Midweek Update

Midweek Update

From the Omicron and siblings front —

Health Day informs us

COVID-19 might be easing into a new status as a widely circulating and somewhat harsher version of the common cold, experts say — a virus that folks could contract repeatedly, even if they were recently infected.

“[SARS-CoV-2] is destined to join four of its family members and become an endemic coronavirus that will repeatedly infect individuals throughout their lifetimes,” said Dr. Amesh Adalja, of Johns Hopkins Center for Health Security, referring to the four circulating coronaviruses that cause the common cold.

“It will become one of several respiratory viruses that people contend with, and will become increasingly less disruptive and more manageable with medical countermeasures and the population’s risk acclimatization,” he added.

The FEHBlog recently has pointed out unusual disease cases involving childhood hepatitis , monkeypox, a flu spike, etc. STAT News seeks to put these unusual cases in perspective.

These viruses are not different than they were before, but we are. For one thing, because of Covid restrictions, we have far less recently acquired immunity; as a group, more of us are vulnerable right now. And that increase in susceptibility, experts suggest, means we may experience some … wonkiness as we work toward a new post-pandemic equilibrium with the bugs that infect us. * * *

Marion Koopmans, head of the department of viroscience at Erasmus Medical Center in Rotterdam, the Netherlands, said she believes we may be facing a period when it will difficult to know what to expect from the diseases that we thought we understood.

“I do think that’s possible,” Koopmans said.

This phenomenon, the disruption of normal patterns of infections, may be particularly pronounced for diseases where children play an important role in the dissemination of the bugs, she suggested.

Ruh roh.

From the Rx coverage front, Fierce Healthcare reports

Prime Therapeutics cut per member per month drug costs by 26% in one year through its MedDrive program, which leverages biosimilars to help drive down expenses.

The program uses advanced analytics to flag ways that health plans can cut down drug spend, with a particular focus on the potential of biosimilars. Pharmacy benefit managers are betting on biosimilar products to introduce new competition to popular branded products and drive down costs.

Prime, which serves 33 million members across 23 Blue Cross Blue Shield plans, first launched MedDrive in May 2021 and in its first year the program drove savings by focusing on just three biosimilar categories, the PBM said. Cancer drugs led the way for savings.

The International Foundation of Employee Benefits Plans adds

The U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced the availability of a final guidance for industry entitled “Importation of Prescription Drugs Final Rule Questions and Answers.” The guidance is intended to help small entities comply with the final rule entitled “Importation of Prescription Drugs.” The final rule was issued to implement a provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow importation of certain prescription drugs from Canada.

In OPM news, OPM announced a group of new staff appointees at the agency today including a new General Counsel and a new Deputy General Counsel.

From the miscellany department —

  • Rebecca G. Baker, Ph.D., the director of the NIH HEAL Initiative, shares insights gained from the Third Annual HEAL Investigators Meeting. HEAL is an NIH branch that focus on creating solutions to the opioid epidemic.
  • EHR Intelligence discusses how a National Patient Identifier could boost population health. It is mystifying that Congress has not released funds for this important initiative.
  • The Medical Group Management Association identifies four ways medical groups can remove barriers to mammography compliance.
  • Health Payer Intelligence outlines 2022 actions today by the U.S. Preventive Services Task Force.

Despite rising availability in online transparency tools, consumers remain unsure about costs and avoid care as a result, a new survey has found.

The annual consumer sentiment survey was conducted in January 2022 by Healthsparq, a health tech company, and reached more than 1,000 insured Americans. Transparency tools were defined as those provided by payers such as in-network provider search, cost estimates and information on treatment. 

The majority (70%) of respondents knew that their health plan offered these, up from 49% last year, and most had used them in the past year. They also said this access helps them better understand their coverage and manage costs. Yet nearly half reported avoiding care due to unclear costs, up from a quarter last year. Care avoidance was even more pronounced among those under the age of 34, at 63%. 

Mark Menton, Healthsparq’s general manager, told Fierce Healthcare he suspects that is because the tools exist, but consumers do not know how to access the information.

“I think that’s a hurdle we as an industry need to overcome,” Menton said. “They don’t know where to find this information.” 

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the Omicron and siblings front —

The Secretary of Health and Human Services has extended the Covid public health emergency for another 90 days. Bloomberg explains, “The declaration allows the US to grant emergency authorizations of drugs, vaccines and other medical countermeasures, as well as administer those products to millions of people at no out-of-pocket cost. It’s also enabled millions of Americans to get health coverage through Medicaid, among other benefits.” Bloomberg’s sources expect the declaration to be renewed again in July 2022.

The American Hospital Association informs us

The Food and Drug Administration today authorized a single Pfizer COVID-19 booster dose for children aged 5-11 who completed the Pfizer vaccine primary series at least five months before. FDA authorized the vaccine for this age group last October.

“The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups,” said Peter Marks, M.D., director of FDA’s Center for Biologics Evaluation and Research.

In public health news —

  • The federal government’s Million Hearts campaign has launched a website discussing hypertensive disorders of pregnancy. The site explains “Hypertensive disorders of pregnancy are a leading cause of maternal mortality and can put both mother and baby at risk for problems during pregnancy.1 High blood pressure can also cause problems during and after delivery. Importantly, hypertensive disorders of pregnancy are often preventable and treatable.”
  • The Centers for Disease Control has updated its website discussing diabetes and heart disease. The FEHBlog knows from his PCP about the dangerous relationship between those two diseases.

In survey news —

  • Beckers Hospital Review relates that “The Lown Institute, a nonpartisan healthcare think tank, released its ranking May 17 of the best hospitals in the U.S. for avoiding overuse of low-value tests and procedures.”
  • Fierce Healthcare tells us, “Utah is the healthiest state for seniors this year, earning high marks for low prevalence of smoking and excessive drinking, according to a new report from the United Health Foundation. The philanthropic arm of UnitedHealth Group issued its annual America’s Health Rankings senior report Tuesday morning, which highlights state-specific performance across a slew of measures as well as progress, or lack thereof, on several key health issues facing seniors.”

