Weekend update

COVID vaccine mandate

Weekend update

David Ermer–ACA, CMS, Congress, COVID vaccine mandate, COVID-19, Federal employment benefits, OPM, SCOTUS, U.S. Healthcare–
Photo by Jessica Delp on Unsplash

Congress has lowered the curtain on the first session of the current two year long Congress, the 117th in our Nation’s history.

Roll Call reports that

Sen. Joe Manchin III said on Sunday that he can’t support the sweeping social safety net and climate change package that President Joe Biden and Democratic leaders have made their top legislative priority.

The West Virginia Democrat’s opposition is likely the final nail in the massive $2 trillion-plus “Build Back Better” legislation given the Senate’s 50-50 split, unless extensive changes are made that would result in key provisions being scuttled.

“I can’t vote for it and I cannot vote to continue with this piece of legislation,” Manchin told “Fox News Sunday.” “I just can’t. I’ve tried everything humanly possible.  I can’t get there … This is a ‘no.’ “

Of course, the legislative struggle over the BBB bill is not over but at least we should enjoy a peaceful holiday period.

From the Omicron front, Bloomberg reports that

Lockdowns in the U.S. will likely not be necessary even as Covid-19 cases increase, according to President Joe Biden’s top medical adviser, Anthony Fauci. Even so, many hospitals may be strained as the omicron variant spreads, especially in regions with lower levels of vaccination, he said. 

New York City Mayor Bill de Blasio called on the federal government to step up supplies of tests and treatments to the city amid a spike in infections caused by the omicron variant. New York state broke a record for new infections for the third consecutive day.

From the COVID mandate challenge front —

Since last Wednesday

  • The Fifth Circuit U.S. Court of Appeals lifted the nationwide stay on the CMS healthcare provider COVID vaccine mandate, but left the stay in place for 24 states which had obtained their own stays. The federal government has asked the U.S. Supreme Court to lift the stays applicable to those 24 states. The Supreme Court has allowed the respondent states until December 30, 2021, to respond to the federal government’s motion.
  • The American Hospital Association (“AHA”) reports in the wake of the Court action that “CMS’s website states that CMS “has suspended activities related to the implementation and enforcement of [the mandate] pending future developments in the litigation.” AHA has confirmed with CMS that this statement applies nationwide and remains accurate even after the Fifth Circuit’s order staying the nationwide effect of the Louisiana district court’s preliminary injunction. 
  • The Sixth Circuit U.S. Court of Appeals lifted the nationwide stay on the OSHA ETS COVID vaccination screening program. The State of Georgia has asked the U.S. Supreme Court to reinstate the stay.
  • The American Hospital Association reports again in the wake of the Court action that “OSHA has announced that it is ‘exercising enforcement discretion with respect to the compliance dates of the’ mandate. OSHA states that ‘it will not issue citations for noncompliance with any requirements of the [mandate] before January 10 and will not issue citations for noncompliance with the [mandate’s] testing requirements before February 9, so long as an employer is exercising reasonable, good faith efforts to come into compliance with the standard.’ OSHA has also promised to ‘work closely with the regulated community to provide compliance assistance.’”
  • The Eleventh Circuit U.S. Court of Appeals upheld the nationwide stay on the government contractor mandate. The federal government is expected to ask the Supreme Court to lift this stay tomorrow.
  • It certainly appears that all three mandate issues will be presented to the Supreme Court simultaneously. 

In Affordable Care Act news, CMS announced on Friday that

Health insurers have provided approximately $2 billion in rebates for the 2020 reporting year to an estimated 9.8 million consumers, the Centers for Medicare & Medicaid Services (CMS) is announcing today. Insurers were generally required to provide such rebates and notice of any rebates owed to consumers no later than September 30, 2021. Rebate payments can be provided in the form of a premium credit, lump-sum check, or, if a consumer paid the premium using a credit card or direct debit, by lump-sum reimbursement to the account used to pay the premium.

CMS released a list today of all insurers owing Medical Ratio Loss (MLR) rebates for the 2020 reporting year, with total amounts by state and market. The CMS market breakdown estimate includes approximately 4.8 million consumers in the individual market and 5 million employees in the group market (this represents 2.6 million employees in the small group market, and 2.4 million employees in the large group market). 

Today’s release also includes the Public Use Files (PUFs) containing the data from all health insurers’ final MLR filings for the 2020 reporting year. 

For more information visit: https://www.cms.gov/CCIIO/Programs-and-Initiatives/Health-Insurance-Market-Reforms/Medical-Loss-Ratio

Link to PUFs here: https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr

If federal employee compensation news, Govexec tells us that

[Last] week, the President’s Pay Agent, which is made up of Labor Secretary Marty Walsh, Acting Office of Management and Budget Director Shalanda Young and Office of Personnel Management Director Kiran Ahuja, issued its annual report ahead of President Biden’s executive order finalizing an average 2.7% pay raise in 2022. The pay agent declined to issue waivers based on a locality’s number of authorized positions, but approved Carroll County’s addition to the Davenport, Iowa, locality pay area due to the fact that it recently has met the 2,500 employee threshold.

Friday Stats and More

David Ermer–COVID vaccine mandate, COVID-19, COVID-19 vaccine, U.S. Healthcare–

Using the CDC’s COVID Data Tracker and Thursday as the first day of the week, here is the FEHBlog’s weekly chart of new COVID cases for 2021:

Here is a link to the CDC’s weekly chart of new COVID admissions which also continues to trend up.

Here is the FEHBlog’s weekly chart of new COVID deaths for 2021.

Here is the FEHBlog’s weekly chart of new COVID vaccinations administered and delivered from the 51st week of 2020 through the 50th week of the 2021. For the second week in a row, administered vaccines including boosters has exceeded 10 million for the week.

Here’s a link to the CDC’s weekly interpretation of its COVID statistics. The CDC weekly review will not be published again until January 7. Hopefully by then the FDA will have granted emergency use authorization to the Pfizer early onset COVID pill. That would be a great holiday gift for America.

The CDC’s Fluview reports that “Seasonal influenza activity in the United States is increasing, including indicators that track hospitalizations. The amount of activity varies by region.”

From the COVID vaccine front, the Wall Street Journal informs us that

Pfizer Inc. and partner BioNTech SE  have pushed back plans to request authorization of their Covid-19 vaccine in children ages 2 to 5, after the shot generated a weaker than expected immune response in a key study. 

The companies said Friday they would begin testing the addition of a third dose in the children, and if successful, would ask U.S. health regulators to authorize use sometime during the first half of 2022.

STAT News tells us that CDC Director Rochelle Walensky has approved her Advisory Committee on Immunization Practice’s unananimous “preferential recommendation to the Covid vaccines based on messenger RNA technology on Thursday — a decision aimed at steering people away from the Johnson & Johnson Covid-19 vaccine because of concerns about a rare but serious side effect.” STAT dives into more detail in an accompanying article titled “The Tragedy of Johnson & Johnson’s COVID vaccine.

