Last night, the FDA granted Moderna emergency use authorization for administering its mRNA based COVID-19 vaccine to Americans aged 18 and older. About an hour ago, the CDC’s Advisory Committee seconded this decision which means that health plans, including FEHB plans, must begin to provide in-network and out-of-network coverage for administration of the Moderna vaccine on January 3, 2021. That is certainly good news.
Last night, as CBS News reports, the Senate joined the House of Representatives in approving a two day extension of the continuing resolution funding the federal government, and the President signed the resolution into law. The Hill adds this afternoon that
Speaker Nancy Pelosi (D-Calif.) told Democratic House members during a conference call Saturday that a deal is within reach as soon as negotiators hammer out an agreement on language being pushed by Sen. Pat Toomey(R-Pa.) to wind down the Federal Reserve credit lending facilities. Pelosi told colleagues that the “good news” is “we’re right within reach” of resolving that disagreement.
In other news —
The American Medical Association offers advice on which masks work best in warding off COVID-19.
The federal government’s Cybersecurity and Infrastructure Security Agency (“CISA”) offered updated guidance today on the SolarWinds backdoor hack.
Bloomberg provided this interesting observation on the scope of this hack:
At least 200 organizations, including government agencies and companies around the world, have been hacked as part of a suspected Russian cyber-attack that implanted malicious code in a widely used software program, said a cybersecurity firm and three people familiar with ongoing investigations.
The number of actual hacking victims has been one of many unanswered questions surrounding the cyber-attack, which used a backdoor in SolarWinds Corp.’s Orion network management software as a staging ground for further attacks.
As many as 18,000 SolarWinds’ customers received a malicious update that included the backdoor, but the number that was actually hacked — meaning the attackers used the backdoor to infiltrate computer networks — is likely to be far fewer.
Based on the CDC’s Cases in the U.S. website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 20th through 50th weeks of this year (beginning May 14 and ending December 16; using Thursday as the first day of the week in order to facilitate this weekly update):
and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:
The FEHBlog has noted that the new cases and deaths chart shows a flat line for new weekly deaths because new cases greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2 through December 9). The FEHBlog extended this chart from April 2 to May 14 in order to display the previous high for this sad metric.
The CDC’s current Fluview report continues to state “Seasonal influenza activity in the United States remains lower than usual for this time of year.” So Americans must be doing something right.
1) substantial increases in drug overdose deaths across the United States, primarily driven by rapid increases in overdose deaths involving synthetic opioids excluding methadone (hereafter referred to as synthetic opioids), likely illicitly manufactured fentanyl; (2) a concerning acceleration of the increase in drug overdose deaths, with the largest increase recorded from March 2020 to May 2020,coinciding with the implementation of widespread mitigation measures for the COVID-19 pandemic; (3) the changing geographic distribution of overdose deaths involving synthetic opioids, with the largest percentage increases occurring in states in the western United States; (4) significant increases in overdose deaths involving psychostimulants with abuse potential (hereafter referred to as psychostimulants) such as methamphetamine; and
The House [of Representatives] passed a two-day spending bill Friday evening, sending it over to the Senate in a bid to prevent a partial government shutdown after midnight, as congressional leaders struggled to wrap up negotiations on a coronavirus relief package.
In the Covid-19 talks, negotiators were still wrestling Friday to close differences on the Federal Reserve’s emergency lending powers among other final snags. Leaders have aimed to pair the passage of the Covid-19 aid bill with a broader spending bill.
The FEHBlog expected a little bit longer extension but a two day extension suggests that the compromise on the COVID-19 relief bill is near. The FEHBlog cannot believe that with the Georgia Senate primary approaching on January 5 that either party would risk a government shutdown or not COVID-19 relief. But we shall see.
In that regard, the FEHBlog read on the American Hospital Association’s daily report about this health system letter to Congress, delivered today, suggesting that there is some crazy language in that bipartisan surprise billing proposal. Again, we shall see.
HHS’s Office for Civil Rights issued “guidance on how the Health Insurance Portability and Accountability Act of 1996 (HIPAA) permits covered entities and their business associates to use health information exchanges to disclose protected health information (PHI) for the public health activities of a public health authority. The guidance provides examples relevant to the COVID-19 public health emergency on how HIPAA permits covered entities and their business associates to disclose PHI to an HIE for reporting to a PHA that is engaged in public health activities.”
