Monday Roundup

Monday Roundup

Photo by Sven Read on Unsplash
  • On the COVID-19 front, David Leonhardt in the New York Times provides valuable insights on how to think about COVID-19 cases that have broken through vaccinations. “

Different vaccinated people are going to make different decisions, and that’s OK. I find the risk of breakthrough infections to be small enough that I’m not going to make major changes to my behavior.

I would feel differently if I lived in a community with a lower vaccination rate — or if I lived with somebody who was vulnerable to Covid because of an immunodeficiency. And the current surge in cases has changed my thinking. I will again wear a mask sometimes when in close contact with strangers, even if it has little tangible effect. The main reason to do so, as Dowdy said, is to contribute to a shared sense that we have entered a worrisome new phase of the pandemic.

  • Fierce Healthcare reports that “Dozens of healthcare professional organizations including the American Hospital Association, America’s Essential Hospitals and the Association of American Medical Colleges have released joint or individual statements calling for providers to implement mandatory COVID-19 vaccination policies for healthcare personnel.” The Wall Street Journal adds that “A significant uptick in Covid-19 cases across the U.S. is leading to new vaccination mandates for public employees, with the Department of Veterans Affairs on Monday becoming the first federal agency, California the first state, and New York the first major city to announce requirements for their workers. “epartment of Veterans Affairs Secretary Denis McDonough said healthcare personnel who work in or visit Veterans Health Administration facilities or provide direct care to people the VA serves would have eight weeks to get vaccinated. Officials in the state of California and New York City said Monday they would require their workers to either be vaccinated against Covid-19 or be tested at least weekly for the virus. California’s order, which also applies to those who work in healthcare settings, goes into effect in August. The New York City mandate begins after Labor Day.”
  • The Wall Street Journal also reports “The U.S. has purchased 200 million additional Covid-19 vaccine doses from Pfizer Inc. and partner BioNTech SE at a higher price than previous deals. The U.S. is paying about $24 a dose, according to Pfizer, up from the $19.50 that the government paid in its earlier deals to supply the country. The deal brings the total purchased from the U.S. to 1 billion doses. The companies said they expect to deliver 110 million of the additional doses by the end of the year, with the rest by the end of next April.  While demand has largely stalled in recent weeks, additional demand could open up if the vaccine is cleared for use in younger children. Pfizer is testing the vaccine in children under 12 years old, and has said it hopes to begin having data available before the end of the year.  The new agreement is in addition to the one announced last month for 500 million doses that the U.S. is scheduled to donate to the rest of the world.”
  • In this regard, the Washington Post reports that “Federal regulators have requested that vaccine companies expand their trials to test coronavirus shots in several thousand school-aged children before seeking [emergency use authorization] — a move intended to assess whether a rare inflammation of the heart muscle that has been seen in young adults shortly after vaccination is more common in younger age groups.”
  • STAT News provides its perspective on the current surge. STAT suggests that this surge is accelerating faster than last summer’s surge which is not surprising because the Delta variant is much more contagious that the variant in circulation last summer.
  • The Department of Health and Human Services (“HHS”) has announced that it ‘will invest more than $1.6 billion from the American Rescue Plan to support testing and mitigation measures in high-risk congregate settings to prevent the spread of COVID-19 and detect and stem potential outbreaks.’
  • Today, in commemoration of “the 31st anniversary of the Americans with Disabilities Act (ADA), (HHS) and the U.S. Department of Justice (DOJ) jointly published guidance on how “long COVID” can be a disability under the ADA, Section 504 of the Rehabilitation Act, and Section 1557 of the Affordable Care Act.  The guidance is on the HHS website and on the DOJ website.

Also today, HHS announced phase 2 of the HPV vaccination campaign for young adults.

Currently, only 40% of young adults in the United States have received one or more doses of the human papillomavirus (HPV) vaccine, and only 22% have completed the vaccine series.i The HHS Office of the Assistant Secretary for Health’s Office on Women’s Health is launching the second phase of the HPV VAX NOW campaign to address this gap. The initial campaign launched on January 6, 2021 to support healthcare providers who counsel young adults in Mississippi, South Carolina, and Texas by providing resources to promote effective HPV vaccine recommendations. The second phase of the campaign will target young adults ages 18–26 in the same three states, with the long-term goal of empowering all to complete the HPV vaccine series.

In health equity developments

  • The American Academy of Actuaries has released a paper on health equity from an actuarial perspective that is worth a gander.
  • Patient Engagement HIT discusses how “a new study [in the New England Journal of Medicine] revealing unequal opioid and pain medication prescription access between White and Black patients is calling into question the prevalence of implicit bias in medicine.” The researchers concluded that “We do not know whether or how these differences affect patient outcomes, because both opioid underuse and overuse can cause harm. We do know that skin color should not influence the receipt of pain treatment. “Our overall observations and system-specific reporting should prompt action by providers, health system administrators, and policymakers to explore root causes, consequences, and effective remediation strategies for racially unequal opioid receipt.”
  • In that regard, Kaiser Health News discusses the pros and cons of state and local government monitoring of opioid prescriptions.

