Judge Upends Effort To Limit Charity Funding For Kidney Patients' Insurance

Judge Upends Effort To Limit Charity Funding For Kidney Patients' Insurance

KFF Health News, February 14, 2017

The federal government has expressed concern that providers of charity for financial assistance to cover health insurance costs might be inappropriately steering patients to marketplace plans instead of Medicare or Medicaid.

This article first appeared February 14, 2017 on Kaiser Health News.

By Michelle Andrews

Every night, Jason Early attaches a catheter in his chest to a machine by his bed that, over the course of nine hours while he sleeps, removes his blood from his body, cleanses it and returns it because his kidneys are no longer able to do the job.

It's been about 18 months since the 28-year-old Dallas resident started getting dialysis after his kidneys failed as a complication from the Type 1 diabetes with which he was diagnosed as a child.

Like many patients with end-stage renal disease, Early, who is completing a bachelor's degree in finance at the University of North Texas at Dallas, turned to a charity for financial assistance to cover his health insurance costs.

Such "third-party payments" by nonprofit groups, health care providers and others are controversial. The federal government has expressed concern that providers and organizations they're affiliated with might be inappropriately "steering" patients to marketplace plans instead of Medicare or Medicaid, for which they are often eligible. The public programs reimburse for the dialysis services at lower rates than most private plans. The efforts by charities have also long been a sore spot with health insurers, who say they encourage sick patients who have expensive health care needs to opt for private coverage.

Insurers suffered a setback recently when a federal judge temporarily blocked a new rule from the Department of Health and Human Services that was set to go into effect Jan. 13. It would require that dialysis centers inform insurers if the centers are making premium payments either directly or indirectly through a third party for people covered by marketplace plans. Insurers would then have the option of accepting or denying the payments.

In granting the preliminary injunction last month, U.S. District Court Judge Amos Mazzant in Sherman, Texas, criticized the government's administrative process for establishing the regulation and said it hadn't considered the benefits of private individual insurance or the fact that the rule would leave thousands of patients without coverage.

Insurers were not pleased. "Inappropriate steering and third-party payments increases costs for all consumers, and it risks harm to patients who are often eligible for public coverage options," said Kristine Grow, a spokesperson for America's Health Insurance Plans, an industry group. "We continue to urge [the Department of Health and Human Services] to prohibit these payments when there is alternative coverage for patients."

But patient advocates were delighted. "We thought this was an important win for dialysis patients because it not only spoke to the procedural elements of the rule but to the substance, the potential of dialysis patients to have their coverage taken away," said Hrant Jamgochian, the chief executive of Dialysis Patient Citizens, an advocacy group and the lead plaintiff in the lawsuit.

Premium assistance has been critical to improving Early's quality of life. "Without the [American Kidney Fund] assistance I would be living to pay my medical costs," he said. "They give me an opportunity to get a breather from medical costs so that I can live my life outside of my illness."

Although some patients, such as Early, are able to undergo dialysis at home, many must spend four hours at a dialysis center three times a week. The process is debilitating and time-consuming.

Many people lose their employer-sponsored health insurance because they are unable to work. Medicare is often an alternative because under the law, people with end-stage renal disease — even those younger than 65 — are generally eligible for coverage.

Others may sign up for private coverage on the exchanges. Some may qualify for Medicaid.

Advocates for kidney patients say coverage on the individual market is better than Medicare for some people. In marketplace plans, the maximum amount that someone can be required to pay out-of-pocket for covered services in 2017 is $7,150. But there's no cap on beneficiaries' spending in Medicare, and patients are on the hook for 20 percent of the cost for doctor visits and other outpatient services such as dialysis. Supplemental "Medigap" plans can help cover out-of-pocket costs, but 23 states don't require insurers to sell those plans to people with end-stage renal disease who aren't yet 65.

Last year, Early bought an Aetna silver plan with a $1,500 deductible and a $6,000 out-of-pocket maximum on the Texas health insurance exchange. The American Kidney Fund paid the $359 monthly premium. The policy covered all of his diabetes drugs and equipment. By the end of the first month of dialysis copayments, Early reached his spending maximum and the plan paid everything after that.

But Aetna exited several marketplaces this year, including Texas, and Early signed up for Medicare in January. Now he's responsible for a $134 monthly Part B premium, $65 for his prescription drug plan and $300 a month in copays for drugs. Medicare doesn't cover the insulin pump he uses, so he'll have to pay $300 monthly out of pocket for that too. At the moment he's also paying $478 each month for the basic Medigap "A" supplemental plan available in Texas to patients younger than 65 with end-stage renal disease. The Medigap plan covers his 20 percent coinsurance payments for dialysis and other outpatient care.

He said he's been told that the American Kidney Fund, a charity that provides assistance to about 20 percent of the more than 450,000 people who are on dialysis and receives funding from dialysis providers, will start picking up his Medigap premiums soon. He hopes so.

"I miss my Aetna plan," he said.

Sixty percent of the people who receive premium assistance from the American Kidney Fund get help with their Medicare or Medigap plans rather than marketplace or other private coverage, said LaVarne Burton, the president and CEO. Even though the judge's order doesn't apply to people in public plans, she hopes it will discourage insurers that are increasingly erecting barriers to third-party payment.

"We want to protect the ability that these individuals have to make the choice that meets their needs," Burton said.

Price could have a rapid impact on policy without a presidential order or an act of Congress.

5 Ways New HHS Secretary Tom Price Could Change The Course Of Health Policy

KFF Health News, February 10, 2017

Price could have a rapid impact on policy without a presidential order or an act of Congress.

This article first appeared February 10, 2017 on Kaiser Health News.