From the healthcare business front

Fierce Healthcare reports

Private insurance plans paid hospitals on average 224% more compared with Medicare rates for both inpatient and outpatient services in 2020, a new study found. 

Researchers at RAND Corporation looked at data from 4,000 hospitals in 49 states from 2018 to 2020. While the 224% increase in rates is high, it is a slight reduction from the 247% reported in 2018 in the last study RAND performed. 

“This reduction is a result of a substantial increase in the volume of claims in the analysis from states with prices below the previous average price,” the study said. 

The report showed that plans in certain states wound up paying hospitals more than others. It found that Florida, West Virginia and South Carolina had prices that were at or even higher than 310% of Medicare. 

But other states like Hawaii, Arkansas and Washington paid less than 175% of Medicare rates. 

The American Hospital Association replies

The RAND Corporation’s latest hospital pricing report again “overreaches and jumps to unfounded conclusions based on incomplete data,” AHA President and CEO Rick Pollacksaid today. “The report looks at claims for just 2.2% of overall hospital spending, which, no matter how you slice it, represents a small share of what actually happens in hospitals and health systems in the real world. RAND also continues to ignore that hospitals are not all the same. Researchers should expect variation in the cost of delivering services across the wide range of U.S. hospitals — from rural critical access hospitals to large academic medical centers. Tellingly, when RAND added more claims as compared to previous versions of this report, the average price for hospital services declined. This suggests what we have long suspected: you simply cannot draw credible conclusions from such a limited and biased set of claims. 

“Further, the results highlight what even the Medicare Payment Advisory Commission (MedPAC) acknowledges: Medicare does not fully cover the cost of providing care to Medicare beneficiaries. Pinning commercial prices to inadequate Medicare rates would cause even more financial strain to hospitals already facing tremendous challenges as a result of the ongoing COVID-19 pandemic and rising inflation. The result could be reduced patient access to care.” 

I agree with the American Hospital Association that the problem is Medicare. Why Sen. Sanders continues to push Medicare for All is a mystery to the FEHBlog.

Also, Healthcare Dive informs us

Humana plans to open about 100 new value-based primary care clinics for Medicare patients between 2023 and 2025 through its second joint venture with private-equity firm Welsh, Carson, Anderson & Stowe, according to a Monday release from the payer.

The clinics will be managed and operated under Humana’s CenterWell Senior Primary Care brand, and WCAS will have majority ownership while Humana will have a minority stake.

The $1.2 billion expansion builds upon an existing venture with the same firm to open 67 clinics by early 2023.

From the Rx coverage front, Drug Channel reports on “The State of Specialty Pharmacy 2022: Reflections, Trends, and Photos from #Asembia22.”

I had the honor of presenting during the event’s general session: The Specialty Pharmacy Industry Update & Outlook. As in past years, I was joined by Doug Long from IQVIA. 

You can download our full slide deck here: https://drugch.nl/asembia22

From the mental healthcare front, Health Payer Intelligence discusses another angle considered in the UHG report on seniors mentioned above.

Over the last decade, seniors have experienced rising rates of mental healthcare needs, drug-related deaths, and early mortality, the UnitedHealth Foundation’s 2022 Senior Report shows.

“The 2022 Senior Report shows that the wellbeing of older adults was declining before the pandemic, which we know exacerbated many of these challenges,” Rhonda Randall, DO, executive vice president and chief medical officer of UnitedHealthcare Employer and Individual, said in the press release

“We urge people to help the seniors in your lives reconnect with the communities and activities they have enjoyed in the past but may not yet have returned to. We are focused on reducing disparities in the health care system for everyone, including older Americans.”

In webinar news — The Labor Department is holding a virtual event on May 25 concerning building mental health-friendly workplaces.

Monday Roundup

From the Omicron and siblings front —

  • Bloomberg observes “Covid hospitalitalization count makes vaccines seem less effective, Researchers say. The researchers point out that a patient who tests positive for Covid is a Covid hospitalization even if the patient is hospitalized for an unrelated reason.
  • In its recent review of Covid pills, the Institute for Clinical Review (ICER) gave a mildly favorable report on using an inexpensive anti-depressant fluvoxamine to treat Covid. This part of the ICER report was physician investigator-initiated. Those investigators sought FDA approval. Today, however, STAT News reports that “In an unusual two-page summary — the FDA does not generally disclose the reasoning behind rejections — regulators said that the doctors failed to provide adequate evidence of the effectiveness of the drug, called fluvoxamine.” The investigators indicated that more fluvoxamine trials are ongoing as well as trials of other repurposed drugs.
  • The National Institutes of Health announced today that a research team is successfully using deidentified electronic health record data to better identify characteristics of persons with long Covid. “One reason long COVID is difficult to identify is that many of its symptoms are similar to those of other diseases and conditions. A better characterization of long COVID could lead to improved diagnoses and new therapeutic approaches.”
  • Roll Call delves into the use of wastewater surveillance to track Covid trends. Urban areas are good — rural areas are not so good.
  • Medpage Today offers an epidemiologist’s perspective on the occasionally observed Omicron rebound from Paxlovid, the Pfizer Covid pill. Reuters adds, “Pfizer has said that from more than 300,000 patients it is monitoring who received the 5-day treatment, around 1-in-3,000 – about 0.03% – reported a relapse after taking the pills.”

