Tuesday’s Tidbits

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the Capitol Hill front, the Wall Street Journal reports that

The Senate passed a measure raising the government’s borrowing limit by $2.5 trillion, as Democrats moved to quickly bring the measure to President Biden’s desk and push the next debt-ceiling standoff past the midterm elections.

The Senate voted 50-49 to approve the legislation, sending it to the House, which could pass it as soon as later Tuesday. 

Meritalk informs us that

The Senate on Dec. 14 voted to invoke cloture on the conferenced version of the fiscal year (FY) 2022 National Defense Authorization Act (NDAA), setting up a final vote on Wednesday for the $768 billion defense spending bill. The cloture motion sailed through the Senate by an 86-13 vote, ending debate on the compromise NDAA bill. 

Roll Call adds that

Senate Democrats on Tuesday softened their optimism that their party’s sweeping safety net and climate spending and tax package will pass before Christmas, citing uncertainty about whether Sen. Joe Manchin III, D-W.Va., is ready to support it and procedural steps that are far from complete. 

“It’s a tough timeline,” Michigan Sen. Debbie Stabenow, a member of Democratic leadership, said. “So we’re still pushing forward. We have a lot of agreement. But, you know, if this is not done in the next two weeks, we’ll come back in January and get it done.”

The House passed a $2.2 trillion version of the bill last month. Senate Democrats have released updated text for nine of their 12 committees that have jurisdiction over the package. The Energy and Natural Resources Committee that Manchin chairs is among the three committees that have not released text, along with Environment and Public Works and Judiciary. 

And STAT News reports that

Robert Califf escaped largely unscathed from a two-hour hearing Tuesday vetting him to be commissioner of the Food and Drug Administration. He gushed about his love of high-quality data, skillfully navigated questions on hot-button topics like abortion and drug pricing, and even had personal anecdotes about Covid-19 testing and opioid prescribing at the ready. * * *

The smooth hearing is the latest signal that Califf, who already survived a confirmation process for the FDA’s top job in 2016, will be easily approved for the job again. A vote on his confirmation has not been scheduled, but is expected in early 2022.

From the Delta/Omicron front

STAT News tells us that

The Omicron variant is starting to eat into Delta’s dominance in the United States.

The new variant accounted for 2.9% of sequenced Covid-19 cases in the United States in the week ending Dec. 11. The week before, 0% of cases were from Omicron. Delta accounted for essentially all of the other sequenced cases, according to data from the Centers for Disease Control and Prevention.

The new figures, updated Tuesday, indicate that Omicron started circulating before that week, given how long it can take for infections to be sequenced and reported. They show that Omicron’s advantage over the highly transmissible Delta variant is becoming noticeable in this country. * * *

Experts have said it appears Omicron is taking over faster than Delta did as it became dominant globally earlier this year.

The National Institutes of Health Director’s blog this week offers the latest on the Omicron variant and COVID vaccines.

It’s important to note that scientists around the world are also closely monitoring Omicron’s severity While this variant appears to be highly transmissible, and it is still early for rigorous conclusions, the initial research indicates this variant may actually produce milder illness than Delta, which is currently the dominant strain in the United States.

But there’s still a tremendous amount of research to be done that could change how we view Omicron. This research will take time and patience.

What won’t change, though, is that vaccines are the best way to protect yourself and others against COVID-19. (And these recent data provide an even-stronger reason to get a booster now if you are eligible.) Wearing a mask, especially in public indoor settings, offers good protection against the spread of all SARS-CoV-2 variants. If you’ve got symptoms or think you may have been exposed, get tested and stay home if you get a positive result. As we await more answers, it’s as important as ever to use all the tools available to keep yourself, your loved ones, and your community happy and healthy this holiday season.

The New York Times observes that

As the coronavirus pandemic approaches the end of a second year, the United States stands on the cusp of surpassing 800,000 deaths from the virus, and no group has suffered more than older Americans. All along, older people have been known to be more vulnerable, but the scale of loss is only now coming into full view.

