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HHS Renews COVID-19 PHE for 11th Time — Here’s Why

From Beckers Healthcare

When President Joe Biden declared the COVID-19 pandemic “over” Sept. 18, his message divided the medical community and sent a clear message: the nation is moving on from COVID-19.

On Oct. 13, HHS extended the public health emergency once again and sent another clear message: the healthcare system is not ready to move on.

“It’s not that we necessarily want to continue the PHE for a long period of time,” Nancy Foster, AHA’s vice president of quality and patient safety, told Becker’s. “We want to make sure that all of the work that needs to get done, does get done, before it ends.”

“There’s 400 people dying every day, and most of those are in hospitals,” Chip Kahn, president and CEO at the Federation of American Hospitals, told Becker’s. “I don’t think we’re really into a new normal where we can say with confidence that this is still not an exceptional situation.”

HHS last renewed the PHE July 15 for an additional 90 days — it also told states it would provide a notice 60 days before if it did decide to end it. Aug. 14, the date in which states would have 60 days’ notice, came without a peep from the federal agency, all but confirming the declaration would be extended once more.

The 11th renewal of the PHE since its first declaration in January 2020 allows the country to continue operating under pandemic-era policies until at least the next deadline: Jan. 11, 2023.

But continuing to label the current situation as an emergency while also declaring that emergency over is increasingly being questioned.

Illinois Gov. JB Pritzker was asked in a political debate Oct. 6 why his state has now issued the same PHE 34 times since March 2020. Ten states still have their emergencies in effect.

“We’re following the federal disaster declaration,” Mr. Pritzker said. “It allows us to bring in Medicaid funds and support people who have COVID-19 and support our hospitals.”

Sen. Richard Burr of North Carolina, the top ranking Republican on the Senate health committee, asked in a Sept. 19 letter to the president when Medicaid redeterminations would begin again, or when federal employees and contractors would no longer need to get vaccinated.

“Without a clear plan to wind down pandemic-era policies, the deficit will continue to balloon and the effectiveness of public health measures will wane as the American people continue to be confused by mixed messages and distrust of federal officials,” he wrote.

The number of Americans who say they’re concerned about COVID-19 is 57 percent — among the lowest seen throughout the pandemic, according to a Sept. 14 Ipsos poll. In addition, 82 percent believe the country is in a better pandemic position now than it was one year ago.

“I think it’s the policymakers that are making the judgment because they’re not happy with the implications of the PHE in terms of spending,” Mr. Kahn said. “Also it’s symbolic. If the president said we moved on and there’s still a PHE, then that may put pressure symbolically on the White House to say by Nov. 15 that we’re going to have to move on.”

Moving on isn’t so simple. The pandemic-era policies led to a complete overhaul of telehealth and who can use it, they fast-tracked approvals of COVID-19 vaccines and treatments, and they preserved healthcare coverage for millions of Medicaid beneficiaries nationwide.

Preserving telehealth

“Despite staffing shortages and financial pressures and all the other things we could also talk about, what has not yet happened is fully thinking through how to unwind some of the flexibilities we currently have, and how to perhaps make permanent some of the others,” Ms. Foster said.

The AHA is in favor of cementing many of the PHE policies through legislation, including several around telehealth, rural care and hospital at home programs.

In April 2020, HHS relaxed telehealth restrictions and told providers it would not enforce HIPAA rules around audio-only telehealth services, meaning video calls could be used to treat patients.

In June, the agency released new guidance explaining how providers can maintain HIPAA compliance with telehealth post-PHE because the nonenforcement policy will only remain in effect while the PHE is in place.

Lawmakers are also looking to extend virtual opioid use disorder treatments for individuals with high-deductible health plans. The current rule allowing payers to offer virtual care to members before they meet their deductibles is set to expire at the end of this year.

In addition, waivers that allow patients to be virtually-prescribed buprenorphine for opioid use disorder will also expire when the PHE does.

For Medicare, preserving telehealth flexibilities is also still a work in progress. Medicare has covered the cost of telehealth visits and allowed all Medicare-enrolled providers to bill for telehealth services since early 2020.

