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Fact Sheet: Final Rules on Religious and Moral Exemptions and Accommodation for Coverage of Certain Preventive Services Under the Affordable Care Act

HHS Gov News - November 08, 2018

On November 7, 2018 the Departments of Health and Human Services, Treasury, and Labor (the Departments) announced two final rules, on display at the Federal Register, that provide conscience protections to Americans who have a religious or moral objection to health insurance that covers contraceptive methods, including certain contraceptives that many view as abortifacients, and/or sterilization procedures.

Background

  • The Affordable Care Act (ACA) did not require contraceptive coverage in health insurance. It did not require the government to violate religious or moral objections to providing or purchasing such coverage. In addition, it exempted plans grandfathered under the ACA – which cover millions of women – from being required to provide preventive services coverage with no cost-sharing.
  • Starting in 2011, the Departments issued regulations and guidance requiring non-grandfathered group health plans and health insurance issuers to cover all FDA-approved contraceptive methods, sterilization procedures, and related education and counseling.
    • The previous administration offered a narrow exemption for churches, religious orders, and integrated auxiliaries (organizations with financial support primarily from churches).
    • The previous administration created an accommodation for religious non-profits and, after the Supreme Court’s decision in Hobby Lobby, for closely held for-profit organizations that had religious objections to covering some or all contraceptives. Under the accommodation, the entity’s insurer or third party administrator was responsible for providing contraceptive services to the entity’s plan participants and beneficiaries.
  • The Trump administration inherited dozens of lawsuits filed against HHS by organizations with sincerely held religious or moral objections to paying for or providing contraceptive or abortion-inducing drugs and devices.
  • In October 2017, the Trump administration issued two interim final rules seeking public comment. The rules protected the conscientious objections of Americans subjected to the federal contraceptive guidelines, while maintaining the contraceptive coverage requirement in nearly all cases. The administration received over 100,000 public comment submissions by the December 2017 deadline.
  • In three lawsuits filed against the interim final rules, the government won one, while two judges enjoined enforcement of the interim final rules. The cases are on appeal.  
  • In many cases filed against the contraceptive mandate promulgated by the previous administration, courts have granted permanent injunctions protecting non-profit organizations from the contraceptive mandate and accommodation.

Final Rules Concerning Religious and Moral Exemptions

Exemptions for Religious Beliefs – (CMS-9940-F2)

  • The first of two final rules provides an exemption from the contraceptive coverage mandate to entities and individuals that object to services covered by the mandate on the basis of sincerely held religious beliefs. Thus, entities that have sincerely held religious beliefs against providing contraceptive services (or services which they consider to be abortifacients) would be exempt from the mandate and no longer be required to provide such coverage.
  • The rules maintain the availability of the accommodation, in which the entity’s insurer or third party administrator is responsible for providing contraceptive services to the entity’s plan participants and beneficiaries, but they make it voluntary, at the option of the entity. That is, an otherwise exempt entity can elect to take advantage of the accommodation, which would provide contraceptive coverage to its employees and their dependents. Entities that object to covering some, but not all, contraceptive items would be exempt with respect to only those methods to which they object.
    • The exemption is also applicable to institutions of higher education, insurance issuers to the extent they provide a plan to otherwise exempt entities, and individuals whose employers and issuers are willing to provide them a plan compliant with the individuals’ beliefs.
  • The Departments thoroughly considered and responded to the many public comments submitted under the interim final rule. In response to various comments, the final rule differs from the interim final rule in technical ways to ensure the text and operation of the rule is clear, and that insurers can rely on its procedures.
  • Read More: https://www.federalregister.gov/documents/2018/11/15/2018-24512/religious-exemptions-and-accommodations-for-coverage-of-certain-preventive-services-under-the

Exemptions for Moral Convictions (CMS-9925-F)

  • This rule gives nonprofit organizations, small businesses, and individuals that have non-religious moral convictions opposing services covered by the contraceptive mandate protections that are similar to the religious final rule’s protections for religious organizations and businesses.
  • The exemptions apply to nonprofit organizations and to closely held businesses, as well as to institutions of education, health insurance issuers serving exempt entities, and individuals. The voluntary accommodation is also available to entities with moral convictions against providing contraceptive services (or services which they consider to be abortifacient) in their health plans.
  • The Departments considered public comments and decided at this time not to extend the moral exemptions to publicly traded businesses or government entities. The Departments thoroughly considered and responded to the many public comments and made technical changes to ensure the rule is clear.
    • Based on case law, the preamble to the rule explains that moral convictions are protected in ways similar to religious beliefs, when the convictions are those: (1) that a person “deeply and sincerely holds”; (2) “that are purely ethical or moral in source and content; (3) “but that nevertheless impose … a duty”; (4) and that “certainly occupy … a place parallel to that filled by … God’ in traditionally religious persons,” such that one could say the “beliefs function as a religion.”
    • Exemptions for moral convictions related to abortion and sterilization were created in federal law 45 years ago by Senators Frank Church and Adlai Stevenson III, Congress has repeated them in many laws since then. In signing the ACA, President Obama issued an executive order promising to respect those laws.
  • Read More: https://www.federalregister.gov/documents/2018/11/15/2018-24514/moral-exemptions-and-accommodations-for-coverage-of-certain-preventive-services-under-the-affordable

Applicable Exemptions: The regulations exempt entities only from providing an otherwise mandated contraceptive item to which they object on the basis of their religious beliefs or moral conviction. The entities include:

  • Churches, integrated auxiliaries, and religious orders with religious objections;
  • Nonprofit organizations with religious or moral objections;
  • For-profit entities that are not publicly traded, with religious or moral objections;
  • For-profit entities that are publicly traded, with religious objections;
  • Other non-governmental employers with religious objections;
  • Non-governmental institutions of higher education with religious or moral objections;
  • Individuals with religious or moral objections, with employer sponsored or individual market coverage, where the plan sponsor and/or issuer (as applicable) are willing to offer them a plan omitting contraceptive coverage to which they object;
  • Issuers with religious or moral objections, to the extent they provide coverage to a plan sponsor or individual that is also exempt.

Effective Date: The rules take effect 60 days after their publication in the Federal Register.

Impact: The Departments estimate the exemptions should affect no more than approximately 200 employers with religious or moral objections, with many entities not being affected because they were already permitted not to cover contraceptives under the previous rules, or are protected by permanent court injunctions. The Departments estimate the exemptions may affect the coverage of approximately 6,400 women, and state that in no case will they impact more than 127,000 women, which the Departments suggest is far more than will actually be impacted.

No Impact: These rules affect a small fraction of the 165 million women in the U.S. The rules leave in place contraceptive coverage guidelines where no religious or moral objection exists, and they do not change the Health Resources and Services Administration’s authority to decide whether to include contraceptives in the women’s preventive services guidelines for other entities.

  • The ACA itself exempts tens of millions of people from the preventive services coverage mandate who are in grandfathered coverage that existed prior to the ACA.
  • The rules leave in place government programs that provide free or subsidized contraceptive coverage to low income women, such as through community health centers.
  • These regulations do not ban any drugs or devices, or prohibit any employer from covering contraceptives.
  • The rules exempt publicly traded religious entities if they object to contraceptive coverage, but no such entity has ever been identified.
  • The rules do not exempt publicly traded entities that have non-religious moral objections, nor has any such entity been identified. The only entities known to express non-religious moral objections are pro-life organizations whose employees share the objections.

Notices: The expanded exemptions use the same approach taken during the previous administration, under which exempt groups are not required to file notices. If an entity improperly claims the exemption, it risks fines and lawsuits for not complying with the mandate. If exempt groups wish to use the optional accommodation process, they may file the same kind of form or notice set forth under the previous accommodation process. Those forms are being updated in conjunction with these final rules.

HHS Officials Deliver Remarks at the Fifth Annual Global Health Security Agenda Ministerial Meeting

HHS Gov News - November 08, 2018

Health and Human Services Secretary Alex Azar delivered a video message at the Fifth Annual Global Health Security Agenda (GSHA) Ministerial Meeting. His remarks focused on the Trump Administration’s commitment to strengthening global health security.

To watch his video, please click here.

To view his remarks online, please click here.

Following Secretary Azar’s video message at the meeting, Health and Human Services Deputy Secretary Eric Hargan delivered remarks where he announced the U.S. will commit an additional $150 million to support capacity strengthening in high-risk countries around the world.

As Prepared for Delivery

Good afternoon.  Thank you for this opportunity to participate in this important meeting.

As Secretary Azar said in his message, we look forward to working with all of you, through GHSA 2024, to achieve our shared global health security goals.

Global health security is fundamentally a health issue. It is about protecting our populations and the well-being of our citizens. It is about preparing for inevitable infectious disease outbreaks that have the potential to cross national borders and indiscriminately affect our people, our communities and our countries.

For the United States—and for many of our partners—it is also a national security priority, actually laid out in our National Security and National Biodefense Strategies. To implement these strategies, we engage with multiple sectors and partners, both in the United States and abroad, because this is a health issue that no single country or sector can adequately address by itself.

We are committed to collaborating across borders and across sectors to strengthen the capacities to prevent, detect and respond to disease outbreaks and other public health emergencies.

One of the biggest challenges the global community faces in our fight against the threat of infectious diseases is maintaining the high-level support needed to ensure that preparedness is a national priority for all countries.

The United States supports GHSA 2024 at the highest levels of our government—from President Trump to his department and agency leaders, like Secretary Azar, to our scientific experts and on-the-ground staff around the world.

We also have significant interest and participation from the private sector, which should be seen as an indispensable player in global health security.

The GHSA 2024 target is achievable so long as we have strong commitments and actions from the countries, multilateral organizations, and non-governmental stakeholders represented here today.

The United States is ready and eager to do its part, by working hard domestically to be one of the 100-plus countries to help achieve the GHSA 2024 target. But further, I am pleased to announce today that the United States will commit an additional $150 million to support capacity strengthening in high-risk countries around the world.

We are working to strengthen our capacities at home as well, through our recently released, prioritized post-JEE National Action Plan for Health Security, which we are committed to implementing.

Today is a milestone for global health security, a chance to celebrate what we have accomplished together.

But there is so much more work to do.  We are going to achieve our goal, but only by working together.

Let us commit to each other that, five years from now, we will have made meaningful progress toward the finish line of a world that is genuinely safe and secure from global health threats posed by infectious diseases. I have no doubt that together we can do it.

Thank you.

Midterm Election Boosts Medicaid Expansion, But Challenges Remain

Kaiser Health News:HealthReform - November 08, 2018

Medicaid — which has been a political football between Washington and state capitols during the past decade — scored big in Tuesday’s election.

Following the vote, nearly 500,000 uninsured adults in five states are poised to gain Medicaid coverage under the Affordable Care Act, advocates estimate. Three deep-red states passed ballot measures expanding their programs and two other states elected governors who have said they will accept expansion bills from their legislatures.

Supporters were so excited by the victories they said they will start planning for more voter referendums in 2020.

Medicaid proponents also were celebrating the Democrats’ takeover of the House, which would impede any Republican efforts to repeal the ACA and make major cuts to the federal-state health insurance program for low-income people.

“Tuesday was huge for the Medicaid program,” said Katherine Howitt, associate director of policy at Community Catalyst, a Boston-based advocacy group. “The overall message is that the electorate does not see this as a Democrat or GOP issue but as an issue of basic fairness, access to care and pocketbook issue. Medicaid is working and is something Americans want to protect.”

But health experts caution that GOP opposition won’t fade away.

David Jones, an assistant professor in the Department of Health Law, Policy and Management at Boston University, said ballot organizers now have a blueprint on how to expand Medicaid in states that have resisted. “I see this as a turning point in ACA politics,” he said. Still, he added‚ “it’s not inevitable.”

Medicaid is the largest government health program, insuring at least 73 million low-income Americans. Half of them are children. To date, 32 states and the District of Columbia have expanded it under the ACA. Before that law, Medicaid was generally limited to children, sometimes their parents, pregnant women and people with disabilities.

