Midweek update

CMS

Midweek update

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, HIPAA Privacy and Security Rules, Telehealth, U.S. Healthcare–

The Postal Service Health Benefits Program was born today as the President signed into law the Postal Reform Act of 2022 (H.R. 3076). Here is a link to the President’s remarks made at the bill signing.

The PSHBP will become operational on January 1, 2025. OPM’s implementing rules must be finalized by April 6, 2023.

Govexec adds

The U.S. Postal Service is once again seeking to raise its rates by historically unusual amounts, announcing the increases on the same day President Biden signed into law a bipartisan bill to erase much of the agency’s debts and allow it to pursue new lines of revenue.  * * *

The new prices, which are set to go into effect July 10, would raise rates for regular, First-Class mail by 6.5% and by 8.5% for package services. A standard stamp would go from $0.58 to $0.60. The large increases were made possible under new authority the Postal Service’s regulator granted it in 2020 and which USPS employed for the first time last year. DeJoy promised as part of his 10-year business plan to use his authority to raise rates above inflation “judiciously,” but predicted USPS would generate between $35 billion and $52 billion by 2031 by raising prices.

From the Capitol Hill front, Roll Call reports “A bipartisan $10 billion COVID-19 supplemental is stuck in the Senate amid a dispute over a tangential pandemic-related border control policy, with both parties at a loss on how the impasse will be resolved.”

In other Omicron (and siblings) news

The Food and Drug Administration’s Vaccine and Biological Products Advisory Committee met today for a general discussion of Covid vaccines. The Wall Street Journal reports

A top U.S. health regulator said that asking people to frequently get Covid-19 boosters wasn’t sustainable because of vaccine fatigue and that authorities needed to develop a long-term strategy for protecting the public from the virus as it evolves.

Dr. Peter Marks, who heads the Food and Drug Administration’s vaccines division, said that last week’s authorization of a second booster dose for people 50 years and older and for people 12 and older with weakened immune systems was a stopgap.

STAT News offers a play-by-play account of that meeting here.

The American Hospital Association informs us

Medicare and Medicaid will cover a second Pfizer or Moderna COVID-19 booster at no cost to eligible enrollees, the Centers for Disease Control and Prevention announced today. Health care providers participating in the Centers for Disease Control and Prevention’s COVID-19 Vaccination Program also must provide authorized COVID-19 vaccines at no cost to recipients.

The FEHBlog discovered from reading an AHA squib that CDC Director Rochelle Wolensky approved the FDA’s March 29 second booster recommendation last week. That joint recommendation permits adults aged 50 and older to receive a second Pfizer or Moderna COVID-19 vaccine booster dose at least four months after an initial booster dose. In addition, those agencies authorized and recommended a second Moderna booster dose for certain immunocompromised adults and a second Pfizer booster dose for certain immunocompromised individuals aged 12 or older.”

What’s odd is that the ACA FAQ 50 indicates that the CDC advisory committee’s recommendation triggers the health plan to cover a particular use of a Covid vaccine with no member cost-sharing. Given that CMS has given the green light and the advisory committee reports to the CDC Director, the FEHBlog concludes that health plans also should step up to the plate and provide no cost-sharing coverage for these second boosters.

STAT Health tells us that

A new survey by STAT and The Harris Poll finds six in 10 Americans have already decided they will get another booster if it’s recommended for them.

Just under one-quarter of U.S. adults indicated they will only receive a second booster shot if a new variant arises or there is a surge in Covid-19 cases in their area, and 18% have no plans to get a booster at all, according to the survey, which polled 2,028 U.S. adults between March 25 and 27.

America has spoken.

From the No Surprises Act front, the AHA notes

The Centers for Medicare & Medicaid Services has released a new FAQ for health care providers on the No Surprises Act’s requirements and prohibitions, and the independent dispute resolution process; and a new FAQ on providing good faith estimates to uninsured and self-pay patients. CMS plans to launch next week the online portal through which uninsured and self-pay patients may initiate the dispute resolution process.

The CMS FAQs are worth reviewing by health plans because they go beyond the out-of-network bill consumer protections to address the NSA good faith estimate, continuity of care, and provider directory accuracy provisions. For example, the good faith estimate discussion on page 6 is quite informative.

From the Health Affairs front

  • Jane Zhu and a team of fellow experts wrote an article on Trends in Outpatient Mental Health Services Use before and during the pandemic. Here are excerpts from the abstract which is quite pro-telemental care.

In-person mental health encounters were reduced by half in the early months of the pandemic, with rapid recovery of service delivery attributable to telehealth uptake (accounting for 47.9 percent of average monthly encounters). We found variation in the degree to which telehealth use increased across groups: People with schizophrenia made up a lower proportion of telehealth encounters relative to in-person visits (1.7 percent versus 2.7 percent), whereas those with anxiety and fear-related disorders accounted for a higher proportion (27.5 percent versus 25.5 percent). These findings highlight the importance of broadening access to services through new modalities without supplanting necessary in-person care for certain groups.

  • Joshua Liao and Amol Navathe wrote an article in the Health Affairs Forefront describing a new Accountable Care Organization model designed to improve health equity.

From the healthcare business front —

Optum continues its buying spree and has picked up Kelsey-Seybold Clinic, a large, multi-specialty group practice based in Houston, Texas, Axios reported Monday.

With more than 500 physicians, Kelsey-Seybold Clinic operates multi-specialty care centers, a cancer center, a women’s health center, two ambulatory surgery center locations, and a specialized sleep center with more than 30 locations in the Greater Houston area. Kelsey-Seybold partners with major insurers to offer value-based commercial health plans. Kelsey-Seybold partners with major insurers to offer value-based commercial health plans. The organization partners with payers to offer value-based commercial health plans also owns its own Medicare Advantage plan for seniors, KelseyCare Advantage.

Intermountain Healthcare and SCL Health completed their merger, creating one of the nation’s largest nonprofit health systems, the two organizations announced Tuesday.

The new system, which will use the Intermountain name to reflect the parent entity, will operate 33 hospitals and hundreds of clinics across seven states and insure 1 million people in Utah and Idaho.

Colorado’s attorney general signed off on the merger last week after conducting a review, concluding the tie-up will not result in a material change to the charitable purposes of nonprofit SCL Health, based in Colorado, and that SCL assets will not leave the state.

  • Business Wire tells us “Millennium Trust Company, LLC (“Millennium Trust”), a leading provider of retirement and financial services for employers, institutions, advisors, and individuals, today announced it has signed a definitive agreement to acquire PayFlex Holdings, Inc. (“PayFlex”), a provider of health savings accounts (HSAs) and consumer-directed benefit administration services, from CVS Health Corporation (“CVS Health”).

