Well-known healthcare executives, public officials, and others are in D.C. this week for the AHA's annual membership meeting.
The annual membership meeting of the American Hospital Association is well underway in Washington, D.C., where events began Sunday and will continue through Wednesday, with appearances by a number of noteworthy guests.
Public officials slated to make appearances Monday include Health and Human Services Deputy Secretary Eric D. Hargan; Sen. Roy Blunt, R-Missouri; and Adam Boehler, director of the Center for Medicare and Medicaid Innovation, according to the AHA's schedule.
They will be followed Tuesday by former HHS secretary Rep. Donna Shalala, D-Florida; Rep. Richard Neal, D-Massachusetts; Rep. Michael Burgess, MD, R-Texas; and retired four-star General Colin Powell. Then attendees will hear from Speaker of the House Nancy Pelosi, D-California, and Senate Majority Leader Mitch McConnell, R-Kentucky, each of whom will share about their legislative priorities and the state of healthcare policymaking.
The annual meeting's schedule also includes a number of prominent healthcare executives, of course, including Carilion Clinic President and CEO Nancy Howell Agee, who was AHA chair last year; Atlantic Health System President and CEO Brian Gragnolati, FACHE, who is current AHA board chair; and Saint Luke's Health System President and CEO Melinda L. Estes, MD, who will be AHA board chair next year.
More information about the annual meeting is available on the AHA website.
The change will make it more likely that MA plans offer telehealth benefits outside their supplemental benefit offerings, CMS said.
In a final rule finalized Friday, the Centers for Medicare & Medicaid Services (CMS) granted greater leeway for Medicare Advantage plans to offer telehealth benefits for plan year 2020.
The change, which was proposed last October, will make it more likely that MA plans offer telehealth benefits outside their supplemental benefit offerings, thereby expanding access to telehealth services for patients who reside in rural or urban areas alike, CMS said.
"With these new telehealth benefits, Medicare Advantage enrollees will be able to access the latest technology and have greater access to telehealth. By providing greater flexibility to Medicare Advantage plans, beneficiaries can receive more benefits, at lower costs and better quality," CMS Administrator Seema Verma said in a statement announcing the development.
Friday's announcement came after CMS released a package of MA payment and policy updates Monday, when the agency finalized plans to grant MA plans greater flexibility in the supplmental benefits they choose to offer.
The part-time role will reportedly occupy only about six hours of Gottlieb's time each month, leaving quite a bit of latitude for family time and pondering future endeavors.
Nearly two years after becoming commissioner of the Food and Drug Administration, Scott Gottlieb, MD, will leave his government post Friday and return to a private-sector role with the American Enterprise Institute.
Gottlieb, who first joined the conservative think tank in 2002, will return to AEI as a resident fellow in health policy studies, the organization said Friday in a statement confirming earlier media reports. Michael Strain, AEI's director of economic policy studies, said the organization is honored to have Gottlieb back.
"All Americans have benefited from his important work at the FDA," Strain said in the statement.
After announcing his resignation last month, Gottlieb expressed confidence in FDA's direction.
"I feel very good about the inflection pointthat FDA is at right now, stepping away from that," Gottlieb said during a moderated discussion last month at the Brookings Institution, adding that he wouldn't leave if he weren't sure the FDA would continue along its current trajectory of success.
Gottlieb has been vocal about his views on what's ailing the healthcare industry, repeatedly criticizing prescription drug makers, pharmacy benefit managers (PBMs), and health plans for their roles in driving drug prices higher. As head of the FDA, he advanced policies to curb cost increases by empowering competitive market forces. To the general public, he may be best known for focusing on tobacco and vaping, especially among teenagers.
In an interview with The New York Times' Sheila Kaplan, Gottlieb said his work for AEI will be part-time, perhaps only about six hours per month. He's not sure what other work he will take on next. Before taking on another full-time workload, he reportedly plans to spend the summer with his family.