When efforts to establish Missouri’s statewide monitoring program stalled, St. Louis County established one in 2017 that 75 local jurisdictions agreed to participate in, covering 85% of the state, according to the county health department. The county now plans to move its program into the state one, which is scheduled to launch in 2023.

Dr. Faisal Khan, director of the county department, said he has no doubt that the St. Louis program has “saved lives across the state.” Opioid prescriptions decreased dramatically once the county established the monitoring program. In 2016, Missouri averaged 80.4 opioid prescriptions per 100 people; in 2019, it was down to 58.3 prescriptions, according to the CDC.

Khan acknowledged that a monitoring program can lead to an increase in overdose deaths in the years immediately following its establishment because people addicted to prescription opioids suddenly can’t obtain them and instead buy street drugs that are more potent and contain impurities.

But he said a monitoring program can also help a physician intervene before someone becomes addicted. Doctors who flag a patient using the monitoring program must then also be able to easily refer them to treatment, Khan and others said.

“We absolutely are not prepared for that in Missouri,” said Winograd, of NoMODeaths. “Substance use treatment providers will frequently tell you that they are at max capacity.”

The FEHBlog would rather see expansion of treatment facilities that loosening standards on opioid prescribing.

Friday Stats and More

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 29th week of this year (beginning April 2, 2020, and ending July 21, 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:

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases materially exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through July 21, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through July 21, 2021, which also uses Thursday as the first day of the week:

Fortune has an excellent, chart-filled article about where we stand with COVID-19. According to the CDC, as of today, nearly half of the total U.S. population (48.9%) is fully vaccinated.

The New York Times reports that “As Israel struggles with a new surge of coronavirus cases, its health ministry reported on Thursday that although effectiveness of the Pfizer-BioNTech vaccine remains high against severe illness, its protection against infection by the coronavirus may have diminished significantly compared with this winter and early spring.” Of course, Pfizer and Moderna have developed a third booster shot, and the Times adds that “Senior [Biden Administration] officials now say they expect that people who are 65 and older or who have compromised immune systems will most likely need a third shot from Pfizer-BioNTech or Moderna, two vaccines based on the same technology that have been used to inoculate the vast majority of Americans thus far. That is a sharp shift from just a few weeks ago, when the administration said it thought there was not enough evidence to back boosters yet.”

STAT News asks and answers burning questions about the COVID-19 pandemic and here is the conclusion

Does Delta mean we’re not going to eradicate Covid-19?

Covid-19 isn’t going to be eradicated, but that was the reality before Delta came around.STAT+: 

Remember, the long game with the virus is that our bodies become so used to recognizing it and warding it off that, over time, it becomes little more than a nuisance. With each exposure to the virus, either through an infection or an exposure-mimicking vaccine, our bodies get retrained to fight it. Eventually, SARS-CoV-2 is likely to join the ranks of respiratory viruses that cause occasional colds, with rare exceptions of serious illness.

A reasonable goal indeed.

Becker’s Hospital Review interviews AHIP’s President Matt Eyles. Here’s a snippet:

Q: What do you think are the top three biggest challenges facing payers at this time?

ME: I’d say continuing to navigate the COVID and post-COVID environment, what the impact is going to be with respect to patients who have deferred care as a result of the pandemic — what will the new normal look like?

I think another area is how do we make sure that we have lasting impacts from the shift to telehealth, and that we continue to move forward with respect to making sure that that becomes a really important part of the permanent landscape post-COVID, but that also is designed in a way so that it doesn’t just become another cost increase because more people are just accessing it through different channels and we’re not actually acting more efficiently.

So I’d say those are probably two of the bigger challenges. And then I think third is how we continue to evolve the system toward a more value-based system and an interoperable one that ensures patients have access to the consumer tools and prices they need to make informed healthcare decisions. It’s an incredibly complex effort. It’s one that we absolutely need to move forward with in the right way. But I think some of the timetables that we’re looking for with respect to implementation are very challenging right now in terms of getting to a truly interoperable healthcare system that shares information seamlessly between providers, payers and consumers.

Finally, Deloitte Consulting opines that health and wellness have become CEO priorities in an detail insight publication.

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

Fierce Healthcare tells us that “Johnson & Johnson’s COVID-19 vaccine presents greater benefits than it does safety risks, especially amid the quickly spreading Delta variant, a key CDC expert panel [,the Advisory Committee on Immunization Practices] decided [today]. However, the panel said that a ruling over the need for a booster added to all COVID shots will have to start with the FDA.”