According to the Wall Street Journal and Bloomberg, legislative negotiations continue over the latest COVID-19 relief bill. This bill will be added to the omnibus spending bill for the federal government’s current fiscal year. That bill is ready to go. In order to allow time for the relief bill negotiations to conclude successfully, it’s likely that tomorrow Congress will extend the current continuing resolution into next week.
On the COVID-19 front —
The Food and Drug Administration yesterday “issued a new Emergency Use Authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test for at-home use with a prescription. The BinaxNOW COVID-19 Ag Card Home Test is an antigen test that detects fragments of proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample. It is authorized for use at home with self-collected samples in individuals age 15 years or older who are suspected of having COVID-19 by a health care provider within the first seven days of symptom onset. The test is also for use with individuals aged four years or older who are suspected of having COVID-19 by a health care provider within the first seven days of symptom onset, when an adult collects the sample.The BinaxNOW COVID-19 Ag Card Home Test is being offered in partnership with eMed Labs, LLC., a telehealth service that will take users step-by-step through the sample collection process, explain how to perform the test, and provide assistance in reading and understanding the results.”
Today the Centers for Disease Control (“CDC”) released a report concluding that the COVID-19 virus can be transmitted person to person on a commercial airline. The report was based on an analysis of a commercial airline trip that occurred in Australia last March before people began to take protective measure seriously. The CDC’s point though is well taken. Be careful.
In other Health and Human Services Department news —
Today HHS released “the first-ever national plan to address the public health crisis caused by alarming increases in rates of sexually transmitted infections (STIs) in the United States over the past six years. The STI National Strategic Plan 2021-2025 (STI Plan) sets national goals, objectives, and strategies to respond to the STI epidemic. The plan will serve as a roadmap to help federal and non-federal stakeholders at all levels and in all sectors reverse the sharp upward trends in STI rates.”
Also today, “the Office for Civil Rights (OCR) at HHS released its 2016-2017 HIPAA Audits Industry Report that reviewed selected health care entities and business associates for compliance with certain provisions of the HIPAA Privacy, Security, and Breach Notification Rules.” Although the report is somewhat dated, the summary of findings likely are still relevant, in the FEHBlog’s view:
Most covered entities met the timeliness requirements for providing breach notification to individuals;
Most covered entities that maintained a website about their customer services or benefits satisfied the requirement to prominently post their Notice of Privacy Practices on their website;
Most covered entities failed to provide all of the required content for a Notice of Privacy Practices;
Most covered entities failed to provide all of the required content for breach notification to individuals;
Most covered entities failed to properly implement the individual right of access requirements such as timely action within 30 days and charging a reasonable cost-based fee;
Most covered entities and business associates failed to implement the HIPAA Security Rule requirements for risk analysis and risk management.
The announcement concludes — “The audit results confirm the wisdom of OCR’s increased enforcement focus on hacking and OCR’s Right of Access initiative,” said OCR Director Roger Severino. “We will continue our HIPAA enforcement initiatives until health care entities get serious about identifying security risks to health information in their custody and fulfilling their duty to provide patients with timely and reasonable, cost-based access to their medical records.”
ArsTechnica offers a comprehensive update on the SolarWinds hack.
The supply chain attack used to breach federal agencies and at least one private company poses a “grave risk” to the United States, in part because the attackers likely used means other than just the SolarWinds backdoor to penetrate networks of interest, federal officials said on Thursday. One of those networks belongs to the National Nuclear Security Administration, which is responsible for the Los Alamos and Sandia labs, according to a report from Politico.
“This adversary has demonstrated an ability to exploit software supply chains and shown significant knowledge of Windows networks,” officials with the Cybersecurity Infrastructure and Security Agency wrote in an alert. “It is likely that the adversary has additional initial access vectors and tactics, techniques, and procedures (TTPs) that have not yet been discovered.” CISA, as the agency is abbreviated, is an arm of the Department of Homeland Security.
Elsewhere, officials wrote: “CISA has determined that this threat poses a grave risk to the Federal Government and state, local, tribal, and territorial governments as well as critical infrastructure entities and other private sector organizations.”
