Friday Stats and More

Mental health care

Friday Stats and More

David Ermer–CDC, COVID-19, COVID-19 vaccine, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–

Based on the Centers for Disease Control’s Covid data tracker and using Thursday as the first day of the week, here are the FEHBlog weekly charts of new Covid cases and deaths from the 27th week of 2021 through the 13th week of 2022:

The CDC weekly review of its Covid data adds

Currently, there are 19 (0.59%) counties with a high COVID-19 Community Level, 146 (4.53%) counties with a medium Community Level, and 3,059 (94.88%) counties with a low Community Level. This represents a slight (−0.84%) decrease in the number of high-level counties, a moderate (−2.73%) decrease in the number of medium-level counties, and a corresponding (+3.57%) increase in the number of low-level counties. Twenty-seven (48.21%) of 56 jurisdictions had no high- or medium-level counties this week. To check your COVID-19 community level, visit COVID Data Tracker.

* * *

The current 7-day daily average [of new Covid hospital admissions] for March 23–29, 2022, was 1,564. This is a 15.8% decrease from the prior 7-day average (1,858) from March 16–22, 2022. * * *

The current 7-day moving average of new [Covid] deaths (627) has decreased 14.4% compared with the previous 7-day moving average (732).

Here’s a link to the FEHBlog’s weekly chart of new Covid vaccinations distributed and administered from the beginning of the Covid vaccination era until last Wednesday.

The CDC’s weekly review notes

As of March 30, 2022, the 7-day average number of adhttps://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.htmlministered vaccine doses reported (by date of CDC report) to CDC per day was 214,405, a 17.8% increase from the previous week.

CDC’s COVID Data Tracker displays vaccination trends by age group, race/ethnicity, and urban/rural status. To see trends by age group and race/ethnicity, visit the Vaccination Demographic Trends tab. To see trends by urban/rural status, visit the COVID-19 Vaccination Equity tab.

The American Medical Association offers guidance to physicians concerning the FDA’s emergency authorization of a second Covid booster for Americans aged 50 and older.

HR Dive discusses what employers should take away from the Biden Administration’s updated approach to Omicron.

Here’s a link to the CDC’s weekly flu surveillance report or Fluview.

From the “and more” department —

  • HR Dive discusses what employers can do to help employees with adolescent children suffering from behavioral health issues. For example, because a shortage of child psychiatrists exists,

Telemental health programs offer convenient access (often at lower cost than in-person care) for many services—and some, like Brightline, are designed specifically for families of children with mental health needs. However, recent studies have shown that telehealth offerings are not being utilized as much for children as they are for adults, for rural populations as they are for urban ones, or for low-income communities as they are for wealthier ones. Clearly, there is an opportunity for employers to make vulnerable populations aware of the telemental health services available to them. 

  • BioPharma Dive identifies “Five FDA decisions to watch in the second quarter. Between April and June, the agency will advance key regulatory reviews in ALS and gene therapy as well as host an advisory meeting on cancer drugs.”

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 vaccine, Employee Wellness Programs, Federal employment benefits, Mental health care, OPM, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill

Roll Call tells us

Senators negotiating a COVID-19 supplemental funding package have an “agreement in principle” to provide roughly $10 billion for the Department of Health and Human Services to stock up on waning domestic supplies for combating the virus, according to Sen. Roy Blunt, R-Mo.

Blunt, the top Republican on the Senate Labor-HHS-Education Appropriations Subcommittee, said both parties have tentatively agreed to offsets for the $10 billion that would repurpose unspent funds from prior pandemic relief laws.

The offsets negotiators agreed to include $2.2 billion from unused grant funds for venues like zoos and theaters and $2 billion in untapped assistance to the aviation and manufacturing industry, Blunt said. His comments to reporters came after a Republican Conference lunch in which lead GOP negotiator Sen. Mitt Romney of Utah briefed his colleagues on the agreement in principle. 

Fierce Healthcare informs us

The House [of Representatives] passed a bill on Thursday that caps the out-of-pocket cost of insulin at $35 a month for beneficiaries in Medicare Part D and for certain group and individual plans.

The Affordable Insulin Now Act, which passed the House via a 232 to 193 vote, comes as work in the Senate continues on a bipartisan alternative that could bring additional changes. * * *

Private plans would also be required to offer first-dollar coverage of insulin without any deductible, according to an analysis from the Congressional Budget Office. 

The cap on cost-sharing for private insurance plans would implement in 2023.

The Hill offers a related article explaining why insulin prices are so “troubling” high.

HR Dive reports

Among the provisions of this month’s $1.5 trillion omnibus spending bill, Congress included a revival of an exemption that allowed high-deductible health plans to cover telehealth before individuals meet their deductible.

The provision was originally created by the Coronavirus Aid, Relief, and Economic Security Act, which sunset at the end of 2021. The provision will resume April 1 but will again sunset at the end of this year.

From the Omicron and siblings front, the Wall Street Journal discusses the state of Covid treatments and offers its advice on who should seek out a second Covid booster besides the immunocompromised.

From the OPM front, Govexec projects OPM’s actions over the next 18 months based on the FY 2022 to FY 2026 strategic plan released last Monday. In short, “Hire, Hire, Hire.”

Govexec also discusses efforts underway by OPM, the Social Security Administration and the Thrift Savings Plan to improve the customer service experience of federal employees and retirees. Good luck with that.

From the research front the National Institutes of Health announced

Scientists have published the first complete, gapless sequence of a human genome, two decades after the Human Genome Project produced the first draft human genome sequence. According to researchers, having a complete, gap-free sequence of the roughly 3 billion bases (or “letters”) in our DNA is critical for understanding the full spectrum of human genomic variation and for understanding the genetic contributions to certain diseases. The work was done by the Telomere to Telomere (T2T) consortium, which included leadership from researchers at the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health; University of California, Santa Cruz; and University of Washington, Seattle. NHGRI was the primary funder of the study.