As of now, the Medicare flexibilities will end 151 days after the PHE expires. In July, the House passed The Advancing Telehealth Beyond COVID-19 Act, but the legislation must still be approved by the Senate for Medicare patients to continue using telehealth through 2024.

“It’s a complex network of flexibilities that have been allowed,” Ms. Foster said. “It is hard to imagine continuing the robust delivery of telehealth and the way we want to do it and the way our patients seem to want if we don’t have all of the policies we’re identifying because they do build on each other.”

Medicaid redeterminations

Medicaid enrollment initially swelled as a result of early pandemic joblessness and a continuous coverage requirement of the Families First Coronavirus Response Act, meaning states had to keep people enrolled in Medicaid for as long as there was a pandemic. Since February 2020, total Medicaid/Children’s Health Insurance Program enrollment has increased by 17.7 million people, or nearly 25 percent.

If the public health emergency expires, a redetermination process will begin a major disenrollment of Medicaid beneficiaries. Once that occurs, HHS estimates up to 15 million people could lose Medicaid coverage, with about half of those being children.

“Comprehensive health insurance coverage is critical for access to care and it would be really disruptive for people and prevent them from seeking care,” Molly Smith, AHA’s group vice president of policy, told Becker’s. 

Ms. Smith says there will be major challenges if a Medicaid redetermination period is triggered – a process that is complicated in normal circumstances. States are suffering from workforce pressures too and it will be difficult for them to process millions of individuals concurrently, many of whom have moved in the last few years.

In addition, the AHA says the Biden administration and CMS have taken steps to support states with more time and information before the PHE eventually ends.

“There are policy things that can be done, and we think the administration has done many of them,” Ms. Smith said. “I know what they are trying to do is really make sure that all of the different stakeholders are aligned and speaking from the same talking points.”

All payers operating Medicaid plans will be affected, but those with higher enrollments are expected to be more impacted. The loss of beneficiaries will be mitigated through the Inflation Reduction Act’s extension of ACA premium tax credits through the end of 2025, which will allow some to regain coverage in the individual market.

Commercialization of COVID-19 vaccines and treatments

Until this fall, the federal government purchased and made available COVID-19 vaccines and treatments at no cost, but the process has begun to shift those costs to the commercial market.

“My hope is that in 2023, you’re going to see the commercialization of almost all of these products. Some of that is actually going to begin this fall, in the days and weeks ahead. You’re going to see commercialization of some of these things,” White House COVID-19 Response Coordinator Ashish Jha, MD, said Aug. 16.

The onus will fall on payers to become more involved in pricing negotiations, likely leading to higher premiums for members. Commercialization would also leave the over 26 million uninsured individuals in the U.S. with a major disadvantage in accessing free vaccines and treatments.

Some of these products only went to market after fast-track approval from the Food and Drug Administration’s emergency use authorizations, including vaccines. According to Bloomberg Law, that doesn’t mean the products disappear once the PHE does.

EUAs must be initially justified by a PHE, but the former is not reliant on the latter to exist. If HHS does terminate an EUA, it must provide an advanced public notice and begin a transition period “for proper dispositioning of the product.”

Physicians: This is still an emergency

It isn’t just the public and politicians looking to move on from COVID.

Starting Oct. 20, the CDC will no longer publish daily updates on total cases and deaths, instead opting to share the data every Wednesday. The agency has also dropped its quarantine protocols for everyone and masking requirements for healthcare facilities not located in a high-transmission community — much to the dismay of some physicians.

“That means that places with substantial transmission can unmask sick patients who haven’t been tested for COVID, right next to the elderly, chemo patients, people with pulmonary disorders, and pregnant women? My kid could identify the flaws with this plan,” said Megan Ranney, MD, emergency physician and academic dean of Brown University School of Public Health in Providence, R.I.

After the president declared the pandemic over, physicians across the country took to social media to express their disagreement.

“Heck no. With all due respect, [President Biden] — you’re wrong. Pandemic is not over. Almost 3,000 Americans are dying from #COVID19 every single week,” Eric Feigl-Ding, PhD, an epidemiologist and former faculty member at Boston-based Harvard Medical School, tweeted. “A weekly 9/11 is a very big deal. Don’t even get me started on #LongCOVID — wreaking havoc on millions more.”