In COVID vaccine mandate news the Wall Street Journal reports this evening that

A federal appeals court Friday reinstated Biden administration rules that require many employers to ensure that their workers are vaccinated or tested weekly for Covid-19.

A divided panel of the Sixth U.S. Circuit Court of Appeals dissolved a stay issued by another court that had blocked the rules. The majority, in a 2-t,o-1 ruling, said legal challenges to the administration’s vaccination-and-testing requirements were likely to fail.

This decision was made in the consolidated challenge to the OSHA action. The Sixth Circuit reversed a Fifth Circuit stay of the OSHA action. The plaintiffs are likely to ask all of the 6th Circuit’s active judges to consider this issue, e.g., a motion for rehearing en banc

In other judicial news, STAT News reports that

A federal court judge has reversed the hotly contested Purdue Pharma bankruptcy plan after deciding a bankruptcy judge did not have authority to grant immunity to the Sackler family members who control the controversial drug maker. * * *

One legal expert explained the decision is significant. “The decision is an important recognition of the arguments made (by the U.S. Trustee and the eight states) and the concerns they had. That is an important value for a justice system,” Melissa Jacoby, a professor at the University of North Carolina who specializes in bankruptcy law, wrote us.

So what happens next?

“…It is too soon to know what the effect will be. It is possible the Sacklers will increase their monetary offer to avoid further litigation to try to make the releases fully consensual, even though I can imagine grounds on which the 2nd circuit (appeals court) would reverse the district court,” she continued. “Presumably, they are examining those options right now.”

In M&A news, Healthcare Dive informs us that

— Intermountain Healthcare and Colorado-based SCL Health signed a definitive agreement Wednesday to move forward with merger plans to create an $11 billion health system spanning six states.

— The deal is expected to close next April. Financial terms were not disclosed.

— Intermountain CEO Marc Harrison will serve as the leader of the combined organization.

Thursday Miscellany

David Ermer–Congress, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

From the Capitol Hill front, Roll Call reports that

President Joe Biden and Democratic leaders reluctantly acknowledged Thursday that the Senate would soon recess for the year without passing their sprawling $2.2 trillion social safety net and climate spending bill or voting rights legislation. 

From the Omicron front, Bloomberg tells us that

President Joe Biden warned that unvaccinated Americans face “a winter of severe illness and death” as he urged initial doses and booster shots amid a surge of coronavirus cases and the emergence of the omicron variant.

David Leonhardt writing in his New York Times Morning column adds that “about 15 percent of American adults remain unvaccinated.”

From the COVID vaccine front, AHIP informs us that

Today, the CDC’s Advisory Committee on Immunization Practices (ACIP) convened to discuss the recent developments and safety considerations for the Janssen/Johnson & Johnson COVID-19 vaccine. 

ACIP voted unanimously to amend their recommendation: mRNA COVID-19 vaccines are preferred over the Janssen COVID-19 vaccine for the prevention of COVID-19 for those 18 years of age and older. 

Deliberations within the committee stressed the importance of updating the Clinical Considerations and educational materials regarding the vaccine to ensure that anyone who chooses to receive the Janssen adenovirus-based vaccine is informed of the potential risks.  

Earlier this week, the FDA updated its Emergency Use Authorization Fact Sheet to indicate that the Janssen vaccine is contraindicated for individuals with a history of thrombosis with thrombocytopenia syndrome (TTS).  This was based on new information showing that cases of TTS have been reported in both males and females, and that approximately 15% of TTS cases have been fatal.

Following the discussion, the Committee reviewed a presentation on safety data regarding the use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years old.  Very few adverse events or severe systemic reactions were reported, with most incidents including pain, fever, fatigue, headache, and/or myalgia, and most beginning one or two days following the second dose with symptoms alleviating within a few days.  To date, there have been two deaths in children who received the vaccine, each with children who have complicated medical histories, both of which are still under investigation.

Finally, CDC presented current data about the Omicron variant.  This variant appears to be more transmissible than earlier variants, but more data is needed to know if it causes more severe illness.  Vaccines are expected to protect against severe illness, hospitalizations, and death, with booster vaccines showing increased protection than the two-dose series.  It is unclear how prior infection impacts neutralization.  CDC is continuing to monitor real-world evidence across all populations to inform further action.

Also from the omicron front, Healthcare Dive reports that

— FDA has identified three COVID-19 molecular tests that are not able to detect the omicron variant and warned that the diagnostics from Applied DNA Sciences, Meridian Bioscience and Tide Laboratories will return false negative results.

— The agency on Wednesday updated its list of tests impacted by virus mutations. While FDA continues to gather additional information and work with the three manufacturers to address these issues, it recommended the diagnostics not be used by clinical laboratory staff and healthcare providers.

— Makers of both polymerase chain reaction and rapid antigen tests have said their tests can detect omicron. Siemens Healthineers is the latest company to claim its testing portfolio is unaffected by the variant. However, Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, told test developers Wednesday during a virtual town hall that the agency continues to receive “a lot of inquiries” about omicron and its potential impact on diagnostics and will continue to focus efforts on evaluating molecular and antigen tests.

The Wall Street Journal adds that

Pfizer Inc. and BioNTech SE  say they have asked U.S. regulators to fully approve their Covid-19 vaccine for adolescents ages 12 to 15. The vaccine was fully approved by the U.S. Food and Drug Administration in August for people 16 years and older. 

From the COVID vaccine mandate front, we have two court decisions:

  • The Society for Human Resources Management explains that “On Dec. 15, the 5th U.S. Circuit Court of Appeals lifted a district court’s order that had blocked the Biden administration’s COVID-19 vaccination directive for health care workers nationwide. But the requirement remains blocked in 24 states.” The 24 states are composed of 14 State plaintiffs in the 5th Circuit case and 10 State plaintiffs in the first PI. The Congressional Research Service recently wrote a report on nationwide injunctions.
  • The government contractor mandate nationwide preliminary injunction (“PI”) followed the same course as the healthcare workers preliminary injunction — a PI issued for three states followed by a court in another state issuing a nationwide injunction. Perhaps the 11th U.S. Circuit Court of Appeals which is hearing the government’s appeal of the government contractor mandate PI (Case No. 21-14269), will follow the 5th Circuit’s lead.
  • The National Law Review reports that

[Also on Dec. 15] The [U.S. Court of Appeals for the] Sixth Circuit denied en banc review in the OSHA vaccine mandate cases.  The vote was a close one, with eight judges voting in favor of initial hearing en banc.  But that’s not enough under the circuit’s rules, which require a majority of the 16 active judges to vote for en banc treatment.  As a result, the current panel reviewing the case will decide whether to continue the stay issued by the Fifth Circuit, which may end up being the most consequential decision in the case until it comes before the Supreme Court.

From the miscellany department —

  • GoodRx brings us up to date on Alzheimer’s Disease research.
  • “The HEALTH CARE TRANSFORMATION TASK FORCE (HCTTF or Task Force), a group of leading health care payers, providers, purchasers and patient organizations, today announced that its provider and payer members reported having 61 percent of their business in value-based payment arrangements at the end of 2020. Value-based care and payment arrangements focus on lowering costs and improving the quality of care to drive overall population health. The new report shows significant progress towards the goal and has increased twofold from the group’s first report of 30 percent in value-based arrangements in 2015.”