Seventy-five percent of people who have died of the virus in the United States — or about 600,000 of the nearly 800,000 who have perished so far — have been 65 or older. One in 100 older Americans has died from the virus. For people younger than 65, that ratio is closer to 1 in 1,400. * * *

Since vaccines first became available a year ago, older Americans have been vaccinated at a much higher rate than younger age groups and yet the brutal toll on them has persisted. The share of younger people among all virus deaths in the United States increased this year, but, in the last two months, the portion of older people has risen once again, according to data from the Centers for Disease Control and Prevention. More than 1,200 people in the United States are dying from Covid-19 each day, most of them 65 or older.

The FEHBlog certainly hope that more readily available boosters and rapid antigen testing combined with the Pfizer and Merck early onset pills will help stem the death toll. The Wall Street Journal reports tonight that

Preliminary laboratory tests gave encouraging signs that Pfizer Inc.’s PFE 0.62% experimental Covid-19 pill for the newly infected could work against Omicron, the company said. * * * The positive results come as the Food and Drug Administration reviews whether to clear use of Paxlovid in high-risk adults, a decision that could come before the end of the year. * * * Meanwhile, a separate, preliminary analysis provided signs the drug may help people at low risk of severe Covid-19, such as vaccinated individuals who end up becoming sick.

From the tidbits department —

Healthcare mergers and acquisitions surged in 2021, growing 56% in the 12 months through Nov. 15 versus 2020.

There was particularly high growth among physician medical groups, which saw more than 400 deals, as well as managed care and rehabilitation subsectors, according to a new report from PwC. This compares to about 200 to 250 deals per year between 2017 and 2019.

There’s the potential for more consolidation and private equity roll-ups in 2022 and beyond as practices have experienced challenging economics and may face 2022 Centers for Medicare & Medicaid Services (CMS) payment cuts.

  • The Leapfrog Group announced its 2021 top hospitals in our country.

This year, 149 hospitals from across the country received the Top Hospital Award. California, Florida, Massachusetts, New Jersey, and Pennsylvania were the states with the most Top Hospitals, with ten or more hospitals in each state receiving the designation. The Top Hospitals are recognized in four categories: Top General Hospitals (46 recipients), Top Rural Hospitals (23 recipients), Top Teaching Hospitals (72 recipients), and Top Children’s Hospitals (8 recipients).

Full results of the 2021 Leapfrog Hospital Survey are publicly reported and available for free on Leapfrog’s website, providing patients with a resource to make informed decisions about where to seek treatment.

To see the methodology for Top Hospitals, please visit https://www.leapfroggroup.org/tophospitals.

  • The Centers for Disease Control offers six tips for eating healthy on a budget.

Monday Roundup

Photo by Sven Read on Unsplash

From the political front, Politico reports that

[Senator] Joe Manchin (D WV) remains at the negotiating table [with his party’s leadership], despite deep concerns about President Joe Biden’s climate and social spending bill [a/k/a the Build Back Better Act]. 

After speaking with Biden on Monday afternoon, Manchin said he was still “engaged” in discussions. And as he left the Capitol, the key Democratic senator made clear he wasn’t ready to commit to voting for or against a bill that is still coming together behind closed doors.

From the White House, the President issued an executive order on improving customer service performed by government agencies. Federal News Network explains that

Jason Miller, the Office of Management and Budget’s deputy director for management, said the EO also directs agencies to coordinate work on services that reflect common life experiences, including turning 65 and planning retirement, having a child or applying for a small business loan. * * *

The executive order gives senior administration officials 90 days to select a limited number of these customer life experiences to prioritize across government. It requires Miller and other members of the President’s Management Council to update [Presidential senior advisor Neera] Tanden and White House Chief of Staff Ron Klain on progress made improving these customer life experiences every six months.

The EO also gives the General Services Administration six months to develop a roadmap of shared services that agencies can use to improve customer experience.

The administration specifically names Login.gov and the U.S. Web Design System, a set of templates meant to create a common look and feel for agency websites, as tools that all agencies should use to improve federal customer experience.

Here is a link to the White House’s press release on the Executive Order as found on performance.gov.

From the Affordable Care Act front, the Internal Revenue Services has released the final Affordable Care Act coverage reporting forms, 1095-B and 1095-C, along with the final instructions for those forms.

