Weekend Update

David Ermer

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

Weekend Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Electronic health records, Government Contracting, Mental health care, SDOH–

As we wrap up the last weekend of summer, we can look forward to the House of Representatives and the Senate holding Committee business and floor voting. Yahoo Finance adds

Once again, the threat of a government shutdown looms at the end of the fiscal year, which arrives on September 30. Lawmakers have two weeks to provide funding to keep large swaths of the federal government open and functioning, and the most likely result at this point is a short-term bill called a continuing resolution that funds the government for about 10 weeks, or until mid-December. Lawmakers would then look to pass an omnibus spending package to cover the rest of the 2023 fiscal year.

From the Omicron and siblings front, the Wall Street Journal offers an engaging interview with Moderna’s CEO Stéphane Bancel who “discusses the company’s latest Covid shot and research on using mRNA in seasonal flu vaccines and personalized treatments for cancer.”

From the social determinants of health front, Health Affairs discusses best practices to improve the collection and distribution of race, ethnicity, and language data for use by health care providers and payers. Healthcare payers, in particular, cannot address SDOH issues strategically without having REL data. The FEHBlog’s idea, which he has floated unsuccessfully to date, is to add REL codes to the AMA’s CPT 4 code system, thereby allowing the ready distribution of that data via reliable coders.

Speaking of the distribution of healthcare data, EHR Intelligence reports that “Large Health IT Networks Unveil Plans to Become Qualified Health Information Network (“QHIN”) Under TEFCA.” TEFCA will act as the Electronic Health Records “backbone” to vastly improve health record interoperability, which has long been a national EHR goal.

From the mental healthcare front, last Friday, “the U.S. Department of Health and Human Services (HHS) released the HHS Roadmap for Behavioral Health Integration (Roadmap), which details policy solutions that would help to better integrate mental health and substance use care into the larger health care system and other systems. The Roadmap is based on feedback Secretary Becerra received from patients and providers during more than two dozen stops on his National Tour to Strengthen Mental Health.”

Finally, a government contract expert discusses in Federal News Network why the 1994 federal acquisition reform law (actually the related 1994 and 1996 laws) aiming to simplify the federal procurement process needs a reboot. The FEHBlog heartily agrees.

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cyberpolicy front, Nextgov informs us that

The Federal Acquisition Regulatory Council will soon propose a rule requiring federal agencies to use a uniform, standard self-attestation form when seeking assurances from software vendors that their products were developed using guidance from the National Institute of Standards and Technology.  

“Agencies are encouraged to use a standard self-attestation form, which will be made available,” in line with the new rule, according to a memo the Office of Management and Budget issued Wednesday [September 14]. 

From the cyberbreaches front, Cybersecurity Dive reports

Uber confirmed its systems were breached Thursday [September 15] in an attack that appears far reaching in scope. The rideshare and food delivery company said it alerted law enforcement to the incident in a Thursday statement.

The threat actor, who claims to be 18 years old, told The New York Times he duped an employee into providing their password via text message and compromised the worker’s Slack account. Slack’s high-level access to other third-party services allowed the attacker to gain access to additional Uber systems, including Amazon Web Services, Google Cloud, VMware virtual machines, OneLogin and other services, the attacker claimed.

The American Hospital Association tells us

The FBI has received multiple reports of cyber criminals increasingly targeting healthcare payment processors to redirect victim payments. In each of these reports, unknown cyber criminals used employees’ publicly-available Personally Identifiable Information (PII) and social engineering techniques to impersonate victims and obtain access to files, healthcare portals, payment information, and websites. In one case, the attacker changed victims’ direct deposit information to a bank account controlled by the attacker, redirecting $3.1 million from victims’ payments.

Here’s a link to the FBI’s report.

From the cybervulernabilities front —

  • Health IT Security calls our attention to an FBI warning of “Patient Safety, Security Risks Associated With Legacy Medical Devices.”
  • CISA also announced “Microsoft has released updates to address multiple vulnerabilities in Microsoft software. An attacker can exploit some of these vulnerabilities to take control of an affected system. CISA encourages users and administrators to review Microsoft’s September 2022 Security Update Guide and Deployment Information and apply the necessary updates.”

From the ransomware front —

  • CISA issued a readout of the “first meeting of the Joint Ransomware Task Force (JRTF), an interagency body established by Congress to unify and strengthen efforts against the ongoing threat of ransomware.” CISA and the FBI co-chair this group.
  • CISA, the FBI, the National Security Agency and other U.S. and foreign intelligence operations released an updated warning on “Iranian Islamic Revolutionary Guard Corps Affiliated Cyber Actors Exploiting Vulnerabilities for Data Extortion and Disk Encryption for Ransom Operations.”
  • Cybersecurity Dive reports on ransomware issues discussed at Rubrik’s virtual Data Security Summit held last week.
  • Here’s a link to the latest Bleeping Computers’ The Week in Ransomware.

From the cyberbusiness front, Cybersecurity Dive reports

Google completed its $5.4 billion acquisition of Mandiant on Monday and said it plans to retain the Mandiant brand under Google Cloud.

The deal for the incident response and threat intelligence firm, inked in March, marks Google’s largest cybersecurity acquisition to date and the second largest in the company’s history. Google announced a deal in early January to buy Siemplify, a security orchestration, automation and response technology provider. 

Google in August 2021 pledged to invest $10 billion in cybersecurity over the next five years.

From the cyberdefenses front —

  • Psychology Today features an article titled “The Cyber Security Head Game; Winning cyber wars means beating your adversary’s mind, not their technology.”
  • The Department of Health and Human Services 405(d) Program released its September 2022 online newsletter.

Friday Stats and More

David Ermer–CDC, COVID-19, NCQA, U.S. Healthcare, Uncategorized–

Based on the Centers for Disease Control’s (CDC) Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s 2022 weekly chart of new Covid cases:

The bulge on the left is the first strain of Omicron.

The CDC’s weekly interpretative summary adds,

As of September 14, 2022, the current 7-day moving average of daily new cases (59,856) decreased 15.9% compared with the previous 7-day moving average (71,190). 