Fedweek reports that “Federal employees, their unions and members of Congress continue to watch for details of federal agency ‘reentry’ and ‘post-reentry’ operational plans, with the deadline having passed on Monday (July 19) for agencies to submit those plans to OMB but with changes to telework and other workplace policies likely still weeks or months away.”

According to a press release,

Senators Patrick Leahy (D-Vt.) and Steve Daines (R-Mont.) on Tuesday [July 20] requested updates from both the Federal Trade Commission (FTC) and the Department of Justice (DOJ) on their recent efforts to combat anticompetitive conduct in the health insurance industry.  The two senators recently served as chief cosponsors of the bipartisan Competitive Health Insurance Reform Act (CHIRA), which protects consumers by repealing a long-outdated antitrust exemption for the health insurance industry.  Decades of consolidation by health insurance brokers has primed the industry for abuse, allowing insurers to exert market power in order to raise premiums, restrict competition, and deny consumers choice. 

Since the CHIRA’s passage in January of this year, neither the FTC nor the DOJ has announced major steps to exercise their expanded antitrust enforcement authority under the new law.  In their letter, the senators called on the agencies to provide information on any enforcement actions, guidelines, rulemaking, or other actions taken to extend antitrust enforcement to the health insurance industry since then.

Following up on Mondays’ ACA FAQ 47, HHS today announced “the launch of The HIV Challenge, a national competition to engage communities to reduce HIV-related stigma and increase prevention and treatment among racial and ethnic minority people. Through this challenge, HHS is seeking innovative and effective approaches to increase the use of pre-exposure prophylaxis medication (PrEP) and antiretroviral therapy (ART) among people who are at increased risk for HIV or are people with HIV. The HIV Challenge is open to the public, and HHS will award a total of $760,000 to 15 winners over three phases. Phase 1 submissions are open from July 26, 2021, through September 23, 2021.”

Kaiser Health News explains how the Centers for Medicare and Medicaid Services is reevaluating its wellness program for pre-diabetic Medicare beneficiaries.

Over the past decade, tens of thousands of American adults of all ages have taken these diabetes prevention classes with personalized coaching at YMCAs, hospitals, community health centers and other sites. But out of an estimated 16 million Medicare beneficiaries whose excess weight and risky A1c level make them eligible, only 3,600 have participated since Medicare began covering the two-year Medicare Diabetes Prevention Program (MDPP) in 2018, according to the federal government’s Centers for Medicare & Medicaid Services (CMS).

Researchers and people who run diabetes prevention efforts said participation is low because of the way Medicare has set up the program. It pays program providers too little: a maximum of $704 per participant, and usually much less, for dozens of classes over two years. It also imposes cumbersome billing rules, doesn’t adequately publicize the programs and requires in-person classes with no online options, except during the pandemic emergency period. Most of the private Medicare Advantage plans haven’t promoted the program to their members.

Now, CMS has proposed to address some but not all of those problems in a rule change. It predicted the changes would reduce the incidence of diabetes in the Medicare population and potentially cut federal spending to treat diabetes-related conditions.

STAT News reports that

Leveraging Food and Drug Administration regulations loosened during the pandemic, Happify Health, which is best known for its consumer wellness app, will launch new prescription-only software to treat depression.

Happify, founded in 2012, recently announced it had raised $73 million to bolster its efforts in digital therapeutics, a space that is rapidly growing as well-funded companies make the case to regulators, insurers, and clinicians that software can be used to treat disease.

The new product, called Ensemble, is designed to treat both major depressive disorder and generalized anxiety disorder. The software, accessible on both computers and smartphones, guides patients through 10 weeks of cognitive behavioral therapy, or CBT, and other related techniques aimed at changing behavior patterns and teaching coping skills.

The FEHBlog likes the company’s name.

The American Medical Association wants the Food and Drug Administration to loosen up on its opioid prescribing rules which conflict with patient care. Perhaps the FEHBlog is oversimplifying this issue, but haven’t we been down this road to perdition before?

In closing, Fierce Healthcare notes that

Large tech giants are jumping into a growing interoperability solutions market as new federal regulations spur the healthcare industry to open up and share medical records data.

Google Cloud rolled out a new tool called the healthcare data engine, currently in private preview, that helps healthcare and life sciences organizations harmonize data from multiple sources, including medical records, claims, clinical trials and research data.

It gives organizations a holistic view of patient longitudinal records, and enables advanced analytics and AI in a secure and compliant cloud environment, according to Google Cloud executives.

Monday Roundup

Photo by Sven Read on Unsplash

David Leonhardt in the New York Times offered an encouraging article this morning:

When the Kaiser Family Foundation conducted a poll at the start of the year and asked American adults whether they planned to get vaccinated, 23 percent said no.

