The doctor and venture capitalist, who announced his resignation Tuesday as FDA commissioner, served nearly two years in the Trump administration.
After having served as Food and Drug Administration commissioner since the early months of the Trump administration, Scott Gottlieb, MD, plans to resign in about a month, the administration said Tuesday.
HHS Secretary Alex Azar released a short statement praising Gottlieb's accomplishments and confirming earlier press reports on the departure. Azar called Gottlieb "an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation."
"I will personally miss working with Scott on the important goals we share, and I know that is true for so many other members of the HHS family," Azar said.
"Scott's leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco and youth e-cigarette use, chronic disease, and more," Azar added. "The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years."
Azar's statement came after The Washington Post's Laurie McGinley and Lenny Bernstein published a 1,700-word story on Gottlieb's departure about 3 p.m., citing "an administration official." The story reported that Gottlieb, a wealthy venture capitalist, wishes to spend more time with his family, based in Westport, Connecticut.
Gottlieb had as recently as two months ago sought to quash rumors that he would be departing the agency. "I'm not leaving," he wrote in a January tweet. "We've got a lot [of] important policy we'll advance this year. I look forward to sharing my 2019 strategic roadmap soon."
In a resignation letter published by Axios, Gottlieb said he's confident the FDA will continue to advance its ambitious goals after his departure.
Widely Respected, Despite Concerns
While some agency heads have prioritized the Trump administration's deregulatory agenda, Gottlieb has won approval for his active embrace of the FDA's authority.
"Commissioners come, and commissioners go, but Scott Gottlieb hands down has been the best," Richard Pazdur, director of the FDA's oncology center of excellence, told The Wall Street Journal's Thomas M. Burton and Jennifer Maloney.
Robert Califf, who was FDA commissioner during the Obama administration, told the Post that Gottlieb did "a great job."
One of his biggest accomplishments at the FDA was accelerating the approvals process for generic drugs while prioritizing cases involving steep prices and a lack of competition, as Bloomberg Opinion columnist Max Nisen wrote, adding that Gottlieb's departure means the Trump administration is "set to lose one of its most competent officials."
Not unlike Azar, Gottlieb's past ties to the pharmaceutical industry had critics worried he might go easy on drug makers and business interests in general. But many naysayers overlooked key attributes that set Gottlieb on a different path, including his penchant for frequent public pronouncements, Ed Silverman wrote for Stat News.
"Gottlieb never missed an opportunity to clearly signal what was going on at the FDA, a politically adept move that he hoped would give him a chance to shape policy rather than have new dictates imposed on him," Silverman wrote.
Centers for Medicare & Medicaid Services Administrator Seema Verma called Gottlieb "a great leader" and "a wonderful friend."
"I am honored and privileged to have had the opportunity to work alongside him and see all that he has accomplished for the American people to spur medical innovation, increase access to generic drugs, and advance many other public health priorities," Verma said in a statement. "I join the entire HHS family in thanking him for his service."
Editor's note: This story was updated Wednesday, March 6, 2019, with additional commentary.
The CMS administrator says a favorite talking point among Democratic presidential hopefuls poses 'the greatest threat to the American healthcare system.'
The head of the federal agency that oversees Medicare stepped up her criticism Monday of a push by some Democrats to expand the program to cover the whole country.
Centers for Medicare & Medicaid Services Administrator Seema Verma has previously criticized the "Medicare-for-All" proposals being proffered by liberal lawmakers and presidential hopefuls, even calling the idea last year's "scariest Halloween costume."
Her remarks Monday at the 2019 Federation of American Hospitals (FAH) Public Policy Conference & Business Expositionin Washington, D.C, however, settled on a more dire superlative, saying "Medicare-for-All" proposals pose "the greatest threat to the American healthcare system."
"Let me be clear: Expanding Medicare will ruin the program for the seniors it was created to serve, and it would decrease the quality of care that we, as Americans, have come to expect as the world's leader in innovative health care," Verma said.
