Weekend update

Congress

Weekend update

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

From Capitol Hill, the House of Representatives and the Senate will be engaged in Committee business and floor voting this week. Bloomberg brings us up to date on the status of $3.5 trillion budget reconciliation bill which the President and Democrat leaders in Congress have been pushing.

From the Delta variant front, it must be recalled that before health plans become obligated to cover the mRNA booster for immunized folks over age 65 and a broader group of immuno-compromised Americans, fifteen days must pass from the time that the Centers for Disease Control ratifies the FDA’s decision from last Friday. The CDC’s Advisory Committee on Immunization Practice is scheduled to consider this issue on September 29. The press reports on Friday indicated that the CDC is expected to establish the scope of the expanded coverage of immuno-compromised Americans.

On Sunday’s talk shows, Drs. Fauci and Collins, according to the Wall Street Journal, predict that the FDA will approve the mRNA booster for the general population before long. Kaiser Health News discusses how these leading scientists got in front of their skis on the scope of the mRNA booster coverage issue.

Precision Vaccines discusses where Britain and American stand in terms of achieving at least limited herd immunity.

In the USA, new data from the U.S. CDC published by the JAMA Network on September 2, 2021, indicates herd immunity may be achievable soon.

This review is based on blood donations in the U.S. from July 2020 through May 2021, including both natural infection- and vaccine-induced SARS-CoV-2 seroprevalence. This repeated cross-sectional study included over 1.4 million blood donation specimens representing 74% of the US population.

The estimated SARS-CoV-2 seroprevalence weighted for differences between the study sample and general population increased from 3.5% in July 2020 to 20.2% for infection-induced antibodies and 83.3% for combined infection- and vaccine-induced antibodies in May 2021. 

The coronavirus seroprevalence differed by age, race, ethnicity, and geographic region of residence, and these differences changed over the course of the study.

Since May 2021, the U.S. CDC has reported significant increases in COVID-19 vaccinations, initial infections, and re-infections. More than 4 million of these cases have been reported in the past few weeks.

These new totals may soon push the USA over the 95% herd immunity goal.

It’s worth noting that Britain is ahead of the U.S. because the Delta variant struck Britain first.

In other updates —

  • The American Cancer Society has released the 2021 edition of Cancer Facts and Figures.
  • The American Medical Association provides background of the 2022 changes to the Current Procedure Terminology. The AMA publishes the CPT which is one of the code sets for HIPAA electronic transactions.
  • Fierce Healthcare reports “The Biden administration has delayed enforcement of payer-to-payer data exchange included in a May 2020 final interoperability rule until future regulations are finalized.” The interoperability rules apply to insurers with HHS contracts, not FEHB carriers.
  • Health Payer Intelligence informs us that “Healthcare B2B payment transactions have been high in 2021, potentially signaling the importance of electronic payment transfers as the nation emerges from the coronavirus pandemic, according to a report from National Automated Clearing House Association (NACHA).” What’s more “‘This data from Nacha is good news for payers, providers and members,’ said April Todd, senior vice president of CORE and explorations at CAQH.  ‘The increase in electronic payment volume likely indicates that people who deferred routine medical appointments due to COVID are now able to get the care they need.  And when that care is paid electronically, it is more efficient and cost-effective for the industry.’  Todd’s organization has been tracking the economic impact of transitioning to electronic payment. A CAQH report estimated that the healthcare industry could see $426 million in cost savings by transitioning to electronic payments. Switching to electronic payment for claims submissions could save providers around $2 for each claim. Exact savings can vary based on the type of transaction.”

President names an OPM Inspector General nominee

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

The Washington Post reports that

President Biden on Thursday made a nomination to fill the long-vacant position of inspector general at the Office of Personnel Management, a watchdog office that has at times publicly clashed with top management of the federal agency.

Nominee Krista Boyd is chief counsel for oversight and policy on the House Oversight and Reform Committee, which oversees federal workplace matters. Boyd has worked on Capitol Hill for more than two decades with a focus on issues including whistleblower protection, transparency and strengthening the access to agency information for inspectors general and other watchdogs, an announcement said.

Ms. Boyd’s nomination is subject to Senate confirmation.

On the Delta variant front, Govexec.com informs us that

The Biden administration released new guidance on Thursday about implementing the COVID-19 vaccine mandate for federal employees, which says even those on telework or remote work must get vaccinated. 

The guidance implements an executive order President Biden issued on September 9 requiring federal employees to get vaccinated against the novel coronavirus, unless they request an exemption. The Safer Federal Workforce Task Force said on Monday that November 22 is the deadline for employees to get fully vaccinated or possibly be subject to progressive discipline. * * *

Postal Service employees are not covered by the mandate, but they will be subject to the forthcoming emergency temporary standard from the Occupational Safety and Health Administration (OSHA) that will require vaccines for companies with 100 or more employees, the senior administration official pointed out. That was another coronavirus measure the president unveiled last week. 

“Our workplaces are subject to regulations from the Occupational Safety and Health Administration,” USPS said in a statement on Thursday. “Therefore, we are working closely with our union leadership so that once OSHA’s COVID-19 Vaccination Emergency Temporary Standard is issued we can move quickly to determine its applicability to our employees and how best to implement [it].” * * *

Other topics covered in the update are: who is considered fully vaccinated and the timeline for getting fully vaccinated (depending on which vaccine individuals receive); vaccination dates for those who are starting government service after November 22; what protocols employees should follow before becoming fully vaccinated; and how agencies should collect and maintain documentation of vaccination for employees. Agencies must collection documentation even if employees previously attested to being vaccinated. 

The Society for Human Resource Management discusses what to expect from OSHA on the vaccination screening program it is developing for private employers with more than 100 employees.