But a significant portion of that group — about one quarter of it — has since decided to receive a shot. The Kaiser pollsters recently followed up and asked these converts what led them to change their minds. The answers are important, because they offer insight into how the millions of still unvaccinated Americans might be persuaded to get shots, too.

What helps move people from vaccine skeptical to vaccinated? The Kaiser polls point to three main themes.

(The themes apply to both the 23 percent of people who said they would not get a shot, as well as to the 28 percent who described their attitude in January as “wait and see.” About half of the “wait and see” group has since gotten a shot.)

1. Seeing that millions of other Americans have been safely vaccinated. * * *

2. Hearing pro-vaccine messages from doctors, friends and relatives. * * * and

3. Learning that not being vaccinated will prevent people from doing some things.

That’s helpful information for the many vaccine advocates, among us.

Today was a busy day for regulatory action:

  • The Secretary of Health and Human Services renewed for another 90 day period the COVID-19 public health emergency. Earlier this month, the HHS Secretary issued a similar renewal for the Opioid public health emergency which of course predates the COVID-19 emergency. Here’s a link discussing the actions that the federal government can take in response to a public health emergency declaration.
  • The Affordable Care Act regulators issued implementation guidance FAQs part 47 today. As background, “on June 11, 2019, the U.S. Preventive Services Task Force released a recommendation with an “A” rating that clinicians offer [pre-exposure prophylaxis (PrEP)] with “effective antiretroviral therapy to persons who are at high risk of human immunodeficiency virus (HIV) acquisition.” Accordingly, [as required by the ACA, non-grandfathered] plans and issuers must cover PrEP consistent with the USPSTF recommendation without cost sharing [when provided in-network] for plan years (in the individual market, policy years) beginning on or after one year from the issue date of the recommendation (in this case, plan or policy years beginning on or after June 30, 2020).” The FAQs concern the scope of the requisite no cost sharing coverage for this particular service. Affected plans and issuers are allowed sixty days to implement the guidance.
  • The Centers for Medicare and Medicaid Services “proposed Medicare payment rates for hospital outpatient and Ambulatory Surgical Center (ASC) services. The Calendar Year (CY) 2022 Hospital Outpatient Prospective Payment System (OPPS) and ASC Payment System Proposed Rule is published annually and will have a 60-day comment period, which will end on September 17, 2021.” Here is a link to the fact sheet on the proposal. Consistent with the President’s recent executive order on competition, the CMS rule making “proposes to set a minimum CMP of $300/day that would apply to smaller hospitals with a bed count of 30 or fewer and apply a penalty of $10/bed/day for hospitals with a bed count greater than 30, not to exceed a maximum daily dollar amount of $5,500.  Under this proposed approach, for a full calendar year of noncompliance, the minimum total penalty amount would be $109,500 per hospital, and the maximum total penalty amount would be $2,007,500 per hospital.” That should be attention getting if finalized. Also the rule making proposes to backtrack on Trump Administration CMS rules that would phase out inpatient only Medicare requirements for certain medical procedures. The former administration’s goal was to lower costs, but the current administration finds that the former administration did not follow all of the necessary patient safety procedural requirements when making this change.
  • Govexec reports that today “marks the deadline for agencies to submit their finalized return to office plans to the Office of Management and Budget. These plans, which are not intended to be public, will vary by agency.”

The American Hospital Association informs us that “The Centers for Medicare & Medicaid Services will host a national stakeholders call July 22 at 3:30 p.m. ET on the interim final rule, Surprise Billing Part 1, that implements aspects of the No Surprises Act that bans balance billing in certain out-of-network scenarios. The call-in number is 888-455-1397; the participant passcode is 8758359.” Thanks AHA and CMS.

Weekend update

Photo by Dane Deaner on Unsplash

Both Houses of Congress are in session this week for Committee business and floor voting. Roll Call reports that the House of Representatives is expected to hold a floor vote on a minibus appropriations bill including OPM appropriations during the week of July 26.

On the COVID-19 front —

  • Fierce Healthcare reports that “This is becoming a pandemic of the unvaccinated,” said Rochelle Walensky, M.D., director of the Centers for Disease Control and Prevention, during a briefing Friday [July 16]. “We are seeing outbreaks of cases in parts of the country that have low vaccination coverage because unvaccinated people are at risk. Communities that are fully vaccinated are generally faring well.” On the brighter side, “States with the highest cases are starting to see their vaccination rates go up, [Jeff] Zients {the White House coronavirus response coordinator] said [at the same briefing]. ‘In the past week, the five states with the highest case rates had a higher rate of people getting newly vaccinated compared to the national average,’ he added.”
  • In Friday’s post the FEHBlog noted that the Food and Drug Administration has fast tracked the Pfizer – Biotech application for full FDA approval of its COVID-19 vaccine. Precision Vaccinations tells us that “The Prescription Drug User Fee Act goal date for a decision by the U.S. FDA is in January 2022.”
  • Looking ahead, the JAMA Network offers an interesting article on the search for a single vaccine against coronaviruses yet to come.

