Weekend Update

Congress

Weekend Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, OPM, U.S. Healthcare, Uncategorized–

Congress is session this week for committee and floor business. On Tuesday morning the House Energy and Commerce Committee will hold a hearing on “The Future of Telehealth: How COVID-19 is Changing the Delivery of Virtual Care”

The Wall Street Journal reports that

The task of passing a coronavirus relief package now rests with the Senate, where Democrats must grapple with emerging divisions over some components of the plan, including a minimum-wage increase. The House early Saturday morning passed [largely along party lines] President Biden’s $1.9 trillion package, which would fund vaccine distribution, enhance and extend federal unemployment benefits, and send direct checks of $1,400 to many Americans and $350 billion to state and local governments.

As mentioned in last Thursday’s post, the Democrat leadership in Congress is trying to figure out a way for the Senate to pass the entire bill under budget reconciliation which requires all fifty Democrat senators plus the Vice President. The $15 minimum wage provision found in the House bill remains a wild card in the Senate.

The President officially sent Kiran Ahuja’s nomination to be OPM Director to the Senate last Wednesday. Federal News Network forecasts six “challenges” that Ms. Ahuja will need to address once confirmed.

In most excellent news, the Food and Drug Administration gave emergency use authorization to the single dose Johnson and Johnson vaccine yesterday and the Centers for Disease Control seconded this action today. This means that health plans, including FEHB plans, become liable for reimbursing administration costs for the Johnson and Johnson vaccine without member cost sharing in 15 days / March 15, 2021. Per CNN with the blessing of these two agencies

[T]he federal government may then begin distributing the 3.9 million available doses of the vaccine, perhaps as soon as Monday.”I just want to state explicitly how very grateful I am that we now have three highly effective vaccines,” said ACIP member Dr. Matthew Daley of the Institute for Health Research with Kaiser Permanente Colorado.

The company has pledged to have 20 million doses available by the end of March and 100 million doses by summer.The vaccine, made by Johnson & Johnson’s Janssen vaccine arm, can be kept at regular refrigerator temperatures, which experts said would make it much easier to distribute than vaccines made by Moderna and Pfizer/BioNTech.

The Wall Street Journal sums it up for us as follows:

The pandemic has opened a new era for vaccines developed with gene-based technologies, techniques that have long stumped scientists and pharmaceutical companies, suggesting the possibility of future protection against a range of infectious disease.

Johnson & Johnson’s Covid-19 vaccine, which was authorized Saturday for use in the U.S., is at the vanguard of a class of shots designed to mobilize a person’s immune defenses against the disease. It will be the first Covid-19 vaccine administered in the U.S. that uses viral-vector technology, which employs an engineered cold virus to ferry coronavirus-fighting genetic code to the body’s cells.

J&J’s vaccine is the third to be authorized in the U.S. after ones from Pfizer Inc. and its partner, BioNTech SE, and Moderna Inc. In a late-stage trial, J&J’s single-shot vaccine was 66% effective in preventing moderate to severe cases of the disease that has killed more than 500,000 people in the U.S. and about 2.5 million world-wide.

“This is one of those giant leap moments for us. These are fundamental shifts in how we will build vaccines for the future,” said C. Buddy Creech, director of Vanderbilt University’s vaccine research program. “I think this really ushers in a golden age of vaccinology.”

By the way the Centers for Disease Control has created its own COVID-19 vaccine finder website. According to the CDC’s COVID-19 data tracker website, currently nearly 20% of the eligible U.S. population has received at least one dose of the vaccine and 10% have received both doses.

Finally, the Choosing Wisely campaign is offering a information and a webinar that address one of the points in OPM’s recent call letter for 2022 benefit and rate proposals from carriers:

In Building A Better Health Care System Post-Covid-19: Steps for Reducing Low-Value and Wasteful Care, Corinna Sorenson, PhD, Duke-Margolis Center for Health Policy, and colleagues outline the impact of the pandemic on low-value care, and the potential opportunities it presents to create a better health care system post COVID-19. She elaborates further on this topic in her January 2021 Choosing Wisely webinar recording.

Cybersecurity Saturday

David Ermer–Congress, Cybersecurity–

On Tuesday February 23, the Senate Select Committee on Intelligence held a hearing on the SolarWinds hack. FCW and CyberScoop report on the hearing here and there. Per CyberScoop

More than two months after the hack became public, the wide-ranging Senate Select Committee on Intelligence hearing committee demonstrated that the U.S. government, the private sector and digital incident responders still are wrestling with the ramifications of an suspected Russian espionage campaign that leveraged the federal contractor SolarWinds. 

