Welcome
Health Law & Business

Democrats Weigh Nullifying a Select Few Trump Health Regulations

Jan. 12, 2021, 10:30 AM

Democrats are considering which Health and Human Services Department regulations they may want to overturn in the early days of the Biden administration, although there are few candidates and other avenues to do so.

Their main candidates for congressional reversal are a drug rebate rule that removes legal shields for reimbursements paid by drugmakers to middlemen and insurers and a rule requiring the department review all previous regulations or otherwise the rules must expire.

The Congressional Review Act allows lawmakers to nullify federal regulations shortly after they’re enacted. Discussion of its use comes amid a flurry of last-minute rulemaking from the outgoing Trump administration, particularly from the HHS. It only requires a simple majority in each chamber to pass a resolution disapproving of a rule and effectively rescinding it. However, many of the Trump administration health regulations Democrats would want to reverse are outside the window of time where they can do so.

And with limited floor time, they may focus on other policymaking areas. This is the one of the shortest windows of time to use the CRA due to Congress being in session for so many days at the end of the year, said Matthew Kent, a regulatory policy associate with consumer advocacy group Public Citizen. Congress will likely be able to look at regulations dating back to the third week of August, he said.

“I think of the CRA as a legislative ‘in case of emergency break glass’ option for legislators—it allows an incoming majority to quickly void recently promulgated regulations they feel warrant elimination quickly and swiftly,” said Ilisa Halpern Paul, president of District Policy Group. “However, other changes need to be undertaken in a more deliberate manner—either through additional rulemaking or, Congress could—if there are the votes—change regulation through statute.”

The Biden administration could reopen public comment, do additional rulemaking, or decide not to enforce the regulations.

“Congress doesn’t use the CRA randomly” and is calculated about doing so, said Mike Strazzella, leader of the federal government relations department at Buchanan, Ingersoll & Rooney.

The discussions around the CRA between the Biden transition and Congress are primarily around environmental regulations and are “more scarce” about health care because several recently issued rules have bipartisan support, like rules changing how two anti-fraud laws are carried out, Strazzella said.

Congress has a limited amount of time to pass legislation involving the CRA, so lawmakers must set priorities as to which regulations they most want to target, Kent said. Use of the CRA also prevents the agency from issuing substantively similar regulations in the future, so that is another part of the calculus.

Rebate Rollback

Advisers for key congressional Democrats are considering rolling back the Trump administration’s drug rebate rule, which could allow them to reap the savings to pay for other priorities, such as expanding the Affordable Care Act or putting a cap on what seniors pay for medicines, according to a senior Democratic aide and one lobbyist familiar with the discussions.

This could be done via the CRA or simply via legislation that reverses the policy. The Congressional Budget Office estimated the rule would increase federal spending by about $177 billion from 2020 through 2029.

Congress and the incoming administration may also consider using the law on a rule that would require HHS regulations be reviewed every 10 years to determine whether they are still needed or expire. Critics say such an endeavor would be an extremely difficult undertaking, especially during a pandemic.

Strazzella says he doesn’t expect Congress to get involved with the rules that have been challenged in court and that lawmakers will let them play out there first. A rule tying domestic drug reimbursement to foreign prices was halted by two judges at the end of December 2020 before taking effect.

They could also consider using the law on a regulation requiring Medicaid insurance plans to take fewer than seven days to decide whether to cover a drug. The comment period was just 25 days, however, so the agency could also reopen that.

To contact the reporters on this story: Shira Stein in Washington at sstein@bloomberglaw.com; Alex Ruoff in Washington at aruoff@bgov.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloombergindustry.com; Brent Bierman at bbierman@bloomberglaw.com; Karl Hardy at khardy@bloomberglaw.com

To read more articles log in. To learn more about a subscription click here.