From the Office of Information and Regulatory Affairs’ website, we find that the federal government’s Fall 2021 regulatory agenda has been published. Here is a link to OPM’s Fall 2021 agency rule list. A chill went up the FEHBlog’s spine when he noticed that the ACA provider non-discrimination proposed rule mandated by the No Surprises Act will be published this month due to a statutory requirement. Cost curve up?

From the employer sponsored care front, Healthcare Dive reports that

— The average per-employee cost of employer-sponsored health insurance jumped 6.3% in 2021, as employees and their families resumed care delayed last year due to the pandemic, according to a new survey of employers from Mercer.

— That’s the highest annual increase since 2010. Health benefit costs outpaced growth in inflation and worker compensation through September, the employee healthcare and investment consultancy said.

— The findings raise questions of whether employers are experiencing a temporary correction to the cost trend following a minimal year-over-year increase of just 3.4% in 2020, or if they’re staring down the barrel of a new period of higher cost growth.

No doubt those questions can keep actuaries awake at night.

From the good COVID news department (yes it exists), STAT News informs us that

Paxlovid, Pfizer’s oral treatment for Covid-19, led to an 89% reduction in hospitalization and death in final data from a pivotal trial, the company said today, confirming the results of an earlier analysis.

The news should allay concerns that the efficacy of Pfizer’s pill would wane over time. Molnupiravir, a Covid-19 antiviral from Merck, appeared 50% effective in an interim trial analysis but fell to about 30% in the final tally. Both studies enrolled unvaccinated patients who were recently diagnosed with Covid-19 and had at least one risk factor for severe disease.

The next step for Pfizer is submitting the results to the FDA, which the company expects to do this month, and applying for an emergency-use authorization. The agency is yet to disclose whether it will convene a panel of expert advisers before deciding on Paxlovid.

Based on the President’s winter is coming plan, the FEHBlog’s bet is on the FDA approving the Pfizer drug without delay.

Weekend Update

Congress will remain in session for Committee business and floor voting.

The focus of attention will be the President’s Build Back Better Act. The Senate Finance Committee released the text of its portion of the Senate version of the BBB Act yesterday. The Wall Street Journal explains that

President Biden this week will lobby Sen. Joe Manchin, the centrist West Virginia Democrat, in an attempt to lock in a deal on a roughly $2 trillion social-policy and climate bill that Democrats hope to finish by Christmas.

Passage hinges largely on the support of Mr. Manchin, who hasn’t endorsed the legislation. He has repeatedly raised concerns about the cost of the bill and the potential effect of new government spending on inflation. Messrs. Biden and Manchin plan to talk early this week, a Senate aide said.

Senator Manchin’s vote is critical because the Democrat’s can’t lose one vote in the evenly divided Senate as the Republicans in the Senate all intend to vote against the bill. The Journal adds

With Democrats holding the narrowest congressional majority in decades, passing the sweeping bill is akin to threading yarn through a tiny needle. Democrats already navigated past opposition from Arizona Democratic Sen. Kyrsten Sinema on several of the tax increases they originally had proposed, making revenue-generation intended to pay for the legislation difficult.

Ms. Sinema hasn’t endorsed the House-passed bill. Democrats have also needed to write a bill that lawmakers from the party’s most progressive wing would support, along with centrists.

Because the Senate bill will not mirror the already passed House bill, the two Houses of Congress might convene a conference committee. Time will tell.

Tomorrow is the last day of the current Federal Benefits Open Season. OPM explains that

The Federal Benefits Open Season ends at 11:59 pm Eastern Time on Monday December 13, 2021 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 11:59 pm, in the location of your electronic enrollment system, on Monday December 13, 2021.

From the No Surprises Act front, the Kaiser Family Foundation offers a consumer friendly overview of the law’s provisions that take effect on January 1, 2021. Basically, FEHB plans will pay certain out-of-network (“OON”) providers (emergency care, air ambulance, and OON providers when the patient is treated at an in-network facility) a qualifying payment amount (“QPA”), net of the in-network cost sharing amount which is the member’s financial responsibility. If the provider is dissatisfied with the QPA, he or she must work out the matter with the health plan. The member therefore is held harmless against the outcome of that controversy.

