Regulatory tweaks? Legislative changes? Trump administration officials seem to be considering it all when it comes to potential reforms to the Stark Law, Anti-Kickback Statute.
The window closed Friday night for public comments on a Centers for Medicare & Medicaid Services request for information regarding possible changes to Stark Law and anti-kickback regulations on the healthcare industry.
When the agency announced the RFI earlier this summer, CMS Administrator Seema Verma signaled that both the laws and the regulations stemming from them could be impeding value-based care. Many commenters agreed, arguing that the decades-old restrictions should be scaled back to make room for the industry to generate and implement new ideas.
"New innovative models of care present a challenge for regulators who want to improve care coordination and outcomes via incentivized value-based arrangements without creating legal uncertainty in advancing these goals," AMGA President and CEO Jerry Penso, MD, MBA, said in a statement Friday. The organization submitted a comment on the RFI last week.
"CMS is in a difficult position, but there are regulatory improvements, however incremental, that can be made to Stark," Penso said.
Beyond the prospect of incremental regulatory tweaks, the information CMS collected could also be used to push for more-permanent legislative changes, says Tobin Lassen, MBA, MPH, chief knowledge officer and co-founder of Global Healthcare Alliance.
"My preference really would be to influence legislation," Lassen tells HealthLeaders. "For the long run, I think that would be the better thing, but you've got to get everybody to agree on that."
We're seeing movement on Stark Law reform on multiple fronts because healthcare leaders are speaking up about what they see as a high priority, Lassen says.
"It is the squeaky wheel, so to speak, that needs the oil right now, so [officials are] paying attention to that because of so many comments," he adds.
Conversations about legislative fixes are already happening on Capitol Hill. Members of the U.S. House heard from Health and Human Services Deputy Secretary Eric Hargan in July that the physician self-referral law needs to be updated. Hargan has been leading what the Trump administration is calling a "regulatory sprint to coordinated care," identifying barriers to care coordination and assessing whether those regulatory hurdles are needed.
To that end, the HHS Office of Inspector General published an RFI of its own on Monday, asking for input on how it might add or alter safe harbors to the anti-kickback statute.
"Through internal discussion and with the benefit of facts and information received from external stakeholders, OIG has identified the broad reach of the anti-kickback statute and beneficiary inducements [civil monetary penalty (CMP)] as a potential impediment to beneficial arrangements that would advance coordinated care," the HHS OIG wrote.
Among questions about potential arrangements that interest the industry and how the government might be able to support those without going easy on fraud and abuse, the HHS OIG request sought assistance in defining a list of sometimes-nebulous terms, such as "gainsharing," "incentive payments" and "value-based care."
One important thing to keep in mind is that the Stark and anti-kickback laws should not simply be repealed, Lassen says.
"We have to protect Medicare beneficiaries. But I think there are probably ways to make these laws a lot more simple to follow, rather than continue to create waivers around the mechanical rules, each waiver being a little bit different from the other depending on the program," he says. "That can get complicated."
Editor's note: A previous version of this story included a link to the wrong AMGA letter. It has been corrected.
Attorneys general argue the AHPs are 'junk' insurance and that the Trump administration is simply trying to undermine the market for ACA-compliant plans.
A group of states challenging the federal government's expansion of Association Health Plans (AHP) has asked a federal judge to hand them an immediate legal victory.
Attorneys general from 12 states and the District of Columbia filed a motion for summary judgment Thursday arguing that the Trump administration's final rule on AHPs was an arbitrary and capricious effort to override the market structure established by the Affordable Care Act.
"Trump's efforts to force working families into junk health plans need to be stopped," California Attorney General Xavier Becerra said in a statement.
"Rather than taking concrete steps to make healthcare more affordable and effective, the President is doing all he can to make America uninsured and unhealthy again," he added. "We will continue using every tool at our disposal to fight for universal, quality healthcare."
Becerra, a Democrat, has been involved in several legal challenges against Trump administration healthcare policies, including in a lawsuit over halted Cost-Sharing Reduction payments and the U.S. Department of Justice's decision to quit defending key provisions of the ACA against a legal challenge by conservative states.
New York is the lead plaintiff in the case challenging the AHPs final rule.
Despite concern that AHPs could raise long-term costs, the U.S. Department of Labor has argued that the expanded access to AHPs will benefit small employersstruggling to pay for health coverage for their workers by allowing businesses to band together to buy insurance as a group.