Resorting to a fully government-driven healthcare system would impede advances in care and exacerbate Medicare's existing problems, she said, rhetorically tying "Medicare-for-All" to a favorite bogeyman of the Trump administration.
"Now, it's true that our present system needs improvement; however, doubling down on government and mimicking the failed socialist healthcare systems of Europe that ration and restrict care, where patients face long periods of time for care, is not the answer," Verma added.
Instead, policymakers should focus on "the hard work" of curbing costs. The best way to do that, she said, is to embrace competition, empower patients with information about price and care quality, scale back regulations, and promote innovation.
While there's no reason to doubt the sincerity of Verma's criticism, some accuse the Trump administration of resorting to scare tactics and political caricature when its officials say "Medicare-for-All" will necessarily lead to failure and socialism. This was the case, anyway, after President Trump similarly invoked socialism in a USA Today op-ed last fallto criticize Democrats and their "Medicare-for-All" proposals.
At the least, Verma's speech should be heard in its political context. It comes shortly after Rep. Pramila Jayapal, D-Wash., introduced a "Medicare-for-All" bill, as Democrats who took control of the House this year see healthcare policy talk as a winning issue, and as a crowded field of Democratic presidential hopefuls ramps up to the 2020 election. When asked about socialism by political pollsters, half of Americans reacted negatively, while just 18% reacted positively, which explains why Trump and fellow Republicans have sought to attach the classification to Democratic policies and politicians alike, as CNBC's John Harwood wrote Sunday.
Verma's remarks were delivered to a host that has indicated at least some agreement with her position. FAH President and CEO Charles "Chip" N. Kahn III released a statement last week opposing Jayapal's bill, and an FAH spokesperson says the organization is a member of the Partnership for America's Healthcare Future(a broad coalition that has mobilized to oppose "Medicare-for-All").
Some had worried the merger would drive prices higher and reduce healthcare access, so state regulators imposed a seven-year price cap and other conditions.
The merger of two major health systems in Massachusetts became official on Friday, forming Boston-based Beth Israel Lahey Health.
"This is just the beginning of our journeyto transform health care in Massachusetts into what we know it can and should be," President and CEO Kevin Tabb, MD, said in a statement Friday.
The combined organization has 13 hospitals, including four academic and teaching hospitals affiliated with Harvard Medical School and Tufts University School of Medicine. It also employs more than 800 primary care doctors and 3,500 specialty physicians.
The tie-up won conditional approval last November from Massachusetts Attorney General Maura Healey, who reached a settlement that includes a seven-year price capto guarantee that BILH keeps its price increases below the state's healthcare cost growth benchmark.
The Federal Trade Commission decided to close its investigation in light of Healey's settlement.
Some had worried the merger would drive prices higher and reduce healthcare access after a report by the Massachusetts Health Policy Commission found the deal would increases costs by $231 million annually and put pressure on smaller hospitals.
The formation of BILH comes as another Boston-based health system, Partners HealthCare, eyes a major target of its own: Care New England, based in Providence, Rhode Island.
Hospitals have long complained that the ratings fail to convey an accurate picture of care quality.
Hospital star ratings were updated publicly Thursday for the first time since 2017, despite long-running accusations that the government's methodology presents a distorted picture of care quality.
The Centers for Medicare & Medicaid Services had repeatedly delayed the release of the updated ratings, citing "stakeholder concerns." Hospitals had complained that preliminary data for the July 2018 release showed inexplicably dramatic shifts in ratings that added to concerns over their reliability.
In announcing the update to the Hospital Compare and Medicare data websites Thursday, CMS Administrator Seema Verma both defended the star ratings and signaled that changes are in the works.
"These decision-making tools offer greater transparency on hospital performance for a wide variety of users—patients, caregivers, families, and the broader healthcare industry," Verma said. "We constantly aim to improve these resources with feedback from stakeholders, and we are confident this latest update of Hospital Compare data further strengthens this data."
The announcement included a list of potential changes to the hospital star ratings and asked the public to comment on the ideas. The changes being considered include a plan to compare hospitals to their similarly situated peers. Comments are due March 29.
