood clinic patients would "lose access to care." These patients generally live in areas without other sources of medical care for low-income people. The Republican bill would cut out Medicaid funding for Planned Parenthood for a year.

Fact-Checking The Chatter Around The GOP Health Bill

KFF Health News, March 13, 2017

In just the week since it was introduced, two committees have approved the "American Health Care Act," and a floor vote is planned before month's end.

This article first appeared March 13, 2017 on Kaiser Health News.

By Julie Rovner

Republicans are in a hurry to get their "repeal and replace" health care bill to the House floor.

In just the week since it was introduced, two committees have approved the "American Health Care Act," and a floor vote is planned before month's end.

But in the rush to legislate, some facts surrounding the bill have gotten, if not lost, a little buried. Here are five things that are commonly confused about the health overhaul effort.

1. The GOP bill would replace the health law's subsidies with tax credits.

Not really. The GOP bill would replace the Affordable Care Act's tax credits with different tax credits.

Under the ACA, people with income above the poverty line (about $12,000 for an individual in 2017) and under four times the poverty line (about $47,000) who buy their own insurance are eligible for advanceable, refundable tax credits. "Advanceable" means they don't have to wait to file their taxes, so the money is available each month to pay premiums; "refundable" means credits are available even to those with incomes too low to owe federal income tax. The ACA's tax credits are based on income and the actual price of health insurance available to each individual.

The GOP bill also has advanceable, refundable tax credits. They are based on different criteria, though. The Republican tax credits would increase with age (from $2,000 for youngest adults to $4,000 for older adults not yet eligible for Medicare), and would gradually phase out with income (starting at $75,000 for individuals and $150,000 for families). They would not vary by geographic region or the cost of coverage. And while older adults would get credits twice as large as younger adults, another change in the bill would let insurers charge those older customers' premiums that are five times as high. In the current law, the difference is 3-to-1.

There are actual subsidies in the ACA — they help people with incomes between 100 and 250 percent of poverty ($12,060 to $30,150 for an individual) pay their deductibles and coinsurance or copays. These subsidies are the subject of an ongoing lawsuit filed by the House against the Obama administration. Those subsidies would be repealed under the GOP bill.

2. Republicans have left popular provisions of the ACA in their bill because they are popular.

Not necessarily. True, the public supports the provisions of the health law that allow adult children to stay on their parents' health plans until they turn 26 and that prohibit insurers from rejecting or charging more to people with preexisting health conditions. Those things remain in the GOP bill.

But even if Republicans had wanted to get rid of those provisions, they likely could not. That's because the budget rules Congress is using to avert a filibuster in the Senate forbid them from repealing much of the ACA that does not affect government spending.

3. This bill is one part of a three-part effort to remake the health law.

This is true; Republicans continually refer to their health care effort as having three "buckets." One is the budget bill currently under consideration. A second is the power of Health and Human Services Secretary Tom Price to make administrative changes that would undermine the ACA.

The third is follow-up legislation that would allow things like selling insurance across state lines and limiting damages in medical malpractice lawsuits. House Speaker Paul Ryan& (R-Wis.) referred to that in a Thursday press conference as "additional legislation that we feel is important and necessary to give us a truly competitive health care marketplace."

What Republicans usually don't say, though, is that the second and third parts are complicated. Changing federal regulations generally requires a cumbersome process of advertising the changes, soliciting comments and revising the rules. Controversial changes also can bring lawsuits and lengthy legal proceedings. In addition, any subsequent bills on the law would require 60 votes to pass the Senate because they would not be covered by the budget rules Republican are using for this first legislation. Republicans currently have a 52-48 vote majority in that chamber, and Democrats have so far been united in opposing the GOP's health changes.

4. The bill's Medicaid provisions just scale back the program's expansion.

In truth, the Medicaid portions of the GOP bill would fundamentally restructure the Medicaid program.

The Affordable Care Act allowed states to expand Medicaid, whose cost is shared between the states and federal government, to everyone with incomes under 138 percent of poverty. Previously, eligibility was restricted to those in specific categories (primarily low-income pregnant women, children, seniors and those with disabilities). Because Medicaid was already a significant financial burden for states, the federal government offered to pay the entire cost for the expansion population for the first three years, eventually dropping back to 90 percent, which is still more than states get for traditionally eligible populations.

The GOP bill would end new enrollment in that expanded program in 2020. It would continue to cover people who had already qualified — but since many people in Medicaid churn in and out of the program, the number of enrollees is likely to gradually decline.