Gottlieb, who had several other healthcare-related public-sector positions before his time as the head of the FDA, has been a practicing physician, a venture capitalist, an entrepreneur, an adviser and board member to a drug company, and more, as the Times reported.
Gottlieb will be succeeded as FDA commissioner, for the time being, by Norman E. "Ned" Sharpless, MD, who is currently director of the National Cancer Institute. Sharpless is said to be in the running to serve as Gottlieb's permanent successor.
Insulin manufacturers have long been criticized for raising their list prices year after year. Now the FDA aims to make it easier to compete.
As insulin manufacturers and pharmacy benefit managers (PBM) face increasing pressure over rising list prices for the drugs millions of diabetics need to survive, the Food & Drug Administration has a plan to curb costs by spurring competition.
Insulin products have been approved as drugs under the Federal Food, Drug, and Cosmetic Act, but the FDA wants to transition insulin to an abbreviated approval pathway for licensure as biologics under the Public Health Service Act in 2020. This transition for insulin and certain other biologics follows congressional intent behind the Biologics Price Competition and Innovation Act (BPCI Act)—which was passed as part of the Affordable Care Act in 2010—outgoing FDA Commissioner Scott Gottlieb, MD, said Tuesday.
"The transition of insulin from the drug to the biologics pathway will open up these products to biosimilar competition," Gottlieb said in a statement. "We're already seeing robust activity among sponsors seeking to bring forward biosimilar copies of insulin."
"Once an interchangeable insulin product is approved and available on the market, it can then be substituted for the reference product at the pharmacy, potentially leading to increased access and lower costs for patients," Gottlieb added. "The FDA anticipates that biosimilar and interchangeable insulin products will bring the competition that's needed to help bring affordable treatment options to patients."
Insulin manufacturers have long been criticized for raising their list prices year after year. Eli Lilly & Co.'s popular fast-acting insulin product Humalog had a list price of about $21 per vial when it first came to market in 1996, but that price rose incrementally over the years, to nearly $100 in 2009, then $275 last year, as Kaiser Health News reported.
Lilly said last month that it will offer a half-price authorized generic version of Humalog for $137.35 per vial—a move that Mayo Clinic hematologist Vincent Rajkumar, MD, and others have described as a gesture made for the sake of public relations.
PBMs, too, have taken action to address the public outcry. Cigna's Express Scripts, one of the nation's largest PBMs, said Wednesday it will give clients the option to limit monthly out-of-pocket insulin costs at $25 per month, as The Wall Street Journal's Joseph Walker reported. The move comes as the Trump administration has blamed PBM middlemen for a chunk of the high cost of U.S. healthcare.
Amid all of this, the FDA said Tuesday that it will host a public hearing May 13 to discuss insulin's affordability and the plan to transition to a biosimilar evaluation and approval process.
"We understand the urgent need to address the high prices and lack of competition in the insulin market," Gottlieb said.
"A drug that's nearly a century old should not have a list price that increases between 15-17% annually," he added. "American patients who rely on insulin to live deserve to have high-quality, affordable options."
The inspector general's tenure will end next month, then his longtime deputy will take the reins.
After serving 15 years as Health and Human Services Inspector General, Daniel R. Levinson resigned Tuesday.
The HHS Office of Inspector General confirmed Levinson's resignation, saying his departure will be effective May 31. Principal Deputy Inspector General Joanne Chiedl, who has worked alongside Levinson for nine years, will step in as acting inspector general on June 1, according to an HHS OIG spokesperson.
In his resignation letter addressed to the president, Levinson did not give a reason for his departure.
"Serving the Nation as the HHS IG for the past decade and a half has been a great privilege and a high honor," he wrote. "I am grateful for the support of your Administration in continuing to help provide the resources necessary for this office to fulfill its important work to protect HHS programs from fraud and abuse, and to promote economy, efficiency and effectiveness in program operations."
In a statement released Tuesday afternoon, HHS Secretary Alex Azar praised Levinson as "a valued friend and colleague since our time together beginning at HHS in the 2000s."