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The ACA encouraged states to open the program to all Americans earning up to 138 percent of the poverty level ($16,753 for an individual in 2018). The federal government is paying the bulk of the cost: 94 percent this year, but gradually dropping to 90 percent in 2020. States pay the rest.

GOP opposition has left about 4.2 million low-income Americans without coverage in various states.

“It’s not over until it’s over is the story of Medicaid expansion and the Affordable Care Act as the politics never ends and the opportunity for obstruction never ends,” said Jones. “But the trend overall has been to increasing implementation and increasing coverage.”

Montana Fails To Endorse Funding

Two years after President Donald Trump carried Idaho, Nebraska and Utah by double-digit margins with a message that included repeal of the ACA, voters in those states approved the ballot referendums Tuesday. Together, the states have about 300,000 uninsured adults who would be eligible for the program.

In addition, Democrats secured the governor’s offices in Kansas and Maine, which will increase the likelihood those states pursue expansion. Legislatures in both states have previously voted to expand, only to have GOP governors block the bills. Maine voters also passed a referendum in 2017 endorsing expansion, but Republican Gov. Paul LePage again refused to accept it.

Current and incoming Republican governors in Utah and Idaho said they wouldn’t block implementation of the effort if voters approved it. Nebraska Gov. Pete Ricketts said Wednesday he would follow the will of the voters but would not support paying for it with a tax increase.

It wasn’t a clean sweep, however, for Medicaid on Tuesday.

In preliminary results, a ballot issue to fund Montana’s Medicaid expansion — which is already in place and slated to expire next July — was failing. Tobacco companies had mounted a campaign to stop the measure, which would have partially financed the expansion with taxes on tobacco products.

The Montana legislature and the Democratic governor are expected to address the issue in the session that starts in January. No state has reversed its Medicaid expansion, even though GOP governors in Kansas and Arkansas have threatened to do so.

Nearly 100,000 Montana residents have received Medicaid since its expansion, twice as many as expected.

Nancy Ballance, the Republican chairwoman of the Montana House Appropriations Committee who opposed the bill that expanded Medicaid in 2015, said she is confident the state legislature will extend the program past July. But she expects the legislature to put some limits on the program, such as adding an asset test and work requirements.

“There are some people in the state who may not have disabilities but need some help to access coverage,” she said. “I think we can pass something without people having a gap in coverage. … That will be a priority.”

“It was never our intent to simply sunset the expansion and have it go away,” she said. Rather, the legislature put the sunset provision in to revisit the provision to make any changes.

Chris Jacobs, a conservative health policy analyst in Washington, D.C., said the Montana results showed that when voters are given a choice of having to pay for Medicaid expansion through a new tax they were not willing to go along.

But in Utah, voters did agree to fund their state plan by adding 0.15 percent to the state’s sales tax, just over a penny for a $10 purchase.

Fernando Wilson, acting director of the Center for Health Policy at the University of Nebraska Medical Center, said the vote on the state’s ballot question indicated many people wanted to help 80,000 uninsured Nebraskans gain coverage.

“I think it showed there was a clear need for it,” he said. The legislature likely won’t block the expansion, Wilson said, though it may try to add a conservative twist such as adding premiums or other steps.

Sheila Burke, a lecturer in health policy at Harvard Kennedy School, said voters approved Medicaid expansion not just because it would help improve health coverage for their residents but to help stabilize their hospitals, particularly those in rural areas. Hospitals have said this step helps their bottom lines because it cuts down on uninsured patients and uncompensated care.

“The broad population does see the value of Medicaid,” she said. “They saw it as a loss by their states not to accept the federal funds,” she said.

Despite the victories, Burke said, advocates should not assume other states such as Florida, Texas and Tennessee will follow suit.

“I don’t see a radical shift, but it moves us closer,” she said.

‘Fertile Ground’ For More Referendums

If advocates press for more referendums, Florida might be a tempting target. More than 700,000 adults there could become eligible, but the campaign would likely also be very costly.

Jonathan Schleifer, executive director of The Fairness Project, which financed the ballot initiatives in Maine in 2017 and the four states this year, refused to say which states would be targeted next.

The group is funded by the Service Employees International Union-United Healthcare Workers West, a California health care workers union.

“The GOP has been bashing the ACA for nearly a decade, and voters in the reddest states in the country just rejected that message,” Schleifer said. “It’s a repudiation and a tectonic shift in health care in this country.”

“There is fertile ground” for more such ballot votes, said Topher Spiro, vice president for health policy at Center for American Progress, a liberal think tank. “It is clear that public opinion is on the side of Medicaid expansion and the election results merely confirm that.”

“This will build momentum for expansion in other states,” he added.

The election results also could have consequences on efforts by states to implement work requirements for Medicaid enrollees.

New Hampshire and Michigan — which expanded the program but recently won federal approval to add controversial work requirements — could revisit that additional mandate as a result of Democrats winning control over both houses of the legislature in New Hampshire and the governor’s office in Michigan.

House Dems In New Seats Of Power Will Steer Health Policy, Attack Drug Prices

Kaiser Health News:HealthReform - November 07, 2018

For the first time since passing the Affordable Care Act, Democrats will soon control the House of Representatives and its powerful health committees. But Republicans’ tightened grip on the Senate means those hoping for another round of dramatic, progressive reforms may be disappointed.

Empowered by voters outraged over Republican attempts to chip away at the law’s protections for the sick, Democrats owe much of their midterm takeback to health care issues. And Democratic leaders say they are ready to get back to work, this time training their sights on skyrocketing drug prices, among other policy conundrums, with a majority of House votes and a slate of new committee chairmanships in hand.

In a few weeks, House Democrats will meet to elect their leaders, including several committee chairs who will be responsible for the nation’s health care policy and spending in the coming years. Hill denizens expect those currently serving as the top Democrat on most House committees to ascend to the chairmanships, with few if any members mounting serious challenges.

Those basking in a post-“blue wave” glow would do well to temper their expectations, recalling that the Republican-controlled House had already voted 54 times to unravel some or all of the Affordable Care Act by its fourth birthday in 2014. In most cases, Democrats in the Senate and White House stopped those efforts in their tracks.

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With the Senate (and the presidency) remaining under Republican control and even fewer moderate Republicans left in the House after this election, Democrats will struggle to move legislation without Republican support. What they can do is hold hearings, launch investigations and generally unnerve the pharmaceutical industry, among other likely adversaries.

And there’s a chance they could strike a deal with President Donald Trump, whose administration is moving to crack down on drug companies.

Who are the members most likely to wield the gavels? And what will they do with that power? Here’s a look at some of the major committees that influence health policy — and the people who may lead them.

The Committee on Energy and Commerce: Rep. Frank Pallone, New Jersey

Pallone, who has served in the House for 30 years, became the top Democrat on this influential committee in 2015. Should he become chairman, he would be responsible for the broadest health portfolio in the House, which includes Medicaid, public health, insurance and drug safety. This is the committee that marked up the Affordable Care Act in 2009 (when Pallone chaired the health subcommittee) and the House Republican repeal effort in 2017.

Under the Trump administration, Pallone has touted his stewardship of bipartisan legislation reauthorizing the fees charged to manufacturers to review the safety of prescription drugs and medical devices. He has also called for hearings on “mega-mergers” like the proposed merger between CVS and Aetna and worked with other Democrats to counter Republican attempts to undermine the Affordable Care Act.

Unsurprisingly, his influence over health care issues has attracted a lot of money from pharmaceutical companies, health professionals, HMOs and other industry players. By mid-October, Pallone had received more than $945,000 in campaign contributions from  the health sector for this election, according to the Center for Responsive Politics. According to a KHN analysis, nearly $170,000 came from political action committees associated with pharmaceutical companies.

The Committee on Oversight and Government Reform: Rep. Elijah Cummings, Maryland 

Cummings could prove the pharmaceutical industry’s biggest headache come next year. Having served as the committee’s ranking member since 2011 — a post that lacks the chairman’s subpoena power — he has been champing at the bit to hold drugmakers accountable.

Shortly after Trump’s inauguration, Cummings approached him about working together to lower the cost of prescription drugs (to no immediate avail), and he has partnered with other lawmakers to demand information from pharmaceutical companies about their drug pricing strategies. Previewing what a Cummings-led committee might look like, he has even launched his own investigations into drug costs, releasing reports with his findings.

Drugmakers have wasted few campaign contributions on Cummings: He has received just $1,000 from their PACs this election, according to data analysis by KHN.

In a statement to Kaiser Health News, Cummings said Democrats would conduct “credible, responsible oversight” of the Trump administration, adding: “For healthcare, that means investigating skyrocketing prescription drug prices, actions that would threaten protections for people with preexisting health conditions, and efforts to undermine the Medicaid program.” 

The Committee on Ways and Means: Rep. Richard Neal, Massachusetts

Ways and Means oversees Medicare and influences health policy through its jurisdiction over taxes. Though Neal became the top Democrat on this committee in 2017, he has been involved in health care much longer, having played a part in the crafting of both the Affordable Care Act and the failed reform effort under the Clinton administration in 1993.

Facing a primary challenger who touted her support for “Medicare-for-all” in his deep-blue district, Neal denied that he opposes the progressive single-payer proposal. But he also said Democrats should focus on shoring up the Affordable Care Act, particularly its protections for those with preexisting conditions and caps on out-of-pocket expenses. (He won handily.)

The health sector was by far one of the top contributors to Neal’s re-election campaign this year, giving more than $765,000, according to the Center for Responsive Politics. Neal’s district includes the headquarters of several health insurers and other medical companies, which makes him a prime target for campaign contributions.

The Committee on Appropriations: Rep. Nita Lowey, New York

If chosen, Lowey would become the first woman to chair the powerful House Committee on Appropriations, holding the nation’s purse strings.

Like Neal and Pallone, Lowey was first elected to Congress in 1988, and she became the committee’s top Democrat in 2013. She has been a dedicated and effective advocate for investing in biomedical research into major diseases like diabetes and Alzheimer’s, as well as public health programs like pandemic preparedness.

She has also long championed women’s health issues, proving a vocal critic of the Trump administration’s proposed gag rule on Title X funding, among other policies. Watch for her to continue to push back on the administration’s efforts to restrict access to abortion rights.

And on the Senate side, the Committee on Finance: Sen. Chuck Grassley, Iowa?

The rumor mill favors Grassley, the Republican who has served most recently as the chairman of the Senate Committee on the Judiciary, to replace retiring Sen. Orrin Hatch (R-Utah).

Senate Republican leaders have signaled that entitlement programs like Medicare and Medicaid could use trimming and, with Republicans emerging from the midterms with a slightly bigger majority, this committee could have its hands full.

Hatch proved a friend to the pharmaceutical industry, and his war chest reflected that, taking in more than $850,000 in campaign contributions from drugmaker PACs in the past decade alone, according to a Kaiser Health News analysis. But Grassley has taken a more adversarial approach to the industry, working with a Democratic colleague last summer to pressure drug companies to list their prices in direct-to-consumer ads, for instance.

Grassley held the chairmanship from 2003 to 2006, leaving him two more years at the top, should he want it. (Senate Republican chairs may serve for only six years.) But he might choose to stay on as head of the Judiciary Committee, in which case the next chairman may be the next-most-senior Republican: Sen. Mike Crapo of Idaho.

Midterm Results Show Health Is Important To Voters But No Magic Bullet

Kaiser Health News:HealthReform - November 07, 2018

[UPDATED at 8:15 a.m. ET]

Health care proved important but apparently not pivotal in the 2018 midterm elections on Tuesday as voters gave Democrats control of the U.S. House, left Republicans in charge in the Senate and appeared to order an expansion of Medicaid in at least three states long controlled by Republicans.

In taking over the House, Democrats are unlikely to be able to advance many initiatives when it comes to health policy, given the GOP’s control of the Senate and White House. But they will be able to deliver an effective veto to Republican efforts to repeal the Affordable Care Act, convert the Medicaid health care system for low-income people into a block grant program and make major changes to Medicare.