In other FDA news, MarketWatch informs us

The Food and Drug Administration on Monday authorized a test developed by Laboratory Corporation of America Holdings LH, -0.92% that allows people in the U.S. to self-test for respiratory syncytial virus (RSV), a type of common cold, as well as the flu and COVID-19. The test does not require a prescription. People swab at home and send the test by mail to a Labcorp lab. Results are then made available in an online portal. Teens and children are also authorized to test with the support of adults. The test kit costs $169 and may be covered by insurance, according to a spokesperson. It is expected to be available within the next three weeks. 

That’s helpful.

From the SDOH front —

  • Health Day informs us that “a new study shows that telemedicine has closed the gap in access to primary care between Black and non-Black Americans.”
  • Beckers Payers Issues tells us “Despite little change before the pandemic, the number of adults with medical debt, issues paying medical bills and medical debt in collections have declined since the pandemic began. New policies will be needed to sustain the decrease, according to a May 11 report from the Urban Institute.” 

From the preventive care front, Healio reports

A decrease in cervical cancer rates in the United States, most notably among younger women, may be associated with HPV vaccination approval, according to a retrospective, cross-sectional study published in JAMA Network Open

Researchers added that an increase in oropharyngeal and anal/rectal cancers, particularly among men, highlights a need for vaccination uptake among both men and women.

From the interoperability front, the Sequoia Project “selected by the Office of the National Coordinator for Health IT (ONC) as the Recognized Coordinating Entity (RCE) to support the implementation of the Trusted Exchange Framework and Common Agreement (TEFCA), today released additional details regarding the process and requirements for becoming a Qualified Health Information Network (QHIN). The Sequoia Project is requesting feedback on these items before the final documents are released.” The Sequoia Project’s comment deadline is June 15, 2022, and “drafts are available on the RCE website.”

From the healthcare business front, Healthcare Dive reports

Hospitals’ labor costs rose by more than a third from pre-pandemic levels by March 2022, according to a report out Wednesday from Kaufman Hall.

Heightened temporary and traveling labor costs were a main contributor, with contract labor accounting for 11% of hospitals’ total labor expenses in 2022 compared to 2% in 2019, the report found.

Contract nurses’ median hourly wages rose 106% over the period, from $64 an hour to $132 an hour, while employed nurse wages increased 11%, from $35 an hour to $39 an hour, the report found.

In other government news —

  • The Department of Health and Human Service is marking the 10th anniversary of the National Plan to Address Alzheimer’s Disease. “HHS is commemorating the Anniversary through a series of publications and presentations highlighting the Department’s accomplishments in addressing Alzheimer’s disease and related dementias (ADRD), including those at the Centers for Disease Control and Prevention (CDC), Administration for Community Living (ACL), National Institutes of Health (NIH), Indian Health Service (IHS), and other HHS agencies. HHS will also sponsor a state policy roundtable to hear from state leaders about their work to address ADRD.  All events and materials will be shared on the 10th Anniversary HHS page.”
  • The Society for Human Resource Management relates that “An FAQ explains that the EEOC will permit employers to submit their EEO-1 Reports after the May 17 deadline, during what the agency is calling the “failure to file” phase. The EEOC stated, “All filers who have not submitted and certified their mandatory 2021 EEO-1 Component Report(s) by the Tuesday, May 17, 2022, published deadline will receive a notice of failure to file instructing them to submit and certify their data as soon as possible, and no later than Tuesday, June 21, 2022.”  All FEHB carriers must file this report.

Weekend update

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

From the omicron and siblings front, Bloomberg Prognosis reports

People who are vaccinated and then get infected with omicron may be primed to overcome a broad range of coronavirus variants, early research suggests.  

A pair of studies showed that infection produced even better immune responses than a booster shot in vaccinated patients. Teams from Covid-19 vaccine maker BioNTech SE and the University of Washington posted the results on preprint server bioRxiv in recent weeks.

The researchers have found the silver lining in the Omicron cloud.

In other encouraging healthcare news, BioPharma Dive informs us

The Food and Drug Administration on Friday approved Eli Lilly’s diabetes drug Mounjaro, a first-of-its-kind treatment that can help control patients’ blood sugar and, potentially, help them lose weight as well.

Mounjaro, also known as tirzepatide, expands Lilly’s diabetes business, which includes insulins as well as other types of therapies. The company recorded $9 billion in diabetes drugs sales last year.

Mounjaro works by stimulating two hormones, called GLP-1 and GIP, that control insulin production. In clinical testing, the drug outperformed several other diabetes medicines, including one made by rival drugmaker Novo Nordisk that only acts on one hormone. Mounjaro was more effective in controlling blood sugar than two types of insulin as well. * * *

The drug’s approval will heighten competition between Lilly and Novo, which have battled for market share in the U.S. for years. Novo, for instance, has recently had success by launching a similar, once-weekly shot to Lilly’s top-selling drug Trulicity, as well as a daily pill that works the same way.

Novo is testing a dual-acting competitor to tirzepatide, but it’s only in Phase 2 testing, well behind Lilly’s drug. Both companies are also trying to develop a once-weekly insulin shot, with similar programs in Phase 3 development.

The next frontier for both companies is in obesity, where they are working to prove their drugs’ worth as weight loss treatments. Novo has already won approval for a drug called Wegovy, while Lilly reported promising data for Mounjaro last month.

The article adds that Lilly did not disclose pricing for its newly approved drug on Friday.

The FEHBlog also noticed that Katie Keith’s latest article on the Affordable Care Act delves into the recent guidance on posting three machine reading pricing files on health plan websites by July 1. The discussion may be found in the closing paragraphs of the article.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the Omicron and siblings front

  • The Wall Street Journal has updated its article on Covid boosters.
  • The Institute for Clinical and Economic Review (ICER) today released “a Final Evidence Report assessing the comparative clinical effectiveness and value of [specific] outpatient treatments for COVID-19 [, principally Pfizer’s pill Paxlovid and Merck’s pill molnupiravir ].

A majority (11-2) found current evidence is not adequate to demonstrate a net health benefit when molnupiravir is compared to symptomatic care alone.