In mergers and acquisitions news, the Deseret News reports that

Intermountain Healthcare announced Thursday that the organization is merging with SCL Health, a faith-based, nonprofit health care organization based in Colorado.

The two organizations are located in adjacent areas with no geographic overlap, so together they will employ more than 58,000 caregivers, operate 33 hospitals and run 385 clinics across Utah, Idaho, Nevada, Colorado, Montana and Kansas.

SCL Health is a $2.8 billion health network that provides comprehensive, coordinated care in hospitals, clinics, home health, hospice and mental health services across Colorado, Montana and Kansas. It brings eight hospitals and more than 160 physician clinics into the merger. Their hospitals will retain their names and their Catholic identity, directives and values.

The merger, which is subject to regulatory approval, is expected to close early next year.

From the studies front —

  • The Centers for Disease Control released updated adult obesity prevalence maps for the U.S. yesterday.
  • The Employee Benefits Research Institute is offering an issues brief on trends in health savings account balances, contributions, distributions and investments and the impact of COVID-19 thereon.

From the reminders front, Fedweek explains the “five year rule” for continuing FEHB and FEGLI coverage into a civil service retirement.

As a rule, you can only continue your FEHB and/or FEGLI coverage into retirement if you are 1) currently enrolled, 2) have been enrolled for at least five years or from your earliest opportunity to enroll, and 3) are retiring on an immediate annuity (including disability).

Further, if you are a FERS employee who is retiring on an immediate annuity but postponing its receipt to a later date to reduce or eliminate the 5 percent per year penalty for retiring under the MRA+10 provision (minimum retirement age—currently 57—with at least 10 but less than 30 years of service), you’ll be able to reenroll in the FEHB program when your annuity begins. Note: If you leave government before being eligible to retire and later apply for a deferred annuity when you have the right combination of age and service, you can’t reenroll in either program.

While there is an automatic waiver of the FEHB five-year rule if you are accepting an offer of early retirement from your agency, no waiver is possible for FEGLI. Nor are waivers of the “currently enrolled” or “retiring on an immediate annuity” requirements available under current law for either program.

Tuesday’s Tidbits

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

Roll Call discusses the status of the $3.5 trillion budget reconciliation bill as “Senate Democrats begin to tweak the House package.” Federal News Network provides a broader perspective on the varied issues facing Congress this month.

From the Delta variant front

  • The Department of Health and Human Services” (HHS) Vaccination Community Corps has updated its resources list.
  • Yesterday, HHS “transitioned from a direct ordering process to a state/territory-coordinated distribution system * * * for the distribution of monoclonal antibody drugs (“mAbs”) [to treat COVID-19 particularly in unvaccinated people].  State and territorial health departments know best where product is needed in their areas. Transitioning to a state/territory-coordinated distribution system gives health departments maximum flexibility to get these critical drugs where they are needed most.” Makes sense.  
  • Healthcare Dive reports that “Just as patients started returning for care they delayed throughout the COVID-19 pandemic, hospitals are again having to put non-emergency procedures on hold to free up resources for patients hospitalized with the delta variant of the coronavirus. Salt Lake City-based Intermountain Healthcare is the latest system to announce it’s postponing elective procedures starting Wednesday at 13 of its hospitals, and expects the pause to last several weeks, CEO Marc Harrison said during a Friday press conference.”
  • JDSupra offers a useful and in the FEHBlog’s opinion accurate legal analysis of the President’s vaccination programs for federal contractors and private employers. Bloomberg expresses concern that “The U.S. may not have enough tests to keep pace with the Biden administration’s tightened workplace Covid-19 mitigation measures.”

In the tidbits department

  • The Mercer consulting firm announced that ‘[a]s the pandemic continues to unfold, the ability of employers to have a positive impact on employee health and resiliency cannot be understated and is one of the most important findings of the latest Mercer “Health on Demand” survey released today.” Since the onset of COVID-19, when employers stepped up to provide essential support, it made a difference. Employees who say they received good support from their employers are much less likely to view their personal experience of the pandemic as mostly or entirely negative compared to those who received little or no support – 25% vs. 49%. And almost half (45%) of those receiving good support say they are less likely to leave their job as a result.
  • The FEHBlog noticed a Modern Healthcare article discussing how employers are incorporating virtual substance abuse programs in their provider networks. As an example the article pointed to Ria Health which describes itself as an evidence based alcohol additional treatment program.
  • The American Medical Association’s President (appropriately in the FEHBlog’s view) is urging physicians and patients to reengage. “As life takes steps to return to normal, it’s urgent that patients and physicians prioritize health screenings and regular procedures.”

Weekend Update

David Ermer–CMS, Congress, COVID-19, COVID-19 vaccine, Rx coverage–
Photo by Dane Deaner on Unsplash

The U.S. House of Representative both will be engaged in committee work through Wednesday this week until Yom Kippur begins on Wednesday evening. The Senate also will be engaged in floor voting for the same period. Committee work principally will focus on the details of the $3.5 trillion budget reconciliation bill and a related Plan B measures including a stopgap extension of federal funding past September 30 and addressing the debt ceiling.

On the Delta variant front

The Wall Street Journal explains that epidemiologists no long think that COVID-19 can be eradicated. We have a good shot at the virus becoming endemic / a routine treatable illness.

When or even whether Covid-19 settles into that status depends on how many more people get vaccinated and how soon, said Adolfo Garcia-Sastre, director of the Global Health and Emerging Pathogens Institute at the Icahn School of Medicine at Mount Sinai in New York.

For Covid-19 to become mild, most people will need some immunity, which studies have shown reduces the severity of the disease. Infections provide some immunity, but at risk of severe illness, death and further spread of the virus, compared with vaccines. People could become vulnerable to SARS-CoV-2 if that immunity erodes or is weak, or if the virus mutates.

“The more people who are vaccinated, the less problems there are going to be,” Dr. Garcia-Sastre said.