Bruce Siegel, MD, MPH, president and CEO of America's Essential Hospitals, said it's "unfortunate" that CMS decided to go ahead and release the data while proposing changes that Siegel says recognize flaws in the methodology.
"Those flaws contribute to ratings that mislead consumers and disadvantage hospitals that care for vulnerable patients, rather than reflect true hospital performance and improvement," Siegel said in a statement. "The ratings also fail to account for social risk factors beyond a hospital’s control and that affect performance."
The updated ratings are available on the Hospital Compare website.
This marks the third time in four years that the Houston-based nonprofit health system's top executive has left the organization, including two retirements and a resignation.
After serving more than a decade as an executive at Memorial Hermann Health System, President and CEO Charles "Chuck" D. Stokes has announced plans to retire at the end of this year.
Stokes joined the Houston-based nonprofit in 2008 as chief operating officer, and he would have been happy to finish out his career in that position, as he told HealthLeaders last year.
Stokes said he wasn't a candidate for the top executive job when longtime President and CEO Dan Wolterman retired in 2016. Benjamin K. Chu, MD, was hired as Wolterman's successor. But when Chu resigned one year later, Stokes stepped into the CEO role in 2017.
"We have always known it was Chuck's intention to retire this year, and we are incredibly appreciative that he decided to make Memorial Hermann the last stop in his long and storied career," Memorial Hermann Board Chair Deborah M. Cannon said in a statement Wednesday.
Stokes, who began his career as a registered nurse, told staff of his retirement in an internal memo Wednesday, as Houston Business Journal's Chris Mathews reported.
"I have penned many memos in my 40-year career, but none as difficult as this," Stokes reportedly wrote. "It is with bittersweet emotions and profound gratitude that today I announce my decision to retire at the end of this calendar year."
The retirement announcement comes about three weeks after Memorial Hermann and Dallas-based Baylor Scott & White Health called off their merger talks. Combining the two organizations would have created the largest nonprofit health system in Texas and one of the largest in the country with 68 hospitals and combined revenue of more than $14 billion. The parties didn't give a specific reason for the fizzling of their proposed deal.
An executive search firm has been hired to conduct a nationwide search for a new president and CEO, the health system said, noting that the board will consider internal and external candidates alike. Stokes will continue to serve as president and CEO until his successor is in place.
Hospitals have joined with insurers, doctors, and drug makers on a coalition to oppose the policy, which has become a favorite talking point among Democrats running for president.
As liberal politicians begin to flesh out the details of what they each mean when they say they support "Medicare-for-All," healthcare industry lobbying groups are moving to oppose the idea as overly disruptive and potentially harmful.
American Hospital Association President and CEO Rick Pollack said in a blog post Friday that the proposals being touted by Democrats in Congress and those running for president "could do more harm than good to patient care."
"Our first priority should be fixing what's broken instead of ripping apart our entire health care system and starting from scratch," Pollack wrote, complaining that government reimbursements are insufficient to cover the cost of care and can be unreliable in the face of government shutdowns.
And hospitals are far from the only industry stakeholders to oppose Medicare-for-All. Insurance companies, doctors, and drug makers, too, have joined with the AHA and other groups in a coalition to oppose the policy. That coalition, the Partnership for America's Health Care Future, is steered by Lauren Crawford Shaver, who worked for Hillary Clinton's presidential campaign in 2016, as The New York Times reported.
Pollack pushed for policymakers to build on the Affordable Care Act's foundation, expand Medicaid in every state that hasn't done so already, and guard the long-term viability of Medicare and other federal health programs.
"As a politically practical matter, we need to focus on finding consensus to improve the system we have rather than subject the nation to yet another polarizing debate on health care," Pollack wrote.
A closely watched trade-secrets dispute in a federal courtroom ended with the judge rejection Optum's request for a temporary restraining order, sending the parties to arbitration.
The federal judge overseeing a lawsuit brought by UnitedHealth Group's Optum Inc. against a former executive who left the company for a high-level job with Amazon's healthcare initiative said late Friday that he will allow the executive to work for the new venture.
