Monday Roundup

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

Monday Roundup

David Ermer–COVID-19, COVID-19 testing, COVID-19 vaccine, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash
  • On the COVID-19 front, David Leonhardt in the New York Times provides valuable insights on how to think about COVID-19 cases that have broken through vaccinations. “

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

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

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

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

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

In health equity developments

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

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

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

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

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

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

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

Weekend update

David Ermer–Congress, COVID-19, Medicare, Rx coverage, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

Both Houses of Congress will be in session this week for Committee business and floor voting. It should be noted that for the next several weeks that FEHBlog will be writing from Austin, TX, way outside the Capital Beltway.

On the COVID-19 front

  • The American Medical Association offers an article on what doctors would like their patients to know about COVID-19 variants.
  • The Wall Street Journal reports on the efforts of Pfizer, Merck and the Japanese drugmaker Shionogi to develop a pill to treat COVID-19. “Drugmakers are looking for a pill that those who get a positive Covid-19 test could take at home while their symptoms are mild. Such medicines already exist for influenza, including Roche Holding AG’s Tamiflu and Shionogi’s Xofluza, although they don’t work for all patients and might be prescribed too late to do much good. Xofluza is marketed in the U.S. by Roche. ‘Our target is a very safe oral compound, like Tamiflu, like Xofluza,’ said Isao Teshirogi, Shionogi’s chief executive officer. He said Shionogi’s Covid-19 pill aims to neutralize the virus five days after a patient takes it.” In contrast to the convenience of pills, existing COVID-19 treatments must be administered by a doctor in a hospital or other healthcare facility.

On the regulatory front

  • The American Hospital Association provides more background on the last week’s proposed Calendar Year 2022 Medicare Part B payment rule. The public comment deadline is September 17.
  • Kaiser Health News reports on Biogen’s rather aggressive response to criticism of its FDA approval Alzheimer’s Disease drug Aduhelm which was rolled out last week.

In other news —

  • AHIP discusses health insurer efforts to address provider burnout stemming from the pandemic.
  • Fierce Healthcare reports that UnitedHealthcare, the largest insurer in the country, will make Peloton’s fitness classes to nearly 4 million fully insured members at no cost through its app, beginning on Sept. 1, the company announced. Eligible members will have access to either a 12-month Peloton digital subscription or a four-month waiver for a Peloton All-Access Membership, the insurer said. All-Access members can take fitness classes through connected devices, such as Peloton’s bikes, and track their metrics, in addition to app access.”
  • Fierce Healthcare also informs us that “Anthem and Humana have signed on for a minority stake in a new joint venture that aims to reshape the claims management experience. DomaniRx, pending regulatory approval, will feature a cloud-native, API-driven claims adjudication platform, according to an announcement. SS&C Technologies, which provides services and software to the financial and healthcare industries, will have a majority stake in the venture. * * * The goal of the venture, according to the announcement, is to arm healthcare organizations with “end-to-end transparency and data analytics” to help them keep up with an ever-changing regulatory environment.”

Cybersecurity Saturday

David Ermer–Cybersecurity–

Bleeping Computer’s This Week in Ransomware leads with the following:

This week has quite a bit of news ranging from the USA formally accusing China of the recent ProxyLogon vulnerability and Kaseya mysteriously obtaining the universal decryption key.

The US government this week officially attributed the ProxyLogon Microsoft Exchange attacks to China. Threat actors used this vulnerability to install a variety of malware, including the BlackKingdom ransomware.

In a surprise announcement, Kaseya has stated that they received the universal decryption key for their July 2nd REvil ransomware attack. This key will allow all victims of the attack to recover their files for free.

Cyberscoop has a more detailed story on the Kaseya hack resolution.

In other ransomware news / protective advice

  • The RSA Conference offers advanced common sense advice on how to handle a ransomware attack. “In the recent ISACA Ransomware Pulse Poll, 21% of respondents reported that they have already experienced a ransomware attack, and 46% consider ransomware to be the cyberthreat most likely to impact their organization within the next 12 months.”
  • ISACA advises that the importance of conducting periodic information security audits of cloud services vendors from the perspectives of the vendor and the customer.
  • Threatpost explains the importance of creating a long term remote security strategy as business begin to formalize permanent hybrid working arrangements. In the author’s opinion.

HHS’s Office for Civil Rights, which enforces the HIPAA Privacy and Security Rules has request public input as follows:

We want to hear from you! OCR and our partners at the HHS Office of the National Coordinator for Health Information Technology (ONC) are seeking user feedback and improvement suggestions on the Security Risk Assessment (SRA) Tool.  The SRA Tool is designed to help small and medium-sized healthcare providers conduct a security risk assessment, as required by the HIPAA Security Rule and the Centers for Medicare and Medicaid Services (CMS) Promoting Interoperability Program. If you have suggestions on how to improve the Tool, we ask you to complete our short survey by July 31, 2021:https://stats.altarum.org/limesurvey/index.php/547532?lang=en.