All panelists (13-0) found that current evidence is adequate to demonstrate a net health benefit when Paxlovid is compared to symptomatic care alone.

Due to uncertainty in the net health benefit for molnupiravir, a majority of panelists voted that it represents “low-to-intermediate” long-term value for money.

A majority of panelists found that Paxlovid represents “high” long-term value for money.

  • ICER presented at the OPM/AHIP carrier conference last month. ICER “is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.”
  • Speaking of the Covid pills, STAT News discusses the use of telehealth services to prescribe them. The upshot, as the FEHBlog understands it, is while using telehealth for this purpose is convenient for patients, experts are unsure whether the telehealth service provides adequate follow-up care to the patient.

Also, from the Rx coverage front, the Food and Drug Administration issued a news roundup today.

From the healthcare business front, BioPharma Dive reports

Pfizer has agreed to acquire Biohaven Pharmaceuticals for $11.6 billion in a deal that turns an existing alliance on a fast-selling migraine drug into a big bet on its future growth.

Pfizer will pay $148.50 per share in cash for each Biohaven share it doesn’t already own, representing a roughly 79% premium to the company’s Monday closing price and a 33% premium to its average share price of $111.70 over the last three months. The deal, which is expected to close early next year, is by far the biggest biotech buyout of 2022, according to data compiled by Biopharma Dive.

Announced Tuesday, the acquisition hands Pfizer full rights to Nurtec ODT, a pill that’s approved in the U.S. and other countries for the treatment and prevention of migraines. Biohaven’s pipeline also includes an experimental nasal spray for migraines, zavepegant, that’s been submitted to U.S. regulators, as well as five additional, preclinical treatments that block the same protein target.

From the mental health parity front, the Labor Department’s Employee Benefits Security Administration announced that the agency will be holding a mental health parity compliance assistance webcast on May 24 from 2-3 pm ET. Here is a link to the announcement which explains how to register for the webcast.

From the patient safety front, the Leapfrog Group “released the spring 2022 Leapfrog Hospital Safety Grade, which assigns a letter grade to nearly 3,000 U.S. general hospitals based on over 30 measures of patient safety.”

At HospitalSafetyGrade.org, the public can find detailed information about a hospital’s performance on patient experience and other safety measures used to grade hospitals.

Across all states, highlights of findings from the spring 2022 Leapfrog Hospital Safety Grade include:

Thirty‐three percent of hospitals received an “A,” 24% received a “B,” 36% received a “C,” 7% received a “D,” and less than 1% received an “F.”

Five states with the highest percentages of “A” hospitals are North Carolina, Virginia, Utah, Colorado, and Michigan.

There were no “A” hospitals in Wyoming, West Virginia, the District of Columbia, or North Dakota.

From the medical research department, Medscape informs us

Eight modifiable risk factors were linked to more than one in three cases of Alzheimer’s disease and related dementia in the U.S., a cross-sectional analysis showed.

The eight risk factors — midlife obesity, midlife hypertension, physical inactivity, depression, smoking, low education, diabetes, and hearing loss — were associated with 36.9% (95% CI 36.5-37.3) of Alzheimer’s and dementia cases, reported Roch Nianogo, MD, PhD, of the University of California Los Angeles, and Deborah Barnes, PhD, MPH, of the University of California San Francisco, and co-authors.

The factors most prominently associated with Alzheimer’s and dementia were midlife obesity, at 17.7% (95% [Confidence Interval] CI 17.5-18.0); physical inactivity, at 11.8% (95% CI 11.7-11.9); and low educational attainment, at 11.7% (95% CI 11.5-12.0).

“We published a similar study a little more than 10 years ago, and the most important risk factors then were physical inactivity, depression, and smoking,” Barnes told MedPage Today.

“Today, the top three risk factors are midlife obesity, physical inactivity, and low education,” she observed. “This is important because it suggests that the growing number of people who are obese in the U.S. could have a major long-term impact on dementia rates.”

From the clarification front, the FEHBlog often reminds folks that federal employees who retired under the Civil Service Retirement System before 1984 are not eligible for free Medicare Part A. The FEHBlog dug into this issue today, and he discovered this 2013 Reg Jones Q&A on this topic that the Federal Times published.

Q. I retired in 2009 under CSRS. I am close to 65, and the answer to one of the questions asked states that people in CSRS are not eligible for Medicare because they didn’t pay into Social Security.

I was in CSRS before the change to FERS and stayed with CSRS. I had Medicare deductions taken from my pay from 1983-84 till I retired in 2009.

Do the Medicare funds I paid since 1983 make me eligible for Medicare or just part of it?

So which is right? I need to know so I can do what needs to be done — enroll or not. I’m currently insured under federal BCBS.

A. CSRS employees who retired before Dec. 31, 1983, aren’t eligible for Medicare Part A. Nor are CSRS employees who retired after that date but before having Medicare deductions taken from their pay for 10 years.

On the other hand, they are eligible to enroll in Medicare Part B, which is open to everyone 65 or older.

Consequently, the cadre of 65 and older federal annuitants without Medicare A is larger than the FEHBlog understood. This cadre is relevant to the Postal Reform Act because that law keeps Postal annuitants over aged 65 without Medicare Part in the legacy FEHBP.

Friday Stats and More

Based on the CDC’s Covid Data Tracker and using Thursday as the first day of the week, here’s the FEHBlog’s weekly chart of new Covid cases displayed from the 27th week of 2021 through the 18th week of 2022.

The CDC reports in its latest weekly review that “The current 7-day daily average of new Covid hospital admissions for April 27–May 3, 2022, was 2,219. This is a 16.6% increase from the prior 7-day average (1,903) from April 20–26, 2022.

Here’s the FEHBlog’s latest weekly chart of new Covid deaths display from the 27th week of 2021 through the 18th week of 2022.