One likely development is an expansion of Medicaid in several of the 18 states that had so far not offered coverage made available by the Affordable Care Act. Voters in Idaho and Nebraska easily approved ballot measures calling for expansion. A similar measure was leading in Utah based on incomplete returns.

In Montana, voters are deciding if the existing expansion should be continued and the state’s expenses covered by raising tobacco taxes. In preliminary results, opponents outnumbered supporters, but key counties were not expected to release their tallies until Wednesday.

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Medicaid might also be expanded in Kansas, where Democratic gubernatorial candidate Laura Kelly defeated GOP Secretary of State Kris Kobach. The Kansas legislature had previously passed Medicaid expansion, but it was vetoed in 2017 by former GOP Gov. Sam Brownback. Kobach had not supported the ACA expansion.

And in Maine, where voters approved Medicaid expansion in 2017 but GOP Gov. Paul LePage refused to implement it, Democrat Janet Mills was victorious. She has promised to follow the voters’ wishes. LePage was not running.

In exit polling, as in many earlier surveys in 2018, voters said that health care, particularly preserving protections for people with preexisting conditions, was their top issue. But health care remained more important to Democrats than to Republicans.

Those who urged Democrats to emphasize health care this year took credit for the congressional successes. “The race for the House was a referendum on the Republican war on health care. You know it, I know it, and the Republican incumbents who shamefully tried to cover up their real record on health care and lost their seats know it,” said Brad Woodhouse of the advocacy group Protect Our Care.

But the issue was not enough to save some of the Senate Democrats in states won by President Donald Trump in 2016. Sen. Claire McCaskill (D-Mo.) was defeated by GOP Attorney General Josh Hawley, who is a plaintiff in a key lawsuit seeking to declare the Affordable Care Act unconstitutional. Sens. Heidi Heitkamp (D-N.D.) and Joe Donnelly (D-Ind.), who also campaigned hard on health care, were defeated.

Nonetheless, Sen. Joe Manchin (D-W.Va.) beat Republican Patrick Morrisey, the state’s attorney general who is also a plaintiff in the lawsuit seeking to upend the ACA.

Rep. Nancy Pelosi (D-Calif.), the leader of the House Democrats who would be first in line to take over as speaker, told supporters gathered in Washington for a victory celebration that her caucus would make health care a key legislative issue.

“It’s about stopping the GOP and [Senate Majority Leader] Mitch McConnell’s assault on Medicare, Medicaid and the Affordable Care Act and the health care of 130 million Americans living with preexisting medical conditions,” she said. She pledged that Democrats would take “very, very strong legislative action” to lower the cost of prescription drugs.

Among the many new faces in the House is at least one with some significant experience in health policy. Former Health and Human Services Secretary Donna Shalala, who ran the department for all eight years of the Clinton administration, won an open seat in Florida.

California Dreamin’? With Newsom’s Win, Single-Payer Unlikely To Follow Anytime Soon

Kaiser Health News:Insurance - November 07, 2018

Californians on Tuesday elected a governor who campaigned for a complete overhaul of how people get their health coverage — but they shouldn’t hold their breath.

Rather, as Gov.-elect Gavin Newsom and the Democratic-controlled legislature take steps to provide more people with health insurance, they’ll likely approach it piecemeal over several years.

Newsom himself is already tempering expectations about California’s move to a single-payer system, saying it will take more than the will of one person to realize.

“I’m not going to hesitate to be bold on this issue, and I also want to set expectations,” Newsom told reporters last week at a campaign stop in Sacramento. “It’s a multiyear process.”

The Democratic lieutenant governor easily routed Republican John Cox in the governor’s race Tuesday, with Newsom vowing to stand up to President Donald Trump and restore the “California Dream” by addressing affordable housing, health care and income inequality in the nation’s most populous state.

Newsom’s views are in stark contrast to Cox’s, who maintained that government should largely stay out of health care. The free-market businessman said single-payer would send health care costs soaring while diminishing quality, and warned that it “is a sure way to destroy the California economy.”

Like many Democrats, Newsom has described health care as a right and vowed to defend the Affordable Care Act as governor. He also criticized the legislature last year when it held up a single-payer bill that would have created one government-run public insurance program for all Californians.

He won the endorsement from the politically powerful California Nurses Association for vigorously advocating single-payer. Going slow on single-payer could test his relationship with the union, which launched a brutal attack against the Democratic state Assembly speaker when he shelved the measure last year.

It could also upset progressive Democrats and donors who are counting on action.

“This is the governor who has the best shot to get this done,” said Stephanie Roberson, the union’s director of government relations. “It takes political will and courage, and I’m going to cash in on what he said to my association.”

Now Newsom’s attitude is cautious — many say realistic — even in a state that aims to set national trends and relishes its role at the forefront of the resistance to the Trump administration.

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Last week, Newsom called single-payer the most “effective and efficient” strategy to achieve universal coverage, but he questioned whether it could be achieved at the state level, given the Trump administration’s opposition to the concept.

Trump’s top Medicare and Medicaid official, Seema Verma, last summer firmly rejected the idea that the federal government would grant the essential exemptions from federal rules to try single-payer, which she called “unaffordable” and “something that’s not going to work.” The exemptions, or waivers, are necessary because the state relies heavily on federal health care dollars that would be needed to pay single-payer costs.

Undaunted, the California Nurses Association said it intends to bring another single-payer bill before the legislature next year and has launched a national campaign to pass single-payer in other states and convince Congress of its merits.

But it’s unlikely that a single-payer bill will make it to Newsom’s desk next year, in part due to the price tag: A single-payer system could cost an estimated $400 billion annually. Lawmakers earlier this year directed a council to study the feasibility of a publicly funded health insurance plan, and its findings aren’t due until 2021 — giving the new governor and lawmakers time to punt on the issue.

Still, Democrats who head the key legislative health committees see Newsom as a partner who will be more engaged on health care than fellow Democrat Gov. Jerry Brown has been these past eight years.

“Health care has not been one of the issues that he’s been particularly focused on,” Assemblyman Jim Wood, chairman of the Assembly Health Committee, said of Brown. “I think we’ve missed some opportunities to really move forward on some policies that would be good for all Californians.”

Brown this year blocked measures that would have expanded health care coverage to some low-income unauthorized immigrants — not because he philosophically opposed the idea, lawmakers say, but because it would have required new state spending.

He also raised cost concerns about bills that would have provided state-funded tax credits and subsidies to people who buy coverage through Covered California, the state’s insurance exchange.

With a new governor, those proposals are back on the table. Newsom was, after all, the San Francisco mayor who signed off on the nation’s first universal health care program for city residents without insurance, including undocumented immigrants. And, as he has reminded reporters, he did it during a recession.

“It’s a question of what do you value, what you prioritize,” he said last week when asked how the state could afford both universal health care and his call for universal preschool.

Newsom’s campaign did not respond to questions about how he would expand coverage absent single-payer. But, earlier this year, his spokesman told California Healthline that proposals to give coverage to undocumented immigrants and earmarking state dollars to help consumers buy insurance coverage were “two major parts” of his plan to deliver health coverage to all state residents. The state’s estimated 1.8 million unauthorized immigrants, for example, make up roughly 59 percent of the state’s remaining uninsured residents, according to Covered California.

The Democratic-dominated legislature would have to approve these moves.

“We’re going to be looking at a variety of ways that we might be able to get everyone covered,” Wood said. But, he added, “it will be significantly expensive to do that.”

Wood and state Sen. Richard Pan, chair of the Senate Health Committee, said lawmakers should look at the structural issues in health care — how prices for services and pharmaceuticals are regulated and how efficiencies, improved access and curbs on costly care of chronic diseases might be achieved.

“I think it’s clear the health care landscape is a focal point for the California legislature,” said Erin Trish, associate director of health policy at University of Southern California’s Schaeffer Center. “They don’t have to push for a single-payer system to push for expanded coverage.”

Expanding health care coverage would require more state spending, but that wouldn’t necessarily mean a hit to the state economy, experts said.

After California implemented the Affordable Care Act (albeit with significant federal assistance), the state’s economy continued to grow and the number of uninsured residents fell to 7.2 percent in 2017, according to the U.S. Census Bureau.

“We’ve expanded coverage and our economy has continued to flourish,” said Dr. Andrew Bindman, a primary care physician who is also a professor at the Philip R. Lee Institute for Health Policy Studies at the University of California-San Francisco, who helped draft the federal health care law. “These things are achievable, and I think California is a model of that.”

Pan, the chair of the Senate Health Committee, said he looks forward to engaging Newsom, someone who proved he could move beyond rhetoric by signing the San Francisco measure that offered more city residents health coverage.

“Hopefully, we have an opportunity to get something done,” Pan said.

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

Hello? It’s I, Robot, And Have I Got An Insurance Plan For You!

Kaiser Health News:HealthReform - November 06, 2018

“Anna” will not stop calling. She really, really wants to sell you health insurance.

What a lot of consumers really, really want is to smack Anna upside her robocalling head.

As health insurance open-enrollment season gets underway in California and nationwide, automated phone calls offering Affordable Care Act or other health plans are spiking — and driving many consumers to the brink. California residents may have it worst, because its open-enrollment period is twice as long as in other parts of the country.

“It’s at epidemic levels at this time of year,” said Aaron Foss, founder of Nomorobo, who estimates his spam call-blocking service, based in Long Island, N.Y., headed off more than 850,000 health-related robocalls in October alone — nearly five times their interceptions for September, Foss said.

Nomorobo tracked about 820 different robocall pitches for health insurance in the last week of October. More than 100 of them were from the robot Anna.

Almost all of these calls are illegal, according to rules published by the Federal Trade Commission in 2009. Many offer skimpy health plans that don’t cover what you might need, insurance regulators and consumer advocates say. Others, they say, are downright fraudulent, with unscrupulous insurance “brokers” taking payment and promising insurance that never comes through.

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Alice Cave, 62, a retired data analyst from Alexandria, Va., who spends winters in Tucson, said she’s gotten so many of these calls that she typically won’t answer her phone unless she recognizes the number. On Monday, expecting a call from a California reporter, she answered her cellphone.

It was “Anne.” (Anna’s robot cousin? Other relatives include “Jordan,” “Allison” and “Mandy,” though variants on Anna remain most prevalent.)

“She was saying, ‘I really need to talk to you — we’ve got deals on health insurance.’ I thought, ‘God, what a crock,’” Cave said. “If it’s too good to be true, it probably is. Anything that comes in on the phone, I’m going to be skeptical. Why would they offer me this deal? I already have great insurance. It’s crazy.”

Some fed-up consumers try to stymie robocallers, with amusing results. Twitter user Jon Heise in June confounded his robot by insisting, after whatever it said, that he was a “meat popsicle.” Eventually, it hung up.

Dealing with a scam robocall yesterday

Scammer: I understand you are looking for new insurance

Me: Negative, I am a meat popsicle.

Scammer: I’m sorry I didn’t under stand, I heard you’re looking for insurance

Me: Negative, I am a meat popsicle.

Scammer, hangs up

— ⛧ jon heise ⛧ (@jubei) June 8, 2018

It’s not all fun and games. In California, the Department of Insurance is investigating health insurance robocalls, said Janice Rocco, deputy commissioner for health policy and reform. In late August, the agency filed a court order against Health Plan Intermediaries Holdings LLC, accusing the Florida company of deceptive and misleading practices in selling “Obamacare” plans that didn’t comply with the health law. The company could face fines of up to $10,000 per violation, Rocco said.

In this case, the company’s robocalls featured “Anne,” according to the court order. In its legal response, the company did not admit to the agency’s allegations and denied responsibility. A hearing date has not yet been set, Rocco said. (Arkansas’ insurance commissioner issued a cease and desist order against the company in 2016.)