CDC Nowcast projections* for the week ending September 17, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100%. There are five lineages designated as Omicron: BA.5, BA.4.6, BA.4, BF.7, and BA.2.75. UPDATE: BF.7 has been separated from BA.5 and BA.2.75 sublineage is separated from BA.2 due to their positive growth rate. Until last week, these were aggregated with BA.5 and BA.2, respectively. The predominant Omicron lineage is BA.5, projected at 84.8% (95% PI 83.2-86.3%).

Here is the CDC’s chart of daily trends in new Covid hospitalizations:

The CDC’s weekly interpretative summary adds “The current 7-day daily average for September 7–12, 2022, was 4,371. This is a 6.1% decrease from the prior 7-day average (4,657) from August 31–September 6, 2022.”

Here’s the FEHBlog 2022 weekly chart of new Covid deaths

The CDC’s weekly interpretative summary adds, “The current 7-day moving average of new deaths (358) increased 3.9% compared with the previous 7-day moving average (344).”

The American Hospital Association points out that

In-hospital mortality among patients hospitalized primarily for COVID-19 fell from 15.1% during the delta period to 4.9% this April through June, the Centers for Disease Control and Prevention reported this week. 

“In-hospital mortality risk was substantially lower during the later Omicron period overall and for older adults, persons with disabilities, and persons with multiple underlying medical conditions, who accounted for a larger proportion of hospitalizations in this period than they did during previous periods and remained at highest risk for death,” the authors said.

Here’s the FEHBlog’s chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era in December 2020 through the 37th week of 2022. In the 37th week of this year, you will note a noticeable jump in distributions and administrations due to the release of bivalent mRNA booster.

The CDC’s weekly interpretative summary adds,

As of September 14, 2022, 612.8 million vaccine doses have been administered in the United States. Overall, about 263.4 million people, or 79.3% of the total U.S. population, have received at least one dose of vaccine. About 224.6 million people, or 67.7% of the total U.S. population, have been fully vaccinated.

Of those fully vaccinated, about 109.2 million people have received a booster dose,* but 50.0% of the total booster-eligible population has not yet received a booster dose. Booster dose eligibility varies by age and health condition. Learn more about who is eligible.

The CDC’s Communities Levels experienced “Compared with last week, * * * a moderate decrease (−3.9 percentage points) in the number of high-level counties, a moderate decrease (-3.8 percentage points) in the number of medium-level counties, and a large increase (+7.4 percentage points) in the number of low-level counties.”

From the unusual viruses front —

  • The AP reports that the CDC warns providers against giving the only monkeypox treatment Tpoxx “to otherwise healthy adults who are not suffering severe symptoms. ‘For most patients with healthy immune systems, supportive care and pain control may be enough,’ agency officials said in a statement.”
  • The New York Times offers information on what parents should know about “the Latest Enterovirus Spike; The C.D.C. has issued an alert [to providers] about enterovirus D68, which has been linked to rare, polio-like paralysis.” In addition, the Times article advises soap and water handwashing and respiratory etiquette.

From the U.S. healthcare business front, we have two articles from Healthcare Dive.

  • “Hospitals are likely to lose “billions of dollars” due to continued depressed margins and heightened labor costs, according to a report Thursday prepared for the American Hospital Association by Kaufman Hall. Even in the report’s optimistic model, more than half of all hospitals could end the year with negative margins, driven by an expected $135 billion increase in expenses this year and an $86 billion rise in labor costs alone.” Here’s a link to the article.

From the medical research front, we have two articles from STAT News:

  • “CAR-T therapy isn’t exclusive to oncology: A half-dozen people with severe lupus, an autoimmune condition, have gone into remission after receiving an infusion of CAR-T cells, STAT’s Isabella Cueto reports. In lupus, B cells create antibodies against a person’s body, resulting in a vicious cycle of inflammation and immune attacks that lead to pain, fatigue, and organ damage. * * * Although the treatment has only been tested in six patients thus far, experts agree it is tantalizing.”
  • “There hasn’t been much in the pharmaceutical arsenal to help people who abuse methamphetamines. But STAT’s Lev Facher reports that researchers are now studying a new monoclonal antibody, which binds to meth molecules and helps prevent them from entering the brain. The antibody is showing early promise in the smattering of emergency rooms involved in the study. One Phase 2 study is testing if the monoclonal antibody can treat meth overdose, and another is measuring its efficacy in helping long-term recovery. Ideally, the drug could be used for both purposes. The drug’s development is overseen by the University of Arkansas for Medical Sciences and the biotech InterveXion.”

From the miscellany front

  • WTW released a study on how large employers are “doubling down on controlling healthcare costs and enhancing affordability.
  • The National Committee for Quality Assurance released its Measurement Year 2021 health plan ratings.
  • RevCycle Intelligence offers an interesting angle on a Health Affairs study of the efficacy of State No Surprise Billing laws in controlling out-of-network spending.

Thursday Miscellany

David Ermer–Congress, COVID-19, Federal employment benefits, No Surprises Act, Telehealth–

From Capitol Hill, Healthcare Dive reports

A group of 375 organizations sent a letter to the Senate on Tuesday urging lawmakers to act to pass legislation extending COVID-19-era telehealth flexibilities for another two years.

The letter was led by health IT and telehealth lobbies, but also joined by a number of health systems including Ascension and Cleveland Clinic, physician groups including the American Medical Association, tech companies including Amazon and Google and large employers including Walmart.

Without action, the policies — which threw open the doors to telehealth and led to skyrocketing utilization in the early days of the pandemic — will expire 151 days after the end of the COVID-19 public health emergency.

Health Payer Intelligence adds that according to a recently conducted survey on consumers enrolled in employer-sponsored health plans commissioned by AHIP:

First, most consumers across the political spectrum agreed that providers should not be permitted to charge unnecessary administrative fees and medical services mark-ups. Nearly eight out of ten respondents said that they supported this statement (78 percent), with three-quarters or more in each political party reporting this response.

Second, there was also strong bipartisan support for protections against hospital monopolies. Over three-quarters of consumers supported preventing hospitals from consolidation, mergers, and acquisitions that involved bringing other medical practices into one hospital system (76 percent). Consumers also indicated support for protections against site-based cost increases (75 percent).

Respondents wanted more transparency about healthcare deals. Slightly more than seven in ten consumers supported improving transparency around private-equity firms’ healthcare acquisitions.

