Richard Payerchin

With COVID-19 pandemic conditions improving, the national emergency declared by the president could end through congressional action.

Sen. Roger “Doc” Marshall, MD, R-Kansas, has introduced a 

 that would end the national emergency first declared by President Donald J. Trump effective March 13, 2020. President Joe Biden extended the national emergency in February 2021 and in February this year.

“Since President Biden used his appearance on ‘60 Minutes’ to declare COVID is over, he must immediately terminate the COVID-19 national emergency declaration and wind down other emergency authorities that his administration continues to force us to live under,” Marshall said in a 

 accompanying introduction of the resolution.

Marshall referred to the president’s Sept. 18 interview on the CBS News 

 among public health experts and news commentators, and on Sept. 21 Biden noted 

“But it basically is not where it was,” the president said about the pandemic, during a visit to New York.

“The American people are fatigued and yearning to operate outside of the confines of supersized government; they long for their God-given freedoms, and for leaders to take their side,” said Marshall, who made his 

 before serving in public office. “In March the U.S. Senate voted for my Resolution to repeal this emergency declaration and delivered a symbolic victory that limited government and our constitutional rights still reign supreme.

“It’s high time to for Joe Biden and his administration stop using COVID to implement their partisan political agenda and focus on the surge in crime and the fentanyl epidemic that is wreaking havoc across this nation and killing Americans at record rates,” Marshall said.

The resolution refers to the National Emergencies Act (NEA), a federal law that allows Congress to review and possibly terminate the president’s emergency declarations.

Marshall cited the law’s provision that “each House of Congress shall meet to consider a vote on a joint resolution to determine whether the emergency shall be terminated.”

“However, Congressional interpretation of this law has determined that the absence of a resolution introduced by any member signals unanimous consent for continuation,” said a statement published by Marshall’s office. “In failing to meet, debate, and vote on an emergency, Congress is effectively ceding more unchecked emergency powers to the executive similar to its failure to enforce War Powers provisions.”

It is not the first time Marshall has acted with legislation regarding the COVID-19 pandemic emergency. In March, the resolution had cosponsorship from Republican Senators Mike Braun of Indiana, Mike Lee of Utah, Ted Cruz of Texas, Rand Paul of Kentucky, Rick Scott of Florida, Steve Daines of Montana, Ron Johnson of Wisconsin, and James Risch of Idaho, and the Senate passed it 48-47, prompting a 

The president argued the national emergency allows the administration to respond to COVID-19 quickly and more effectively than without it, which benefits health care workers and those who contract the illness. Ending it prematurely “would be a reckless and costly mistake,” the administration’s veto warning said.

“Our health care workforce has been incredibly resilient, but after two years of fighting the pandemic we must continue to do everything we can to limit the burdens on our health care system,” said the letter from the Office of Management and Budget in the president’s administration. “Preventing further strain on our health care workers and their ability to deliver care to COVID patients will also enable treatment of people suffering from other illnesses who are also put at risk when hospital systems are overwhelmed.”

The House of Representatives did not take up the March resolution.

Once the latest resolution is introduced and approved by the Senate parliamentarian, the Senate Finance Committee will consider it and make a recommendation to the full Chamber. Marshall noted the process is outlined in the NEA.

This article originally appeared on Medical Economics.

Articles

Congress could overrule presidential declaration, but White House threatened veto of similar measure in March.

Senator Roger Marshall Seeks to End COVID-19 Pandemic National Emergency

Prescriptions for opioid pain medications decreased and prescriptions for nonopioid prescription painkillers grew after federal regulators published the 2016 guideline on using the drugs.

The federal Centers for Disease Control and Prevention published the “CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016,” with recommendations for primary care physicians who were prescribing opioids for patients with chronic pain outside active cancer treatment, palliative care, and end of life care. The 

 acknowledged “serious risks, including overdose and opioid use disorder,” with overdose death rates climbing in the preceding 10 years.

Once the guideline was published, opioid prescriptions declined and prescriptions increased for nonopioid medicines, according to 

 of insurance claims data of more than 15.87 million patients across the United States. Prescriptions for nonopioids such as acetaminophen, nonsteroidal anti-inflammatory drugs, antidepressants and antiseizure drugs grew by 3% in 2016, the first year of the guideline, then by 8.7% in 2017 and by 9.7% by 2018, the third year after the CDC guideline.

“These findings suggest that clinicians have been prescribing nonopioid pain medications more frequently since the 2016 guideline was released, and that may mean that they’ve considered opioid therapy only if its expected benefits exceeded the expected risks to the patient,” lead author Jason Goldstick, PhD, said in a 

“Though many characteristics – such as pain intensity and effectiveness of pain management – are not available in these data, these results may represent an increase in guideline-concordant pain treatment,” said Goldstick is a research associate professor of emergency medicine at University of Michigan Medical School.

Researchers said the analysis was the first they knew of to focus on changes to nonopioid prescribing after the CDC recommendations on opioids.

