The confirmation of Tom Price, the orthopedic surgeon-turned-Georgia congressman, as secretary of Health and Human Services represents the latest victory in the ascendancy of a little-known but powerful group of conservative physicians in Congress he belongs to — the GOP Doctors Caucus.
During the Obama administration, the caucus regularly sought to overturn the Affordable Care Act, and it's now expected to play a major role determining the Trump administration's plans for replacement.
Robert Doherty, a lobbyist for the American College of Physicians, said the GOP Doctors Caucus has gained importance with Republicans' rise to power. "As political circumstances have changed, they have grown more essential," he said.
"They will have considerable influence over the considerable discussion on repeal and replace legislation," Doherty said.
Price's supporters have touted his medical degree as an important credential for his new position, but Price and the caucus members are hardly representative of America's physician in 2017. The "trust us, we're doctors" refrain of the caucus obscures its heavily conservative agenda, critics say.
"Their views are driven more by political affiliation," said Mona Mangat, an allergist-immunologist and chair of Doctors for America, a 16,000-member organization that favors the current health law. "It doesn't make me feel great. Doctors outside of Congress do not support their views."
For example, while the American College of Obstetrics and Gynecology has worked to increase access to abortion, the three obstetrician-gynecologists in the 16-member House caucus are anti-abortion and oppose the ACA provision that provides free prescription contraception.
While a third of the U.S. medical profession is now female, 15 of the 16 members of the GOP caucus are male, and only eight of them are doctors. The other eight members are from other health professions, including a registered nurse, a pharmacist and a dentist. The nurse, Diane Black of Tennessee, is the only woman.
On the Senate side, there are three physicians; all of them Republican.
While 52 percent of American physicians today identify as Democrats, just two out of the 14 doctors in Congress are Democrats.
About 55 percent of physicians say they voted for Hillary Clinton and only 26 percent voted for Donald Trump, according to a survey by Medscape in December.
Meanwhile, national surveys show doctors are almost evenly split on support for the health law, mirroring the general public. And a survey published in the New England Journal of Medicine in January found almost half of primary care doctors liked the law, while only 15 percent wanted it repealed.
Rep. Michael Burgess, R-Texas, a caucus member first elected in 2003, is one of the longest serving doctors in Congress. He said the anti-Obamacare Republican physicians do represent the views of the profession.
"Doctors tend to be fairly conservative and are fairly tight with their dollars, and that the vast proportion of doctors in Congress [are] Republican is not an accident," Burgess said.
Price's ascendancy is in some ways also a triumph for the American Medical Association, which has long sought to beef up its influence over national health policy. Less than 25 percent of AMA members are practicing physicians, down from 75 percent in the 1950s.
Price is an alumnus of a boot camp the AMA runs in Washington each winter for physicians contemplating a run for office. Price is one of four members of the caucus who went through the candidate school. In December, the AMA immediately endorsed the Price nomination, a move that led thousands of doctors who feared Price would overturn the health law to sign protest petitions.
Even without Price, Congress will have several GOP physicians in leadership spots in both the House and Senate.
Those include Rep. Phil Roe of Tennessee, the caucus co-chair, who also chairs the House Veterans Affairs Committee, and Burgess, who chairs the House Energy and Commerce subcommittee on health. Sen. Bill Cassidy of Louisiana sits on both the Finance and the Health, Education, Labor and Pension Committees. Sen. John Barrasso of Wyoming chairs the Senate Republican Policy Committee.
Roe acknowledges that his caucus will have newfound influence. Among his goals in molding an ACA replacement are to kill the requirement that most people buy health insurance (known as the individual mandate) as well as to end the obligation that 10 essential benefits, such as maternity and mental health care, must be in each health plan.
He said the caucus will probably not introduce its own bill, but rather evaluate and support other bills. The caucus could be a kingmaker in that role. "If we came out publicly and said we cannot support this bill, it fails," Roe said.
The GOP Doctors Caucus has played a prominent role in health matters before Congress. For example, in 2015, when former House Speaker John Boehner needed help to permanently repeal a Medicare payment formula that threatened physicians with double-digit annual fee cuts, he turned to the GOP Doctors Caucus. It got behind a system to pay doctors based on performance — the so-called doc fix.
"When the speaker had a unified doctors' agreement in his coat pocket, he could go to Minority Leader Nancy Pelosi and show that, and that had a lot to do with how we got this passed," Roe said.
But not all doctors are unified behind the caucus. Rep. Raul Ruiz, one of the two physicians in the House who are Democrats, said he worries because few doctors in Congress are minorities or primary care doctors.
Ruiz, an emergency room physician from California who was elected in 2012, said he is wary about Price leading HHS because he is concerned Price's policies would increase the number of Americans without insurance.