In HIPAA Privacy and Security Rule News, the Department of Health and Human Services announced issuing

a Request for Information (RFI) seeking input from the public on two requirements of the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), as amended in 2021.  The growing number of cybersecurity threats are a significant concern driving the need for enhanced safeguards of electronic protected health information (ePHI).  This RFI will enable OCR to consider ways to support the healthcare industry’s implementation of recognized security practices. The RFI also will help OCR consider ways to share funds collected through enforcement with individuals who are harmed by violations of the HIPAA Rules.

* * *

Individuals seeking more information about the RFI or how to provide written or electronic comments to OCR should visit the Federal Register to learn more: https://www.federalregister.gov/documents/2022/04/06/2022-07210/considerations-for-implementing-the-health-information-technology-for-economic-and-clinical-health

Please note that comments must be submitted by June 6, 2022 in order to be considered.

Interestingly, the HHS seeks public input on developing the safe harbors created by the 2021 law.

Monday Roundup

David Ermer–CDC, CMS, COVID treatment, COVID-19, OPM, Rx coverage–
Photo by Sven Read on Unsplash

The President released his Administration’s fiscal year 2023 proposed budget today. Here are links to OMB’s budget website and a Roll Call overview of the proposal.

Here is OPM’s budget wishlist (Budget at 130):

  • Amend administration of tribal FEHB enrollment system
  • Expand family member eligibility under FEDVIP (presumably increasing the age limit for eligible children from 22 to 26)
  • Expand FEDVIP to tribal employees
  • Expand FEHB to tribal colleges and universities.

OPM also released the agency’s FY 2022 to FY 2026 strategic plan today. Here is a link to OPM’s lookbook on that plan. The lookbook (p. 9) identifies one current agency priority goal related to the FEHBP (out of six in total)

Improve customer experience by making it easier for Federal employees, annuitants, and other eligible persons to make more informed health insurance plan selection. By September 30, 2023, complete user-centered design and develop a minimum viable product for a new, state-of-the-art FEHBP Decision Support Tool that will give eligible individuals the necessary information to compare plan benefits, provider networks, prescription costs, and other health information important to them and their families.

In other government reports, the Centers for Medicare and Medicaid Services issued

the 2021-2030 National Health Expenditure (NHE) report, prepared by the CMS Office of the Actuary, that presents health spending and enrollment projections for the coming decade. The report notably shows that despite the increased demand for patient care in 2021, the growth in national health spending is estimated to have slowed to 4.2%, from 9.7% in 2020, as supplemental funding for public health activity and other federal programs, specifically those associated with the COVID-19 pandemic, declined significantly.

From the Omicron and siblings front —

  • The Centers for Disease Control posted a new “Quarantine and Isolation Calculator — A tool to help determine how long you need to isolate, quarantine, or take other steps to prevent spreading COVID-19.”
  • The Institute for Clinicial and Economic Review issued an evidence report on four Covid outpatient treatments, including the Pfizer and Merck Covid pills.

This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC (Midwest England CEPAC) on April 12, 2022. The Midwest England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
Register here to watch the live webcast of the virtual meeting.

ICER’s evidence ratings for the treatments reviewed include:

Sotrovimab delivers at least a small net health benefit when compared to no active treatment, with the possibility of a substantial net health benefit (“B+”).

[Merck’s] Molnupiravir is at least comparable to no active treatment, with the potential of a small net health benefit (“C+”).

[Pfizer’s] Paxlovid delivers at least a small net health benefit when compared to no active treatment, with the possibility of a substantial net health benefit (“B+”).

Fluvoxamine is at least comparable to no active treatment, with the potential of a small net health benefit (“C+”).

From the health equity front, Health Leaders Media reports

Despite willingness to address social drivers of health, two-thirds of physicians report inadequate time or ability to act, according to a new survey report.

KEY TAKEAWAYS

Nearly all physicians reported that at least one social driver of health affected the health outcomes of all or some their patients.

Financial instability (34% of patients) and transportation problems (24% of patients) were the top two social drivers of health experienced by physicians’ patients.

A solid majority of physicians (80%) reported that addressing social drivers of health is essential to improve health outcomes and decrease healthcare costs.

From the Rx coverage front, the FEHBlog noticed today that GoodRx has added a telehealth option to its website.

Midweek Update

David Ermer–CMS, Congress, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, overnight, the FY 2022 onmnibus appropriations bill language was released. The bill is over twenty one hundred pages long. The American Hospital Association has taken the time to summarize the bill’s healthcare provisions. Federal News Network discusses the bill’s federal workforce provisions. The Wall Street Journal notes

Democratic House leaders said they would remove a contentious $15.6 billion Covid-19 aid provision from the omnibus spending bill to try to get it over the finish line, after angry rank-and-file members rejected clawing back states’ unused coronavirus money to fund the proposal.

The decision to drop the Covid-19 aid was a dramatic setback for both House Speaker Nancy Pelosi (D., Calif.), who negotiated the plan, and President Biden, whose administration originally asked for $22.5 billion for Covid-19 aid and now will get nothing from the bill.

The House of Representative currently is considering the bill and a fourth continuing resolution that would last the four days beyond March 11 that the Senate needs to pass the bill. The House is expected to vote on the bill around 9:15 pm ET. Passage of the bill and the brief continuing resolution is expected.

From the Rx coverage front, Fierce Healthcare informs us

Amazon Pharmacy is partnering with Blue Plans in five states and Prime Therapeutics to tackle the affordability of prescription medications.

The online retail giant’s pharmacy arm is rolling out a prescription discount savings card that’s available to some Blue Plans members.

Integrating this discount card pricing into the shopping experience lets eligible customers compare their co-pay or discount price upfront and then apply purchases for eligible medications to the out-of-pocket maximums and deductibles associated with their insurance plan, according to Nworah Ayogu, M.D., chief medical officer for Amazon Pharmacy. * * *

Eligible plans now include Horizon Blue Cross Blue Shield of New Jersey, Blue Cross Blue Shield of Nebraska, Blue Cross Blue Shield of Alabama, Florida Blue and Blue Cross and Blue Shield of Kansas. 

From the miscellany department —

  • The National Committee for Quality Assurance has created a health equity website.
  • America’s Health Insurance Plans celebrated International Womens’ Day yesterday with remarks from healthcare leaders on how health plans can improve healthcare for women.
  • The Centers for Medicare and Medicaid Services issued new guidance for group health plans on submitting a valid documented defense to Medicare overpayment recovery demands.