Analyses of the complete genome sequence will significantly add to our knowledge of chromosomes, including more accurate maps for five chromosome arms, which opens new lines of research. This helps answer basic biology questions about how chromosomes properly segregate and divide. The T2T consortium used the now-complete genome sequence as a reference to discover more than 2 million additional variants in the human genome. These studies provide more accurate information about the genomic variants within 622 medically relevant genes. * * *

The now-complete human genome sequence will be particularly valuable for studies that aim to establish comprehensive views of human genomic variation, or how people’s DNA differs. Such insights are vital for understanding the genetic contributions to certain diseases and for using genome sequence as a routine part of clinical care in the future. Many research groups have already started using a pre-release version of the complete human genome sequence for their research.  

From the mental healthcare front, the American Hospital Association calls our attention to a new GAO report.

Consumers with health coverage experience challenges finding in-network mental health providers, who may not be accepting new patients or have long wait times to see them, according to a new report from the Government Accountability Office. Factors contributing to these challenges include low reimbursement rates for mental health services and inaccurate or out-of-date information on provider networks, GAO said. The report also looks at ongoing and planned federal efforts to address these challenges, for example by increasing the mental health workforce, mental health system capacity and oversight of health plan compliance with mental health parity laws.

This squib caused the FEHBlog to recall a comment that he heard at a conference — Four out of five doctors are in-network but only one out of five mental health providers are in-network with the notable exception of hub and spoke telemental services.

Yesterday the FEHBlog suggested that in return for three free primary care visits and three behavioral health visits, plan members should name and use their in-network primary care provider and primary mental health provider. The FEHBlog is sticking with this idea for the in-network primary care provider but he recognizes the idea may be premature for the in-network primary mental health provider. Of course, creating a looser standard for free mental health care compared to primary care is compliant with the federal health parity rule. The reverse would violate the often fuzzy non-quantitative treatment limitations created by the law.

From the miscellany department —

  • STAT News tells us “With Medicare expected to cover a projected 80 million people by 2030,He entrepreneurs and investors are cashing in on what analysts see as an inevitable shift in health care away from the hospital and into the homes of aging patients.” The publication identifies five related technology trends.
  • Fierce Healthcare reports “Virtual care startup Hims & Hers is teaming up with Carbon Health to offer patients in California with direct access to providers for in-person medical appointments at clinics. The collaboration will provide easy and comprehensive access to a broader range of care options through the Hims & Hers platform, company executives said.”
  • Health Payer Intelligence informs us “Large employers are investing more in their wellness program design in 2022 and their programs revolve around hybrid work environments, job satisfaction, and equity, the Business Group on Health found in a survey.”

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, COVID-19 vaccine, Federal employment benefits, Mental health care, OPM, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Congress.gov informs us that Congress has sent the Postal Reform Act of 2022 (HR 3076) to the President for his signature.

MedPage Today discusses a Congressional hearing on Medicare for All held today. Democrats (for) and Republicans (against) remain split.

The FEHBlog finds the President’s budget proposal useful for identifying new Administration FEHB priorities, several of which were identified in yesterday’s post. What’s more, FedWeek tells us

[T]he FEHB program would be among programs affected by a broader proposal regarding mental health service coverage in health insurance. It would require coverage of three primary visits and three behavior health visits without cost-sharing.

In the FEHBlog’s opinion, this idea would drive up premiums for no reason because federal and postal employees already are offered employee assistance programs that offer free counseling sessions. OPM needs to do a better job coordinating its various benefit programs.

Fierce Healthcare identifies four other healthcare items from the President’s budget proposal that should be watched.

From the Omicron (and siblings) front —

The Wall Street Journal reports

The Omicron BA.2 variant represents more than half of new Covid-19 cases in the U.S., the latest federal estimates show, as signs suggest infections are edging higher again in parts of the Northeast.

The region has the highest BA.2 concentrations, including more than 70% in an area including New York and New Jersey, according to estimates the Centers for Disease Control and Prevention released Tuesday. BA.2 has been moving steadily higher for more than a month and represents an estimated 55% of national cases in the week ended March 26, the CDC said. * * *

“Predictions are hard, but I am expecting that the U.S. will have a surge in at least some locations,” said Aubree Gordon, an associate professor of epidemiology at the University of Michigan School of Public Health.

AHIP tells us

Today the Food and Drug Administration (FDA) authorized a second single Pfizer-BioNTech or Moderna COVID-19 vaccine booster dose for persons aged 50 and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. A second booster dose of the Pfizer-BioNTech COVID-19 vaccine or Moderna COVID-19 vaccine may also be administered to certain immunocompromised individuals, for those 12 years of age and older or 18 years of age and older, respectively, at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.

The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. This action will now make a second booster dose of these vaccines available, for a total of five vaccine doses authorized for populations at higher risk for severe disease, hospitalization and death. Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns. * * *

This authorization still requires the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) to formally recommend the vaccine for the specific populations.  No date for an ACIP meeting has yet been announced.

Health plans are not required to reimburse these authorized vaccines until ACIP makes its decision.

From the healthcare business front —

Healthcare Dive reports

Hospitals’ operating margins were negative in February for the second consecutive month even as cases of the omicron variant waned, according to Kaufman Hall’s National Hospital Flash report. Negative margins in January were the first seen in 11 months.

The median Kaufman Hall Operating Margin Index was -3.45%, up from -4.25% in January but still well below levels hospitals can sustain, the report said.

Volumes for inpatient services fell while outpatient volumes staggered with revenues in those categories falling 19.3% and 5%, respectively, from January, according to the report.

Healthcare Finance News reports

UnitedHealth Group subsidiary Optum will combine with in-home healthcare service provider LHC Group, with UHG purchasing the latter for about $5.4 billion.

LHC provides healthcare services in the home for a demographic of mostly older patients dealing with chronic illnesses and injuries. It will be melded with Optum, which manages drug benefits and offers data analytics services and works with more than 100 health plans.