Optum had asked the judge for a temporary restraining order to block David Smith from contributing to the venture's work, arguing that Smith would be taking Optum trade secrets to a competitor. Smith, meanwhile, had asked the judge to send the parties into closed-door arbitration.
After hearings on Friday, U.S. District Judge Mark Wolf rejected Optum's request and allowed Smith's, putting court proceedings on hold until the arbitration process is complete.
"If the parties agree to a resolution to their dispute, they shall promptly inform the court and this case will be dismissed," Wolf wrote.
"If and when the arbitrator issues a decision, the party that did not prevail shall promptly report whether it or he intends to appeal the decision to this court," he added. "If it or he does not, this case will be dismissed."
A spokesperson for Optum told HealthLeaders in a statement Monday that the company will not back down from its challenge.
"We are committed to protecting our confidential information and will aggressively do so in arbitration," the Optum spokesperson said.
An attorney for Smith declined to comment.
Since it was filed last month, the lawsuit has been closely watched for clues about Amazon's joint venture with Berkshire Hathaway and JPMorgan Chase, a much-hyped initiative described as "ABC" in court filings. The case highlights a sense of unease among some major incumbents in the healthcare industry as aspiring disruptors scope out one or more entry points.
Smith and his two ABC-funded legal teams argued the matter is a "purely private dispute," but the parent companies for The Boston Globe and The Wall Street Journal persuaded Wolf to unseal testimony that had previously been withheld from the public. The unsealed testimony revealed that ABC aims to "make health insurance intelligible," as Kate Sheridan reported last week for Stat, a healthcare-focused standalone site produced by the Globe.
The testimony from ABC Chief Operating Officer Jack Stoddard revealed the venture is asking if it can "reinvent what insurance looks like in terms of benefit design," as the Journal's Jon Kamp and Anna Wilde Mathews reported. While the venture is scrutinizing pharmacy costs, Stoddard said there are no plans to compete with pharmacy-benefit managers, the Journal reported.
In denying Optum's motion, Wolf said the company had failed to establish that Smith was likely to violate a noncompete agreement, noting that the Amazon-backed venture doesn't currently offer any products that compete with Optum's business and could become a customer of Optum rather than a competitor, as Reuters' Nate Raymond reported.
A long-running feud between UPMC and Highmark is heating up as the expiration date on a five-year consent decree draws near.
Two weeks after Pennsylvania Attorney General Josh Shapiro announced a lawsuit accusing the University of Pittsburgh Medical Center (UPMC) of neglecting its charitable obligations, the nonprofit countersued on Thursday, claiming the state's top law enforcement official lacks the legal authority to meddle in UPMC's negotiations with Highmark and other health plans.
Shapiro asked a state court to modify a five-year consent decree that govern UPMC's dealings with Highmark and which are set to expire this summer. His actions are needed "to restore fairness to the healthcare system" in the region, he said. But UPMC's countersuit alleges that Shapiro has crossed not only a legal line but also a constitutional one.
"Without rulemaking, legislation or public comment, ... Shapiro has announced new 'principles' that radically (and often in direct contravention of existing federal and state law) change how nonprofit health insurers and providers operate, now rendering the Attorney General the arbiter of how nonprofit health organizations should envision and achieve their mission," the UPMC complaint states.
The UPMC-Highmark feud has been long-running, as the payer-provider organizations have jockeyed for market dominance in western Pennsylvania. State officials required the two to work together, imposing a consent decree in 2014 that required each health plan to cover services provided by the other organization. That decree is set to expire June 30.
In a separate filing on Friday, UPMC asked a federal judge to issue a preliminary injunction to prevent Shapiro from proceeding with his efforts.
The joint letter comes two months after major payer groups outlined a framework of their own, as the industry debates who's to blame for unexpected medical bills.
Six major hospital groups sent a joint letter Wednesday to lawmakers on Capitol Hill, where a rare show of bipartisan political willseems to be forming around the potential for legislation to combat surprise medical bills.