On the telehealth front, Becker’s Hospital Review discusses how Amazon, Walmart and seven others have been expanding their respective telehealth businesses in 2021.

On the fraud waste and abuse front, Kaiser Health News reports that

Tens of thousands of times a year, hospitals charge enormously expensive trauma alert fees for injuries so minor the patient is never admitted.

In Florida alone, where the number of trauma centers has exploded, hospitals charged such fees more than 13,000 times in 2019 even though the patient went home the same day, according to a KHN analysis of state data provided by Etienne Pracht, an economist at the University of South Florida. Those cases accounted for more than a quarter of all the state’s trauma team activations that year and were more than double the number of similar cases in 2014, according to an all-payer database of hospital claims kept by Florida’s Agency for Health Care Administration.

While false alarms are to be expected, such frequent charges for little if any treatment suggest some hospitals see the alerts as much as a money spigot as a clinical emergency tool, claims consultants say.

“Some hospitals are using it as a revenue generator,” Tami Rockholt, a registered nurse and medical claims consultant who appeared as an expert witness in the Sutter Health car-accident trial, said in an interview. “It’s being taken advantage of” and such cases are “way more numerous” than a few years ago, she said.

Finally, the American Medical Association offers common sense views on what doctors wish their patients knew about healthy eating.

Friday Stats and More

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 28th week of this year (beginning April 2, 2020, and ending July 14, 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:

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases materially exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through July 14, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through July 14, 2021 which also uses Thursday as the first day of the week:

As of today, according to the Centers for Disease Control, 160.7 million Americans are fully vaccinated against COVID-19, which figure represents 59.6% of the population eligible to be vaccinated (age 12 and up). 79.3% of the population over age 65 is fully vaccinated. That’s a key fact.

The American Hospital Association informs us that “Pfizer today said its COVID-19 vaccine will receive a priority review from the Food and Drug Administration, indicating that Pfizer has completed its rolling submission of its application for the vaccine’s full authorization. The company’s Biologics License Application, which is intended for individuals age 16 and older, is supported by clinical date from its phase 3 clinical trial.” That’s good news.

The Washington Post reports that “A federal advisory panel [the CDC’s Advisory Committee on Immunization Practices] is expected next week to consider whether health-care workers should be allowed to give additional coronavirus shots to patients with fragile immune systems, even as top U.S. health officials have said an additional dose of vaccine is not widely needed. * * * The advisory panel[on July 22] plans to focus on the 2 to 4 percent of U.S. adults who have suppressed immunity, a population that includes organ transplant recipients, people on cancer treatments and people living with rheumatologic conditions, HIV and leukemia.”

From the prescription drug front —

  • STAT News reports that “A prominent panel of medical experts [convened by the Institute of Clinical and Economic Review] unanimously voted that there is no evidence to suggest the recently approved Alzheimer’s drug offers patients any health benefits beyond the usual care. * * * After the voting, a roundtable discussion was held during which Mark McClellan, a former Centers for Medicare & Medicaid Administrator, said that access to Aduhelm “is going to be pretty limited at least until the nine-month period is over” and that we are “not going to see very big numbers in the near term.” This is likely because many payers will want to wait for Medicare to make its coverage decision in early 2022.”
  • Bloomberg reports that ” When a new obesity medication from the Danish drugmaker Novo Nordisk A/S began selling in the U.S. in June, it became the most effective weight loss drug on the market. Wegovyhelps patients lose an average of about 15% of their body weight, almost double the rates demonstrated by other prescription treatments, according to study results. That translates to a loss of about 20 to 70 pounds for eligible patients. Only costly and invasive bariatric surgery has shown the ability to eliminate more pounds. With more than 100 million people categorized as obese, the U.S. is a potentially huge market for Wegovy, which costs $1,350 for four weekly injections and is being pitched as a long-term therapy. * * * Insurance companies, pharmacy benefit managers, and employers determine whether health plans cover weight loss drugs, and which ones. Today only about half the clients of Cigna Corp.’s Express Scripts unit and Prime Therapeutics LLC, two major pharmacy benefit managers, reimburse for weight loss drugs. Express Scripts recently added Wegovy to its largest formulary, covering about 24 million people. Insurers Anthem Inc. and CVS Health Corp.’s Aetna don’t typically cover weight loss drugs, but both have indicated Wegovy will likely get some coverage. Others have yet to decide. Although “it’s not for everyone,” Wegovy has a role to play in treating obesity, says Amy Bricker, president of Express Scripts. She says she’s optimistic that treating obesity will lower costs for Express Scripts’ health plans.”

HealthTech Magazine offers a useful article on integrating virtual care into a healthcare organization’s overall delivery strategy. During the NCQA / HL7 Digital Quality Measure conference this week more than one doctor remarked that no one has found the Goldilocks level for virtual care, but at least study appears underway.

