Thursday Miscellany

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

In the wake of the Democrat victories in the Georgia Senate elections, Katie Keith in the Health Affairs blog provides her insightful thoughts on what a Democratic Congress means for the Affordable Care Act.

The Robert Wood Johnson Foundation offers for our consideration five experts reflecting on the health equity implications of the COVID-19 public health emergency.

When Medicare pricing changes the healthcare industry takes notice.

  • The American Hospital Association reports today that ” The Centers for Medicare & Medicaid Services has recalculated the Medicare [Part B] Physician Fee Schedule payment rates and conversion factor for calendar year 2021 to reflect changes effective Dec. 27 under the Consolidated Appropriations Act. The new conversion factor is $34.89, which is 3.3% less than the CY 2020 conversion factor of $36.09 but more than the $32.26 conversion factor finalized in the PFS final rule, which would have represented a 10.2% net decrease in PFS payments for CY 2021. This change affects what FEHB plans pay for Medicare prime annuitants. Also where an annuitant over 65 does not pick up Medicare Part B, fee for service FEHB plans pay for doctors services using Medicare Part B payment rates.
  • Beckers Payer Issues reports that “A change in how Medicare pays laboratories for COVID-19 diagnostic tests took effect Jan. 1 * * * Medicare lowered the base payment for COVID-19 tests that use high-throughput technology to $75. Labs can get an additional $25 if they provide results in two days or less.” Medicare testing rates are sound benchmark for out-of-network COVID-19 labs which fail to comply with internet price post requirements.

The Centers for Disease Control yesterday issued an initial report concerning allergic reactions to the COVID-19 vaccines. Here’s the report’s summary:

What is already known about this topic?

Anaphylaxis is a severe, life-threatening allergic reaction that occurs rarely after vaccination.

What is added by this report?

During December 14–23, 2020, monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis after administration of a reported 1,893,360 first doses of the Pfizer-BioNTech COVID-19 vaccine (11.1 cases per million doses); 71% of these occurred within 15 minutes of vaccination.

What are the implications for public health practice?

Locations administering COVID-19 vaccines should adhere to CDC guidance for use of COVID-19 vaccines, including screening recipients for contraindications and precautions, having the necessary supplies available to manage anaphylaxis, implementing the recommended postvaccination observation periods, and immediately treating suspected cases of anaphylaxis with intramuscular injection of epinephrine.

The Department of Health and Human Services announced today

a national plan to address the serious, preventable public health threat caused by viral hepatitis in the United States. The Viral Hepatitis National Strategic Plan for the United States: A Roadmap to Elimination 2021–2025 sets national goals, objectives, and strategies to respond to viral hepatitis epidemics. Building on three prior National Viral Hepatitis Action Plans over the last 10 years, the Viral Hepatitis National Strategic Plan is the first to aim for elimination of viral hepatitis as a public health threat in the United States by 2030.  This plan serves as a roadmap for stakeholders at all levels and across many sectors, both public and private, to guide development of policies, initiatives, and actions for viral hepatitis prevention, screening, care, treatment, and cure.  

Federal News Network reports that

Federal payroll providers and agencies are beginning to detail exactly how and when federal employees and servicemembers will repay the Social Security taxes that were deferred from their paychecks during the last four months of 2020. The latest omnibus spending package, which the president signed into law last week, allows those subject to the president’s payroll tax deferral to repay the deferred taxes — worth 6.2% of their income — throughout the entire year of 2021, rather than the first four months of the year.

The article provides examples but generally the services are collecting in equal installments over the course of 2021.

Monday Roundup

Photo by Sven Read on Unsplash

The FEHBlog should rename Monday’s column COVID-19 Vaccine Good News because for the fourth Monday in a row that news leads the FEHBlog.

Healthcare Dive reports that “Moderna on Monday released new study results showing the [messenger RNA based] coronavirus vaccine it developed with U.S. government scientists to be 94.1% effective at preventing COVID-19 in a large clinical trial, data the company will use to request emergency approval” from the Food and Drug Administration.

According to Moderna’s announcement

[P]rimary analysis was based on 196 cases [of COVID-19 within the test group of 30,000 individuals, half of whom received the vaccine and the other half of whom received a placebo]. 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 [vaccine] group, resulting in a point estimate of vaccine efficacy of 94.1%. A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases (as defined in the study protocol) in this analysis. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one COVID-19-related death in the study to date, which occurred in the placebo group.

Efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants).

The safety profile of the Phase 3 study of mRNA-1273 was previously described on November 16. A continuous review of safety data is ongoing and no new serious safety concerns have been identified by the Company. Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose.