Roughly 40% of U.S. healthcare payments were tied to alternative payment models (APMs) last year, with Medicare Advantage claims representing the largest amount, a new survey found.

The survey, published Wednesday by the Health Care Payment Learning & Action Network, showed that more work needs to be done as most healthcare payments were still tied to a fee-for-service model.

“The survey shows we have made limited progress in moving away from fee for service between 2019 and 2020,” said Mark McClellan, M.D., Ph.D., director of Duke University’s Margolis Center for Health Policy and co-chair of the LAN CEO forum, during the LAN Summit Wednesday. “Most payments are still in fee-for-service, especially outside of Medicare.”

  • If you are bit confused by these findings, APMs are a type of value based pricing arrangement. Health Affairs offered a useful article on the various value based payment models earlier his year.

Thursday Miscellany

David Ermer–Congress, COVID vaccine mandate, COVID-19, COVID-19 vaccine, No Surprises Act, U.S. Healthcare–
Photo by Clarisse Meyer on Unsplash

From the Capitol Hill front, Roll Call reports that

The Senate broke a logjam over the statutory debt limit Thursday, clearing a measure that would allow Democrats to increase the nation’s borrowing capacity on their own without any Republican assistance necessary.

On a 59-35 vote, the Senate sent President Joe Biden a bill granting a one-time exemption to Senate rules so that a debt ceiling increase can go straight to final passage on a simple majority vote, rather than first having to clear a 60-vote procedural hurdle. 

Passage of the fast-track process legislation effectively ends weeks of partisan brinkmanship over whether and how to raise the statutory debt limit. Without congressional relief, the government may be unable to meet all its financial obligations after Dec. 15, Treasury Secretary Janet L. Yellen has warned.

Democrats have yet to release the bill that will actually raise the debt limit, though Senate Majority Leader Charles E. Schumer and Speaker Nancy Pelosi hope to clear that measure before Wednesday to meet Yellen’s deadline.

The legislation heading to the White House also would delay Medicare cuts that would otherwise be triggered Jan. 1, including across-the-board reductions to provider reimbursements as well as separate cuts to physician and laboratory services payments. It would temporarily waive statutory pay-as-you-go rules that would require steeper Medicare cuts next year as well as major reductions in farm price supports and a host of other federal benefits.

So Congress will remain in session next week.

Govexec adds that “The House on Thursday approved a package of reforms to add new protections to federal civil servants, further empower agency watchdogs and limit who can lead federal offices on a temporary basis.” The bill now heads over to the Senate.

From the COVID vaccine front, AHIP informs us that

The U.S. Food and Drug Administration (FDA) today authorized a booster dose of the Pfizer-BioNTech COVID-19 vaccine for 16- and 17-year-olds. Eligible teens will be able to get the shot once they are at least six months past their second dose.

New data from Israel published this week showed that a Pfizer booster increased immunity among citizens 16 and older, and though the study focused on the Delta variant, Pfizer announced this week that a third dose can help fight the Omicron variant.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) are not expected to meet to develop new clinical recommendations for teen boosters, according to a report from Politico.

From the COVID vaccine mandate front, Federal News Network tells us that

The Biden administration offered more details Thursday for federal contractors tracking the multiple legal challenges to the president’s vaccine mandate, while reporting a slight increase in the number of executive branch employees who have complied with their agency’s own requirements.

Agencies will not enforce the provisions of the president’s federal contractor vaccine mandate while a nationwide preliminary injunction is in place, the Biden administration said.

Specifically, the government won’t enforce those clauses embedded in existing contracts where the work is performed inside the United States or an outlying area and is subject to a recent court order, according to a brief update to the Safer Federal Workforce Task Force issued Thursday.

the Wall Street Journal adds that

General Electric Co., Union Pacific Corp. and other large employers have suspended Covid-19 vaccine requirements for workers after a U.S. court ruling blocked the Biden administration’s plan to mandate vaccines for federal contractors.

A federal judge on Tuesday issued a nationwide preliminary injunction after concluding that federal procurement law didn’t give the administration the clear authority to impose the vaccine rules for contractors. Lawyers for the federal government filed a notice of appeal Thursday.

The court’s injunction applies to the federal government, including OPM, not to the government contractors. The government contractors therefore are free to choose whether or not to continue with their vaccine mandate programs while government enforcement of the program is enjoined. This news nevertheless suggests that the squeeze may not be worth the fallout.

From the No Surprises Act front, the American Hospital Association announced that

The American Hospital Association (AHA) and American Medical Association (AMA), representing hospitals, health systems, and physicians, sued the federal government today over the misguided implementation of the federal surprise billing law. The associations are joined in the suit by plaintiffs including Renown Health, UMass Memorial Health and two physicians based in North Carolina. 

The complaint was filed in the U.S. District Court for the District of Columbia. The plaintiffs also have moved for a preliminary injunction or a summary judgment.

The provider groups are freaking out over the regulator’s decision to use the plan’s payment in No Surprises Act situations, known as the qualifying payment amount, as the lodestar for baseball arbitration purposes in the No Surprises Act independent dispute resolution process. The QPA is based on the health plan network’s median payment as of January 2019 adjusted for inflation and regional differences. The QPA should be similar to what plans pay in-network providers which always has been materially more than the out-of-network rate which usually is based on Medicare’s fee schedule. Paying the out of network providers more than the in-network doctors under the No Surprises Act would disrupt health plan networks. The rule’s lodestar use of the QPA is perfectly reasonable.

From the miscellany department –

  • Beckers Payer Issues reports that “CMS is continuing to use discretion on enforcing payer data exchange guidelines introduced in a May 2020 interoperability rule, HHS stated in a Dec. 7 notice.  * * * “We are now announcing that we expect to extend this exercise of enforcement discretion of the payer-to-payer data exchange requirement until we are able to address the identified implementation challenges through future rulemaking,” the notice stated. “We anticipate providing an update on any evaluation of this enforcement discretion notification and related actions during calendar year 2022.” This is one of the 21st Century Cures Act’s three interoperability initiatives for HHS regulated health plans.
  • “Health and Human Services Secretary Xavier Becerra today announced that Lawrence A. Tabak, D.D.S., Ph.D., the principal deputy director of the National Institutes of Health (NIH), will serve as the acting director of NIH effective December 20, 2021.”

President Joe Biden selected 230 federal leaders to receive a Presidential Rank Award in 2021, nearly double the usual number of employees recognized.

The Presidential Rank Awards are one of the most prestigious civil service recognitions and come with a 35% of base salary award for Distinguished Rank recipients, who have demonstrated sustained, extraordinary career accomplishments, and a 20% award for Meritorious Rank recipients, who have demonstrated sustained accomplishments.

Congratulations to the recipients.