Indeed, many doctors feel the caucus' proposals will not reflect their views — or medical wisdom. "My general feeling whenever I see any of their names, is that of contempt," said Don McCanne of California, a senior fellow and past president of the Physicians for a National Health Program. "The fact that they all signed on to repeal of ACA while supporting policies that would leave so many worse off demonstrated to me that they did not represent the traditional Hippocratic traditions which place the patient first."
Robert Califf, MD, who stepped down last month, shared his thoughts about keeping Americans safe — and making sure drugs actually work — after about a year overseeing the federal agency.
The just-departed commissioner of the Food and Drug Administration has concerns about plans to speed up drug approvals and dramatically reduce regulations at the agency, as advocated recently by President Donald Trump.
Dr. Robert Califf, who stepped down last month, shared his thoughts about keeping Americans safe — and making sure drugs actually work — after about a year overseeing the federal agency. His takeaways:
1. Faster drug approvals, being advocated by Trump and others, don't necessarily mean less expensive drugs.
"What I'm concerned about is that when people hear 'faster approval,' you get an image of the FDA sitting on this application and, you know, twiddling thumbs," Califf said. "That's not what happens."
Califf explained that the slow part of getting a drug into patients' hands happens well before the drugmaker submits an application to the FDA. It can take decades to discover, tweak and test a new drug molecule, and that development process is what needs a boost.
"The real action [happens] before the application gets submitted and that can be a time frame from years to decades as people try to figure out what will work and what will not," Califf said.
Although faster drug development could bring development costs down, Califf said, "There's not a direct relationship between the cost of development and the price of drugs or devices."
2. A law passed in December should streamline drug approvals — in a positive way.
The 21st Century Cures Act, a bipartisan bill signed by President Barack Obama late last year, is a "very well-rounded piece of legislation that will speed up product development."
To begin with, it encourages the FDA to consider pieces of information in its approval process in addition to traditional clinical trials, including "real world evidence" and biomarkers. Biomarkers are used in studies in place of outcomes that are more difficult to measure. For example, tumor shrinkage is sometimes a biomarker for surviving cancer.
"Using real world evidence in clinical trials is one that I'm particularly excited about as a way to get better answers at a lower cost and faster at the same time," Califf said.
3. But Califf has concerns about maintaining drug safety standards and ensuring thorough clinical trials.
"The concept of safety is much more complex than most people think about until they look into it deeply," Califf said. "All drugs have risk. None of them are absolutely safe. And the actual safety risks are only revealed through clinical trials with the same quality and number of patients involved as it takes to look at efficacy."
About 92 percent of drugs that get into human clinical trials don't make it to market because they fail to show any benefit or, worse, they have unexpected toxicity, he said.
"Declaring a drug is safe after very little information is treacherous," Califf said.
Califf recently wrote for JAMAon the FDA's balancing act of protecting the public and encouraging innovation. And the FDA released a paper last month documenting examples of a promising drug, vaccine or device that each did well in a Phase 2 clinical trial but "bombed out" in Phase 3, Califf said. Drugs typically go through three "phases" of studies called clinical trials before gaining FDA approval. With each new phase, researchers test drugs or other products on more people and on more measures of safety and effectiveness.
"It's 22 examples of why it's a big mistake to think that you can judge the balance of risk and benefit from a small amount of data," Califf said.
4. Faster, better drugs can't be approved if the FDA is understaffed, he argued.
Califf called a potential FDA hiring freeze "unfortunate" and said new staff is needed to meet the faster approval timelines and to give advice to those developing drugs so "bad mistakes" aren't made.
The FDA has been steadily hiring staff to keep up with the growing industry it oversees. But hundreds of openings are still left to be filled.
Califf said the drug industry's most valued interaction with the FDA is "during the process of [drug] development," which begins before a drug application is submitted for approval. FDA staff can provide timely feedback and advice that can help a company choose the right studies needed for approval and, effectively, speed up drug development.
"A hiring freeze at this time when we are just revving up with 21st Century Cures is unfortunate. I hope that the dust will settle soon and the FDA can get back to its hiring," Califf said.
5. The FDA is using big data to track the safety of drugs already on the market — and it plans to do that a lot more.
The FDA has an established adverse event database but after pain reliever Vioxx was pulled from the market in 2004, the agency began working on a system called Sentinel.
The initiative uses claims data to look at drug safety. It has 180 million individual electronic records and tracks every dispensed prescription, hospitalization as well as serious outcomes, Califf said. In addition, Sentinel is now being opened up to industry and academia.
"It's used every day by the FDA," Califf said, adding that the system is "getting better and better."
KHN's coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.
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.
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.
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:
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.
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.
President Trump's promise to undo the health law could compromise anti-addiction efforts, says President Obama's former "drug czar," Michael Botticelli.
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 Representatives.
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.
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
"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.
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.
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.
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.
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.