But that's just the beginning of the Medicaid changes. The Republican bill would, for the first time ever, limit the amount the federal government provides to states for Medicaid spending. It would make payments based on the number of enrollees in each state and that "per-capita" cap is expected over time to shift more financial responsibility for the program to the states. The left-leaning Center on Budget and Policy Priorities estimates that states could be on the hook for an additional $370 billion over 10 years if the bill becomes law.

5. The GOP bill is a huge tax break for the wealthy.

This is technically true — the bill would provide nearly $600 billion in tax breaks over the next decade, almost all of it going to the wealthy, according to the nonpartisan Committee for a Responsible Federal Budget.

But that's not because Republicans set out to lower taxes on wealthy people. It's because they are repealing nearly all the taxes that helped pay for the health law's benefits, and the Democrats had targeted many of those to higher-income people.

HMO Doctors Take Pains To Slash Opioid Prescriptions

KFF Health News, March 13, 2017

Taking advantage of their HMO's massive health data system, a set of Kaiser Permanente physicians set about tapering the number of patients on high doses of narcotic painkillers. Five years later, prescriptions of opioids have plunged.

This article first appeared March 13, 2017 on Kaiser Health News.

By Sam Quinones

On a summer afternoon in 2009, eight Kaiser Permanente doctors met in Pasadena to review the HMO's most prescribed drugs in Southern California. Sun blasted through the windows and the room had no air conditioning, but what unsettled the doctors most were the slides a pharmacist was presenting.

"We were doing so much work treating people with hypertension and diabetes, we thought those drugs would be on the list," said Dr. Joel Hyatt, then Kaiser's quality management director in Southern California.

Instead, hydrocodone, a generic opioid painkiller, led the list. OxyContin was near the top, even though the HMO didn't subsidize it and patients had to pay for it themselves.

At the time, few if any physicians were talking about an "opioid epidemic." But to the doctors in the room, the slides told a bleak story: Narcotics were being dispensed in numbers and doses higher than any of them had ever seen. The potential for addiction and overdoses among patients was frightening, something doctors around the country would later realize.

"People [were] getting prescriptions for a thousand pills," said Steve Steinberg, a Kaiser family doctor who attended the meeting. "The numbers were so striking that it led us to look into it."

Thus began an effort by Hyatt, Steinberg and a task force of others at Kaiser Permanente-Southern California to change how their colleagues practiced, and thought about, pain management. (Kaiser Health News is not affiliated with Kaiser Permanente.)

Taking advantage of the HMO's massive health data system and its status as both insurer and health provider, the Southern California Kaiser doctors set about tapering the number of patients on high doses of narcotic painkillers. They reprogrammed computer software for doctors, developed new urine tests for patients and empowered pharmacists to question potentially excessive prescriptions.

They also pushed colleagues to expand the use of non-drug options for chronic pain sufferers: physical therapy, acupuncture, cognitive behavioral therapy, healthier diets and increased exercise.

Five years into its initiative, Kaiser's Southern California operation reports prescriptions of opioids have plunged.

Prescriptions of opioid pills such as Vicodin and Percocet in amounts greater than 200 tablets dropped from 2,500 a month to almost zero, according to the HMO. So, too, have prescriptions that include potentially dangerous combinations of muscle relaxants, anti-anxiety medications and opioids, as well as prescriptions of brand-name opioids in general.

Kaiser patients coming out of routine surgery no longer receive 60 Vicodin, a month's worth of pills for what are usually a few days of pain, Hyatt says. Now "you would probably be given no more than 18" pills of generic hydrocodone.

Kaiser is deploying these strategies across the organization, and the prescription of opioids has fallen by a third since March 2015, officials at Kaiser's Oakland headquarters said.

Researchers at the federal Centers for Disease Control and Prevention in Atlanta say in an upcoming paper that Kaiser has struck a good balance between reducing prescriptions and managing patients' pain.

"It's important to demonstrate that, yes, it's possible and that action can be taken now," said behavioral scientist Jan Losby, the paper's lead author.

But it's not clear whether Southern California Kaiser's approach can be adopted with success outside large HMOS. Many doctors operate in smaller clinics, under intense time pressure and without much opportunity to talk about alternative treatments. Not many have access to the kind of data Kaiser collects.

Some patients and their advocates worry about denying patients pain drugs they really need, a concern that has gained traction nationally.

"Not prescribing is as bad as over-prescribing," said Paul Gileno, founder and president of the Connecticut-based U.S. Pain Foundation, an advocacy organization for chronic-pain patients. "We don't want all or nothing. We want that balance."

Kaiser patient Nancy Walter, who has experienced chronic pain since a serious motorcycle accident, agrees.

"They found something that worked and then they kicked me out," said Walter, 59, of Brentwood, California. "It's utterly ridiculous. I'm not going to sell this stuff. I need it. It's hard enough to get it."