Tuesday’s Tidbits

David Ermer–AHRQ, CDC, COVID vaccine mandate, COVID-19, Government Contracting, Mental health care, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Roll Call reports that

The House and Senate are moving swiftly toward passing legislation introduced Tuesday that would limit Senate debate on debt limit legislation to 10 hours, creating a loophole in that chamber’s 60-vote legislative filibuster rules.in his Morning’s column in the New York Times andor a vote Tuesday night, Speaker Nancy Pelosi wrote in a letter to lawmakers, along with a revised fiscal 2022 defense policy bill that would be sent to the Senate separately.

The two legislative vehicles are unrelated bills that previously passed both chambers with amendments; using them to carry the budget and defense measures allows Senate leaders to avoid a time-consuming motion to proceed in that chamber. Instead, only one cloture vote per bill would be needed. 

Senate Minority Leader Mitch McConnell, who briefed his caucus at lunch on Tuesday, blessed the arrangement in comments to reporters. He said the new debt limit measure could pass as early as Thursday, after the Senate clears the bill to create an expedited process.

“I’m confident that this particular procedure coupled with the avoidance of Medicare cuts will achieve enough Republican support to clear the 60 vote threshold,” McConnell said.

If Congress accomplishes all of these actions, it may just call it quits at the end of this week which was the original schedule. A delay in Medicare cuts is extremely important to the medical facility and provider professional associations.

On the COVID vaccine mandate front, a federal district judge in Georgia today ordered a nationwide preliminary injunction against enforcement of the federal government contractor mandate per Govexec which adds

The Biden administration’s vaccine rule for private businesses and vaccine mandate for Medicare- and Medicaid-certified providers and suppliers are also temporarily blocked by courts. So far, the vaccine mandate for federal employees has not been stopped.

This PI applies to all FEHB plan contractors and subcontractors.

From the Delta variant front, David Leonhardt who is the FEHBlog’s go-to COVID columnists recommends in his Morning column in the New York Times today

For now, vaccinated people can reasonably continue to behave as they were — but many should feel urgency about getting booster shots. Older people and others who are vulnerable, like people receiving cancer treatment, should continue to be careful and ask people around them to test frequently.

Unvaccinated people remain at substantial risk of serious illness. About 1,000 Americans have been dying each day of Covid in recent weeks, the vast majority of them unvaccinated.

Look up case and deaths counts for your county here.

From the Rx coverage front, Drug Channels released its

annual deep dive into employer-sponsored coverage for prescription drugs. 

For 2021, employers backed away slightly from high-deductible health plans. However, their pharmacy benefit designs increased the use of coinsurance for specialty and fourth-tier drugs. These designs have significantly raised patients’ out-of-pocket obligations and are likely to have reduced adherence. 

Manufacturers’ patient support funds help offset patients’ higher expenses. But employer plans are rapidly adopting copay accumulators, which allow payers and PBMs to absorb these funds. 

From the health benefits trends front, the Society for Human Resource Management informs us that

Three-quarters of health insurers say that managing a health plan’s network of care providers is critical to controlling rising medical costs.

The finding is from consultancy Willis Towers Watson’s 2022 Global Medical Trends Survey, conducted from July through September 2021 among 209 leading insurers globally.

The plan features mostly likely to keep costs under control, insuers said, were:

— Contracting with high-quality, cost-competitive doctors and hospitals for in-network coverage (cited by 75 percent of respondents).

— Requiring preapproval for scheduled inpatient services (67 percent).

— Offering telehealth services (63 percent).

Telehealth or virtual care rose to the third spot from the fifth position last year, “a sign that more insurers see potential savings from remote options for diagnosing and treating patients,” according to the report.

Yesterday was the deadline for submitting public comments on the the second No Surprises Act interim final rule, which concerns the independent dispute resolution process. For a ying and yang take on the comments, here are links to American Hospital Association’s comments and to AHIP’s comments.

Let’s wrap it up with a bunch of HHS tidbits

  • HHS today announced its plan to “propose a national “Birthing-Friendly” hospital designation on the Hospital Compare section of the CMS Care Compare website, and also encourages states to provide 12 months postpartum coverage to people with Medicaid and CHIP.”
  • The National Institutes of Health reported that “Researchers identified brain cells that help suppress hunger and regulate food intake” and that “The findings may help lead to better treatments for excessive eating and obesity.”
  • NIH also announced “The winners of the National Institutes of Health’s Decoding Maternal Morbidity Data Challenge were announced today in conjunction with the White House “day of action” on maternal health. Twelve prizes were awarded to seven winners who proposed innovative solutions to identify risk factors in first-time pregnancies. Without a prior pregnancy for comparison, it is difficult to identify risks for adverse pregnancy outcomes. Early detection of these risks can help reduce pregnancy complications and prevent maternal deaths.”
  • The Agency for Healthcare Quality and Researched released

A final report on strategies to improve patient safety and reduce medical errors has been delivered to Congress by the U.S. Department of Health and Human Services in consultation with AHRQ. Required by the Patient Safety Act of 2005, the report was made available for public review and comment and review by the National Academy of Medicine. It outlined several strategies to accelerate progress in improving patient safety, including using analytic approaches in patient safety research, measurement, and practice improvement to monitor risk; implementing evidence-based practices into real-world settings through clinically useful tools and infrastructure; encouraging the development of learning health systems that integrate continuous learning and improvement in day-to-day operations; and encouraging the use of patient safety strategies outlined in the National Action Plan by the National Steering Committee for Patient Safety. 

Access the final report, “Strategies to Improve Patient Safety: Final Report to Congress Required by the Patient Safety and Quality Improvement Act of 2005” (PDF, 1.16 MB).

  • The Centers for Disease Control “announced today that it has awarded $22 million to nearly 30 organizations around the world to combat antimicrobial resistance (AR) and other healthcare threats through the establishment of two new networks—the Global Action in Healthcare Network (GAIHN) and the Global AR Laboratory and Response Network (Global AR Lab & Response Network).”

Citing mounting evidence of ongoing harm, U.S. Surgeon General Vivek H. Murthy on Tuesday issued a public health advisory on the mental health challenges confronting youth, a rare warning and call to action to address what he called an emerging crisis exacerbated by pandemic hardships.

Symptoms of depression and anxiety have doubled during the pandemic, with 25% of youth experiencing depressive symptoms and 20% experiencing anxiety symptoms, according to Murthy’s 53-page advisory. There also appear to be increases in negative emotions or behaviors such as impulsivity and irritability — associated with conditions such as attention deficit hyperactivity disorder or ADHD.

And, in early 2021, emergency department visits in the United States for suspected suicide attempts were 51% higher for adolescent girls and 4% higher for adolescent boys compared to the same time period in early 2019, according to research cited in the advisory.

Monday Roundup

David Ermer–Congress, COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 testing, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, Roll Call discusses the Senate Parliamentarian’s role in refereeing budget reconciliation bills like the Build Back Better Act.

Senate committees have been updating the House-passed $2.2 trillion climate and social spending package text to ensure it complies with budget reconciliation rules, but most have yet to begin the formal review process with the Senate parliamentarian known as “the Byrd bath.”