Under federal law, calls using prerecorded messages are legal only for such things as doctor appointment reminders, flight cancellations, credit card fraud alerts and political candidates. Calls to sell products and services are not.

In a typical robocall sales pitch, a friendly female voice comes on the line. Sometimes the call appears to originate from major insurers like Blue Cross Blue Shield or Aetna or from a local number a caller might suppose is a school or neighbor.

Often, the voice will ask the consumer to dial “1” to enroll or “2” to opt out of future calls. Both options can be a trap, experts say.

“If you pick up, you become a lead that’s sent to health insurance agents or brokers,” Nomorobo’s Foss said. And option 2 doesn’t put you on a do-not-call list; it merely lets the spammers know they’ve hit a working number, he added.

A reporter from Kaiser Health News connected with one of the insurance brokers behind one of these robocalls by pressing the dreaded “1.”

A man identifying himself as “Ray Khan” said he’s a licensed insurance broker and provided a National Insurance Producer Registry number. The reporter was unable to locate Khan in that national registry with that number, which was not assigned to anyone.

Khan asked for the reporter’s Social Security number and other personal information. He said he did not have an office and that enrollment needed to be done over the phone. He referred the caller to a website that does not provide information about plans offered but is a platform for consumers to be contacted by brokers.

“It’s a legitimate company. We work for different insurance carriers,” Khan said. “You have to trust someone if you want to do it.”

How to file a consumer complaint about health insurance robocalls:
  • Contact your state’s insurance department. Use this interactive map to find your state agency.
  • Contact the Federal Trade Commission’s consumer complaint website.
  • Contact the Federal Communications Commission’s consumer complaint website.

Remember: Your robocaller may sound friendly, but she is not your friend.

That’s exactly what you shouldn’t do — trust folks who call you out of the blue, according to the Department of Insurance’s Rocco. “Someone selling a comprehensive medical plan is not going to be reaching you via a robocall,” Rocco said.

Most of what’s sold through these automated calls are so-called skinny plans that don’t comply with Affordable Care Act requirements, or are short-term insurance plans, which typically offer coverage for only a few months and often don’t cover preexisting conditions or prescription drugs. Such plans have been outlawed in California, starting Jan. 1.

Despite state and federal crackdowns — some involving multimillion-dollar fines — robocalls aren’t going away anytime soon. So the best thing for consumers to do when they receive one is to just hang up or, like Virginia resident Cave, not respond to unfamiliar numbers, advises the Federal Communications Commission.

Instead, check out the federal Obamacare exchange, healthcare.gov, or your state’s marketplace.

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

Beyond The Buzz: What Do Americans Mean By ‘Medicare-For-All’?

Kaiser Health News:Insurance - November 06, 2018

https://kaiserhealthnews.files.wordpress.com/2018/11/medicare_for_all_bb.mp3
Can’t see the audio player? Click here to download.

Kaiser Health News Editor-in-Chief Elisabeth Rosenthal discussed “Medicare-for-all” and how the U.S. health system differs from others around the world on a recent episode of KERA’s “Think,” a public affairs radio talk show in Dallas. The wide-ranging interview with KERA’s Krys Boyd touched on the ideas Rosenthal and KHN correspondent Shefali Luthra wrote about in a news analysis piece co-published by The New York Times. Times readers, including several physicians, also wrote interesting responses to the analysis.

KHN’s Samantha Young also explored why many voters say they’re “just confused” as politicians across the country toss around health care catchphrases, sometimes interchangeably.

Soda Industry Steals Page From Tobacco To Combat Taxes On Sugary Drinks

Kaiser Health News:States - November 06, 2018

In the run-up to the midterm elections, the soda industry has poured millions of dollars into fighting taxes on sugary drinks, an increasingly popular approach to combating obesity, which affects 40 percent of American adults.

Soda makers have campaigned against sugary drink taxes in dozens of cities in recent years, mostly successfully. But after a string of recent defeats, the industry is now pushing statewide measures that strip cities and towns of their ability to tax soda. Two of these state initiatives are on the ballot Tuesday in Washington and Oregon.

Arizona and Michigan already ban localities from enacting soda taxes. In California, where four cities have soda taxes, the beverage industry pressured lawmakers this summer into accepting a 12-year moratorium on local taxes on sugar-sweetened drinks. Some California lawmakers said they felt they were “held hostage” by the soda industry, which spent $7 million on a ballot initiative that would have made it much harder for cities to raise taxes of any kind. The beverage industry dropped the initiative after lawmakers agreed to the moratorium.

Soda makers also have cultivated close relationships with doctors, scientists and professional societies, including the Obesity Society and the Academy of Nutrition and Dietetics. Both groups say there’s not enough evidence to know if sugar taxes are effective.

Public health advocates say Big Soda is following a script perfected by the tobacco companies, which denied that their products were harmful and funded research that cast doubt on scientific studies while forcefully resisting taxes and regulations. Tobacco companies used their lobbying clout to persuade state lawmakers to prevent cities and counties from passing smoke-free ordinances. In 2006, 21 states pre-empted local smoke-free laws, according to Americans for Nonsmokers’ Rights. Even today, 13 states have some sort of ban on local smoke-free laws.

“There are definitely parallels with the tobacco industry,” said Betsy Janes, an activist with the American Cancer Society Cancer Action Network. Soda makers “are happy to take a page from their playbook.”

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Following recommendations from the World Health Organization, more than 30 countries and seven U.S. cities — including Seattle, San Francisco and Boulder, Colo. — now tax sugary drinks. These laws usually exempt diet soda, pure fruit juice and bottled water.

Most public health advocates describe soda taxes as a proven way to reduce Americans’ consumption of added sugars, which have been linked to 40,000 deaths from heart disease every year. A study published last year in PLOS One projects that Mexico’s soda tax will prevent up to 134,000 cases of diabetes by 2030. In Philadelphia, sales of sweetened beverages fell 57% after a city tax of 1.5 cents per ounce took effect, according to a 2017 study.

Soda companies used their war chests to fund the Washington and Oregon ballot measures. Coca-Cola has contributed nearly half the $20 million raised in support of the Washington initiative, while the American Beverage Association has contributed about half the $5.6 million behind the Oregon measure.

PepsiCo, one of the largest soda companies, did not respond to calls or emails. Coca-Cola declined to comment on the issue, referring all questions to the American Beverage Association, which represents the soda industry. William Dermody, a spokesman for the beverage association, declined to comment on the comparison with Big Tobacco. But Dermody said the soda industry supports “keeping food and beverages affordable” and is “standing up for small business and working families” by supporting the ballot measures. Taxes on soda and other groceries “are harmful; they raise prices and they cost jobs,” he said.

Health advocates say the ballot measures aren’t really about groceries. The beverage industry’s strong support suggests the measures are really about protecting soda profits, said Hillary Caron, senior policy associate at the Center for Science in the Public Interest.

In Washington, basic groceries are exempt from sales taxes, said state Sen. Reuven Carlyle, a Seattle Democrat opposed to the initiative. “In 41 years, there hasn’t been one bill to tax groceries,” Carlyle said. The beverage industry “is retaliating against our state” because of Seattle’s soda tax.

Matthew Myers, of the Campaign for Tobacco-Free Kids, said the tobacco industry has long allied itself with anti-tax and pro-business groups, which have helped it fend off cigarette taxes. The tobacco industry fought smoke-free laws by warning that they would drive customers away from restaurants and bars. In fact, the Centers for Disease Control and Prevention reports that smoking bans increase business at bars and restaurants because customers enjoy clean air. Similarly, research shows that Philadelphia’s sugary drink tax hasn’t hurt business, Myers said. Although sales of sugary drinks have fallen, overall business at chain stores hasn’t suffered, according to a 2017 study. A study of a soda tax in Berkeley, Calif., found similar results, with residents buying less soda but more bottled water.

Public health groups said they aren’t giving up on soda taxes. In California, the state dental and medical associations have filed a ballot measure for 2020 to create a statewide tax on sugary drinks.

Two of the largest exhibits at the October meeting of the Academy of Nutrition and Dietetics belonged to PepsiCo and Ocean Spray, both of which sell sweetened drinks. Unlike other health groups, which support taxes on sugary drinks, the academy says there’s not enough evidence to know if these measures improve health.(Liz Szabo/KHN)

At Ocean Spray’s booth at the October meeting of the Academy of Nutrition and Dietetics in Washington, dietitians could don waterproof overalls and pose for selfies in an artificial cranberry bog. (Liz Szabo/KHN)

A Show Of Force

Soda makers have plenty of money for a fight. The food and beverage industry spends $22.3 million a year on lobbying, including $5.4 million by Coca-Cola. That’s more than the tobacco industry, which spends $16.7 million on lobbying, according to OpenSecrets.org.

The tobacco industry spent decades funneling money into research that made cigarettes look less harmful than they really were, Myers said. Beverage companies also have tried to win over scientists and medical societies by funding research, said Marion Nestle, an emeritus professor of nutrition, food studies and public health at New York University and author of “Unsavory Truth: How Food Companies Skew the Science of What We Eat.”

Soda industry funding of medical meetings, journals and researchers is ubiquitous. Coca-Cola acknowledges spending $146 million on “well-being related scientific research, partnership and health professional activities” from 2010 through 2017. A 2016 study found that Coca-Cola and PepsiCo funded 95 national medical organizations from 2011 to 2015, while lobbying against 29 public health bills that aimed to reduce soda consumption or improve diet. Coca-Cola funded the publication of 389 articles in 169 journals from 2008 to 2016, according to a study published this year in Public Health Nutrition.

Nestle said no one should be surprised that industry-funded research tends to absolve soda from any role in causing obesity. Beverage industry research typically shifts the blame for obesity onto inactivity and “energy balance,” suggesting that exercise is far more important to weight loss than cutting back on sugar and calories, she said.

Yet independent researchers have found “quite compelling” evidence linking sugary drinks to obesity, heart disease and diabetes, said Dr. Frank Hu, chair of the nutrition department at the Harvard T.H. Chan School of Public Health. The CDC notes that sodas are among the largest sources of added sugar in the American diet. A 12-ounce can of Coke contains 9 1/3 teaspoons of sugar; the American Heart Association recommends that women consume no more than six teaspoons of sugar a day, and that men limit themselves to nine.

Dermody questioned the link between sugary drinks and obesity. Obesity has increased steadily over the past three decades. Yet in 2015, sales of carbonated soft drinks fell to their lowest level in 30 years, suggesting the obesity epidemic is being driven by something other than soda, Dermody said. He noted that half the soft drinks sold today have no calories. That shows that voluntary industry efforts to reduce sugar and calories in soft drinks are working, and that taxes aren’t needed.

A number of medical groups and universities stopped accepting soda industry funding in 2015, after extensive publicity of Coca-Cola’s attempts to influence science. Most health groups — including the American Heart Association, American Cancer Society and American Diabetes Association — now support soda taxes.

Two medical groups have defied this trend.

In July, just after California lawmakers approved the moratorium on soda taxes, the Obesity Society, which represents doctors who treat overweight patients, issued a statement saying there’s no proof that such measures will save lives. The Academy of Nutrition and Dietetics, which includes dietitians, has taken a “neutral” stand on soda taxes, noting that “scientific evidence is insufficiently clear.” In a statement similar to positions taken by the beverage industry, the nutrition academy said, “No single food or beverage leads to overweight or obesity when consumed in moderate amounts and within the context of the total diet.”

Both the obesity and nutrition groups have had close relationships with the soda industry. Coca-Cola and PepsiCo were “premier sponsors” of the nutrition academy in 2016, according to the group’s annual report. PepsiCo and Ocean Spray paid for “premium” exhibit booths at the nutrition academy’s national conference in October. Booths that size were priced at nearly $40,000 to $50,000 each.