By Julie Rovner

After a bruising confirmation process, the Senate confirmed Rep. Tom Price, R-Ga., to head up the Department of Health and Human Services, by a 52-to-47 vote.

As secretary, Price will have significant authority to rewrite the rules for the Affordable Care Act, some of which are reportedly nearly ready to be issued.

But there is much more now within Price's purview, as head of an agency with a budget of more than $1 trillion for the current fiscal year. He can interpret laws in different ways than his predecessors and rewrite regulations and guidance, which is how many important policies are actually carried out.

"Virtually everything people do every day is impacted by the way the Department of Health and Human Services is run," said Matt Myers, president of the Campaign for Tobacco-Free Kids. HHS responsibilities include food and drug safety, biomedical research, disease prevention and control, as well as oversight over everything from medical laboratories to nursing homes.

Price, a Georgia physician who opposes the Affordable Care Act, abortion and funding for Planned Parenthood, among other things, could have a rapid impact without even a presidential order or an act of Congress.

Some advocates are excited by that possibility. "With Dr. Price taking the helm of American health policy, doctors and patients alike have sound reasons to hope for a welcome and long-overdue change," Robert Moffit, a senior fellow at the conservative Heritage Foundation, said in a statement when Price's nomination was announced.

Others are less enthusiastic. Asked about what policies Price might enact, Topher Spiro of the liberal Center for American Progress said at that time: "I don't know if I want to brainstorm bad ideas for him to do."

Here are five actions the new HHS secretary might take, according to advocates on both sides, that would disrupt health policies currently in force:

Birth control coverage: Under the ACA, most insurance plans must provide women with any form of contraception approved by the Food and Drug Administration at no additional cost. This has been particularly controversial in regards to religious employers who object to artificial contraception, leading to alterations in the rules, and resulting in a two separate Supreme Court rulings, one about private firms' rights to make religious objections, and one about nonprofit religious hospitals and schools.

As secretary, Price would have two main options. He could expand the "accommodation" that already exempts some houses of worship from the requirement to any employer with a religious objection. Or, because the specific inclusion of birth control came via a regulation rather than the law itself, he could simply eliminate no-copay birth control coverage from the benefits insurance plans must offer. (This assumes continuing existence of the health law, at least for the short term.)

Medicare payment changes: The health law created an agency within Medicare, called the Center for Medicare and Medicaid Innovation, that was tasked with exploring new ways to pay doctors and hospitals that would reduce costs while maintaining quality. The HHS secretary has the authority to require doctors and hospitals to participate in the experiments and new payment models. Some have proved unpopular with physician and hospital groups, in particular the idea of paying providers so-called bundled payments for packages of care, rather than allowing them to bill item-by-item; one such package covers hip and knee replacements, from the time of surgery through post-surgical rehabilitation. Price, as a former orthopedic surgeon himself, would likely act to scale back, delay or cancel that project, since he "has been a critic in the past," said Dan Mendelson, CEO of Avalere Health, a Washington-based consulting firm.

Planned Parenthood funding: Republicans have been agitating to separate Planned Parenthood from its federal funding literally for decades. Congress would have to change Medicaid law to permanently defund the women's health group, which also performs abortions (with non-federal funds) at many of its sites. But an HHS secretary has many tools at his disposal to make life miserable for the organization.

For example, during the Reagan and George H.W. Bush administrations, rules were put in place, and eventually upheld by the Supreme Court, that would have banned staff in federally funded family planning clinics from counseling or referring for abortion women with unintended pregnancies. The subsequent Clinton administration repealed the rules, but they could make a comeback under the new secretary's leadership.

Price could also throw the weight of the department into a probe into Planned Parenthood's ties to firms allegedly selling fetal tissue for profit, which has also been investigated by a House committee.

Tobacco regulation: After years of discord, Congress finally agreed to give the Food and Drug Administration (limited) authority to regulate tobacco products in 2009. "The core authority is statutory," said Matt Myers of the Campaign for Tobacco-Free Kids, who advocated for the law. That means Congress would have to act to eliminate many of its changes. But a secretary who opposes the law (Price voted against it at the time) could weaken enforcement, says Myers. Or he could rewrite and water down some rules, including recent ones affecting cigars and e-cigarettes.

"The secretary has very broad discretionary authority not to vigorously enforce or implement the statute in an aggressive manner," Myers said.

Conscience protections: At the very end of the George W. Bush administration, HHS issued rules intended to clarify that health care professionals did not have to participate in performing abortions, sterilizations or other procedures that violated a "religious belief or moral conviction."

Opponents of the rules complained, however, that they were so vague and sweeping that they could apply not just to opponents of abortion, but also to those who don't want to provide birth control to unmarried women, or HIV treatment to homosexuals.

The Obama administration revised the rules dramatically, much to the continuing consternation of conservatives. They were among the few health-related items included in the health section of Trump's website before he was inaugurated and the page was taken down. "The Administration will act to protect individual conscience in health care," it said. Many expect the rules to be reinstated in their original form.

This is an updated version of a story that initially ran Dec. 9, 2016. It was updated Feb. 10, 2017 to reflect that Tom Price had been confirmed by the Senate.

President Donald Trump has acknowledged that the effort to remake the health law could last into next year. Conservatives, however, are pushing back.

Conservatives Urge Speed Up Of Health Law Repeal

KFF Health News, February 9, 2017

President Donald Trump has acknowledged that the effort to remake the health law could last into next year. Conservatives, however, are pushing back.

This article first appeared February 9, 2017 on Kaiser Health News.

By Julie Rovner

Leading conservative Republicans from the House and Senate say Congress is moving too slowly on efforts to "repeal and replace" the Affordable Care Act. But their potential resistance to compromise—even with other members of their own party—underscores just how hard a task Republicans have set for themselves.

