Thursday Miscellany

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.

Monday Roundup

The Wall Street Journal reports today that

Photo by Sven Read on Unsplash

“Public-health experts increasingly agree—including critics of the Great Barrington Declaration—that the broad, months long lockdowns imposed in March may be too unpopular to sustain [again]. Experts who backed lockdowns in the spring now worry another round of the same type could backfire if the public ceases to comply.

Even proponents of more lockdowns are generally pushing for briefer, more targeted closures, dubbed circuit-breakers, in which governments would shut specific businesses for two or three weeks, such as bars, restaurants and possibly universities. Other institutions that appear to be lower risk—including day cares, elementary schools and outdoor facilities—could remain open.

“The opinion of public health experts is changing very rapidly,” said Jayanta Bhattacharya, a professor of medicine at Stanford University, who is one of the co-authors of the Great Barrington Declaration. “In March, I felt alone. [Now] I think there are a very large number of public health experts, epidemiologists, and doctors who oppose further lockdowns.”

That’s a consensus that the FEHBlog can support.

Fierce Healthcare reports from the HLTH Conference on Humana CEO Bruce Broussard’s talk on how he adjusted his leadership style to the COVID-19 public health emergency. “He said that a virtual work environment has forced him to be much more “intentional” in his leadership approach, which meant adopting new strategies to reach workers and being more thoughtful about how he approaches communicating with Humana’s employees. * * * In addition,Broussard said he believes COVID-19 is putting a spotlight on the value of taking a whole-person approach to care. Having flexible access to a number of different services at home was crucial for the insurer’s largely-Medicare Advantage member base, who were at high risk from complications if they caught the virus. Broussard said he doesn’t foresee the momentum toward those options going away once COVID-19 is under control.

Today, the FEHBlog ran across another interesting conference which is being held later this week — American Healthcare Information Management Association (“AHIMA”) 20. The FEHBlog, who is an AHIMA member, purchased access to this virtual conference. The conference runs from October 14 to October 17.

A related organization, the Workgroup for Electronic Data Interchange (WEDI) holds its virtual annual conference from October 20 to 22. WEDI focuses on the HIPAA standard transactions while AHIMA focuses on the HIPAA-coded data included in those transactions. It is the umbrella law that piques this lawyers interest among other things.

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.”

Happy New Fiscal Year

Today, October 1, 2020, is the beginning of the new 2021 federal fiscal year and the fourth calendar quarter of 2020. Federal News Network reports that the President signed the compromise continuing resolution into law at 1 am this morning. The federal government is now funded through December 11, 2020.

The Washington Post reminds us that

Most federal employees [became] eligible Thursday [October 1] for paid parental leave, a benefit valued at about $1 billion a year and one of the most significant expansions of their benefits since the creation of unpaid parental leave more than 25 years ago. The new entitlement will allow employees to take paid time off for part or all of 12 weeks over a 12-month period, effective with births, adoptions or foster placements that occur Thursday and after. Previously, employees could take 12 weeks of unpaid time available under the Family and Medical Leave Act.

On the COVID-19 front —

  • The Wall Street Journal provides operational background on the current Phase III COVID-19 vaccine trials.
  • The Department of Health and Human Services announced an agreement with the Rockefeller Foundation “to identify and share effective approaches for using rapid point-of-care (POC) antigen tests to screen for COVID-19 in communities, with a focus on safely reopening K-12 schools. The partnership establishes a pilot program with select cities and states in The Rockefeller Foundation’s Testing Solutions Group (TSG), a network of public officials devoted to rapidly scaling COVID-19 testing, tracing, and tracking in their communities.”
  • STAT News discusses the somber connection between diabetes and COVID-19.

Data from the U.S. Centers for Disease Control and Prevention show more than three-quarters of people who died from Covid-19 had at least one preexisting condition. Overall, diabetes was noted as an underlying condition for approximately 4 in 10 patients. Among people younger than 65 who died from the infection, about half had diabetes.