The Journal’s Numbers columnist explains why COVID-19 vaccination boosters will be necessary.

“We’re fortunate with tetanus, diphtheria, measles and vaccinia,” Dr. [Mark] Slifka [from the Oregon Health & Science University] said. “We have identified what the threshold of protection is. You track antibody decline over time, and if you know the threshold of protection, you can calculate durability of protection. With Covid, we don’t know.”

Complicating things further, viruses and bacteria that mutate to escape the body’s immune response are harder to control.

Measles, mumps, rubella and chickenpox hardly mutate at all, but at least eight variants of SARS-CoV-2, the virus that causes Covid-19, have been found, according to the British Medical Journal.  

“It does make it more complicated for the vaccine to work,” Dr. Slifka said. “You’re chasing multiple targets over time. Flu also mutates. With flu, we’ve adjusted by making a new flu vaccine each year that as closely as possible matches the new strain of flu.”

The FDA’s Vaccines Advisory Committee meets on the topic of COVID-19 boosters this Friday September 17. The CDC’s Advisory Committee on Immunization Practices has scheduled a complementary meeting for September 29.

The FEHBlog ran across this interesting WebMD article titled “Monoclonal Antibodies vs. Vaccines vs. COVID-19: What to Know.” “‘As hospitalizations go up nationwide, we have a therapy here that can mitigate that,’ says William Fales, MD, medical director of the Michigan Department of Health and Human Services Division of EMS and Trauma. Getting monoclonal antibodies is one of ‘the best things you can do once you’re positive.’” However, the vaccine’s protection against COVID-19 has a much longer duration than this treatment. “There are two authorized uses for monoclonal antibodies: To treat or stop COVID-19’s progression in a high-risk person who tests positive, and to prevent COVID-19 in a high-risk person who’s been exposed.” The treatment is administered while hospitalized or while outpatient at an infusion center.

In RX news, Managed Healthcare Executive reports

The FDA has approved 30 biosimilars and 21 have been launched. But it won’t be till biosimilars for some of the more widely prescribed biologics are on the market before biosimilars really start to have a major impact on American healthcare and its cost, according to a top-ranking executive at OptumRx.

“We’re still a few years away from the point at which the most widely-utilized … products in the U.S. today will be available as biosimilars,” Savitha Vivian, senior vice president of clinical and formulary Services for OptumRx, said in an interview with Managed Healthcare Executive®. “And that’s really what we’re looking for, because that’s going to enable a more sizable and impactful bottom-line savings.”

Ms. Vivian expects Humira to hit the bio-similar market in 2023.

“Another significant biosimilar launch that is still two to three years away from one for Novo Nordisk’s insulin aspart injection (Novolog), a “highly utilized medication, especially in the outpatient setting,” noted Vivian.Biosimilars for Genentech’s Actemra (tocilizumab), a medication for rheumatoid arthritis and other forms of arthritis, and Stelara (ustekinumab), Janssen’s immunosuppressive drug for plaque psoriasis and psoriatic arthritis, are also two or three years away.”

Patient and provider comfort with biosimilars is still a “critical barrier” to the adoption of biosimilars, she said.

Switching therapies in patients who are stable on the biosimilar’s reference product to the biosimilar is not typically recommended, according to Vivian. “So from a clinical perspective, we need to be cautious in implementing strategies that force these types of switching.”Instead, she said, “what we really need is data showing that there’s really no additional risk from switching therapies in these hard-to-treat or hard-to-control chronic diseases. That’s going to really increase the confidence for prescribers to start using biosimilars in … those stable patients.”

Another barrier is a lack of interchangeability in biosimilars, with notable exception of Semglee (insulin glargine-yfgn), which was FDA-approved as biosimilar to, and interchangeable with Lantus (insulin glargine) this summer. In order to demonstrate interchangeability, studies must show there is no additional risk or reduced efficacy if a patient switches back and forth between the interchangeable biosimilar and the reference product.

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

On the Delta variant front and acccording to the CDC’s COVID Data Tracker, the United States reached two data points today — the number of COVID cases now exceeds 40 million and the percentage of Americans aged 18 and over who have received at least one dose of a COVID-19 vaccine reached 75%.

At the end of 2020, the number of cases according to the CDC stood at 20 million. In his blog, National Institutes of Health Director Francis Collins discusses a recent Nature study estimating that “the true number of [COVID] infections by the end of 2020 at more than 100 million [1]. That’s equal to just under a third of the U.S. population of 328 million. This revised number shows just how rapidly this novel coronavirus spread through the country last year. It also brings home just how timely the vaccines have been—and continue to be in 2021—to protect our nation’s health in this time of pandemic.” It also suggests to the FEHBlog that we may to closer to effective herd immunity in some areas of the U.S. than generally thought.

Also David Leonhardt in today’s New York Times tells us about another way to look at the situation.

The C.D.C. reported a terrifying fact in July: Vaccinated people with the Delta variant of the Covid virus carried roughly the same viral load in their noses and throats as unvaccinated people.

The news seemed to suggest that even the vaccinated were highly vulnerable to getting infected and passing the virus to others. Sure enough, stories about vaccinated people getting Covid — so-called breakthrough infections — were all around this summer: at a party in Provincetown, Mass.; among the Chicago Cubs; on Capitol Hill. Delta seemed as if it might be changing everything.

In recent weeks, however, more data has become available, and it suggests that the true picture is less alarming. Yes, Delta has increased the chances of getting Covid for almost everyone. But if you’re vaccinated, a Covid infection is still uncommon, and those high viral loads are not as worrisome as they initially sounded.

How small are the chances of the average vaccinated American contracting Covid? Probably about one in 5,000 per day, and even lower for people who take precautions or live in a highly vaccinated community. * * *

I will confess to one bit of hesitation about walking you through the data on breakthrough infections: It’s not clear how much we should be worrying about them. For the vaccinated, Covid resembles the flu and usually a mild one. Society does not grind to a halt over the flu.