From the tidbits department —

  • The CDC has posted a new, improved anti-biotic resistance website. The CDC explains that the site is “refreshed to better engage and share information on antibiotic resistance (AR) in the United States and around the world. We all have a role to play—from travelers, animal owners, and care givers to patients and healthcare providers—to fight this deadly threat and now you can quickly access CDC’s latest resources.”
  • MedPage Today reports “Prediabetes prevalence nearly doubled among U.S. youth from 1999 to 2018, national data indicated. According to National Health and Nutrition Examination Survey (NHANES) data on over 6,500 youth, the prevalence of prediabetes increased from 11.6% in 1999-2002 to 28.2% in 2015-2018, Junxiu Liu, PhD, of Icahn School of Medicine at Mount Sinai in New York City, and colleagues reported in JAMA Pediatrics.” Obesity is a common thread.
  • The Endocrinology Network informs us “Participation in a tele-mentoring program led by Robert Wood Johnson Medical School was associated with a 44% decrease in inpatient admissions and a more than 60% decrease in inpatient spending among Medicaid patients with diabetes.” Bravo.
  • The International Foundation of Employee Benefit Plans discusses evaluating high cost gene therapy financing programs.

Friday Stats and More

David Ermer–COVID-19, COVID-19 vaccine, Mental health care, No Surprises Act, Telehealth, U.S. Healthcare–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s weekly chart of new Covid cases from the 27th week of 2021 through the 12th week of 2022:

In the current CDC Covid Data Weekly Tracker, the CDC explains

In February, CDC’s COVID Data Tracker released a Wastewater Surveillance tab, which tracks changes and detections of SARS-CoV-2 viral RNA levels at more than 600 testing sites across the country. Because many people with COVID-19 shed the virus in their feces, wastewater testing can help us monitor COVID-19 in communities. Virus levels in wastewater usually increase four to six days before clinical cases increase, so surveillance results can help communities act quickly to prevent the spread of COVID-19.

Currently, virus levels in wastewater are relatively low across the country. More than half of all sites reporting wastewater data are experiencing a decrease in SARS-CoV-2 levels, but some have reported a modest uptick. These upticks may reflect minor increases from very low levels to levels that are still low. It’s important to note that even a small increase when levels are very low can appear like a dramatic increase in the percent change. However, there is a possibility that some communities might start to see an increase in COVID-19 cases. This could happen for a variety of reasons, like waning immunity, new circulating strains, and eased prevention strategies.

Right now, it’s too early to know if we’ll see a corresponding increase in reported cases across the country. Wastewater data are meant to be used with other COVID-19 surveillance data. CDC encourages local public health officials to watch for sustained increasing levels of the virus in wastewater, and to use wastewater surveillance data with other kinds of data to inform their decisions. CDC continues to encourage people to use COVID-19 Community Levels to find out what actions they should take to protect themselves and others. The whole community can be safe only when we all take steps to protect each other.

Using the same approach, here is the FEHBlog’s latest weekly chart of Covid deaths:

Precision Vaccinations adds that

[T]he 2022 trend data from the CDC indicates pneumonia may soon overtake COVID-19 as the leading cause of respiratory death in the U.S.

Historically, the CDC reported the number of visits to emergency departments with pneumonia as the primary diagnosis averaged about 1.5 million, which led to 47,000 deaths annually.

The good news is pneumonia is a vaccine-preventable disease.

Unfortunately, the percentage of adults who had ever received a pneumococcal vaccination was 25.5% in 2020.

Increasing the pneumococcal vaccination rate is a worthy goal for health plans and primary care providers.

Here’s is the FEHBlog’s weekly chart of Covid vaccinations distributed and administered in the Covid vaccination era:

While recent vaccinations numbers are nothing to crow about, over 75% of Americans age 18 and older are fully vaccinated. Nearly half of the same population and over two-thirds of Americans age 65 and older have received a booster.

Politico adds

The Biden administration could authorize a second Covid-19 booster shot for older Americans within weeks, amid rising concern over a potential resurgence of cases, four people with knowledge of the matter told POLITICO.

The move under consideration by senior health officials would recommend the additional vaccine dose for adults 65 and older, in an effort to better protect high-risk people and stave off a wave of hospitalizations should infections climb rapidly as a result of the spread of the Omicron subvariant, BA.2. Currently, second boosters are only recommended for those with compromised immune systems.

From the No Surprises Act front, last Monday, Federal District Judge Richard Leon heard oral argument on dispositive cross-motions submitted by medical associations and the federal government regulators concerning the status of the qualifying payment amount in the baseball arbitration process. The FEHBlog has heard from a couple of sources who attended the hearing that Judge Leon indicated that he does not plan to put deciding the case on his front burner because the federal regulators advised him about their intent to issue the final, final rule on the Independent Dispute Review process in May 2022. The case is pending in the U.S. District Court for the District of Columbia.

From the telehealth front, mHealth Intelligence informs us

More than two-thirds of telehealth providers said they use audio-only modalities to offer telehealth services, according to a recent survey conducted by the American Medical Association.

The survey polled 2,232 physicians between Nov. 1 and Dec. 31, 2021.

The popularity of telehealth among physicians is apparent, with 85 percent saying they still use it. But 52 percent agreed that their telehealth usage has decreased since they first started offering the services. The top reason for the decrease was that they moved to a hybrid model of care with both in-person and virtual care services.

From the healthcare business front —

Fierce Healthcare reports

Optum has quietly acquired Refresh Mental Health from private equity firm Kelso & Company, Axios reported Thursday.

The company confirmed the deal in a statement to the outlet. The acquisition has not been announced publicly as of yet.

“Optum and Refresh Mental Health are excited to expand effective behavioral care to patients through a more coordinated health system,” the company said in a statement to Axios. * * *

Refresh was founded in 2017 and provides outpatient mental and behavioral health services. It runs 300 locations across 37 states that offer a variety of services including psychiatry and substance abuse treatment.

and

Bicycle Health, a virtual provider for opioid use disorder, is partnering with five additional payers, it said in an announcement provided exclusively to Fierce Healthcare.