Healthcare Dive adds that

Moderna said it will submit on Monday [today] an application for emergency use authorization in the U.S. and for conditional marketing approval in Europe. The FDA will convene a panel of independent advisers to publicly review Moderna’s application, likely on Dec. 17. * * *

An authorization for either vaccine [Pfizer – BioNTech or Moderna] would kick off a mass immunization campaign in the U.S. But supplies of each shot will be extremely limited for months. Moderna expects to have just 20 million doses available in the U.S. this year, and between 500 million to 1 billion in 2021. [Two doses protect one person. The Wall Street Journal notes that Pfizer and BioNTech said they would deliver about 25 million doses by year’s end, potentially enough for about 12.5 million people in the U.S.]

A Centers for Disease Control and Prevention advisory committee will meet on Tuesday to vote on how vaccine doses will allocated. Healthcare workers on the front lines of the pandemic will likely be vaccinated first.

The Wall Street Journal expands on this last point:

Expected to be first in line: health workers treating coronavirus patients and in something of a surprise, nursing-home residents.

The Advisory Committee on Immunization Practices, the outside medical experts advising the U.S. Centers for Disease Control and Prevention, will vote on who should get the first doses, after discussing plans for distributing the shots and monitoring for potential side effects.

In other news

  • The FEHBlog overlooked the CDC’s Antibiotic Awareness Week which was held from November 18 – 24. Better late than never right. This is an important public health cause and the link provides useful resources.
  • The FEHBlog noticed a Health Payer Intelligence article about a health plan that “has reduced out-of-pocket healthcare spending by collectively giving members millions of dollars in rewards through their My Health Pays program.” The FEHBlog did a little investigative work and he discovered that the health plan in question participates in the ACA marketplace. It is crazy that individual health plans have no limits on wellness reward uses while group health plans generally must limit their wellness rewards to reimbursing medical services and supplies or Medicare premiums. Congress should level the playing field.

Happy National Rural Health Day

Photo by Tomasz Filipek on Unsplash

It is National Rural Health Day which HHS’s Health Resources and Services Administration is proud to celebrate.

The Defense Department reports on yesterday’s Operation Warp Speed press conference. The Wall Street Journal adds that

Initially, people will be vaccinated at hospitals and large medical centers because supplies will be limited, said Marion Whicker, deputy chief of supply, production and distribution at Operation Warp Speed, the federal initiative to speed development of Covid-19 drugs and vaccines. “When you see vaccines start to equal or exceed demand is when you’ll see it out of the pharmacies,” said Ms. Whicker.

According to Endpoint News, “BioNTech CEO Ugur Sahin told CNN Wednesday that they and Pfizer plan to file for an emergency use authorization for their jointly developed vaccine on Friday [/ tomorrow].

The Wall Street Journal further reports on the COVID-19 front that

U.S. hospitals say they are facing the pandemic’s largest surge armed with treatment improvements that allow them to save lives, care for more patients and accelerate the recovery of coronavirus sufferers.

HCA Healthcare Inc., one of the nation’s largest hospital chains with 186 hospitals, has more intensive-care capacity as the sickest patients recover more quickly. At the Mayo Clinic’s hospital in Rochester, Minn., coronavirus patients now stay a median of five days, half as long as in March. The time Covid-19 patients spend at Advocate Aurora Health’s 26 Midwestern hospitals has fallen 25% on average since May.

The shift could be a result of several factors and more study is needed, said doctors and researchers. But the results are consistent with anecdotal reports from doctors saying that new tools and a better understanding of how Covid-19 attacks the body are helping to improve medical outcomes.

Also HHS announced today launching

a pilot program with five states to use portable, cartridge-based COVID-19 molecular test kits that provide rapid results. The pilot program will assess how to best integrate diagnostic technology developed by Cue Health, Inc., into strategies for disease surveillance and infection control in institutions such as nursing homes.

Used successfully as the primary molecular point-of-care (POC) test to control the spread of COVID-19 within in the National Basketball Association “bubble,” as well as by leading healthcare providers in the U.S., the nasal swab POC test generates results in about 20 minutes. Currently, molecular COVID-19 tests provided by HHS must be sent to a laboratory for interpretation, which can take two to three days.

The Centers for Disease Control and the American Medical Association, the American Hospital Association and the American Nursing Association are encouraging Americans to curb holiday travel and scale back holiday gatherings due to the recent surge in COVID-19 cases. That’s a useful message for health plans circulate to members and employees.