Thursday Miscellany

David Ermer–CDC, CMS, COVID-19, Electronic health records, No Surprises Act, Rx coverage, U.S. Healthcare–
U.S. Supreme Court building

Let’s start today with news from the litigation front —

The Wall Street Journal reports that in advance of the February 27 deadline,

The Justice Department filed an antitrust lawsuit Thursday challenging UnitedHealth Group Inc.’s $13 billion acquisition of health-technology firm Change Healthcare Inc., arguing the tie-up would unlawfully reduce competition in markets for commercial insurance and the processing of claims.

The deal, announced in January 2021, sought to bring a major provider of healthcare clinical and financial services, including the handling of claims, under UnitedHealth’s Optum health-services arm.

The Justice Department filed its lawsuit in federal court in Washington, saying Change provided key industry technologies that are relied upon by UnitedHealth’s health-insurance rivals, making it a hub for competitively sensitive information. If the deal were allowed, UnitedHealth would have access to data that it could potentially use for its own benefit, at the expense of other insurers, the department alleged. The department also argued the deal would reduce head-to-head competition in the businesses of insurance claims transmission and review, because UnitedHealth competes with Change in those areas.

Healthcare Dive reports

A federal judge in Texas struck down a narrow part of the surprise billing rule that outlines how to resolve payment disputes between payers and providers over out-of-network claims. Wednesday’s ruling is a win for providers who were opposed to the dispute resolution process spelled out by CMS in an interim rule, arguing it favored insurers.

The judge’s ruling essentially tosses out a part of the dispute resolution process that instructs arbiters to begin with the presumption that the qualifying payment amount, or median in-network rate, is the appropriate payment amount for providers.

This is not the final word because the decision, which resulted in a final judgment is appealable to the U.S. Court of Appeals for the Fifth Circuit. A case raising the same issue is currently pending oral argument in the U.S. District Court for the District of Columbia.

The Hill adds

Katie Keith, a health law expert at Georgetown University, said the ruling is evidence of how hard doctors groups will fight even relatively modest efforts by Congress to cut health care costs.  

The surprise billing action was “one of the few things Congress has tried to do on cost containment,” she said.   

Amen to that.

From the Omicron front, Medpage Today provides background on a Centers for Disease Control decision permitting

Extended dosing intervals for Pfizer or Moderna vaccines * * * for certain individuals ages 12 to 64 years, not only to lower the risk of vaccine-associated myocarditis, but to potentially improve vaccine effectiveness, CDC staff said on Thursday.

According to the agency’s new interim guidance, young people ages 12 to 39 may especially benefit from a second mRNA dose 8 weeks after their first dose.

However, the regular 3-week interval for Pfizer and 4-week interval for Moderna is appropriate for patients who are moderately to severely immunocompromised, adults ages 65 and up, those who need rapid protection (such as “during high levels of community transmission”), and children ages 5 to 11.

From the social determinants of health front, HR Dive tells us

Though employers have invested increasingly in a variety of healthcare and healthcare-adjacent benefits, few of these efforts effectively address social determinants of health that can negatively affect patient outcomes, according to a report published this month by the Northeast Business Group on Health.

Social determinants of health include factors such as education access and quality; healthcare access and quality; economic stability; neighborhood and built environment; and social and community factors. Differences in these areas lead to disparities not only in terms of health outcomes, but also in cost management and general employee health and well-being, NEBGH said.

Employers can start addressing social determinants by collecting survey data on employees’ needs and risk factors, per the report. From there, NEBGH recommended that benefits design focus on equitable benefits access, such as evaluating what percentage of pay their health plans comprise at different pay levels. Other strategies cited include improving health literacy, taking advantage of partnerships and improving organizational culture around health and well-being, among others.

From the Rx coverage front, Fierce Healthcare discusses CVS Health’s annual Drug Trend Report.

CVS Caremark kept overall drug trend for clients to 2.4% over the first three quarters of 2021, marking multiple years of single-digit trend in drug price growth.

The pharmacy benefit management arm of CVS Health also kept its specialty drug trend to single digits through the third quarter, at an industry-low 5.8%, according to the company’s annual Drug Trend Report released Thursday. Caremark found that 35.9% of its clients saw negative specialty trend in 2021.

In addition, 65.3% saw specialty trend under 10%, according to the report.

The article explains how CVS Health accomplished this feat.

From the Medicare front, CMS announced a redesign of its Accountable Care Organization model

that better reflects the agency’s vision of creating a health system that achieves equitable outcomes through high quality, affordable, person-centered care. The ACO Realizing Equity, Access, and Community Health (REACH) Model, a redesign of the Global and Professional Direct Contracting (GPDC) Model, addresses stakeholder feedback, participant experience, and Administration priorities, including CMS’ commitment to advancing health equity. 

In addition to transitioning the GPDC Model to the ACO REACH Model, CMS is canceling the Geographic Direct Contracting Model (also known as the “Geo Model”) effective immediately. The Geographic Direct Contracting Model, which was announced in December 2020, was paused in March 2021 in response to stakeholder concerns.

Good luck, CMS, with this new model.

Midweek update

David Ermer–CDC, CMS, COVID-19, COVID-19 testing, COVID-19 vaccine, Mental health care, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Omicron front —

MedCity News reports

Sanofi and GlaxoSmithKline weathered clinical trial delays for their Covid-19 vaccine, but the partners now have data to support filings seeking regulatory authorizations. Key features of the vaccine may be able to persuade the vaccine hesitant; it may also be well-suited for use as a booster. 

This news bears similarities to the reports about the Novavax Covid vaccine already submitted to the Food and Drug Administration for emergency use authorization.

The American Hospital Association informs us

The Food and Drug Administration yesterday listed all over-the-counter COVID-19 diagnostic tests authorized for home use, including links to home use instructions for each test.

Fierce Healthcare adds

Walmart has administered tens of millions of COVID-19 vaccines to date, with 80% delivered in medically underserved communities, the retail giant announced Wednesday.

The company released a report (PDF) looking back at its progress in providing vaccines over the course of 2021. Cheryl Pegus, M.D., executive vice president of health and wellness at Walmart, told Fierce Healthcare the company has focused on connecting with people who may not otherwise have been able to get the shot.

From the health equity front —

The American Hospital Association tells us

The U.S. maternal mortality rate increased to 23.8 deaths per 100,000 live births in 2020 from 20.1 in 2019 as rates for Black and Hispanic women increased, according to data released today by the Centers for Disease Control and Prevention. The maternal mortality rate for Black women was nearly three times the rate for white women. Mortality rates increased with maternal age, with the rate for women aged 40 and over nearly eight times higher than the rate for women under 25.