In October, PepsiCo underwrote a special issue of the Obesity Society’s journal, which was devoted entirely to the science of artificial sweeteners, at a cost of $26,880. Although PepsiCo paid the journal’s publisher for the special issue, part of the money also went to the Obesity Society, said Dr. Steven Heymsfield, the group’s president-elect. The Obesity Society also has nurtured close ties with soda makers through a “food industry engagement council.” Past meetings were chaired by executives of PepsiCo and attended by employees of the Dr Pepper Snapple Group, now known as Keurig Dr Pepper.

Anthony Comuzzie, the Obesity Society’s executive director, said the society has disbanded the food industry council. In an email, Comuzzie denied that the society’s ties to industry have influenced its position on soda taxes. “To imply that the group or society collectively is biased by food companies has no basis in reality,” he said in an email.

The nutrition academy notes that sponsorships make up less than 5 percent of its budget. “Revenue generated from sponsorships has no impact on the Academy’s policymaking or any stance on issues,” the group said in a statement.

Nestle said that the soda industry appears to have bought the nutrition academy’s silence.

“It is shameful that the academy is not strongly supporting public health measures to prevent obesity,” Nestle said. “The academy’s position puts it squarely on the side of the food industry and against public health.”

Tobacco Tax Battle Could Torch Montana Medicaid Expansion

Kaiser Health News:Madicaid - November 05, 2018

Montana legislators expanded Medicaid by a very close vote in 2015. They passed the measure with an expiration date: It would sunset in 2019, and all who went onto the rolls would lose coverage unless lawmakers voted to reapprove it.

Fearing legislators might not renew funding for Medicaid’s expanded rolls, Montana’s hospitals and health advocacy groups came up with a ballot measure to keep it going — and to pay for it with a tobacco tax hike.

If ballot initiative I-185 passes Tuesday, it will mean an additional $2-per-pack tax on cigarettes and levy a tax on e-cigarettes, which are currently not taxed in Montana.

The tobacco tax initiative has become the most expensive ballot measure race in Montana history — drawing more than $17 million in opposition funding from tobacco companies alone — in a state with fewer than 200,000 smokers.

Amanda Cahill works for the American Heart Association and is a spokeswoman for Healthy Montana, the coalition backing the measure. She said coalition members knew big tobacco would fight back.

“We poked the bear, that’s for sure,” Cahill said. “And it’s not because we were all around the table saying, ‘Hey, we want to have a huge fight and go through trauma the next several months.’ It’s because it’s the right thing to do.”

Most of the $17 million has come from cigarette maker Altria. According to records from the National Institute on Money in Politics, that’s more money than Altria has spent on any state proposition nationwide since the center started keeping track in 2004.

Meanwhile, backers of I-185 have spent close to $8 million on the initiative, with most of the money coming from the Montana Hospital Association.

“What we want to do is — No. 1 — stop Big Tobacco’s hold on Montana,” Cahill said. Also, she continued, it’s imperative that the nearly 100,000 people in Montana who have gotten Medicaid under the expansion will be able to keep their health care.

Cahill said I-185 will allocate plenty of money to cover the expansion, though some lawmakers say the state can’t afford the expansion even with higher taxes.

Nancy Ballance, a Republican representative in the Montana state Legislature, opposes the measure.

“In general I am not in favor of what we like to refer to as ‘sin taxes,’ ” Ballance said. “Those are taxes that someone determines should be [levied] so that you change people’s behavior.”

Ballance also isn’t in favor of ballot initiatives that, she said, try to go around what she sees as core functions of the Legislature: deciding how much revenue the state needs, for example, or where it should come from, or how it should be spent.

“An initiative like this for a very large policy with a very large price tag — the Legislature is responsible for studying that,” Ballance said. “And they do so over a long period of time, to understand what all the consequences are — intended and otherwise.”

Most citizens, she said, don’t have the time or expertise to develop that sort of in-depth understanding of a complicated issue.

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Montana’s initiative to keep Medicaid’s expansion going would be a “double whammy” for tobacco companies, said Ben Miller, the chief strategy officer for the nonprofit Well Being Trust.

“People who are covered are more likely to not smoke than people who are uninsured,” said Miller, who has studied tobacco tax policies for years. He notes research showing that people with lower incomes are more likely than those with higher incomes to smoke; and if they’re uninsured, they’re less likely to quit.

Federal law requires Medicaid to offer beneficiaries access to medical help to quit smoking.

Plus, Miller added, every time cigarette taxes go up — thereby increasing the price per pack — that typically leads to a decrease in the number of people smoking.

And that, he said, works against a tobacco company’s business model, “which is, ‘you need to smoke so we can make money.’ ”

Ballance agrees that tobacco companies likely see ballot initiatives like I-185 as threats to their core business. But, she said, “for anybody who wants to continue smoking, or is significantly addicted, the cost is not going to prohibit them from smoking.”

The U.S. Centers for Disease Control and Prevention says tobacco use is the leading cause of preventable disease and death in the U.S.

Montana’s health department says that each year more than 1,600 people in the state die from tobacco-related illnesses.

This story is part of a reporting partnership with Montana Public Radio, NPR and Kaiser Health News.

Quick: What’s The Difference Between Medicare-For-All and Single-Payer?

Kaiser Health News:Insurance - November 05, 2018

MODESTO, Calif. — Betsy Foster and Doug Dillon are devotees of Josh Harder. The Democratic upstart is attempting to topple Republican incumbent Jeff Denham in this conflicted, semi-rural district that is home to conservative agricultural interests, a growing Latino population and liberal San Francisco Bay Area refugees.

To Foster’s and Dillon’s delight, Harder supports a “Medicare-for-all” health care system that would cover all Americans.

Foster, a 54-year-old campaign volunteer from Berkeley, believes Medicare-for-all is similar to what’s offered in Canada, where the government provides health insurance to everybody.

Dillon, a 57-year-old almond farmer from Modesto, says Foster’s description sounds like a single-payer system.

“It all means many different things to many different people,” Foster said from behind a volunteer table inside the warehouse Harder uses as his campaign headquarters. “It’s all so complicated.”

Across the country, catchphrases such as “Medicare-for-all,” “single-payer,” “public option” and “universal health care” are sweeping state and federal political races as Democrats tap into voter anger about GOP efforts to kill the Affordable Care Act and erode protections for people with preexisting conditions.

Republicans, including President Donald Trump, describe such proposals as “socialist” schemes that will cost taxpayers too much. They say their party is committed to providing affordable and accessible health insurance, which includes coverage for preexisting conditions, but with less government involvement.

Voters have become casualties as candidates toss around these catchphrases — sometimes vaguely and inaccurately. The sound bites often come across as “quick answers without a lot of detail,” said Gerard Anderson, a professor of public health at the Johns Hopkins University Bloomberg School Public Health.

“It’s quite understandable people don’t understand the terms,” Anderson added.

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For example, U.S. Sen. Bernie Sanders (I-Vt.) advocates a single-payer national health care program that he calls Medicare-for-all, an idea that caught fire during his 2016 presidential bid.

But Sanders’ labels are misleading, health experts agree, because Medicare isn’t actually a single-payer system. Medicare allows private insurance companies to manage care in the program, which means the government is not the only payer of claims.

What Sanders wants is a federally run program charged with providing health coverage to everyone. Private insurance companies wouldn’t participate.

In other words: single-payer, with the federal government at the helm.

Absent federal action, Democratic gubernatorial candidates Gavin Newsom in California, Jay Gonzales in Massachusetts and Andrew Gillum in Florida are pushing for state-run single-payer.

To complicate matters, some Democrats are simply calling for universal coverage, a vague philosophical idea subject to interpretation. Universal health care could mean a single-payer system, Medicare-for-all or building upon what exists today — a combination of public and private programs in which everyone has access to health care.

Others call for a “public option,” a government plan open to everyone, including Democratic House candidates Antonio Delgado in New York and Cindy Axne in Iowa. Delgado wants the public option to be Medicare, but Axne proposes Medicare or Medicaid.

Are you confused yet?

Sacramento-area voter Sarah Grace, who describes herself as politically independent, said the dialogue is over her head.

“I was a health care professional for so long, and I don’t even know,” said Grace, 42, who worked as a paramedic for 16 years and now owns a holistic healing business. “That’s telling.”

In fact, most voters approached for this article declined to be interviewed, saying they didn’t understand the issue. “I just don’t know enough,” Paul Her of Sacramento said candidly.

“You get all this conflicting information,” said Her, 32, a medical instrument technician who was touring the state Capitol with two uncles visiting from Thailand. “Half the time, I’m just confused.”

Paul Her, 32, a medical instrument technician from Sacramento, says he’s “just confused” by the conflicting health care pitches he hears from politicians. (Samantha Young/KHN)

The confusion is all the more striking in a state where the expansion of coverage has dominated the political debate on and off for more than a decade. Although the issue clearly resonates with voters, the details of what might be done about it remain fuzzy.

A late-October poll by the Public Policy Institute of California shows the majority of Californians, nearly 60 percent, believe it is the responsibility of the federal government to make sure all Americans have health coverage. Other state and national surveys reveal that health care is one of the top concerns on voters’ minds this midterm election.

Democrats have seized on the issue, pounding GOP incumbents for voting last year to repeal the Affordable Care Act and attempting to water down protections for people with preexisting medical conditions in the process. A Texas lawsuit brought by 18 Republican state attorneys general and two GOP governors could decimate protections for preexisting conditions under the ACA — or kill the law itself.

Republicans say the current health care system is broken, and they have criticized the rising premiums that have hit many Americans under the ACA.

Whether the Democratic focus on health care translates into votes remains to be seen in the party’s drive to flip 23 seats to gain control of the House.

The Denham-Harder race is one of the most watched in the country, rated too close to call by most political analysts. Harder has aired blistering ads against Denham for his vote last year against the ACA, and he sought to distinguish himself from the incumbent by calling for Medicare-for-all — an issue he hopes will play well in a district where an estimated 146,000 people would lose coverage if the 2010 health law is overturned.

Yet Harder is not clinging to the Medicare-for-all label and said Democrats may need to talk more broadly about getting everyone health care coverage.

“I think there’s a spectrum of options that we can talk about,” Harder said. “I think the reality is we’ve got to keep all options open as we’re thinking towards what the next 50 years of American health care should look like.”

To some voters, what politicians call their plans is irrelevant. They just want reasonably priced coverage for everyone.

John Byron, a 73-year-old retired grandfather from Modesto, wants a government-run health care system that doesn’t include private insurance companies. What politicians call the program is irrelevant to him, he says. (Samantha Young/KHN)

Sitting with his newspaper on the porch of a local coffee shop in Modesto, John Byron said he wants private health insurance companies out of the picture.

The 73-year-old retired grandfather said he has seen too many families struggle with their medical bills and believes a government-run system is the only way.

“I think it’s the most effective and affordable,” he said.

Linda Wahler of Santa Cruz, who drove to this Central Valley city to knock on doors for the Harder campaign, also thinks the government should play a larger role in providing coverage.

But unlike Byron, Wahler, 68, wants politicians to minimize confusion by better defining their health care pitches.

“I think we could use some more education in what it all means,” she said.

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

U.S. Government Participates in Fifth Annual Global Health Security Agenda Ministerial Meeting

HHS Gov News - November 03, 2018

On November 4-6, 2018, Health and Human Services Deputy Secretary Eric Hargan will attend the Fifth Global Health Security Agenda (GHSA) Ministerial Meeting in Indonesia, which will officially launch the next five-year phase of GHSA, known as GHSA 2024. Delivering on President Trump’s commitment to global health security, he will lead the multi-sectoral U.S. delegation, including representatives from the Departments of Health and Human Services, State, Defense, Agriculture, the U.S. Agency for International Development, and the National Security Council.

In Indonesia, the U.S. delegation will hold bilateral meetings with government officials from GHSA member countries to discuss ongoing collaborations between the U.S. and our partners on global health security. At the meeting HHS Secretary Alex Azar will deliver a video message and Deputy Secretary Hargan will deliver remarks on behalf of the Trump Administration, reaffirming U.S. support for GHSA and underscoring the goal to prevent, detect, and respond to infectious diseases.