A number of big questions remain: SolarWinds still hasn’t determined how the hackers originally got into its systems, nobody has fully settled debates on whether the incident amount to espionage, or something worse, and suspicions abound that more victims remain unrevealed.

“It has become clear that there is much more to learn about this incident, its causes, its scope and scale, and where we go from here,” said Senate Intelligence Chairman Mark Warner, D-Va.

The House Oversight and Reform Committee held its own SolarWinds hack hearing yesterday. “The hearing examine[d] the role of the private sector in preventing, investigating, and remediating these attacks, as well as the need for Congress and the Executive Branch to implement a strategy to strengthen cybersecurity across federal government networks and improve information-sharing with the private sector.”

In other SolarWinds hack related news, CyberScoop reports that

Microsoft is offering up the tool it used to track down potential indicators of compromise in the sweeping SolarWinds breach, the company announced Thursday.

Microsoft is releasing the so-called CodeQL queries it used to investigate its source code, in an effort to help other organizations mitigate the risk from the cascading cyber-espionage campaign involving a breach at the U.S. federal contractor SolarWinds. Microsoft is aiming to help firms pinpoint code-level indicators of compromise (IoCs), Microsoft’s Security Team said in a blog. 

By digging into their own code, organizations can assess if they have been compromised by the hack, in which suspected Russian hackers laced malicious software in a SolarWinds product’s software update, Microsoft said. The company has described the campaign as “Solorigate.”

  • CyberScoops reports that on Wednesday February 24, “President Joe Biden signed an executive order on Wednesday directing federal agencies to conduct a review of supply chain security risks in industries including information technology. * * * Specifically, the order directs reports within one year from the the secretaries of Agriculture, Defense, Energy, Health and Human Services and Transportation — along with a joint Commerce/Homeland Security report — that include an assessment of cyber risks within key industry sectors that could disrupt the U.S. supply chain.”

In other cybersecurity related news —

  • Bleeping Computer discusses at reasonable length the Zero Trust security model that the FEHBlog referenced in a recent post. “The National Security Agency (NSA) and Microsoft are advocating for the Zero Trust security model as a more efficient way for enterprises to defend against today’s increasingly sophisticated threats. The concept has been around for a while and centers on the assumption that an intruder may already be on the network, so local devices and connections should never be trusted implicitly and verification is always necessary. Cybersecurity companies have pushed the zero-trust network model for years, as a transition from the traditional security design that considered only external threats.”
  • Bitglass, a cloud security vendor, released its seventh annual healthcare data breach report.

Key Findings [from the company’s announcement]

  • The average cost per breached record increased from $429 in 2019 to $499 in 2020. With 26.4 million records exposed in 2020, data breaches cost healthcare organizations $13.2 billion.
  • Outside of hacking and IT incidents, the remaining breach categories exposed the personal details of about 2.3 million people, exposing victims to identity theft, phishing, and other forms of cyberattacks. 
  • This year, breach numbers were up across the board, with 37 out of 50 U.S. states suffering more breaches than they did in 2019. California had the most healthcare breaches in 2020 with 49 incidents–surpassing last year’s leader, Texas, which suffered 43 breaches in 2020. 
  • In 2020, the average healthcare firm took about 236 days to recover from a breach. 
  • The FEHBlog recently noticed that the Office of Personnel Management has posted its 4th Quarter 2020 report on the implementation of its FEHB Master Enrollment Index.

Friday Stats and More

David Ermer–Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, Telehealth, U.S. Healthcare, Uncategorized–

Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 8th week of this year (beginning April 2, 2020, and ending February 24, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):

and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:

In this regard, Bloomberg reports that

Covid-19 hospital admissions plummeted 72% in a month in the U.S. as the virus ebbed and the vaccination push accelerated.

Americans 85 years old and over saw the most pronounced drop, down 81% from January to February, according to the U.S. Centers for Disease Control and Prevention, which monitors the data through its Covid-19-Associated Hospitalization Surveillance Network.

The rate was 23.4 hospitalizations per 100,000 residents 85 and over for the week of Feb. 7-13, the latest data available. That was down from 120.3 per 100,000 four weeks earlier. The overall rate across age groups was 4.6, down from 16.7.

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths because new cases greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through February 24, 2021):

Finally here is a COVID-19 vaccinations chart for past ten weeks which also uses Thursday as the first day of the week:

In other COVID-19 vaccination news

  • The Wall Street Journal reports that

Johnson & Johnson’s JNJ -2.64% single-dose Covid-19 vaccine worked safely and should be authorized for use in the U.S., a panel of experts advised federal health regulators Friday.  The advisory committee’s unanimous vote in support of the vaccine’s authorization is the last step before the U.S. Food and Drug Administration issues a decision, which is expected Saturday. 

Yippee!