Centers for Medicare & Medicaid Services Administrator Seema Verma has similarly argued that AHPs and short-term limited-duration health plans—which offer coverage that's both cheaper and skimpier than ACA-compliant options—are needed to give consumers more affordable choices as premiums for exchange plans rise out of control.
This is the fourth waiver approval of its kind in the past month and the seventh in the past two years.
Maryland lawmakers are expected to announce Wednesday that the federal government has approved a waiver under the Affordable Care Act to permit the state to launch a reinsurance program, as The Baltimore Sunreported.
The anticipated approval would make Maryland the fourth state to secure such a waiver from the Trump administration in the past month, following Wisconsin, Maine, and New Jersey, although each state customizes its own program plan.
The recent spree of approvals comes after three other states—Alaska, Minnesota, and Oregon—had the waivers for their programs authorized last year.
In Maryland, the program enjoyed bipartisan backing, with the state's Republican governor collaborating alongside Democratic legislative leaders, as the Sun reported. The plan they came up with includes a one-year state tax on insurance companies to subsidize the most expensive claims from Maryland's exchange plans.
The Centers for Medicare & Medicaid Services, which determined last month that Maryland's waiver application was complete, had not as of 10 a.m. Wednesday announced a decision on whether it would approve the waiver.
The governor's suit against residents who are challenging Medicaid work requirements, which were blocked by another judge earlier this summer, cannot continue.
A federal judge in Kentucky ruled Monday that Gov. Matt Bevin's lawsuit against 16 residents who challenged the commonwealth's Medicaid work requirement cannot move forward.
The decision to dismiss the countersuitputs to bed an iffy attempt by the Bevins administration to shift the litigation to a jurisdiction perceived as more conservative.
The dispute will instead continue in the D.C. District Court, where Judge James E. Boasberg blocked Kentucky's work requirement for Medicaid recipients earlier this summer by vacating the federal government's approval of a waiver that had authorized the controversial requirement. Boasberg remanded the matter to Health and Human Services for further review.
"That ruling effectively forces the Secretary to revisit its obligations under the Administrative Procedure Act regarding the Kentucky HEALTH waiver; thus, there remains at least some possibility that the waiver—or some version of it—could still be granted," Judge Gregory F. Van Tatenhove in the Eastern District of Kentucky wrote in Monday's decision.
Although it had not initially been named in the D.C. suit, the Bevins administration intervened as a defendant there after filing its countersuit in Kentucky—which means the Bevins administration could file a counterclaim against any plaintiff in the D.C. District Court, Van Tatenhove wrote.
Research has shown that medical school debt deters some physicians from choosing careers in primary care, but the factors at play may be a bit more complicated than some expect.
New York University made waves last week when it announced it will cover all tuition expenses for all its medical students in perpetuity.
While the news left some NYU alumni wishing they had waited just a few years longer to enroll, it also reanimated debate over the problems high educational debt levels can cause for doctors and the healthcare delivery system at large.
In an op-ed for Stat News, fourth-year NYU medical student Eli Cahan noted that researchers have identified debt burden as one of the factors propelling doctors into more lucrative specialty areas, leaving a shortage of primary care physicians.
But research suggests the burden of educational debt is one factor among several in a complex relationship affecting the likelihood of new doctors to choose primary care.
A study published in 2014 by the Annals of Family Medicine, for example, concluded that reducing debt for medical students could help to enlarge the primary care physician workforce but that the positive effects of such an initiative would vary depending on which types of students benefited from the debt reduction.
"Students from lower-income families, in general, tend to have more interest in primary care careers, and students from disadvantaged backgrounds tend to have more interest in primary care careers," lead researcher Julie Phillips, MD, MPH, an associate professor of family medicine at Michigan State University College of Human Medicine, tells HealthLeaders.
"Those same students also tend to have more debt because students from lower-income families don't have the parents' resources to help them with medical school costs," Phillips adds.
The study, which analyzed data from more than 136,000 physicians, found that students from higher-income families were significantly less influenced by educational debt in their specialization decisions. What's more, although the researchers found that educational debt deterred graduates of public medical schools from choosing primary care, the same could not be said of graduates of private medical schools.
This research suggests that the benefits of tuition-free medical school on primary care could be diminished by the fact that NYU is a private institution. That's not to say, of course, that the decision to go tuition-free comes without benefits.
"I think it will make a difference. It's hard to know if it will make a big difference," Phillips says, calling NYU's announcement "a great step in the right direction."