Following the GHSA Ministerial Meeting, Deputy Secretary Hargan will travel to Thailand and Laos to underscore the U.S. commitment to global health security and to meet with partners in the region who are crucial to our efforts in addressing global health security concerns such as influenza, artemisinin-resistant malaria, dengue, and tuberculosis.

On November 7, Deputy Secretary Hargan will travel to Thailand where he will visit the CDC Bamrasnaradura Infectious Disease Institute laboratories, Bumrungrad Hospital, and meet with his Thai counterparts as well CDC staff in country. This is the 200th year of friendship between the U.S. and Thailand, and his visit will highlight the important work on health we do together as nations. On November 9, Deputy Secretary Hargan will arrive in Vientiane, Laos, to meet with the Ministry of Health before traveling back to the U.S. on November 10.  Laos is an important partner in our global efforts to combat emerging and re-emerging disease threats.

Additional information regarding Deputy Secretary Hargan’s meetings is forthcoming and will be released via social media posts.

Background:

Launched in 2014, GHSA is a worldwide effort to help build countries’ capacity to help create a world safe and secure from infectious disease threats and elevate global health security as a national and global priority. Through a growing multisectoral partnership of international organizations, non-governmental stakeholders, and more than 60 countries, GHSA is accelerating efforts to build countries’ capacity to prevent, detect, and respond to infectious diseases.

Like Clockwork: How Daylight Saving Time Stumps Hospital Record Keeping

Kaiser Health News:Marketplace - November 03, 2018

Modern technology has helped medical professionals do robot-assisted surgeries and sequence whole genomes, but hospital software still can’t handle daylight saving time.

One of the most popular electronic health records software systems used by hospitals, Epic Systems, can delete records or require cumbersome workarounds when clocks are set back for an hour, prompting many hospitals to opt for paper records for part of the night shift.

And it happens every year.

“It’s mind-boggling,” said Dr. Mark Friedberg, a senior physician policy researcher at RAND, adding that in 2018, “we expect electronics to handle something as simple as a time change. “Nobody is surprised by daylight savings time. They have years to prep. Only, surprise, it hasn’t been fixed.”

Dr. Steven Stack, a past president of the American Medical Association, called the glitches “perplexing” and “unacceptable,” considering that hospitals spend millions of dollars on these systems, and Apple and Google seem to have dealt with seasonal time changes long ago. Epic was founded in 1979, but some hospitals have used these electronic systems longer than others.

Carol Hawthorne-Johnson, an ICU nurse in California, said her hospital doesn’t shut down the Epic system during the fall time change. But she’s come to expect that the vitals she enters into the system from 1 a.m. to 2 a.m. will be deleted when the clock falls back to 1 a.m. One hour’s worth of electronic record-keeping “is gone,” she said.

Hospital staff have learned to deal with it by taking extra chart notes by hand, but it’s still a burden, she said, especially if vitals change, or a patient needs something like a blood transfusion.

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Although hospitals often avoid the software glitches by turning the software off and switching to paper charts, it’s far from ideal because hospitals have evolved to become increasingly reliant on electronic systems, said Stack, an emergency physician in Kentucky.

“When [electronic medical records] work, it’s wonderful,” he said, but when the system is turned off, doctors can’t use it to access patient records or order tests. Whiteboards are a thing of the past, and some staff members aren’t as comfortable with paper records because they’ve relied on electronic records their entire careers.

“It’s an hour where you’re flying sort of blind,” Friedberg said.

The one-hour pause slows everything down, which can cause patients to spend more time in emergency department waiting rooms, prompting some to go home before seeing a health care provider. That’s dangerous, Stack said.

Not all hospitals turn Epic off, however. At Johns Hopkins Hospital, providers who need to check patients periodically through the night use a workaround. They enter vitals at 1 a.m. and then when the clock falls back an hour later and they have to enter new vitals, they list them at 1:01 a.m. They leave a note that it’s an hour later, not a minute later. That’s how the Cleveland Clinic does it, too.

“I don’t disagree with the sentiment that we would like health IT systems to be much more sophisticated,” said Dr. Peter Greene, Johns Hopkins chief medical information officer. But there are plenty of other problems he’d like to see fixed first. “This particular aspect is not one that has caused us a lot of trouble.”

Other electronic medical records systems may require similar workarounds, said Jennifer Carpenter, vice president of IT clinical systems at University Hospitals in Cleveland, which uses several electronic medical records systems. Cerner, another major electronic medical records company, was unavailable for comment, but many hospitals plan for Cerner to be down during the time change, too.

When asked to comment on the glitches and workarounds, Epic spokeswoman Meghan Roh provided the following statement:

“Daylight savings time is inherently nuanced for healthcare organizations, which is why we work closely with customers to provide guidance on how to most effectively use their system to care for their patients during this time period. We’re constantly making improvements and looking for opportunities to enhance the system.”

But Friedberg pointed out that hospitals are locked into their electronic medical record systems because they’ve invested so much money in them. And it would cost even more to convert and transfer the records into a new system. As a result, there’s little incentive for software companies to improve their products, he said.

“I shudder to think … what does it do with leap years?” Friedberg wondered.

OCR Releases “Here to Serve You” Educational Video in Spanish

HHS Gov News - November 02, 2018

En Español

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) has released an educational video in Spanish to raise awareness within the Hispanic community about the work of OCR and to highlight important conscience and religious freedom rights protected by our federal laws.

“Because respect for the conscience and religious freedom rights of patients and providers ensures diversity in healthcare, we are reaching out to the Spanish speaking community to foster greater understanding of the laws protecting our first freedoms,” said Roger Severino, OCR Director.

In this video, Director Severino highlights the new Conscience and Religious Freedom Division and describes the work of all of OCR’s divisions in order to help patients, healthcare providers, stakeholders, and the public know their rights and responsibilities and how to file a complaint with OCR if they think that their rights have been violated. OCR protects and enforces civil rights laws in health and human services, including health information privacy and security (HIPAA); laws prohibiting discrimination based on race, national origin, age, sex, or disability; and laws protecting conscience and religious freedom.  

To view the “Here to Serve You” video and for more information about the work of OCR, please visit www.hhs.gov/ocr.

La OCR publica video educativo en español titulado “Estamos aquí para servirle”

HHS Gov News - November 02, 2018

In English

La Oficina de Derechos Civiles (OCR) del Departamento de Salud y Servicios Humanos de los Estados Unidos ha publicado un video educativo en español para informar la comunidad hispanohablante sobre el trabajo de la OCR y para destacar los derechos de conciencia y libertad religiosa protegidos por nuestra Constitución y leyes federales.

“Respetar el derecho a la libertad de conciencia y religión garantiza la diversidad en la atención médica, por esto, nos dirigimos a la comunidad hispanohablante para fomentar una mayor comprensión de las leyes que protegen nuestras principales libertades”, dijo Roger Severino, director de la OCR.

En este video, el Director Severino hace énfasis en la nueva División de Conciencia y Libertad Religiosa y describe el trabajo de todas las divisiones de la OCR para ayudar a que los pacientes, proveedores de atención médica, y el público conozcan sus derechos y responsabilidades y cómo presentar una queja si consideran que sus derechos han sido violados. La OCR hace cumplir las leyes que protegen el acceso a servicios de salud y servicios humanos, incluyendo la privacidad y seguridad de la información médica (HIPAA); las leyes que prohíben la discriminación por raza, nacionalidad, edad, sexo o discapacidad; y las leyes que protegen la libertad de conciencia y religión 

Para ver el video “Estamos aquí para servirle” y para más información sobre el trabajo de la OCR, visite www.hhs.gov/ocr.

The Election’s Impact On Health Care: Some Bellwether Races To Watch

Kaiser Health News:HealthReform - November 02, 2018

Voters this year have told pollsters in no uncertain terms that health care is important to them. In particular, maintaining insurance protections for preexisting conditions is the top issue to many.

But the results of the midterm elections are likely to have a major impact on a broad array of other health issues that touch every single American. And how those issues are addressed will depend in large part on which party controls the U.S. House and Senate, governors’ mansions and state legislatures around the country.

All politics is local, and no single race is likely to determine national or even state action. But some key contests can provide something of a barometer of what’s likely to happen — or not happen — over the next two years.

For example, keep an eye on Kansas. The razor-tight race for governor could determine whether the state expands Medicaid to all people with low incomes, as allowed under the Affordable Care Act. The legislature in that deep red state passed a bill to accept expansion in 2017, but it could not override the veto of then-Gov. Sam Brownback. Of the candidates running for governor in 2018, Democrat Laura Kelly supports expansion, while Republican Kris Kobach does not.

Here are three big health issues that could be dramatically affected by Tuesday’s vote.

1. The Affordable Care Act

Protections for preexisting conditions are only a small part of the ACA. The law also made big changes to Medicare and Medicaid, employer-provided health plans and the generic drug approval process, among other things.

Republicans ran hard on promises to get rid of the law in every election since it passed in 2010. But when the GOP finally got control of the House, the Senate and the White House in 2017, Republicans found they could not reach agreement on how to “repeal and replace” the law.

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This year has Democrats on the attack over the votes Republicans took on various proposals to remake the health law. Probably the most endangered Democrat in the Senate, Heidi Heitkamp of North Dakota, has hammered her Republican opponent, U.S. Rep. Kevin Cramer, over his votes in the House for the unsuccessful repeal-and-replace bills. Cramer said that despite his votes he supports protections for preexisting conditions, but he has not said what he would do or get behind that could have that effect.

Polls suggest Cramer has a healthy lead in that race, but if Heitkamp pulled off a surprise win, health care might well get some of the credit.

And in New Jersey, Rep. Tom MacArthur, the moderate Republican who wrote the language that got the GOP health bill passed in the House in 2017, is in a heated race with Democrat Andy Kim, who has never held elective office. The overriding issue in that race, too, is health care.

It is not just congressional action that has Republicans playing defense on the ACA. In February, 18 GOP attorneys general and two GOP governors filed a lawsuit seeking a judgment that the law is now unconstitutional because Congress in the 2017 tax bill repealed the penalty for not having insurance. Two of those attorneys general — Missouri’s Josh Hawley and West Virginia’s Patrick Morrisey — are running for the Senate. Both states overwhelmingly supported President Donald Trump in 2016.

The attorneys general are running against Democratic incumbents — Claire McCaskill of Missouri and Joe Manchin of West Virginia. And both Republicans are being hotly criticized by their opponents for their participation in the lawsuit.

Although Manchin appears to have taken a lead, the Hawley-McCaskill race is rated a toss-up by political analysts.

But in the end the fate of the ACA depends less on an individual race than on which party winds up in control of Congress.

“If Democrats take the House … then any attempt at repeal-and-replace will be kaput,” said John McDonough, a former Democratic Senate aide who helped write the ACA and now teaches at the Harvard School of Public Health.

Conservative health care strategist Chris Jacobs, who worked for Republicans on Capitol Hill, said a new repeal-and-replace effort might not happen even if Republicans are successful Tuesday.

“Republicans, if they maintain the majority in the House, will have a margin of a half dozen seats — if they are lucky,” he said. That likely would not allow the party to push through another controversial effort to change the law. Currently there are 42 more Republicans than Democrats in the House. Even so, the GOP barely got its health bill passed out of the House in 2017.

And political strategists say that, when the dust clears after voting, the numbers in the Senate may not be much different so change could be hard there too. Republicans, even with a small majority last year, could not pass a repeal bill there.

2. Medicaid expansion

The Supreme Court in 2012 made optional the ACA’s expansion of Medicaid to cover all low-income Americans up to 138 percent of the poverty line ($16,753 for an individual in 2018). Most states have now expanded, particularly since the federal government is paying the vast majority of the cost: 94 percent in 2018, gradually dropping to 90 percent in 2020.

Still, 17 states, all with GOP governors or state legislatures (or both), have yet to expand Medicaid.

McDonough is confident that’s about to change. “I’m wondering if we’re on the cusp of a Medicaid wave,” he said.

