Healthcare in 2019: Divided

Year one of a divided government in the Trump era begins with the Affordable Care Act again in legal peril. Political rhetoric around the law and healthcare generally will only intensify in the lead-up to the 2020 election cycle, but the industry is most closely watching how the administration will use executive authority to try to beat down soaring costs.

A Texas judge's decision to overturn the ACA closed out a year where, despite congressional gridlock on healthcare, the Trump administration gained ground on systemic attempts to trim hospital payments and pharmaceutical prices, as well as reshape insurance markets. HHS Secretary Alex Azar maintains he will not bend to corporate pressure as he pushes policies like site-neutral payments and price transparency.

The policy outlook is less straightforward in Congress, where Democrats plan to use their newfound power in the House to blanket the Trump administration with oversight.

Meanwhile, Sens. Chuck Grassley (R-Iowa) and Lamar Alexander (R-Tenn.) will wrap up their legacies chairing the upper chamber's two most influential healthcare committees—Finance and Health, Education, Labor and Pensions, respectively. Grassley has a history of scrutinizing tax-exempt providers. And Alexander orchestrated a series of hearings in 2017 delving into the high cost of healthcare.

Hospitals want the Trump administration to more aggressively push executive authority to roll back red tape, particularly around the Stark law and accompanying regulations, which providers say stand in the way of some pay-for-value reforms, including building clinically integrated networks.

But hospitals have also been quick to sue over what they claim is executive overreach, such as in the case of HHS' sweeping cuts to the controversial 340B drug discount program. Pharmaceutical discounts through the program yield tens of millions of dollars annually for a growing number of hospitals, and it has become a territorial fight.

“This administration pushes the envelope on how far they can go with powers from Congress,” said Erik Rasmussen, a vice president at the American Hospital Association. “It's a double-edged sword. When they go too far, we sue them.”

Hospitals sued over the government's substantial clawback of money through a cut to 340B hospitals' Medicare Part B drug reimbursements. Launched Jan. 1 of last year, the policy is winding its way through courts under ongoing litigation after a late-breaking 2018 win for hospitals in a federal district court. The cuts were extended to hospitals' off-campus facilities at the beginning of this year.

Hospitals also poured lobbying dollars last year into a fight against Republican-sponsored legislation to cut back the 340B program. With a Democratic takeover of the House, hospitals are expecting a break on Capitol Hill and they plan to use the time to try to forestall political pressures over the program. Hospitals will have to disclose the community benefit funded by their 340B discount money from manufacturers, accurately estimate their discounts, and pledge to stick to the letter of the 340B law.

“We want to use the time while the field is fallow to make sure our fences are strong,” Rasmussen said. “Good fences make good neighbors.”

Hospitals and HHS anticipate a ruling on the so-called site-neutral payment policy, proposed in July and finalized in a watered-down version in November. The AHA, along with several other hospital groups, sued over the policy, again claiming executive overreach.

Under the new policy that starts this month, Medicare will pay off-site clinics the same rate it pays independent physicians for certain services.

Economist Douglas Holtz-Eakin, a former director of the Congressional Budget Office who heads the conservative American Action Forum, said it is unclear how hard the administration will ultimately come down on hospitals in light of the intense pressure.

“It has turned out to be harder than the administration expected,” Holtz-Eakin said of the payment policy. “They keep going back and forth on a policy to pay for the quality of the service, rather than paying the same rate for every site, and they're just struggling.”

While the administration would like to keep balancing Medicare payments, he added, officials “don't know where to go next” as they try to work out designs for these policy changes.

Congress has a hard deadline of Sept. 30 to decide how to manage the scheduled disproportionate-share hospital payment cuts, passed with the ACA, but never implemented.

Lawmakers last year authorized a one-year-only delay to billions of dollars in cuts to these payments, teeing up a potential legislative overhaul of the program in 2019. Republican Sen. Marco Rubio of Florida, one of the states least favored under the current formulas, has already introduced a proposal to start negotiations.

Hospital lobbyists, eager to protect overall DSH funding, have signaled lawmakers could modify the law, which has largely remained untouched since 1992.

“The devil's in the details,” said Carlos Jackson of America's Essential Hospitals—a trade group for hospitals that benefit significantly from the program. “We are happy to have conversations about changes, but the details matter.”