Finally the Washington Examiner reports that

The House Energy and Commerce committee passed eight bipartisan bills this week to better equip the government and businesses with tools to handle the recent explosion in ransomware attacks.

The bills, which passed with overwhelming bipartisan support, are focused on increasing coordination between the government and relevant industries, implementing cybersecurity best practices, educating everyday technology users, limiting the use of Chinese devices, and strengthening the security programs at the Federal Communications Commission and the National Telecommunications and Information Administration. * * *

One key purpose for the bills is to increase coordination between the federal government and affected businesses and industries.

“These bills will really improve the information sharing and cybersecurity readiness testing of the government by forcing all the right people to get into a room and fix things,” said Shane Tews, a senior fellow who focuses on cybersecurity and technology issues at the American Enterprise Institute, a right-of-center think tank.

“Hopefully, we get to a stage where the government is gaming out cyber problems and vulnerabilities in advance and then sending out software patches to solve them every week, like Microsoft, and other companies do internally on a regular basis,” she added.

Sound idea.

Friday Stats and More

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

Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 29th week of this year (beginning April 2, 2020, and ending July 21, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):

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

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

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

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

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

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

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

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

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

A reasonable goal indeed.

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

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

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

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

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

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

Thursday Miscellany

David Ermer–Congress, COVID-19 vaccine, Electronic health records, Medicare, Mental health care, OPM, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

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

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

According to a press release,

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

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

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

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

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

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

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

STAT News reports that

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

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

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

The FEHBlog likes the company’s name.

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

In closing, Fierce Healthcare notes that

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

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

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

Midweek update

David Ermer–COVID-19 testing, OPM, U.S. Healthcare–
Photo by Piron Guillaume on Unsplash

Yesterday, “at her first meeting of the Chief Human Capital Officers (CHCO) Council, Office of Personnel Management (OPM) Director and Council Chair, Kiran Ahuja, announced that the CHCO Council’s functions will be restored to OPM, after the Council’s leadership and administration were bifurcated between OPM and General Services Administration (GSA) since 2019.”  Sic semper attempted GSA merger.

The North Carolina Attorney General announced “a historic $26 billion agreement that will help bring desperately needed relief to people across the country who are struggling with opioid addiction. The agreement includes Cardinal, McKesson, and AmerisourceBergen – the nation’s three major pharmaceutical distributors – and Johnson & Johnson, which manufactured and marketed opioids. The agreement also requires significant industry changes that will help prevent this type of crisis from ever happening again. The agreement would resolve investigations and litigation over the companies’ roles in creating and fueling the opioid epidemic. State negotiations were led by Attorneys General Josh Stein (NC) and Herbert Slatery (TN) and the attorneys general from California, Colorado, Connecticut, Delaware, Florida, Georgia, Louisiana, Massachusetts, New York, Ohio, Pennsylvania, and Texas.”

Healthcare Dive informs us that “Anthem, the nation’s second largest insurer [and a Blue Cross licensee], saw robust membership growth during the second quarter, adding 1.9 million members, a 4.4% increase over the prior-year period. The growth was fueled entirely by government programs, largely Medicaid and Medicare, while commercial membership declined slightly.  The Indianapolis-based insurer raised its forecast for the full year as its performance in the second quarter outperformed expectations. Even though COVID-19 cases continue to rise due to the delta variant and non-COVID-19 care resumes, Anthem’s medical loss ratio of 86.8% came in below company and analyst expectations.”

Healthcare Dive further reports that “Americans’ medical debt may have reached $140 billion last year, significantly higher than past estimates and outweighing all other types of personal debt in the U.S., according to a new study published in JAMA. Researchers analyzed a tenth of all credit reports from rating agency TransUnion to find nearly one in five Americans had medical debt in collections in June last year — more than any other type. Debt was significantly more concentrated in states that had yet to expand Medicaid under the Affordable Care Act. The analysis reflects care provided prior to COVID-19, but early data shows the pandemic has likely only exacerbated the perennial issue of medical debt in the U.S.” The FEHBlog is surprised that one decade into the Affordable Care Act this issue has not diminished.

In another downbeat but important story, AHIP tells us that “price gouging on COVID-19 tests by certain providers continues to be a widespread problem, threatening patients’ ability to get the testing they need.”