These QPA provisions, however, are inapplicable to claims submitted for FEHB plan members who have primary Medicare coverage or in the case of fee for service plans have primary Medicare Part A only. Also if another payer is primary to the FEHB plan, e.g., a spouse’s plan, then the primary plan is responsible for compliance with the No Surprises Act. The FEHB plan is responsible only for making the secondary payment, which usually equals the primary plan’s deductibles and co-insurance.

From the health care business front, Medcity News informs us that

After a challenging quarter, insurance company Bright Health is raising $750 million in financing. In an unusual move, another insurance company is joining as an investor. Cigna Ventures and Bright’s largest shareholder, New Enterprise Associates, both participated in the financing.

Head of Cigna Ventures Tom Richards talked about potential opportunities to collaborate with NeueHealth, Bright’s provider enablement platform to help practices move to value-based contracts.

“We seek to be partners of choice and we look forward to exploring new ways that NeueHealth and Evernorth can potentially provide services to each other’s customers and clients,” he said in a news release.

From the Omicron front, Bloomberg reports (recall last week’s post about U.S. experts tracking the U.K.’s experience with Omicron because the United Kingdom started to experience Omicron cases before the U.S.):

Prime Minister Boris Johnson warned the U.K. is facing a “tidal wave” of omicron infections and set an end-of-year deadline for the country’s booster vaccination program. Infections in the U.K. from the new variant doubled in the last day and now make up a third of new cases in London. 

Anthony Fauci, U.S. President Joe Biden’s chief medical adviser, said omicron appears able to evade vaccines and some Covid-19 treatments but that a booster shot can increase protection. At least 30 U.S. states are reporting cases of the variant.  

CNBC adds that “Covid booster shots are “optimal care” as the deadly virus continues to mutate and spread, but the U.S. government is staying firm for the time being on the definition of fully vaccinated, top U.S. infectious disease expert Dr. Anthony Fauci said Sunday.”

Friday Stats and More

Based on the Centers for Disease Control’s COVID data tracker and using Thursday as the first day of the week, here is the FEHBlog’s weekly chart of new COVID cases for 2021:

STAT News reports today that Omicron may give Delta a run for its money.

As the Omicron variant snowballs in South Africa and widens its inroads in Europe, evidence is mounting that it can outcompete the highly transmissible Delta variant — a potential warning signal for the United States.

The Wall Street Journal adds that

The U.K. is emerging as a testing ground in the battle for dominance between the new Omicron variant of the coronavirus and Delta, the earlier strain that is currently driving most infections in the U.S. and Europe.

How Britain fares against Omicron will offer clues to the U.S. and the rest of the industrialized world about how the variant behaves in a highly vaccinated population, how sick those who are infected get and if its dozens of mutations have given Omicron enough of an advantage on the evolutionary ladder to starve Delta of the hosts it needs to stay on top.

The CDC’s weekly new COVID hospitalizations chart up week to week from 6.500 to 7,500 which is 54% below the number of new hospitalizations in January 2020. The Wall Street Journal adds that

As the pandemic heads into its third year, doctors are screening more effectively for these clots and improving treatment regimens, marking a significant medical advance alongside the vaccines and antiviral pills under review for Covid-19 that get the most attention.

Even before test results come in, doctors may sometimes treat patients with a high dose of anticoagulants if they suspect blood clots, often termed thrombosis, said Michael Streiff, a clot specialist at Johns Hopkins University.

“The incidence of thrombosis was very high in the beginning but has declined over time. I think this is due to better supportive care,” Dr. Streiff said.

Still, some doctors say there’s much to be done to improve outcomes further. Recent studies are helping to define more precise treatment protocols for clots.

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

The Wall Street Journal notes that

The Omicron variant of Covid-19 has so far caused mostly mild cases of Covid-19 in a small group of largely vaccinated people in the U.S., federal data show.

Among at least 43 people infected with the variant in 25 states in recent days, there has been one hospitalization and no deaths so far, the Centers for Disease Control and Prevention said Friday.

Out of 43 cases identified between Dec. 1 and Dec. 8, nearly 80% of the people infected with Omicron were fully vaccinated, according to CDC data, and one-third had received a booster shot. Fourteen percent of the people had a previous Covid-19 infection. Patients most commonly reported mild symptoms like cough, fatigue, congestion or runny nose, the CDC said. Nearly 60% of cases were in people 18 to 39 years old.