Increases in nonopioid pain medication prescribing were consistent across several patient subpopulations, including patients with recent opioid exposure, anxiety or mood disorders. The changes in prescribing may have led to greater use of nonpharmacologic treatments, such as physical therapy and cognitive behavioral therapy, according to the researchers.

“The 2016 guideline encouraged caution in prescribing opioids, and it was possible that it could have reduced the use of pain treatments overall,” senior author Amy Bohnert, PhD, MHS, said in the news release. Bohnert is associate professor of psychiatry at U-M Medical School. “Our analysis provides an encouraging sign that patients were more often offered other treatments for pain than before the guideline, rather than only being offered opioids less often.”

The data came from the national Optum Clinformatics Data Mart Database from 2011 to 2018 for patients with at least two years of continuous coverage. Coming from a single national insurer, data focused on a population with relatively high socioeconomic status, but did not identify patient comorbidities or differences in CDC guideline implementation across regions, institutions or medical specialties, the study said.

The study, “Patterns in Nonopiod Pain Medication Prescribing After the Release of the 2016 Guideline for Prescribing Opioids for Chronic Pain,” was published in the 

Study finds growth in three years after CDC guideline for primary care clinicians.

Nonopioid Pain Reliever Prescriptions on the Rise, as Opioid Prescriptions Decline

The U.S. Centers for Disease Control and Prevention (CDC) have recommended using 

 to stem a projected fall surge of the disease.

CDC’s Advisory Committee on Immunization Practices (ACIP) met Sept. 1 to consider using the bivalent vaccines from 

 to fight the virus’ omicron BA.4 and BA.5 variants. The vaccines aim “to restore protection that has waned since previous vaccination by targeting variants that are more transmissible and immune-evading,” the centers’ announcement said.

“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” CDC Director Rochelle P. Walensky, MD, MPH, said in a news release. “They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”

The Pfizer-BioNTech bivalent boosters may be used for people aged 12 years and older. The Moderna bivalent boosters are recommended for people aged 18 years and older.

CDC announced in the coming weeks the health experts expect to recommend updated COVID-19 boosters for other pediatric groups, per the discussion and evaluation of the data by ACIP on Sept. 1, 2022.

“When data are available and FDA authorizes these other types of COVID-19 boosters, CDC will quickly move to help make them available in the United States,” the centers’ announcement said.

The move came a day after the U.S. Food and Drug Administration (FDA) announced 

 for the vaccines. FDA Commissioner Robert M. Califf, MD, encouraged anyone who qualifies to get a booster for the fall season, at least two months after finishing their initial vaccine cycle or after one or two previous boosters.

From December 2020 to December 2021, vaccinations are estimated to have prevented 13.7 million to 15.9 million deaths across 185 countries, an estimated 63% reduction in total COVID-19 deaths globally, according to 

The American Medical Association also has published 

Move comes after FDA give emergency use authorization for bivalent vaccines.

CDC Recommends Updated COVID-19 Boosters Incase of Fall Surge

As autumn approaches with possibilities of COVID-19 surges, 

 are seeking federal emergency use authorization (EUA) for a booster vaccine against the Omicron BA.4/BA.5 variant.

The U.S. Food and Drug Administration will consider EUA for a booster dose for people aged 12 years and older and if approved, the vaccine will be available to ship immediately, according to the announcement from the companies.

“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” Pfizer Chairman and CEO Albert Bourla said in a 

. “Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges."

A conditional marketing authorization application has also been initiated with the European Medicines Agency (EMA) for the Omicron BA.4/BA.5-adapted bivalent vaccine and is expected to be completed in the coming days.

“Given the ongoing evolution of SARS-CoV-2 and its variants, it's of great importance that vaccines can be rapidly adapted to the major circulating Omicron lineages,” BioNTech CEO and cofounder Prof. Ugur Sahin, MD, said in the news release. “In less than three months after the FDA provided its guidance for adapted vaccines in the U.S., we are ready to ship the first doses of our Omicron BA.4/BA.5-adapted bivalent vaccine, pending regulatory authorization, to provide people in the U.S. with the possibility to get a booster adapted to the currently most dominant strain of the virus.”

The Pfizer and BioNTech announcement said the bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein with mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant. “Preclinical data showed a booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response” against the Omicron variants and the original strain.

Pfizer-BioNTech hopes booster can be available for use this fall.

FDA EUA Sought by Pfizer-BioNTech for Omicron Booster

Federal health leaders are ramping up the monkeypox vaccine production pipeline as the disease spreads around the United States.

The U.S. Department of Health and Human Services 

 between Bavarian Nordic and Grand River Aseptic Manufacturing (GRAM), a Michigan-based pharmaceutical maker, to make the Jynneos vaccine domestically.

“The Biomedical Advance Research and Development Authority (BARDA), within the HHS Administration for Strategic Preparedness and Response (ASPR), has ordered 5.5 million vials of JYNNEOS from Bavarian Nordic to be filled, finished and delivered from U.S. government-owned bulk vaccine stored in Denmark,” the HHS announcement said. “Under the procurement, Bavarian Nordic agreed to complete a technology transfer that would allow for 2.5 million of those vials to be filled and finished by a U.S.-based contract manufacturer.”