Monday Roundup

Photo by Sven Read on Unsplash

From the COVID-19 vaccine front

  • The New York Times reports that “The Food and Drug Administration warned on Monday that Johnson & Johnson’s coronavirus vaccine can lead to an increased risk of a rare neurological condition known as Guillain–Barré syndromeanother setback for a [one dose] vaccine that has largely been sidelined in the United States. Although regulators have found that the chances of developing the condition are low, they appear to be three to five times higher among recipients of the Johnson & Johnson vaccine than among the general population in the United States, according to people familiar with the decision. The warning was attached to fact sheets about the vaccine for providers and patients.”
  • USA Today offers a success story on AHIP’s Vaccine Community Connectors program. “Most important, this effort helped the industry home in on one specific strategy to accelerate health equity: better access to health care data that incorporates the social determinants of health.” Speaking SDOH data, Health IT Analytics informs us about the use of SDOH data in researching and managing Alzheimer’s Disease.
  • The American Hospital Association reminded folks today to keep its Vaccine Communications Resources website in mind.

Fierce Healthcare reports that

“The Biden administration has started to investigate whether Medicare should cover the extremely pricey Alzheimer’s drug aducanumab. The Centers for Medicare & Medicaid Services announced Monday it is opening a National Coverage Determination (NCD) analysis on the drug that will cost patients $56,000 a year. Advocates and experts have called for the agency to move quickly to decide whether to cover the drug. “We want to consider Medicare coverage of new treatments very carefully in light of the evidence available,” said CMS Administrator Chiquita Brooks-LaSure, in a statement Monday. “That’s why our process will include opportunities to hear from many stakeholders.”

Earlier press reports on Aduhelm, as well as common sense, indicate that commercial health plans likely will follow CMS’s lead on coverage of that drug.

Healthcare Dive tells us that “Telehealth use overall has stabilized at levels 38 times higher than before the COVID-19 pandemic, ranging from 13% to 17% of visits across all specialties, according to new data from McKinsey released roughly a year since the first major spike in COVID-19 cases.” * * * On the provider side, 58% of physicians continue to view virtual care more favorably than before the pandemic, though that’s down slightly from September, when 64% of physicians were in support. As of April this year, 84% of doctors were offering telehealth, and 57% said they’d prefer to continue offering it. However, that’s largely dependent on reimbursement: 54% of doctors said they wouldn’t provide virtual care if it was paid at a 15% discount to physical services.”

HR Dive discusses the President’s July 9 executive order provision “taking aim at” non-compete agreements.

Biden’s order leaves some questions unanswered. It does not ban or impact any existing employment agreement, Chris Marquardt, partner at Alston & Bird, told HR Dive in an email. “Employers will need to wait and see what the Federal Trade Commission does in response to the Executive Order before thinking about its potential impact,” he said.

Among other reasons, intellectual property and trade secrets have been cited as cause for use of non-competes. But the agreements have been the subject of criticism for potentially driving down wages in certain industries and geographic areas.

Govexec.com offers an interesting take on how the July 9 executive order seeks to use Federal procurement and regulations to promote competition 

Happy 4th of July

The Wall Street Journal reports tonight that

On Sunday evening, roughly 1,000 people—mostly essential workers and military families—gathered on the White House’s South Lawn. It was covered with red, white and blue decorations and dotted with festive tables and signs that read “America’s Back Together.” The crowd listened to military bands and dined on burgers, chicken sandwiches and pulled pork.

Mr. Biden struck an optimistic tone in his remarks, noting that Americans were gathering and celebrating for the holiday. However, he emphasized the lives lost and acknowledged that the virus hasn’t been defeated yet, urging people to get vaccinated.

“Do it now, for yourself, for your loved ones, for your community and for your country,” he said. “While the virus hasn’t been vanquished, we know this: It no longer controls our lives, it no longer paralyzes our nation, and it’s within our power to make sure it never does again.”

True that.

However, while grateful for our great country, the principal reason why the FEHBlog is posting tonight is to supplement yesterday’s post on the “REvil * * * attack on Kaseya VSA, software used by large companies and technology-service providers to manage and distribute software updates to systems on computer networks, according to security researchers and VSA’s maker, Kaseya Ltd.” The Journal reports that “REvil is a well-known purveyor of ransomware—malicious software that locks up a victim’s computer until a digital ransom is paid, typically in the form of bitcoin. This latest attack appears to be its largest ever. The incident may have infected as many as 40,000 computers world-wide, according to cybersecurity experts.”