Third, the researchers also found bipartisan alignment around telehealth. Slightly more than two-thirds of respondents agreed that the government should eliminate regulatory barriers to telehealth utilization (67 percent).

“Consumers value choice and flexibility in how they access health care. Telehealth proved to be an essential resource for consumers throughout the COVID-19 pandemic and should continue to play a role in the future of health care,” the survey stated.

To provide context, Beckers Hospital CFO Report informs us

HHS is set to extend the COVID-19 public health emergency [PHE] by its standing deadline of Oct. 13. 

HHS last renewed the PHE July 15 for another increment of 90 days with a pledge to provide states with 60 days’ notice if it decided to terminate the declaration or allow it to expire. Aug. 14, the date in which states would have 60 days’ notice, came and went without updates or notifications from the agency, suggesting the declaration will extend.

If renewed on the deadline of Oct. 13, the next deadline would be Jan. 11, 2023. * * *

For an overview of the flexibilities tied to the PHE and what occurs when the declaration ends, check out a comprehensive brief from Kaiser Family Foundation here.

In No Surprises Act news yesterday, the NSA regulators issued a request for information (RFI) from stakeholders and the general public. The RFI concerns the law’s requirement that health plans provide an advance explanation of benefits (AEOB) in response to a good faith estimate (GFE) of healthcare costs requested by the patient to their healthcare provider. The provider would submit the GFE request to the health plan. HIPAA governs many similar claims transactions involving providers and payers. Surprisingly, Congress did not add these claim transactions to HIPAA, which would have made perfect sense. The FEHBlog does not understand why the regulators have not asked Congress to take this necessary step. At first glance, the contemplated process strikes the FEHBlog as unnecessarily complicated if the object is to avoid patient surprises. Nevertheless, at least the regulators are seeking public input.

From the Omicron and siblings front, the National Institutes of Health announced

A research team funded by the National Institutes of Health has shown that commercially available rapid antigen tests can detect past and present variants of concern and has identified potential mutations that may impact test performance in the future. As new variants of the SARS-CoV-2 virus continue to emerge, concerns have been raised about the performance of rapid antigen tests.

The team, which was funded by NIH’s Rapid Acceleration of Diagnostics (RADx®) Tech program, developed a method to evaluate how mutations to SARS-CoV-2 can affect recognition by antibodies used in rapid antigen tests. Since most rapid antigen tests detect the SARS-CoV-2 nucleocapsid protein, or N protein, the team directly measured how mutations to the N protein impacted diagnostic antibodies’ ability to recognize their target.

“Rapid antigen tests remain an important COVID-19 mitigation tool, and it is essential to ensure that these tests can detect the SARS-CoV-2 virus as it continues to evolve,” said Bruce J. Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and lead for the RADx Tech program at the NIH. “Considering the endless cycle of new variants, the data from this study will be useful for years to come.”

From the healthcare technology front, Fierce Healthcare informs us

[Cigna’s] Evernorth is expanding its digital health formulary yet again, adding five new solutions to the platform.

The formulary will now include Big Health’s Sleepio for insomnia and the tech company’s Daylight tool for anxiety. In addition, Evernorth said it will expand inclusion of Quit Genius’ tools to its platforms for alcohol use disorder and opioid use disorder.

Lastly, Evernorth will now include HealthBeacon’s Injectable Care Management System for inflammatory conditions, which is meant to assist patients in managing injectable medications. Glen Stettin, M.D., chief innovation officer at Evernorth, told Fierce Healthcare that all of the new tools fit key concerns for employers and plan sponsors, such as mental health and high-cost inflammatory conditions.

“Our clients care about areas where either lots of people need help and treatment or where they’re spending lots of money,” Stettin said.

From the federal employee benefits front, benefits expert Tammy Flanagan writing in Govexec discusses how federal employees should time their retirement.

Midweek Update

David Ermer–Congress, COVID-19, Federal employment benefits, HIPAA Privacy and Security Rules, OPM, U.S. Healthcare–

From Capitol Hill, Fierce Healthcare tells us

The House unanimously passed the Improving Seniors’ Timely Access to Care Act on Wednesday via a voice vote. The legislation, which has new transparency requirements for MA plans, now heads to the Senate.

Lawmakers behind the legislation said in a joint statement the bill will “make it easier for seniors to get the care they need by cutting unnecessary red tape in the healthcare system,” said Reps. Suzan DelBene, D-Washington, Mike Kelly, R-Pennsylvania, Ami Bera, M.D., D-California, and Larry Bucshon, M.D., R-Indiana.

It’s worth noting that traditional Medicare has no prior authorization requirements. Beckers Payer Issues adds

Enrollees in Medicare Advantage were less likely to receive low-value care than those enrolled in traditional Medicare, a new study published in JAMA Open Network found. 

The study, published Sept. 9, found Medicare Advantage enrollees received 9.2 percent fewer low-value services than their counterparts using traditional Medicare. 

Low-value care is services that provide little clinical benefit or cause more harm than benefits for a patient. 

The study’s authors, lead by researchers from Humana and Boston-based Tufts University School of Medicine, compared enrollees in a large, national Medicare Advantage plan to a random sample of 5 percent of traditional Medicare beneficiaries. 

The study found among Medicare Advantage enrollees, those who had HMO plans were less likely to receive low-value care than those with PPO plans.

Read the full study here.

Hopefully, Congress will not throw out the baby with the bath water.

From the federal employee benefits front, FedWeek informs us

OPM has issued a reminder to agencies of their authority to verify that family members being covered under the FEHB actually are eligible, including the process to be used and the documentation required.

The notice calls attention to a revision of the FEHB handbook section on family member eligibility reflecting several instructions of recent years, including one telling agencies to tighten scrutiny of those covered and another laying out procedures for removing those deemed ineligible. That is a response to several inspector general reports warning that ineligible persons are being insured under the program, raising premium costs to the government and to other FEHB enrollees.

That directive, now part of the handbook, lists agency responsibilities to verify eligibility of family members during initial enrollment of newly hired employees and when family members are being added to an existing enrollment due to a “qualifying life event” such as marriage.