Majority Leader Charles E. Schumer sent a “Dear Colleague” letter on Monday reiterating his goal to pass the legislation in the Senate before Christmas. But the update he provided on the procedural steps needed to get there suggests senators will be lucky if they can meet that deadline. 

Schumer said Senate committees are continuing informal conversations with Senate Parliamentarian Elizabeth MacDonough about their pieces of the package and “making necessary technical and ‘Byrd proofing’ edits to the House bill.” The Byrd rule requires any policy changes made through reconciliation to have more than a “merely incidental” impact on the budget, among other restrictions.

From the COVID vaccine front, Medscape informs us that

Adolescents and adults younger than age 21 who develop myocarditis after mRNA COVID-19 vaccination frequently have abnormal findings on cardiac MRI(cMRI) but most have a mild clinical course with rapid resolution of symptoms, a new study concludes.

“This study supports what we’ve been seeing. People identified and treated early and appropriately for the rare complication of COVID-19 vaccine-related myocarditis typically experienced only mild cases and short recovery times,” American Heart Association (AHA) President Donald M. Lloyd-Jones, MD, said in a podcast.

“Overwhelmingly, the data continue to indicate the benefits of COVID-19 vaccine far outweigh any very rare risks of adverse events from the vaccine, including myocarditis,” Lloyd-Jones added.

and that

The U.S. Food and Drug Administration on Friday authorized the use of Eli Lilly’s COVID-19 dual-antibody therapy in treating mild to moderate symptoms in all children, including newborns, who are at risk of severe illness.

The therapy, bamlanivimab plus etesevimab, was previously authorized for children aged 12 years and older and weighed at least 88 pounds.

“Children under one year of age, who are exposed to the virus that causes COVID-19, may be at particularly high risk for severe COVID-19 and this authorization addresses the medical needs of this vulnerable population,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.

The FDA authorization also allows the administration of the therapy as a preventive measure in children who are exposed to the virus.

Per STAT News

People who received the Pfizer (PFE)-BioNTech (BNTX) vaccines may get as much benefit from a Johnson & Johnson (JNJ) booster shot as a Pfizer one, The New York Times explains, citing the findings of a small study released on Sunday. Researchers at Beth Israel Deaconess Medical Center in Boston studied 65 people who had received two shots of the Pfizer vaccine. Six months after the second dose, the researchers gave 24 of the volunteers a third dose of the Pfizer vaccine and gave 41 the Johnson & Johnson shot. The study was funded in part by Johnson & Johnson and has not yet been published in a scientific journal.

As of today according to the Centers for Disease Control, 60% of the U.S. population is fully vaccinated and 25% of the U.S. population over age 18 has had a booster.

From the Delta variant testing front

  • The American Medical Association reviews the different COVID tests that are available in our country. The article warns that the at home tests must be performed correctly. This will be useful information to share with health plan members.
  • A friend of the FEHBlog pointed out this HHS website that lists low or or no COVID cost testing facilities in each of the states and DC. Another friend of the FEHBlog informed him that local public libraries in the Washington DC area offer at home rapid COVID tests like Binax to their visitors at no cost. The FEHBlog learned long ago that when a health plan is asked to provide a service or supply that it typically does not cover, like over the counter drugs or tests, you typically can find a government resource to fill the gap. To soften the financial blow of the the President’s unexpected mandate that health plans cover the cost of at home rapid COVID tests, health plans also should consider educating members about community resources.

Speaking of which, Health Payer Intelligence reports on payer efforts to fund various community resources to address the social determinants of health, a thoughtful idea particularly at the holiday season.

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 testing, Rx coverage–

From the Capitol Hill front, Roll Call reports that

The Senate looks set to clear a House-passed a temporary spending bill Thursday night that would keep the lights on at federal agencies through Feb. 18, buying 11 more weeks to try to resolve partisan disputes over funding levels and policy riders that have stalled progress on fiscal 2022 appropriations.

The stopgap measure passed the House on a 221-212 vote earlier in the evening. The Senate timeline cleared up once it became apparent a group of GOP conservatives would get an up-or-down vote on an amendment to bar funding to implement a new private sector vaccine mandate.

“I think we’re gonna get our amendment at a 50-vote threshold,” Sen. Roger Marshall, R-Kan., told reporters after the House vote. 

A Senate GOP leadership aide said the vote would occur in that chamber Thursday evening. With three absences on the Republican side, senators expected Marshall’s amendment to be defeated, which would set up a vote on clearing the stopgap bill for President Joe Biden’s signature ahead of a midnight Friday deadline to avert a partial government shutdown.

So as the FEHBlog expect, no government shutdown which is good news.

From the Delta variant front —

STAT News informs us that

Health officials on Thursday reported the country’s second Covid-19 infection from the Omicron variant in a Minnesota resident who notably did not travel internationally recently, unlike the first case.

The case in Minnesota is an adult male who had been vaccinated and, in early November, received a booster shot. He lives in Hennepin County, which includes Minneapolis, state health officials said. He developed mild symptoms on Nov. 22, was tested on Nov. 24, and no longer has symptoms. 

The man had been in New York City in the days leading up to feeling sick and attended the Anime NYC 2021 convention at the Javits Center from Nov. 19 to Nov. 21. Minnesota health officials are collaborating with New York City authorities and the Centers for Disease Control and Prevention on their case investigation.

Bloomberg adds

In some of the first data to come back on the omicron variant of the coronavirus, researchers in South Africa, where it was first identified, say the mutation is spreading faster than the delta strain. There also seems to be a greater risk of reinfection—where previously infected people get the virus again. Three times higher, in fact. But scientists also said hospitalizations in South Africa remain muted, a sign that may be attributable in part to vaccinations. Shabir Madhi, a vaccinologist at the University of the Witwatersrand, said he’s “optimistic that in this resurgence, while the total number of cases will probably be greater, hospitalizations and deaths will be lower.” —David E. Rovella

The Wall Street Journal reports that

Early laboratory studies suggest that a Covid-19 antibody treatment developed byGlaxoSmithKline GSK 0.24% PLC and Vir Biotechnology Inc. VIR -2.19% is effective against the Omicron variant, the companies said, setting it apart from similar therapies that appear to work less well against the highly mutated strain.

The companies said Thursday that they had tested the drug, called sotrovimab, against certain individual mutations found in Omicron, which has now been detected in at least 24 countries, including the U.S. Glaxo and Vir said the findings were preliminary and they would need to test the treatment against the whole of the mutated spike protein found in the variant to confirm the result. The companies published the preliminary research, which hasn’t yet been peer reviewed.

From the White House, the President announced a bevy of new COVID control measures today. Of particular interest to health plans is the following one:

Providing health plan coverage of no-cost rapid, over-the-counter (OTC) COVID-19 tests:  To expand access and affordability of at-home COVID-19 tests, the Departments of Health and Human Services, Labor and the Treasury will issue guidance by January 15th to clarify that individuals who purchase OTC COVID-19 diagnostic tests will be able to seek reimbursement from their group health plan or health insurance issuer and have insurance cover the cost during the public health emergency. Workplace screening would remain consistent with current guidance. 