[Moreover,] Juliana Chan, director of the Hong Kong Institute of Diabetes and Obesity, said the pandemic has intertwined with and exposed two other widespread problems: diabetes and disparities triggered by social determinants of health.

“What we are seeing is nothing new, but it is really just on a massive and global scale,” she said in an interview. “I hope that there is something positive out of this, that people understand that we are hit by three epidemics.”

  • The U.S. Department of Labor issued additional FAQs “regarding the need to report employees’ in-patient hospitalizations and fatalities resulting from work-related cases of the coronavirus.”

Because October is National Cybersecurity Awareness Month, the FEHBlog wishes to point out this Health IT Security report that

From October 2019 to July 2020, Microsoft data shows hackers have rapidly improved the sophistication and increased the frequency of cyberattacks. And when it comes to incident response engagements, ransomware attacks were the most common cause. The report follows reports that the Universal Health Services health system is currently recovering from what appears to be one of the biggest ransomware attacks in recent history. Further, nearly a dozen healthcare entities in the past month have either faced similar incidents or saw their data leaked online by ransomware threat actors.

Midweek Update

Photo by Manasvita S on Unsplash

Late this afternoon, the Senate approved the compromise FY 2021 continuing resolution (H.R. 8337) by a vote of 84-10. The President is expect to sign the bill into law tonight. The bill provides continued funding for the federal government through December 11. Congress will hold a lame duck session following the national election on November 3 to consider next steps on FY 2021 appropriations.

This bill includes two provisions relevant to the FEHBP:

  • Section 2401 caps any increase to the Medicare Part B premium at 25% of what it otherwise would be for 2021. Presumably this cap only applies to the basic Part B premium and not to the increased premiums paid by high earners. In any event it should help encourage annuitants to join or stay enrolled in Part B. CMS should be announcing Medicare Part B and other traditional Medicare cost sharing amounts later in October.
  • Section 138 allows OPM, “which is still grappling with its own funding shortfall after the governmentwide security clearance business transferred to the Defense Department last year, to tap into the trust funds it oversees to keep its own operations going.” How would this impact the FEHBP? Section 8909 of the FEHB Act imposes a 4% surcharge on net to carrier premiums. 75% of that surcharge is deposited in a contingency reserve for the carrier which acts like a premium stabilization fund. The remaining 25% of that surcharge is available to cover OPM costs of FEHB administration to the extent appropriated by Congress. Congress typically appropriates only 1/4 of the administration fund to OPM and the balance per Section 8909 is deposited into the FEHB plan contingency reserves based on enrollment. It appears to the FEHBlog that this new law has given OPM the authority to tap into that surplus that otherwise would have been available to the FEHBP carriers. This is not the only such trust fund available to OPM.

The Wall Street Journal and the Hill report that the House Speaker Nancy Pelosi and the Secretary of the Treasury Steven Mnuchin will continue to discuss a compromise fourth COVID-19 relief bill tomorrow. The two leaders met today for 90 minutes and they hope for more progress tomorrow.

On the COVID-19 front —

  • The U.S. National Science Foundation discusses how it has been funding small businesses in the fight to control COVID-19. “Startups nationwide responded with creativity and a diversity of experiences to create innovative technology solutions in the COVID-19 crisis,” said Andrea Belz, director for the Division of Industrial Innovation and Partnerships. “NSF-funded solutions have the potential to make a significant impact in the fight against COVID and future pandemic threats.” That’s encouraging.
  • Forbes reports on a deal between startup tech company doc.ai and major health and Blue Cross licensee Anthem. “One of the products that Anthem is offering its members through doc.ai is called Passport, which helps employees safely return to in-person work during the Covid-19 pandemic. An employer decides on the parameters and each morning the employee answers a self-assessment that determines whether or not the app generates a unique barcode to enter the office building. But the key here is that the protected health information is never sent to the employer—it stays on the employee’s phone—and all the employer sees is whether the QR code was issued. De Brouwer likens it to “soft contact tracing,” where privacy comes first. The data is never uploaded to a server, but stays on the mobile device.” Also encouraging
  • In not so encouraging but understandable news, MedPage Today reports that “Overall frequency of alcohol consumption among adults ages 30-80 increased 14% versus 2019, with increases of 17% for women, reported Michael Pollard, PhD, of RAND Corporation in Santa Monica, California, which administers the survey, and colleagues. * * * ‘Health systems may need to educate consumers through print or online media about increased alcohol use during the pandemic and identify factors associated with susceptibility and resilience to the impacts of COVID-19,’ Pollard and co-authors wrote.”