In the middle of the last decade, OPM added a standard contract provision to FEHB contract requiring carriers to share the cost of any family member eligibility audit that OPM undertakes. OPM has not yet exercised that provision.

It turns out that for the past two weeks federal employee benefits expert Reg Jones has been writing in Fedweek about federal employee retirement benefits. Today’s he discusses survivor benefits which includes a squib about perhaps the most unique and valuable survivor benefit — FEHB coverage for the survivor’s life with the full government contribution as explained here:

If your spouse receives a survivor annuity and was covered under either the Self Plus One or Self and Family option of your Federal Employees Health Benefits plan when you died, he or she and all eligible children can continue that coverage. If the annuity amount is less than the premiums required, your spouse will be able to make payments directly to OPM to cover the cost.

From the Omicron and siblings front, we have two thoughtful pieces from MedPage Today

In other virus news, the American Hospital Association reports

The recent paralytic polio case in an unvaccinated adult in Rockland County, N.Y. and wastewater samples from communities near the patient’s residence meet the World Health Organization’s criteria for circulating vaccine-derived poliovirus, the Centers for Disease Control and Prevention announced yesterday. Genetic sequences from the virus in the patient and wastewater specimens have been linked to wastewater samples in Jerusalem and London, indicating community transmission, CDC said.
 
Thirty other countries have circulating vaccine-derived poliovirus, which is not caused by the polio vaccine but occurs when local immunity to poliovirus is low enough to allow prolonged transmission of the original weakened virus in the oral polio vaccine. Oral polio vaccine has not been used or licensed in the U.S. since 2000 but continues to be used in some countries. N.Y. Governor Kathy Hochul last week declared a state of emergency to help expand vaccination efforts and surveillance. 
 
“Polio vaccination is the safest and best way to fight this debilitating disease and it is imperative that people in these communities who are unvaccinated get up to date on polio vaccination right away,” said Dr. José R. Romero, director of CDC’s National Center for Immunization and Respiratory Diseases. “We cannot emphasize enough that polio is a dangerous disease for which there is no cure.”

From the No Suprises Act front, Beckers Hospital CFO Report relates

The No Surprises Act, which prevents patients from receiving surprise bills from out-of-network providers at emergency rooms, could lead to an increase in emergency department visits, a new study from the Agency for Healthcare Research and Quality found. 

The study, published Sept. 12 in The American Journal of Medical Care, compared emergency department visits rates in 15 states that implemented bans on balance billing between 2007 and 2018 to rates in 16 states where these bills were not banned. 

The study’s authors found that state-level bans reduced spending per emergency room visit by 14 percent but increased emergency room visits by 3 percentage points. These visits were 9 percent less urgent than before the balance billing ban, according to an emergency department severity index. 

Based on the state-level analysis, the study’s authors, led by AHRQ researcher William Encinosa, PhD, conclude that the No Surprises Act, which took effect this year, could result in 3.5 million more emergency room visits annually. 

“Because individuals will no longer have the fear of a possible catastrophic surprise ED bill not covered by their insurer, they may be more inclined to go to the ED in marginal, less severe cases,” the authors wrote. 

Read the full study here.

In the FEHBlog’s opinion, the No Surprises Act is working well, and he does not foresee a surge in ER visits because going to the emergency room is no picnic.

In preventive services news, MedPage Today reports

The jury is still out on whether asymptomatic children and adolescents should be screened for diabetes, the U.S. Preventive Services Task Force (USPSTF) said.

In a new recommendation statement published in JAMA, the task force concluded that there is insufficient evidence to weigh the benefits and harms of screening for type 2 diabetes in this pediatric population, despite rising rates of disease.

“[T]here is inadequate evidence that screening and early intervention lead to improvements in health outcomes such as renal impairment, cardiovascular morbidity, mortality, and quality of life,” wrote Carol M. Mangione, MD, MSPH, of the University of California Los Angeles, and colleagues.

From the miscellany department —

  • The Department of Health and Human Services announced that today HHS “Secretary Xavier Becerra formally swore in Melanie Fontes Rainer as Director of the Office for Civil Rights (OCR). Director Fontes Rainer previously served as the Acting Director and was officially appointed to the role last month.  OCR is responsible for enforcing federal civil rights; conscience protections; the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach Notification Rules; and the Patient Safety and Quality Improvement Act and Patient Safety Rule – which together protect individuals’ fundamental civil rights and medical privacy.”
  • The Justice Department announced “the establishment of three Strike Force teams created to enhance the Department’s existing efforts to combat and prevent COVID-19 related fraud. “These Strike Force teams will build on the Department’s historic enforcement efforts to deter, detect, and disrupt pandemic fraud wherever it occurs,” said Attorney General Merrick B. Garland. “Since the start of this pandemic, the Justice Department has seized over $1.2 billion in relief funds that criminals were attempting to steal, and charged over 1,500 defendants with crimes in federal districts across the country, but our work is far from over. The Department will continue to work relentlessly to combat pandemic fraud and hold accountable those who perpetrate it.” The Strike Force teams will operate out of U.S. Attorney’s Offices in the Southern District of Florida, the District of Maryland, and a joint effort between the Central and Eastern Districts of California.”

The good news is there’s a cure for hepatitis C. The bad news is how hard it is to bring that miracle cure to the people who need it. For years experts assumed the drug’s astronomical price was the biggest barrier. So in 2019, Louisiana and Washington state adopted the “Netflix model,” as in paying a lower price for abundant access to the drug. Just last week the White House jumped on board for a national version.

But STAT’s Nicholas Florko has found that neither state is near its goal. In Washington, the treatment rate for Medicaid patients is now lower than before the initiative began, even with a lower price. “The further you get out in the population … the more you start to hit this population that is harder — harder to identify, more costly to convert to treatment,” Rena Conti of Boston University told Nick. Read his investigation here.

  • The National Institute of Health’s HEAL Program offers ways to build opioid use disorder prevention into everyday life.
  • Govexec discusses OPM’s efforts to “highlight ways federal employees can contribute to the White House’s fight against hunger and to improve Americans’ health and nutrition, including through an event later this month.”

Tuesday Tidbits

David Ermer–AHRQ, COVID vaccine mandate, Electronic health records, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the omicron and siblings front, Govexec and Federal News Network recount today’s oral argument before the Fifth Circuit U.S. Court of Appeals over the legality of the Administration’s Covid vaccine mandate on federal employees.