Here is a link to “CISA-FBI Guidance for Managed Service Providers (MSP) and their Customers Affected by the Kaseya VSA Supply-Chain Ransomware Attack”:

CISA and FBI recommend affected MSPs:

  • Download the Kaseya VSA Detection Tool. This tool analyzes a system (either VSA server or managed endpoint) and determines whether any indicators of compromise (IoC) are present.    
  • Enable and enforce multi-factor authentication (MFA) on every single account that is under the control of the organization, and—to the maximum extent possible—enable and enforce MFA for customer-facing services.
  • Implement allowlisting to limit communication with remote monitoring and management (RMM) capabilities to known IP address pairs, and/or
  • Place administrative interfaces of RMM behind a virtual private network (VPN) or a firewall on a dedicated administrative network.

CISA and FBI recommend MSP customers affected by this attack take immediate action to implement the following cybersecurity best practices. Note: these actions are especially important for MSP customer who do not currently have their RMM service running due to the Kaseya attack.

CISA and FBI recommend affected MSP customers:

  • Ensure backups are up to date and stored in an easily retrievable location that is air-gapped from the organizational network;
  • Revert to a manual patch management process that follows vendor remediation guidance, including the installation of new patches as soon as they become available;
  • Implement:
    • Multi-factor authentication; and
    • Principle of least privilege on key network resources admin accounts.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

In today’s Morning Rounds email, the American Medical Association informs us that

The New York Times (6/28, Mandavilli) reports a new study published in Nature has found the COVID-19 vaccines from Pfizer-BioNTech and Moderna “set off a persistent immune reaction in the body that may protect against the coronavirus for years, scientists reported on Monday.” Researchers gathered samples from the lymph nodes of 14 recruits at five different points following the first dose, finding “the number of memory cells that recognized the coronavirus had not declined” 15 weeks later. The Times adds, “The results suggest that a vast majority of vaccinated people will be protected over the long term.”

In a separate article, the New York Times (6/28, Mandavilli, Zimmer, Robbins) says the study adds to other research suggesting that “widely used vaccines will continue to protect people against the coronavirus for long periods, possibly for years, and can be adapted to fortify the immune system still further if needed.”

The Federal Times reports that GEHA, the second largest FEHB plan carrier, has launched a COVID-19 vaccination reward program for its members. Here is a link to GEHA’s website on this program.

As of today just about two thirds of Americans over age 18 have had at least one dose of a COVID-19 vaccination. Most importantly, approaching 90% of Americans over age 65, the cadre that suffered the most COVID-19 fatalities, has received at least one dose of the COVID-19 vaccine and 78% of that cadre are fully vaccinated. However, Bloomberg warns that

The gap between the most vaccinated and least vaccinated places in the U.S. has exploded in the past three months, and continues to widen despite efforts to convince more Americans to get a Covid shot. * * * In the least vaccinated group of counties, many of which are in the South and Central regions of the U.S., less than half as many people have gotten at least one Covid vaccine dose as in the most vaccinated counties in the cities and on the coasts. Those less vaccinated places are not catching up, either. The gap between more- and less-vaccinated counties is expanding, and the trailing counties are far below levels needed to halt future waves of infection

As the FEHBlog has pointed out previously, such herd immunity is built on both natural immunity and vaccination-created immunity. The FEHBlog encourages COVID-19 vaccination which has been miraculous. Nevertheless you cannot predict Delta variant devastation in certain areas of our country without considering natural immunity and the fact that most of elderly cadre is vaccinated. The FEHBlog also has confidence in the federal, state and county authorities as well as the Nation’s physicians to complete the vaccination campaign.

And now for Tuesday’s tidbits

  • The FEHBlog nearly fell off his chair when he read in Healthcare Dive that Nearly 70% of U.S. physicians are now employed by a hospital or a corporate entity, according to the latest report by Avalere for the Physicians Advocacy Institute, a coalition of state doctors’ groups. This is the first time the report included ownership by corporate entities outside of just hospitals. Hospitals and corporate entities, which include insurers or private equity groups, own nearly half of the physician practices in this country, according to the report released Tuesday that examines the two-year period from 2019 through 2020.  This longtime trend [really since the Affordable Care Act became law in 2010] was exacerbated during the COVID-19 pandemic, according to the report, which shows 48,400 physicians left private practice during the study period across all regions of the country.” The FEHBlog does not see this course reversing itself.
  • Buck consultants reminds FEHB plan carriers that the PCORI fee is due on August 2 this year because July 31 falls on a Saturday.
  • Medscape reports that “In the U.S. House [of Representatives], 20 Democrats and 10 Republicans have signed on as co-sponsors to the Protecting Seniors Through Immunization Act of 2021 (HR 1978), introduced in March by Rep. Ann Kuster (D-NH). The companion Senate measure (S 912) has the backing of two Democrats and two Republicans. This legislation would end copays in Medicare Part D plans for vaccines recommended for adults by the CDC’s Advisory Committee on Immunization Practices.” The FEHBlog, who is on Medicare, got hit for $400 in copayments to obtain two doses of the new ACIP recommended Shingles vaccine last year. Why it is taking over a decade for Medicare to align with the ACA on this point is beyond the FEHBlog’s understanding.
  • AHRQ’s Director Dr. David Meyers offers his perspective on getting telehealth properly integrated into our health care system.
  • The showstopper of this week will be the first interim final rule on implementation of the No Surprises Act which has a statutory deadline of Thursday July 1. The rule is expected to principally pertain to calculating the initial payments in the NSA scenarios. Hopefully the rule will provide more guidance than that. The rule has been pending approval from the Office of Management and Budget’s Office of Information and Regulatory Affairs since June 8. Since then OIRA has sponsored seven listening sessions with interested organizations. The last such listening session will be held tomorrow at 1 pm ET. Once the listening session is completed, a list of attendees and the meeting materials are posted on OIRA’s online calendar.