The partnerships are with Molina Healthcare and McLaren Health Plans in Michigan, UHC Community Plan in Arizona, Health First Colorado (the state’s Medicaid program) and Blue Cross Blue Shield Texas. In total, these payer partnerships have the potential to reach more than 8 million patients, the company said. Coverage will include medication management, behavioral health (individual or group psychotherapy, medical care), support groups and care coordination.

“From high costs to significant time commitments, many traditional OUD recovery programs just aren’t realistic options for the vast majority of patient experiences,” Bicycle Health CEO and founder Ankit Gupta said in a statement. “We are committed to making science-based, holistic OUD treatment accessible to all who need it—and these partnerships are an exciting step towards that goal.”

Friday Stats and More

David Ermer–CDC, COVID treatment, COVID-19, COVID-19 vaccine, Mental health care, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s latest weekly charts of new Covid cases and deaths (a lagging indicator):

The CDC observes in its weekly review of its Covid statistics

COVID-19 cases, hospitalizations, and deaths all continue to decrease in the United States. According to CDC’s COVID Data Tracker, as of March 16, 2022, 76.7% of the total U.S. population has received at least one dose of a COVID-19 vaccine, and 65.3% has completed their primary series. However, only about half of the booster-eligible population has received a booster dose and is considered up to date on their COVID-19 vaccines.

Two new studies show the effectiveness of COVID-19 vaccines and boosters across periods of three variants of concern (Alpha, Delta, and Omicron). CDC released a study today showing that, among adults hospitalized with COVID-19 during the Delta and Omicron waves, those who received two or three doses of the Pfizer-BioNTech or Moderna vaccine had 90–95% less risk of dying or needing a ventilator compared with adults who were not vaccinated. Protection was highest in adults who received a third COVID-19 vaccine dose. A study published in the British Medical Journalexternal icon found that vaccines gave a high level of protection against hospitalization for all variants, but not as much for Omicron among adults who received only a primary series. However, boosters increased protection against Omicron. The study also showed that hospital patients who were vaccinated had much lower disease severity than patients who were not vaccinated.

These studies emphasize the importance of staying up to date with vaccinations—they are our best protection against severe COVID-19 illness. Vaccination is also the safest way to reduce the chance that new variants will emerge. Find a vaccine provider and get your booster dose as soon as you can.

In that regard, here is the FEHBlog weekly chart of Covid vaccinations distributed and administered from the beginning of the vaccination era in late 2020:

Here’s a link to the Food and Drug Administration’s March 18 round of its Covid related activities.

While the bulk of Covid care spending goes to hospitals, Becker’s Hospital Review reports that a “sizable minority” have a significant amount out-of-pocket spending for this care, according to a study published in the American Journal of Managed Care March 16.”

It’s worth adding that the Wall Street Journal reports that

The biggest credit-reporting firms will strip tens of billions of dollars in medical debt from consumers’ credit reports, erasing a black mark that makes it harder for millions of Americans to borrow.

Equifax Inc.,  Experian  PLC and TransUnion are making broad changes to how they report medical debt beginning this summer. The changes, which have been in the works for several months, will remove nearly 70% of medical debt in collections accounts from credit reports.

Beginning in July, the companies will remove medical debt that was paid after it was sent to collections. These debts can stick around on a consumer’s credit report for up to seven years, even if they are paid off. New unpaid medical debts won’t get added to credit reports for a full year after being sent to collections.

The firms are also planning to remove unpaid medical debts of less than $500 in the first half of next year. That threshold could rise, according to people familiar with the matter.

From the compliance front —

  • The Internal Revenue Services issued a notice on how to calculate the No Surprises Act’s Qualified Payment Amount when the health plan does not have enough data to calculate a January 2019 median.
  • The Department of Labor is offering a webinar on March 30 at 11 am that “will help employers, service providers, and benefit professionals understand how the provisions of [the federal mental health partity act] apply to employer-sponsored group health plans and provide information on how to avoid common problems. The webinar runs about 45 minutes to an hour and is limited to 200 participants.

From this week’s healthcare conferences front

  • Fierce Healthcare discusses the electronic medical records interoperability theme of the HIMSS conference.
  • Fierce Healthcare also offers a wrap report on “the most interesting innovations at SXSW 2022: From holograms to the future of psychedelics.”

From the telehealth front

  • Becker’s Payer Issues reports that most consumer driven plans have taken advantage of the IRS offered flexibility to cover telehealth before the “high” annnual deductible.
  • Forbes informs us “Telehealth Accounts For One In Three Mental Health Visits Two Years Into Pandemic.” Whoopee.

From the good works department, the American Medical Association tells us about a North Carolina physician who is talking the diabetes problem.

Dr. [Brian] Klausner is the medical director of WakeMed’s Community Population Health program in Raleigh. He also is a physician champion for DiabetesFreeNC. That is the statewide initiative where AMA partnered with the North Carolina Medical Society and others to support collaborative efforts to end type 2 diabetes in the Tar Heel State.  

Rather than think of the pandemic as having “derailed” diabetes prevention or other population health efforts, Dr. Klausner said that “COVID-19 expedited new perspective in how we can do a better job addressing historic roadblocks to community health initiatives, including those related to diabetes and prevention.”

Midweek update

David Ermer–COVID vaccine mandate, COVID-19, Electronic health records, HIPAA Privacy and Security Rules, Mental health care, No Surprises Act, U.S. Healthcare–

From the FEHB front, the Office of Personnel Management released the 2023 call letter for benefit and rate proposals and the related technical guidance letter.

OPM is to be congratulated for releasing the two letters simultaneously. Historically, OPM has released the call letter weeks or months before the technical guidance letter. As a result, carriers cannot start preparing their benefit and rate proposals, due May 31, until they receive both letters.