The CDC’s weekly review sums it up as follows:

COVID-19 cases and hospitalizations are on the rise in the United States. Although deaths continue to decrease, the United States is expected to reach 1 million deaths soon. * * *

As of May 5, 2022, there are 78 (2.42%) counties, districts, or territories with a high COVID-19 Community Level, 316 (9.81%) counties with a medium Community Level, and 2,826 (87.76%) counties with a low Community Level. This represents a slight (0.75 percentage points) increase in the number of high-level counties, a small (+1.86 percentage points) increase in the number of medium-level counties, and a corresponding (−2.61 percentage points) decrease in the number of low-level counties. Sixteen (28.57%) of 56 jurisdictions had no high- or medium-level counties this week.

To check your COVID-19 community level, visit COVID Data Tracker.

Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the inception of the vaccination program until this 18th week of 2021.

Nearly 75% of the U.S. population aged 12 and older are fully vaccinated and nearly 50% of the U.S. population aged 18 and older have received a booster.

STAT News reports

The White House could run out of Covid-19 vaccines if it moves forward with plans to encourage all adults to get a second Covid-19 vaccine booster dose by roughly Sept. 1, according to a tranche of budget documents sent to Congress that have not previously been made public.

In other CDC news, the American Hospital Association informs us

The Centers for Disease Control and Prevention is investigating 109 potential hepatitis cases of unknown cause in U.S. children since last October, including five deaths. More than 90% of the patients were hospitalized, 14% received liver transplants and more than half had a confirmed adenovirus infection, but officials still don’t know the actual cause of their hepatitis and cautioned that it may take time to assess the evidence and learn more. CDC alerted clinicians to the first cases last month.

To date, 25 states and territories have reported potential cases: Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New York, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Washington and Wisconsin.

Potential cases also have been reported in the United Kingdom and other countries

From the Rx coverage front, Medscape tells us

The US Food and Drug Administration (FDA) has cleared the first in vitro diagnostic to aid in the early detection of Alzheimer’s disease (AD).

The Lumipulse G β-Amyloid Ratio 1-42/1-40 (Fujirebio Diagnostics) test detects amyloid plaques associated with AD in adults age 55 or older who are under investigation for AD and other causes of cognitive decline.

“The availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive [positron emission tomography (PET)] scans is great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

“With the Lumipulse test, there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease,” he added.

From the healthcare business front, Beckers Payer Issues informs us

Cigna reported over $44 billion in total revenues in the first quarter, with the strongest growth in the company’s Evernorth business. Projected revenues at year end stand at $177 billion, according to the company’s earnings report released May 6.

“We’ve had a strong start to the year as we advance our growth strategy and support the health and well-being of our clients and customers,” Chair and CEO David Cordani said. “We’re taking decisive steps forward with innovation, new partnerships and re-investing in our company so we can achieve greater impact for the customers and communities we’re privileged to serve.”

Also, Becker’s Hospital CFO Report tells us

Driven mainly by nonoperating losses, Oakland, Calif.-based Kaiser Permanente recorded a net loss of $961 million in the first quarter of 2022, down from a net income of $2 billion in the same quarter in 2021, according to financial data released May 6. 

For the quarter ending March 31, Kaiser reported total operating revenue of $24.2 billion, up from $23.2 billion the year prior. Tom Meier, corporate treasurer of Kaiser Permanente, said the revenue increase was attributed to several factors, including growth of its health plan. 

Kaiser also saw its expenses increase significantly in the first quarter of 2022 to $24.3 billion, up 9.5 percent from the same quarter last year. Mr. Meier said the health system incurred about $1.4 billion in costs from COVID-19, including $900 million for the cost of care, $550 million for testing and $50 million for vaccinations. 

In related news, Govexec reports

USPS saw a net loss of $639 million in the period between Jan. 1 and March 31, up from $82 million in the same period last year. The Postal Service Reform Act was not enshrined into law until after the second quarter of fiscal 2022, meaning the relief it will provide by eliminating the requirement that the Postal Service prefund health care costs for future retirees was not reflected in the financial results. USPS grew revenue in the quarter by about $900 million, a 5% increase from the same period in 2021. Volume grew by about 3%. 

Federal News Network adds

Postmaster General Louis DeJoy expects the Postal Service will need to keep raising prices on its monopoly mail products for the foreseeable future, as part of a 10-year reform plan to improve its long-term financial health.

DeJoy said Thursday said the mailing industry needs to be prepared for USPS to raise prices on its market-dominant products “at an uncomfortable rate,” until it reaches a point where the agency is on track to be self-sustaining in the long term.

As we approach Mothers’ Day this weekend, the American Hospital Association tells us

The Health Resources and Services Administration will launch May 8 a toll-free hotline for expecting and new mothers experiencing mental health challenges, where trained counselors will provide brief interventions and referrals to community-based and telehealth providers as needed. Callers also will receive evidence-based information and referrals to support groups and other community resources.

“Today, we are creating a safe space for expecting and new moms who are experiencing maternal depression, anxiety or other mental health concerns to have confidential conversations and get the support they need,” said HRSA Administrator Carole Johnson. “Moms can call or text 1-833-9-HELP4MOMS and connect with a counselor at no charge. We are going to continue to grow our investments in this resource, as we know it’s what women need.”

Nothing is too good for our Moms.

Midweek update

Photo by Thought Catalog on Unsplash

From the Omicron and siblings front

The American Hospital Association informs us

COVID-19 vaccinations prevented an estimated 107,000 Medicare hospitalizations between January and May 2021, resulting in $2.6 billion in savings for Medicare and Medicare Advantage plans, according to a new report by the Department of Health and Human Services. The report estimates the impact of COVID-19 vaccination during a five-month period shortly after the first vaccine was authorized and recommended for health care workers and elderly people in long-term care facilities. Future analyses will examine hospitalizations prevented by vaccination during the delta and omicron waves, HHS said.