The en banc ruling, expected in the next few weeks, could be the last step after a lengthy court battle that has played out through many fits and starts over the last year. Feds for Medical Freedom has previously said it will take its case to the Supreme Court if the Fifth Circuit rules against it, though the high court may be less inclined to weigh in on the case after it already ruled on two vaccine mandate cases in January. If the mandate is ultimately permitted to stand, individual employees could still wind up in the federal circuit if they take their cases to MSPB and appeal further after an initial decision. The mandate has not been enforced since a U.S. district judge in Texas first enjoined it in January.

In other virus news, the Wall Street Journal offers one of its helpful overview articles titled “What to Know About Polio Symptoms, Vaccines and the Virus’s Spread in New York.”

From the healthcare cost front, HHS’s Agency for Healthcare Quality and Research called attention to a recent agency report about the characteristic “high spenders”:

• In 2019, the top 1 percent of persons ranked by their healthcare expenditures accounted for about 21 percent of total healthcare expenditures, while the bottom 50 percent accounted for only 3 percent.
• Hypertension and osteoarthritis/other non-traumatic joint disorders were the most commonly treated conditions among the top 5 percent of spenders.
• Persons ages 65 and older and Whites were disproportionately represented in the top spending tiers.
• Inpatient hospital care accounted for about 37 percent of spending for persons in the top 5 percent of spenders.
• Over three-quarters of aggregate expenses for persons in the top 5 percent of spenders were paid for by private insurance or Medicare.

From the SDOH front, MedCity News reports about “Information as a social determinant: Three ways Google is addressing health inequity: Google announced three updates at the Google Health Equity Summit, including a new video series partnership, improved search features and an expanded program with Fitbit.”

In coding news, Healthcare Dive tells us

The American Medical Association said its 2023 Current Procedural Terminology code set, released Friday, contains burden-reducing revisions to the codes and guidelines for providers.

The updates to the data-sharing terminology for medical procedures and services are intended to make coding and documentation easier and more flexible, freeing providers from time-wasting administrative tasks that are clinically irrelevant to providing high-quality care to patients, the AMA said.

The modifications follow the 2021 revisions made to the evaluation and management codes for office visit services. They extend to inpatient and observation care services, consultations, emergency department services, nursing facility services, home and residence services and prolonged services.

HHS regulations implementing HIPAA electronic transaction standards require that the CPT be used to code outpatient services.

Monday Roundup

David Ermer–Congress, COVID-19, Rx coverage, U.S. Healthcare, Wellness–

From Capitol Hill, Govexec informs us that

Congress is looking to fund federal agencies at their current spending levels through mid-December, with momentum growing for a 10-week stopgap bill to avoid a government shutdown on Oct. 1. 

Lawmakers must clear several hurdles before voting on a continuing resolution to kick off fiscal 2023, but they could act as soon as this week. Senate Majority Leader Chuck Schumer, D-N.Y., said last week he would work with Republicans to “avoid even a hint of a shutdown,” though several disagreements remain. Negotiations appear to have settled on a CR that would fund agencies through approximately Dec. 16, but lawmakers have yet to determine exactly which provisions will be added to it. 

From the federal appointment front, STAT News reports

President Joe Biden on Monday appointed longtime biologist and former government scientist Renee Wegrzyn as the first director of the nascent Advanced Research Projects Agency for Health.

Biden’s announcement comes as ARPA-H advocates debate where the multibillion-dollar agency should be headquartered and which elusive disease areas should be prioritized. The president officially launched the agency in March with $1 billion in initial funding allotted by Congress, but the search for its inaugural director has taken months.

Wegrzyn, 45, currently works at Boston-based Ginkgo Bioworks, a company focused on biological engineering, but has prior experience in two government agencies Biden has said he hopes to emulate with ARPA-H — the Pentagon’s Defense Advanced Research Projects Agency and the Intelligence Advanced Research Projects Activity.

Good luck, Dr. Wegryzn.

From the omicron and siblings front

The American Hospital Association tells us

Insured and uninsured Americans can receive the new bivalent Pfizer or Moderna COVID-19 booster and other COVID-19 vaccines at no cost as long as the federal government continues to purchase and distribute them, the Centers for Medicare & Medicaid Services announced today.

The Centers for Disease Control and Prevention this month recommended Pfizer’s updated COVID-19 vaccine booster for Americans aged 12 and older and Moderna’s updated COVID-19 vaccine booster for Americans aged 18 and older at least two months after completing a primary COVID-19 vaccine series or booster. Authorized by the Food and Drug Administration, the updated boosters are bivalent, meaning they help protect against the most recently circulating omicron variants as well as the original virus strain.

Americans can find local sites administering the new COVID-19 vaccine booster here. For more on provider requirements and payment, visit the CDC COVID-19 Vaccination Program and CMS toolkit.

The Wall Street Journal reports

Illness caused by Covid-19 shrank the U.S. labor force by around 500,000 people, a hit that is likely to continue if the virus continues to sicken workers at current rates, according to a new study released Monday.

Millions of people left the labor force—the number of people working or looking for work—during the pandemic for various reasons, including retirement, lack of child care and fear of Covid. The total size of the labor force reached 164.7 million people in August, exceeding the February 2020 prepandemic level for the first time. The labor force would have 500,000 more members if not for the people sickened by Covid, according to the study’s authors, economists Gopi Shah Goda of Stanford University and Evan J. Soltas, at the Massachusetts Institute of Technology.

“If we stay where we are with Covid infection rates going forward, we expect that 500,000-person loss to persist until either exposure goes down or severity goes down,” said Mr. Soltas. That assumes that some of those previously sickened eventually return to work.

The authors “provide the most credible evidence to date about labor-market impacts for a large set of workers,” said Aaron Sojourner, an economist at the W.E. Upjohn Institute for Employment Research, who wasn’t involved in the study.

From the U.S. healthcare business front —

Healthcare Dive relates

Escalating costs for labor, drugs, supplies and equipment are adding to the long-term pressures facing rural hospitals, raising the risk of more closures that could jeopardize patient access to care, the American Hospital Association warned in a new report. 