From the Omicron (and sibling) front, the American Medical Association informs us

The New York Times (3/15, Mandavilli) reports about “17 million Americans received the Johnson & Johnson Covid vaccine, only to be told later that it was the least protective of the options available in the United States.” However, “new data suggest that the vaccine is now preventing infections, hospitalizations and deaths at least as well as the Pfizer-BioNTech and Moderna vaccines.” The reasons are unclear, “and not all experts are convinced that the vaccine has vindicated itself.” Still, “the accumulating data nonetheless offer considerable reassurance to recipients of the vaccine and, if confirmed, have broad implications for its deployment in parts of the world.”

From the mental health care front, the American Hospital Association tells us

The Substance Abuse and Mental Health Services Administration yesterday released a toolkit to help health care providers and others prepare for the July 16 launch of 988, the new phone number for anyone experiencing suicidal thoughts or a mental health or substance use crisis to speak, text or chat with a trained crisis counselor. Authorized by the National Suicide Hotline Designation Act of 2020, the three-digit number will operate through the National Suicide Prevention Lifeline’s network of over 200 crisis centers.

“In the longer term, our vision is to build a robust crisis care response system across the country that links callers to community-based providers who can deliver a full range of crisis care services, if needed (like mobile crisis teams or stabilization centers),” SAMHSA notes.

To access the toolkit and other suicide prevention resources, visit SAMHSA’s new 988 website. 

From the U.S. healthcare front, Healthcare Dive reports

The long-term shift from hospital-based care toward more treatment delivered in the home and ambulatory centers picked up pace during the COVID-19 pandemic and is expected to continue to gain momentum, pressuring revenue growth and margins in the hospital sector, according to new research from Moody’s Investors Service.

Reimbursement changes, risk-sharing, investment in outpatient services including ambulatory surgery centers, advances in drugs and medical devices and greater use of at-home acute care services are among the forces driving the movement away from more expensive hospital inpatient care.

Medicare telehealth visits increased 63-fold during 2020, Moody’s said, citing HHS data. Although hospitals are reporting that telehealth use is receding as more patients return to in-person physician visits, it will likely remain above pre-COVID levels, the ratings agency said.

Kaiser Health News looks at the No Surprises Act from the patient’s perspective. It’s an important article because health plans should help their members keep the new law’s billing protections in perspective.

From the provider of the future front, mHealth Intelligence reports

Though a majority (63 percent) of clinicians worldwide expect most of their consultations to be remote within the next decade, 51 percent believe that telehealth will negatively impact their ability to demonstrate empathy with their patients, a new report revealed.

Developed by Elsevier Health and Ipsos, the Clinician of the Future report includes a quantitative survey, qualitative interviews, and roundtable discussions with nearly 3,000 practicing physicians and nurses worldwide. Of the total number of respondents, 434 were from the US. * * *

Empathy from physicians is becoming increasingly important for patients. A vast majority of clinicians (82 percent) surveyed said that soft skills like listening and displaying empathy have become more critical in the last decade. In the US, 76 percent of clinicians agreed with this statement.

Though the importance of soft skills has grown, the report notes that technical skills will be key in the future.

From the HIMSS Conference in Orlando, Florida, Healthcare Dive holds an interview concerning the FEHBlog leading interoperability innovation of 2022, TEFCA:

Healthcare Dive caught up with Mariann Yeager to talk TEFCA at the HIMSS annual healthcare conference in Orlando on Monday. Yeager is CEO of the Sequoia Project, a nonprofit that was selected in 2019 to serve as the recognized coordinating entity (RCE) charged with developing, updating and maintaining the common agreement and overseeing QHINs.

Yeager shared more details on the timeline of TEFCA implementation, why organizations should join the voluntary framework and how the Sequoia Project and the Office of the National Coordinator for Health IT are at the beginning of a long process of monitoring and modernizing a living document that, given uptake, could shape the future of health data exchange for decades into the future.

“We’re really proud of the work that we’ve done,” Yeager said.

Check out the full interview.

Tuesday Tidbits

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 vaccine, Mental health care, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

Happy Ides of March. The President signed the Consolidated Appropriations Act 2022 into law today. The Postal Reform Act of 2022 continues to await the President’s signature.

From the Omicron front, David Leonhardt reports on COVID surges in China and Europe. He concludes

Even if [Covid] cases rise [in the U.S. again], as seems likely, there are good reasons not to panic. Vaccination tends to turn Covid into a mild illness, especially for people who have received a booster. For the unvaccinated and unboosted, BA.2 is another reason to get a shot.

It’s also a reason for the federal government and states to expand access to both Evusheld — a drug that can help protect the immunocompromised — and Paxlovid — a post-infection treatment. Finding either is often difficult today. (If you’re looking for one of them, click on this link for Evusheld and this one for Paxlovid.)

The bottom line: Covid isn’t going away, but vaccination and other treatments can keep future increases manageable. The biggest problem remains the millions of people who remain unvaccinated, many of them by choice. That’s the case in the U.S., in Hong Kong and across much of Europe, Africa and the rest of the world.

Inducing more people to get shots — through persuasion or mandates — would probably save more lives than any other Covid policy.

What is the FDA’s hold up in reviewing the standard Covid vaccines for which emergency use authorizations have been filed? As previously noted, the traditional vaccines may be appealing to those resistant to the state-of-the-art mRNA vaccines.

The Wall Street Journal reports

Pfizer Inc. and partner BioNTech SE have asked U.S. health regulators to authorize a second booster dose of its Covid-19 vaccine for people 65 years and older.

The companies said Tuesday that they had filed the application. The Food and Drug Administration is expected to make a decision in time for the Biden administration to begin a potential fall vaccine campaign.

The FDA has been reviewing data and looking at potentially authorizing a fourth dose of the shot for use in the fall, The Wall Street Journal reported last month.