  • Reuters reports that “The U.S. Food and Drug Administration on Thursday approved storage and transportation of COVID-19 vaccine developed by Pfizer Inc and German partner BioNTech SE at standard freezer temperatures for up to two weeks instead of ultra-cold conditions. * * * “Alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said.

In other COVID-19 news

  • The AP informs us that “February is usually the peak of flu season, with doctors’ offices and hospitals packed with suffering patients. But not this year. Flu has virtually disappeared from the U.S., with reports coming in at far lower levels than anything seen in decades.” It’s a silver lining in the COVID-19 cloud.  
  • The Centers for Medicare and Medicaid Service released updated guidance today for health plans, including FEHB plans, on coverage of COVID-19 testing and vaccinations.
  • Bloomberg reports that

States should maintain Covid-19 restrictions such as mask wearing and capacity limitations as case numbers halt their decline, the head of the U.S. Centers for Disease Control and Prevention said Friday, citing the circulation of new variants and infection rates that remain alarmingly high.

CDC Director Rochelle Walensky issued a sobering warning during a press briefing Friday, where she said the more contagious B.1.1.7 variant, first found in the U.K., now accounts for an estimated 10% of current U.S. cases, and that variants in California and New York also appear to spread more easily.

“Things are tenuous — now is not the time to relax restrictions,” Walensky said. “The latest data suggest that these declines may be stalling, potentially leveling off at still a very high number. We at the CDC consider this a very concerning shift in the trajectory.”

  • STAT News punctured a CDC recent statistic as follows:

The Centers for Disease Control and Prevention made headlines last week when it announced that Covid-19 had reduced the average life expectancy of Americans in 2020 by a full year. The news seemed to starkly illustrate the devastation wrought by our nation’s worst public health crisis in 100 years.

But there was a problem. The pandemic’s appalling toll could not have reduced life span by nearly that much. My own estimate is that when Covid-19’s ravages in 2020 are averaged across the country’s entire population, we each lost about five days of life.

The CDC’s mistake? It calculated life expectancy using an assumption that is assuredly wrong, which yielded a statistic that was certain to be misunderstood. * * * The CDC’s report boils down to a finding that bears no relation to any realistic scenario. Running the 2020 gauntlet for an entire life results in living one year less on average than running that same gauntlet in 2019.

In other healthcare news, Fierce Healthcare informs us that

Cigna will acquire telehealth platform MDLive, the insurer announced Friday morning.

Cigna has been a longtime partner of and investor in MDLive and will fold it into its Evernorth subsidiary, which houses its health services business. The deal is expected to close in the second quarter of 2021, pending regulatory approvals.

Cigna said that it expects to deliver $20 in earnings per share this year, including impacts of the acquisition, and will present additional details about the deal at its investor day on March 8.

Finally, the FEHBlog has been continuing to review the draft Postal Service bill creating a Postal Service Health Benefits Program. He has updated Wednesday’s post on the topic and he wishes to point out an important clarification on how the bill would treat Postal Service annuitants. Per the Committee staff memorandum:

The bill would require future retirees to enroll in Medicare in order to participate in the Postal Employee Benefits Program (similar to the Federal Employee Health Benefit Program but established as a separate risk pool). However, the bill includes several exceptions:

  • Residents of foreign countries and others without access to Medicare providers would not automatically be enrolled in Medicare; and
  • Retirees who do not have the requisite 40 quarters of creditable service would not be automatically enrolled in Medicare. This would include many Civil Service Retirement System (CSRS) retirees.
  • In addition, current retirees would be granted a three-month grace period from the Medicare penalty for late enrollment but would not be required to enroll.

This helps explain why NARFE is willing to support the bill.

Thursday Miscellany

David Ermer–Congress, Rx coverage, Telehealth–
Photo by Juliane Liebermann on Unsplash

The American Hospital Association informs us that “President Biden yesterday [February 24] continued the national emergency for the COVID-19 pandemic [indefinitely] beyond March 1. The renewed national emergency, along with the recently renewed public health emergency, allow the Department of Health and Human Services to continue Section 1135 waivers and other flexibilities to ensure sufficient health care services and items to respond to the pandemic.” In the FEHBlog’s opinion, this action also applies to the Labor Department’s May 4, 2020, extension of various deadlines applicable to ERISA-governed health plans and their members.

From Capitol Hill Reuters reports on the evenly divided Senate’s measured reaction to the House of Representatives COVID-19 relief budget reconciliation bill which is expected to pass the House on party lines tomorrow. Politico reports this evening that

The Senate parliamentarian ruled Thursday that Democrats would be deemed out of order if they include a $15 minimum wage hike in their coronavirus relief package, a major blow to Senate Budget Committee Chair Bernie Sanders (I-Vt.) and progressives. The parliamentarian’s ruling means that any senator could raise a point order against the minimum wage increase, which would force the provision to be axed from the bill. House Democrats still plan to pass the minimum wage hike on their version of the Covid bill on Friday, but the Senate decision means the party needs to find an alternative route to increasing the minimum wage, a key campaign promise.