Many hospitals were already in difficult financial positions before the COVID-19 pandemic began, due to challenges including low patient volume and reimbursement, geographic isolation, staffing shortages and aging infrastructure, the AHA said. From 2010 through 2021, 136 rural hospitals closed, according to data from the University of North Carolina’s Cecil G. Sheps Center for Health Services Research. In 2020, when the pandemic hit, a record 19 rural hospitals closed.

The public health emergency put additional pressure on margins and patient volumes. “While rural hospitals were partially buoyed by the Provider Relief Fund and other sources of COVID-19 assistance that limited closures in 2021, the financial outlook for many rural hospitals moving forward is precarious,” the AHA said.

Revcycle Intelligence reports

Private equity acquisition of physician practices in dermatology, gastroenterology, and ophthalmology was associated with increased healthcare spending and utilization, according to a study published in JAMA Health Forum. * * *

Following a private equity acquisition, physician practices saw consistent growth in spending during the next eight quarters. Acquired practices saw a mean increase of $71 in charges per claim or a 20.2 percent increase. In addition, practices saw an increase of $23 in the allowed amount per claim—an 11 percent increase.

Patient utilization of healthcare services grew as well after practices underwent acquisitions.

Across the eight post-acquisition quarters, the mean number of unique patients increased by 25.8 percent. This increase was mainly driven by more new patient visits, which rose by 37.9 percent. The number of encounters grew by 16.3 percent and the number of evaluation and management (E/M) visits increased by 37.1 percent.

The increase in patient visits may reflect changes in management and practice operations or overutilization of profitable services and low-value care, the study suggested. This could lead to higher healthcare spending without corresponding benefits.

Additionally, researchers said the growing number of visits was consistent with private equity firms’ common strategy to maximize revenue through a fee-for-service delivery system.

Ruh roh on both counts.

Healthcare Finance adds

Quality can go a long way in determining if a consumer is willing to pay more for their healthcare, as indicated by new survey responses published by revenue cycle company AKASA.

Out of more than 2,000 respondents, the survey found that 57% would pay more for a higher quality of care. Out of all categories in the survey, care quality was the only area in which a majority said they would be willing to pay more.

Forty-seven percent said they would pay more for the ability to work with the care team of their choice. Forty-one percent said they would pay more for the ability to work with hospitals of their choice, while the same percentage said they’d pony up more cash for better location proximity or convenience.

In public health news, the American Hospital Association celebrates the fact that

The United Network for Organ Sharing, which serves as the nation’s transplant system under contract with the federal government, Friday reported its millionth U.S. organ transplant. UNOS and the Organ Donation and Transplantation Alliance credited the organ donation and transplantation community, including transplant hospitals, with making the historic milestone possible. The first successful transplant took place at Peter Bent Brigham Hospital (now Brigham and Women’s Hospital) in Boston in 1954.

UNOS and the Alliance encourage the transplant community to join Living It Forward, a national initiative to commemorate the achievement and accelerate the path forward to the next million transplants. They also encourage members of the public to register as organ donors, noting that each donor can save up to eight lives and help up to 75 people through tissue donation. Over 100,000 people remain on the transplant waitlist.

From the Rx coverage front, BioPharma Dive tells us that

The Food and Drug Administration on Friday approved Bristol Myers Squibb’s psoriasis pill Sotyktu, the first medicine of its type and the last of three potential blockbuster drugs the company sought to bring to market this year.

Sotyktu will compete with biologic drugs like AbbVie’s Humira and Amgen’s Enbrel, but as a pill could be more attractive to patients who don’t want to inject themselves regularly. Importantly, Sotyktu’s labeling doesn’t require patients to first try biologic drugs, giving doctors an opportunity to prescribe it widely.

Approval came after Phase 3 testing in which the pill, also known as deucravacitinib, was tested against a placebo as well as another oral therapy, Amgen’s Otezla. In patients with moderate-to-severe plaque psoriasis, Sotyktu outperformed both on two commonly used measures for assessing skin clearing: PASI and sPGA.

“All in all, the overall efficacy and safety profile as a new first-in-class agent for plaque psoriasis bodes well for it becoming the standard of care,” said Samit Hirawat, Bristol Myers Squibb’s chief medical officer, setting a high bar for his company’s commercial expectations.

In wellness news, Healio informs us that

Widespread adoption of simple lifestyle changes, including switching to a well-known eating plan, could reduce risk for CV events and death for millions of adults with stage 1 hypertension, researchers reported.

“Millions of working-age people are walking around with elevated BP, which is symptomless but is also a leading preventable cause of disability and death,” Kendra D. Sims, PhD, MPH, a postdoctoral fellow at the University of California, San Francisco (UCSF) School of Medicine who presented the findings at the American Heart Association Hypertension Scientific Sessions, told Healio. “Our study found that 27,000 CVD events and 2,800 deaths could be prevented during the next 10 years if people with elevated BP follow through with recommended lifestyle changes. We would then save $1.6 billion in associated health care costs. The largest benefit comes from eating more fruits and vegetables and less salt, as outlined in the Dietary Approaches to Stop Hypertension (DASH) diet.

Weekend Update

David Ermer–Congress, COVID-19, Mental health care, SDOH–

The House of Representatives and the Senate will be engaged in Committee business and floor voting this coming week.

From the Omicron and siblings front —

Bloomberg Prognosis offers an interesting observation from Katrine Wallace, an epidemiologist at the University of Illinois at Chicago,

“For some viruses, where there is better mucosal immunity in the nose (via past infection or vaccines), people can fight off pathogens and develop an immune response without ever feeling ‘sick.’” In other words, for certain infections, your immune system might get revved up by recognizing a virus, and then swiftly fight it off. 

“However, Covid-19 is not a virus that we have developed lasting mucosal immunity for, either through vaccines or via previous infections,” says Wallace.

This is the whole rationale for the development of the new Covid shots that are inhaled instead of injected, she says. The nose and mouth are where Covid first enters the body, so the vaccine antibodies elicited by those types of vaccines give people a more immediate line of defense. 

The Wall Street Journal provides details on nagging Covid death levels:

Roughly 85% of people who died from Covid-19 through mid-August this summer were 65 or older, a Wall Street Journal analysis of death-certificate data show. The rate is similar to 2020 peaks, before vaccines were available. Deaths trended younger for much of last year.