So the hacking effort may expand beyond the identified Solarwinds “backdoor.” Wow.
The FEHBlog just watched the Food and Drug Administration’s (“FDA”) Vaccines and Biological Products Advisory Committee unanimously recommend by a 20-0 vote (one abstention) that the FDA grant emergency use authorization (EUA) to the Moderna COVID-19 vaccine. Last week the same Committee appro/ved the Pfizer-BioNTech vaccine by a 17-4-1 vote. Both vaccines rely on mRNA technology. In the FEHBlog’s view, the difference between the votes is that Moderna limited its EUA application to people aged 18 or older while Pfizer’s extension of the EUA to sixteen and seventeen year old people was controversial. If recent history is any guide, the FDA can be expected to grant the EUA tomorrow and over the weekend the CDC’s Advisory Committee on Immunization Practices will trigger health plan coverage of the vaccine effective fifteen days later.
Politico reports that the Johnson & Johnson vaccine will be presented to this FDA committee in late January 2021. “The vaccine is the only one among the frontrunners that is given as a single dose. “Because it’s a one dose vaccine, they can really scale up very quickly,” said Moncef Slaoui, the chief adviser to Operation Warp Speed.
It’s the 250th anniversary of the birth of that great composer Ludwig van Beethoven. Speaking of birthdays, the FEHBlog heard today that Dr. Anthony Fauci turns 80 on December 24. According to the Washington Post, he is urging Americans to have a merry little Christmas. Touche.
On the omnibus/COVID-19 relief bill front, Bloomberg reports that
Congressional leaders are still haggling over the final details of nearly $900 billion in coronavirus aid as staff members try to write the legislative language needed for House and Senate votes this week.
If the aid deal, combined with a spending bill needed to fund the government, isn’t ready to get a vote in both chambers by Friday, another stopgap measure will be needed to avert a partial government shutdown after midnight Friday.
People briefed on the negotiations say the draft of the plan includes $600 in payments for individuals, $300-per-week in supplemental unemployment insurance payments and aid for small businesses, but it omits aid to state and local governments and lawsuit liability protection. It also includes roughly $17 billion for airlines.
Senate Majority Leader Mitch McConnell, House Speaker Nancy Pelosi, Senate Democratic leader Chuck Schumer and House Republican leader Kevin McCarthy continued negotiations on Wednesday, although the deal is more likely to come together by Thursday, according to a lawmaker briefed on the talks.
The FEHBlog expected the legislative language today but good things come to those who wait, right?
The CMS actuary released his annual report on the previous year’s healthcare spending. “Total national healthcare spending in 2019 grew 4.6%, which was similar to the 4.7% growth in 2018 and the average annual growth since 2016 of 4.5%.” 2020 may be the outlier.
HHS began distributing the third phase of COVID-19 relief funding for providers Wednesday, with $24.5 billion to go to more than 70,000 providers through the end of January. The amount exceeds the original $20 billion planned for this tranche as officials realized more would be needed to get providers close to whole from coronavirus-related losses. HHS said up to 88% of applicants’ reported losses are being reimbursed.
In that regard, Fierce Healthcare reports that major healthcare systems which own a health insurer are weathering the COVID-19 storm better than most health systems according to a PwC report. “PwC pointed to major health systems such as Intermountain, Kaiser Permanente and Presbyterian Healthcare Services that used health plans to help bolster their finances.” It’s not surprising to the FEHBlog that hedges like this work. Large health insurers similarly are acquiring healthcare providers.
In other news —
The EEOC offers guidance for employers who want to make sure that their employee are vaccinated again COVID-19 and also want to comply with federal anti-discrimination law. This new guidance is Q&A K.
EHR Intelligence discusses the Gravity Project’s efforts to introduce social determinants of health data into electronic health records.
Health Payer Intelligence informs us about a PwC Health Research Institute report concluding that “Payers and stakeholder collaborators have the opportunity to rebuild the healthcare system into a more effective and consumer-centric system in 2021 by honing virtual care and other strategies.”
Krebs on Security details the malicious hack on the SolarWinds/Orion platform used by federal agencies and Fortune 500 companies “to monitor the health of their IT networks.”