Bloomberg Prognosis tells us

Pfizer Inc. executives said patients who suffer a relapse in Covid-19 symptoms after taking a full course of Paxlovid should take more of the treatment, though current U.S. guidelines limit use to five consecutive days.

“Paxlovid does what it has to do: it reduces the viral load,” Chief Executive Officer Albert Bourla said in an interview. “Then your body is supposed to do the job.” But for unknown reasons, the CEO said, some patients aren’t able to clear the virus with the first course of treatment.

In cases where virus levels do rebound, Bourla said, “then you give a second course, like you do with antibiotics, and that’s it.”

As noted in the article, the fly in the ointment is that the FDA emergency use authorization does not expressly approve a second course of the medication.

From the Rx coverage front

MedCity News reports on Bristol Myers Squibb’s (BMS) NEX-T program to improve CAR-T treatments.

The company has described NEX-T as changes to manufacturing driven by the translational insights it has gleaned from treating thousands of patients with its CAR T therapies. In addition to a faster turnaround time, the strategy is intended to reduce the costs of the overall process.

One of the key goals for the next-generation of cell therapies is treating solid tumors.

Another strategy that BMS is pursuing is going after two targets with a single therapy, reducing the risk that a tumor escapes from the treatment

Looking at the flip side of this coin, Forbes reports

Health plans and pharmacy benefit managers (PBMs) that manage drug costs speaking at this year’s Asembia Specialty Pharmacy Summit in Las Vegas say specialty drugs now account for 50% or greater of the total prescription spending they manage. In some cases, employer clients are seeing specialty costs account for 60% or even greater of their total drug spending.

“It really is frightening for our clients,” Lucille Accetta, senior vice president of pharmacy benefit management and specialty product development at CVS Health told hundreds of attendees at the Asembia event, which runs through Thursday and drew more than 5,000 people from the healthcare industry. “We have to be the best purchaser for our clients.” * * *

To reign in the costs of prescription drugs while maintaining access to life-saving treatments, health plans and pharmacies say they are more closely monitoring patients as soon as they are on the drug, said Rina Shah, group vice president of pharmacy operations and services at Walgreens.

The Forbes article adds

Abarca Health [is] an independent PBM that manages more than $5 billion in drug costs annually for more than four million Americans has executives at this week’s Asembia meeting talking up its efforts to better manage specialty pharmacy costs.

The company’s Assura solution launched earlier this year “guarantees the net cost of drugs, including specialty medications, by offering an annual fixed per script cost for a health plan’s entire population,” Abarca said in announcing the new pricing solution earlier this year. The guarantee, Abarca CEO Jason Borschow says, is adjusted each year based on drug benefit coverage changes.

From the healthcare business front

Healthcare Dive informs us

Even as COVID-19’s benefit waned, new plan members across multiple product lines helped drive CVS to $2.3 billion in profit in the first quarter, slightly higher than the $2.2 billion brought in at the same time last year.

In results published Wednesday, the company beat Wall Street expectations on earnings and revenue, with a topline of $76.8 billion, up 11% year over year.

Fierce Healthcare explains how CVS has shifted from a retail to a digital marketing focus.

The Wall Street Journal reports

Moderna Inc. MRNA 5.81% said that its first-quarter revenue and profit tripled from a year earlier on higher sales of its Covid-19 vaccine and that a fall booster-shot campaign could drive continued sales gains.

The biotechnology company’s revenue topped $6 billion in the period ended March 31, beating analyst expectations and rising from $1.94 billion a year earlier, driven almost entirely by sales of its messenger RN

Moderna Inc. MRNA 5.81% said that its first-quarter revenue and profit tripled from a year earlier on higher sales of its Covid-19 vaccine and that a fall booster-shot campaign could drive continued sales gains.

The biotechnology company’s revenue topped $6 billion in the period ended March 31, beating analyst expectations and rising from $1.94 billion a year earlier, driven almost entirely by sales of its messenger RNA-based vaccine, branded as Spikevax. * * *

Moderna is the latest drugmaker to show surging sales due to demand for Covid-19 vaccines and treatments, following recent reports fromEli Lilly & Co., Merck & Co. and Pfizer Inc.

From the health risks front, MedPage Today explains that

Seven risk factors, some modifiable and some not, accounted for the vast majority of risk for first-time acute myocardial infarction (MI) in young adults, according to a case-control study.

The seven factors — diabetes, depression, hypertension, smoking, family history of premature MI, low household income, and hypercholesterolemia — were responsible for 83.9% of the total acute MI risk in young women and 85.1% of the risk in young men, reported Harlan Krumholz, MD, SM, of Yale New Haven Hospital in New Haven, Connecticut, and colleagues.

The UPI reports

Older adults who obtain a flu shot are less likely to suffer a heart attack or stroke and are at lower risk for death from heart-related health events in the year after getting vaccinated, an analysis published Friday found.

Just under 4% of older adults vaccinated against the seasonal virus experienced a “cardiovascular event” within the next year compared to just over 5% of those who did not receive the shot, data published Friday by JAMA Network Open showed.

From the meetings department,

  • HHS provides a readout of a high-level meeting among Labor Department, health insurance and business executives “to discuss compliance with the Mental Health Parity and Addiction Equity Act, adequacy of in-network providers and mental health and substance use disorder treatment during the pandemic, as the nation observes Mental Health Awareness Month.”
  • The National Committee for Quality Assurance reviews the presentations at last week’s Quality Talks conference.

From the federal employee benefits front, FedWeek discusses OPM’s planned improvement to processing retirement applications as unveiled in the Fiscal Year 2023 budget document. Processing federal retirement benefits will be a heavy lift for OPM until Congress simplifies the pension calculation.