The AHA’s Better Health for Mothers and Babies initiative offers resources to help hospitals and health systems eliminate maternal mortality and address health disparities for mothers and babies. 

What can be more tragic than a baby losing a mother?

Beckers Payer Issues adds from the mental health perspective

Work-sponsored health plans aren’t addressing the growth of loneliness, which leads to employees missing work and decreased productivity, according to data from Cigna’s Loneliness Index shared with Becker’s. 

The data, which is slated to be published in the Journal of Organizational Effectiveness: People and Performance, surveyed nearly 6,000 employees between July 16 and Aug. 2, 2019. 

Six insights:

1. The widespread presence of loneliness affected 3 in 5 (62 percent) adults before the COVID-19 pandemic. Feelings of loneliness play key roles both in employee health and work performance, according to the study.

2. On average, preventable, stress-related absences caused lonely employees to miss about five more work days than their counterparts who did not identify as lonely.

3. Employees who reported higher levels of loneliness were almost twice as likely to consider quitting their current job than employees who were less lonely. 

4. The study estimates that absenteeism and productivity losses tied to preventable loneliness cost employers $154 billion each year. 

5. The study said work-based factors like communication, work-life balance and social companionship play key roles in determining employee loneliness. Personal resilience and a feeling of connection outside of the workplace also play a role. 

6. Employers looking to combat employee loneliness should consider actions that hit on these factors, including flexible work hours, email “blackout” periods and forming employee resource groups.

From the Black History Month department, Everywell, an at-home testing service, celebrates ten Black pioneers who improved healthcare in our country. Bravo.

From the U.S. healthcare front, Healthcare Finance News reports

Including federal government support, national health spending grew by 3.4% in 2021, according to new data released by Altarum.

This growth in spending, the analysis found, reflected the fact that support from the federal government was strong in 2020, likely in response to the recession caused by the COVID-19 pandemic, and was lower in 2021.

Taking these support dollars out of both 2020 and 2021 estimates, spending growth from 2020 to 2021 would have been 8.4%, as the economy continued to recover.

From the healthcare business front —

Healthcare Dive informs us

Despite worries that demand for telehealth could fall as the U.S. emerges from the COVID-19 pandemic, virtual care giant Teladoc beat Wall Street expectations with its 2021 financial results, and issued strong future growth projections Tuesday.

The New York-based vendor posted revenue of more than $2 billion in 2021, 86% higher than in 2020. Total visits were up 38% to 15.4 million, and Teladoc closed out the year with 53.6 million U.S. paid members, up just slightly from the year prior.

Beckers Hospital Review identifies 92 U.S. health systems with CMS-approved “hospital at home” programs.

Managed Healthcare Executive tells us

Tired of grappling with the rising costs and poor quality of healthcare, a coalition of major healthcare purchasers is taking things into its own hands, establishing a company that is designing healthcare products to meet its members’ needs. “There’s an incredibly high frustration level among buyers of healthcare,” says Elizabeth Mitchell, president and CEO of the Purchaser Business Group on Health (PBGH) in San Francisco. 

The nonprofit PBGH represents almost 40 large private employers and public entities that together spend $100 billion each year on healthcare services for more than 15 million Americans and their families. PBGH members include Microsoft, Walmart and American Airlines.

The decision to create the company, Emsana Health, was made about two years ago, with the initial focus on “really understanding the needs on a deep level,” Mitchell says. The company officially launched in the fall, and its first venture is setting up a pharmacy benefit manager (PBM), EmsanaRx, which went started operating on Jan. 1.

Finally, in a troubling tidbit, the Wall Street Journal reports

U.S. life insurers, as expected, made a large number of Covid-19 death-benefit payouts last year. More surprisingly, many saw a jump in other death claims, too.

Industry executives and actuaries believe many of these other fatalities are tied to delays in medical care as a result of lockdowns in 2020, and then, later, people’s fears of seeking out treatment and trouble lining up appointments.

Some insurers see continued high levels of these deaths for some time, even if Covid-19 deaths decline this year.

Weekend update

David Ermer–CMS, Congress, COVID-19, Medicare, U.S. Healthcare–
Vince Lombardi Trophy

Happy Super Bowl Sunday!

The House of Representatives will engage in limited Committee business this week while the Senate will convene for Committee business and floor voting. Indeed, tomorrow the Senate will resumes consideration of the motion to proceed to H.R.3076, Postal Service Reform Act of 2022.

The Wall Street Journal observes that Congress has passed several bills on a bipartisan basis since the President’s Build Back Better plan stalled on Capitol Hill.

Already, bills to make the U.S. Postal Service more financially viable, boost U.S. competitiveness with China and ban mandatory arbitration in cases of sexual assault and harassment have picked up steam in Congress. Senators passed the arbitration bill by voice vote, sending it to the president’s desk without a single member of either party demanding a roll call to record yeas and nays.

Legislators also announced an agreement on a framework for legislation to fund the federal government through fiscal year 2022, and a deal to reauthorize a landmark domestic-violence bill, which lapsed in 2019.

Pretty, pretty good.

From the national health emergency front, Vox tells us the latest about the second Omicron variant, and The New York Times’ Morning column reviewed the disgraceful course of our country’s opioid epidemic. The article concludes

“The solutions are costly. A plan that President Biden released on the campaign trail, which experts praised, would total $125 billion over ten years. That’s far more than Congress has committed to the crisis. Lawmakers haven’t taken up Biden’s plan, and the White House hasn’t pushed for it, so far embracing smaller steps.
“But inaction carries a price, too. Overdose deaths cost the economy $1 trillion a year in health expenses, reduced productivity and other losses, a new  report concluded — equivalent to nearly half of America’s economic growth last year.”

While the FEHBlog has not read the President’s plan, he does believe that a solution is desperately needed.

From the healthcare business front, Fierce Healthcare reviews the fourth quarter of 2021 financial results of significant health payers. At the top of the head were United Health Group and CVS Health /Aetna. “Both healthcare giants expect to top $300 billion in revenue this year, according to their forecasts.”

From the compliance front, Healthcare Dive reports

An analysis of 1,000 U.S. hospitals found that only 14.3% were complying with federal price transparency rulesand about 38% of hospitals posted a “sufficient amount of negotiated rates” on their websites.

The PatientRightsAdvocate.org analysis follows a report in July 2021 that showed only 5.6% of 500 random hospitals were in compliance with the rules that were introduced at the start of 2021.

“The largest hospital systems are effectively ignoring the law with no consequences,” the 61-page report said, noting that only two hospitals of 361 at three of the largest hospital systems were in compliance.