The FEHBlog also ran across the following three interesting articles in Forbes:

  • “Most hospital executives will say it’s impossible to run a business on Medicare rates. The government health insurance program for seniors pays less for services than it costs to deliver them and private insurance has to make up the difference. But Eren Bali doesn’t buy the cost-shifting argument. The serial entrepreneur who grew up in rural southeast Turkey believes the issue isn’t the rates but an outdated system using old technology. “There’s so much waste because providers are so used to charging through the roof in this country, they’ve never thought about being efficient,” says Bali, 37, the CEO and cofounder of Carbon Health.” This article is a day brightener.
  • “UnitedHealth Group is rolling out an increasing number of partnerships to “address health equity challenges” across the U.S.” The article adds that “UnitedHealth’s effort comes as the company and rivals including Anthem, CVS Health’s Aetna health plan unit, Humana and others address social determinants of health as insurers intensify strategies to reduce costs and improve outcomes beyond covering traditional medical treatments.”
  • “The coronavirus pandemic forced many hospitals to confront an uncomfortable truth: they were sitting on troves of patient data but, despite tens of millions of dollars spent on electronic health records and IT infrastructure, couldn’t extract useful insights to help treat the virus ravaging the wards. This experience was the tipping point that pushed a group of 17 hospitals to come together, including three new members announced this week, to raise $95 million for a startup called Truveta.” The article adds that “The aim of the company is to enable hospitals to monetize patient data that has been de-identified in ways that may both improve existing treatments and develop new ones. With the addition of Texas-based Baylor Scott & White Health, Maryland-based MedStar Health and Texas Health Resources, the hospital-governed Truveta now says it represents organizations that provide 15% of patient care in the United States. The Seattle, Washington-based startup is helmed not by a veteran of the healthcare world, but by former Microsoft executive Terry Myerson, who’s better known for his work on Windows and Xbox.”

Tuesday’s Tidbits

David Ermer–Uncategorized–
Photo by Patrick Fore on Unsplash

GEHA, the largest employee organization sponsored plan in the FEHB, has a new President and CEO, Arthur A. Nizza, DSW. According to GEHA’s press release, “Dr. Nizza has more than 25 years of leadership experience in the health care industry and has held senior leadership roles at major integrated delivery systems in the Midwest and Northeast. His experience includes roles as Chief Executive Officer, Chief Operating Officer and Chief Information Officer at for-profit and non-profit companies, academic medical centers and faith-based institutions. Most recently, Nizza served as the Executive Vice President and Chief Operating Officer of UnityPoint Health (UPH) in Des Moines, Iowa.” Good luck, Dr. Nizza.

In the tidbits department for this Tuesday —

  • The Agency for Health Research and Quality issued a study of diagnoses causing U.S. hospitalizations in 2018. For example, “Of the 10 most common principal diagnoses among nonmaternal, nonneonatal inpatient stays in 2018, septicemia was the most frequent and accounted for the highest aggregate costs ($41.5 billion). The mean cost per stay was also higher for septicemia than for the other top 10 conditions, with the exception of acute myocardial infarction (AMI).” Healthline explains that “Septicemia is a serious bloodstream infection. It’s also known as blood poisoning. Septicemia occurs when a bacterial infection elsewhere in the body, such as the lungs or skin, enters the bloodstream. This is dangerous because the bacteria and their toxins can be carried through the bloodstream to your entire body. Septicemia can quickly become life-threatening. It must be treated in a hospital. If left untreated, septicemia can progress to sepsis.
  • Becker’s Hospital review tells us that “The pandemic led to a dip in emergency room visits, and the numbers may not recover, UnitedHealth CEO Andrew Witty said during the company’s July 15 earnings call. * * *While still speculative, Mr. Witty said urgent care centers may see the patients who turned away from the emergency room.”
  • The National Institutes of Health (NIH) informs us at a glance that “By combining parts of spike proteins from different coronaviruses, researchers developed an mRNA vaccine that protected mice against a range of coronaviruses. The results point the way toward a universal coronavirus vaccine that could prevent future pandemics.” Keep hope alive.
  • NIH Director Dr. Francis Collins discusses in his weekly blog research into genetic reasons for a person’s susceptibility to COVID-19 illnesses and more specifically to severe COVID-19 illnesses.
  • The Drug Channels blog discusses the state of the 340B program market in our country. According to HRSA, the HHS agency that runs the 340B program,

The 340B Program enables covered entities to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.

Manufacturers participating in Medicaid agree to provide outpatient drugs to covered entities at significantly reduced prices.

Eligible health care organizations/covered entities are defined in statute and include HRSA-supported health centers and look-alikes, Ryan White clinics and State AIDS Drug Assistance programs, Medicare/Medicaid Disproportionate Share Hospitals, children’s hospitals, and other safety net providers. See the full list of eligible organizations/covered entities.

  • Drug Channels observes that “The 340B Drug Pricing Program continues to expand far more quickly than the overall pharmaceutical market—and some channels are benefiting more than others. [M]ail and specialty pharmacies’ purchases of products that are eligible for 340B discounts have grown by an incredible 56% per year since 2017. That’s about six times faster than the overall mail and specialty market. 