On the healthcare fraud front, the HHS Inspector General announced today

The Department of Health and Human Services (“HHS”) Office of Inspector General, along with our state and federal law enforcement partners, participated in a health care fraud takedown in September 2020. More than 345 defendants in 51 judicial districts were charged with participating in health care fraud schemes involving more than $6 billion in alleged losses to federal health care programs. Since 2016, HHS-OIG has seen a significant increase in “telefraud”: scams that leverage aggressive marketing and so-called telehealth services. The conspirators include telemedicine company executives, medical practitioners, marketers, and business owners who scammed hundreds of thousands of unsuspecting patients in their homes.

Wow.

In miscellaneous news —

  • HHS created a Hospital Price Transparency website today three months before the final rule takes effect on January 1, 2021.
  • HHS also announced today “five cooperative agreements to health information exchange organizations (HIEs) to help support state and local public health agencies in their efforts to respond to public health emergencies, including disasters and pandemics such as COVID-19.” These HIEs provide a vital framework for sharing health information.
  • “The U.S. Cybersecurity and Infrastructure Security Agency (CISA) and the Multi-State Information Sharing & Analysis Center (MS-ISAC) have released a joint Ransomware Guide that details practices that organizations should continuously engage in to help manage the risk posed by ransomware and other cyber threats. The in-depth guide provides actionable best practices for ransomware prevention as well as a ransomware response checklist that can serve as a ransomware-specific addendum to organization cyber incident response plans.” Check it out.
  • Health Payer Intelligence helpfully reports on a surprise billing study published in the American Journal of Managed Care which finds that

More than 10% of health plan spending is attributable to ancillary and emergency services that commonly surprise-bill. Reducing payment for these services by 15% would reduce premiums by 1.6% ($67 per member per year), and reducing average payment to 150% of traditional Medicare rates—the high end of payments to other specialists—would reduce premiums by 5.1% ($212 per member per year). These savings would reduce aggregate premiums for the nation’s commercially insured population by approximately $12 billion and $38 billion, respectively.

The study is based on claims data from major health insurers housed in the Healthcare Cost Institute.

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 38th weeks of this year (beginning May 14 and ending September 23; 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:

For context take a look at this USA Today article on the three leading causes of death in the United States over the past 85 years (ending in 2018). COVID-19 will be taking over at least the spot for the third leading cause of death, which is currently held by accidental injuries.