That workplace guidance currently requires the employer to fund the cost of testing, e.g., in programs that require vaccinations or weekly testing / masking. However, I think that once this Pandora’s box is open, employers will be telling their employees to pick up a test at the local pharmacy if they need to be tested. What’s stopping them? Healthcare Dive explains that the mandate will remove the market incentive currently on manufacturers to lower costs.

The plan is a potential boon for medtech companies that produce at-home tests. With insurers on the hook for payment, it may drive up demand, particularly among those who were sensitive to prices before. Abbott, BD and Quidel are big players in the at-home testing space.

Furthermore the FEHBlog doesn’t see the sense in taking this step before the Food and Drug Administration give emergency use authorization to Merck and Pfizer COVID pills to treat COVID at its onset.

From the COVID vaccine mandate front, Beckers Hospital Review reports that

HHS is appealing a federal court’s decision to temporarily block the start of its vaccination mandate for healthcare workers, according to Bloomberg Law. 

U.S. District Judge Terry Doughty in Louisiana granted a preliminary injunction Nov. 30 halting the vaccination rule for healthcare workers until legal challenges are resolved.  * * *

HHS Secretary Xavier Becerra and other defendants filed an appeal Dec. 1. The U.S. Court of Appeals for the 5th Circuit will hear the appeal. 

From the pharmacy front —

Healthcare Dive informs us that

CVS Health and Microsoft are forming a strategic alliance to co-develop products around the areas of personalized care and digital health, the two companies announced Thursday.

CVS said it plans to use Microsoft’s computing capabilities to deliver more customized health recommendations when and where consumers need them as the retail pharmacy giant continues to focus on digitally enabled and consumer-centric health services. The two will also look for new ways to leverage technology and machine learning to automate CVS operations and reduce waste.

Fierce Healthcare tells us that

CVS Pharmacy is expanding an in-app feature for visually impaired patients, which reads prescription information out loud, to all of its nearly 10,000 U.S. locations.

The solution, called Spoken Rx, was designed in collaboration with the American Council of the Blind. Patients enrolled in the program can scan the labels on their prescription containers and have their information, including the medication’s name and directions for use, read out loud to them in either English or Spanish.

* * * The feature is free to all patients who enroll. CVS can provide a standalone speaker device to read prescription labels if the patient doesn’t have a smartphone.

CVS also offers ScripTalk on its website, which allows patients who get their medications delivered to their homes to have their prescriptions read aloud through the separate ScripTalk app. The pharmacy giant first made the service available in 2014.

The company has options for braille and large-print prescription labels through their online pharmacy too.

Midweek Update

David Ermer–Congress, COVID vaccine mandate, COVID-19, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–

From Capitol Hill, The Wall Street Journal reports that

Lawmakers worked Wednesday to reach an agreement on a short-term spending patch to avoid a potential partial government shutdown this weekend, with Democrats and Republicans still haggling over the details of the funding extension.

Party leaders had initially hoped to release an agreement earlier this week. Democrats have eyed a spending patch that would last until mid-or-late-January, while Republicans have pushed for a longer extension.

With just days until the government runs out of current funding at 12:01 a.m. on Saturday, Dec. 4, lawmakers will need to act quickly to pass the eventual agreement through the House and Senate. Meeting that tight timeline would require unanimous consent in the Senate to waive some of the chamber’s procedural hurdles, and any individual senator can slow down the process.

The article points out that Congressional leadership from both parties expects a continuing resolution to pass without a government shutdown. Of course we know from past experience that because the funding runs out on a Saturday, Congress has some additional time to complete work on the continuing resolution over the weekend if necessary.

From the Delta variant front the Centers for Disease Control announced today that

The California and San Francisco Departments of Public Health have confirmed that a recent case of COVID-19 among an individual in California was caused by the Omicron variant (B.1.1.529). The individual was a traveler who returned from South Africa on November 22, 2021. The individual had mild symptoms that are improving, is self-quarantining and has been since testing positive. All close contacts have been contacted and have tested negative.

The FEHBlog senses that Delta variant is becoming jealous over the attention that the Omicron varian is receiving.

From the Delta variant vaccine mandate front, the Society for Human Resource Management tells us that

Consultancy Willis Towers Watson conducted a survey of large U.S. companies from Nov. 12-18 and asked if they currently require employees to be vaccinated against COVID-19 or plan to do so; 543 companies responded to the survey. Respondents indicated that they: 

— Currently require vaccinations (18 percent).

— Will require vaccinations only if OSHA’s ETS takes effect (32 percent).

— Plan to mandate vaccinations regardless of the ETS status (7 percent). 

Few employers (3 percent) with vaccination mandates have reported a spike in resignations, although nearly 1 in 3 (31 percent) of those planning mandates were very concerned that this could contribute to employees leaving their organizations. On the other hand, nearly half of employers (48 percent) believe vaccine mandates could help recruit and retain employees.

In addition to vaccine mandates, many large employers have taken or plan to take the following actions to protect employees who are returning to the workplace, saying that they will:

— Offer COVID-19 testing (84 percent), most on a weekly basis (80 percent).

— Require unvaccinated employees to pay for testing unless prohibited by state law (25 percent).

— Require or plan to require masks to be worn indoors (90 percent).

In hospital news, Healthcare Dive reports that

Hospitals saw operating margins continue to erode in October, declining 12% from September under the weight of rising labor costs, according to a national median of more than 900 health systems calculated by Kaufman Hall. It was the second consecutive monthly drop and comes as facilities are preparing for the fast-spreading omicron variant of the coronavirus.

Although expenses remained highly elevated, patient days and average length of stay fell for the first time in months in October, likely reflecting lower hospitalization rates as the pressure of treating large numbers of COVID cases began to ease, Kaufman Hall said in its latest report.

At the same time, operating room minutes rose 6.8% from September, pointing to renewed patient interest in elective procedures.

Fierce Healthcare adds that

Despite the threat of daily fines, hospitals have so far been slow to publish their prices online in accordance with a new federal regulation.

Radiology services look to be no exception, with new study data now suggesting roughly two-thirds of U.S. hospitals have not published commercial negotiated prices for at least one of the 13 radiology services designated as a common shoppable service by the Centers for Medicare & Medicaid Services (CMS). Hospitals are required to publish these prices in compliance with CMS’ Hospital Price Transparency final rule.

Further, the hospitals that did share their radiology service commercial negotiated prices appear to be all over the map, often setting price tags that varied by hundreds or thousands of dollars for certain imaging services.

The analysis—published in Radiology by Michigan State University and Johns Hopkins researchers—found than a mean 2,053 out of 5,700 hospitals (36%) had reported a price for one of these services as of Sept. 6.

From the telehealth front, Healthcare Dive informs us that

When U.S. patients envision their future medical care, the majority see telehealth playing a role. But when presented with the choice between an in-person or video visit for nonemergent care, most prefer a traditional in-office visit, according to new research analyzing consumer telehealth preferences.

The survey conducted by the nonprofit Rand Corporation published in JAMA on Wednesday found those who leaned toward in-person care were more willing to pay for their preferred visit modality, while those who preferred video visits were more sensitive to out-of-pocket costs.