From the Rx coverage front —

STAT News informs us

The prices pharmacy benefit managers and insurers pay for Sanofi medicines have decreased for a sixth consecutive year, yet patient out-of-pocket costs are rising. Once again, there is further evidence that focusing solely on lowering the list price of medicines doesn’t guarantee lower costs for patients. Sanofi pulls back the curtain on the impact of list and net prices and more in its annual pricing report.

and

Back in 2019, when the Senate Finance Committee called seven drug industry CEOs to testify, it seemed like proof that Washington was within striking distance of actually reining in the industry’s high prices. “It’s past time to get beyond the excuses and make prescription drugs affordable,” Sen. Ron Wyden, the top Democrat on the committee, told drugmakers that day. Tomorrow, almost exactly three years later, Wyden will chair another hearing on prescription drug pricing. He’s billing the hearing as “an opportunity for members to discuss how high drug prices have impacted seniors and families in their states and identify solutions” — even though lawmakers have had more than a dozen such hearings to “discuss” high drug prices over the past three years. STAT’s Nicholas Florko tallies what’s at stake in STAT+.

In FDA News, the agency reports approving today “the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions: asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks.”

From the opioid epidemic front, “the Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced two grant programs totaling $25.6 million that will expand access to medication-assisted treatment for opioid use disorder and prevent the misuse of prescription drugs. By reducing barriers to accessing the most effective, evidence-based treatments, this funding reflects the priorities of HHS’ Overdose Prevention Strategy, as well as its new initiative to strengthen the nation’s mental health and crisis care systems.”

From the patient front, HHS’s Agency for Healthcare Research and Quality announced the agency’s

Support for Patient Safety Awareness Week. Ongoing investments in safety research, the development of safety toolkits and training resources, and a growing emphasis on improving diagnostic safety are all part of a mission to make healthcare safe for all Americans. Access more information about AHRQ’s support of Patient Safety Awareness Week, including a special introductory video from Jeff Brady, M.D., director of the Center for Quality Improvement and Patient Safety; information about how to get involved in Patient Safety Awareness Week activities; and recent patient and diagnostic safety resources, including:

— Diagnostic Safety Supplemental Items for the Surveys on Patient Safety Culture (SOPS) Medical Office Survey

— Safer Together: A National Action Plan to Advance Patient Safety

— Making Healthcare Safer III: A Critical Analysis of Existing and Emerging Patient Safety Practices

— AHRQ QuestionBuilder App (also available in Spanish) 

From the HIMSS conference in Orlando, Healthcare Dive tells us

The Biden administration has been working on additional rulemaking to address issues with the payer-to-payer data exchange requirements set out in sweeping interoperability rules finalized in early 2020, and “we look forward to sharing this rule with you soon,” CMS administrator Chiquita Brooks-LaSure told attendees at the HIMSS annual conference in Orlando on Tuesday.

CMS decided not to enforce those provisions when they kicked in this year, after health insurers raised concerns about operational challenges and risks to data quality given a lack of specificity in the rule.

The new rule will incorporate extensive public comment to try to address stakeholder concerns, and will standardize how payers exchange data through application programming interfaces, Brooks-LaSure said.

and

An online tool that allows patients in markets across the country to compare prices for hundreds of hospital services before getting treatment has launched in its beta development stage.

Turquoise Health’s platform uses cost data from machine-readable files made public by hospitals as part of compliance with a federal price transparency rule that went into effect in January 2021.

The San Diego-based startup’s platform includes a scorecard that lets users assess price transparency compliance with the CMS requirements for nearly 6,000 hospitals, Turquoise Health said Monday. Hospitals receive a score based on an algorithm-driven five-star rating system.

Fierce Healthcare reports from the SXSW Conference in Austin, TX.

Samsung and Best Buy executives shared why they place big bets on tech to help elderly Americans age at home.

Experts are laying out the business case to invest in care for underserved communities.

Leaders in women’s health say empowering female patients is key to addressing gender biases in healthcare.

Monday Roundup

David Ermer–Congress, COVID treatment, COVID-19, Mental health care, Patient safety, Rx coverage–
Photo by Sven Read on Unsplash

From the Omicron front

Medpage Today offers an interesting discussion of the test to treat program.

The Wall Street Journal informs us

A new Covid-19 pill from Merck & Co. and Ridgeback Biotherapeutics LP has been more widely used than expected since rolling out late last year, though regulators and many doctors consider it a last resort. 

Many doctors and health officials anticipated a rival pill, Pfizer Inc.’s Paxlovid, would be the Covid-19 drug of choice. Paxlovid was found to be far more effective than Merck-Ridgeback’s molnupiravir in clinical trials, and regulators and guidelines recommended using Paxlovid if possible.

Prescriptions for the two antivirals have been running about equal since their authorization in December, however. The larger-than-expected use is a sign of the high demand for easy-to-use coronavirus treatments that can be taken at home, especially during surges like the recent Omicron wave.

Govexec tells us

Federal agencies are not restricted on the size of events they host, unless under certain conditions, according to new guidelines. 

The Biden administration’s Safer Federal Workforce Task Force issued updated and new guidance on March 11, most of which reflects the Centers for Disease Control and Prevention’s new framework released in late February. That framework “moves beyond just looking at cases and test positivity to evaluate factors that reflect the severity of disease, including hospitalizations and hospital capacity, and helps to determine whether the level of COVID-19 and severe disease are low, medium, or high in a community,” as CDC Director Dr. Rochelle Walensky said on a briefing call. 

There are no “restrictions on the size of agency-hosted in-person meetings, events, or conferences,” said one of the new “frequently asked question” prompts. “Should an agency intend to host a meeting, conference, or event that will be attended in-person by more than 50 participants at a facility in a county where the COVID-19 Community Level is HIGH, the agency should first seek the approval of its agency head or official to which this responsibility has been delegated, in consultation with the agency’s COVID-19 coordination team.” 