“Rapidly increasing the supply and safe delivery of monkeypox vaccine to those at the highest risk of contracting the virus is a top priority for President Biden,” said Bob Fenton, Coordinator of the White House National Monkeypox Response. “This partnership between Bavarian Nordic and GRAM will significantly increase the capacity to fill and finish government-owned doses – for the first time in the U.S. – and allow us to deliver our current and future supply more quickly to locations nationwide.”

Fenton was the lead speaker Aug. 18 in a 

 by the White House Monkeypox Response Team.

Starting Aug. 22, an additional 1.8 million doses of vaccine will be available to jurisdictions for ordering.

As of Aug. 18, the United States had 14,115 cases of monkeypox reported in 49 states; Wyoming was the last state without a recorded case. New York hat 2,744 cases; California had 2,663 cases; Florida had 1,372; Texas had 1,079; and Georgia had 1,066, among states with 1,000 or more cases, according to the 

 from the U.S. Centers for Disease Control and Prevention (CDC).

 on obtaining and using Tpoxx (Tecovirimat) for treating 

. Clinicians and care facility pharmacists requesting the drug should contact state or territorial health departments to obtain it through the jurisdictions where it has been pre-positioned by the Strategic National Stockpile.

This article was originally published by Medical Economics.

Domestic production to begin at Michigan-based pharmaceutical maker.

Plan for Monkeypox Vaccine Production Released by Federal Officials

The national rate of people without health insurance dropped to a record low 8% in the first quarter of 2022, according to federal researchers.

 estimated about 26.4 million people lacked health insurance in the first quarter of 2022, down from an annual estimated of 31.6 million people without insurance in 2020. That indicates about 5.2 million people – an estimated 4.1 million adults aged 18 to 64 years, and 1 million children aged 17 years or younger – gained health coverage since 2020.

The figures were in an analysis published Aug. 2 by the Office of Health Policy in the 

Assistant Secretary for Planning and Evaluation

 (ASPE) in the U.S. Department of Health and Human Services (

). APSE credited the administration of President Joe Biden for 2021 actions that built on large reductions in uninsured rates due to the 2014 Affordable Care Act (ACA).

“Overall, these results highlight the significant gains in health insurance coverage that occurred in 2021 and early 2022 associated with the Biden-Harris Administration’s policies to support health insurance expansion,” the report said. “These gains build on the large reductions in the uninsured rate that occurred after the implementation of the Affordable Care Act (ACA) in 2014, which research demonstrates produced improved health outcomes, better access to care, and improved financial security for families.”

Before 2022, the previous record low uninsured rate was 9% in 2016, for the annual rate. The lowest quarterly estimate was 8.6% in the first quarter of 2016, though the report noted quarterly estimates are more volatile due to smaller sample sizes.

About 5.4% of adults aged 18 to 64 years reported having ACA Marketplace coverage in early 2022, up about 2 million people from the 4.4% Marketplace coverage rate of 2020.

The American Rescue Plan,the administration’s response to the economic woes caused by the COVID-19 pandemic, included enhanced subsidies for people seeking insurance through the Marketplace at HealthCare.gov. The subsidies were retroactive to the start of 2021, boosted the size of premium tax credits for people with incomes between 100% and 400% of the federal poverty level (FPL), and extended tax credits to those with incomes above 400% of the FPL for the first time, the report said.

The Inflation Reduction Act, introduced in the Senate, would extend ACA Marketplace insurance subsidies through 2025.

“And I'm hopeful that with Congressional action we can continue the work to lower costs for more Americans by both extending the enhanced Affordable Care Act tax credits that have helped drive the uninsured rate to an all-time low and increasing the affordability of prescription drugs for Medicare beneficiaries – reducing their cost sharing and allowing Medicare to negotiate a better deal on prescription drug prices,” HHS Secretary Xavier Becerra said in a statement.

Without an extension, there have been predictions that millions of people will face premium increases for Marketplace plans, leading to a decline in overall health care spending. Regardless of subsidies, at least one report has forecasted a spike in 2023 premiums due to inflation.

Additional factors for the declining uninsured rate included the continuous enrollment provision in Medicaid for adults aged 19 to 64 with incomes less than 138% of the FPL.

Five states expanded Medicaid for adults in 2019 and 2020. From 2018 to 2020, the most recent year data are available, those states had the largest decreases in uninsured rates: Idaho (-8.4%), Virginia (-7.2%), Maine (-4.9%), Nebraska (-2.8%), and Utah (-1.4%).

Two states that expanded Medicaid in 2021 posted increases in the rates of uninsured: Missouri (1.7%) and Oklahoma (2.9%). The report did not explain why.

Among the 50 states and the District of Columbia, only four – Washington D.C., Massachusetts, Rhode Island and Vermont – had single digit uninsured rates for those who qualify for Medicaid.

 that “Medicaid expansion was shown to have improved preventive care and financial security for adults with disabilities.”

More people getting health coverage, but 26.4 million still don’t have it.