麻豆传媒

WASHINGTON -- As practically everyone has heard by now, Thursday marks the end of the COVID-19 public health emergency (PHE) in the U.S. What does that mean for physicians and their patients?

The PHE was originally declared for several reasons, Mario Ramirez, MD, an emergency physician and managing director of Opportunity Labs, said on a webinar sponsored by the COVID-19 Vaccine Education and Equity Project (CVEEP). For one thing, "it grants broad authority to the [HHS] secretary to enter into contracts that are non-traditional and are really designed to decrease and remove some of the bureaucratic hurdles that exist" -- for example, no-bid or single-source contracts. In addition, funds made available during the PHE "can be used to directly treat patients and it can be used to mobilize the private sector to produce vaccines or other therapeutics."

The other big pot of money that the PHE unlocks "comes from CDC, and that is the infectious disease emergency response plan. So those funds are not usable unless there's a public health emergency in place," he added. "It can also sort of unlock some of the telehealth flexibilities which folks may be more familiar with, and allows providers to treat patients in their homes so that we're not necessarily pulling people together in hospitals or other large settings."

Effect on Medicaid

Medicaid is one area that has gotten a lot of attention. Part of the PHE's end includes the end of a provision that required states to keep everyone who was on Medicaid during the pandemic on the Medicaid rolls if the state wanted to receive a 6.2% bump in their Medicaid matching funds from the federal government.

That provision ended on March 31, and states began a 1-year "unwinding" period during which they can assess Medicaid patients for possible disenrollment, Tesch West, JD, an associate at the Morgan Lewis law firm here, explained during a phone call at which a public relations person was present.

"Obviously there are concerns that people will lose coverage as a result of the unwinding," she said. "HHS itself has estimated about 15 million people will lose coverage based on the new screening, and they expect 6.8 million of those individuals will still be eligible for Medicaid but will lose their enrollment anyway, and that's largely because the Medicaid agencies do not have updated contact information for individuals. In addition to that, they're worried about folks that have limited English proficiency, people who have moved, and people who have disabilities" who may not be able to fill out the necessary forms to retain their coverage.

Another element in play will be PHE-era waivers for Medicaid plans to cover home- and community-based services (HCBS), West continued. Many of these waivers, especially those provided through a regulation called 1915(c), "have to do with individuals with intellectual disabilities, and they allow those individuals to have services [provided] in their home or in a non-institutional setting, which has been a very welcome service."

The 1915(c) waivers have a little bit of extra time, "but they'll expire on Dec. 11," she said. "Some states want to finalize and allow those new payment allowances to continue beyond the PHE, some states are not sure, and some don't want them to continue." There are about 330 HCBS waivers across the U.S., with some states using multiple waivers to target different populations, West said.

One positive Medicaid move has been that Congress has required states to wait until at least Sept. 30, 2024, before they can consider requiring cost-sharing for Medicaid patients' COVID-19 vaccines and treatments, Anand Parekh, MD, chief medical advisor of the Bipartisan Policy Center here, said on a phone call. "I think that that helps for that vulnerable population."

In a HHS emphasized that even after the PHE ends, Americans will continue to be able to access COVID-19 vaccines and treatments free of charge, but that "once the federal government is no longer purchasing or distributing COVID-19 vaccines and treatments, payment, coverage, and access may change."

Parekh also praised the way the CDC is handling the disappearance -- starting Thursday -- of its reporting on COVID cases and hospitalizations. "They've made [the reporting] like [they do for] flu, and I think that's good," he said. "They're using existing systems, and I think it's very sound and it's logical. But this virus compared to flu is even more transmissible and it is continuing to mutate very quickly. So ensuring that we have surveillance systems that can catch and provide early warning, I think, is going to be important."

Telehealth Flexibilities Extended

Telehealth is another area to watch, Jake Harper, JD, partner at Morgan Lewis, said on the Morgan Lewis call. "So luckily, the Consolidated Appropriations Act extended most of the telehealth flexibilities to the end of 2024," he said. "So now we're sort of in this interim period where there's additional data being collected, and within the course of the next year, I suspect that we will receive further congressional guidance on what a permanent telehealth solution will look like."

A big flexibility in that area has been the decision by the Drug Enforcement Administration (DEA) to let clinicians prescribe controlled substances -- everything from buprenorphine to attention-deficit/hyperactivity disorder medications -- via telehealth during the PHE, Harper said.

After issuing a in March regarding what would change following the end of the PHE -- a rule that drew many critical comments -- DEA on Monday "released a to keep everything status quo for 6 months," Harper said. "So we will get, over the next month or two, a final rule from DEA that will provide more clarity on what they perceive at the expectations for teleprescribing controlled substances ... If this hadn't come out, there was going to be chaos on Friday."

Similarly, the HHS Office for Civil Rights (OCR) has said it will allow a 90-day "transition period" for winding down its PHE-era policy of enforcement discretion regarding HIPAA violations. "OCR issued a very public policy at the start of the PHE that said they were going to have a policy of enforcement discretion for certain kinds of non-compliance," he said. For example, "if you were a physician and communicating with your patient via FaceTime or Skype or some other method that wasn't necessarily fully encrypted, OCR was not going to make an issue of that." So giving this 90-day grace period "is sort of like kicking the can down the road a little bit" to help providers ease back into the old rules, he said.

Learning From the Past

One lesson to be learned from the pandemic is that "the cycle of panic and neglect is not the best way to be prepared for public health emergency," Brent Ewig, MSPH, chief policy and government relations officer for the Association of Immunization Managers, said on the CVEEP call. "I don't want to be flip about that. But I think the idea that having a system in place to deliver a vaccine to broad amounts of the population -- if we could do that every day, then we'd be prepared to do that in the next emergency."

Instead, however, although the number of the country's public vaccine providers increased from 44,000 in the Vaccines for Children program to over 400,000 COVID vaccine providers, "when that funding dries up for the pharmacy program, we're going to snap back to our prior system. And it just doesn't make sense," he said. "It was like you you built up a bunch of Navy battleships to go out and win this one battle against COVID, and now we're going to bring them back to port and dismantle them and mothball them, only to have to rebuild them in the next emergency."

"It's been clear for months now that most Americans have already moved on and they think that we may be done with COVID," Ewig added. "But COVID may not be done with us. If we've learned anything, it's to expect the unexpected ... Just remaining vigilant and doing surveillance is going to be key."

One thing clinicians should look out for in the coming months is possible audits and "lookbacks" from the federal government to make sure federal rules were being complied with during the PHE, Harper said. "It's sort of the old saying, 'No good deed goes unpunished,' and those providers that are trying to do the best they can to take care of patients [during a PHE] -- oftentimes they don't get a lot of credit on the back end. To the extent that there's not compliance or there was an inappropriate relationship, remuneration, or a billing error that occurred, regulatory agencies are going to look back at what providers did."

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