In Britain, many people have become comfortable with the current Covid risks. The vaccines make serious illness rare in adults, and the risks to young children are so low that Britain may never recommend that most receive the vaccine. Letting the virus continue to dominate life, on the other hand, has large costs.

“There’s a feeling that finally we can breathe; we can start trying to get back what we’ve lost,” Devi Sridhar, the head of the global public health program at the University of Edinburgh, told The Times.

Well put, Mr. Leonhardt, as usual.

From the federal employee benefits front, OPM posted on the Federal Register website today a notice of changes to Federal Group Life Insurance premium rates for “Employee Basic Insurance, Option A (most age bands), Option B (most age bands), Option C (most age bands), and Post-Retirement Basic Insurance. These rates will be effective the first pay period beginning on or after October 1, 2021.”

From the tidbits department

  • Federal News Network reports that “The White House is proposing billions of dollars in supplemental funding for disaster relief and other programs, which it’s asking Congress to attach to a short-term continuing resolution that will be critical toward avoiding a government shutdown at the end of the month. ‘With the end of the fiscal year rapidly approaching, it’s clear that Congress will need to pass a short term continuing resolution to provide more time for the fiscal 2022 process to unfold,’ Shalanda Young, the Office of Management and Budget’s acting director, said Tuesday in a blog post.” 
  • Fierce Healthcare informs us that “The American Medical Association [“AMA”] released updates to its medical codes for 2022 with many tied to new technology services and the administration of COVID-19 vaccines. The AMA made 405 changes in the 2022 Current Procedural Terminology code set, including 249 new codes, 63 deletions and 93 revisions. The changes will take effect Jan. 1. ” The CPT is recognized as a HIPAA electronic transaction code set.
  • AP News reports that “Four companies in the drug industry said Saturday that enough states had agreed to a settlement of lawsuits over the opioid crisis for them to move ahead with the $26 billion deal. An announcement from the three largest U.S. drug distribution companies and a confirmation from drugmaker Johnson & Johnson, which had previously announced that it would move ahead, came Saturday. That was the deadline for the companies to decide whether there was enough buy-in to continue the settlement plan. * * * Together, the settlements are likely to represent the biggest piece of a string of settlements between companies in the drug industry and state and local governments over the addiction and overdose epidemic in the U.S.”
  • Healthcare Dive tells us that “The use of telehealth for patient visits seems to have leveled off at 20% or fewer of all appointments, more than a year and a half after COVID-19 first spurred an unprecedented jump in utilization, according to a new survey from KLAS Research and the Center for Connected Medicine.”
  • The AMA discusses “what doctors wish patients knew about a prediabetes diagnosis,” which of course is a fairly common diagnosis in our country.
  • The Wall Street Journal continues its series on the Future of Everything in healthcare with an article about sensor studded smart clothes. “From a prescription bra that signals cardiac arrest to a mosquito-proof textile, startups and scientists are developing garments for healthier living.”

Tuesday Tidbits

David Ermer–AHRQ, CDC, Congress, COVID-19, COVID-19 vaccine, Patient safety, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Delta variant front —

Medscape reports on yesterday’s CDC Advisory Committee on Immunization Practices meeting:

“Vaccines remain effective in preventing hospitalization and severe disease but might be less effective in preventing infection or milder symptomatic illness,” Sara Oliver, MD, the CDC scientist who presented the information [about the mRNA vaccines], told the committee.

In a new data analysis released by the CDC on Sunday, unvaccinated adults were 17 times more likely to be hospitalized than vaccinated adults. Hospitalization rates were higher for unvaccinated people in all age groups.

Among the fully vaccinated, people who were hospitalized were much older, more likely to be nursing home residents and more likely to have three or more underlying medical conditions. Nearly a third had immunosuppressive conditions.

Healthcare Dive tells us that

The U.S. government will resume distribution of Eli Lilly’s COVID-19 antibody drug combination in a number of states, HHS said Friday, as cases and hospitalizations in the U.S. are driven higher by the spread of the delta variant.The decision comes roughly two months after administration of Lilly’s therapy was halted by U.S. officials due to concerns of reduced efficacy against coronavirus infections stemming from the beta and gamma variants. Those are now much less prevalent compared with delta, which laboratory testing has shown remains susceptible to treatment with the dual-antibody therapy, HHS said.

Fierce Pharma reports that

Last week’s FDA approval of Pfizer’s Comirnaty vaccine boosted consumer confidence among both vaccinated and unvaccinated people.

A Harris Poll survey over the weekend found that 80% of Americans who were aware of the approval now have more confidence in it. Even more encouraging? Almost half (49%) of unvaccinated people who heard about the approval said they will “probably” or “definitely” get vaccinated.

Overall awareness of the Pfizer approval was high—79% of those surveyed by The Harris Poll were aware of the FDA thumbs-up.

From the telehealth front, Kaiser Health News discusses re-emerging state law barriers to telehealth. “’The whole challenge is to ensure maximum access to health while assuring quality,’said Barak Richman, a Duke University law professor, who said laws and policies haven’t been updated to reflect new technological realities partly because state boards want to hang onto their authority.” The article provides an overview of options available to doctors and state boards.

From the miscellany front

  • Beckers Hospital Review unveils six big ideas in health innovation. For example, Jason Joseph. Senior Vice President and Chief Digital and Information Officer at Spectrum Health (Grand Rapids, Mich.). As we innovate, we are forcing hidden barriers into the light via experimentation. We saw so many of these barriers uncovered within health care, such as lack of connectivity, digital competency, and the need for comprehensive managed workflow. We have shined a spotlight on how much of healthcare relies on people and inconsistent manual processes to get through the system. That needs to change, and that also requires changing a leader’s traditional mindset.
  • The Agency for Healthcare Quality and Research is offering a toolkit to help healthcare providers and possible health plans get patients and members engaged with the diagnosis process.