Four states — Nebraska, Idaho, Utah and Montana — have Medicaid expansion questions on their ballots. All but Montana have yet to expand the program. Montana’s question would eliminate the 2019 sunset date included in its expansion in 2016. But it will be interesting to watch results because the measure has run into big-pocketed opposition: the tobacco industry. The initiative would increase taxes on cigarettes and other tobacco products to fund the state’s increased Medicaid costs.

In Idaho, the ballot measure is being embraced by a number of Republican leaders. GOP Gov. Butch Otter, who is retiring after three terms, endorsed it Tuesday.

But the issue is in play in other states, too. Several non-expansion states have close or closer-than-expected races for governor where the Democrat has made Medicaid expansion a priority.

In Florida, one of the largest states not to have expanded expanded Medicaid, the Republican candidate for governor, former U.S. Rep. Ron DeSantis, opposes expansion. His Democratic opponent, Tallahassee Mayor Andrew Gillum, supports it.

In Georgia, the gubernatorial candidates, Democrat Stacey Abrams and Republican Brian Kemp, also are on opposite sides of the Medicaid expansion debate.

However, the legislatures in both states have opposed the expansion, and it’s not clear if they would be swayed by arguments from a new governor.

3. Medicare

Until recently, Republicans have remained relatively quiet about efforts to change the popular Medicare program for seniors and people with disabilities.

Their new talking point is that proposals to expand the program — such as the often touted “Medicare-for-all,” which an increasing number of Democrats are embracing — could threaten the existing program.

“Medicare is at significant risk of being cut if Democrats take over the House,” Rep. Greg Gianforte (R-Mont.) told the Lee Montana Newspapers. “Medicare-for-all is Medicare for none. It will gut Medicare, end the VA as we know it, and force Montana seniors to the back of the line.”

Gianforte’s Democratic opponent, Kathleen Williams, is proposing another idea popular with Democrats: allowing people age 55 and over to “buy into” Medicare coverage. That race, too, is very tight.

Meanwhile, back in Washington, congressional Republicans are more concerned with how Medicare and other large government social programs are threatening the budget.

“Sooner or later we are going to run out of other people’s money,” said Chris Jacobs.

Senate Majority Leader Mitch McConnell suggested in an Oct. 16 interview with Bloomberg News that entitlement programs like Medicare are “the real driver of the debt by any objective standard,” but that bipartisan cooperation will be needed to address that problem

Republican Jacobs and Democrat McDonough think that’s unlikely any time soon.

“Why would Democrats give that up as an issue heading into 2020?” asked McDonough, especially because Republicans in recent years have been proposing deep cuts to the Medicare program.

Agreed Jacobs, “Trump may not want that to be the centerpiece of a re-election campaign.”

Heart Drug Spotlights Troubling Trends In Drug Marketing

Kaiser Health News:Marketplace - November 02, 2018

At the end of September, Amarin Corp. teased some early findings for Vascepa, its preventive medicine for people at risk of heart disease. The claim was astounding: a 25 percent relative risk reduction for deaths related to heart attacks, strokes and other conditions. Headlines proclaimed a potential game changer in treating cardiovascular disease. And company shares quickly soared, from $3 a share to about $20.

Vascepa is Amarin’s only product. The company wants to turn its pill made of purified fish oil into a cash cow, allowing it to staff up both in the United States and abroad so it can sell doctors and millions of consumers on its medical benefits. Although the product has been on the market for more than five years, its first TV ad campaign rolled out this summer in anticipation of the study findings.

Except there is one problem. The particulars of the scientific study on which this claim was based remain a mystery.

Amarin’s preliminary announcement came via a news release on Sept. 24. The company plans to release detailed findings in November at the national American Heart Association conference. Then early next year, it plans to seek Food and Drug Administration approval to use the drug as a preventive for a range of heart conditions, beyond its current role targeting high triglyceride levels.

In the interim, a battle is brewing among physicians, cardiovascular experts and pharma watchers who say Vascepa brings to the foreground troubling trends in the marketing and advertising of new drugs. Companies sometimes promote new products, but withhold the detailed findings until much later. The consequences for both consumers and the health system are vast.

“Until all the data is available for review by the public and medical community, it’s really premature to see some of the cheerleading that’s being done,” said Dr. Eric Strong, a hospitalist and clinical assistant professor at Stanford School of Medicine. “It’s harder to change people’s minds once you have these rosy pictures.”

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John Thero, Amarin’s CEO, argued that the imminent release of the drug’s complete picture should alleviate those concerns.

In unveiling topline findings in a news release, he said, the company’s playbook doesn’t diverge from that of other pharmaceutical makers, and provides a necessary level of disclosure for shareholders.

But it’s the specifics in the data — for instance, which patients benefited, by how much, their absolute risk reduction and which precise conditions saw improvement — that illustrate whether a product is cost-effective, said medical and drug experts.

That’s especially true in the case of Vascepa, whose manufacturer is working hard to convince people the product is clinically superior to ordinary fish oil supplements. Fish oil, which can retail for a few dollars a bottle, has long been promoted as a preventive for heart disease. But the substance has never held up in clinical trials as a way to systematically lower disease risk, said experts.

That’s where Amarin’s product is superior, Thero said.

The manufacturer has tried to limit competition by seeking to block other fish oil products —arguing to the U.S. International Trade Commission that omega-3 supplements aren’t equivalents, and calling on the FDA to block a chemical component of fish oil, known as EPA and marketed by a number of supplement companies, from being sold as a dietary supplement. Amarin hasn’t yet prevailed.

Preston Mason, a biologist who consults for Amarin and has advocated on its behalf, argued that ordinary fish oil supplements carry risks because they are not regulated or approved by the FDA, which does oversee prescription drugs like Vascepa.

How Vascepa performs against regular fish oil remains unknown. Amarin’s trial compared the drug against a placebo, not over-the-counter supplements.

Vascepa itself isn’t new. It was approved in 2012 as a remedy for extremely high triglyceride levels, which can put patients at risk for pancreatic problems. But reducing that fat hadn’t been conclusively tied to, say, lowering the risk of heart attacks, or other major cardiac problems.

That link, ostensibly, is what Amarin is trying now to assert. And there’s plenty of money to be made if it succeeds.

As of last December, Vascepa retailed for about $280 for a month-long supply, a list price increase of 43 percent over five years, though the company says its net sale price has stayed the same. (That difference would come if Amarin increased the size of rebates, or discounts it provides, commensurate with price hikes.)

Now, citing the drug’s potentially increased value, Amarin has declined to say whether it will change the price again — though Thero said he sees greater profit potential if the company increases sales volume rather than price.

This gets at the crux of this debate. If a company makes available the technical details of a product, but only after hyping the findings, and if the details undercut some of that buzz — is it too late?

Dr. Khurram Nasir, a Yale cardiologist, acknowledged that it’s unclear how effective Vascepa really is, but maintained those ambiguities will be cleared up soon enough.

“As the findings reveal themselves, there will be a lot of discussion around cost effectiveness, and whether this is worth the spend,” Nasir said.

Mason, the Amarin scientist, said FDA scrutiny can also alleviate concerns about overhype.

But others worry the perception of Vascepa’s effectiveness is now set.

“People are weighing in with really strong language, without enough information,” said Dr. Lisa Schwartz, who co-directs the Dartmouth Institute’s Center for Medicine and Media and studies effective scientific communication.

That has both clinical and financial consequences, she added. Doctors are more likely to prescribe a product that’s been heavily promoted, even if subsequent discussion indicates the drug isn’t as powerful as initially implied. And manufacturers can cash in, whether through increased company stock market value or by charging higher list prices.

For Vascepa, the central question is which specific heart conditions saw risk reduction, she and others said. In its news release, Amarin noted a “composite outcome” — that is, the 25 percent relative improvement encompassed all conditions for which the researchers tested.

“People are saying, Wow, it reduced heart attack, stroke and blah, blah, blah — when it may just reduce the least important one,” said Dr. Steven Woloshin, Schwartz’s research partner.

Another issue: The Vascepa trial focused on a specific population — patients with high triglyceride levels plus elevated risk of cardiovascular disease or diabetes who were already taking a daily statin. That means any proof of benefit is limited to that group.

Woloshin and Schwartz both suggested that nuance could get lost in translation. “It is this much narrower, high-risk population,” Schwartz said.

Woloshin added, “The fear is [the message] would generalize to anyone with high triglycerides.”

This concern is amplified by a 2016 court settlement in which the FDA permitted Amarin to market Vascepa to audiences for whom it hasn’t been specifically approved — so long as the company doesn’t say anything untrue about the drug.

Thero said Amarin’s marketing of Vascepa has stayed, and will remain, consistent with what is factual and relevant.

“We are proceeding consistently with what the FDA has guided,” he said.

But, some experts said, the 2016 settlement could unlock the door to wider marketing of Vascepa’s off-label use, implying the pill benefits more people than it actually does.

“They’ll take pains to show how different this is from everything out there … and its results in these populations,” said Dr. Ameet Sarpatwari, an epidemiologist and lawyer at Harvard Medical School, who studies the pharmaceutical industry. “What they can’t do is say it will be beneficial to these other populations. But they can hint at that.”

Podcast: KHN’s ‘What The Health?’ Open Enrollment And A Midterm Preview

Kaiser Health News:HealthReform - November 01, 2018
Julie Rovner

Kaiser Health News

@jrovner

Read Julie's Stories Anna Edney

Bloomberg

@annaedney

Read Anna's Stories Joanne Kenen

Politico

@JoanneKenen

Read Joanne's Stories Margot Sanger-Katz

The New York Times

@sangerkatz

Read Margot's Stories

Nov. 1 marks the start of Open Enrollment for people buying their own coverage for 2019 in most states. Despite the turmoil surrounding the Affordable Care Act, most consumers will have more choices and mostly flat — and in some cases lower — premiums.

What will happen to the health law going forward, however, will depend largely on what happens in the midterm elections Tuesday. Important health decisions will result not just from which party controls the U.S. House and Senate, but who wins governorships and comes to control state legislatures as well.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Anna Edney of Bloomberg News, Margot Sanger-Katz of The New York Times and Joanne Kenen of Politico.

Among the takeaways from this week’s podcast:

  • With changes in the ACA marketplace for 2019, it will be very important for consumers to look at the variety of options. Those earning less than 200 percent of the federal poverty level (just under $24,300 for an individual) are likely well served by silver plans on the federal health law’s exchanges. But the choices for benefits and prices are much more complicated for people earning more than that.
  • People who don’t get insurance through work or the government and earn too much to qualify for premium subsidies under the health law might be tempted to try the new, less-expensive short-term plans being touted by the Trump administration. But they should be cautious and consider two major downsides: The plans likely won’t cover preexisting conditions, and the benefits will be skimpier than those of ACA plans. For example, many short-term plans are expected not to cover mental health and maternity services or prescription drugs.
  • Federal officials announced Wednesday that Wisconsin could implement work requirements for some Medicaid enrollees. They also said, however, that the state could not begin drug testing for the enrollees.
  • If Democrats take control of the House or Senate, it’s possible that they could work with President Donald Trump on some specific issues, especially efforts to bring down drug prices or consumer protections against surprise medical bills.
  • Perhaps the biggest change that could come from the election results is an increase in the number of states that expand Medicaid under a provision of the ACA. Seventeen states have not taken that step, but several deep-red states in the West have the question on their ballots, and the outcomes from governors’ races in other states could also lead to expansion.

Rovner also interviews Barbara Feder Ostrov, who wrote the latest “Bill of the Month” feature for Kaiser Health News and NPR. It’s about a California college professor whose skin rash led to a $48,000 bill for allergy skin testing. You can read the story here.

If you have a medical bill you would like NPR and KHN to investigate, you can submit it here.

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

Julie Rovner: The Washington Post and Kaiser Health News’ “For The Disabled, A Doctor’s Visit Can Be Literally An Obstacle Course — And The Laws Can’t Help,” by Rachel Bluth.

