Government Works to Match Health Rules to Rapid Virus Response

The Trump administration is playing catch-up, relaxing and temporarily tossing out rules some hospitals have already been forced to disregard as they cope with a flood of coronavirus patients, limited supplies, and a shortage of staff.

Federal agencies in recent weeks waived certain rules for nursing homes, expanded insurance coverage for coronavirus testing under Medicare Part B and plans purchased through HealthCare.gov, and gave hospitals a reprieve from certain requirements intended to protect patient privacy. The Centers for Medicare & Medicaid Services went even further Monday, making a series of changes that allow hospitals to treat more patients in temporary facilities, free them of certain paperwork demands, and beef up their workforce.

“It’s a recognition of the need to increase the capacity of our health-care system as quickly as possible, and they’re doing that,” said Robert Field, a professor of law and public health at Drexel University. “It’s recognizing actions that are already underway, for instance creating hospitals without walls in places like Central Park, but it’s legitimizing a lot of that.”

Health professionals may have been trying to keep up with regulatory requirements in the midst of the pandemic, but their mission first and foremost is to save lives. “Bureaucracy has to come second,” Field said.

“Right now we need to do whatever we can to really be able to provide good, effective, safe patient care,” said Jennifer Kreick, of Haynes and Boone’s Dallas office. “To the extent that regulatory requirements prohibit us from doing that, [health-care providers] are going to focus on good patient care and then come back and ask for forgiveness or leniency in some of these health regulatory policies.”

The changes so far have been helpful, but Field said the government still needs to better coordinate its response.

“I think we’ve seen over the last few months a series of baby steps, and what we need now are giant strides,” he said. “You don’t fight a war with baby steps. We need coordinated national policy. We still have an undersupply in crucial areas like personal protective equipment, tests, and ventilators, and nationwide the situation seems to be chaotic.”

Remote Care

Likely the single biggest change for health-care providers so far has been a waiver that allows for the massive expansion of teleheath, with reimbursement rates that are on par with face-to-face visits, said Tom Bulleit, of Ropes & Gray’s Washington office.

The waiver allows patients to receive care from their homes without a three-year prior patient relationship, and doctors can treat patients in other states to reach more people, as needed. However, physicians should keep in mind one major limitation: The change applies to Medicare coverage, not Medicaid or private insurance, Bulleit said.

The CMS took that a step further late Monday, announcing that emergency departments of hospitals may use telehealth to quickly and remotely assess patients so they may then direct them to the most appropriate site for care. The goal is to slow the spread of Covid-19 while freeing up emergency room space for patients most in need. The new rules also provide for patients to be screened at alternate treatment and testing sites for the duration of the national emergency.

While many state laws have exceptions for in-state licensing for health-care providers during an emergency that would allow them to use telehealth to treat patients in or out of state, health-care attorneys say the states could do more to expand upon the CMS’ steps promoting telehealth.

“State licensing laws, including those related to telemedicine, could benefit from clear relaxation during this public health emergency to allow health-care providers to more easily provide care across state lines and move resources to locations most in need,” Kreick said.

In an effort to promote health-care across state lines, the CMS established a toll-free hotline for physicians and other practitioners who aren’t Medicare-certified to get that certification. The agency is also temporarily waiving application fees, criminal background checks, and site visits.

The stimulus bill that was enacted March 27 also included limited protections for health-care professionals who volunteer their services during the health emergency. Providers will not be liable under federal or state law for any harm caused by an act or omission in caring for patients, according to the legislation.

Help for Expected Surge

One of the most important changes for hospitals and facilities is a CMS waiver eliminating requirements that critical access hospitals—typically small facilities in rural areas—are limited to 25 beds, Kreick said. The expansion will allow these hospitals to treat the anticipated wave of new virus patients in the days and weeks to come.

Another important provision is the elimination of a requirement that patients must be hospitalized for three days prior to being transferred to a skilled nursing facility, Kreick said. That will allow hospitals to triage patients and relocate them as needed at a faster rate as admissions for Covid-19 continue to rise.

“CMS took proactive steps to allow hospitals to move patients within their facility and to discharge patients to allow for a surge of Covid-19 patients and also to ensure that other vulnerable patients that are already in the hospital are not exposed, inadvertently, to the disease while they recover or obtain treatment,” said Susan Feigin Harris, of Morgan Lewis in Houston.

“It was absolutely necessary and an important step as many of my clients are doing what they can to prepare for and accept the surge of Covid-19 patients,” she added.

However, not everyone is happy about the elimination of the three-day requirement. Savera Sandhu, an attorney with Newmeyer Dillion in Las Vegas, said skilled nursing facilities aren’t necessarily prepared to handle patients with Covid-19.

“It harms these types of health-care providers who are not equipped to manage acute issues and who are now exposing themselves and their patients to an increased risk of infection,” she said.

States are able to ask the CMS to grant them Medicaid waivers, and at least 34 have done so to date. That includes requests for waivers for prior authorization when treating Covid-19 patients; more and faster provider enrollment processes to ensure more patients have access to more doctors; and allowing care to be provided in alternate settings—even in unlicensed facilities—as demand grows, Kreick said.

“The most critical thing is allowing health-care providers to practice in other states in which they do not hold a license,” she said.

“Providers were already facing a shortage of health-care staff, and especially to the extent that providers have become infected with Coronavirus and aren’t able to provide care, we need to fill those gaps and allow providers to move around to the states with the most need,” she said. “I think that’s really going to help.”

To help with staffing shortages, the CMS said it’s waiving requirements to allow physicians with expiring privileges to continue practicing at a hospital and for new physicians to be able to practice before full medical staff or governing body review. The country’s health-care system is still struggling with shortage of PPE and coronavirus testing.

As a result, the Centers for Disease Control and Prevention is now allowing certain N95 respirator masks that have passed their shelf-life to be used by health-care professions during the pandemic. The Food and Drug Administration has also issued guidance that allows laboratories and commercial manufacturers to accelerate the production of coronavirus tests.

Learning as We Go?

The number of confirmed coronavirus cases in the U.S. surpassed the number of cases in China last week, according to data compiled by Johns Hopkins University. Some states like New York have been hit harder than others and need more supplies.

“We don’t yet have a clear national allocation policy,” Field said. “This is a situation where we don’t want competition among the states.”

Conservative regulatory experts, however, say everyone, including the federal government, is learning as we go through this for the first time.

Federal agencies, particularly in the health-care space, are taking pretty necessary measures to relax some regulatory requirements given the unusual time in our country, said Daniel Bosch, director of regulatory policy at the American Action Forum, a conservative think tank in Washington.

“I’m sure there’s more that they can do,” he said. “They’ve done what’s been necessary, especially in the testing regard and easing some restrictions on PPE, but I think the bigger question is did they do that in time to begin with, and it seems pretty clear they didn’t.”