Of the respondents who had used telehealth at least once since last March, only 2.3% said they were unwilling to use telehealth in the future, suggesting the method’s continued importance in hybrid models of care even after the pandemic — though it’s unlikely to be most patients’ first choice, researchers said.

In other news —

  • Drug Channels offers its take on CVS Health’s recent announcement to right size its number of retail pharmacies (a roughly 10% reduction) and add even more healthcare focus to the remaining locations.
  • Today “the Centers for Medicare & Medicaid Services (CMS) issued a Request for Information (RFI) to solicit stakeholder and public feedback that will be used to inform potential changes and future rulemaking to improve the organ transplantation system and seek to enhance the quality of life of those living with organ failure.”
  • Becker’s Hospital Review discusses and provides interesting executive interview on how healthcare providers and health plans are seeking to improve and expand mental healthcare.
  • This week’s Econtalk episode on our sense of hearing is outstanding. Check it out.

Tuesday’s Tidbits

David Ermer–AHRQ, CDC, COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, Telehealth, U.S. Healthcare–

From the Delta variant vaccination and treatment front, AHIP informs us that

The Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) held a meeting to discuss the safety and efficacy of the COVID-19 antiviral treatment molnupiravir, developed by Merck and Ridgeback Biotherapeutics. The oral treatment is the first COVID-19 therapy that could be taken outside a clinical setting. The Committee reviewed data by Merck and the FDA on molnupiravir’s toxicity, efficacy, and safety, and discussed concerns over treatment of pregnant persons and the potential effects of viral mutation and evolution. Initial data from Merck showed that molnupiravir reduced the hospitalization risk among high-risk patients by 48%, however data released November 26 suggests the reduction in hospitalizations may be closer to 30%.

The Committee voted 13-10 that the potential benefits of molnupiravir outweigh the known and potential risks when used for the treatment of mild-moderate COVID-19 in adult patients who are within 5 days of symptom onset and are at high risk of severe COVID-19, including hospitalization or death. Given concerns about the potential harmful effects on fetal development, Committee members further stressed the need for pregnancy testing prior to taking molnupiravir.

The FDA will review AMDAC’s conclusions and formally decide whether or not to grant emergency use authorization (EUA) to molnupiravir in the coming weeks. 

Acting Food and Drug Commissioner Dr. Janet Woodcock announced

The [Food and Drug Administration] is working as quickly as possible to evaluate the potential impact of this variant on the currently available diagnostics, therapeutics and vaccines. We are closely monitoring the situation and are committed to communicating with the public as we learn more. 

Historically, the work to obtain the genetic information and patient samples for variants and then perform the testing needed to evaluate their impact takes time. However, we expect the vast majority of this work to be completed in the coming weeks.

Healthcare Dive informs us that

The emergence of a new COVID-19 variant, named Omicron (B.1.1.529), is putting pressure on diagnostics manufacturers who test for the presence of SARS-CoV-2 to ensure its results are not impacted. Thermo Fisher Scientific, Qiagen and Lucira Health were quick to claim their tests can detect the emerging variant.    

The Wall Street Journal reports that

The Omicron variant of the Covid-19 virus could lead to more infections among vaccinated people, according to several scientists, but some said there were reasons to believe the shots would protect against severe disease.

While the new variant might evade the antibodies generated in reaction to the vaccines, the virus will likely remain vulnerable to immune cells that destroy it once it enters the body, said Ugur Sahin, co-founder of BioNTech SE, which sells a Covid-19 shot with partner Pfizer Inc.

“Our message is: Don’t freak out, the plan remains the same: Speed up the administration of a third booster shot,” Dr. Sahin said in an interview Tuesday.

In that regard, Govexec.com notes that “Pfizer/BioNTech are expected to apply for approval for their booster shots for 16 and 17 year olds and the FDA “could authorize extra shots within roughly a week,” The New York Times reported on Monday.”

In COVID vaccine mandate legal news, the FEHBlog was quite surprised to read in Govexec that

On Tuesday, a federal judge temporarily blocked the COVID-19 vaccine mandate for federal contractors in three states.

U.S. District Judge Gregory Van Tatenhove, who serves in the U.S. District Court for the Eastern District of Kentucky, issued a preliminary injunction for the vaccine mandate for federal contractors and subcontractors in all covered contracts in Kentucky, Ohio and Tennessee. Following President Biden’s issuance of the executive order on the mandate on September 9, there have been numerous legal challenges. 

“This is not a case about whether vaccines are effective. They are. Nor is this a case about whether the government, at some level, and in some circumstances, can require citizens to obtain vaccines. It can,” wrote Van Tatenhove. “The question presented here is narrow. Can the president use congressionally delegated authority to manage the federal procurement of goods and services to impose vaccines on the employees of federal contractors and subcontractors? In all likelihood, the answer to that question is ‘no.’”

The New York Times adds

A federal judge issued a preliminary injunction on Tuesday to halt the start of President Biden’s national vaccine mandate for health care workers, which had been set to begin next week. 

The injunction, written by Judge Terry A. Doughty, effectively expanded a separate order issued on Monday by a federal court in Missouri. The earlier one had applied only to 10 states that joined in a lawsuit against the president’s decision to require all health workers in hospitals and nursing homes to receive at least their first shot by Dec. 6 and to be fully vaccinated by Jan. 4.

“There is no question that mandating a vaccine to 10.3 million health care workers is something that should be done by Congress, not a government agency,” Judge Doughty of U.S. District Court for the Western District of Louisiana wrote. He added: “It is not clear that even an act of Congress mandating a vaccine would be constitutional.”

The plaintiffs, he added, also have an “interest in protecting its citizens from being required to submit to vaccinations” and to prevent the loss of jobs and tax revenue that may result from the mandate.

It looks like the vaccine mandates are creating more work Judicial Panel on Multidistrict Litgation.

From the HIV front —

  • The National Institutes of Health tells us that “Among people with HIV worldwide who are receiving antiretroviral therapy (ART), adults are getting closer to the global target of 95% achieving viral suppression, but progress among children and adolescents is lagging and long-term viral suppression among all groups remains a challenge. These findings of a study funded by the National Institutes of Health suggest that substantial efforts are needed to help people with HIV durably suppress the virus. The findings were published today in the journal The Lancet HIV.”
  • The Centers for Disease Control informs us that “Improving access to and use of HIV services for [men having sex with men] MSM, particularly Black MSM, Hispanic/Latino MSM, and younger MSM, is essential to ending the HIV epidemic in the United States.”
  • Here is a link to the CDC’s website on HIV treatment.

From the tidbits department —

  • Fierce Healthcare calls to our attention the fact that

The Business Group on Health has identified several trends in health and wellness to keep an eye on next year, which they say highlight the sense of “collective urgency” employers and their workforces feel.

For example, the organization echoed an ongoing industry trend: virtual care isn’t going away following a massive increase in use during the pandemic. However, the Business Group argues that taking full advantage of its strengths will require integration with in-person offerings.