The FEHBlog wonders whether compliance would be higher if the compliance deadline (January 1, 2021) had not been at the height of a COVID surge in the ongoing pandemic.

From the preventive care front, the FEHBlog noticed in Health Payer Intelligence a Medicare national coverage determination on lung cancer screening that aligned Medicare coverage with a 2021 U.S. Preventive Services Task Force B graded recommendation.

This in turn reminded the FEHBlog that FEHB plans must cover all 21 USPSTF A and B graded recommendations made in 2021 with no member cost-sharing when delivered in-network beginning January 1, 2023. The FEHBlog counted a dozen such 2021 recommendations in the USPSTF list. Standing alone, those are a lot of changes to include in the 2023 benefit and rate proposals at the end of May 2022.

From the general healthcare front, NPR explains that the surprising details of the 65-year-old actor and comedian Bob Saget disclosed last week illustrate the importance of seeking immediate medical attention if you suffer a blow to your head.

According to his family, [Mr. Saget] “accidentally hit the back of his head on something, thought nothing of it and went to sleep.” No drugs or alcohol were involved, according to a coroner’s report.

Saget had “fractures to the back of his head and around his eyes” at the time of his death, according to an autopsy report from the Orange County, Fla., medical examiner obtained by People. Saget was also COVID-19 positive at the time of his death, the autopsy noted.

While details of how exactly Saget hit his head were not released, doctors stress the importance of seeking medical care immediately if you sustain a head or brain injury.

If you are concerned that you may have a head injury, consider getting yourself checked out,” said Dr. Amit Sachdev, medical director in the department of neurology at Michigan State University.

“Unfortunately, it’s all too common and we in neurology see it quite frequently that head injuries lead to bleeding,” said Sachdev.

The FEHBlog wonders what would have happened if Mr. Saget had been wearing an Apple watch with a fall detection monitor.

Friday Stats and More

David Ermer–CDC, CMS, Congress, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, 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 FEHBlog’s weekly chart of new COVID cases from the 27th week of 2021 through the second week of this year:

Four million new cases of COVID in a week. Wow. The Delta surge is the long hill that starts at the left of the chart. Omicron is Mount Everest by comparison.

Here’s the FEHBlog’s weekly chart of new COVID deaths for the same time span.

Weekly COVID deaths haven’t crossed 10,000 since the Delta surge peaked. Of course deaths are a lagging indicator.

The FEHBlog does think based on his reading that we are close to turning another corner but it’s not showing in these charts yet. We remain in the soup.

Here’s the FEHBlog’s chart of weekly Covid vaccinations distributed and administered since COVID shots were made available to the public in December 2020.

For the first time since before the holidays the number of administered vaccines, including boosters, exceeded 10 million last week. We are closing on 75% of the U.S. population aged 18 and older being fully vaccinated and over 65% of the U.S. population aged 65 and older being boostered.

Here are links the the CDC’s interpretation of its recent Covid and Flu statistics. The American Hospital Association informs us that

As urged by the AHA, the Department of Health and Human Services today renewed the COVID-19 public health emergency declaration for another 90 days effective Jan. 16. The extension will help hospitals and health systems combat COVID-19 in their communities.

In the wake of the Supreme Court lifting the stay on the CMS healthcare worker stay mandate, the American Hospital Association explains

The Centers for Medicare & Medicaid Services today released updated interpretive guidance on its Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule for states affected by yesterday’s Supreme Court’s decision  on the rule. The guidance does not apply to Texas, where the Interim Final Rule is still subject to a preliminary injunction in a separate legal action that was not before the Supreme Court. Under the guidance, the first dose compliance date for those states is Feb. 14, 2022, with full compliance expected from providers by March 15, 2022. For states not impacted by the Supreme Court decision, the previously announced compliance dates of Jan. 28 and Feb. 27 remain in effect. For both groups, the underlying interpretive guidance released on Dec. 28 applies and all members can still refer to the previously released Frequently Asked Questions for additional information. 

Tomorrow is the implementation date for the President’s mandate that health plans cover over-the-counter COVID tests. It’s worth noting that health plans generally don’t cover any products sold over-the-counter so needless to say plans needed many more than the four days that federal govenment gave them to implement. The New York Times delves into the details.

The Wall Street Journal reports that

The U.S. public can begin ordering free at-home rapid Covid-19 tests through a new government website on Jan. 19, senior Biden administration officials said.

Initially, orders will be limited to four tests per residential address. Tests will ship via mail within 7-12 days of ordering, the officials said. The administration expects that timeline to shorten as the program ramps up, one of the officials said.

The public will be able to order tests at covidtests.gov. Those without access to the internet can place orders via phone, and the administration will work with community groups to help people request tests, the officials said. The government will give priority to orders from areas that have been hard-hit by the pandemic and low-income parts of the country.

Here’s a link to the White House’s fact sheet on these programs. Govexec discusses the Postal Service’s important role in distributing the tests ordered over the government website.

From the masking front, STAT News reports that

U.S. health officials on Friday encouraged more Americans to wear the kind of N95 or KN95 masks used by health-care workers to slow the spread of the coronavirus.

Those kinds of masks are considered better at filtering the air. But they were in short supply previously, and Centers for Disease Control and Prevention officials had said they should be prioritized for health care workers.Related: Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson

In updated guidance posted late Friday afternoon, CDC officials removed concerns related to supply shortages and more clearly said that properly fitted N95 and KN95 masks offer the most protection.

However, agency officials noted some masks are harder to tolerate than others, and urged people to choose good-fitting masks that they will wear consistently.

“Our main message continues to be that any mask is better than no mask,” Kristen Nordlund, a CDC spokeswoman, said in a statement.

In other news —

  • Regulatory News informs us that “The Senate Health, Education, Labor and Pensions (HELP) Committee on Thursday voted 13-8 to advance the nomination of Robert Califf for a second stint as commissioner of the US Food and Drug Administration (FDA).”

Researchers at Weill Cornell Medicine and the University of Oxford announced on January 10, 2022, their new study shows that common vaccines could help reduce the health burden of the COVID-19 pandemic. 

A peer-reviewed study published in the Proceedings of the National Academy of Sciences crystallizes decades of evidence suggesting that the generalized immune-boosting properties of many vaccines can cross-protect people against multiple pathogens.

While these researchers did not specify particular vaccines, they chose values for cross-protection consistent with data from earlier studies on measles, influenza, tuberculosis, and other immunizations.

  • Fierce Healthcare tells us that “A top Medicare advisory board [MEDPAC] did not recommend any new payment hikes for acute care hospitals or doctors for 2023, stating that targeted relief funding has helped blunt the impact of the COVID-19 pandemic.” We shall see.