Following up on this week’s launch of Amazon’s online Pharmacy, the Drug Channels blog comments that

This announcement is much less disruptive than it appears to be. Amazon is copying the GoodRx discount card model—including GoodRx’s partnership with Express Scripts. At the same time, Amazon is launching a mail pharmacy that will accept insurance and be in PBM pharmacy networks. Amazon’s actions are another negative headwind for retail pharmacies, but not a fatal blow to the system. Perhaps Amazon will one day become a true disrupter. For now, Amazon is choosing to join the drug channel, not fundamentally change it.

Healthcare Dive lets us in other expert insights on this development.

In other prescription drug coverage news, the Wall Street Journal reports this evening that

The Trump administration is planning on Friday [/ tomorrow] to roll out two final rules aimed at lowering drug prices—one curbing rebates paid to middlemen in Medicare and another pegging the prices of certain prescription drugs in the U.S. to their prices in other developed countries, according to a person familiar with the planning. The plans, slated to be announced in the White House Rose Garden, have been a signature pledge of President Trump’s since his 2016 election campaign. Both rules are expected to be final, meaning they have completed the required public comment period and can take effect immediately.

“Immediately” in this setting would not prevent the incoming Biden Administration from putting the brakes on the iniative without trouble, in the FEHBlog’s opinion.

In other news —

  • According to a press release, “The Sequoia Project, a non-profit and trusted advocate for nationwide health information exchange, patient identity management experts collaborated with the Blue Cross Blue Shield Association (BCBSA) to apply A Framework for Cross-Organizational Patient Identity Management for the payer community and develop person matching strategies. Today, The Sequoia Project published Person Matching for Greater Interoperability: A Case Study for Payers which demonstrates high matching accuracy rates, and provides actionable insights for improving person identity matching across the payer community, a critical component of successful health information exchange and interoperability.” Helpful.
  • According to Fierce Healthcare, “While insurers are set to weather COVID-19’s financial storm, an inability to keep up with how the pandemic is changing healthcare will be credit-negative in the long term, according to a new report from Moody’s Investors Service. The coronavirus pandemic has put a spotlight on chronic conditions, the need for continued investment in telehealth and virtual care and the drive toward value-based care, according to the report. Health plans that are able to adapt to these changing trends are far better positioned for long-term success, Moody’s said.”

Monday Roundup

Photo by Sven Read on Unsplash

Perhaps at last we are beginning to see the light at the end of the COVID-19 tunnel. Pfizer announced positive initial results from the phase three trial of its two dose COVID-19 vaccine.

“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

The Wall Street Journal explains (in part) that ‘

“When will the Pfizer vaccine be ready for [emergency use] authorization?

“It will be several more weeks at the earliest, because researchers and regulators still need to make sure the shot is safe. The U.S. Food and Drug Administration has said it wants to see two months’ worth of safety outcomes after vaccination for at least half of the people participating in any large, final-stage clinical trial before it considers authorizing a Covid-19 vaccine. The FDA says this will allow identification of any side effects, such as neurological or heart conditions, that weren’t apparent immediately after vaccination. So far, no serious safety issues have been found, Pfizer says. It expects the two months of safety data later this month, and can ask the FDA to authorize the vaccine soon thereafter. It isn’t yet clear how long the FDA will take to make a decision.

“When will people start getting vaccinated?

“Shots from Pfizer and BioNTech could start becoming available before the end of the year, as production has already begun, but initial supplies will be limited. Pfizer says it expects to produce up to 50 million doses globally in 2020—enough for 25 million people because the vaccine is given in two doses—and up to 1.3 billion doses in 2021. This means only the highest risk groups, such as front-line health care workers, could be inoculated this year. Many more doses would be needed to cover the U.S. and global population. Other Covid-19 vaccines in development will likely be needed for everyone to get vaccinated. Their makers have projected they could produce billions of doses next year if their vaccines are successful in clinical testing.”

The Centers for Disease Control released a study of hospital readmissions of COVID-19 patients from March through July 2021.

Among 126,137 unique patients with an index COVID-19 admission during March–July 2020, 15% died during the index hospitalization. Among the 106,543 (85%) surviving patients, 9% (9,504) were readmitted to the same hospital within 2 months of discharge through August 2020. More than a single readmission occurred among 1.6% of patients discharged after the index hospitalization.

The CDC also offered us guidance on avoiding COVID-19 during the Thanksgiving holidays.

The Centers for Medicare and Medicaid Services (“CMS”) released Affordable Care Act medical loss ratio rebate data from the latest health insurer reports for the three year period ending in 2019. The medical loss ratio data is broken out into three cohorts — individual insurance (minimum MLR 80%), small group insurance (minimum MLR 80%), and large group insurance (minimum MLR 85%). Each cohort then is further broken down state by state which no doubt increase the rebates. FEHB plan insurer rebates sensibly are paid to the the carrier’s contingency reserve, which is FEHB lingo for a premium stabilization fund.