The report is an early piece of the picture scientists are working to assemble on Omicron’s infectiousness and virulencerelative to other variants.

Here’s the FEHBlog’s weekly chart of new COVID vaccinations administered and distributed from the 51st week of 2020 through the 49th week of 2021:

This past week was the first week since June 2021 that administered vaccinations topped 10 million. Slightly over 50% of the U.S. population over 65 is boostered according to the CDC.

Here is a link to the CDC’s weekly interpretation of its COVID statistics which urges all Americans aged 16 and older to get boostered.

From the flu front, the CDC reports that seasonal flu activity remains low but continues to increase. The CDC encourages Americans to fight the flu by getting vaccinated, engage in preventative measures, and take flu antiviral drugs if your doctor prescribes them. We are about a month away from the CDC giving the same advice about COVID.

From the Capitol Hill front, FedWeek informs us that

Congress is moving toward passing a compromise version of the annual DoD authorization bill (S-1605) containing a number of provisions affecting personnel policies government-wide, including two new weeks of paid leave for federal employees on the death of a son or daughter.

The new “parental bereavement leave” replaces a House provision that would have expanded the authority for federal employees to take paid time rather than unpaid time for parental purposes covered by the Family and Medical Leave Act. The Senate version had not included any provision on parental leave.

The compromise provision uses the same definitions for children as under the FMLA; rules likely will be needed to define the policy, including the effective date.

The bill also: extends long-running authorities for all agencies to pay certain special allowances to employees working in areas of active military operations; requires OPM to perform a study of allowances for employees working in remote areas; and orders OPM to establish or update occupational series in the fields of software development, software engineering, data science, and data management.

However, the final version drops House language to require OPM to redefine locality pay areas for wage grade employees so that they align with the areas used for the GS system. Currently, in some cases wage grade employees receive smaller raises than GS employees at the same location. The bill however encourages OPM to address that issue. 

From the judicial front

  • The Society for Human Resource Management brings us up to date on oral arguments before the U.S. Supreme Court this week on human resources and employee benefit issues.
  • The Coalition against Surprise Billing blasted the American Medical Association and the American Hospital Association for bringing a lawsuit against the independent dispute resolution regulations under the No Surprises Act.

From the healthcare business front —

New York-based Hydrogen Health, a joint venture between Anthem, investment firm Blackstone and digital primary care company K Health, is launching its virtual primary care offerings nationwide, the provider announced Dec. 9. 

Anthem and its partners formed Hydrogen Health in April 2021 to leverage artificial intelligence to drive down healthcare costs in both employer and consumer markets. The joint venture offers employers and insurers text and video-based digital primary care, and taps K Health’s artificial intelligence to personalize that care. 

Hydrogen Health shared that since its initial launch with Anthem, its customers now include multiple Fortune 500 companies and other large employers. 

Moving into 2022, the plan anticipates it will expand the conditions it can diagnose and manage and grow its membership by 10 million — all digitally, according to the announcement. 

  • Healthcare Dive reports that on CVS Health’s investors day held yesterday.

— CVS Health plans to ramp up its acquisitions of physician practices and clinics as it continues to pursue its primary care strategy and races with other retail pharmacies to build out medical networks.

— The Woonsocket, Rhode Island-based healthcare behemoth already operates a network of MinuteClinics, urgent care locations staffed by nurse practitioners. But CVS wants to broaden its care delivery strategy into a primary care model, including “physician-led primary care centers with integrated virtual and home assets,” CVS EVP and president of pharmacy services Alan Lotvin said Thursday at CVS’ investor day.

— CVS plans to add a few hundred primary care centers to its network of MinuteClinics, drugstores and health-focused HealthHUB locations launched a few years ago, as it moves from an episodic to more longitudinal approach to care, Lotvin said. CVS also wants to eventually add more specialty services to compete as the retail healthcare market becomes increasingly saturated.

From the benefit design front, Health Payer Intelligence informs us that “Employing personalized, in-home chronic disease management services can have a significant impact on spending for seniors with chronic conditions, a study from Avalere found.”