From the Rx coverage front –

BioPharma Dive reports good news

The Food and Drug Administration has approved AstraZeneca and Merck & Co.’s drug Lynparza for people with a genetic form of early breast cancer, a decision that could spur greater use of DNA testing in diagnosing and treating the disease.

Lynparza is already used to treat metastatic breast cancer in patients with so-called BRCA gene mutations. The new approval makes Lynparza available earlier in their disease, after surgery to remove a tumor and standard drugs like chemotherapy and radiation. People with cancers that are “HER2-negative” and at a high risk of relapsing are eligible for treatment.

The decision is based on the results of a large study published last year in The New England Journal of Medicine last year. In it, Lynparza reduced the risk of disease progression or death by 42% versus placebo after a median of 2.5 years of follow-up. Updated results show the drug cut the risk of death by about a third, a finding the companies will detail at a medical meeting on Wednesday.

The National Institutes of Health announced launching “a Phase 1 clinical trial evaluating three experimental HIV vaccines based on a messenger RNA (mRNA) platform—a technology used in several approved COVID-19 vaccines.” mRNA developers were working on HIV vaccines before the pandemic struck. Fingers crossed.

Healthcare Dive reports from Capitol Hill

Sen. Chuck Grassley (R Iowa) is urging the Federal Trade Commission to “find consensus” and vote again to launch a study into the business practices of pharmacy benefit managers, according to a letter he sent to FTC Chairwoman Lina Khan dated March 9.

“PBMs operate with little to no transparency, making it very difficult if not impossible to understand the flow of money in the prescription drug marketplace,” the Republican senator from Iowa said in his letter, nodding to the bipartisan consensus for such an examination.

Grassley urged the commissioners to come up with a more targeted focus for the study and suggested narrowing a review to the impact on consumers and their out of pocket costs.

From the patient safety front, Beckers Hospital Review explains

Staffing shortages are the top threat to patient safety in 2022, according an annual report on patient safety concerns from ECRI, an organization that conducts independent medical device evaluations, published March 14. 

Researchers identified the top threats to patient safety by analyzing a wide range of data, including scientific literature, patient safety events or concerns reported to or investigated by ECRI. 

Ten top patient safety concerns this year: 

1. Staffing shortages

2. COVID-19 effects on healthcare workers’ mental health

3. Bias and racism in addressing patient safety 

4. Vaccine coverage gaps and errors

5. Cognitive biases and diagnostic error

6. Nonventilator healthcare-associated pneumonia 

7. Human factors in operationalizing telehealth

8. International supply chain disruptions

9. Products subject to emergency use authorization

10. Telemetry monitoring 

From the mental healthcare front, the Department of Health and Human Services announced

A new U.S. Department of Health and Human Services (HHS) study published in the American Medical Association’s journal JAMA Pediatrics  reports significant increases in the number of children diagnosed with mental health conditions. The study, conducted by the Health Resources and Services Administration (HRSA), finds that between 2016 and 2020, the number of children ages 3-17 years diagnosed with anxiety grew by 29 percent and those with depression by 27 percent. The findings also suggest concerning changes in child and family well-being after the onset of the COVID-19 pandemic.

No bueno.

Weekend Update

David Ermer–Congress, Mental health care, Telehealth, U.S. Healthcare–

From Capitol Hill, the House of Representatives and the Senate will be in session this week for floor voting and Committee business.

Healthcare Dive reminds us that the Healthcare Information and Management Systems Society will hold its annual conference in Orlando, Florida, this week. In addition, Healthcare Dive notes several headliner presentations planned for that conference.

From the health equity front, the Wall Street Journal reports

The fatal overdose rate among Black people surpassed that for white people in the first year of the pandemic, as an increasingly lethal drug supply and Covid-19’s destabilizing effects exacted a heavy toll on vulnerable communities in the U.S.

The proliferation of the potent opioid fentanyl, and a pandemic that has added hazards for people who use drugs, are driving new records in U.S. overdose deaths, and Black communities have been hit especially hard. Black people often have uneven access to healthcare including effective drug treatment, putting them at high risk, researchers and public-health experts say. 

The most recent full-year of federal data, through 2020, shows the rate of drug deaths among Black people eclipsed the rate in the white population for the first time since 1999, researchers at the University of California, Los Angeles recently demonstrated.

What is an effective treatment for substance use disorder? The Journal adds

Researchers at the University of Michigan examining outpatient visits for substance use in recent years found white patients were three to four times as likely as Black patients to receive buprenorphine, a prescription medication to treat opioid dependence that is more readily available to people with health insurance or the means to pay out of pocket.

Health providers are more likely to direct Black patients to methadone, which is delivered by highly regulated opioid-treatment programs that often require daily visits to obtain the medication, researchers have found.

According to Sam Quinones’s books on the opioid and fentanyl problems plaguing our country, drug dealers hang out at methadone clinics.

On a related note, The Psychiatric Times informs us

The positive implications for screening for and treating individuals with SUDs are vast, from preventing HIV and hepatitis in injection-drug users to improving patients’ physical health, mental health, employment, and housing.

Elisa Gumm, DO, who is presenting on “Screening for Addiction in a 20-Minute Appointment” at the “Psychiatry for Non-Psychiatrists: The University of Arizona Update in Behavioral Medicine for Primary Care” conference, stated that “offering addiction interventions at every level reduces the overall costs to the person and society

Also, the New York Times reports on today’s front page about the serious logistical problems facing the federal and state governments as they seek to launch the new 988 suicide hotline on July 1, 2022.

Fierce Healthcare discusses the advantages of using teledentistry with rural patients.

Teledentistry enables rural access to care, lowers costs and helps provide preventive services, a new study has found. 

The CareQuest Institute looked at data for patients in Oregon and Washington. The study included data from more than 60,100 individuals who had a dental visit either in person or through teledentistry in the second half of 2020.

Most (79%) patients with a teledentistry visit had a follow-up visit sometime in 2021, the vast majority of which were in person. Most (60%) had this visit within three weeks of their teledentistry visit, which primarily consisted of diagnostic and restorative services. 