"It would be really wonderful if public schools were able to implement this," she adds, "but I just think they don't typically have those resources."
"The income disparity between primary care doctors and specialists in the United States is concerning, and there's pretty good evidence that if you change that, the whole game changes," Phillips says.
"As a culture, we tend to look on people who make money as being more valuable," she adds, "so the income disparity between primary care doctors and specialists sort of creates a culture or contributes to a culture where primary care is not as well-respected, and that's a really big problem."
Three policies in The Garden State aim to shore up the individual insurance market.
There's currently only one state in the country that has enacted three key policies to stabilize its Affordable Care Act markets.
The third prong in New Jersey's triad strategy fell into place Thursday, when the Trump administration approved the state's waiver request to establish a reinsurance program that's projected to make premiums 15% cheaper next year than they would be otherwise.
Although other states had already established their own reinsurance programs under ACA waivers, New Jersey is the first to combine such an initiative with two other prongs: an individual mandate and restrictions on short-term health plans.
In this sense, The Garden State has responded to the Trump administration's loosening of restrictions on health insurance policies by imposing stricter standards on the state level—an agenda that could serve as a blueprint, at least for fellow blue states.
"In spite of the President's attempt to destroy access to health care, New Jersey now leads the nation in preserving the ACA while reducing premiums," said state Sen. Joseph Vitale, a Democrat, as NJ Advance Media reported.
👏 to New Jerseyans, who will see their premiums in the individual market ↓ by about 15% from the expected premiums because @NJGov took action to address the failures of Obamacare. Today, @CMSgov approved NJ’s 1332 State Innovation Waiver. https://t.co/xvX4kcVZLW
Here's a brief overview of New Jersey's three-pronged approach:
Reinsurance waiver: The waivergranted Thursday allows New Jersey to establish a reinsurance program partially funded by pass-through dollars from the federal government. It resembles similar waivers granted to Wisconsin and Maine earlier this year and to Alaska, Minnesota, and Oregon last year. Maryland has an application pending. The details differ from state to state, but New Jersey's reinsurance program will reimburse insurers of high-risk enrollees for 60% of coinsurance on claims of $40,000-215,000, according to a Centers for Medicare & Medicaid Services fact sheet.
Individual mandate: Congress zeroed out the financial penalty associated with the ACA's individual mandate on the federal level, effective next year. But state lawmakers in New Jersey responded by passing a state-level individual mandate, which Gov. Phil Murphy, a Democrat, signed in May.
Short-term plans: Trump administration officials have touted short-term limited-duration health plans—which will soon be renewable for up to three years, rather than being capped at three months—as an affordable alternative to ACA-compliant options. In an op-ed for The Washington Post this week, Health and Human Services Secretary Alex Azar wrote that such plans "can be a good option for many Americans priced out of Obamacare's regulations." But policymakers in New Jersey (as well as New York and Massachusetts) have imposed restrictions that effectively ban such plans over concerns that they're too skimpy, as Bloomberg reported.
More details on the ACA waivers in New Jersey and other states are available on the CMS website.
Some of the same groups that prompted a federal judge to block Kentucky's work requirements are following a similar play book in Arkansas.
Advocacy groups that successfully challenged the approval of Medicaid work requirements in Kentucky earlier this summer have turned their attention to Arkansas.
In a lawsuit filed Tuesday in the D.C. District Court, the National Health Law Program (NHeLP), Southern Poverty Law Center (SPLC), and Legal Aid of Arkansas argued that Health and Human Services acted in an "arbitrary and capricious" manner when it approved the Medicaid waiver that allowed Arkansas to implement work requirements in June.
"This lawsuit is the continuation of our work, with our state and national partners, to stop the Trump administration's attempt to transform Medicaid from a health insurance program to a work program—and along the way, to end coverage of medically necessary care for thousands of low-income people," NHeLP Legal Director Jane Perkins said in a statement.
Charles Gresham, one of three plaintiffs in the suit, suffers from a seizure disorder and has a tough time maintaining steady employment, putting his health insurance at risk, according to an SPLC statement. What's more, the 37-year-old cannot use the program's required online reporting system without assistance, the lawsuit states.
The other two plaintiffs, 40-year-old Cesar Ardon and 44-year-old Marisol Ardon, are separated spouses. Each of them had major surgeries to remove tumors within the past two years, and each have had difficulty accessing the mandatory online portal, according to the complaint.