"Under Dan’s leadership, the HHS Office of Inspector General (OIG) has done tireless, invaluable work to protect program beneficiaries and taxpayer funds, improve the management and integrity of HHS programs, and respond to emerging challenges such as the ongoing opioid crisis," Azar said. "In 2018, it was an honor to see OIG participate in another record-breaking Healthcare Fraud Takedown Day, charging defendants with schemes involving more than $2 billion in false billings.
"Dan should be proud of the results of his work as Inspector General, as should every member of OIG," Azar added.
Editor's note: This story has been updated to include a statement from HHS Secretary Alex Azar.
'Vote will be taken right after the Election when Republicans hold the Senate & win ... back the House,' Trump tweeted a week after his administration shifted its position on the ACA's legality.
In a series of tweets Monday evening, President Donald Trump appeared to punt his renewed focus on eliminating and replacing the Affordable Care Act until after the 2020 election.
The White House made news a week earlier by shifting its position on the ACA's legality, arguing that federal judges should invalidate the entire law. Trump then said the GOP would become "The Party of Healthcare," and he signaled that another GOP-driven legislative proposal to replace the ACA with something better was forthcoming.
This week, however, he said Congress will vote on such a legislative proposal in about 19 months—in the event that Republicans maintain their majority in the Senate and regain control of the House.
"Everybody agrees that ObamaCare doesn't work," Trump tweeted Monday. "Premiums & deductibles are far too high - Really bad HealthCare! Even the Dems want to replace it, but with Medicare for all, which would cause 180 million Americans to lose their beloved private health insurance. The Republicans....."
"....are developing a really great HealthCare Plan with far lower premiums (cost) & deductibles than ObamaCare. In other words it will be far less expensive & much more usable than ObamaCare," he continued. "Vote will be taken right after the Election when Republicans hold the Senate & win......"
"....back the House. It will be truly great HealthCare that will work for America. Also, Republicans will always support Pre-Existing Conditions," Trump wrote. "The Republican Party will be known as the Party of Great HealtCare. Meantime, the USA is doing better than ever & is respected again!"
Trump's apparent punt comes after GOP leaders said they wanted him to back down. Republican lawmakers have even declined to voice support for a new legislative proposal before seeing its details, so they can distance themselves from it if necessary, as Politico's Quint Forgey and John Bresnahan reported.
"I look forward to seeing what the president is proposing and what he can work out with the speaker," Senate Majority Leader Mitch McConnell, R-Kentucky, told Politico in a brief interview Thursday.
This development comes also as two Republican state attorneys general formally disagreed with those who argue the entire ACA should fall, arguing in an amicus brief filed Monday that only the ACA's individual mandate should be struck down.
They argue that only the ACA's individual mandate should be struck down, leaving the rest of the legislation in place.
The GOP attorneys general in Montana and Ohio are publicly dissenting from the pack of 18 Republican attorneys general who are urging federal appellate judges to take down the entire Affordable Care Act.
Montana Attorney General Timothy C. Fox and Ohio Attorney General Dave Yost filed a joint amicus brief Monday in the Fifth Circuit, where an appeal is pending after a lower court declared the entire ACA invalid. They argued that only the ACA's individual mandate should be struck down, leaving the rest of the legislation in place.
"This is the rare case that involves constitutional overreach by two separate branches," Fox and Yost wrote. "Congress acted unconstitutionally by enacting the individual mandate and the court below exceeded its power by striking down the Affordable Care Act in full."
Their contribution to the legal wrangling over the ACA comes as the Trump administration shifted its legal position last week to argue the entire law should fall—an outcome that would undercut some of the Trump administration's own healthcare policy agenda.
The final policy also gives Medicare Advantage plans a 2.53% pay bump for fiscal year 2020, up from the 1.59% projected in the advance notice.
In a package of payment and policy updates finalized Monday, the Centers for Medicare & Medicaid Services said Medicare Advantage (MA) plans will have broad flexibility next year to offer supplemental benefits that maintain or improve the health of chronically ill beneficiaries.
