ASHINGTON — The upcoming fight over repealing and replacing the Affordable Care Act promises to shake up hospitals and insurers, but drug makers also stand to gain — or lose — a lot.
On the upside, congressional Republicans have already signaled that they plan to roll back billions of dollars in fees the law imposed on the industry.
But drug makers also risk losing millions of new customers who became insured under the health care law. And if President-elect Donald Trump and Congress decide they need to cover the full cost of whatever they propose to replace the law, they might turn to drug companies to pay up.
Drug makers are “going to be trying to stay part of the conversation to anticipate and get ahead of any risks,” said Caroline Pearson, senior vice president at the consulting firm Avalere Health.
When the ACA was negotiated, drug companies acquiesced to paying billions of dollars in annual fees as well as providing rebates and discounts to cut drug costs — and were largely left alone otherwise. In turn, they hoped to see millions of new customers and better coverage through the law’s reforms.
That bargain hasn’t really paid off, though, people inside and outside the industry told STAT. Drug makers ponied up for their fees and chipped in to help seniors afford medications under Medicare — but, because many of the people covered by the law ended up in Medicaid or faced high out-of-pocket costs and restrictive drug coverage in the private market, the law hasn’t really been a boon to business.
”The coverage sucked,” said one high-ranking industry official, who spoke on the condition of anonymity to speak candidly.
For now, the drug industry sounds willing to work with the new Congress and Trump on their plans for health care reform. Heading into that debate, there are some obvious opportunities but quite a few potential pitfalls for pharma.
The bad news: People could lose coverage
The various plans that Republicans have proposed to replace the law are expected to result in some number of people — and maybe millions of them — losing their health coverage.
“Coverage expansion is something that pharma cares about, because you have X number of people now carrying a pharma coverage card,” said Kim Monk, a health care analyst at Capital Alpha Partners, which tracks health care policy for investors.
So pharma will be heavily invested in whatever the GOP comes up with to insure at least some of that population.
Some experts, like Monk, believe the Republican plan could cover nearly as many people as the ACA did while loosening regulations on health plans. Insurers could then in theory scale back other benefits and shore up their drug coverage, good news for the industry.
“They could certainly do better in terms of the quality of the coverage provided post-reform,” Monk said.
Others are skeptical, though, that there is any upside for drug makers if the ACA’s coverage expansion and insurance regulations are undone. Pearson pointed out that in the employer insurance market, which was largely untouched by the health care law, plans have still tried to control drug costs by restricting coverage.
“I don’t think there’s any reason that, without regulation, plans will improve drug coverage,” Pearson said. “Plans can’t construct benefits that disproportionately attract sicker customers.”
Then there’s Medicaid, which was expanded under the ACA and has covered millions of poorer Americans.
The program isn’t a cash cow for the drug industry, because of federally mandated rebates that were increased through the health care law. But the GOP’s preferred reforms — a block grant or per-person spending caps — could still have major ramifications for the number of people insured through Medicaid and the coverage they receive.
On both fronts, drug makers will be weighing in on “what coverage needs to look like,” the industry official said. “It has to provide patients with treatment options that doctors want them to have.”
‘The 800-pound gorilla’: offsets
The problem of offsets — spending cuts that make up for whatever new spending Republicans propose in their plan — is perhaps the biggest unknown and the greatest risk for drug makers heading into the ACA fight.
“Any time there’s a discussion of offsets, the pharmaceutical industry is at risk,” Pearson said.
For now, it’s unclear how Republicans envision paying for their health care plan. But there are some ideas floating out there that make drug companies nervous, including one that Pearson called “the 800-pound gorilla.”
Lawmakers could require drug companies to pay a minimum rebate for medications prescribed to people who are eligible for both Medicare and Medicaid. Right now, those rebates are negotiated by drug makers and the private health plans that provide Medicare’s prescription-drug coverage.
The Congressional Budget Office has estimated that requiring drug makers to instead pay the federally mandated Medicaid rebate, which the ACA increased, would save the federal government $123 billion over 10 years. That’s big savings for the federal government — and a big loss for pharma.
It’s considered less likely under a Republican-controlled government, but that policy specifically and any other offsets will be one of pharma’s top issues.
The other unknown: the Medicare donut hole
Before the ACA, Medicare covered many prescription drugs up to a certain dollar limit. But then once seniors hit that limit, they were forced to pay for their own drugs. Their benefits didn’t kick back in until they hit another threshold, putting a serious financial strain on them while they paid the full cost of their medications.
Wonks call it the donut hole.
The health care law closed the donut hole over time, fully eliminating it in 2020, and drug makers offered discounts to seniors in the interim to offset their costs.
“I think the question is, if the law is repealed, what happens with the donut hole?” Monk said.
The prevailing theory seems to be: nothing. The ACA changes will stick. The test-run GOP bill didn’t reverse that policy. Republicans could face a huge political backlash if they tried to undo it and put seniors on the hook for hundreds of dollars in drug costs.
In that case, drug makers would continue to offer those discounts even if the ACA is largely repealed and the hole in Medicare benefits would still close by the end of the decade.
The good news: Pharma fee repealed
Republicans passed a repeal-and-replace bill last year (and President Obama vetoed it) as a test run for the arcane parliamentary procedure they’ll need to undo much of the ACA without any Democratic support. That legislation, seen as the blueprint for what the new Congress will propose in 2017, repealed the law’s fee on brand-name drug manufacturers and importers.
The fee was projected to bring in more than $25 billion by 2019. Pharma never lobbied hard to get it repealed, unlike the medical device makers that launched a massive campaign to overturn the excise tax on their industry.
But repealing it, with billions of dollars still left to be paid, would still be unequivocally good news for the industry.
“We’d love to get that money back,” the industry official said.
The token gesture: reimportation
Drug makers have a few other odds and ends they’ll be following — they would like to see a Medicare payment board, created by the ACA and given broad authority to make cuts, disbanded — and one big one is drug reimportation.
Republicans are already hinting that they might make a token gesture on drug costs in order to win some Democratic support for their replacement proposal. Reimportation is an obvious candidate; it has attracted bipartisan support in the past and Trump even included something similar in his original health care plan.
The policy would allow prescription drugs manufactured in the United States and shipped elsewhere to be reimported from foreign countries at a lower cost.
“We’re hoping that we can avoid reimportation,” the official said.