Thursday Miscellany

David Ermer–AHRQ, CMS, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, Patient safety, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare–

In yesterday’s post, the FEHBlog accurately predicted that the Supreme Court would decide today whether to stay the OSHA ETS vaccination screening program and end the partial stay on the CMS healthcare worker vaccination mandate.

This afternoon, the Supreme Court issued its decision reinstating the nationwide stay of the OSHA ETS and its companion decision ending all stays on the CMS mandate. The decisions came down as many, many pundits predicted.

The Secretary of Labor who oversees OSHA commented that

“We urge all employers to require workers to get vaccinated or tested weekly to most effectively fight this deadly virus in the workplace. Employers are responsible for the safety of their workers on the job, and OSHA has comprehensive COVID-19 guidance to help them uphold their obligation. 

“Regardless of the ultimate outcome of these proceedings, OSHA will do everything in its existing authority to hold businesses accountable for protecting workers, including under the Covid-19 National Emphasis Program and General Duty Clause.”

In the OSHA ETS decision, the Supreme Court expressed the key point of administrative law on which the two cases turned:

Administrative agencies are creatures of statute. They accordingly possess only the authority that Congress has provided.

The Court reasoned that Congress had granted CMS the necessary authority to issue its broad mandate but had not granted OSHA the same level of authority.

The cases now return to the courts of appeal for a decision on the merits — 6th Circuit for the OSHA ETS case and 5th Circuit for the CMS mandate case. In the meantime the Court’s decisions on the stays will remain in place.

Given how the Court handled these stay decisions, we have a pretty good idea where the Supreme Court will land should either of those merits decisions return to the Court.Such a return likely only will happen if either appellate court disagrees with the Court’s administrative law conclusion on the merits.

In that regard, Bloomberg Law reports that

The Justice Department will appeal a Louisiana federal court’s ruling that blocked President Joe Biden‘s order for government-contractor workers to get the Covid-19 vaccine. 

The U.S. Court of Appeals for the Fifth Circuit will be the third federal appeals court to consider a challenge to the measure. A coalition of three states—Louisiana, Mississippi, and Indiana—sought to block the mandate for companies that do business with the federal government. U.S. District Court Judge Dee Drell of the Western District of Louisiana granted a preliminary injunction in December. 

The federal contractor mandate—which won’t be enforced while litigation proceeds—would apply to roughly a quarter of the U.S. workforce, and affect businesses including Lockheed Martin Corp., Microsoft Corp., Alphabet Inc.‘s Google, and General Motors Co.

Appeals are ongoing in the Eleventh and Sixth circuits, respectively, over a nationwide injunction against the measure from a Georgia federal court and a narrower one from a Kentucky federal judge for a coalition that includes Ohio and Tennessee. A Missouri federal court also blocked the executive order, but that ruling has yet to be appealed.

From the Omicron front, David Leonhardt writing in today’s New York Times cautiously senses that the Omicron surge is cresting in our country following Europe’s and South Africa’s leads. “To be clear, the current emergency is not on the verge of ending. Cases appear to be peaking only in places where Omicron arrived early, mostly in the Northeast. In much of the country, cases are still soaring.”

From the Covid vaccine front, the AP reports that

Distrust, misinformation and delays because of the holidays and bad weather have combined to produce what authorities say are alarmingly low COVID-19 vaccination rates in U.S. children ages 5 to 11.

As of Tuesday, just over 17% were fully vaccinated, more than two months after shots became available to the age group. While Vermont is at 48%, California is just shy of 19% and Mississippi is at only 5%.

Vaccinations among the elementary school set surged after the shots were introduced in the fall, but the numbers have crept up slowly since then, and omicron’s explosive spread appears to have had little effect.

The low rates are “very disturbing,” said Dr. Robert Murphy, executive director for the Institute for Global Health at Northwestern University’s Feinberg School of Medicine. “It’s just amazing.”

Parents who hesitate “are taking an enormous risk and continuing to fuel the pandemic,” Murphy said.

From the telehealth front, STAT News informs us that

A handful of virtual care companies are inking new types of contracts that reward them for keeping patients’ cost low and penalize them for overspending — a model known as risk-sharing. It’s a departure from the traditional “fee-for-service” billing process, and a move  companies hope could help them get paid for the services they offer in addition to virtual doctors’ appointments, like in-app messaging, medication reminders, and digital health coaching. They’re also betting that embracing risk could endear them to the health plans and employers they depend on for contracts.

Execs from companies like Heartbeat Health and Teladoc say they’re in the very early stages of cementing these contracts. While there’s no clear roadmap for how to structure them, whether they take hold could clarify how virtual care will fit into the brick-and-mortar healthcare system and incentivize those companies to work with traditional providers on prevention, said Jennifer Goldsack, CEO of the Digital Medicine Society. “There is an opportunity to reimagine what health care looks like when it is around the patient,” she told Mohana. Read the full story. 

From the healthcare cost front, STAT News tells us that

— Medical cost growth trailed that of other industries in 2021, though rising pressure from the omicron variant could fuel future increases in healthcare costs.

— Prices for goods and services skyrocketed at the fastest pace in four decades, rising 7% between December 2020 and December 2021, according to new data released Wednesday from the Bureau of Labor Statistics.

— By comparison, prices for healthcare services rose roughly 2.5% last year, while the cost of medical care goods rose just 0.4%. However, that slow rate of growth could accelerate as COVID-19 cases persist in 2022 and beyond.

From the miscellany department —

  • The Agency for Healthcare Quality and Research’s Acting Director Dr. David Meyers looks back at 2021.
  • Biopharma Dive considers five questions facing gene therapy in 2022.
  • Fierce Healthcare notes that

As the healthcare system faces significant labor challenges, a new report suggests pharmacists are well positioned to fill some of the critical gaps.

The analysis, conducted by Express Scripts and the Columbia University Mailman School of Public Health, found that a majority of pharmacists see their roles transitioning to more direct patient care responsibilities over the next decade.

  • AARP’s Public Policy Institute examines the importance of medication literacy in the medication decision-making of older adults.

While health literacy is widely understood as a quality measure of health care decision making, another related measure calls for increased attention, particularly regarding older adults: medication literacy. Medication literacy is the degree to which individuals can obtain, comprehend, communicate, calculate, and process patient-specific information about their medications to make informed medication and health decisions in order to safely and effectively use their medications, regardless of the mode by which the content by which the content is delivered (i.e., written, oral, or visual).