Healthcare Dive reports that Xavier Becerra favorably weathered his two Senate confirmation hearings this week.

“If I was a betting man, I’d bet that you’ve got the votes to be approved,” Sen. Bill Cassidy, R-La., said Wednesday at the Senate Finance Committee hearing. In both hearings he distanced himself from previous endorsements of “Medicare for All,” in several rounds of questioning from Republicans seeking to tie him to the policy idea. The former House lawmaker noted that President Joe Biden has no intention of pursuing such a policy and said he stands ready to build on the Affordable Care Act, including with a public option. * * * At the finance panel, Becerra also voiced support for continuing to expand reimbursement of telehealth services beyond the COVID-19 pandemic. “I don’t think we’re going back to the old days when it comes to telehealth,” he said.

In that regard, according to Fierce Healthcare, Teladoc reported its fourth quarter 2020 earnings today:

Teladoc’s 2020 revenue reached $1.1 billion as virtual care visits continued to soar. The telehealth giant reported it delivered 10.6 million virtual visits last year, up 156% from 2019. The company’s U.S. paid membership hit 51.8 million, up about 41% from 36.7 million users in 2019. Teladoc, one of the nation’s top telehealth providers, reported 3 million total virtual visits during the fourth quarter, up 139% from 1.2 million visits in the fourth quarter of 2019.

The FEHBlog firmly believes that our country’ patent laws lie at the root of soaring prices for specialty drugs. He therefore was pleased to read today this STAT News article reporting that

 [A] U.S. appeals court [for the Federal Circuit] recently restricted wide-ranging patent claims for antibody treatments, a ruling legal experts say may force [specialty drug]/biologics makers to re-examine patent protections for their products.

In this instance, Amgen (AMGN) and Sanofi (SNY) were battling over the market for injectable cholesterol-lowering medicines called PCSK9 inhibitors. For the past several years, the companies have been locked in patent disputes, but earlier this month the appeals court decided that two Amgen patents for its Repatha cholesterol medication were invalid.

In the process, the ruling is raising questions about the sort of patent claims that companies can make about monoclonal antibodies, which is the type of medicine that was at issue in this case. The upshot is that, because of the way Amgen went about asserting claims in its patents, companies will have to be more careful about crafting their patents and can also expect more legal challenges.

“I think this is a huge deal,” said Jacob Sherkow, a law professor at the University of Illinois at Urbana-Champaign who specializes in patents and life sciences. “A huge swath of antibody patents out there is just like Amgen’s patents. So if those are not valid under this new standard [issued by the appeals court], then one can think the other patents are also likely not to be valid.”

Midweek Update

David Ermer–Congress, COVID-19, U.S. Healthcare–
Photo by Manasvita S on Unsplash

The Federal Times, Govexec, and Federal News Network each report on today’s Postal reform legislation hearing before the House Oversight and Reform Committee. The draft proposed legislation, among other things, would create a Postal Service Health Benefits Program (“PSHBP”) within the FEHBP effective January 1, 2023. FEHB plans covering at least 1500 Postal employees and annuitants in 2022 would be eligible to offer coverage in the PSHBP.

Postal employees first becoming eligible for the FEHB in 2023 or later years must enroll in a PSHBP participating plan. If a Postal employee or annuitant is enrolled in 2022 in a FEHB plan that does not join the PSHBP in 2023, that Postal employee or annuitant may continue to participate in the plan outside the PSHBP. However, a Postal employee or annuitant must follow his or her plan into the PSHBP if that plan joins the PSHBP. (Presumably that employee or annuitant could choose another PSHBP participating plan in that event.)

If a Postal employee or annuitant enrolled in a plan outside the PSHBP decides to changes plans he or she can only choose a PSHBP plan. Also once the PSHBP is up and running, a Postal Service employee enrolled in a plan outside the PSHBP would be required to transfer to the PSHBP upon retirement. Federal News Network indicated that NARFE finds this approach allows acceptable freedom of choice to current annuitants.

Future PSHBP annuitants, e.g., Postal employees who retire on or after January 1, 2023) would be required to pick up Medicare Part B with a limited exception for economic hardship. The PSHBP plan would offer a Medicare Part D EGWP prescription drug coverage to their annuitant members, a big benefit savings. The bill also would relieve the Postal Service of the ability to prefund their employees’ coverage in the FEHBP as annuitants.