Kevin De Liban, an attorney with Legal Aid of Arkansas Attorney, said the Arkansas waiver plan is "backwards."
"Cutting people's health care and making them jump through administrative hoops will make it harder for our clients to work and make a better life, not easier," De Liban said in a statement.
"Medicaid coverage enables people with limited incomes and no health insurance to become healthy. Without access to health services, it is nearly impossible to be healthy enough to find and keep a job," he added.
Medicaid work requirements have been approved in Kentucky, Arkansas, Indiana, and New Hampshire, with applications pending in Arizona, Kansas, Maine, Mississippi, Ohio, and Wisconsin.
HHS Secretary Alex Azar said late last month that the Trump administration would continue approving such waiver requests, despite Kentucky's waiver being blocked, as The Hill reported.
"We will continue to litigate, we will continue to approve plans, we are continuing to work with states, and we'll drive forward," Azar said.
The academic health system's top executive praised the organization's teams for continuing to earn recognition for high-quality care.
NewYork-Presbyterian Hospital slipped two spots in the latest U.S. News & World Report's annual hospital rankings announced Tuesday. But the New York City–based academic health system held on to its coveted status as a Top 10 hospital.
NewYork-Presbyterian President and CEO Steven J. Corwin, MD, praised the hospital's employees for continuing to provide the high-quality care that has consistently earned them a spot in the Top 10.
(Photo courtesy of NewYork-Presbyterian Hospital)
"Our dedicated staff works hard every day to provide our patients with the highest quality, most compassionate care because we believe every patient deserves to be treated with respect and receive the most advanced, life-saving treatments," Corwin said in a statement.
"Together with our affiliated medical schools, Columbia University Vagelos College of Physicians and Surgeons and Weill Cornell Medicine, we are committed to providing world-class care, advancing clinical research and educating the next generation of physicians," he added.
NewYork-Presbyterian had four specialties ranked in the top five nationally: cardiology and heart surgery (4th), neurology/neurosurgery (5th), psychiatry (3rd), and rheumatology (3rd).
The L.A. medical center finished nine places higher this year than it did just two years ago.
Cedars-Sinai Medical Center climbed into the Top 10 list for U.S. News & World Report's annual hospital rankings announced Tuesday.
The Los Angeles medical center ranked eighth among the 20 hospitals named to the publication's 2018-2019 honor roll. Cedars-Sinai ranked 11th last year and 17th the year before that.
"At Cedars-Sinai, we strive to strengthen our community by delivering the highest quality patient care, advancing the frontiers of medical research and striving to enhance the health of those we serve," President and CEO Thomas M. Priselac said in a statement.
"We are honored that our physicians, nurses and other healthcare professionals have been recognized for their excellence and service, which has been at the core of our mission since our founding in 1902," Priselac added.
Cedars-Sinai had 12 of its specialties ranked among the best in the nation, including two specialties that each ranked third in the nation: cardiology and heart surgery, and gastroenterology and GI surgery.
By climbing into eighth place, Cedars-Sinai overtook the University of Pennsylvania's Penn Presbyterian, Stanford Health Care's Stanford Hospital, and NewYork-Presbyterian Hospital-Columbia, Cornell.
The way CMS rolled out a technical clarification for the 2017 benefit year ran afoul of the Administrative Procedure Act, a second federal lawsuit claims.
A nonprofit health plan that sued the federal government over the way risk-adjustment payments under the Affordable Care Act are calculated is redoubling its effort to block the program's implementation for the 2017 benefit year.
New Mexico Health Connections persuaded a federal judge to declare the government's methodology illegal last February. That prompted the Centers for Medicare & Medicaid Services to freeze the program then reinstate it with a technical clarification last month.
The health plan, which has accused Health and Human Services of causing "a purely self-inflicted wound," filed a second federal lawsuiton Monday, alleging that the way the technical clarification was rolled out without a period for public comment violated the Administrative Procedure Act.
"We contend that the emergency regulation continues a risk adjustment formula that disadvantages small, new, and lower-priced health plans in favor of their larger, more expensive competitors," New Mexico Health Connections CEO Marlene C. Baca said in a statement.
"The CMS formula does not, as it is supposed to, transfer funds equitably from health plans with healthy enrollees to health plans with sick enrollees," Baca added. "We support the concept of fair and equitable risk adjustment and we will continue to fight to protect consumers and provide fair insurance rates."