A Hard Time Saying No
After that 2009 meeting, Steinberg began to study Kaiser's centralized patient data system. The statistics showed that doctors regularly were boosting the dosage for hundreds of patients by about 30 percent every six months, Steinberg found.

Particularly disturbing was the high number of branded opioids that Kaiser doctors prescribed — Vicodin and Percocet, especially — instead of generic hydrocodone or oxycodone. Brand-name pills are more popular on the street and more likely to end up on the black market.

Soon Steinberg, Hyatt and other physicians were talking to colleagues at the health plan's 14 medical centers in the region, citing studies that connected over-prescribing to overdoses.

"We [used] the same type of strategy that Pharma used," said drug use manager Denis Matsuoka, referring to the big drug companies. To promote opioid prescribing years ago, Big Pharma offered free seminar lunches, handed out pens and other knickknacks to reinforce essential messages. Kaiser did the same — to reduce prescriptions rather than boost them.

Still, physicians had a hard time saying no while face-to-face with insistent patients. So Steinberg asked Kaiser's tech people to reprogram the computer records system for doctors to guide their decisions in the clinic.

"We're … providing the choices to the doctors, with the ones we want them to prefer at the top: Tylenol, Motrin, physical therapy, meditation, exercise," Hyatt said. "Down at the very bottom are opioids."

Today, a Kaiser physician about to prescribe OxyContin will receive an alert that the drug has a high risk of abuse. A doctor about to prescribe a benzodiazepine to a patient already receiving an opiate painkiller — a dangerous combination — gets a large yellow alert on the computer screen, along with scientific articles describing the hazards of prescribing the two classes of drugs. The physician has to override the alert to go ahead with the prescription.

Meanwhile, Kaiser developed broader urine tests for opioids allowing doctors to establish verifiable agreements with patients about how much opiate medication they would take.

The simplest change was also the most difficult. It came from a pain specialist, Dr. Quan Nguyen, and it involved leveling with patients.

Time For The Talk
"We weren't taught to have a conversation with patients," Nguyen explained. So over the years, as he worked with people on high doses of narcotics who needed to taper down, he developed what he calls The Difficult Pain Conversation — and he presented his approach to many other doctors.

A 60-year-old grandmother named Maria, who asked that her last name not be used to protect her privacy, underwent the conversation three years ago. The Riverside resident was on high doses of fentanyl and hydrocodone for chronic back pain. She felt dopey, took long naps, forgot where she was at times and gained weight due to poor exercise and eating habits.

Dr. Kim Thai, a pain specialist at Kaiser Permanente, asked her to do things to help herself as he tapered her dosage, she said. "He was on my side," Maria said. "It felt less scary."

As the dosages dropped, Thai had her enroll in physical therapy and acupuncture; she joined a wellness program. Maria began eating better and walking up to 7,000 steps a day.

Three years later, Maria reports she no longer takes hydrocodone and is down to 25 micrograms of fentanyl every three, and sometimes up to five, days. She's lost 34 pounds. She still has pain, but less than before, and said she's learned to manage it better.

"I'm back to smiling," she said. "I enjoy our grandchildren very much. I can actually go to family functions and remember what happened."

Walter, the patient who had the motorcycle accident, had a less satisfactory experience with her doctors in Northern California. At first, she said she felt well-served by Kaiser's pain management program. She liked having access to different therapies and specialized doctors who found a regimen that would work for her.

When Walter returned to her primary care doctor, she said, he prescribed enough to make her pain tolerable for a while — but when her pain increased, he refused to prescribe more narcotics, saying, "You don't need it."

She said she heard the same thing from a neurologist who was not a pain specialist. Neither doctor consulted her former pain specialist, she said. She felt she was treated like a junkie, she said, and now makes do with her original prescriptions that include methadone and muscle relaxants.

Dr. Ramana Naidu, an assistant professor of anesthesiology and pain specialist at University of California, San Francisco, agrees with the Kaiser approach overall but cautioned that weaning patients off of opioids should be done in a "slow and gradual manner" to avoid the risk of rebound pain and a withdrawal syndrome.

He said that while it's important to discern whether patients are seeking prescriptions to abuse or sell opioids, pill counting and urine drug screens may introduce distrust into the patient-doctor relationship.

Kaiser's Hyatt said the Kaiser approach is founded on building that trust. The biggest problem he sees is patients' headlong rush for relief.

"Patients in America are impatient. They want a quick fix," said Hyatt. "But I think we've made real progress. The more we can arm physicians and pharmacists with the right information and scripting, the more likely the right thing is going to happen."

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

California Healthline senior editor Barbara Feder Ostrov contributed to this story.

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