Per Govexec

Oversight Committee Chairwoman Carolyn Maloney, D-N.Y., made clear her primary focus was on shepherding her reform legislation through Congress and to Biden’s desk. 

“We will not be delayed or deterred from our north star,” Maloney said. “We need to pass meaningful reforms, and hopefully bipartisan reforms, to put the Postal Service on more sustainable and financially firm footing for years to come.”

Speaking of federal retirement (the Postal Service operates under the federal retirement program too), Fedweek offers a helpful Reg Jones column on “the main retirement-related question regarding the Federal Employees Health Benefits (FEHB) program—carrying coverage into retirement.”

On the COVID-19 front

  • Bloomberg reports that “The shot made by Pfizer Inc. and BioNTech SE was overwhelmingly effective against the virus in a[n Israeli] study, prompting experts to say that immunizations can end the pandemic. Johnson & Johnson’s Covid-19 vaccine is safe and effective, U.S. regulators said, a milestone toward giving Americans the first shot to work in a single dose.” The FDA advisory committee with consider the Johnson & Johnson emergency use application for its COVID-19 vaccine on Friday February 26.
  • Fierce Healthcare informs us that “There’s no question outpatient visits plummeted in the earliest days of the pandemic as providers scrambled to move care to virtual settings. But as the year—and the roller coaster of COVID-19 cases nationwide it brought—went on, it turned out outpatient visits overall were down but still relatively stable, a Harvard University analysis published by The Commonwealth Fund found.”

From Capitol Hill, the Wall Street Journal reports that Office of Management and Budget Director nominee Neera “Tanden’s nomination appears to be in peril, after two Senate committees delayed confirmation votes that had been scheduled for Wednesday morning.” Also the House Rules Committee has scheduled a hearing on Friday morning to consider the $1.9 trillion COVID-19 relief bill which is the last step before the bill reaches the House floor.

President nominates an OPM Director

David Ermer–Congress, COVID-19 vaccine, OPM, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

The Federal Times, Govexec, and Federal News Network all report on today’s announcement that the President is nominating Kiran Ahuja to be OPM Director. Ms. Ahuja led the President’s transition review team lead for the agency. “Ahuja has over 20 years of public service and philanthropy experience. She’s currently the CEO of Philanthropy Northwest, and she spent several years as a career civil rights attorney at the Justice Department.” Her nomination is subject to Senate confirmation. In due course, the President also is expected to nominate an OPM Deputy Director and an OPM Inspector General.

Healthcare Dive reports on the first confirmation hearing for the President’s nominee for Secretary of Health and Human Services, Xavier Becerra. Mr. Becerra “told senators on the health committee Tuesday morning he would continue work he did as California attorney general to combat anticompetitive practices in healthcare and go after providers that ‘unfairly jack up prices on patients.'” According to the report, Mr. “Becerra will be back in the hot seat Wednesday for his second confirmation hearing, this one in front of the Senate Finance Committee. That will be the committee voting on whether to send his nomination to the full Senate for a vote.”

Tomorrow, the Senate Homeland Security and Governmental Affairs Committee at 10 am and the Senate Budget Committee at noon each will hold a business meeting on whether to advance to the Senate floor the President’s nomination of Neera Tanden to be Director of the Office of Management and Budget.

Tomorrow at 10 AM, the House Oversight and Reform Committee will hold a hearing on “Legislative Proposals to Put the Postal Service on Sustainable Financial Footing.” The Committee Staff explains in a memorandum,

the Committee will hold a hybrid hearing to review legislative proposals to place the Postal Service on a more sustainable financial footing. The Committee will consider a discussion draft that includes several provisions to relieve the financial burdens under which the Postal Service is currently operating and to enhance transparency regarding performance. That draft is being circulated with this memo. The discussion draft includes provisions on Medicare integration [for Postal annuitants participating along with Postal employees in a separate program within the FEHB] , repealing a requirement for the Postal Service to pre-fund retiree health care, and service performance standards.”

Earlier today, the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee held a hearing on the availability of COVID-19 vaccinations. The hearing featured testimony from executives at the companies manufacturing those vaccines. Fierce Healthcare reports that “Pfizer, Moderna and Johnson & Johnson execs say [at the hearing] they’re working all the angles on increasing COVID-19 vaccine production and expect to amp up weekly deliveries by tens of millions by the end of March.”  

In that regard, a friend of the FEHBlog pointed him to this NIH Director’s blog entry released today

For the millions of Americans now eligible to receive the Pfizer or Moderna COVID-19 vaccines, it’s recommended that everyone get two shots. The first dose of these mRNA vaccines trains the immune system to recognize and attack the spike protein on the surface of SARS-CoV-2, the virus that causes COVID-19. The second dose, administered a few weeks later, boosts antibody levels to afford even better protection. People who’ve recovered from COVID-19 also should definitely get vaccinated to maximize protection against possible re-infection. But, because they already have some natural immunity, would just one shot do the trick? Or do they still need two?