Katie Keith in the Health Affairs blog offers her insights into tomorrow’s California v. Texas oral argument before the U.S. Supreme Court. C-SPAN will play the audio live on radio and the internet.

“The main issues to listen for are:

  • “Do the challengers—a coalition of states led by Texas and two individuals—have standing to challenge the ACA?
  • “Is the individual mandate, with a $0 penalty, unconstitutional?
  • “If the mandate is unconstitutional, is it severable from the rest of the ACA? If not, which other ACA provisions should be struck down alongside the mandate?”

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

Today’s big news is that the ACA regulators (the Departments of Health and Human Services (“HHS”), Labor, and Treasury) finalized a lengthy pricing transparency rule for payers, including ERISA and FEHBP group health plans (see footnote 233). The related fact sheet explains

This final rule includes two approaches to make health care price information accessible to consumers and other stakeholders, allowing for easy comparison-shopping.

First, most non-grandfathered group health plans and health insurance issuers offering non-grandfathered health insurance coverage in the individual and group markets will be required to make available to participants, beneficiaries and enrollees (or their authorized representative) personalized out-of-pocket cost information, and the underlying negotiated rates, for all covered health care items and services, including prescription drugs, through an internet-based self-service tool and in paper form upon request. For the first time, most consumers will be able to get real-time and accurate estimates of their cost-sharing liability for health care items and services from different providers in real time, allowing them to both understand how costs for covered health care items and services are determined by their plan, and also shop and compare health care costs before receiving care. An initial list of 500 shoppable services as determined by the Departments will be required to be available via the internet based self-service tool for plan years that begin on or after January 1, 2023. The remainder of all items and services will be required for these self-service tools for plan years that begin on or after January 1, 2024.

Second, most non-grandfathered group health plans or health insurance issuers offering non-grandfathered health insurance coverage in the individual and group markets will be required to make available to the public, including stakeholders such as consumers, researchers, employers, and third-party developers, three separate machine-readable files that include detailed pricing information.
The first file will show negotiated rates for all covered items and services between the plan or issuer and in-network providers.
The second file will show both the historical payments to, and billed charges from, out-of-network providers. Historical payments must have a minimum of twenty entries in order to protect consumer privacy.
And finally, the third file will detail the in-network negotiated rates and historical net prices for all covered prescription drugs by plan or issuer at the pharmacy location level.
Plans and issuers will display these data files in a standardized format and will provide monthly updates. This data will provide opportunities for detailed research studies, data analysis, and offer third party developers and innovators the ability to create private sector solutions to help drive additional price comparison and consumerism in the health care market. These files are required to be made public for plan years that begin on or after January 1, 2022.

The final rule also provides some medical loss ratio relief to compliant health insurance issuers as explained in the fact sheet. Here is AHIP’s reaction to the final rule.

Also today HHS issued an interim final rule with a comment period that “extends the compliance dates and timeframes necessary to meet certain requirements related to information blocking and Conditions and Maintenance of Certification (CoC/MoC) requirements. Released to the public on March 9, 2020, ONC’s Cures Act Final Rule established exceptions to the 21st Century Cures Act’s information blocking provision and adopted new health information technology (health IT) certification requirements to enhance patients’ smartphone access to their health information at no cost through the use of application programming interfaces (APIs).” The rule had been scheduled to take effect beginning next week.

Fierce Healthcare reports that “Regeneron’s anti-SARS-CoV-2 antibody cocktail has significantly reduced medical visits in ambulatory COVID-19 patients. The phase 2/3 clinical trial linked REGN-COV2 to a 57% decline in medical visits associated with COVID-19 in the 29 days after treatment.”

HealthPartners, a Minneapolis health insurer that participates in the FEHBP, offers a helpful, complete explanation of the benefits of wearing masks to prevent COVID-19. “At its core, wearing a mask is an act of kindness and neighborliness. It’s one of the simplest good deeds you can do these days, and a great way to be a force of positivity for the people in your life.”

Fierce Healthcare reports

The financial crisis for hospitals and physician practices caused by the COVID pandemic is a “clarion call” for the healthcare industry to move from a fee-for-service payment model to value, said Kevin Mahoney, chief executive officer of the University of Pennsylvania Health System (Penn Medicine).

“The hospital sector has taken a giant hit. We keep hearing about ‘the new normal.’ The lesson that we learned is that there is nothing new or normal about a pandemic, there’s just been an acceleration of trends,” Mahoney said during a recent virtual event hosted by the University of Pennsylvania. “It has laid bare how dependent hospitals are on commercially-insured, elective procedures, and without them, we don’t make money.”