"We think it's time to do something, and that's to get rid of this law," Rep. Jim Jordan, R-Ohio, told reporters at an event sponsored by the conservative Heritage Foundation. "The biggest problem with waiting is that's not what we told the voters."

Sen. Mike Lee, R-Utah, pictured above, one of the leading conservative voices in that chamber, said he will vigorously oppose efforts for Republicans to wait until they have a plan ready to replace the law before they repeal it. "There is a lot less agreement about what comes next," he said. "If we load down the repeal bill with what comes next, it's harder to get both of them passed."

After getting off to a quick start, GOP efforts to dismantle the health law appear to have slowed considerably. House and Senate committees have already missed a deadline of Jan. 27 to write and pass their proposed repeal and replace provisions, although Senate leaders acknowledged early this year that marker would likely not be met. At a party retreat last month, Republicans still seemed uncertain exactly how and when they would proceed.

In an interview that aired just before the Super Bowl, President Donald Trump for the first time acknowledged that the effort to remake the health law could last into next year.

Conservatives, however, are pushing back.

Rep. Mark Meadows, R-N.C., who heads the hard-right House Freedom Caucus, said he recognizes that people are "anxious" about changing the health law. "The quicker we can give them answers, the better off we are," he said.

"Health care gets better and costs less once you repeal Obamacare," said Jordan.

All three said they are sensitive to the needs of health insurers, who are threatening to stop offering coverage in the individual market after this year unless they get a better idea of what rules they will have to follow.

"Every month that goes by we create a heavier burden for insurance companies to figure out," said Meadows.

They insisted that adds imperative to the repeal push.

At a minimum, said Lee, Congress should immediately pass the bill it passed in 2015 that was vetoed by President Barack Obama. That partial repeal would have eliminated the expansion of the Medicaid program for the poor, as well as all the insurance subsidies that help people afford coverage and the taxes that pay for the program.

"If we can get something more aggressive, then great," he said. "But we cannot make progress until we first repeal Obamacare."

Insurers and others, including the Congressional Budget Office, have said that repealing parts of the law without a replacement could plunge the individual insurance market into chaos and increase the number of people without any insurance by 32 million over 10 years.

But the conservatives rejected that characterization. "The chaos the American people are facing right now is related to a set of circumstances put in place by Obamacare," said Lee. "I wish there were a non-chaotic path" to fix it.

Obama’s Drug Czar: The Opioid Crisis Must Continue To Be A Federal Priority

Obama's Drug Czar: The Opioid Crisis Must Continue To Be A Federal Priority

KFF Health News, February 9, 2017

President Trump's promise to undo the health law could compromise anti-addiction efforts, says President Obama's former "drug czar," Michael Botticelli.

This article first appeared February 9, 2017 on Kaiser Health News.

By Shefali Luthra

The GOP is working to repeal and replace the 2010 health law, known for insuring more than 20 million people. And the change could affect another health concern: the nation's opioid abuse problem.

Just ask President Barack Obama's former "drug czar," Michael Botticelli.

Botticelli just finished running the White House's Office of National Drug Policy, a post he assumed in early 2014 as the opioid epidemic began making national headlines. The drugs, which claimed more than 33,000 lives in 2015, include heroin and painkillers like OxyContin.

Fighting addiction—and opioids in particular—defined his tenure. But Botticelli was known for bringing a patient's perspective. His background, after all, isn't medicine or law enforcement. He previously headed Massachusetts' Bureau of Substance Abuse. And he's in recovery himself, having spent almost 30 years sober after battling alcoholism.

Q: What do you think is needed to address the opioid epidemic?

We have not heard President Donald Trump talk about how he is going to deal with this. He heard [about] this issue on the campaign trail.

There is significant concern on the potential impact repealing the Affordable Care Act might have. We had a whole host of initiatives, but one of the main components was to ensure people had adequate access to treatment. Clearly, the Affordable Care Act had a major impact. When you look at data about why people are not able to get treatment, not having access to insurance is one of the major reasons people cite.

Q: What are the specific elements of repealing and replacing the law that you're concerned about?

People with opioid addiction do not just need general access to substance abuse services. They often have a variety of comorbid mental health and medical conditions. We've seen a dramatic increase in people with hepatitis C among people with opioid addiction who are injecting drugs. We've seen in certain parts of the country outbreaks of HIV. Medicaid expansion has played a huge role in people's ability to access treatment for both substance use disorder and other conditions.

One of the concerns is not just for people's ability to access care—but what happens to those millions who are already receiving it? If there is a significant disruption in people's ability to access treatment, it has a devastating impact.

Q: In addition to the repeal effort, the GOP has talked about revamping Medicaid so that it would be funded through block grants, which could give states more freedom to manage the program, but also could limit its budget. Could those affect the fight against opioid addiction?

In addition to requiring treatment for substance use disorders be considered an essential benefit, the Affordable Care Act imparted federal parity regulations to cover those. Without federal oversight, states might choose to not cover those services, and not cover them on par with other medical needs.

There are reasons we have federal parity laws. There's a long history of both private and public insurance plans not adequately covering—or covering at all—substance use disorder services.

And so there's a potential [to lose those protections by] moving to a block grant, where states have much more flexibility over who they cover and the kinds of services they pay for.

This goes back to the very long history of Medicaid, both private and public insurance, either not paying or not adequately covering these [services].

Q: Has the Trump administration been in touch with you—about opioid policy specifically, or drug policy generally?

No. And we had no contact with anyone on the Trump transition team before I left. It's giving me and other people pause about to what extent this administration considers this a priority.