Jackson also questioned whether lawmakers in this supercharged political environment would be able to dive into real policy changes by September.

“Will they have the time?” he asked.

A small number of states—Alabama, Missouri, New Jersey and New York—benefit more than others from DSH. Financially, the payments are a very big deal for hospitals with high numbers of Medicaid patients, such as major university medical centers.

Here, too, ongoing litigation is a complicating factor. Hospitals have challenged an Obama-era rule requiring them to deduct any Medicare or commercial insurance reimbursements from their total DSH allotment.

Hospitals also want the Democratic House to pick up where Republicans left off on a “Red Tape Relief” project targeting Medicare regulations that hospitals say cost them billions a year in extra work and unnecessary or redundant expenses.

Democrats haven't decided what they will do, but lobbyists think House Republicans may be able to work with the Trump administration on policy work that could gain bipartisan support.

“It's been a while since we've had a GOP minority in the House with a Republican president,” the AHA's Rasmussen said. “Republicans in the House will still be important because they can work on the administration on this sort of thing.”

Tax-exempt hospitals are also bracing for the spotlight. Grassley—who for years has been investigating whether hospitals with not-for-profit status are producing enough justifying community benefit—is retiring in two years. Former and current aides said his scrutiny of hospitals with massive tax benefits will continue. Throughout this year, he has kept up communication with the IRS on how the agency monitors activity of not-for-profit hospitals.

If hospitals are wary about mixed financial prospects in 2019, the pharmaceutical industry is preparing for full-on political war.

Manufacturers lost a key lobbying battle in 2018 when they tried to recoup billions of dollars from the money Congress appropriated through the Medicare Part D coverage gap known as the “donut hole.”

This year will bring much more: the specifics of a proposal to control U.S. drug prices by tying them to an international price index; step therapy in Medicare Part B; and the authority for Medicare Part D insurers to exclude some protected-class drugs that are currently off limits.

“We face all of that, and then there's the change in the majority of the House,” said James Greenwood, CEO of the Biotechnology Innovation Organization trade group. “Democrats have run very hard on the issue of drug pricing and investigation.”

There's also Grassley, who has long been zealous on Big Pharma oversight.

“It'll be busy,” Greenwood said.

He said he is focused on messaging and public perception of manufacturers who, he said “shoulder 95% of the rhetoric” for skyrocketing healthcare costs.

“If the issue is that we need to protect Medicare, I'm all in as long as Congress looks at where the real money is: hospitals and elsewhere,” Greenwood said.

Manufacturers are also looking to the administration's use of executive authority for some wins, specifically on 340B where they clash most intensely with hospitals.

“There's a lot the administration can do,” Greenwood said. “The powers they are using with the other proposals, like (the CMS Innovation Center), they can apply to the 340B program.”

Obamacare's individual market premiums have stabilized, but at a high price. And as Democratic progressives push a single-payer approach in the lead-up to the 2020 presidential election, insurers want to make sure the individual market can attract people who have ditched or so far avoided the exchanges because of cost.

Justine Handelman of the Blue Cross and Blue Shield Association wants Congress to try again on reinsurance funding and to look at expansion of the tax credit subsidy, particularly to draw younger people into the exchanges.

Given the breakdown of bipartisan talks to fund reinsurance and cost-sharing reduction payments in 2018, it's unlikely the Democratic proposal to further subsidize the exchanges will go anywhere with the Trump administration and Republican Senate.

Key to watch as the year unfolds is what the fallout of the ACA litigation—panned by most legal analysts but also possibly headed to the Supreme Court—will herald for both parties for healthcare ahead of 2020 when progressive Democrats want their party to embrace “Medicare for all.”

Sen. Elizabeth Warren of Massachusetts, the first Democrat to jump into the presidential race, has already made the policy part of her platform.

Progressive Democratic Reps. Ro Khanna of California and Pramila Jayapal of Washington state, who are leading the way on a new “Medicare for all” draft, plan to push a floor vote on the legislation. They told Modern Healthcare they will introduce the new version once the 676 bill number is available—a nod to the original House legislation from former Rep. John Conyers (D-Mich.).

State policy experimentation likely to create uncertainty for providers in 2019