The FEHBlog’s youngest son is a research coordinator for Penn Medicine. The FEHBlog seconds his boss’s sentiments.

The Surgeon General issued a timely

Call to Action to Control Hypertension (Call to Action) seeks to avert the negative health effects of hypertension by identifying evidence-based interventions that can be implemented, adapted, and expanded in diverse settings across the United States.

The Call to Action outlines three goals to improve hypertension control across the United States, and each goal is supported by strategies to achieve success:

Goal 1. Make hypertension control a national priority.
Goal 2. Ensure that the places where people live, learn, work, and play support hypertension control.
Goal 3. Optimize patient care for hypertension.

Following up on yesterday’s post about mandatory of coverage of COVID-19 vaccines with no member cost sharing once available, the FEHBlog wants to add that the same rule applies to Medicare. CMS “estimates the overall cost of providing the vaccine to every senior on Medicare would be around $2.6 billion, which would be covered by the federal government. CMS will also cover the vaccine for any uninsured individuals by using money from a $175 billion provider relief fund passed as part of the CARES Act.” It appears however that the vaccine would be administered through the Part D program. That would not be much help to FEHB plans as most FEHB members with primary Medicare coverage does not carry Medicare Part D.

Nextgov reports that

The Health and Human Services Department, the Cybersecurity and Infrastructure Security Agency and the FBI warn hospitals face an imminent threat from cybercriminals that encrypt and hold their data hostage—and some health care facilities are already dealing with the fallout.

The agencies collectively issued an advisory Wednesday detailing the tactics, techniques and procedures reportedly used against at least five hospitals already this week. The advisory includes recommendations for mitigating what observers are referring to as the most serious cyber threat the U.S. has seen to date, being perpetrated by an especially ruthless group of criminals.  

“CISA, FBI, and HHS have credible information of an increased and imminent cybercrime threat to U.S. hospitals and healthcare providers,” reads the advisory.

Friday Stats and More

Based on the Centers for Disease Control (CDC) Cases in the U.S. website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 20th through 40th weeks of this year (beginning May 14 and ending October 7; 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:

Because the FEHBlog does look at his charts which are intended to show trends, he realized that new deaths chart is flat because new cases greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the same period (May 14 through October 7 (nearly five months).

Chris Conover recently wrote about your risk of dying from COVID-19 in the Forbes Apothecary. Three takeaways from the article:

  • Covid-19 has increased the risk of death for the average American by about 10 percent, but this increase in risk is much higher for seniors than children.
  • For seniors age 70 and older, getting Covid-19 is riskier than climbing Mt. Everest; in contrast, for those under age 20, the infection fatality risk is equivalent to driving a car for 7,500 miles.
  • Those under age 50 who get infected with the coronavirus lose less than one day of discounted quality-adjusted life expectancy; seniors age 70 or older lose nearly 90 days.

Today the CDC released the first weekly influenza update for this flu season in our country. The key update is brief: “Seasonal influenza activity in the United States remains low.” In contrast, the key update from this week’s COVID-19 update from the CDC is more nuanced:

Nationally, indicators that track COVID-19 activity continued to decline or remain stable (change of ≤0.1%). However, one region reported a slight increase in the percentage of specimens testing positive for SARS-CoV-2 and four regions reported slight increases in the percentage of visits for influenza-like illness (ILI). Mortality attributed to COVID-19 declined but remains above the epidemic threshold.

Today, the CDC also issued its National Action Plan for Combating Antibiotic Resistance 2020-2025, a worthy goal. “The U.S. Government will report annually on progress toward the objectives set in the Plan.”

In his Libertarian podcast this week, law professor Richard Epstein discussed why the Supreme Court will uphold the constitutionality of the Affordable Care Act in the California v. Texas case, which will be argued on November 10. The FEHBlog is buying what the good professor is selling. The discussion is in the first 10 minutes of the podcast which is less than 30 minutes overall.

The HHS Office for Civil Rights took its second scalp this week from a healthcare provider that allegedly failed to give patients HIPAA required access to their medical records, a big OCR priority. “NY Spine Medicine (NY Spine) has agreed to take corrective actions and pay $100,000 to settle a potential violation of the HIPAA Privacy Rule’s right of access provision. NY Spine is a private medical practice specializing in neurology and pain management with offices in New York, NY, and Miami Beach, FL.”

Have a good weekend.

Midweek Update

Photo by Maria Teneva on Unsplash

The Blue Cross Blue Shield Association has a new president and CEO effective January 4, 2021 — Kim A. Keck. Ms. Keck, who will be the first woman to hold this position, is currently president and CEO of Blue Cross of Rhode Island. She worked for Aetna for 28 years. Of course, she succeeds Scott Serota. Congratulations, Ms. Keck.