Becker’s Health IT reports that “Healthcare workers in Indiana who tried signing up for the first round of COVID-19 vaccinations Dec. 14 overwhelmed the state’s enrollment website, resulting in down time, according to Indianapolis NBC affiliate WTHR.” Why is this good news? Because now that the COVID-19 vaccine is a reality, people will want the jab as the call it in Britain. That’s human nature.
The Wall Street Journal reports that “The Food and Drug Administration [“FDA’] said Tuesday that the Covid-19 vaccine developed by Moderna Inc. was “highly effective,” setting the stage for an emergency authorization later this week that would add a second vaccine to the arsenal against the pandemic.” Here’s a link to the Moderna briefing document for Thursday’s meeting with the FDA’s Vaccines and Related Biological Products Advisory Committee.
A friend of the FEHBlog pointed out the following encouraging FDA announcement
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older.
“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over- the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, M.D. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.”
The announcement today of the first fully at-home OTC COVID-19 diagnostic test follows last month’s authorization of the first prescription COVID-19 test for home use and last week’s announcement of the first non-prescription test system, in which a lab processes the self-collected sample. The FDA has authorized more than 225 diagnostic tests for COVID-19 since the start of the pandemic, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing. The Ellume COVID-19 Home Test is the first COVID-19 test that can be used completely at home without a prescription.
On the omnibus / COVID-19 relief bill front, the Wall Street Journal reports
The top four congressional leaders discussed a coronavirus relief package and sweeping spending bill on Tuesday and planned to return for another meeting in the evening, as lawmakers raced to reach an agreement before critical support programs expire at year’s end.
House Speaker Nancy Pelosi (D., Calif.), Senate Majority Leader Mitch McConnell (R., Ky.), Senate Minority Leader Chuck Schumer (D., N.Y.) and House Minority Leader Kevin McCarthy (R., Calif.) first conferred in the afternoon, with the meeting of both parties’ leaders a signal that they could be ready to make the difficult decisions needed to cut a deal.
The group will meet again late Tuesday.
“We’re continuing to work. I think there’s progress. We’ll get back together,” Mr. McCarthy said following the afternoon meeting.
Treasury Secretary Steven Mnuchin, who spoke to Mrs. Pelosi earlier Tuesday for more than an hour, also joined the first meeting by phone.
The legislative text must be released tomorrow if Congress want to stick with the current December 18 deadline for action.
A friend of the FEHBlog pointed out the Office of Management and Budget’s Office of Information and Regulatory Affairs has issued its Fall 2020 Unified Agenda of “Regulatory and Deregulatory Actions. Here’s a link to the OPM agenda. The FEHBlog noticed a FEHBP centralized enrollment proposed rule and a final FEHBAR rule involving the Truth in Negotiations Act threshold change which the FEHBlog called to OPM’s attention.
In other healthcare news
Health Payer Intelligence offers “Five Pivotal Payer Industry Trends To Watch in 2021.”
Healthcare Finance News reports that various healthcare trade associations have asked a federal district court in Maryland to preliminarily enjoin implementation of the Trump Administration’s Medicare Part B international drug price index pilot scheduled for January 1, 2021. The motion was filed on December 10 and the government filed its opposition today.
A friend of the FEHBlog pointed out this NIH press release on the state of bad teenager habits.
Findings released today from the most recent Monitoring the Future (MTF) survey of substance use behaviors and related attitudes among teens in the United States indicate that levels of nicotine and marijuana vaping did not increase from 2019 to early 2020, although they remain high. The annual MTF survey is conducted by the University of Michigan’s Institute for Social Research, Ann Arbor, and is funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.
In the four years since the survey began including questions on nicotine and marijuana vaping, use of these substances among teens have increased to markedly high levels From 2017 to 2019, the percentage of teenagers who said they vaped nicotine in the past 12 months roughly doubled for eighth graders from 7.5% to 16.5%, for 10th graders from 15.8% to 30.7%, and for 12th graders from 18.8% to 35.3%. In 2020, the rates held steady at a respective 16.6%, 30.7%, and 34.5%. However, somewhat encouragingly, daily, or near daily (20 occasions in the past 30 days), nicotine vaping declined among 10th and 12th graders from 2019 to 2020, by close to half — from 6.8% to 3.6% in 10th grade and from 11.6% to 5.3% in 12th grade.