The groups acknowledged the stress and financial burden unexpected bills can have on patients, and they gave Congress a checklist to consider in drafting legislation to address the problem.
Their letter came two months after health plans outlined a framework of their own, in a joint letter with business and consumer groups, highlighting the competing interests at play among industry players who have at times blamed each other.
"We must work together to protect patients from surprise bills," the hospital groups' letter states, outlining a checklist with eight critical items for legislators to consider:
1. Define 'surprise bills.'
The hospital groups said surprise bills typically occur in three scenarios: (1) when someone uses out-of-network emergency services, such as while traveling, (2) when someone uses out-of-network physician services at an in-network hospital, and (3) when a health plan declines to cover emergency services deemed to be unnecessary.
2. Protect the patient financially.
Providers should not engage in balance billing, the letter states.
"Patients should have certainty regarding their cost-sharing obligations, which should be based on an in-network amount," the hospital groups wrote.
3. Ensure patient access to emergency care.
Patients should be able not only to access emergency services but also enjoy coverage for those services without having to self-diagnose in advance, the letter states.
"This requires that health plans adhere to the 'prudent layperson standard' and not deny payment for emergency care that, in retrospect, the health plan determined was not an emergency," the hospital groups wrote.
4. Preserve the role of private negotiation.
Lawmakers shouldn't empower the government to set fixed payments or reimbursement for healthcare services that are out-of-network, as that "could create unintended consequences for patients by disrupting incentives for health plans to create comprehensive networks," the letter states.
5. Remove the patient from health plan/provider negotiations.
"Patients should not be placed in the middle of negotiations between insurers and providers," the hospital groups wrote. "Health plans must work directly with providers on reimbursement, and the patient should not be responsible for transmitting any payment between the plan and the provider."
6. Educate patients about their health care coverage.
Providers, health plans, employers, and others should all seek to boost healthcare literacy among patients, they argued.
"We urge you to include an educational component to help patients understand the scope of their health care coverage and how to access their benefits," the hospital groups told lawmakers.
7. Ensure patients have access to comprehensive provider networks and accurate network information.
Health plans should be giving patients easy-to-understand information about their provider network, and regulators should make sure both that the health plan provider networks are adequate and that provider directors are accurate, the hospital groups wrote.
8. Support state laws that work.
With a nod to state-led efforts to protect patients from surprise bills, the hospital groups said federal policies should account for various state laws.
"Any federal solution should provide a default to state laws that meet the federal minimum for consumer protections," they wrote.
The letter was signed by six organizations: the American Hospital Association, America's Essential Hospitals, Association of American Medical Colleges, Catholic Health Association of the United States Children's Hospital Association, and the Federation of American Hospitals.
The statement expresses support for handling medical errors with 'a full and confidential peer review process.'
As a former nurse for Vanderbilt University Medical Center in Nashville, Tennessee, was scheduled to appear in court Wednesday morning for an arraignment on felony charges of reckless homicide and impaired adult abuse, the American Nurses Association raised concerns about the precedent the case could set.
Radonda Vaught administered a fatal dose of the wrong medication to a 75-year-old woman in late 2017, after overriding system safeguards, as The Tennessean's Brett Kelman reported, citing an investigation report by the Centers for Medicare & Medicaid Services. That incident, which VUMC reportedly failed to conveyto the medical examiner, prompted CMS to threaten VUMC's Medicare status last November.
Vaught was indicted earlier this month, prompting the ANA to voice some concerns.
"Health care is highly complex and ever-changing resulting in a high risk and error-prone system," the ANA said in a statement Tuesday. "However, the criminalization of medical errors could have a chilling effect on reporting and process improvement."
The statement, which specifically mentions Vaught's case, expresses support for handling medical errors with "a full and confidential peer review process."
The ANA also offered its condolences to the those who have suffered as a result of this error.
"This tragic incident should serve as reminder to all nurses, other health care professionals, and administrators that we must be constantly vigilant at the patient and system level," the ANA added.