Congratulations as well to the 2020 winners of the Nobel Prize in Chemistry, Emmanuelle Charpentier of the Max Planck Institute in Berlin and Jennifer Doudna of the University of California, Berkley, for their work in developing “genetic scissors” known as CRISPR-Cas9 “that can cut DNA at a precise location, allowing scientists to make specific changes to specific genes.” NPR explains that

“Once in a long time, an advance comes along that utterly transforms an entire field and does so very rapidly,” says Francis Collins, director of the National Institutes of Health, which has long supported Doudna’s research. “You cannot walk into a molecular biology laboratory today, working on virtually any organism, where CRISPR-Cas9 is not playing a role in the ability to understand how life works and how disease happens. It’s just that powerful.”

In other good news Precision Vaccinations reports that

The CDC researchers noted in the Morbidity and Mortality Weekly Report published on October 2, 2020, that during the 2019-20 flu season, 61.2 percent of surveyed pregnant women received the flu vaccine, which was 7.5 percentage points higher than the previous flu season. In addition, 56.6 percent of the women received the Tdap vaccine during pregnancy, and 40.3 percent received both vaccines. The percentage of women receiving both vaccines significantly increased from 35 percent just one year ago.

These increases were driven by increased vaccination coverage among Black and Hispanic women and those of other races reported the CDC. The CDC authors stated: “Racial disparities in vaccination coverage could decrease further with consistent provider offers or referrals for vaccination, in combination with culturally competent conversations with patients.” Specifically, this data found approximately 20 percent of pregnant women reported not receiving a provider recommendation for these vaccinations.

On the COVID-19 front, STAT News informs us that Eli Lilly reports good results with its synthetic antibody treatments for COVID-19. Lilly is seek emergency authorization use approval from the Food and Drug Administration as it continues to clinical trials on the treatments.

In other news —

The Department of Health and Human Services (“HHS”) announced today that

Surgeon General VADM Jerome M. Adams, M.D., M.P.H., issued a Call to Action urging Americans to recognize and address hypertension control as a national, public health priority. The Surgeon General’s Call to Action to Control Hypertension provides strategies for those on the frontlines of health care and public health to address this costly, dangerous and far too common chronic health condition.

According to Fierce Healthcare, Express Scripts has added new tools to its digital formulary that address “women’s health needs, tobacco cessation, muscle and joint pain, caregiver care and COVID-19 workplace support. The formulary’s goal is to assist employers and other plan sponsors in finding the digital health solutions that best fit their worker’s needs, and which have been vetted by experts at Express Scripts for key concerns like effectiveness, value, user experience and security.”

Healthcare Dive lets us know that

Doctors and consumers expect to use virtual care more often after COVID-19 than they did before, according to a new survey from telehealth vendor Amwell, hinting at the long-term potential of the virtual care model in healthcare. Prior to the pandemic, the majority of virtual visits were for on-demand urgent care. But this year, the volume of virtual specialty and scheduled visits outpaced urgent care, suggesting telehealth is becoming normalized across more fields and use cases. Only about 21% of consumers had a virtual visit for on-demand urgent care visit this year. By comparison, 54% had a scheduled visits with their primary care physician.

HHS’s Office for Civil Rights announced another HIPAA scalping of a healthcare provider that failed to provide individual access to their medical record, a top OCR priority at this time. “Dignity Health, doing business as St. Joseph’s Hospital and Medical Center (“SJHMC”), has agreed to take corrective actions and pay $160,000 to settle a potential violation of the HIPAA Privacy Rule’s right of access provision. SJHMC, based in Phoenix, Arizona, is a large, acute care hospital with several hospital-based clinics that provide a wide range of health, social, and support services.”

Monday Roundup

Photo by Sven Read on Unsplash

In COVID-19 vaccine news —

  • The American Hospital Association has a COVID-19 vaccine resources and information website.
  • PharmaManufacturing is reporting that ” Pfizer’s CEO recently stated that the company could be ready to submit data from a late-stage trial of its coronavirus vaccine by the end of October — but experts are urging the company to slow its roll. According to Bloomberg Law, more than 60 bioethicists and researchers have penned a letter asking Pfizer to delay data reporting until November.” Why not let the Food and Drug Administration do its job?