A small, NIH-supported study, published as a pre-print on medRxiv, offers some early data on this important question [1]. The findings show that immune response to the first vaccine dose in a person who’s already had COVID-19 is equal to, or in some cases better, than the response to the second dose in a person who hasn’t had COVID-19. While much more research is needed—and I am definitely not suggesting a change in the current recommendations right now—the results raise the possibility that one dose might be enough for someone who’s been infected with SARS-CoV-2 and already generated antibodies against the virus.

Encouraging news.

Monday Roundup

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

The Wall Street Journal reports from Capitol Hill that

The House Budget Committee approved the $1.9 trillion coronavirus relief package Monday, setting up a vote in the full House later this week.

The Budget Committee on Monday officially fused together different portions of the legislation that had advanced earlier this month in nine different House committees. A full House vote is expected Friday or Saturday.

The bill moving through the House would provide $400-a-week unemployment benefits through Aug. 29, send $1,400 per-person payments to most households, provide billions in funding for schools and vaccine distribution, expand the child tax credit, broaden child-care assistance and bolster tax credits for health insurance. It would also increase the federal minimum wage to $15 an hour over four years, a point of division among Democrats.

From the COVID-19 front:

  • The Hill reports that “Johnson & Johnson said Monday [February 22] that it plans to have enough doses of its vaccine for more than 20 million Americans by the end of March if its vaccine is authorized by the Food and Drug Administration.”
  • The Wall Street Journal informs us that

The Food and Drug Administration said Monday it will quickly analyze any vaccine booster shots against Covid-19 variants such as those from South Africa and the U.K., and won’t require further large clinical trials of the new shots’ effectiveness.

The agency issued new guidance for vaccine manufacturers as it looks to establish speedier procedures to deal with virus mutations that could worsen the pandemic. Acting FDA Commissioner Janet Woodcock said in a statement the agency is seeking ‘efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants.’”

  • Federal News Network points out that federal agencies have been issuing new COVID-19 safety plans for employees and visitors. Here is a link to OPM’s plan.

Healthcare Dive informs us that “The Biden administration [officially] nominated Chiquita Brooks-LaSure as CMS administrator Friday [February 19]. A press release touted her more than 20 years of experience in health policy and previous work guiding the ACA through passage and implementation.” This position requires Senate confirmation. The White House sent her nomination to the Senate today.

Health Payer Intelligence discusses a Health Action Council and UnitedHealth Group report about the following five conditions other than COVID-19 that fuel costs for employer sponsored health plans: (1) asthsma, (2) diabetes, (3) hypertension, (4) back disorders, and (5) mental health / substance use. Check it out.

Earlier this month, the Health Care Cost Institute announced

the launch of its new health care claims dataset for research. The new dataset is more than 25% larger than the original HCCI dataset, containing more than 1 billion claims per year for more than 55 million people who receive health care coverage from their employers. Researchers will initially have access to data from 2012 to 2018, with 2019 and 2020 information being added as soon as possible. The data is sourced from Aetna/CVS, Humana, Kaiser Permanente and more than 30 non-profit health plans included in the Blue Health Intelligence® national dataset , enabling researchers to conduct analysis at the national, state, and sub-state level. HCCI’s patient-, provider-, and payer-deidentified dataset contains comprehensive diagnostic, procedure, site of care and cost information, including payments made by insurers as well as what patients pay out of pocket. 

“This rich new claims data enables the critical research and reporting that will be needed in the coming years, to understand the impact of the COVID-19 pandemic and other challenges facing the health care system as the US approaches spending 20% of GDP on health care,” said Niall Brennan, President and CEO of HCCI. “HCCI is a critical national resource for researchers, policymakers, employers, journalists, and the public to understand trends in health care access, spending and utilization.”

Good luck.

Weekend update

David Ermer–Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, Medicare–

Photo by JOSHUA COLEMAN on Unsplash

Both the House of Representatives and the Senate are attending to committee and floor business this coming week. The House is expected to vote on the $1.9 trillion COVID-19 relief budget reconciliation bill this week. The Hill provides access to the text of the “mammoth” legislation here.