The idea is that MA plans are positioned to solve patients' problems that may impact quality outcomes but fall outside the traditional concept of healthcare delivery. Plans could choose, for example, to provide carpet cleaning to a patient with asthma, healthy food to a patient with heart disease, or transportation to a diabetes education program, CMS said.
"It allows them to manage the patient's health more holistically," CMS Administrator Seema Verma said Monday on a call with reporters. "They can see what the patient needs and tailor benefits accordingly."
"Sometimes the patient just needs something relatively minor that can keep them out of the emergency room, that can keep them healthy," Verma added. "Because they're managing the total cost of care for that patient, the idea is to allow them more flexibility to manage cost and quality for that patient."
The CMS announcement framed the policy as a way to keep costs down through competition among MA and Part D plans.
The updates also include a 2.53% payment increase for MA plans in fiscal year 2020, up from the 1.59% increase CMS had projected in its advance notice.
The significant uptick came from one input in the formula: the effective growth rate, which rose to 5.62% in the final rate announcement, from 4.59% in the advance notice, according to a CMS fact sheet.
The effective growth rate is based on Medicare fee-for-service data that are regularly updated to reflect more recent claims, Verma said Monday when asked about the significant increase.
About one-third of Medicare beneficiaries—more than 20 million people—are enrolled in MA plans, according to the Kaiser Family Foundation.
Judges have repeatedly blocked the Trump administration's efforts to bypass the ACA, as the DOJ declares all-out war on the sprawling Obama-era law.
As anyone who closely watches the interplay between federal court cases and healthcare policy will tell you, last week was noteworthy, to say the least.
As if the Trump administration switching its position in the high-stakes dispute over the Affordable Care Act weren't significant enough for one week, two federal judges chimed in with headline-grabbing actions of their own, each blocking policies the administration has advanced with much fanfare.
All three cases in which these three major developments took place are subject to further appeals, so it could be a long while before we know precisely how they shake out. But last week's developments, taken together, offer some clues about where we're headed and what to expect next.
1. Trump Asks Court to Wipe ACA Slate Clean.
The U.S. Department of Justice had argued in court proceedings last fall that most of the ACA should remain intact, even if its individual mandate were to be struck down. But the DOJ signaled in a filing at the appellate level last Monday evening that its position has shifted.
Rather than continuing to argue that only three ACA provisions—i.e., its individual mandate, community-rating, and guaranteed-issue provisions—should be struck down, the DOJ will now argue that the entire law should fall. That would have far-reaching consequences, even undermining some of Trump's own healthcare policy agenda.
The DOJ's shift, which was criticized by hospital groups and others, was advanced by the White House over objections from Health and Human Services Secretary Alex Azar and Attorney General William Barr, according to reporting by Politico's Eliana Johnson and Burgess Everett. Azar had reportedly noted that Republicans lack an ACA replacement.
In other words: As judges in the Fifth Circuit review a lower court's decision, the Trump administration has asked the judiciary for a clean repeal of the massive Obama-era law, so Republicans can start from scratch with their own healthcare legislation—after a similar feat failed on Capitol Hill.
In a letter to Barr on Monday, Sen. Susan Collins, R-Maine, urged the White House to reconsider its new position. "The Administration should not attempt to use the courts to bypass Congress," Collins wrote.
Democrats responded to the shift last week by introducing legislation to bolster the ACA and undo certain healthcare policy actions taken by the Trump administration, as Health Affairs' Katie Keithexplained.
The case is widely expected to be decided by the Supreme Court.
2. Medicaid Work Requirements Blocked—Again.
Nine months after he blocked Medicaid work requirements from taking effect in Kentucky, U.S. District Judge James Boasberg issued twin opinions Wednesday blocking such requirements a second time in Kentucky and a first time in Arkansas.
While the administration has argued work requirements help to improve Medicaid beneficiaries' lives, Boasberg ruled that the HHS secretary had been advancing objectives not found in the Medicaid Act and failing to thoroughly consider how such requirements would affect coverage. Even so, proponents of the requirements say they are undeterred.