Monday Roundup

Photo by Sven Read on Unsplash

The President has declared May 1 through May 7 to be Public Service Recognition Week. OPM explains

Celebrated annually during the first week of May since 1985, Public Service Recognition Week (PSRW) (external link) is time set aside to honor the men and women who serve our nation as federal, state, county and local government employees. 

Throughout the country, mayors, governors, agency leaders, communities and public service organizations participate in PSRW by issuing proclamations; hosting award ceremonies and special tribute events; and delivering messages about the value of public service.

To that end, Govexec reports the President took the time today to virtually award Presidential Rank Awards to 230 senior federal employees from 37 agencies.

Speaking directly to the career civil service, Biden said: “Over the last 15 months you’ve helped us deliver so much to the American people,” such as the getting Americans vaccinated against COVID-19, delivering economic relief checks, caring for veterans, implementing the infrastructure package and working to restore the public’s faith in government and democracy. He gave a big “thank you” to them as well as their families. 

The FEHBlog heartily agrees.

From the Omicron and siblings front, WebMd informs us

The FDA’s independent panel of advisors will meet in June to discuss the Pfizer and Moderna COVID-19 vaccines for children under age 5, as well as the Novavax vaccine for adults, according to an FDA announcement released Friday.

On June 7, the FDA’s vaccine committee will review the Novavax shot, which could become the first new COVID-19 vaccine to hit the U.S. market in more than a year. The shot is already authorized in more than three dozen countries, including across Europe.

The FDA has also selected three possible dates — June 8, 21, and 22 — to discuss the shots for kids under age 5. The dates are tentative because the companies haven’t completed their submissions, the agency said.

The FEHBlog is pleased to read about these developments because the Novovax shot which uses a traditional vaccination approach may be acceptable to the vaccine inquisitive and the country needs a vaccine for younger children.

STAT News adds

Pfizer released news late Friday that Paxlovid, the antiviral currently subject to a big push from the U.S. government, failed to prevent people living with Covid patients from catching the infection.

The news is one of several bad headlines for the new Covid pill, but one experts say doesn’t affect the medicine’s primary use: treating people who are already sick.

Paul Sax, clinical director of the division of infectious diseases at Brigham and Women’s Hospital, said he would “absolutely” prescribe Paxlovid to people at high risk of severe disease who have Covid. “Without hesitation,” he said. “Because the net benefit in the high risk study was extremely high.”

From the Affordable Care Act front, Health Affairs Forefront has posted the second part of Katie Keith’s three-part series on last week’s HHS final 2023 notice of ACA benefit and payment parameters. The second part concerns changes specific to the ACA marketplace or exchange plans.

From the Rx coverage front, Health Affairs informs us

UnitedHealthcare is restricting insurance coverage of Aduhelm across all of its health plans, saying the drug “is unproven and not medically necessary for the treatment of Alzheimer’s disease due to insufficient evidence of efficacy,” according to the company’s new policies.

Physicians who plan on giving Aduhelm to UnitedHealthcare patients will need to obtain prior approval from the insurance company, effective June 1. Patients also need to be in an approved clinical trial.

UnitedHealthcare’s decision follows Medicare, which said last month it would only pay for the costly infusion drug for patients who participate in a clinical trial. UnitedHealthcare is the largest Medicare Advantage insurer in the country, covering 8 million people older than 65 and people with disabilities, making this policy particularly important for older Americans on those private plans.

The FEHBlog expects UHC’s announcement to be the tip of the eventual iceberg of similar Aduhelm coverage decisions.

Following up on previous stories mentioned in the FEHBlog, the Wall Street Journal reports

Online pharmacy company Truepill Inc. said it is temporarily halting prescriptions for Adderall and other controlled substances used to treat attention-deficit hyperactivity disorder, and partner Cerebral Inc. told its clinicians to direct those orders to patients’ local pharmacies.

Cerebral, an online mental-health company based in San Francisco that describes Truepill as its preferred pharmacy, informed its clinicians of Truepill’s decision in a Friday email viewed by The Wall Street Journal. The email said Truepill would no longer support mailing Schedule 2 controlled substances, including Adderall and Vyvanse, “to any of their customers.”

Truepill said that, “out of an abundance of caution,” it is temporarily pausing all fulfillment of Schedule 2 substances while it evaluates appropriate next steps. It said Schedule 2 substances such as Adderall make up less than 1% of its total prescription volume. Truepill didn’t provide a list of other partners affected by its decision.

Some of the nation’s largest pharmacies have blocked or delayed prescriptions over the past year from clinicians working for telehealth startups that have sprung up to treat ADHD, according to pharmacies and people familiar with the issue.

The Journal reported last week that pharmacies including Walmart Inc., CVS Health Corp. and Walgreens Boots Alliance Inc. have blocked or delayed prescriptions for companies treating ADHD online or have blocked individual prescribers, according to people familiar with the issue.

That was the right outcome as far as the FEHBlog is concerned.

In U.S. Supreme Court news, Business Insurance reports “Private plaintiffs cannot be reimbursed for emotional distress damages under the 1973 Rehabilitation Act and the Patient Protection and Affordable Care Act, the U.S. Supreme Court ruled” last Thursday in the linked opinion. The Affordable Care Act provision at issue is the ACA’s convoluted individual non-discrimination provision, Section 1557.

From the healthcare business front, Fierce Healthcare tells us

Outpatient volumes and revenue for hospitals and health systems showed a robust rebound in March as expenses eased due to fewer extremely sick patients, a new report said. 

Consulting firm Kaufman Hall released its latest hospital flash report Monday (PDF) detailing the impact of system finances for the month of March. A key takeaway from the report is that while actual hospital margins were negative for the third month in a row, outpatient revenues had a massive bump.

“While the road to recovery remains long for many hospitals, these trends indicate some pressures of the pandemic may be lifting,” said Erik Swanson, senior vice president of data and analytics with Kaufman Hall, in a statement. 