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 testing, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, the Senate has adjourned until Monday March 7 after setting another cloture vote on the Postal Reform Act of 2022 (HR 3076) for Monday at 5:30 pm. While the FEHBlog is not a Senate procedure expert, it appears that another cloture vote is required because a minor Senate amendment was filed after the first cloture vote. Postal reform must be getting real because the Wall Street Journal posted an account of the decade-long effort to pass this legislation today.

From the Omicron front, the FEHBlog’s favorite part of the President’s new strategy was explained by the White House Covid czar yesterday:

Pfizer’s pill {Paxlovid] is a gamechanger — 90 percent effective at keeping people out of the hospital.

We collaborated with Pfizer to accelerate development of the pill.  And we’ve ordered 20 million courses.

As the President announced last night, Pfizer worked overtime to further accelerate delivery.  This month alone — the month of March — we’ll have 1 million of these treatment courses available.  And in April, that number will more than double.

To ensure these lifesaving treatments are easily accessible, the President’s Plan launches a new “Test to Treat” initiative to provide individuals access to testing and treatment for free, all in one stop. 

Hundreds of one-stop sites will open across the country this month, located at local pharmacy clinics, community health centers, long-term care facilities, and veterans’ health centers.

Marketwatch adds today that “CVS Health Corp., the Walgreens Boots Alliance Inc., and Walmart Inc. said they will participate in the test-to-treat initiative, a new program that allows someone who has tested positive for the virus to get antiviral pills during the same visit at no cost.”

Covid treatment costs were astronomical because care principally was given in hospitals and other healthcare facilities, creating a major burden on the healthcare system. Facilitating the use of Flonase for Covid will avoid the vast majority of those hospitalizations, thereby lowering healthcare costs.

Speaking of testing, the Wall Street Journal reports that

Manufacturers are developing new types of at-home tests, including for flu and strep throat, aimed at consumers who are increasingly monitoring and managing their own health through fitness apps and smartwatches.

Boulder, Colo.-based fertility company MFB Fertility Inc. received clearance from the U.S. Food and Drug Administration in February 2020 for its Proov test, designed to help women measure their hormone levels and to know when in a given month they are most likely to become pregnant. A typical kit includes 20 testing strips, allowing a woman to test daily, which the company said would be tough to achieve through visits to a doctor’s office.

Amy Beckley, the company’s chief executive, said the rise of at-home Covid-19 tests over the past year has made it much easier for people to understand her product.

“All of a sudden, home diagnostics and home testing became a thing,” she said.

Mobihealth News reported last June

The U.S. Air Force has inked a $1.3 million deal with MFB Fertility in order to provide military members and their partners the former’s home fertility tests.

The Air Force’s AFWERX office will invest in Proov, an at-home ovulation test with FDA clearance. The test works by measuring Pregnanediol Glucuronide (PdG), the urine metabolite of progesterone, which is released by the ovary after ovulation. High levels of PdG over multiple days can confirm that successful ovulation took place.

The contract will provide free Proov kits to Air Force couples upon request and connect them to fertility specialists.

Two cool innovations.

From the healthcare policy front —

  • The White House released a fact sheet on steps underway to address the Nation’s opioid epidemic.
  • The Associated Press reports on the President’s mental healthcare policy proposals made in Tuesday’s State of the Union address. For example, under the President’s plan, “Health insurance plans would have to cover three mental health visits a year at no added cost to patients.” I suggest that the Administration consider the fact that most employers offer employee assistance plans that already offer two or three free mental health therapy visits. The overcomplicated federal mental health parity law fails to look at the big picture.

From the diabetes front —

  • The AMA offers six tips for screening patients for pre-diabetes. Many of the tips also could be applied by health plan case managers and coaches.
  • The American Diabetes Association delves into the relationship between diabetes and kidney disease.

From the litigation front, Reuters reports

The Sackler family owners of Purdue Pharma LP reached a deal with a group of attorneys general to pay up to $6 billion in cash to resolve widespread litigation alleging that they fueled the U.S. opioid epidemic, bringing the OxyContin maker closer to exiting bankruptcy.

The attorneys general for eight states and the District of Columbia, who had blocked a previous settlement that included a $4.3 billion cash payment, announced the deal after weeks of mediation with the Sacklers.

The family agreed to pay at least $5.5 billion in cash, which will be used for abating a crisis that has led to nearly 500,000 U.S. opioid overdose deaths over two decades.

The value of the deal could grow as the family members sell additional assets.

U.S. Bankruptcy Judge Robert Drain must approve the deal, which protects the Sacklers from civil lawsuits. Purdue requested a March 9 hearing for Drain to review the agreement.

From the Rx coverage front, Biopharma Dive reports

Civica is making plans to offer three versions of insulin that can be sold at dramatically lower prices than today’s alternatives, targeting a need highlighted by President Joe Biden during this week’s State of the Union Address.

The nonprofit company, created by hospital systems and philanthropies to address drug shortages, said Wednesday it will recommend pricing of no more than $30 for the vials it produces. Name-brand versions can currently cost 10 times that amount at cash prices.

Civica announced an ambitious timeline, projecting that the first product — designed to be interchangeable with Sanofi’s Lantus — would be available as soon as early 2024. The company also aims to manufacture cheaper versions of Eli Lilly’s Humalog and Novo Nordisk’s Novolog, in both vials and pre-filled pens.

Also the Institute for Clinical and Economic Review (“ICER”) announced

it will assess the comparative clinical effectiveness and value of subcutaneous semaglutide (Wegovy, Novo Nordisk), phentermine / topiramate (Qsymia, Vivus Pharmaceuticals), liraglutide (Saxenda, Novo Nordisk), and naltrexone/bupropion (Contrave, Currax Pharma) for the treatment of obesity. 

The assessment will be publicly discussed during a meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC) in September 2022, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.

ICER’s website provides timelines of key posting dates and public comment periods for this assessment.