  • Money offers a comprehensive update on the President’s mandate that health plans cover over the counter COVID tests effective on Saturday January 15.

Midweek update

David Ermer–CDC, CMS, COVID vaccine mandate, COVID-19, COVID-19 vaccine, Medicare, Mental health care, Rx coverage, SCOTUS, U.S. Healthcare–

From the Omicron front, Roll Call reports that

The White House COVID-19 Response Team stopped short of announcing major changes to anticipated guidance surrounding masks and instead focused on changes to testing strategy on Wednesday.

Experts have been calling for the Centers for Disease Control and Prevention to update its mask guidance to recommend high-filtration masks such as N95s and KN95s in light of the surge of the omicron variant. * * *

CDC Director Rochelle Walensky also echoed that an update to the CDC’s mask guidance was coming to “best reflect the options that are available to people, as you note, and the different levels of protection different masks provide.”

But she also doubled down on refusing to endorse a certain type of mask, instead repeating that the “best” masks are those that individuals will wear continuously in indoor settings.

“We are updating information on our mask website to provide information to the public,” she said. “We will provide information on improved filtration that occurs with other masks, such as N95s, and information that the public needs about how to make a choice of which mask is the right one for them. But most importantly, we want to highlight the best mask for you is the one that you can wear comfortably.”

For context, Bloomberg tells us that

The omicron variant represents about 98% of cases, Centers for Disease Control and Prevention Director Rochelle Walensky said Tuesday. That number is based on data for the week ending Jan. 8 and is a significant increase from just two weeks prior, when omicron accounted for 71.3% of cases. 

Omicron’s heightened transmissibility coupled with the immunity some have built to combat the delta through vaccination and exposure, have made conditions favor the “more mild” variant, said David Wohl, a professor at the Institute of Global Health and Infectious Diseases at the University of North Carolina-Chapel Hill. But experts warn that for those who remain unvaccinated or who suffer from other health concerns, infection from any Covid-19 variant is a major concern. 

For even additional context, Bloomberg informs us that

Switzerland joined Spain and the U.K. in suggesting that the coronavirus pandemic may be shifting to an endemic phase. 

From the COVID vaccine front, Bloomberg reports that

Almost all teenagers who needed intensive care for Covid-19 were unvaccinated, according to a study published by the New England Journal of Medicine, bolstering the case for using the Pfizer-BioNTech shot in youths.

The vaccine prevented 98% of ICU visits and 94% of Covid-related hospitalizations in the real-world study of more than 1,000 adolescents ages 12 to 18 in 23 states. The research from the Centers for Disease Control and Prevention and a network of 31 hospitals is one is one of the most detailed yet showing that vaccines can prevent severe Covid complications in teenagers.

Following up on yesterday’s proposed national Medicare coverage determination on Aduhelm, Healthcare Finance News provides stakeholder perspectives on that decision. STAT News points out that because the CMS decision, if finalized would apply to all drugs under development to treat Alzheimers Disease that fall into the same drug class as Aduhelm — monoclonal antibody, the proposed decision is bad news for several of Biogen’s competitors too.

Both Eli Lilly and Roche have such treatments in the works, and Biogen has still two more, developed in partnership with Eisai, as well. All of those drug makers now have a big incentive to pressure Medicare to loosen the restrictions in the final version of its policy, which is due out this April.

“While so much of the focus has been on what this means for [the Biogen drug], this recommendation impacts an entire class of drug and is likely to result in a more aligned effort by stakeholders as they try to influence the final version,” said a consultant for different drug makers, including Biogen.

“All of the other companies have to start over,” said George Vradenburg, the founder of the advocacy group UsAgainstAlzheimer’s. “This now applies to three drugs that, in fact, might be better.”

In other healthcare news —

  • Fierce Healthcare reports on the third day of the JPMorgan Healthcare Conference.
  • Health Affairs discusses how to create a stronger Medicare.
  • The director of NIH’s Heal Inititiative which focuses on substance use disorders / overdose deaths offers her ideas on the new year.
  • Forbes reports that “Walgreens Boots Alliance will have more than 160 of its doctor-staffed Village Medical clinics open next to drugstores by the end of this year.”

In Postal Service news, Govexec reports that

The U.S. Postal Service on Wednesday elected a new Republican chairman of its governing board, elevating one of President Trump’s appointees over President Biden’s picks.  

Roman Martinez, who joined the USPS board of governors in 2019, will serve as the panel’s 25th chairman. Anton Hajjar, a former American Postal Workers Union official nominated to his post by Biden, will serve as vice chairman. The board members voted unanimously for the leadership positions at a meeting on Wednesday. * * *

The new chairman has been an ally of Postmaster General Louis DeJoy, defending his controversial decisions, endorsing his 10-year plan to improve postal finances through, among other things, service cuts and price hikes, and calling him the right leader for the Postal Service. Hajjar, meanwhile, has voiced a lukewarm response to DeJoy’s tenure. The new vice chairman has said, however, that there was “a lot to like” in DeJoy’s plan, despite having reservations over some provisions.  * * *

DeJoy said on Wednesday he has “benefited from Martinez’s broad experience and wise counsel throughout my tenure as postmaster general and especially during the development of the Delivering for America plan.”

Keeping DeJoy in charge and one of his allies in charge of the board raises the prospect for sweeping postal reform legislation to make its way through Congress, with a House bill so far earning only tepid Republican support. 

It’s worth noting too that at 10 am ET tomorrow the U.S. Supreme Court will release decisions in pending cases which could include a stay of the OSHA ETS as OSHA began the enforcement clock on that measure last Monday.

Tuesday’s Tidbits

David Ermer–ACA, CDC, CMS, COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 testing, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

The Centers for Medicare and Medicaid Services (CMS) announced its proposed national coverage decision for Biogen’s Alzheimers Disease FDA-approved treatment, Aduhelm, today.

The proposed National Coverage Determination would cover Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease through coverage with evidence development (CED) – which means that FDA-approved drugs in this class would be covered for people with Medicare only if they are enrolled in qualifying clinical trials. The proposed National Coverage Determination is open to public comment for 30 days.

STAT News sums it up as follows:

Normally, Medicare covers drugs if the FDA approves them. Aduhelm has been different because the agency approved the treatment without a guarantee that patients actually will see slower cognitive decline. The process that led to the drug’s approval is the subject of multiple investigations, following STAT’s reporting that Biogen had an extensive back-channel relationship with the FDA. * * *

Medicare officials don’t require participation in clinical studies for beneficiaries very often — there are only about two dozen other health care products with a similar designation, called a Coverage with Evidence Development (CED), listed on Medicare’s website. Most are for medical devices or diagnostic imaging, and are less restrictive than the policy Medicare announced Tuesday. * * *

Sean Tunis, a principal at Rubix Health who helped develop the CED process during his tenure at the Centers for Medicare and Medicaid Services, said the proposal is almost as restrictive as if Medicare had decided not to cover the drug at all. Medicare, he estimated, would pay for drug costs for perhaps a few thousand patients that enroll in randomized trials over the next three to five years.