STAT News offers a portrait of the COVID-19 virus at one year — what scientists know about how it spreads, infects, and sickens. Meanwhile, the AP provides its perspective on today’s first COVID-19 vaccinations, which should be view as a miracle as vaccines normally take at least four years to develop.
Healthcare Dive and Revcycle Intelligence discuss industry reaction to the bipartisan, bicameral surprise billing legislation introduced in Congress last week. The articles make it clear that neither providers nor payers are entirely happy with the legislation and that the legislators’ goal is to attach the bill to this week’s must pass omnibus spending bill (“the omnibus”). It could go.
A friend of the FEHBlog pointed out today another bill that could get attached to the omnibus. Last week the House passed H.R. 7898 which would permit HHS’s Office for Civil Rights to mitigate HIPAA fines and other remedies when the covered entity or business associate has adequately demonstrated that it “had, for not less than the previous 12 months, recognized security practices in place.” “The term ‘recognized security practices’ means the standards, guidelines, best practices, methodologies, procedures, and processes developed under section 2(c)(15) of the National Institute of Standards and Technology Act, the approaches promulgated under section 405(d) of the Cybersecurity Act of 2015, and other programs and processes that address cybersecurity and that are developed, recognized, or promulgated through regulations under other statutory authorities. Such practices shall be determined by the covered entity or business associate, consistent with the HIPAA Security rule (part 160 of title 45 Code of Federal Regulations and subparts A and C of part 164 of such title).” That’s quite reasonable and equitable.
Bloomberg reports today that legislative work on the omnibus itself remains on track. Also the FEHBlog appreciated Bloomberg’s insights into the COVID-19 relief bill which would be the key measure to be attached to the omnibus. What better time than now for Christmas tree legislation” In any event, according to Bloomberg,
[U.S Senator John] Cornyn [R TX] said the $908 billion bipartisan proposal unveiled Monday isn’t likely to go forward by itself but will be used as jumping-off point for the leaders from both parties in both chambers. ”It’s having a positive influence on what will ultimately included,” Cornyn said of the bipartisan proposal.
Forbes provides more background on the status of the COVID-19 relief legislation for those who are interested (as the FEHBlog is).
While the FEHBlog is a subscriber to the WSJ, Bloomberg and STAT News, among others, he does not subscribe to Modern Healthcare. That’s difficult at this time of year because he does get a kick out of their list of the 100 people who have most influence on U.S. healthcare. Fortunately, AHIP provided a list of their members’ executives who made the list. Congratulations to them.
The Federal Benefits Open Season for 2021 ends tomorrow. OPM explains on its website that
The Federal Benefits Open Season ends at 11:59pm Eastern Time on Monday December 14, 2020 for the Federal Employees Dental and Vision Insurance Program (FEDVIP) and the Federal Flexible Spending Account Program (FSAFEDS). Open Season for the Federal Employees Health Benefits Program (FEHB) ends at 11:59pm, in the location of your electronic enrollment system, on Monday December 14, 2020.
Both Houses of Congress have scheduled Committee hearings / meetings and floor voting for this week. The Hill reports that
A bipartisan group of lawmakers is splitting its $908 billion coronavirus relief proposal into two packages as it prepares to release text on Monday.
The plan, confirmed by a source familiar with the talks, will include a $160 billion proposal that ties together the two most controversial elements: more money for state and local governments and protections against coronavirus-related lawsuits.
The second proposal will total $748 billion and include ideas that garner broader support, including another round of Paycheck Protection Program funding for small businesses, unemployment benefits, and more money for vaccine distribution, testing and schools.
Sen. Joe Manchin (D-W.Va.), a member of the group, announced earlier Sunday that it would release text on Monday. “The plan is alive and well, and there is no way we’re going to leave Washington without taking care of the emergency needs of our people,” Manchin said on “Fox News Sunday.” “We’ll have a bill produced for the American people tomorrow, $908 billion.”
Congress is quickly running out of time to cut a big deal on coronavirus relief, with lawmakers having until Friday to pass a government funding bill that will act as the vehicle for any agreement. But the bipartisan group has been negotiating for weeks, including over the weekend, to try to finalize its bill after announcing a framework earlier this month.