Covid-19 is on pace to be the third-leading cause of death for the third straight year, said Dr. Robert Anderson, chief of the mortality statistics branch at the CDC’s National Center for Health Statistics. Since 2020, it has trailed only heart disease and cancer, significantly reducing life expectancy. * * *

The health system AdventHealth counted 24 deaths related to Covid-19 at its Orlando, Fla.-area hospitals in August. Age was the biggest factor, although younger patients with compromised immune systems were also at risk, doctors with the health system said. All but one Covid-19 patient who died had serious health problems such as diabetes, chronic obstructive pulmonary disease, heart failure and obesity.

Unfortunately, the Journal’s article discusses vaccination status but does not factor in the Paxlovid pill or other available treatments, which should be a game changer for older folks with Covid.

From the mental healthcare front — ‘

Yesterday, September 10, was World Suicide Awareness Day. McKinsey and Company reported,

The suicide rate in the United States has risen over the past 20 years to become the second-leading cause of death for people between the ages of ten and 34, write partner Erica Hutchins Coe, senior partner Martin Dewhurst, senior partner Tom Latkovic, and co-authors in a recent report from the McKinsey Health Institute (MHI). And by winter of 2021, the weekly rate of ER visits by adolescents who attempted suicide was 39 percent higher than pre-pandemic levels. By taking action to address this urgent public health issue, organizations, educators, healthcare professionals, governments, and society at large could help millions in crisis. This #WorldSuicidePreventionDay, learn about ongoing efforts by MHI and its collaborators to improve crisis care in the United States * * * .

The article provides links to relevant McKinsey publications on this important topic.

The American Medical Association’s “What Doctors Wish Their Patients Knew” column delves into loneliness and health.

From the social determinants of health front, Fierce Healthcare looks into CVS’s Healths efforts to improve health equity.

When the CVS Caremark team geared up to take on health disparities, it quickly realized that any initiative would require a significant basis in data to succeed.

That entailed both gathering more data and building the tools necessary to track and analyze them.  For example, Joel Helle, vice president of physician services at CVS Specialty, told Fierce Healthcare that Caremark has not historically gathered race and ethnicity data, but now asks payers and plans sponsors for that information to more accurately target where disparities are occurring.

“It’s real race and ethnicity data, and we know who those patients are,” he said. “That’s the future, in my mind, of what everybody needs to do.”

In addition, the company built a proprietary tool that combs data from 17 different indexes to identify where disparities exist, he said. That tool, he said, puts “red dots” on the map to highlight risks, and the Caremark team can then use its internal data to further drill down to challenges in specific communities.

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cyberpolicy front, Cyberscoop reports

Federal cyber officials will formally ask industry leaders “in the next couple of days” to help shape the regulatory structure for cybersecurity incident reporting, Jen Easterly, director of the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency, said Wednesday.

The incident reporting framework follows the new law that President Biden signed in March requiring that critical infrastructure owners and operators to report major cyberattacks to CISA within 72 hours and ransomware attacks within 24 hours.

CISA has said that it will use the reports to rapidly deploy resources to victims under attack and share information with network defenders. Easterly, who spent four years working on cyber defense at Morgan Stanley prior to coming to CISA, emphasized that she wants to work with industry to create a smart regulatory apparatus that doesn’t create problems for the private sector.

“This will finally allow us a much better understanding what’s going on across the ecosystem,” Easterly said at the Billington Cybersecurity Summit in Washington. “We don’t want to burden industry and we don’t want to burden the federal government with noise either.”

Easterly said that after CISA issues a request for information from the private sector, she intends to also host several listening sessions with industry to ensure the rule-making process is “consultative.”

From the cyberbreach front —

Health IT Security reports

Healthcare data breaches are continuing to impact the healthcare sector at alarming rates, even as more organizations adopt updated security solutions in an attempt to keep pace with the influx of new cyber threats.

The healthcare sector suffered about 337 breaches in the first half of 2022 alone, according to Fortified Health Security’s mid-year report. More than 19 million records were implicated in healthcare data breaches in the first six months of the year.

What’s more, IBM’s annual “Cost of a Data Breach” report showed that the average cost of a healthcare data breach is now $10.1 million per incident, signifying a 9.4 percent increase from its 2021 report.

Cyberscoop adds

Nearly 90% of information technology professionals working in health care said their facilities suffered a cyberattack in the past year, according to a report out Thursday from the research organization Ponemon Institute. 

Many of them said the attacks, which averaged 43 at various types of health care organizations including hospitals and insurance providers, increasingly affected patient care.

More than 600 IT and IT security practitioners responded to the survey sponsored by the cybersecurity firm Proofpoint. The report comes amid frequent warnings from federal cybersecurity officials about ransomware and other cyberattacks on health care organizations.

Fifty-three percent of the respondents said their organization had experienced at least one ransomware incident over the past two years, while a third said they’d suffered between two and five. Nine percent of respondents said their organizations suffered six to 10 incidents.

The findings mark an increase from a year ago when Ponemon conducted a similar survey commissioned by cybersecurity firm Censinet. That survey found that just over 40% of respondents suffered a ransomware attack in the previous year.

From the cybervulnerability front —

This past week, HHS’s Health Sector Cybersecurity Coordination Council (HC3) released its August 2022 Cybersecurity Vulnerability Bulletin and a PowerPoint presentation about emerging technology and security implications for the health sector.

Security Week adds “Security researchers with AT&T Alien Labs are warning of a new piece of malware that can take full control of infected Linux systems, including Internet of Things (IoT) devices. Dubbed Shikitega, the threat is delivered as part of a multi-stage infection chain, where each step is responsible for a part of the payload and fetches and executes the next module.”

From the ransomware front —

Cybersecurity Dive reports

Barely one in five organizations consider their organization as prepared as possible for a potential ransomware attack, according to a survey of 400 IT leaders and professionals involved in their company’s cybersecurity strategy. Almost 15% said they are very or somewhat unprepared for an attack.

The majority of respondents said they spend less than five hours per week on ransomware preparedness. Almost one-third invest less than an hour per week on the matter.