Q: Do you have a sense that the new administration has a sense of policy that might be effective? And what are the challenges they'll face going forward?

Well, I think that we have seen not only in my time in the Obama administration, but in my time in Massachusetts—that this really requires a comprehensive response. And a dedicated response. And it needs to be well resourced, to be a priority across the federal government

I think if we were able to achieve anything, it was really understanding that this was an 'all hands on deck' approach, and we needed various elements of the administration focused on this issue if we're going to make progress on this. We need it. And I think part of what was successful was this was a clearly articulated priority by President Obama. You know, I think that we were able—and whether it was getting the billion dollars for treatment through the [21st Century] Cures Act, I think it was a demonstrated priority on the part of the president.

We still have over 140 people dying every single day as a result of drug overdoses. And the entirety of the response can't be, "We're just going to build a wall to stop the flow of drugs coming in from across the border."

This was an epidemic that was created by legally prescribed drugs, here in the United States, and so we need to make sure we're doing everything in our power to make progress. Fundamental to that is making sure people have appropriate and timely access to treatment.

Q: Addiction science is a fairly new field. There's a lot of unanswered questions. How does the administration's interest in federally funded research fit in here?

Any drug policy that's going to be effective has got to be based on science and research.

The research that the National Institute of Drug Abuse and National Institutes of Health funded to understand addiction as a brain disorder and not a moral failing made us pivot to a drug policy that was based on scientific principles. People have raised concerns to what extent those principles and that science are going to continue.

Q: Is this an area you plan to stay involved in?

This has been my life's work, and I have every intent to continue that. I'm trying to decide now in what capacity. But I'm pretty certain I'm going to stay involved.

Q: Do you think policy makers will continue to focus on addiction—not just the administration, but Congress as well?

My hope is that we are not going to lose momentum, and that we're not going to backslide on the focus on the opioid epidemic. We can't. We are losing too many people on a daily basis.

Tom Price made dozens of health industry stock trades during a three-year investigation by the Securities and Exchange Commission that focused on the Ways and Means Committee, according to financial disclosure records he filed with the House of Representa

HHS Pick Price Made 'Brazen' Stock Trades While His Committee Was Under Scrutiny

KFF Health News, February 8, 2017

Tom Price made dozens of health industry stock trades during a three-year investigation by the Securities and Exchange Commission that focused on the Ways and Means Committee, according to financial disclosure records he filed with the House of Representatives.

This article first appeared February 7, 2017 on Kaiser Health News.

By Marisa Taylor and Christina Jewett

Health and Human Services secretary nominee Tom Price showed little restraint in his personal stock trading during the three years that federal investigators were bearing down on a key House committee on which the Republican congressman served, a review of his financial disclosures shows.

Price made dozens of health industry stock trades during a three-year investigation by the Securities and Exchange Commission that focused on the Ways and Means Committee, according to financial disclosure records he filed with the House of Representatives. The investigation was considered the first test of a law passed to ban members of Congress and their staffs from trading stock based on insider information.

Price was never a target of the federal investigation, which scrutinized a top Ways and Means staffer, and no charges were brought. But ethics experts say Price's personal trading, even during the thick of federal pressure on his committee, shows he was unconcerned about financial investments that could create an appearance of impropriety.

"He should have known better," Richard Painter, former White House chief ethics attorney under President George W. Bush and a professor at the University of Minnesota Law School said of Price's conduct during the SEC inquiry.

As Price awaits a Senate vote on his confirmation, Senate Democrats and a number of watchdog groups have asked the SEC to investigate whether Price engaged in insider trading with some of his trades in health care companies. Price has said he abided by all ethics rules, although he acknowledged to the Senate Finance Committee that he did not consult the House Ethics Committee on trades that have now become controversial.

The SEC's inquiry began in 2013, as it battled Ways and Means for documents to develop its case.

A few weeks ago, the day before President Donald Trump's inauguration, the SEC quietly dropped its pursuit of committee documents without explanation, according to federal court records. No charges were brought against the staffer, Brian Sutter, who is now a health care lobbyist. Sutter's lawyer declined to comment.

Craig Holman, government affairs lobbyist with Public Citizen, described Price's volume of stock trades during the SEC inquiry as "brazen," given the congressman's access to nonpublic information affecting the companies' fortunes.

"The public is seeing this and they really don't like it," said Holman whose watchdog group recently filed complaints about Price's stock trading with both the SEC and the Office of Congressional Ethics.

Trump administration officials and Price have dismissed questions that news reports and lawmakers have raised about stock trades coinciding with official actions to help certain companies, saying Price's brokers chose the stocks independently and all of his conduct was transparent.

After acknowledging that he asked his broker to buy stock in an Australian drug company, he told the Senate Finance Committee that he did not direct his broker to make other trades.

"To the best of my knowledge, I have not undertaken such actions," he wrote in response to finance committee questions. "I have abided by and adhered to all ethics and conflict of interest rules applicable to me."

An analysis of Price's trades shows that he bought health stocks in 2007, the first year Congress financial disclosures are posted online. In 2011, the the first year Price sat on the health subcommittee, he traded no health-related stocks, according to his financial disclosures filed with Congress.

That same year, members were facing public criticism because of a book detailing how they could use inside information and a "60 Minutes" investigation focused on how members and staff could legally use inside information to gain from their own stock trades.

In 2012, President Barack Obama signed the Stop Trading on Congressional Knowledge Act to rein in insider trading by members and require more disclosure. Public watchdog groups suggested at the time that the law would curb the practice.

That year, after his one-year break in health care trades, Price resumed investing in health care companies.