Anna Edney: Bloomberg Businessweek’s “Your DNA Is Out There. Do You Want Law Enforcement Using It?” by Drake Bennett and Kristen V Brown.

Margot Sanger-Katz: The Federalist’s “How An Obscure Regulatory Change Could Transform American Health Insurance,” by Christopher Jacobs.

Joanne Kenen: The Atlantic’s “The Harder, Better, Faster, Stronger Language Of Dieting,” by Amanda Mull.

To hear all our podcasts, click here.

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

Billions In ‘Questionable Payments’ Went To California’s Medicaid Insurers And Providers

Kaiser Health News:Insurance - November 01, 2018

California’s Medicaid program made at least $4 billion in questionable payments to health insurers and medical providers over a four-year period because as many as 453,000 people were ineligible for the public benefits, according to a state audit released Tuesday.

In one case, the state paid a managed-care plan $383,635 to care for a person in Los Angeles County who had been dead for more than four years, according to California State Auditor Elaine Howle.

She said she found “pervasive discrepancies” in Medicaid enrollment in which state and county records didn’t match up from 2014 to 2017, leading to other errors that persisted for years. The bulk of the questionable payments, or $3 billion, went to health plans that contract with the state to care for 80 percent of enrollees in California’s Medicaid program, known as Medi-Cal.

The program for low-income residents is the nation’s largest and funded by both the federal and state governments. The state findings echo similar problems cited by federal officials and come at a time when the Trump administration has applied extra scrutiny to California’s spending on Medicaid.

In the report, the state auditor said it’s critical for the state to have accurate information on eligibility “because it pays managed care plans a monthly premium for an increasing number of Medi-Cal beneficiaries regardless of whether beneficiaries receive services.”

(Story continues below.)

California paid a managed-care plan $383,635 to care for a person in Los Angeles County who had been dead for more than four years.

California’s Medicaid program has 13.2 million enrollees, covering about 1 in 3 residents. It has an annual budget of $107 billion, counting federal and state funds. Nearly 11 million of those enrollees are in managed care plans, in which insurers are paid a monthly fee per enrollee to coordinate care.

The state’s Medicaid enrollment soared by more than 50 percent since 2013 due to the rollout of the Affordable Care Act and the expansion of Medicaid. Enrollment grew from 8.6 million in December 2013 to more than 13 million in December 2017, according to the audit report.

In the case of the dead patient, a family member had notified the county of the enrollee’s death in April 2014. However, the person’s name remained active in the state system, and California officials assigned the patient to a managed-care plan in November of that year.

From then on, the state kept making monthly payments of about $8,300 to the health plan until August 2018, shortly after the auditor alerted officials of the error. Auditors didn’t identify the health plan.

There also were costly mistakes in cases in which Medi-Cal pays doctors and hospitals directly for patient care – a program known as “fee for service.”

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For instance, the state auditor found that Medi-Cal paid roughly $1 million in claims for a female patient in Los Angeles County from June 2016 to December 2017 even though the county office had determined in 2016 that she was ineligible.

In a written response to the auditor, the California Department of Health Care Services said it agreed with the findings and vowed to implement the auditor’s recommendations. However, the agency warned it may not meet the auditor’s timeline, which called for the main problems to be addressed by June 2019.

In a statement to California Healthline, the agency said it is implementing a quality control process and “where appropriate, DHCS will recover erroneous payments.”

Early on in 2014, as the ACA rolled out, the state struggled to clear a massive backlog of Medi-Cal applications, which reached about 900,000 at one point. There were widespread computer glitches and consumer complaints amid the increased workload at the county and state level.

In addition to questionable payments for care of ineligible enrollees, Howle and her audit team also discovered some patients who may have been denied benefits improperly. The state auditor identified more than 54,000 people who were deemed eligible by county officials but were not enrolled at the state level. As a result, those people may have had trouble getting medical care.

In February, a federal watchdog estimated that California had signed up 450,000 people under Medicaid expansion who may not have been eligible for coverage.

The inspector general at the U.S. Department of Health and Human Services said California made $1.15 billion in questionable payments during the six-month period it reviewed, from Oct. 1, 2014, to March 31, 2015.

In August, Seema Verma, administrator of the U.S. Centers for Medicare and Medicaid Services, told a U.S. Senate committee that she was closely tracking California to ensure the state “returns a significant amount of funding owed to the federal government related to the state’s Medicaid expansion.”

Verma expressed concern that states had overpaid managed-care plans during the initial years of Medicaid expansion, resulting in “significant profits for insurance companies.” By year’s end, she said she expects the federal government to recoup about $9.5 billion from California’s Medicaid program, covering overpayments from 2014 to 2016.

Tony Cava, a spokesman for Medi-Cal, said the state has already returned about $6.9 billion to the federal government and expects more than $2 billion more to be sent back by December.

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

Pricey Precision Medicine Often Financially Toxic For Cancer Patients

Kaiser Health News:Insurance - November 01, 2018

Kristen Kilmer hugs her 12-year-old daughter at their home in Spearfish, S.D.(Kristina Barker for KHN)

When Kristen Kilmer was diagnosed with incurable breast cancer at age 38, her first thought was of her 8-year-old daughter. Kilmer lost her own mother as a teenager and was determined to get more time with her only child.

Kilmer searched for experimental treatments, opting for an unproven approach in which researchers select drugs based on the genes in patients’ tumors. Doctors have selected her treatments for the past three years based on the unique, ever-changing DNA of her cancer cells. Now 41, Kilmer has responded better than anyone dared to hope. Her cancer has gone into hiding; her tumors are no longer visible on medical scans.

This story also ran on USA Today. This story can be republished for free (details). Researchers call the strategy “precision medicine.”

Kilmer’s insurance company calls it experimental. As a consequence, her insurer has covered only a fraction of her care, forcing Kilmer to make an agonizing choice: stop taking a drug that costs nearly $17,000 a month or pay out-of-pocket, burdening her family with tremendous debt.

“When you are looking at your daughter, you ask yourself, ‘Do I take a medication that might allow me to see her graduate high school?’” asked Kilmer, of Spearfish, S.D. “Or do you stop taking it to avoid causing her financial harm?”

Kristen Kilmer says she would rather go without her cancer treatment than financially burden her daughter and husband, Chet Kilmer.(Kristina Barker for KHN)

The high cost of cutting-edge tests and treatments is threatening to keep precision medicine — one of the most celebrated areas in cancer research — out of reach for many patients. Patients who pay for these new treatments on their own “could be in debt for decades,” said Dr. Scott Ramsey, director of the Hutchinson Institute for Cancer Outcomes Research in Seattle.

Already cancer care is hugely expensive. A recent study in the American Journal of Medicine found that 42 percent of patients depleted 100 percent of their assets — an average loss of $92,000 — within two years of diagnosis.

Precision medicine involves running expensive tests called genomic sequencing, which scan the DNA of tumors to find mutations that might be susceptible to available drugs. Although the field is relatively new, hundreds of thousands of cancer patients have had their tumors sequenced to identify cancer-related mutations, according to testing companies.

Medicare, the government insurance plan for people 65 and older, announced in March that it will pay for genomic testing for people with advanced cancers — a decision that could add $2.5 billion to federal health care costs, according to a May analysis in Health Affairs.

Few private insurers cover the tests, leaving some patients with surprise medical bills.

Carrie Wyman, who also has advanced breast cancer, discovered that her insurance plan doesn’t cover genomic sequencing only after she received a $5,800 statement.

“I just assumed it would be covered,” said Wyman, 50, a resident of La Plata, Md., who has six children and stepchildren. “I was blindsided, to be honest with you.”

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Looking For Financial Assistance

Yet paying for that initial test is just the beginning. As Kilmer learned, finding the money for ongoing treatment is far more challenging, said Dr. Gary Lyman, who studies way to improve health care quality at Seattle’s Fred Hutchinson Cancer Research Center.

In some cases, genomic tests match patients to experimental drugs available only in clinical trials. Although these trials sometimes provide free medications, many cancer patients can’t afford to travel to participate in them. Kilmer drives 12 hours round-trip every month to participate in a clinical trial in Sioux Falls, S.D. The expenses add up quickly, she said.

Kilmer, who was diagnosed with incurable breast cancer at 38, takes Lynparza, which costs nearly $17,000 per month. (Kristina Barker for KHN)

Kilmer spreads out her daily medications, including Lynparza (center).(Kristina Barker for KHN)

Kilmer’s genomic tests identified a rearrangement in the PALB2 gene. Preliminary studies suggest that tumors with this genetic rearrangement could be susceptible to the drug Lynparza, but those effects haven’t been definitively proven in large-scale studies. The Food and Drug Administration has approved Lynparza only for breast cancer patients with a mutation called BRCA.

Legally, doctors can prescribe Lynparza “off label” to anyone with cancer. But insurance programs are reluctant to cover off-label treatments, unless they’re specifically recommended in expert guidelines.

Kilmer has spent much of the past three years battling insurance officials and begging drug companies for financial assistance. The drugmakers have been generous, allowing her to take a rotating cocktail of experimental drugs for free because of her modest income.

In September, however, AstraZeneca decided to end Kilmer’s financial aid. Kilmer appealed the drug company’s decision.

Paying thousands of dollars a month is not an option, Kilmer said. Her family already carries significant credit card debt from earlier cancer treatments. She estimates that she has spent about $80,600 out-of-pocket treating her illness, including $23,600 on her early breast cancer therapy and $57,000 treating metastatic disease.

Kilmer said she would rather stop taking Lynparza than financially burden her daughter and husband, a truck driver.

“It’s not worth it,” Kilmer said. “I will not put my family into that kind of debt.”

Kristen and Chet Kilmer, a truck driver, outside their home in Spearfish, S.D.(Kristina Barker for KHN)

Uncertain Benefits

Insurers say costs aren’t their only concern. Evidence is lacking that the precision medicine approach will work consistently, they argue.

America’s Health Insurance Plans, an industry group, said genetic sequencing remains unproven.

Cathryn Donaldson, the group’s spokeswoman, described recent scientific advances as “remarkable and noteworthy.” But she said insurers “need a more definitive answer” about whether the tests help the average patient live longer.

The South Dakota State Employee Health Plan — which runs Kilmer’s insurance plan — said it bases its coverage decisions on science and reviews “published, randomized data about the safety and efficacy of the requested drugs.”

Although genetic testing has become the standard of care for melanoma and a common type of lung cancer, no one knows if genomic sequencing will extend the lives of people with other types of cancer, said Dr. Carolyn Presley, an assistant professor at the Ohio State University Comprehensive Cancer Center.

In early October, after Kaiser Health News began researching Kilmer’s story, she learned that AstraZeneca has agreed to continue providing Lynparza for free.(Kristina Barker for KHN)

Without insurance coverage, some cancer patients simply give up on treatment.

A study of more than 1,000 women with advanced breast cancer — presented at a September meeting of the American Society of Clinical Oncology — found that 54 percent had stopped or refused treatment due to cost. The women in the study may have been more vulnerable than most, because 30 percent were uninsured, about twice the national rate.

In an August study in JAMA, researchers found that relatively few of those who hoped to benefit from precision medicine actually ended up on a medication. Just 15 percent of those who underwent genomic sequencing ended up taking a targeted therapy, according to the study. The study didn’t ask participants why they failed to get a targeted drug, but Presley, the lead author, said it’s likely that some patients couldn’t afford them.

“We’re finding the mutations, but patients aren’t getting the drugs,” Presley said. Without insurance, she said, “you and I would not be able to afford these medications. It’s a huge barrier.”

Within hours of the publication of this story, AstraZeneca called Kilmer to notify her that it would continue to provide financial aid. Her medication arrived in the mail the next day.

“It’s a huge relief,” Kilmer said.

KHN’s coverage of these topics is supported by Laura and John Arnold Foundation and Gordon and Betty Moore Foundation

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