Patients with quadriplegia saw the highest healthcare spending difference in total cost of care after receiving home healthcare. The group that received the home healthcare solution spent $12,807. In contrast, the group that did not receive in-home chronic disease management support spent nearly $30,000 more, with average spending of $42,709.

The condition that ranked lowest in the top ten chronic conditions was intestinal obstruction or perforation. But even for this condition, patients with the intervention spent on average $17,738 less than their counterparts.

Despite the major differences in total cost of care between the two groups, the group that received the targeted home healthcare intervention did not display drastic differences between healthcare spending levels before and after implementing the intervention.

Thursday Miscellany

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.

Monday Roundup

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 oneThe 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.

Weekend Update

Hanukkah greeting template. Nine candles and wishing. Hand drawn sketch illustration. White, yellow and blue colors

The House and the Senate will be holding Committee business and floor votes this week. Yesterday when writing up Cybersecurity Saturday, the FEHBlog could not find any fresh news on the National Defense Authorization Act (“”NDAA”) vote. The NDAA often includes federal procurement law changes and this year may include cyberbreach and cyber-ransom payment notice requirements.

The Wall Street Journal reports today that

Congress is expected to focus this week on the defense policy bill known as the National Defense Authorization Act, or NDAA, which was held up in the Senate last week over provisions regarding Russia and China. Instead of the Senate passing its own bill, a compromise bill—negotiated by leadership in the House and Senate—is expected to come to the House for a vote as early as this week.

The Journal further reports that Congressional leadership is working on the debt ceiling issue which may come to a head mid-month and hoping to bring the Build Back Better multi-trillion dollar budget reconciliation bill to a vote before Christmas.

The House of Representatives’ Postal Reform bill (H.R. 3076) would create a new Postal Service Service Health Benefits Program within the FEHB Program. The PSHBP would be tightly integrated with Medicare with respect to annuitant coverage. For that reason, the bill initially was referred to the House Oversight and Reform, Energy and Commerce, and Ways and Means Committees.

A friend of the FEHBlog called to his attention the fact that last Friday December 3, the Energy and Commerce and Ways and Means Committee were granted an extension for further consideration of the bill ending not later than Jan. 21, 2022. Of course, the Oversight and Reform Committee approved a substitute bill for House floor voting on May 13.

The ongoing Federal Employee Benefits Open Season ends on a week from tomorrow December 13, a few day following the end of Medicare Open Enrollment period which ends this week on December 7.

From the Delta variant front —

  • Today’s Washington Post has an interesting article on early analyses of the Omicron variant. The Post notes that

The omicron variant is likely to have picked up genetic material from another virus that causes the common cold in humans, according to a new preliminary study, prompting one of its authors to suggest omicron could have greater transmissibility but lower virulence than other variants of the coronavirus.FAQ: What to know about the omicron variant of the coronavirus

Researchers from Nference, a Cambridge, Mass.-based firm that analyzes biomedical information, sequenced omicron and found a snippet of genetic code that is also present in a virus that can bring about a cold. They say this particular mutation could have occurred in a host simultaneously infected by SARS-CoV-2, also known as the novel coronavirus, and the HCoV-229E coronavirus, which can cause the common cold. The shared genetic code with HCoV-229E has not been detected in other novel coronavirus variants, the scientists said.

The study is in preprint and has not been peer-reviewed.

  • National Public Radio offers conservative yet sensible guidance filled with expert opinions on how to navigate the holiday season without contracting COVID. For example,

The good news is, you don’t have to hibernate like it’s 2020. Experts note we’re in a much different place than we were last winter, with COVID-19 vaccines and boosters now widely available. There’s good hope that the current vaccines offer protectionagainst severe disease with omicron. 

That said, if this pandemic has taught us anything, it’s that when you don’t know what you’re dealing with, “we should invoke the precautionary principle,” says Dr. Abraar Karan, an infectious disease physician at Stanford University. 

In other words, don’t panic, but do be thoughtful about what risks you want to take.

In the FEHBlog’s opinion, that’s sound approach to living one’s life.

Friday Stats and More

Based on the Centers for Disease Control’s COVID Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s weekly chart of new COVID cases for this year.