In other news —

  • Forbes offers an update on Rite-Aid pharmacies and its prescription benefit manager. “Rite Aid said it will fully transition the PBM to Elixir in December and is “committed to becoming a dominant mid-market PBM, Rite Aid chief executive office Heyward Donigan said Thursday on the company’s second quarter earnings call.”
  • Benefits Pro (registration required) discusses the critical importance of educating employees about the advantages of health savings accounts. “Employers and financial advisors should discuss HSAs in the context of emergency savings and retirement planning, not just health care elections during annual enrollment.” The FEHBlog misses his ability to contribute to an HSA, an ability that he lost when he became Medicare eligible last year.
  • The Federal Times notes that Congress appears to be successfully convincing the Trump Administration to allow affected federal employees to opt out of the currently mandatory payroll tax deferral program. The article erroneously states that “The private sector does have the choice of whether to opt into the program, but feds and military members were automatically included.” Just like in the federal sector, it is the employer who makes the primary decision to participate in the payroll deferral program. It’s also the employer’s choice to allow employees to opt out of payroll deferral.
  • HHS’s Office for Civil Rights, which enforces the HIPAA Privacy and Security Rules took a big scalp today. “Premera Blue Cross (PBC) has agreed to pay $6.85 million to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) and to implement a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules related to a breach affecting over 10.4 million people. This resolution represents the second-largest payment to resolve a HIPAA investigation in OCR history. PBC operates in Washington and Alaska, and is the largest health plan in the Pacific Northwest, serving more than two million people.” The breach dates from the bad old days of 2014-15 when Anthem and OPM announced massive data breaches due to cyberattacker gaining deep access to company information systems.
  • ZDnet reports on recent cyberattack on an unidentified federal agency system. It’s worth reading because

[While] The name of the hacked federal agency, the date of the intrusion, or any details about the intruder, such as an industry codename or state affiliation, were not disclosed, CISA officially publish[ed] an in-depth incident response (IR) report detailing the intruder’s every step. The report, which ZDNet analyzed today, reveals how the intruder gained access to the federal agency’s internal networks through different channels, such as leveraging compromised credentials for Microsoft Office 365 (O365) accounts, domain administrator accounts, and credentials for the agency’s Pulse Secure VPN server.

Midweek Update

Photo by Manasvita S on Unsplash

Roll Call informs us that the House of Representatives pass the compromise Fiscal Year 2021 continuing resolution (H.R. 8337) by a wide margin. The bill heads onto the Senate which is expected also to pass the bill before the end of the current fiscal year next Wednesday September 30.

In COVID-19 news —

Johnson & Johnson (J&J) has begun a 60,000-subject phase 3 assessment of its COVID-19 vaccine. The trial will enroll participants in the U.S. and other countries with a high incidence of COVID-19 with a view to generating data to support emergency use authorization early next year. * * * Unlike its rivals, J&J is evaluating the safety and efficacy of a single dose of a COVID-19 vaccine. If the one-dose regimen is successful, J&J could eliminate the logistical complexity and dropouts associated with trying to get people to return for a second shot. A one-shot regimen would also enable J&J to vaccinate 1 billion people each year. Few manufacturers of two-dose regimens can match that figure. * * *

In disclosing the start of the phase 3, J&J also called out the storage requirements of its vaccine. The candidate is expected to be stable for two years at -20°C and for upward of three months in the 2°C to 8°C range used to store many biologics. J&J said the candidate is “compatible with standard vaccine distribution channels and would not require new infrastructure to get it to the people who need it.” Pfizer’s mRNA vaccine must be kept at -70⁰C and be used within 24 hours of being thawed. Other COVID-19 vaccines have storage requirements more comparable to those of J&J’s shot.

Good news.

  • Fierce Healthcare reports that Walmart plans to use drones to deliver self-administered COVID-19 tests to single family homes within a one miles radius of one of their “pilot” stores. The recipient will need to mail the nasal sample to a lab. The gold standard will be self administered tests that can read out at home like a pregnancy test, but they are getting closer.

Fierce Healthcare also calls our attention to the fact that Optum’s latest quarterly drug pipeline report explains how health plans can prepare to cover “chimeric antigen receptor T-cell (CAR-T) therapies coming to market. CAR-T treatments for cancer are costly but are proliferating as they offer a potentially curative treatment for the disease. Through CAR-T therapy, a patient’s cells are modified in a lab and then reintroduced to the body to attack the cancer.”

The Health and Human Services Office for Civil Rights, which enforces the HIPAA Privacy and Security Rules, took another HIPAA business associate scalp today.

CHSPSC LLC, (“CHSPSC”) has agreed to pay $2,300,000 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 Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules related to a breach affecting over six million people. CHSPSC provides a variety of business associate services, including IT and health information management, to hospitals and physician clinics indirectly owned by Community Health Systems, Inc., in Franklin, Tennessee.