A friend of the FEHBlog called to his attention this bipartisan, bicameral surprise billing relief proposal. The House Ways and Means Committee released the bill and the President expressed his support for it on Thursday December 11. It’s certainly not clear to the FEHBlog whether this bill will be dropped into the must pass spending bill later this week as the President suggests.
Amazon has rolled out a new data aggregation and standardization service for healthcare and life sciences organizations, the tech giant announced Tuesday.
The goal of the HIPAA-eligible tool, called Amazon HealthLake, is to make it simpler for healthcare organizations to manipulate, structure and search their data.
In other Amazon news, the e-commerce behemoth has expanded its network of health clinics for employees with four additional locations in the Dallas-Fort Worth area, the company said last week.
Last night, the Food and Drug Administration announced that it has granted emergency use authorization for administering the Pfizer-BioNTech COVID-19 vaccine to people aged 16 and older in our country.
Initial supplies will be limited. Pfizer projects it will deliver 25 million doses to the U.S. this year, including 2.9 million doses the first week. Inoculation requires two doses three weeks apart, so only half that many people will be vaccinated. States will decide where many doses go.
Gen. Gustave Perna, chief operating officer of the federal government’s Operation Warp Speed vaccine effort, said Saturday the initial supplies will be distributed among 636 locations nationwide, with 145 sites expected to get the doses Monday.
Another 425 sites should receive deliveries Tuesday, while the remaining 66 sites are slated to get their supplies Wednesday, Gen. Perna said.
The U.S. government is dividing up the supply among states, territories and jurisdictions based on their adult populations.
First in line will largely be the nation’s 21 million health-care workers such as doctors and nurses treating Covid-19 patients, as well as residents of nursing homes and other long-term care facilities.
The Centers for Disease Control’s Advisory Committee for Immunization Practices (“ACIP”) made this phase 1A distribution recommendation earlier this month. Medscape reports that at a meeting held today,
ACIP voted 11-0, with three recusals, to recommend use of the Pfizer-BioNTech mRNA vaccine in individuals 16 years or older according to the guidelines of the Food and Drug Administration’s (FDA’s) emergency use authorization issued on Friday.
The panel also voted unanimously to include the vaccine in 2021 immunization schedules. All panel members said the recommendation should go hand-in-hand with ACIP’s previous recommendation on December 1 that allocation of the vaccine be phased-in, with health care workers and residents and staff of long-term care facilities in phase 1a, as reported byMedscape Medical News.
Of course, more medical guidance will be forthcoming as the vaccine is rolled out to the general public. To that end,
Peter Marks, MD, PhD, director of the FDA’s Center for Biologic Evaluation and Research (CBER) clarified this in a briefing on December 12, noting that women who are pregnant or lactating can make the decision in consultation with their physician. And, he said, patients with any other history of allergy should be able to safely get the vaccine.
The bottom line is that
Committee members breathed a sigh of relief at the end of the 2-day meeting, saying that although the Pfizer vaccine is not perfect, it represents a scientific milestone and a significant advance against the continuing march of the SARS-CoV-2 pandemic.
“This vaccine and future vaccines do provide a promise for a lot of progress in the future,” said panelist Beth P. Bell, MD, MPH, clinical professor of global health at the University of Washington School of Public Health in Seattle.
Peter Szilagyi, MD, MPH, executive vice-chair and vice-chair for research at the University of California, Los Angeles pediatrics department, said, “I’m really hopeful that this is the beginning of the end of the coronavirus pandemic.”
Thank goodness.
Pursuant to the CARES Act, health plans, including FEHB plans, become obligated to cover administration of this vaccine to its members with no cost sharing fifteen days from now, December 27, 2020.
Based on the CDC’s COVID Data Trackers website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 20th through 49th weeks of this year (beginning May 14 and ending December 9; using Thursday as the first day of the week in order to facilitate this weekly update):
and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:
It’s interesting that the weekly rate dropped two weeks in a row. Typically the chart would show a one week drop which the FEHBlog discounted.
The FEHBlog has noted that the new cases and deaths chart shows a flat line for new weekly deaths because new cases greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the same period (May 14 through December 9):
The FEHBlog’s record high for weekly deaths remains 13,504 for the week ended April 22 which we now are approaching.