Organizations’ perceived state of preparedness and time spent bolstering defenses against ransomware stands out considering how many have already been hit. More than four out of 10 respondents said they’ve had a ransomware attack that resulted in infiltration or data encryption.

Here’s a link to the latest Bleeping Computer’s Week in Ransomware for your reading pleasure.

In cybersecurity leadership news —

  • Cybersecurity Dive discusses “Today’s top cybersecurity concerns and what comes next; CISOs are up against talent shortages and retention concerns amid an increasingly sophisticated threat landscape.
  • The Wall Street Journal reflects on “Why Companies Need to Think About Cyber Resilience, Not Just Cybersecurity; Cyber resilience concedes that breaches are inevitable, and it makes minimizing risk or loss in the event of an attack the end goal.”

Friday Stats and More

David Ermer–Congress, COVID-19, Mental health care, U.S. Healthcare–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first week, here is the FEHBlog’s updated weekly chart of new Covid cases for 2022:

The enormous surge on the right is the original Omicron strain. Its sibling variants follow. The CDC’s weekly review of its Covid stats is back this week:

As of September 7, 2022, the current 7-day moving average of daily new cases (70,488) decreased 18.8% compared with the previous 7-day moving average (86,853).

CDC Nowcast projections* for the week ending September 10, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100% with the predominant Omicron lineage being BA.5, projected at 87.5% (95% PI 86.2-88.7%).

Here is the CDC’s current chart of daily trends of new Covid hospitalizations:

The CDC’s weekly review adds “The current 7-day daily average for August 31–September 6, 2022, was 4,620. This is a 10.5% decrease from the prior 7-day average (5,163) from August 24–30, 2022.”

Here’s the FEHBlog’s weekly chart of new Covid deaths for 2022 which also is trending down.

The CDC’s weekly review adds “The current 7-day moving average of new deaths (314) has decreased 28.1% compared with the previous 7-day moving average (437).”

Here’s the FEHBlog’s chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era (51st week of 2020) through the 36th week of 2022.

The CDC’s weekly review adds

As of September 7, 2022, 610.7 million vaccine doses have been administered in the United States. Overall, about 263.1 million people, or 79.2% of the total U.S. population, have received at least one dose of vaccine. About 224.4 million people, or 67.6% of the total U.S. population, have been fully vaccinated.*

Of those fully vaccinated, about 109.0 million people have received a booster dose,* but 50.0% of the total booster-eligible population has not yet received a booster dose. Booster dose eligibility varies by age and health condition. Learn more about who is eligible.

Last week, according to the CDC’s stat review, the CDC’s Covid community level evaluations saw an 8.6% decrease in high-level communities and a 10.2% increase in low-level communities.

To check your COVID-19 Community Level, visit COVID Data Tracker. To learn which prevention measures are recommended based on your COVID-19 Community Level, visit COVID-19 Community Level and COVID-19 Prevention.

In other Covid news, Benefits Pro discusses a Brookings Institution report on long Covid’s impact of the U.S. workforce, and the Society for Human Resource Management offers an article confirming the FEHBlog’s take on the recent federal appellate court decision concerning the federal government’s stayed vaccine mandate on federal government contractors.

In other federal litigation news —

A federal judge grilled the Justice Department on Thursday over its antitrust claims that UnitedHealth Group Inc.’s $13 billion acquisition of health-technology firm Change Healthcare Inc.  would suppress competition and limit innovation in health insurance markets.

During closing arguments, U.S. District Judge Carl J. Nichols questioned the department’s arguments that he should block the deal because it would limit competition for technology used in claims processing and would give UnitedHealth access to sensitive industry data that it could use to harm competitors. * * *

Judge Nichols is expected to issue his ruling in the coming weeks.

Home improvement retailer Home Depot and two other, smaller employers are appealing a recent $2.67 billion settlement that covers allegedly anticompetitive behavior from Blue Cross Blue Shield insurers.

The appeals could potentially delay the release of the funds and the broader terms of the settlement, which U.S. District Judge R. David Proctor finalized in August.

STAT News also tells us from Capitol Hill

Negotiations are intensifying over massive, multibillion-dollar legislation to fund the Food and Drug Administration, with just weeks left before the current agreement expires, four sources following the talks said. * * *

Talks are still fluid, and there is no final agreement yet. Lawmakers are aiming to finalize a package by early next week.

The FDA agreement could ride along with a government funding package before the end of September, when government funding runs out. There’s a chance the user fee legislation could pass on its own, however, if there is a bipartisan deal. The Democrats’ user fee offer was a full five-year agreement, not a shorter-term deal.

From the fraud, waste, and abuse front, Beckers Hospital Review informs us

A small number of primary care providers have been responsible for most of the recent growth in remote patient monitoring, though it’s not known how much their patients needed that type of potentially expensive care, a new Health Affairs study found.

Remote patient monitoring grew fourfold during the pandemic’s first year, according to the analysis of OptumLabs Data Warehouse data from January 1, 2019, to March 31, 2021. The database includes Medicare Advantage claims that total about 20 million people annually.

Out of a group of 342 high-volume providers, 0.1 percent accounted for 69 percent of all general remote patient monitoring claims, the Sept. 6 study found.

But the Harvard University researchers said they didn’t observe that the high-volume providers targeted patients with more severe or uncontrolled disease. They said growth rates “indicate that total spending on remote patient monitoring could quickly escalate” and potentially burden CMS and other payers financially.

“More research is needed to identify which patients and use cases benefit most from remote patient monitoring,” the study’s authors wrote. “In the meantime, payers and policymakers should closely monitor its use and be prepared to establish appropriate controls as informed by new evidence.”

From the mental healthcare front, the American Hospital Association relates

The Department of Health and Human Services today reported a 45% increase in call volume and improved answer rates and wait times for the 988 Suicide and Crisis Lifeline this August compared to a year ago. The 10-digit National Suicide Prevention Lifeline in July transitioned to the 988 Suicide and Crisis Lifeline, meaning individuals experiencing a suicide, mental health or substance use crisis can simply call, chat or text 988 to connect with a trained crisis counselor.

The Substance Abuse and Mental Health Services Administration also announced a $35 million grant opportunity to better support 988 Lifeline services in tribal communities, which face unique challenges to accessing technology and crisis services.