From the COVID-19 front —

  • On Friday February 26, “[t]he [Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory] committee will meet in open session to discuss [emergency use authorization] EUA of the [single dose] Janssen Biotech Inc. [a/k/a Johnson & Johnson] COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years and older.” This committee’s meetings on the Pfizer and Moderna vaccines were held on Thursdays, and the FDA EUA approval was issued within 48 hours after those meetings. The only turmoil was in the Pfizer hearing because Pfizer sought and received EUA for people beginning at age 16. That was a helpful move in terms of getting colleges back open in the fall.
  • Medicity News reports that the FDA late last week approved consumer purchase of the Everywell COVID-19 test without a prescription. “Users swab their nose and send in the sample, which is then processed at one of Everlywell’s partner labs. It takes one to two days to get results from the rt-PCR test. If users have a positive or an undetermined result, they’re contacted by a clinician. On Everlywell’s website, tests are priced at $109 — generally more costly than most antigen test alternatives. The company also plans to partner with retailers to sell it over the counter.”
  • NPR Shots now offers a website for COVID-19 vaccine hunters.
  • The Kaiser Family Foundation offers a COVID-19 vaccine site that covers a number of significant topics, including vaccine hesitancy, distribution, and messaging.

In other healthcare news, Kaiser Health News reports that

The federal government has penalized 774 hospitals for having the highest rates of patient infections or other potentially avoidable medical complications. Those hospitals, which include some of the nation’s marquee medical centers, will lose 1% of their Medicare payments over 12 months.

The penalties, based on patients who stayed in the hospitals anytime between mid-2017 and 2019, before the pandemic, are not related to covid-19. They were levied under a program created by the Affordable Care Act that uses the threat of losing Medicare money to motivate hospitals to protect patients from harm. * * *

“The all-or-none penalty is unlike any other in Medicare’s programs,” said Dr. Karl Bilimoria, vice president for quality at Northwestern Medicine, whose flagship Northwestern Memorial Hospital in Chicago was penalized this year. He said Northwestern takes the penalty seriously because of the amount of money at stake, “but, at the same time, we know that we will have some trouble with some of the measures because we do a really good job identifying” complications.

Other renowned hospitals penalized this year include Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center in Los Angeles; UCSF Medical Center in San Francisco; Beth Israel Deaconess Medical Center and Tufts Medical Center in Boston; NewYork-Presbyterian Hospital in New York; UPMC Presbyterian Shadyside in Pittsburgh; and Vanderbilt University Medical Center in Nashville, Tennessee.

There were 2,430 hospitals not penalized because their patient complication rates were not among the top quarter. An additional 2,057 hospitals were automatically excluded from the program, either because they solely served children, veterans or psychiatric patients, or because they have special status as a “critical access hospital” for lack of nearby alternatives for people needing inpatient care.

Weekend update

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Uncategorized–
Photo by JOSHUA COLEMAN on Unsplash

Happy Valentines Day.

In the coming week, the Senate is on a State work period and the House of Representatives remains engaged in committee work. Fierce Healthcare reports that last Thursday

The House Ways and Means Committee voted 24-18 along party lines Thursday to approve a section of a $1.9 trillion COVID-19 relief package that includes the [two year long Affordable Care Act] subsidy boost. * * * [Also [t]he House Energy and Commerce Committee released legislation aimed at expanding Medicaid coverage and eligibility. * * * The legislation now moves to the House Budget Committee, which will roll it into the final package and send to the House floor [later this month].

On the COVID-19 vaccination front —

Students as young as first grade [age 6] might be able to get vaccinated against COVID-19 by September, White House chief medical adviser Dr. Anthony Fauci predicted in an interview published by ProPublica on Thursday.

Fauci cited clinical trials now underway in the U.S. from vaccine developers Pfizer and Moderna to test the safety and efficacy of the doses in children. He had said previously that the Food and Drug Administration might allow for vaccinations in American children “by the time we get to the late spring and early summer.” 

  • The Wall Street Journal reports that

Walmart Inc., the U.S.’s largest retailer and private employer, is set to become one of the biggest distributors of the Covid-19 vaccine as the federal government enlists retail pharmacies to accelerate what has been a choppy rollout.

Last week, 21 retail chains and pharmacy networks started administering those doses, including CVS, Walgreens, Kroger and grocers in all 50 states. The government initially plans to give around a million doses a week directly to pharmacies. Around 200,000 of those are going to Walmart, a spokeswoman said.

That is in part because out of the roughly 5,000 U.S. stores under the company’s Walmart and Sam’s Club banners, about 4,000 are located in what the federal government defines as medically underserved areas.

  • The Washington Post informs us about volunteer COVID-19 vaccine hunter who are helping the elderly get their protection. Bravo.
  • According to the CDC’s COVID-19 vaccine tracker, over six million doses COVID-19 vaccines were administered from February 11 through February 13. 38,292,270 Americans have receive their first dose and another 14,077,440 have received both doses of either the Pfizer or the Moderna vaccine. We are likely only two weeks away from the single dose Johnson & Johnson vaccine joining this portfolio.