The toolkit contains two strategies, Be The Expert On You and 60 Seconds To Improve Diagnostic Safety. When paired together, these strategies enhance communication and information sharing within the patient-provider encounter to improve diagnostic safety. Each strategy contains practical materials to support adoption of the strategy within office-based practices.

Be The Expert On You is a patient-facing strategy that prepares patients and their families to tell their personal health stories in a clear, concise way. Research suggests that 79 percent of diagnostic errors are related to the patient-clinician encounter and up to 56 percent of these errors are related to miscommunication during the encounter. Environmental scan findings show that inviting patients to share their entire health story, uninterrupted, and in a way that gives clinicians the information they need can reduce diagnostic errors.

60 Seconds To Improve Diagnostic Safety prepares providers to practice deep and reflective listening for one minute at the start of a patient-encounter. Research suggests that patients are interrupted by their providers in the first 11 to 18 seconds of telling their diagnostic story. Diagnostic safety can be improved when a provider allows a patient to tell his or her health story without interruption for one minute, and then asks questions to deepen understanding.

  • Not every innovative idea makes sense to implement though. The President and Democrat leadership in Congress want the Centers for Medicare Services to “negotiate” drug prices for Medicare Part D plans. Regulatory Focus informs us that “A new drug development model released by the Congressional Budget Office (CBO) estimates a Medicare drug pricing bill like the one proposed by Democrats in the US House of Representatives could result in between 21 and 59 fewer drugs brought to market over the next three decades.”

Tuesday’s Tidbits

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

From Capitol Hill, Roll Call reports that the House Speaker Nancy Pelosi negotiated a Democrat legislative victory when the House narrowly approved a rule adopting the $3.5 trillion budget blueprint and agreeing to hold a floor vote on the Senate’s bipartisan, $1 trillion infrastructure bill no later than September 27, 2021.

Leadership is hoping to have the reconciliation package, which committees have a Sept. 15 deadline to assemble, ready for floor action around the same time as the infrastructure bill with the goal of passing both by the end of September, House Majority Leader Steny H. Hoyer told reporters on a press call Tuesday afternoon.

How soon the reconciliation package is ready “will dictate to some degree the flow of legislation,” the Maryland Democrat said. “We have not got a hard view on sequencing.”

Federal News Network informs us about three items for federal employees to watch in the bipartisan infrastructure bill.

From the Delta variant front, the American Hospital Association tells us

The Centers for Disease Control and Prevention today released research highlighting two important trends emerging from the COVID-19 pandemic regarding vaccines’ current effectiveness. The first, which looked at breakthrough infections among fully vaccinated front-line health care workers, found that, following the emergence of the SARS-CoV-2 delta variant, there has been a moderate reduction in the effectiveness of COVID-19 vaccines in preventing infection in this group. However, the authors note that “this trend should be interpreted with caution because [vaccine efficacy] might also be declining as time since vaccination increases and because of poor precision in estimates due to limited number of weeks of observation and few infections among participants.” Additionally, the CDC notes that even a sustained two-thirds reduction in infection risk underscores COVID-19 vaccinations’ continued importance and benefits in preventing deaths, hospitalizations and the virus’ spread. 

The second study reviewed SARS-CoV-2 infections in Los Angeles County over the course of nearly three months, starting in May 2021. Researchers found that approximately three out of four cases were among unvaccinated individuals. Additionally, infection and hospitalization rates among unvaccinated persons were 4.9 and 29.2 times more likely, respectively, than those in fully vaccinated persons, with little change when the delta variant took root as the nation’s dominant virus strain.

The Society for Human Resource Management discusses what the FDA’s full approval for the Pfizer vaccine means for employer COVID-19 policies.

The Wall Street Journal informs us that

Johnson & Johnson said [over Tuesday night] that a second dose of its [one dose] Covid-19 vaccine was found in a study to generate a strong immune response, justifying a booster shot after eight months. * * * J&J said researchers found antibody levels increased ninefold among people who received a second dose of its vaccine, compared with one month after they received a first dose. * * *

“We look forward to discussing with public health officials a potential strategy for our Johnson & Johnson Covid-19 vaccine, boosting eight months or longer after the primary single-dose vaccination,” [said] Dr. Mathai Mammen, global head of R&D at Janssen Pharmaceutical Cos. of Johnson & Johnson.

The Biden administration said last week that people ages 18 and older who got the Covid-19 vaccines from Pfizer Inc. or Moderna Inc. should get an extra dose eight months later, reflecting heightened concern over the highly contagious Delta variant and data showing initial immunity to Covid-19 diminishes over time. J&J’s suggested timeline would be in sync with that broader strategy.

Currently boosters are only authorized for immunocompromised people who received two-dose messenger-RNA vaccines. The Food and Drug Administration must authorize extra doses before they can be offered more broadly as recommended by the Biden administration to those 18 and older who received two-dose messenger-RNA vaccines, and it is expected to do so before Sept. 20, when health authorities said messenger-RNA boosters would become available

The CDC’s expert advisory panel on vaccines will meet next week to discuss the Biden administration’s plans for booster shots.

According to the CDC’s website, this virtual ACIP meeting will be held on August 30 and 31.

Finally STAT News reports that

The age at which adults who are overweight or obese should be screened for type 2 diabetes is going down while the prevalence of both forms of the disease is going up among children and adolescents — two developments reported Tuesday that signal a growing burden of these chronic health conditions among Americans.