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.

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

The Hill reports on the House leadership’s strategy for the COVID-19 relief bill.

Speaker Nancy Pelosi (D-Calif.) on Tuesday sought to heighten the pressure on Republicans to move a new round of coronavirus relief, announcing that the House will return to the Capitol next month to vote on another aid package if a bipartisan agreement is struck before the elections. * * *

House Majority Leader Steny Hoyer (D-Md.) acknowledged that most lawmakers will likely return to their districts when the scheduled session ends on Oct. 2, leaving party leaders seeking to hash out an agreement with the White House. If such a deal emerges, then members would be called back to Washington. In that sense, the dynamics would look very similar to those surrounding the long August recess, when the Capitol was virtually empty.

We must remember in this regard that the House can now vote virtually.

The House Problem Solvers Caucus which is truly bipartisan has offered its own COVID-19 relief proposal. The New York Times explains that

Lawmakers had acknowledged that the plan was unlikely to become law. But in unveiling it, the group sought to signal to Ms. Pelosi and the lead White House negotiators — Mark Meadows, the chief of staff, and Steven Mnuchin, the Treasury secretary — that there was ample common ground to be found in talks that have been dormant for weeks.

Health Payer Intelligencer reports that UnitedHealthcare has teamed up with Canopy Health to offer a concierge style health plan known as the California Doctors Plan to San Francisco area employers. “The payer projects that members will save up to 25 percent compared to other health plan premiums. Also, plan members will have no copay for primary care services and urgent care.” The FEHBlog enjoys reading about creative plan designs.

The HHS Agency for Healthcare Research and Quality has announced today that

the National Steering Committee for Patient Safety released Safer Together: A National Action Plan To Advance Patient Safety, which is the result of 2 years of work by 27 steering committee members who represent a diverse group of organizations and individuals, including healthcare systems, Federal agencies, provider associations, accrediting organizations, and patient advocates. Our goal was to provide healthcare system leaders with renewed momentum and clearer direction for reducing medical harm. Especially relevant during the COVID-19 pandemic, this national action plan and a companion implementation resource guide provide the latest implementation tactics, tools, and resources in a format that’s ready for immediate implementation. These important new resources are built on four foundational areas: culture, leadership, and governance; patient and family engagement; workforce safety; and learning systems.

This worthy initiative is certainly worth a gander.

In COVID-19 news

  • The National Institutes of Health have determined that substance use disorders (SUD) are linked to COVID-19 susceptibility.

By analyzing the non-identifiable electronic health records (EHR) of millions of patients in the United States, the team of investigators revealed that while individuals with an SUD constituted 10.3% of the total study population, they represented 15.6% of the COVID-19 cases. The analysis revealed that those with a recent SUD diagnosis on record were more likely than those without to develop COVID-19, an effect that was strongest for opioid use disorder, followed by tobacco use disorder. Individuals with an SUD diagnosis were also more likely to experience worse COVID-19 outcomes (hospitalization, death), than people without an SUD.

The Centers for Disease Control and Prevention (CDC) and the EU’s Joint Research Centre (JRC) will begin working with Siemens Healthineers to help standardize international antibody tests for COVID-19. This will include defining the proper concentrations of antibodies in the bloodstream—mapped to the novel coronavirus’s specific proteins—that could one day be used to establish the clinical threshold for a test to correctly determine whether a person is immune to the disease.

Finally, HHS’s Office for Civil Rights which enforces the HIPAA Privacy and Security Rules announced four settlements with different healthcare provider organizations over allegations of their non-compliance with HIPAA Privacy Rule requirements to give individuals access to their own health records.

“Patients can’t take charge of their health care decisions, without timely access to their own medical information,” said OCR Director Roger Severino. “Today’s announcement is about empowering patients and holding health care providers accountable for failing to take their HIPAA obligations seriously enough,” Severino added.

How true.