Along with investments in technology, financial services and retail stocks, he also bought and sold stock in companies that could be impacted by actions of his subcommittee, which has a role in determining rates the government pays under the Medicare program.

Health care firms spend heavily to influence members of Congress, lobbying on health matters, funding political campaigns and seeking favor with Medicare officials who decide how much the program will pay for certain drugs and devices. The Food and Drug Administration holds similar power, approving or putting conditions on drug and device use.

Beyond his personal investments in health care companies, Price has also advocated their interests in letters to officials and proposed laws, government records show.

In 2012, disclosure records show Price sold stock in several drug firms, including more than $110,000 worth of Amgen stock. Amgen's stock price had steadily climbed out of a recession-level slump, but Price's sale came a few weeks before the company pleaded guilty to illegally marketing an anemia drug.

By 2013, the health subcommittee was at the center of a major conflict between Medicare, which sets Medicare Advantage rates, and the insurance industry. Medicare issued a notice early that year announcing its intention to reduce Medicare Advantage rates by 2.3 percent as part of a major cost-cutting initiative.

That prompted fierce lobbying by the health insurance industry. Members of Congress, including Price, wrote a letter to Marilyn Tavenner, then acting administrator for the Centers for Medicare & Medicaid Services, protesting the rate cut, saying the decrease would "disadvantage vulnerable beneficiaries with multiple chronic conditions."

Ultimately, Medicare decided not to cut rates but instead, to increase them. Yet an hour before Medicare announced the change, a Height Securities analyst fired off a "flash" report to 200 clients that touched off a surge of trading.

The analyst's report said a political deal was hatched on Capitol Hill to prevent the cuts as a condition for moving forward on Tavenner's confirmation. Medicare officials increased rates by nearly 4 percent, a change that would positively impact the bottom lines of health insurance companies.

The SEC began looking for the leak's source, and within weeks, FBI agents began interviewing staffers at the Ways and Means Committee, court records show.

They discovered communications between Sutter and a health care lobbyist. The HHS Inspector General also began a probe, and federal prosecutors briefly examined the matter activity as well.

As the case unfolded, Price bought more health care-related stocks, according to his financial disclosures. He has testified that his broker directed all of the trades, except for his investments in Innate Immunotherapeutics, an Australian company partly owned by Rep. Chris Collins (R-N.Y.), according to Collins' disclosures. An HHS spokesman said Monday that Price held three broker-directed accounts.

Ethics experts have said that Price should have further distanced himself by placing his assets in a blind trust.

On April 30, 2013, Price bought $2,093 worth of stocks in Incyte, a company that develops cancer drugs; $2,076 in Onyx Pharmaceuticals, a drugmaker that would soon merge with a larger drug firm; and $2,097 in Parexel International, a consultancy that helps drugs and devices win FDA approval, according to the financial disclosure records.

The same day, Price shed shares of Express Scripts, a drug management firm, and Danaher, which makes products hospitals and doctor's offices using for testing and diagnostics. In August of that year, he bought a $2,429 stake in Jazz Pharmaceuticals, which makes sleep and cancer drugs.

On May 6, 2014, the SEC served its first subpoena for the Ways and Means Committee documents. The committee launched a vigorous fight, appealing a federal district judge's ruling that it should comply with the SEC subpoena.

Price continued his health stock trades, including $1,000 to $15,000 in drug firms Amgen, Eli Lilly and Co., Pfizer, Biogen and Bristol-Myers Squibb. He also bought stocks in Aetna, a major health insurer, and Athenahealth, which sells electronic medical record and medical billing software. In 2016, he also increased his investment in Innate Immunotherapeutics.

The purchase became controversial because both he and Collins bought stock in a private placement at a discounted price.

"You're asking for trouble if you have access to nonpublic information about the health care industry and you're buying and selling health care stocks," Painter said.

Could Minnesota Health Reforms Foreshadow Repeal And Replace?

KFF Health News, February 7, 2017

In the midst of the uncertainty about the Affordable Care Act, Minnesota has taken three unusual actions.

This article first appeared February 7, 2017 on Kaiser Health News.

By Mark Zdechlik, Minnesota Public Radio

What's going to happen to the federal health law? The quick answer is no one knows. But in the midst of the uncertainty about the Affordable Care Act, states still must govern their insurance markets. Most have been muddling through with the 2017 status quo, but Minnesota is a special case, taking three unusual actions that are worth a closer look.

Last month, Minnesota:

  • Passed a one-time bailout for some consumers in the individual insurance market dealing with skyrocketing premiums.
  • Rejected an attempt to let insurers offer cheaper, bare-bones coverage.
  • Laid the groundwork for a sort of homegrown "public option" insurance plan.

Here's more on each item.

The Bailout
Faced with some of the country's highest hikes on premiums in the individual market — 50 to 67 percent, on average — Minnesota lawmakers passed a bailout for people who earn too much to qualify for the Affordable Care Act's federal tax credit. The $300 million law will cut monthly 2017 premiums by 25 percent for about 125,000 Minnesotans.

Democratic Gov. Mark Dayton backed the measure since October when he called the ACA "no longer affordable to increasing numbers of people." But passage wasn't assured as both houses of Minnesota's legislature are controlled by Republicans.

It is thought to be the second time a state has offered up state tax dollars to stabilize an insurance marketplace created by the ACA. (Alaska came up with a $55 million bailout for insurers in 2016.)

Bare-Bones Coverage
A failed amendment to the Minnesota legislation sought to strip dozens of so-called "essential benefits" from health plans with the expectation that slimmed-down coverage would cost less.

Republican State Rep. Steve Drazkowski, who offered the amendment, said he was trying to eliminate the current, "government-controlled, one-size-fits-all, dictating set of mandates.