Monday Roundup

David Ermer–ACA, CMS, COVID-19, COVID-19 vaccine, Medicare, Patient safety, U.S. Healthcare–
Photo by Sven Read on Unsplash

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

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

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

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

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

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

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

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

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

Today was a busy day for regulatory action:

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

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

Weekend update

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

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

On the COVID-19 front —

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

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

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

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

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

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

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

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

Cybersecurity Saturday

David Ermer–Cybersecurity–

The American Hospital Association informs us that

The White House yesterday announced an interagency task force and other initiatives to protect U.S. organizations from ransomware attacks [on July 15]. The task force has been coordinating federal efforts to improve the nation’s cybersecurity as directed by the president in April. In addition, the departments of Homeland Security and Justice yesterday launched a one-stop website for federal resources to help organizations reduce their ransomware risk; the Treasury Department’s Financial Crimes Enforcement Network will convene public and private sector stakeholders in August to discuss ransomware concerns and information sharing; and the State Department will offer up to $10 million for information leading to the identification or location of anyone engaged in malicious cyber activities against U.S. critical infrastructure.

Here’s a link the Bleeping Computer’s Week in Ransomware.

Ransomware operations have been quieter this week as the White House engages in talks with the Russian government about cracking down on cybercriminals believed to be operating in Russia.

This increased scrutiny by law enforcement and the growing fear that Russia is no longer a safe haven for cybercriminals has led to what is believed to be the shutdown of the notorious REvil ransomware operation. * * *

This shutdown is not believed to be caused by law enforcement, and it is likely we will see this group rebrand as a new operation in the future.

On the Microsoft front, Security Week reports yesterday that

After spending the last two months pushing out multiple Print Spooler fixes (one as an emergency, out-of-band update), Redmond’s security response team late Thursday acknowledged a new, unpatched bug that exposes Windows users to privilege escalation attacks.

Microsoft’s advisory describes an entirely new vulnerability — CVE-2021-34481 — that could be chained with another bug to launch code execution attacks.  

There is no patch available and Microsoft says the only workaround is for Windows users to stop and disable the Print Spooler service.

From the advisory:

An elevation of privilege vulnerability exists when the Windows Print Spooler service improperly performs privileged file operations. An attacker who successfully exploited this vulnerability could run arbitrary code with SYSTEM privileges. An attacker could then install programs; view, change, or delete data; or create new accounts with full user rights.

An attacker must have the ability to execute code on a victim system to exploit this vulnerability.

Microsoft said the vulnerability has already been publicly disclosed and credited Dragos security researcher Jacob Baines with the discovery.

SC Media informs us

More than 22.8 million patients have been impacted by a health care data breach so far in 2021, a whopping 185% increase from the same time period last year where just 7.9 million individuals were affected according to a new report from Fortified Health Security.

Malicious cyberattacks caused the majority of these security incidents, accounting for 73% of all breaches. Unauthorized access or disclosure accounted for another 22%, and the remaining 5% were caused by smaller thefts, losses, or improper disposals.

Further, the number of breaches reported to the Department of Health and Human Services during the first six months of 2021 increased by 27% year-over-year. Health care providers accounted for the most breaches with 73% of the overall tally, compared to health plans with 16% and business associates that accounted for 11%.

“Healthcare organizations have literally hundreds of electronic entry points into their data networks, everything from EHRs, radiology and lab systems, to admission, discharge and transfer systems, to supply chain ordering and internet-enabled medical devices — and any one of these could be the Achilles’ heel exploited by a bad actor,” the report authors wrote.

In other cybersecurity news

  • Per Homeland Security Today, “The Senate [on July 23] confirmed by unanimous consent former NSA deputy for counterterrorism Jen Easterly to lead the Cybersecurity and Infrastructure Security Agency at the Department of Homeland Security.” “Easterly was a managing director at Morgan Stanley, serving as global head of the firm’s Fusion Resilience Center, and a senior fellow at New America’s International Security program. After her NSA role from 2011-2013, she served on the National Security Council as special assistant to the president and senior director for counterterrorism. Easterly served more than 20 years in the Army and was responsible for standing up the Army’s first cyber battalion. She was also instrumental in the creation of U.S. Cyber Command, and served as executive assistant to National Security Advisor Condoleezza Rice for a time.” Good luck, Ms. Easterly
  • Earlier this week the HHS Office for Civil Rights which enforces the HIPAA Privacy and Security Rules issued its Summer 2021 Cybersecurity Newsletter. The newsletter is headlined “Controlling access to electronic protected health information; for whose eyes only? “Ensuring that workforce members are only authorized to access the ePHI necessary and that technical controls are in place to restrict access to ePHI can help limit potential unauthorized access to ePHI for both threats.”