On the brighter side, the Wall Street Journal reports that
The U.S. Food and Drug Administration said it was finalizing the work needed to clear a Covid-19 vaccine developed byPfizer Inc. and German partner BioNTech SE, after the injection was endorsed by an expert panel. “We could see people getting vaccinated Monday, Tuesday of next week,” Health and Human Services Secretary Alex Azar said on ABC’s “Good Morning America.”
Fierce Healthcare reports that “CVS [Health] is planning to begin administering COVID-19 vaccines in nursing homes beginning on Dec. 21, a top executive told Reuters.”
Govexec.com reports that “Civilian federal personnel are likely to begin receiving COVID-19 vaccinations as soon as Monday, officials said on Friday, though only [healthcare] employees at certain offices will receive the doses directly from their agencies. Govexec.com offered the most details on the Defense Department’s plans which provide a helpful perspective
The Defense Department also anticipates vaccinating 44,000 employees next week, officials said on Wednesday, the vast majority of whom will be health care staff. The Pentagon plans to provide vaccines to both military and civilian staff, though it has not committed to vaccinating to its entire civil service workforce.
“The eligibility we defined in terms of dependents, select contractors, civilian employees, and it’s going to be then how do they match up in terms of the prioritization tiers,” said Tom McCaffery, the assistant secretary of Defense for Health Affairs.
In the initial phase, Defense will target health care workers who are closest to patients, early emergency responders and public security staff. Defense will distribute vaccines to 16 sites in that phase, 13 of which are located within the United States. McCaffery said the department recently held a “virtual tabletop exercise” to go through the first phase “in great detail to ensure seamless distribution and dissemination” of the vaccine. Defense will ultimately be responsible for vaccinating millions of individuals, including active duty personnel, civilian workers, at-risk dependents and some contractors.
All told, Defense maintains 83 sites that have ultra-cold storage, including all 13 of those in the initial distribution.
will purchase an additional 100 million doses of COVID-19 vaccine candidate, called mRNA-1273, from Moderna.
If authorized by the U.S. Food and Drug Administration for emergency use as outlined in agency guidance, doses of the vaccine will begin shipping immediately. The vaccine would be provided at no cost to Americans. Vaccine administration costs for private-sector administration partners will be covered by healthcare payers: private insurance, Medicare or Medicaid, and an HHS program to cover COVID-19 costs for the uninsured which is reimbursing the provider at Medicare rates from the provider relief fund.
Under the agreement, Moderna will leverage its U.S.-based manufacturing capacity to fill, finish and ship vials of mRNA-1273 as the bulk material is produced. The additional doses ordered today provide for continuous delivery through the end of June 2021. This strategy will help meet the anticipated demand for mRNA-1273 and safely accelerate the delivery schedule for all 200 million doses the U.S. government is purchasing.
“Securing another 100 million doses from Moderna by June 2021 further expands our supply of doses across the Operation Warp Speed portfolio of vaccines,” said HHS Secretary Alex Azar. “This new federal purchase can give Americans even greater confidence we will have enough supply to vaccinate all Americans who want it by the second quarter of 2021.”
In other news,
Congress approved the one week long extension of the continuing resolution funding the federal government. The new deadline is December 18 and Federal News Network reports that “Negotiators on a $1.4 trillion catchall spending bill appeared to be moving in a positive direction, said the chairman of the Senate Appropriations Committee, Sen. Richard Shelby, R-Ala.. This bill would serve as a vehicle to carry any year-end virus assistance.” Negotiations over that COVID-19 relief bill continue.
The HHS, the Labor Department, and the Treasury Department (a/k/a the tri-agencies) “announced a final rule that amends the [Affordable Care Act] requirements for grandfathered group health plans and grandfathered group health insurance coverage to preserve their grandfather status.”
The U.S. Supreme Court unanimously rejected an ERISA preemption challenge to an Arkansas state law regulating prescription benefit manager pricing of drugs. Here is Healthcare Dive’s report. This decision will raise healthcare prices in the FEHBlog’s opinion.
Govexec.com reports that President Trump is giving a half day off to federal employees on Christmas Eve.
The FEHBlog’s link to the HHS fact sheet on the proposed HIPAA Privacy Rule changes (posted yesterday) was inoperable until the FEHBlog fixed it tonight. Here’s a link. Have a good weekend.
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11 months
The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