Still, COVID-19 numbers have continued their downward trend. The nation’s seven-day case average was 40,631 as of Oct. 9, a 25 percent decrease in the last two weeks. The CDC forecasts new hospital admissions will remain stable or have an uncertain trend over the next month, and deaths are expected to fall.

“We don’t know what’s going to happen in the next few months,” Mr. Kahn said. “And if we look at Europe and the U.K., we see COVID on the rise. It is still a present issue.”

CDC Updates COVID-19 Infection Prevention Recommendations for Healthcare Personnel

On September 23 the Centers for Disease Control and Prevention (CDC) updated their COVID-19 infection prevention recommendations for healthcare personnel. Several updates were made that may be of special interest to health centers:

  • Vaccination status is no longer used to inform source control (masking), screening testing, or post-exposure recommendations.
  • When SARS-CoV-2 Community Transmission levels are high, source control is recommended for everyone in a healthcare setting when they are in areas of the healthcare facility where they could encounter patients.
  • When SARS-CoV-2 Community Transmission levels are not high, healthcare facilities could choose not to require universal source control. However, even though source control is not universally required, it remains recommended in some specific circumstances.
  • Updated circumstances when universal use of personal protective equipment should be considered.
  • Updated recommendations for testing frequency to detect the potential for variants with shorter incubation periods and to address the risk for false negative antigen tests in people without symptoms.
  • Clarified that screening testing of asymptomatic healthcare personnel, including those in nursing homes, is at the discretion of the healthcare facility

Health centers will need to follow the level of Community Transmission in their location to determine whether masking is required within their facility. Additionally, the Pennsylvania Department of Health (PA DOH) issued additional guidance and clarification in Health Alerts 661 and 662 issued this week.

Pennsylvania Health Department Recommendations Regarding the Bivalent COVID-19 Booster Vaccine

CDC Guidance released on September 1, 2022, recommends that patients 12 and older who received the primary series of any of the authorized COVID-19 vaccines should receive a booster dose of a mRNA bivalent COVID-19 vaccine. The mRNA bivalent booster dose should occur at least two months after the last dose of a COVID-19 vaccine. The bivalent Pfizer BioNTech booster is approved for patients aged 12 years and older and the bivalent Moderna booster is approved for patients aged 18 years and older. The mRNA bivalent vaccines are only available for booster vaccinations. The original monovalent COVID-19 vaccine must be used for the primary series. The original monovalent COVID-19 vaccine can no longer be used for booster doses except for children aged 5-11 who are not eligible for the booster dose of the bivalent COVID-19 vaccine. Since there are now multiple formulations of the mRNA COVID-19 vaccines it will be extremely important for vaccine providers to make sure that the correct vaccine is given to each patient. The CDC definition of up-to-date with COVID-19 vaccine is someone who has completed their primary vaccine series and received the most recent COVID-19 booster vaccine recommended for them by the CDC. It is highly recommended that patients also receive their Influenza vaccine this fall and can receive both the COVID-19 bivalent booster and the influenza vaccine during the same visit. For complete details, the full Health Advisory 659 will be available here when it is published.

Updated COVID-19 Vaccines Providing Protection Against Omicron Variant Available at No Cost

The Department of Health and Human Services (HHS), through CMS, announced that people with Medicare, Medicaid, Children’s Health Insurance Program coverage, private insurance coverage, or no health coverage can get COVID-19 vaccines, including the updated Moderna and Pfizer-BioNTech COVID-19 vaccines, at no cost, for as long as the federal government continues purchasing and distributing these COVID-19 vaccines. CMS issued four new CPT codes effective Aug. 31, 2022: Code 91312 for Pfizer-BioNTech COVID-19 Vaccine, Bivalent Product; Code 91313 for Moderna COVID-19 Vaccine, Bivalent Product; Code 0124A for Pfizer-BioNTech COVID-19 Vaccine, Bivalent – Administration – Booster Dose; and Code 0134A for Moderna COVID-19 Vaccine, Bivalent – Administration – Booster Dose. Visit the COVID-19 Vaccine Provider Toolkit for more information, and get the most current list of billing codes, payment allowances, and effective dates. See the full news alert.