"What we're doing is trying to create an environment that, if and when the ACA goes away, that Minnesotans will have the freedoms they need in order to start to bring some free-market competition, some free-market ingenuity and innovation into the health insurance market," he said.

The laundry list of benefits that consumers could choose to have covered or not under Drazkowski's amendment included maternity care, diabetes treatment and mental health care among many others. Some items on the list are very specific: Lyme disease, prostate cancer screenings, outpatient surgery.

Dayton and other Democrats opposed the amendment and it dropped out of the final legislation.

Still, it caught the eye of Minnesota native Andy Slavitt, who is the former administrator of the Centers for Medicare & Medicaid Services, which oversee the health law marketplaces. Slavitt, who tweeted about the amendment, said it is a cautionary tale about high-deductible catastrophic plans that cover little or no basic care.

 

Americans are scared & don't want to go back to pre-existing conditions or "health plans" that look like the new one proposed in MN. 18 pic.twitter.com/z75hyQLnC7

— Andy Slavitt (@ASlavitt) January 28, 2017

 

There's no replacement plan for ACA in Congress.

But good news is there is one put forward in a state to look at. https://t.co/bG9D3IWlZd

— Andy Slavitt (@ASlavitt) January 29, 2017

 

"Telling people, 'Only buy what you need,' implies that people know that they're not going to need the emergency room or that there's not going to be an addiction problem in their family," Slavitt said in an interview. "I don't think we, as a country, want people to not have access to the services they need."

He did not dispute the notion that the individual market needs help, but he says offering extremely limited plans is ill-conceived, "gotcha" insurance.

"This is the most blatant one I've seen," Slavitt said of the failed amendment.

But other amendments did get passed, including a provision that changes longstanding laws requiring HMOs, insurance plans that will cover only services provided by their network of doctors and other health providers, to be not-for-profit. The new law allows out-of-state, for-profit HMOs to sell health plans in Minnesota.

Dayton said these measures were not well thought out. "I think it is unnecessary and unwise to rush the 'reforms' added to this bill, without proper public review or full consideration of their consequences," he said.

A State-Based Public Option?
Minnesota is one of just two states offering a so-called basic health plan that can cover lower and moderate income residents. MinnesotaCare provides subsidized health coverage to about 100,000 state residents, capping eligibility for a family of four at $49,000 in earnings per year. Dayton wants to open the plan to all Minnesotans, with higher income residents paying full price for their coverage.

"This public option could offer better benefits than any policies presently on commercial markets, more options for people to keep their doctors and clinics and less expensive than what is available today," said Dayton during an announcement of his annual budget plan last week.

Dayton said allowing people with higher incomes to buy MinnesotaCare coverage, paying full-freight, would reduce prices and increase competition on the individual market.

Supporters of the "public option" say it could provide better coverage for less cost because the government can leverage its massive buying power to negotiate optimal deals from insurance companies.

Opponents said expanding government's role in health care is a bad idea. As he campaigned for the presidency, Donald Trump said he opposed a national "public option" because it would drive away private insurers, "leaving Americans with fewer options and eventually no choices but a government-run plan."

The one-time bailout is just the beginning of what are expected to be broader health insurance reform efforts in Minnesota. Among them is a renewed call for state-sponsored single payer insurance that is not likely to be well-received in the state's Republican legislature.

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

The Byzantine Rules For Disassembling The Health Law

KFF Health News, February 6, 2017

Since Republicans can't get around a Democratic filibuster in the Senate, they are forced to use an arcane legislative tool called budget reconciliation to disassemble parts of the law.

This article first appeared February 6, 2017 on Kaiser Health News.

By Julie Rovner and Francis Ying

After capturing the White House, Republicans put repealing the health law at the top of their to-do list. But since they can't get around a Democratic filibuster in the Senate, they are forced to use an arcane legislative tool called budget reconciliation to disassemble parts of the law. KHN's Julie Rovner and Francis Ying explain the process.

 

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Renewed Cleaning Efforts For Scopes Not Enough To Vanquish Bacteria

KFF Health News, February 2, 2017

Rigorous cleaning practices don't ensure that medical scopes are free of contamination, and many of these reusable devices have scratches and dents that could harbor blood, tissue and bacteria, a new study found.

This article first appeared January 31, 2017 on Kaiser Health News.

By Chad Terhune

The seven-month study, published Tuesday in the American Journal of Infection Control, found that 12 of 20 gastroscopes and colonoscopes examined tested positive for bacterial growth, even after being disinfected using the current guidelines or additional measures.

In addition, 17 of the scopes were pulled from use at the end of the study and returned to the manufacturer for repair due to serious defects. Photos in the study show numerous scratches and dents on the ends of the scopes that could trap organic material as well as brown stains, debris and residual fluid stuck inside scope channels.

The scopes were relatively new at the beginning of the study and all were manufactured by Tokyo-based Olympus Corp., the leading maker of gastrointestinal scopes used in the United States and worldwide.

"Physicians, other caregivers, hospitals and regulators should be paying keen attention to this issue, as patients have a right to assume that clean instruments are being used on them," said Cori Ofstead, the study's lead author and an epidemiologist in St. Paul, Minn.

Since 2015, federal prosecutors, lawmakers and government regulators have been investigating a series of outbreaks of antibiotic-resistant "superbugs" across the country tied to scopes. Most of the scrutiny has been focused on a specific device known as a duodenoscope, which is used to inspect and treat problems in the gastrointestinal tract. It has been tied to at least 35 deaths in the past four years.

But this study and other outbreak reports suggest a broader problem affecting other types of scopes, which could put more patients at risk of dangerous infections nationwide. However, the bacteria this latest study found weren't the drug-resistant superbugs that can be deadly for patients.