Friday Stats and More

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 25th week of this year (beginning April 2, 2020, and ending June 23, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):

According to the Centers for Disease Control (“CDC”),

The current 7-day moving average of daily new cases (11,343) decreased 4.4% compared with the previous 7-day moving average (11,867). Compared with the highest peak on January 10, 2021 (252,166), the current 7-day average decreased 95.5%. A total of 33,409,895 COVID-19 cases have been reported as of June 23.

Here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19 which also has been steadily decreasing:

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases significantly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through June 23, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through June 23, 2021, which also uses Thursday as the first day of the week:

As of today, according to the Centers for Disease Control, over 150 million Americans are fully vaccinated. The vaccination campaign has lead to the low levels of new cases and deaths in our country. The Associated Press observes:

Nearly all COVID-19 deaths in the U.S. now are in people who weren’t vaccinated, a staggering demonstration of how effective the shots have been and an indication that deaths per day — now down to under 300 — could be practically zero if everyone eligible got the vaccine.

An Associated Press analysis of available government data from May shows that “breakthrough” infections in fully vaccinated people accounted for fewer than 1,200 of more than 853,000 COVID-19 hospitalizations. That’s about 0.1%.

And only about 150 of the more than 18,000 COVID-19 deaths in May were in fully vaccinated people. That translates to about 0.8%, or five deaths per day on average.

The CDC also reminds us that

Currently, several variants are found around the world, including in the United States. On June 15, 2021, the B.1.617.2 (Delta)* variant was classified as a VOC because it spreads from person to person more easily than other variants and may cause more severe disease. B.1.617.2 has been reported in 77 countries and in the United Kingdom has become the main variant in COVID-19 cases. In the United States, the proportion** of B.1.617.2 for the 2-week period ending June 19, 2021, is predicted to increase to 20.6% nationally and be higher in regions 2, 6, 7, 8, and 9.

The more a virus circulates in a population, the more opportunities it has to transform itself and can reduce the effectiveness of our vaccines. Recent studies have shown that the vaccines available in the United States are effective against variants currently circulating, including B.1.617.2. Vaccines interrupt the ability of the virus that causes COVID-19 to move between people and mutate, so it is important for everyone to get vaccinated as soon as they’re eligible. If you have questions or concerns about vaccines, please contact your healthcare professional, state or local health department, or local pharmacist or visit the CDC website. To find a place in your community to get a vaccine, visit Vaccines.gov or your local public health department website.

In the More department

  • The American Managed Care Journal reports that AHIP hosted a small group of U.S. Senators at a recent conference where the Senators offered their thoughts on future federal healthcare legislation.
  • Tammy Flanagan in Govexec discusses NARFE’s legislative conference on pending legislation in Congress affecting federal employees, annuitants and their benefit programs, including the Postal Reform Act.
  • Healthcare Dive informs us that “The Biden administration’s top health policy official on Thursday [June 24] reiterated his support for expanded telehealth access after the COVID-19 national emergency expires, as Congress considers a slate of bills that would permanently nix regulatory barriers to virtual care. “We are absolutely supportive of efforts to give us the authority to utilize telehealth in greater ways,” HHS Secretary Xavier Becerra said at a virtual event on digital health hosted by The Washington Post. Becerra also stressed that, though affordable telehealth should be available to all, HHS would be doubling down in making sure there’s accountability for quality of care. “We’re going to be doing a lot of bird-dogging, a lot of oversight,” he said.”
  • Fierce Healthcare reports on the winners of the IBM XPrize competition to create artificial intelligence tools to tackle global problems. For example, “An Israeli startup that uses artificial intelligence and other tech tools to wipe out malaria took the top prize in IBM Watson’s AI competition, nabbing $3 million to expand its operations. ZzappMalaria, a subsidiary of Sight Diagnostics, developed an AI-powered mobile app and dashboard to tackle malaria on the eradication level, specifically in developing countries.” Very 21st Century.