Pennsylvania Health Department Says Providers Are Ready to Give Updated COVID-19 Booster Shots

The Pennsylvania Department of Health (DOH) announced that vaccine providers across the state are prepared to begin administering updated COVID-19 booster vaccines as soon as they receive them. The vaccines, which provide additional protection against the original coronavirus and Omicron variants BA.4 and BA.5, were recently approved by the Centers for Disease Control and Prevention (CDC) after receiving emergency use authorization from the Food and Drug Administration.

Pennsylvania Assessing Current PPE Stockpile for Future COVID-19 and PHE Purposes

The Department of Health (DOH), Department of General Services (DGS), and Pennsylvania Emergency Management Agency (PEMA) are collaborating to right-size the current PPE stockpile for future COVID-19 and public health emergency purposes, and to ensure partners have sufficient quantities of PPE to protect against a likely fall/winter resurgence of COVID-19.

To that end, partners are encouraged to request PPE through this form. These resources are intended to support organizations for current or future COVID-19 protection, or other associated purposes (including training purposes) and are available at no cost to the recipient. These resources are NOT permitted to be used to offset normal operational costs for the procurement of PPE.

Please note that while you will be able to indicate requested quantities and size preferences, we will not be able to accommodate requests for specific brands/styles of products in the following categories:

  • N95 masks
  • Surgical masks
  • Isolation gowns
  • Face shields
  • Nitrile gloves
  • Hand sanitizer
  • Sanitizing wipes

Depending on how quickly you intend to use these resources, you may request to be sent “long dated” materials (expiration dates >6 months), “short dated” materials (expiration >1 month but <6 months), or recently expired materials if they are to be used for non-healthcare and/or training purposes that do not involve human contact. Organizations receiving recently expired materials must complete the attached waiver and submit to HOC_log@pa.gov prior to receipt of PPE. We encourage facilities to request the shortest timeline product that can be used by your site.

This survey will be kept open and orders will be filled on a first-come, first-served basis through at least October 2022. Please email HOC_Log@pa.gov if you have any questions about this program. Thank you.

Just Announced, An Extended Shelf Life for COVID At-Home Tests

 While the federal program for free at-home tests will be suspended on Friday, September 2, the Food and Drug Administration provides a list of authorized testing products that are still available over the counter.  In some cases, the expiration date for a test may be extended, meaning the manufacturer provided data showing that the shelf life is longer than was known when the test was first authorized.

Creating a Roadmap for the End of the COVID-19 Public Health Emergency

With the eventual end of the Medicare Public Health Emergency (PHE), many of the waivers and broad flexibilities CMS provided to healthcare providers during this time will terminate, as they were intended to address the acute and extraordinary circumstances of a rapidly evolving pandemic and not replace existing requirements. To help healthcare facilities and providers understand the coming changes, CMS has developed a roadmap for the eventual end of the Medicare PHE waivers and flexibilities. Similar to the guidance CMS has made available to states, CMS is releasing fact sheets that will help the health care sector transition to operations once the PHE ends, whenever that may occur. For information on waivers and flexibilities applicable to rural healthcare facilities and providers, please see the rural crosswalk CMS published in May 2021.

A COVID-19 Guidance Update for the General Population

Individuals who are exposed to COVID-19 are recommended to wear a high-quality mask for 10 days and get tested on day 6 after exposure. Quarantine for individuals who are exposed is no longer recommended. If you have questions about this guidance, please call your local health department or 1-877-PA-HEALTH (1-877-724-3258). For the full update, click here.

FDA Updates Guidance on At-Home COVID-19 Antigen Tests

Updated guidance from the FDA advises people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test. This can reduce the risk that an infection may be missed (false negative result). It will help prevent people from unknowingly spreading COVID-19 to others. If you believe you have been exposed to COVID-19, the FDA recommends repeat testing at 48-hour intervals for a total of at least three tests, regardless of whether you have COVID-19 symptoms.