Sally C. Pipes, president and CEO of the Pacific Research Institute, says she expects Boasberg's decision to be appealed and ultimately decided by the Supreme Court.
"With the makeup of the court now, I would think they would tend more to support the idea of Medicaid work requirements," Pipes tells HealthLeaders, arguing that states can justify Medicaid work requirements because they have a responsibility to keep their spending under control while prioritizing coverage for those in greatest need.
"I don't think it's about booting people off Medicaid at all. I think it's about having Medicaid there, under the expansion and the old program, there for the people who need it," Pipes says. "Why should the federal and state governments be supporting people that actually could go out and work and contribute to the economy?"
Other than Kentucky and Arkansas, there were six states for which the Trump administration had approved waivers to allow work requirements for certain Medicaid beneficiaries: New Hampshire, Ohio, Indiana, Arizona, Michigan, and Wisconsin. Then the administration approved a waiver for Utah on Friday as part of a partial Medicaid expansion in that state, as Politico's Rachana Pradhan reported. (Many of the work requirements apply only to certain beneficiaries who gained coverage through Medicaid expansion under the ACA, but some states' requirements apply to traditional Medicaid beneficiaries as well.)
U.S. District Judge John D. Bates blocked the Trump administration's final rule on Association Health Plans (AHP) on Thursday, saying the policy had been devised to bypass the ACA's market requirements.
Bates ruled that the U.S. Department of Labor had unreasonably stretched the definition of "employer" and ignored the language and purpose of both the ACA and the Employee Retirement Income Security Act (ERISA). He vacated key provisions of the final rule and sent the rest back to DOL for further consideration.
This is far from the first time the Trump administration has been accused of devising healthcare policies that seek to offer more ways around the ACA's requirements. In addition to AHPs, the administration has expanded access to short-term limited-duration plans that are not required to abide by the ACA's consumer protections.
The DOL ignored 'the language and purpose of both ERISA and the ACA,' the judge ruled, vacating key provisions of the final rule and sending the rest back for further consideration.
A federal judge dealt another blow Thursday to the Trump administration's healthcare policy agenda, rejecting key provisions of the Association Health Plans (AHP) final rule it released last year.
The rule had been designed to make it easier for small businesses to band together and buy insurance coverage in groups, but U.S. District Judge John D. Bates in the D.C. District Court blocked the rule, calling it a blatant attempt to bypass the Affordable Care Act (ACA).
In drafting the rule, the U.S. Department of Labor (DOL) unreasonably expanded the Employee Retirement Income Security Act's (ERISA) definition of "employers," Bates wrote.
"Because the ACA defines terms key to its implementation—including 'employer' and 'employee'—according to the definition of these terms in ERISA, the Final Rule expands AHPs in a way that allows small businesses and some individuals to avoid the healthcare market requirements imposed by the ACA," Bates wrote in his ruling.
The idea that expanding access to AHPs was part of an effort to ease the burden imposed by the ACA is well established. U.S. Labor Secretary Alexander Acosta has said that himself. The problem, Bates wrote, came in how DOL handled the laws. The rule bypassed the ACA's requirements "only by ignoring the language and purpose of both ERISA and the ACA," he wrote.
"DOL's explanation of how the Final Rule operates under the ACA relies on a tortured reading of the ACA's statutory text that undermines the market structure that Congress so carefully crafted," he added.
Bates vacated key provisions of the rule and sent the rest back to DOL for further consideration.
Proponents of AHPs criticized the decision. Kev Coleman, president and founder of AssociationHealthPlans.com, said the decision will harm small businesses nationwide.
"Thousands of employees and family members within the small business community have already enrolled in association health plans—which help lower health care costs—since they first became available last fall," Coleman said in a statement to HealthLeaders. "They have provided a means by which broad benefits may be accessed at more economical prices."
Coleman said he believes Bates' decision will be overturned on appeal.