The U.S. Preventive Services Task Force lowered its recommended age to 35 — down from 40 in its 2015 guidance — to test people with above-normal BMIs for elevated glucose levels that could mean prediabetes or diabetes itself. The new evidence review and recommendations, published in the Journal of the American Medical Association, would make more than 40% of adults eligible for screening, and an estimated one-third will likely meet USPSTF criteria to undertake preventive steps.

Monday Roundup

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

From Capitol Hill, Roll Call reports that

Speaker Nancy Pelosi floated a compromise to moderate holdouts Monday that would advance the budget resolution needed to unlock a $3.5 trillion package of aid to families, students and clean energy subsidies in exchange for a guaranteed vote on a separate, $550 billion infrastructure package.

The plan would “deem” the fiscal 2022 budget resolution adopted when the chamber adopts the combined rule for floor debate on the Senate-passed infrastructure bill and voting rights legislation. Pelosi, D-Calif., also committed to a floor vote on the infrastructure bill before Oct. 1, when current surface transportation program authorizations lapse.

The House of Representatives convened at 5 pm ET this evening and went into a recess at 5:30 pm ET for a Democrat member caucus. The House resumed its session with routine business at 6 pm ET and the House recessed again at 8 pm likely for another Democrat member caucus. [Follow-up — Early Tuesday morning the Wall Street Journal reports that “Plans to hold that vote Monday night were [later] abandoned, though, and Mrs. Pelosi said the chamber would vote on the measure on Tuesday as she left the Capitol after midnight.”

From the Delta variant front, Mondays have tended to be a good day for COVID-19 vaccine news. This morning the Food and Drug Administration “approved [for marketing] the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.” This action occurred two weeks before the Labor Day.

The Wall Street Journal reports that

The Food and Drug Administration’s approval was seen by public health officials as a key step to convince hesitant individuals to get the shot and to encourage employers to mandate it. 

“Today I’m calling on more companies in the private sector to step up with vaccine requirements that will reach millions more people,” President Biden said. “I call on you to do that—require it.” * * *

The vaccine is now eligible for off-label prescriptions—or use beyond the approved populations. That could include booster doses, according to the FDA. Prescribing the vaccine off label for children wouldn’t be appropriate as there is no data on proper dosing or safety in youth, said acting FDA Commissioner Janet Woodcock. * * *

Pfizer * * * is now permitted to market the vaccine to doctors, healthcare providers and the general public as it does with other approved products. Pfizer declined to share its marketing and advertising plans but said it seeks to take a thoughtful approach with such communications in hopes of increasing vaccine confidence. 

Pfizer made its FDA marketing approval application last May and Moderna, which produces the other mRNA vaccine, applied for FDA marketing approval in June so Moderna now moves from the on deck circle to at bat.

Federal News Network informs us that “The Pentagon said Monday that it will require service members to receive the COVID-19 vaccine now that the Pfizer vaccine has received full approval. Pentagon spokesman John Kirby said Defense Secretary Lloyd Austin is making good on his vow earlier this month to require the shots once the Food and Drug Administration approved the vaccine. He said guidance is being developed and a timeline will be provided in the coming days.”

Govexec tells us that

During the White House’s daily press briefing, Press Secretary Jen Psaki said that some agencies may roll out requirements that subsets of the federal workforce must be vaccinated, similar to those announced for health care workers at the Veterans Affairs and Health and Human Services departments. Across the federal government, agencies are working to implement President Biden’s requirement that all federal workers and contractors either attest that they have been vaccinated against COVID-19 or submit to a stringent regimen of wearing masks and being tested regularly for the virus.

“I expect there will be more . . . we certainly expect there will be more mandates for factions of federal employees,” Psaki said. “I think you’re looking more at agency-to-agency, or different factions of the government at this point, but expect there will be more on that front.”

In the meantime, federal employee unions have already begun engaging with management at various agencies to negotiate how the Biden administration’s vaccine mandate will be implemented. Matt Biggs, president of the International Federation of Professional and Technical Employees, said that although his union publicly announced its support for the vaccine mandate, it is working to ensure workers’ rights are protected, regardless of whether they elect to be vaccinated.

In other vaccine news, the UPI reports

Most teens and young adults want to get vaccinated against COVID-19, a survey published Friday by JAMA Health Forum found.

About 75% of people ages 14 to 24 years in the United States who responded to the survey, conducted by the University of Michigan’s Institute for Healthcare Policy and Innovation, said they would get the shot, the data showed.

Most agreed with the statement that vaccination was important to “help stop the spread [of the virus], as well as get back to normal as soon as possible,” the researchers said.

Still, about 42% of respondents said they were concerned about COVID-19 vaccine side effects and 12% indicated they worried about the shot’s effectiveness, according to the researchers.

From the health savings account front, Benefits Pro informs us that

“Devenir has given another peek into the current state of HSAs with its demographic survey. Among its key findings:

  • As of December 31, 2020, the study estimates there were over 30 million HSAs covering 63 million people in the United States.
  • Nearly 1 in 5 Americans in their 30s had a health savings account by the end of the year.
  • HSAs are just as popular with older Americans: Account holders over 50 years of age held more than $44 billion in their accounts, with an average balance of just over $4300.

The study also found that HSAs are being used in every state in the country, with some states reporting nearly 77% of the privately insured populations being covered by an HSA. See our slideshow above for the states with the highest and lowest numbers of people covered by HSAs, and click here for the full study.” Here’s a link to another interesting Benefits Pro article on HSAs.

From the telehealth front, mHealth Intelligence reports that

The pandemic has proven the value of telehealth to parents, according to a recent survey by Nemours Children’s Health. But it has also highlighted the need to continue emphasizing the value of virtual visits to overcome barriers to care and improve health and wellness.

A survey of more than 2,000 adults conducted earlier this year in conjunction with Amwell found that while 35 percent of parents used telehealth prior to the COVID-19 crisis (based on a 2017 survey), that percentage jumped to 77 percent during the pandemic. In addition, almost 80 percent have accessed pediatric telehealth services, compared to 35 percent before the pandemic.