The Wall Street Journal reports that

The new Omicron variant was identified in more than a dozen people in at least nine states, early evidence of its presence across the U.S.

While some of the people in the U.S. who have contracted the Omicron variant of the coronavirus that causes Covid-19 had recently traveled to southern Africa, where it was first identified last week, at least two states reported community spread of the new variant. States to report Omicron cases span the country from Hawaii to California and New York.

“It’s certainly spreading in the U.S.,” said Samuel Scarpino, managing director of pathogen surveillance at the Rockefeller Foundation. 

The Delta variant begs to note add “all of the other cases are mine.”

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

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

Oddly the number of deaths popped up last week.

Here’s the FEHBlog’s weekly new COVID vaccinations delivered and administered during the last two weeks of 2020 and this year.

In this regard, the Wall Street Journal reports that

The U.S. has plenty of Covid-19 vaccines but retail pharmacies are struggling to quickly administer them in some places.

Vaccine seekers in some states face waits of days or weeks for doses as local health officials hustle to improve access to meet surging demandCVS Health Corp.  Walgreens Boots Alliance Inc. and Walmart Inc., which are facing staffing shortages, now say they may not be able to accommodate people without appointments.

Millions of Americans are newly eligible for booster shots, and federal health officials in November recommended the vaccine for use in children as young as 5 years old. Concerns about the risks posed by the new Omicron variant also are driving more people to get vaccinated, health officials say.

An average of 1.4 million doses were administered daily in the U.S. in the week ended Thursday, a 22% increase from the previous week, which included Thanksgiving, according to the Centers for Disease Control and Prevention.

(The FEHBlog’s chart does not show a sharp increase because the government was not reporting vaccination statistics over the four day Thanksgiving weekend.)

Here is a link to the CDC’s weekly interpretation of its COVID statistics.

The Society for Human Resource Management discusses the impact of Omicron and the President’s COVID awareness program on employers.

From the influenza front, the CDC reports that “Seasonal influenza activity in the United States remains low, but in recent weeks, the number of influenza virus detections reported by clinical and public health laboratories has increased, and the percent of outpatient visits for respiratory illness has trended upward.” Next week is National Flu Vaccination Week.

From the Capitol Hill front, Federal News Network informs us that as expected,

President Joe Biden signed a continuing resolution Friday to keep funding federal government operations for another three months [precisely February 18, 2022], avoiding a government shutdown.

The  passed the Senate late last night by a margin of 69-28, while the House had approved the same measure earlier in the day on a party line vote, with only one Republican voting in favor.

Federal News Network reports at length about the House Oversight and Reform Committee vote approving an Committee leadership sponsored bill to strengthen OPM (H.R. 6066). The article notes that today OPM Director Kiran Ahuja “spoke at a virtual discussion hosted by NAPA. She reiterated that rebuilding the agency is one of her top priorities. In the last year, OPM has hired about 340 new employees, Ahuja said.”

From the pharmacy / PBM front —

  • Forbes interviews Walgreens CEO Roz Brewer about her primary care oriented strategy for the large pharmacy chain.
  • Fierce Healthcare tells us that

Express Scripts has launched a new solution that aims to integrate prescription discount card pricing into members’ existing benefits.

Through the new Right Price offering, a member who is eligible for savings through a discount card will automatically see those savings applied at the pharmacy counter. Matt Perlberg, senior vice president of supply chain at Express Scripts, told Fierce Healthcare that the pharmacy benefit manager most often sees these discounts come into play for members who have yet to meet their deductible.

For about 2% of claims, members who are purchasing generic drugs but have not yet met the deductible may find these coupon cards lead to a lower price than their drug benefits, Perlberg said.

In other strategy news, Beckers Payer Issues reports that

UnitedHealth Group CEO Andrew Witty said during a Forbes Annual Healthcare Summit discussion he is exploring how the company’s payer and provider branches can work together more closely. 

The initiative aims to provide government and employer customers with more comprehensive offerings, Mr. Witty said Dec. 2, according to Forbes

Mr. Witty pointed to developing mental health strategies as one avenue for combined growth.

That makes sense to the FEHBlog.

Thursday Miscellany

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

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.