Midweek update

David Ermer–Congress, COVID-19, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Capitol Hill —

  • Katie Keith helpfully provides more detail on the healthcare provisions found in the draft House of Representative’s COVID-19 relief budget reconciliation bill.
  • Govexec.com reports on the federal employee related provisions of the same draft bill.
  • FedSmith informs that “Some Members of Congress are asking the Office of Personnel Management to give federal employees administrative leave for any time they spend getting vaccinated for COVID-19. The letter was sent to OPM by Reps. Don Beyer (D-VA), Eleanor Holmes Norton (D-DC), Gerald E. Connolly (D-VA), Anthony Brown (D-MD), Jamie Raskin (D-MD), David Trone (D-MD), and Jennifer Wexton (D-VA). They state in the letter that mandating that federal agencies provide administrative leave to federal employees is necessary to fight the pandemic. “…it is imperative that the federal government take every possible step to encourage federal employees to receive the vaccine, including providing them with the administrative time to do so,” reads the letter.”
  • Politico reports on Office of Management and Budget Director nominee’s confirmation hearing this morning before the Senate Budget Committee.
  • The Brookings Institute released a report with recommendations on making Capitol Hill a better place to the work. This recommendation caught the FEHBlog’s eye:

Since 2014, members and certain congressional staff have been required to use Washington, D.C.’s small-business marketplace established by the Affordable Care Act to obtain insurance, rather than having their health benefits provided via the Federal Employees Health Benefits Program that insures other federal employees. As the HSCMC’s final report noted, “The transition to the D.C. exchange has been particularly challenging for some district-based staff as finding local health providers who accept patients covered by the D.C. exchange is difficult.” The HSCMC recommended that Congress eliminate this setup, allowing both D.C.- and district-based staff to either enroll in standard federal health plans or to use their relevant local marketplace to purchase coverage.

OPM could implement the “local marketplace” fix via regulation. An interim regulation would be nice as the federal ACA marketplace is about to reopen for three months.

While on the topic of the Affordable Care Act, the Biden Administration’s Justice Department filed a very sensible letter today with the U.S. Supreme Court regarding the California v. Texas case concerning the ACA’s constitutionality. It states that it is now the Justice Department’s position that zeroing out the individual mandate did not render the ACA unconstitutional. “[T]he 2017 amendment preserved the choice between lawful options and simply eliminated any financial or negative legal consequence from choosing not to enroll in health coverage.” How true.

From the COVID-19 front —

  • MedCity News reports that “An Eli Lilly therapy comprised of two antibodies given together has been awarded FDA emergency authorization for treating Covid-19, providing yet another option for patients diagnosed with the disease. The decision comes two weeks after Indianapolis-based Lilly reported clinical trial data showing that given together, the antibodies bamlanivimab and etesevimab reduced Covid-19 patients’ risk of hospitalization and death by 70 percent. The FDA authorization, issued late Tuesday, covers adults and children 12 and older with mild-to-moderate Covid-19 whose cases are at high risk of progressing to severe disease. The authorization also includes patients 65 and older who have certain chronic medical conditions.

New data from the Blue Cross and Blue Shield Association (BCBSA) take a look at just how much COVID-19 cases are costing insurers.

BCBSA studied more than 90,000 confirmed cases of the novel coronavirus pulled from a diverse selection of its membership. The group found COVID-19 cases treated in an outpatient setting cost between $500 and $1,000 per member on average, with the average age of patients seeking such care being 34.

When members were hospitalized with the virus, however, costs were 45 times higher than for cases treated on an outpatient basis. For members who needed a stay in the intensive care unit, costs jumped another 2.5 times compared to other hospitalizations, BCBSA found. The average age for members hospitalized with COVID-19, including in the ICU, was 54, according to the analysis.

  • The Wall Street Journal tonight adds more detail to yesterday’s report on the World Health Organization of the spread of COVID-19 in China.

About 90 people were hospitalized with Covid-19-like symptoms in central China in the two months before the disease was first identified in Wuhan in late 2019, according to World Health Organization investigators, who said they pressed Beijing to allow further testing to determine whether the new virus was spreading earlier than previously known. * * * If the 90 cases included Covid-19 infections, it could help explain suspected coronavirus cases that researchers believe occurred in Europe and possibly the U.S. in November and December 2019. * * * The U.S. said Tuesday it saw no potential origin other than in China and wanted to examine the underlying data from the WHO’s four-week mission.

Finally, Health Payer Intelligence provides its perspective on fourth quarter financial reports from health insurers. “Payers anticipate that increased membership, lower utilization, potentially a higher federal medical assistance percentage, and other factors could offset healthcare spending as it returns to normal levels.”