  • The Society for Human Resource Management, having lost respect for the Delta variant, discusses how the Omicron variant may impact the workplace.
  • AHRQ tells us that “Patients with retail medications to treat opioid use disorders spent on average 3.4 times more for out-of-pocket prescriptions than the rest of the U.S. population, according to an AHRQ-study published in the Journal of Substance Abuse and Treatment.” No bueno.
  • Also “AHRQ has released an updated Chartbook on Rural Healthcare that shows that people in rural areas face difficulty getting timely, high-quality, affordable healthcare. 
  • HHS’s Office for Civil Rights which enforces the HIPAA Privacy and Security Rules now has settled in OCR’s favor 25 complaints against healthcare providers for allegedly violating HIPAA’s individual right to access medical records.

Monday Roundup

David Ermer–CDC, Congress, COVID vaccine mandate, COVID-19, COVID-19 vaccine, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Capitol Hill front, the Hill reports that Senate continues to squabble over the must pass National Defense Authorization Act for the current federal fiscal year. Meanwhile Roll Call informs us that

Democrats and Republicans on Monday haggled over details of a stopgap spending bill that appears likely to run into late January at a minimum, with Republicans still trying to extend the duration into February or March.

Sources said House Appropriations Chair Rosa DeLauro, D-Conn., wants to file the temporary spending bill Tuesday with a goal of passing it in the House on Wednesday. That would presumably give the Senate enough time to clear it for President Joe Biden’s signature before the current stopgap funding law expires Friday.

Extending the continuing resolution into late January would represent a compromise between DeLauro, who previously was pushing for a shorter two-week CR, and senators from both parties who say more time is needed to wrap up work on fiscal 2022 appropriations bills.

Negotiations were ongoing, however, with Republicans arguing for more time. Senate Appropriations ranking member Richard C. Shelby told reporters Monday night that he prefers a stopgap through February or March. “I think it gives us more time to seriously sit down,” the Alabama Republican said.

From the Delta variant front, David Leonhard sagely writes in this New York Time column this morning

The public reaction to new Covid-19 variants has followed a familiar cycle. People tend to assume the worst about two different questions — whether the variant leads to faster transmission of the Covid virus and whether it causes more severe illness among infected people.

The first of those worries came true with the Alpha and Delta variants: Alpha was more contagious than the original version of the virus, and Delta was even more contagious than Alpha. But the second of the worries has largely not been borne out: With both Alpha and Delta, the percentage of Covid cases that led to hospitalization or death held fairly steady.

This pattern isn’t surprising, scientists say. Viruses often evolve in ways that help them flourish. Becoming more contagious allows a virus to do so; becoming more severe has the potential to do the opposite, because more of a virus’s hosts can die before they infect others.

It is too soon to know whether the Omicron variant will fit the pattern. But the very early evidence suggests that it may. Unfortunately, Omicron seems likely to be more contagious than Delta, including among vaccinated people. Fortunately, the evidence so far does not indicate that Omicron is causing more severe illness * * * .

The Boston Globe reports that

The Centers for Disease Control and Prevention [(CDC) today] broadened its recommendation for COVID-19 booster shots to include all adults because of the new Omicron variant. The agency had previously approved boosters for all adults, but only recommended them for those 50 years and older or living in long-term care settings.

“Everyone ages 18 and older should get a booster shot either when they are six months after their initial Pfizer or Moderna series or two months after their initial J&J vaccine,” CDC Director Dr. Rochelle Walensky said in a statement.

Healthcare Dive adds

Facing a coronavirus variant that experts fear could more easily evade vaccine protection, drugmakers raced last week to set in place plans to respond to omicron, the latest threat in the nearly two-year-old COVID-19 pandemic. 

BioNTech, which partnered with Pfizer to develop one of the world’s most effective coronavirus vaccines, is already working on a version of its shot tailored to omicron and expects adapting it could take as little as six weeks. Moderna and Johnson & Johnson, makers of two other vaccines for COVID-19, both said they would advance omicron-specific candidates, as did Maryland-based Novavax, which aims to soon ask for U.S. approval of its shot. 

On a related note, last Wednesday, the CDC released a health alert about increasing seasonal flu activity especially among young adults and in college and university settings.

On the Delta variant vaccine mandate front, the Biden Administration came to its senses today by announcing per Govexec that “it would delay until 2022 [a/k/a post holiday season] issuing suspensions and other serious penalties related to noncompliance with its mandate that the federal workforce be vaccinated against COVID-19.”

The White House Safer Federal Workforce Task Force updated guidance on its website to reflect the change, encouraging agencies to issue a letter of reprimand prior to more serious sanctions against noncompliant employees, as well as allowing for multiple rounds of suspensions before agencies move to fire them.

“Agencies may consider the length of the education and counseling period or following an initial brief suspension (14 days or less) with a longer second suspension (15 days or more), rather than moving from a first suspension to proposal of removal,” the task force wrote. “That said, consistency across government in enforcement of this government-wide vaccine policy is desired, and the executive order does not permit exceptions from the vaccination requirement except as required by law.”

Also Reuters reports that

A federal judge on Monday blocked in 10 states a Biden administration vaccine requirement, finding the agency that issued the rule mandating healthcare workers get vaccinated against the coronavirus likely exceeded its authority.

The ruling by U.S. District Judge Matthew Schelp in St. Louis prevents the U.S. Centers for Medicare and Medicaid Services (CMS) from enforcing its vaccine mandate for healthcare workers until the court can hear legal challenges brought by the 10 states. * * *

“Congress did not clearly authorize CMS to enact this politically and economically vast, federalism-altering, and boundary-pushing mandate, which Supreme Court precedent requires,” [Judge Schelp] wrote.

[Judge] Schelp’s ruling applied in the 10 states that brought the case: Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota and New Hampshire.

A Washington Post article reminded the FEHBlog of this New York Times squib posted on November 21

The article concludes

In Suffolk County, [on Long Island] Odette R. Hall, the chief medical examiner, is using the new mass spectrometer to dig through deaths, to figure out whether fentanyl or its analogues were to blame — or, she fears, whatever novel drug is coming next.

“Whatever is happening on the street,” Dr. Hall said, “is always going to be a step ahead.”

The Washington Post reports that

Forensic analysts have identified a new and highly potent family of synthetic opioids in the District’s illicit drug supply, a worrisome discovery in a city already struggling with a wave of fatal overdoses that shows no signs of abating. The opioids, found on used syringes examined by scientists at the D.C. Department of Forensic Sciences in September and October, are called protonitazene and isotonitazene, respectively. Experts estimate that each is at least several times more powerful than fentanyl, the synthetic opioid that has displaced heroin in many parts of the United States and is now responsible for the majority of the country’s drug overdoses, including those in the nation’s capital. * * *

It is unknown whether fentanyl testing strips — which alert users to the possibly higher potency of their drugs — pick up the presence of the nitazene family of substances. And more of the overdose antidote naloxone, commonly known as Narcan, may be needed to revive someone who has used the new drugs.

“For us, it is concerning,” [D.C. Public Health Lab chemist Alexandra] Evans said. “Naloxone should work, but because of the potency additional doses might be required.”