Overall, the survey reports, more than 60 percent of parents want to continue using connected health services after the pandemic – including almost 30 percent of parents who hadn’t used any telehealth in the past.

“While one might expect that factors such as income or access to technology are barriers to telehealth, this survey underscores how telehealth proved to be a viable solution to expanding access and reducing disparities in providing timely care during COVID-19,” R. Lawrence Moss, MD, president and CEO of Nemours Children’s Health System, said in a press release. “Regulations that were eased during the pandemic need to become permanent to support telehealth access for the long-term. Telehealth can be part of building health equity among people experiencing social, economic and family challenges.”

From the research front, the National Institutes of Health announced the results of a study of pregnant women:

Drinking alcohol and smoking tobacco cigarettes throughout the first trimester of pregnancy is associated with nearly three times the risk of late stillbirth (at 28 or more weeks), compared to women who neither drink or smoke during pregnancy or quit both before the end of the first trimester, according to a study funded by the National Institutes of Health. Although prenatal smoking is known to increase stillbirth risk, the researchers conducted the study to examine how smoking combined with alcohol use might influence the risk. The researchers also confirmed the higher stillbirth risk from alcohol alone, which has been suggested by earlier, less comprehensive studies.

In healthcare business news, Healthcare Dive tells us that

  • “Google is dissolving its health division, Google Health, after three years as the head of the unit, David Feinberg, departs to become CEO of health IT vendor Cerner.
  • “Google is splitting its health projects and teams across several other divisions of the company, according to an Aug. 19 internal memo to employees from Jeff Dean, the head of Google’s research division, obtained by Insider.
  • Alphabet’s Google created the Google Health division in 2018 to bring its health initiatives under a single umbrella. The Mountain View, California-based company remains committed to healthcare and will continue to invest in the space, but the goal of the reshuffling is to put its teams in the areas that make the most sense for its projects, a​ Google spokesperson told Healthcare Dive.”

Finally, the American Medical Association President Gerald E. Harmon, MD, opines on the actions that the medical community needs to take into order for American life expectancy to resume its upward track:

The AMA is committed to vigorous advocacy and broad-based collaboration to help people everywhere live longer, healthier lives. Our longstanding efforts targeting heart disease and type 2 diabetes—two of our country’s most common and most devastating chronic diseases—bring physicians in multiple practice settings and specialties together with patients, community groups, and both public- and private-sector organizations to better treat those struggling with these conditions, and also to prevent at-risk individuals from developing them.

The AMA Opioid Task Force and our Pain Care Task Force work with lawmakers and policymakers to guide their decision-making, to shift the perspective from responding to overdoses to preventing them, and to develop clinical best practices to reverse and eventually end the epidemic of fatal overdoses that worsened once the pandemic began.

Additional AMA efforts target: (1) behavioral health integration and suicide prevention;(2)firearm safety; (3) reducing maternal mortality; (4) eliminating racial and ethnic disparities in health care; (5) ensuring that digital health technology improves patient care and health outcomes, and (6) transforming medical education to ensure physicians are prepared to meet patient needs today and tomorrow.

Tuesday’s Tidbits

David Ermer–AHRQ, Congress, COVID-19, COVID-19 vaccine, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, the Wall Street Journal reports that “Top House Democrats said the chamber would move forward with voting on the budget blueprint for a $3.5 trillion healthcare, education and climate package next week, rebuffing demands from a group of centrist Democrats to first vote on a $1 trillion infrastructure bill and urging their caucus to stay unified around President Biden’s agenda” According to the article the centrist Democrats opposed the Speaker’s compromise approach discussed in Sunday’s Post and the much larger Democrat progressive causus pushed hard for this outcome. Speaker Pelosi can only afford to lose three of the nine Democrat centrists as the Republicans are expected to unanimously oppose the budget blueprint.

From the Delta variant front

  • Bloomberg reports that the Southern states continue to experience robust vaccination rates one month after the mid-July low point.
  • The Wall Street Journal informs us that “The Delta variant of the Covid-19 virus appears to be breaking through the protection vaccines provide at a higher rate than previous strains, a Wall Street Journal analysis found, though infections among the fully inoculated remain a tiny fraction of overall cases, and symptoms tend to be milder.”
  • Most significantly the New York Times reports tonight that

The Biden administration has decided that most Americans should get a coronavirus booster vaccination eight months after they received their second shot, and could begin offering third shots as early as the third week of September, according to administration officials familiar with the discussions.

Officials are planning to announce the decision on Wednesday at the White House. Their goal is to let Americans who received the Pfizer-BioNTech or Moderna vaccines know now that they will need additional protection against the Delta variant, which is causing caseloads to surge across much of the nation. But the new policy will depend on the Food and Drug Administration authorizing additional shots.

Recipients of the Johnson & Johnson vaccine, which was authorized as a one-dose regimen, will also most likely require an additional dose, the officials said. But they are waiting for results, expected this month, from a clinical trial that provided participants with two doses. So far, only about 14 million people in the United States have gotten the Johnson & Johnson shot, which the government began offering in March. The first Pfizer and Moderna vaccines were given in December.

The first boosters would probably go to nursing home residents, health care workers and emergency workers, who were the first to be vaccinated last winter. They would likely be followed by other older people, then by the general population. Officials envision giving people the same vaccine they originally received.

On the federal employment front, Federal News Network tells us that OPM is promulgating an interim final rule that will allow agencies to “hire [bachelors degree or graduate] students to a temporary appointment of a year or a term appointment of one-to-four years. Students will work for their agency at the General Schedule 11 level or below while in school. Students who finish their degrees and meet a series of other requirements are eligible for a permanent position at the same agency, OPM said.”