In COVID-19 rapid testing news, HHS announced today a detailed “national distribution plan for the Abbott BinaxNOW Ag Card rapid test to assist Governors’ efforts to continue to safely reopen their states. BinaxNOW is a unique testing option to provide support to K-12 teachers and students, higher education, critical infrastructure, first responders, and other priorities as governors deem fit. The BinaxNOW rapid test – the only U.S. Food and Drug Administration-authorized antigen rapid point-of-care test that does not require an instrument – is easy to use, will produce COVID-19 test results in 15 minutes, and costs $5. * * * The Federal government purchased these Abbott BinaxNOW diagnostic tests on August 27, 2020, to ensure equitable distribution of the first 150 million units – one day after an Emergency Use Authorization (EUA) was issued by the FDA to ensure they would be expeditiously distributed to vulnerable populations as quickly as possible.

In other news —

  • The Centers for Disease Control reported today about COVID-19 trends among school age children in our country. “Since March, 277,285 COVID-19 cases in children have been reported [out of seven million in total]. COVID-19 incidence among adolescents aged 12–17 years was approximately twice that in children aged 5–11 years.”
  • Healio reports on the multiple uses of telehealth beyond acute primary care. “[T]elehealth has been routinely incorporated in specialties such as psychiatry and asthma/allergy care, even prior to the COVID-19 era [‘PC”]. * * * Further, telemedicine allows for triage of patients with COVID-19 symptoms without requiring face-to-face visits to help direct next steps for testing and treatment. Telehealth can be effectively incorporated into oncology care — provided thoughtful and appropriate measures are taken.”
  • There has been a lot of press about the nomination of Judge Amy Coney Barrett to the Supreme Court following the sad occasion of Justice Ruth Bader Ginsburg’s death. It is quite likely that Judge Barrett will be sitting on the Supreme Court when the California v. Texas case is argued on November 10. Speculation is rife about this development and it is truly unfortunate that the Trump Administration is now siding with the States opposing the law’s constitutionality in the California v. Texas case. In the FEHBlog’s opinion, the position against the law’s constitutionality is a weak cup of tea. The FEHBlog is confident that the Supreme Court opted to hear the case to end this litigation in favor of the ACA’s general constitutionality. Congress obviously did not intend to render the ACA unconstitutional by zeroing out the individual mandate. The American Prospect observes

The whole legal argument [against the ACA’s constitutionality] depends on the fact that Republicans used reconciliation to pass the 2017 tax bill through the Senate with a simple majority. Due to the restrictions around reconciliation, Republicans couldn’t technically repeal the mandate in total, instead just lowering the penalty to nothing. The case effectively goes away if Congress either adds back in a penalty (even of just one cent), or just officially repeals the mandate, thereby severing it from the whole health care law.

Trying to bring back a penalty is a terrible option. The mandate is deeply unpopular, and it would be easy for Senate Republicans to oppose that move. What’s more, in the months since the mandate penalty went away, we’ve learned that it wasn’t as necessary to making the Obamacare system work as Democrats insisted in 2009 and 2010. Fully repealing the individual mandate, on the other hand, is an easy fight to win, as well as good policy. It is generally bad to have unenforced laws on the books.

Congress should take this action now by enacting an individual mandate repeal just as it repealed other ACA taxes in 2019. This is not to suggest that Congressional action is the only step that could save the law. But it would short circuit this craziness.

Monday Roundup

Photo by Sven Read on Unsplash

The House of Representatives Rules Committee issued a rule today on the FY 2021 continuing resolution (H.R. 8913) by a 7-3 vote. The House is expected to vote on the bill soon. Nothing is certain in this world but the FEHBlog considers this CR to be on track to become law.

Katie Keith writes in the Health Affairs Blog on the impact of Justice Ruth Bader Ginsburg’s death on the California v. Texas case (No. 19-840) raising the constitutionality of the Affordable Care Act (“ACA”) That case is scheduled for oral argument on November 10 one week after the national election. The FEHBlog expects the Supreme Court to preserve the ACA no matter who wins the Presidential election because the Texas case challenging the law is weak. The proof is in the pudding as the preexisting condition free ACA marketplace has kept running without the individual mandate, just like the FEHBP.

The Centers for Disease Control last week issued its 2019 U.S. maps of adult obesity prevalence. Here are the CDC’s obesity tidbits which should be useful for FEHB plans which cover the nation in particular:

  • 6 states had an obesity prevalence of 35 percent or higher among non-Hispanic White adults.
  • 15 states had an obesity prevalence of 35 percent or higher among Hispanic adults.
  • 34 states and the District of Columbia had an obesity prevalence of 35 percent or higher among non-Hispanic Black adults.
  • Obesity decreased by level of education. Adults without a high school degree or equivalent had the highest self-reported obesity (36.2%), followed by high school graduates (34.3%), adults with some college (32.8%) and college graduates (25.0%).
  • Young adults were half as likely to have obesity as middle-aged adults. Adults aged 18-24 years had the lowest self-reported obesity (18.9%) compared to adults aged 45-54 years who had the highest prevalence (37.6%).
  • All states and territories had more than 20% of adults with obesity.
  • 20% to less than 25% of adults had obesity in 1 state (Colorado) and the District of Columbia.
  • 25% to less than 30% of adults had obesity in 13 states.
  • 30% to less than 35% of adults had obesity in 23 states, Guam, and Puerto Rico.
  • 35% or more adults had obesity in 12 states (Alabama, Arkansas, Indiana, Kansas, Kentucky, Louisiana, Michigan, Mississippi, Oklahoma, South Carolina, Tennessee, and West Virginia).
  • The Midwest (33.9%) and South (33.3%) had the highest prevalence of obesity, followed by the Northeast (29.0%), and the West (27.4%).

The Health and Human Services Office for Civil Rights announced today that the “Athens [Georgia] Orthopedic Clinic PA (“Athens Orthopedic”) has agreed to pay $1,500,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) and to adopt a corrective action plan to settle potential violations of the HIPAA Privacy and Security Rules.” Athens Orthopedic which serves 138,000 patients annually settled allegations of widespread system violations of those rules.

Friday Stats and More

Based on the CDC’s Cases in the U.S. website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 20th through 37th weeks of this year (beginning May 14 and ending September 16; 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:

Because the FEHBlog does look at his charts which are intended to show trends, he realized that new deaths chart is flat because new cases greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the same period (May 14 through September 16 (basically four months).

In other COVID-19 news:

  • The Wall Street Journal reports

U.S. hospitals expect to be better prepared if a second wave of Covid-19 cases hits in coming months, doctors and administrators say, after gaining a better understanding how to triage patients, which drugs to use and what supplies are needed. When the new coronavirus first struck, beds filled up at record speed, ventilators were in short supply and proven treatments were scant. Since then, doctors say, they have developed a better understanding of who needs a ventilator and how quickly a patient can be discharged, and studies have pointed to a few drugs like the antiviral remdesivir and the steroid dexamethasone that can help

The FEHBlog heartily agrees that the country is better prepared but he believes that the Journal is assuming facts not in evidence when it speaks about a second wave because we really are still in the first wave.

  • Medscape offers an MD’s perspective on the leading COVID-19 vaccine candidates.
  • The Wall Street Journal reports that the Centers for Disease Control withdrew last month’s highly criticized advice that people who had contact with asymptomatic COVID-19 patients don’t need a COVID-19 test. “The Sept. 18 updated recommendation now says that close contacts of a person with a confirmed Covid-19 infection need a test even in the absence of symptoms. The changes were described as a clarification, rather than a revision, on the CDC website.”
  • Speaking of COVID-19 testing, Mercer Consulting offers advice on how to cover COVID-19 testing which Congress made unnecessarily complicated.

In other news,

  • Govexec.com reports that “House Democrats are preparing to vote [next week] on a six-week stopgap spending bill that would keep agencies open through Dec. 11, according to Democratic aide.” From reading the article, it looks like the continuing resolution which is not fully backed will be enacted thereby avoiding what would be the craziest government shutdown in American history.
  • Speaking of criticism, Fierce Healthcare reports that “the American Academy of Family Physicians, which represents about 135,000 physicians, said the recommendations miss the mark and skew toward virtual-only telehealth vendors and large medical systems with established telehealth infrastructure. The task force’s report doesn’t address the needs of independent practices that need guidance, support and payment advocacy, wrote Stephanie Quinn, AAFP senior vice president of advocacy, practice advancement and policy in a blog post Tuesday.” The most encouraging tele heath acceleration that the FEHBlog witnessed during the great hunker down is patients holding telehealth visits with their own doctors. That FEHBlog agrees with AAFP that this trend that should be strongly encouraged.
  • Healthcare Dive reports that “Privately insured patients pay 247% more at hospitals on average than Medicare patients for the same care, according to a new study by nonprofit think tank RAND. The study, based on 2018 data, shows the gap is increasing from 2017 and 2016, which saw disparities of 230% and 224%, respectively. If private payers had paid Medicare rates over the three-year study period, they would have saved $19.7 billion, RAND determined. The study could provide fodder for proponents of a government-run public option, a key tenet of Democratic presidential nominee Joe Biden’s healthcare agenda, which — like Medicare — would negotiate prices with hospitals and other providers.

Hey, Healthcare Dive, in contrast to health plans which do negotiate with healthcare providers Medicare imposes prices on providers. Government price fixing leads to disparities like this and it’s far from a good thing.