The CMS national coverage decision if finalized would help the FEHB Program dodge a bullet because it has many annuitant enrollees without Medicare Part B and for whom the FEHB plan would be the primary Aduhelm payer.

Following up on yesterday’s post about Affordable Care Act FAQ 51 implementing the President’s mandate on health plans to cover over the counter COVID tests, the FEHBlog noticed the fourth FAQ in this section of FAQ 51 which reads as follows:

Q4: When providing coverage of OTC COVID-19 tests, are plans and issuers permitted to address suspected fraud and abuse?

Yes. As stated in FAQs Part 44, Q2, although the FFCRA prohibits medical management of coverage of COVID-19 diagnostic testing, plans and issuers may act to prevent, detect, and address fraud and abuse. Examples of permissible activities include the following:

  • A plan or issuer may take reasonable steps to ensure that an OTC COVID-19 test for which a covered individual seeks coverage under the plan or coverage was purchased for the individual’s own personal use (or use by another participant, beneficiary, or enrollee who is covered under the plan or coverage as a member of the individual’s family), provided that such steps do not create significant barriers for participants, beneficiaries, and enrollees to obtain these tests. For example, a plan or issuer could require an attestation, such as a signature on a brief attestation document, that the OTC COVID-19 test was purchased by the participant, beneficiary, or enrollee for personal use, not for employment purposes, has not been (and will not be) reimbursed by another source, and is not for resale. In contrast, the Departments are of the view that fraud and abuse programs that require an individual to submit multiple documents or involve numerous steps that unduly delay a participant’s, beneficiary’s, or enrollee’s access to, or reimbursement for, OTC COVID-19 tests are not reasonable.
  • A plan or issuer may require reasonable documentation of proof of purchase with a claim for reimbursement for the cost of an OTC COVID-19 test. Examples of such documentation could include the UPC code for the OTC COVID-19 test to verify that the item is one for which coverage is required under section 6001 of FFCRA, and/or a receipt from the seller of the test, documenting the date of purchase and the price of the OTC COVID-19 test.

It occurred to the FEHBlog that FSAFeds the flexible spending account program for federal employees must be reimbursing participants for OTC Covid test kits. In fact the FSAFeds does offer reimbursement for OTC test kits on the condition that the participant furnishes a detailed receipt. For OTC products, FSAFeds generally requires a receipt including Vendor name, Date of purchase, Product name, and Cost. This should be a reasonable documentation standard for FEHB plans to adopt.

Also from the testing front, the Wall Street Journal looks into the reliability of rapid antigen COVID tests sold OTC.

Rapid antigen tests are a useful tool if we are smart about how we use them.

Because the data suggest that rapid tests may be yielding more false negatives at the beginning of an Omicron infection, you’ll have a better chance of getting an accurate result if you wait a day or two after developing symptoms to test, says Katelyn Jetelina, assistant professor of epidemiology at the University of Texas Health Science Center at Houston. If your test is negative, take a second test a day or two later, or get a PCR test if you can. (Easier said than done these days.)

Understand the limitations of rapid tests if you’re considering using them to screen people before gatherings. Rapid tests before a wedding or other large indoor gathering could miss early infections that could be contagious, Dr. [Blythe] Adamson says.

If you have a positive rapid test, you almost definitely have Covid-19, Dr. [Gigi] Gronvall says. False positives are rare, especially when case rates are as high as they are now. You likely don’t need to confirm a positive rapid-test result with a follow-up PCR test, unless an employer or other institution requires it.

In other Omicron news —

  • The Journal also tells us that “U.S. officials on Tuesday ordered 600,000 doses of Covid-19 treatment sotrovimab, the only monoclonal antibody therapy thought to work against the Omicron variant, as a record number of cases puts hospitals under increasing pressure in parts of the U.S. and Europe.  Sotrovimab, made by GlaxoSmithKline PLC and Vir Biotechnology Inc., is now the only Covid-19 monoclonal antibody available for patients in the U.S.”

ACA FAQ 51 also includes reminders to health plans about the wide scope of the ACA’s contraceptive mandate.

From the federal employee COVID vaccination front Federal News Network reports that

The first update by the Safer Federal Workforce task force in more than a month is addressing the challenge of testing employees and contractors who work on-site or with the public on a regular basis for COVID-19, the types of tests that are permitted and who is responsible for paying for said tests.

The crux of the updated and new frequently ask questions is agencies have until Feb. 15 to set up a testing program “for employees who are not fully vaccinated, including due to a pending or approved request for exception or extension from the COVID-19 vaccination requirement for federal employees.”

The task force said the testing program is only for employees who work on-site or interact with the public like safety inspectors, and not for those who work remotely.

Fedweek adds that “A period of waiting is continuing on two major federal workplace issues on which action was expected around now—enforcement of the Coronavirus vaccine mandate and the “reentry” from telework to regular worksites by more employees and for more often.”

From the preventive services department, the Department of Health and Human Services announced today that

Today, the U.S. Department of Health & Human Services (HHS) announced that the Health Resources and Services Administration (HRSA) has updated comprehensive preventive care and screening guidelines for women and for infants, children, and adolescents. Under the Affordable Care Act (ACA), certain group health plans and insurance issuers must provide coverage with no out-of-pocket cost for preventive health services within these HRSA-supported comprehensive guidelines. Among a number of updates, for the first time the guidelines will require such group health plans and insurance plans to provide coverage without a co-pay or deductible for double electric breast pumps.

Fierce Healthcare reports news from the second day of the JPMorgan Healthcare Conference.

From the tidbits department —

  • Last week, the Office of National Coordinator for Health Information Technology announced “the release of the Project US@ (“Project USA”) Technical Specification Final Version 1.0 and thereby completed our one year goal to coordinate the creation of a health care specification that could be used across the industry for representing patient addresses (mailing, physical, billing, etc.). This new “tech spec” will advance the health care industry’s proficiency in recording and managing accurate and consistently formatted patient addresses and support more efficient patient matching and record linkage. As a reminder, among the many data elements that are used in patient matching, research has shown patient address to be one of the most sensitive to standardization and therefore impactful on patient matching, especially at scale. However, patient addresses change frequently, are often entered incorrectly or imprecisely.”