The research was limited to a small number of scopes at one surgery center affiliated with the University of Minnesota Health System. But outside experts said the research was rigorous and raised serious concerns.

"It was quite shocking to see the pictures in this study," said Michelle Alfa, a professor in the department of medical microbiology at the University of Manitoba and an adviser to U.S. regulators on scope testing.

"Those scopes shouldn't be in use. I'm amazed the gastroenterologist could even see anything because the lens was covered in so much crud. The insides look pretty gruesome, too," Alfa said.

Alfa said the staining and discoloration inside the scopes indicated a buildup of biofilm, a slimy material that shields bacteria and other microbes from being removed during cleaning. "It's like your roast pan that gradually gets brown crud baked on it and you can't pick it off," she said.

The U.S. Food and Drug Administration, which regulates medical devices, said it's aware of the study's findings and urges hospitals to immediately remove from service any scopes that show signs of damage.

"The FDA continues to actively monitor challenges associated with reprocessing reusable medical devices and to look for ways to reduce the risk of infection with reprocessed endoscopes," said agency spokeswoman Deborah Kotz.

Since the recent outbreaks and subsequent government warnings, many hospitals have adopted a variety of new safety measures to combat scope-related infections.

But Ofstead said subjecting scopes to additional rounds of manual cleaning, automated washing and a different disinfectant didn't have much impact. "The findings suggest that cleaning wasn't working, perhaps because cleaning doesn't work when endoscopes are damaged," said Ofstead, chief executive of the medical research firm Ofstead & Associates.

This study focused on widely used colonoscopes and gastroscopes, which have somewhat simpler designs than duodenoscopes and are believed to be easier to disinfect. The study didn't track patients and there was no evidence of infection among people treated at the study site.

At the surgery center, researchers split the 20 scopes into two groups. One group got regular cleaning and high level disinfection with glutaraldehyde. The other group received additional cleaning and tests to verify that the scopes were clean before disinfection with peracetic acid.

The colonoscopes, which peer at the inner lining of the large intestine, presented fewer problems than gastroscopes, designed to examine the upper gastrointestinal tract. When the clinic's technicians performed tests to detect contamination, they found the first manual cleaning worked 99 percent of the time for colonoscopes. (Subsequent testing showed further contamination.)

For gastroscopes, only 48 percent were deemed clean after the first try. And 11 percent never reached the benchmark for clean even after two rounds of manual scrubbing and two rounds of automated cleaning and high-level disinfection.

The researchers said gastroscopes may be incurring more damage and becoming more resistant to cleaning due to exposure to stomach acid and bile in the upper gastrointestinal tract. They said more research is needed to determine the reasons and to identify more effective cleaning methods.

Olympus, the device manufacturer, issued repair reports on 14 of the scopes and it said 13 of them had at least one critical defect, according to researchers.

In a statement, the company said it "welcomes additional research and perspectives as helpful to the entire medical community and our own efforts to increase patient safety related to endoscopes."

In October 2015, the FDA ordered Olympus and two other scope manufacturers, Pentax and Fujifilm, to study the effectiveness of their cleaning protocols for duodenoscopes at clinical sites in the field.

Ofstead said medical providers are still waiting for that critical information while problems in the field persist. "They haven't yet published any real-world results showing their protocols work even though the FDA told them to do these studies," Ofstead said.

Those studies appear to be in the early stages, according to data on the FDA website. Olympus said it's planning for its duodenoscopes to be tested for bacterial growth after reprocessing at four different sites.

Linda Greene, a registered nurse and president of the Association for Professionals in Infection Control and Epidemiology, agreed manufacturers need to address the safety issues posed by scope defects.

"The concerns about damage in frequently used scopes begs questions about design issues," said Greene, the manager of the infection prevention program at the University of Rochester's Highland Hospital in New York.

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

Hospitals Worry Repeal Of Obamacare Would Jeopardize Innovations In Care

Hospitals Worry Repeal Of Obamacare Would Jeopardize Innovations In Care

KFF Health News, February 1, 2017

The ACA has used financial incentives to encourage hospitals to experiment with ways to improve care, which has led sizable upfront investment by many hospitals in ACOs, EHRs, staff training and hiring and creating new services.

This article first appeared February 1, 2017 on Kaiser Health News.

By Kristin Espeland Gourlay, RINPR

Much has been written about the 20 million people who gained health insurance under the Affordable Care Act, and what could happen to these patients if the ACA is repealed without a replacement. But some people don't realize that hospitals nationwide could take a big financial hit on several fronts, too.

First, it's likely that fewer patients would be able to pay their hospital bills, health policy analysts say, so the institutions would be stuck with that bad debt, as they were before Obamacare.

"If the Medicaid expansion goes away wholesale, and things go back to the way they were before this expansion was in place, a lot of those hospitals would see an increase in their uncompensated care costs," said Rachel Garfield, an analyst with the Kaiser Family Foundation. The American Hospital Association estimates that hospitals across the U.S. could lose more than $160 billion from the reduction in Medicaid revenue and the increase in unpaid medical bills. (KHN is an editorially independent program of the foundation.)

Then there's this: The ACA has used financial incentives to encourage hospitals to experiment with ways to improve their care of patients, while reducing health care's cost. That sort of experimentation has included a sizable upfront investment by many hospitals.

Massachusetts General Hospital in Boston, for example, signed agreements with physicians and insurers to create accountable care organizations, in hopes of saving money in the long run. With an ACO, insurers pay doctors for making sure the patient is getting the best and most appropriate care, instead of paying for every test and procedure a doctor does.