From the federal guidance front

  • The National Law Review informs us that “OSHA’s Revised COVID-19 Guidance [released August 13] Adopts CDC’s Latest Recommendation on Masks for Vaccinated Employees, Advocates for Vaccination, and Suggests Periodic Testing for Unvaccinated Employees.” “Although OSHA disclaims that its recommendations are legally binding on employers, the agency also includes language that signals that failure to adhere to the recommendations could be legally significant for the employer.  Specifically, OSHA prefaces its guidance by stating: “The recommendations are advisory in nature and informational in content and are intended to assist employers in providing a safe and healthful workplace free from recognized hazards that are causing or likely to cause death or serious physical harm.”
  • The tri-agencies issued Affordable Care Act FAQ 48 informing interested parties that in response to litigation they are working on an amending the “2018 final regulations that expanded exemptions for entities with religious or moral objections to the contraceptive coverage requirement to which their health plans would otherwise be subject.” That rulemaking of course will lead to more litigation and so on.

On the drug news front, STAT News reports that

A new study found that the number of adults who used two widely prescribed stimulants nearly doubled in recent years, raising concerns about a potential wave of abuse since both medicines can be highly addictive.

Specifically, an estimated 4.1 million adults reported using amphetamines and methylphenidate in 2018, an increase of nearly 80% from 2013. Measured by total prescriptions, the use of amphetamines rose 119% during that time, while the use of methylphenidate grew about 39%, according to the study, which was published in BMJ Open.

The article warns that this surge could turn into another epidemic.

On the healthcare utilization front, Fierce Healthcare reports that

Hospitals did not experience a major rebound in deferred care in the first part of 2021, foretelling that such care may not be coming back, a new analysis finds.

The analysis from Kaiser Family Foundation and the Epic Health Research Network, released Tuesday, found hospital spending was 4.1% below expected levels in June. It is the latest evidence of how the lingering impact of the pandemic could affect hospital finances, especially as the highly transmissible delta variant is causing new surges in most states.

“Several factors may be contributing to the lower-than-expected number of hospital admissions in early 2021,” the analysis said. “For example, the economic effects of the pandemic may depress the number of people seeking services.”

Researchers explored data from 250 hospitals across 47 states and 112 million patients through April 9, 2021.

Hospital admission rates were nearly 90% of what were expected if the pandemic did not happen, the analysis found.

From the tidbits department

  • Health Day tells us that “A small, new study suggests that getting out of your chair every half hour may help improve your blood sugar levels and your overall health.”
  • Fierce Healthcare informs us that “New York City-based Unite Us announced this morning [August 17] the acquisition of Carrot Health, a consumer data and predictive analytics platform offering engagement insights to payer and provider customers. With its new purchase, the social determinants of health software platform said it will be better positioned to help healthcare organizations identify patients with unmet social needs and connect them to community resources across all 50 states. Unite Us did not disclose the terms of the deal, which has already closed.”
  • In this week’s NIH Director’s blog, Dr. Francis Collins discusses how advanced brain scanning can help guide neurosurgeons.
  • Last but certainly not least the HHS Agency for Healthcare Quality and Research issued a call to action on achieving health equity.

Weekend update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

The House of Representatives and the Senate remain on District / State work breaks this week. Of course the Congressional staff never rests. The Wall Street Journal reports that “House Speaker Nancy Pelosi (D., Calif.) on Sunday asked a top committee [the House Rules Committee] to look at moving forward on a $1 trillion bipartisan infrastructure bill along with the $3.5 trillion budget framework in an effort to balance the demands of her party’s ideological factions.” Fierce Healthcare identifies three major healthcare policy areas in the budget framework which healthcare lobbyists are watching carefully.

On the Delta variant front

  • The Wall Street Journal informs us that “Hospitalizations of Covid-19 patients in their 30s have hit a new record, U.S. government data show, a sign of the toll that the highly contagious Delta variant is taking among the unvaccinated.”
  • The message about the inportance of being vaccinated appears to be breaking through to the reluctant. Bloomberg tells us that “The U.S. reported almost 1 million Covid-19 vaccine doses on Saturday, the most for a single day since early July, reflecting a faster pace of inoculation as the delta variant spreads.” Nearly 60% of the vaccine eligible U.S. population (at least 12 years old) is fully vaccinated.

On the healthcare business front, Fierce Healthcare tells us that

UnitedHealth Group and Change Healthcare have entered into a timing agreement with the Department of Justice for their planned $8 billion merger.

In late March, DOJ made a second request for additional details and documentary information related to the merger. Under the timing agreement, which was reached on Aug. 7, UnitedHealth and Change agree to not “consummate” their merger before 120 days have passed since the two certified their compliance with the agency’s request.

The exception is if they receive written confirmation from DOJ that it has completed its investigation in that window, according to a Securities and Exchange Commission filing from Change Healthcare.

As we all know, timing is everything.

On the federal retirement front, Federal News Network reports

Federal retirements in July saw a big jump compared to last year, but the average processing time has swelled to nearly three months.

OPM received 8,922 retirement claims last month, compared to 6,819 claims in July 2020 — a 30.8% increase. Processed claims, meanwhile, only saw a 4.5% increase from 6,620 in July 2020 to 6,920 last month.

The latest numbers show that 2021 is generally seeing far more federal retirements than in 2020, when the pandemic reached its height. With the exception of January and February, every month this year has had year-over-year increases ranging from 10.8% to 47.2%.

Most notably, the 22% increase in federal retirements from June to July has led to a growing claims backlog. The inventory of claims ballooned from 24,999 in June to 27,001 in July, reversing the backlog’s downward trend after its peak in March.

Congress created two extremely complicated federal retirement programs. In the FEHBlog’s view, it’s up to those busy Congressional staffers to streamline the programs in order to facilitate automated claims processing.