"We have now more than 20 different programs," said Dr. Timothy Ferris, an internist and medical director of the Mass General Physicians Organization. "Video visits, electronic consultation with specialists, home hospitalization, [and] programs for patients with diabetes and heart disease. I would be worried that a repeal of the ACA would undermine our ability to invest in services for our patients."

Ferris acknowledged that most of those experiments haven't yet saved money. But they need more time to work out the kinks safely, he said.

"One of the things that it's difficult for people outside of health care to appreciate — particularly politicians — is how long it takes to make significant improvements in the delivery of care," Ferris said. "You have to be very careful when you make changes."

Ferris said the threatened repeal of the ACA makes him worry "that the progress we've made over the past five years would be threatened."

Many other hospitals across the country have invested in accountable care organizations — often overhauling their medical records systems, hiring staff and creating new services. Dennis Keefe, head of a large hospital chain called Care New England in Rhode Island, said he, too, worries about the future of his ACO, Integra.

"I think, if there's a real change in direction away from these alternative payment models, we will be assuming risk to care for a population," Keefe said. "We have invested enormously to be successful in this area."

But these seismic changes in the way hospitals do business were predicated, he adds, on long-term support from the federal government — support that might disappear if the ACA is repealed.

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

Demand For Popular Short-Term Insurance Plans Could Surge If Health Law Is Relaxed

KFF Health News, January 31, 2017

"These short-term plans are not regulated like Obamacare plans, so carriers have a lot of flexibility in benefits and pricing," said the executive director of Agile Health Insurance. "It's almost like the old individual market before the ACA."

This article first appeared January 31, 2017 on Kaiser Health News.

By Michelle Andrews

Short-term health plans have been around for decades, bridging coverage gaps for people who are between jobs or have recently graduated from school, among other things. After the health law passed, some people gravitated toward them because they were willing to trade comprehensive coverage for a cheaper sticker price — even if it meant paying a tax penalty for not having the comprehensive coverage required in the law. Sales increased.

Now, as Republicans look for ways to weaken the health law's coverage requirements and explore the possibility of not enforcing the requirement that people have health insurance, short-term plans may be poised to grow even more. If that happens, consumer advocates warn it could be bad for consumers.

As their name suggests, short-term plans provide coverage for a limited period of time, often six months or less. They generally don't cover such things as preexisting conditions, maternity services or prescription drugs. The policies typically have maximum coverage limits of about $1 million. Insurers can turn people down if they're sick and may decide not to renew someone's policy. All of these practices are prohibited in plans that qualify as individual insurance under the Affordable Care Act.

Precisely because of these limitations, however, the premiums are typically a lot cheaper than those for ACA-compliant coverage. In the fourth quarter of 2016, the average monthly premium a shopper would pay for a short-term plan sold through online insurance vendor ehealth.com was $124, compared with $393 for someone who bought a regular Obamacare plan and didn't qualify for premium subsidies.

When the health law passed, insurers increasingly began offering short-term plans that stretched the definition of "short," sometimes providing coverage for as long as 364 days.

"Carriers were exploiting a loophole in the law that defined a health insurance plan as one that was 365 days," said Sabrina Corlette, a research professor at Georgetown University's Center on Health Insurance Reforms. "If they were shorter they didn't have to comply with ACA protections."

Short-term plans serve a tiny but growing proportion of the roughly 22 million people who have coverage on the individual market. At the end of 2013, before the health law's major reforms took effect, there were approximately 108,800 people covered by these policies, which earned premiums of $97.5 million, according to figures from the National Association of Insurance Commissioners. Two years later, roughly 148,100 people had short-term plans and premium earnings have grown to $160.5 million.

Some insurers have taken notice. Online health insurance vendor Health Insurance Innovations launched Agile Health Insurance in the spring of 2015 to focus on sales of short-term plans. In the third quarter 2016, Agile sold 21,000 short-term policies.

"These short-term plans are not regulated like Obamacare plans, so carriers have a lot of flexibility in benefits and pricing," said Sam Gibbs, Agile's executive director. "It's almost like the old individual market before the ACA."

And that's just the problem, said some policy experts.

"To many consumers it looks like health insurance, except it's cheaper," said Karen Pollitz, a senior fellow at the Kaiser Family Foundation. But the plans don't protect people when unforeseen events occur such as a car accident or a cancer diagnosis. With a short-term plan, if you get sick or you're in the hospital when your plan comes up for renewal, "it won't be renewed," Pollitz said. (KHN is an editorially independent program of the foundation.)

Not all insurers embrace widespread sale of short-term plans. "The big health insurance companies are really mixed on this," said Timothy Jost, emeritus professor at Washington and Lee University School of Law and an expert on the health law. "They see this as a seriously destabilizing force in the market, this crap coverage."

Last October, the Obama administration issued a final rule that would make it more difficult for consumers to buy short-term plans to substitute for regular Obamacare plans. The regulation, which takes effect April 1, said short-term plans must be less than three months in duration. People can request a renewal of the policies, but insurers can turn them down. The policies and related materials also have to prominently display a warning that they don't satisfy the law's requirement that people have health insurance.

Some hope that the rule may be changed or rescinded by the Trump administration or overturned by the new Congress under the little-used Congressional Review Act. Neither option can happen at the stroke of a pen, however.

Health insurance brokers and agents are one group that would like to continue to sell longer term short-term plans.

"Our folks do a lot of business with short-term plans," said Marcy Buckner, vice president of government affairs at the National Association of Health Underwriters, an industry group. The regulation is one that the group will request that the Trump administration rescind.

"In most areas [a short-term plan] is cheaper, and it's some consumers' way of saying, 'I don't need all of those things,' " said Buckner.

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