From the mental healthcare front,

Fierce Healthcare reports

Mental health concerns are on the rise across the board, and especially among Blacks, seniors, young adults and LGBTQIA people, a new survey finds.

CVS Health and Morning Consult polled more than 2,200 adults in early April and found that 59% of respondents have experienced challenges with their mental health or that of a friend or family member. That is a 9% increase over 2020 survey data.

More than half (57%) of people surveyed who identify as LGBTQIA expressed concern about their own mental health, 20 percentage points higher than other groups included in the study. Nearly three-quarters (74%) of those aged 18 to 34 said they experienced such concerns either themselves or for a friend or family member, up 12 percentage points from 2020.

The survey also found an 11 percentage point increase in mental health concerns among Black respondents compared to pre-COVID levels. A double-digit increase was also found among people over age 65; about 40% reported mental health concerns for themselves or family and friends, up 10 percentage points from 2020.

AHIP describes ten ways that people can get the mental healthcare services that they need.

Weekend update

Happy Law Day 2022!

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

From the Omicron and siblings front

The Wall Street Journal informs us

As new Omicron variants further infiltrate the U.S., a jumble of signals suggest the latest increase in Covid-19 infections hasn’t sparked a commensurate surge in severe illness even as risks remain.

Covid-19 virus levels detected in wastewater in the Northeast, the first region to see significant concentrations of the easily transmitted Omicron BA.2 variant, appear to have flattened out in the past two weeks. Covid-19 hospital admissions have risen in the region, but they remain far below levels during earlier surges that indicated widespread severe illness and taxed healthcare facilities. 

“This wave of Covid in the United States, in the places where it is, is not dangerous in a way that prior waves of Covid were,” said Megan Ranney, an emergency physician and academic dean at Brown University’s School of Public Health.

The fast-mutating virus still poses risks, she said. 

The new Fortune Well website offers timely guidance on the symptomatic differences between Covid and allergies.

Bloomberg Prognosis posted its late April Word Covid resilience rankings. Norway rides atop the rankings for the second month in a row The U.S. dropped six rankings to 30th. The article notes that the U.S. and the U.K are “weighed down by ongoing fatalities—their Covid Mortality Rate scores are among the worst of developed economies.

From the Affordable Care Act front, Health Affairs Forefront posted the ever-reliable Katie Keith’s first of three articles on the final 2023 ACA notice of benefit and payment parameters that was issued last week. This article’s section on Essential Health Benefits is relevant to FEHB carriers as each of them must select an EHB benchmark in order to apply the ACA’s restriction on annual dollar limits. The article’s section on Medical Loss Ratio is relevant to community-rated FEHB plans who generally use that benchmark to determine the reasonableness of their prices.

From the Rx coverage front, Medcity News reports “Bristol Myers Squibb drug Camzyos has received FDA approval for treating obstructive hypertrophic cardiomyopathy, a rare and potentially fatal heart disorder. The drug is projected to become a blockbuster seller, and its approval marks a payoff for BMS’s 2020 acquisition of the medicine’s developer, MyoKardia.”

From the telehealth front, mHealth Intelligence informs us

A majority of clinics (79 percent) used telemedicine to provide contraceptive services during the COVID-19 pandemic, according to a recent study published in the journal Reproductive Health.

For the study, researchers surveyed 907 US providers and clinic staff between April 10, 2020, and Jan. 29, 2021. They collected data on contraceptive service delivery challenges and strategies, including telehealth. The sample of respondents included physicians (17 percent), advanced practice clinicians (41 percent), registered nurses (16 percent), and health educators and social workers (11 percent).

The respondents practiced in a wide array of care settings, including youth clinics/school-based health centers or college health centers (36 percent), primary care clinics or health departments (29 percent), family planning clinics (22 percent), and independent abortion care clinics (4 percent). They saw, on average, 3,184 contraceptive patients annually.

Though only 11 percent of the clinics offered telemedicine for contraceptive services before the pandemic, this figure shot up to 79 percent after March 2020.

Friday Stats and More

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’s weekly charts of new Covid cases and deaths from the 27th week of 2021 through the 17th week of 2022:

In addition, here’s the CDC’s Chart of Daily Trends in the Number of New COVID-19 Hospital Admissions in the United States:

Can you say endemic?

Below you will find the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era in December 2020 to the current week 17.

The CDC’s Covid Data Tracker Weekly Review points out, “This week, the U.S. COVID-19 Vaccination Program marks two milestones: 500 days since the first COVID-19 vaccine was approved for use in the United States, and 100 million first booster doses administered.”

In the New York Times, David Leonhardt reports that the FDA is waiting to receive additional data from Pfizer and Modera [likely next month] to support their emergency use authorizations for Covid vaccines for children between six months and five years. Although the FDA’s preference is to give EUAs to both vaccines simultaneously to provide parents a choice, the agency will not delay a EUA decision on one or the other unnecessarily.

The CDC’s weekly review adds,

Currently, there are 54 (1.68%) counties, districts, or territories with a high COVID-19 Community Level, 256 (7.95%) counties with a medium Community Level, and 2,910 (90.37%) counties with a low Community Level. This represents a slight (0.59%) increase in the number of high-level counties, a small (+1.43%) increase in the number of medium-level counties, and a corresponding (−2.02%) decrease in the number of low-level counties. Seventeen (30.36%) of 56 jurisdictions had no high- or medium-level counties this week.

To check your COVID-19 community level, visit COVID Data Tracker.

From the health savings account front, the Society for Human Resource Management reports

Health savings account (HSA) contribution limits for 2023 are going up significantly in response to the recent inflation surge, the IRS announced April 29, giving employers that sponsor high-deductible health plans (HDHPs) plenty of time to prepare for open enrollment season later this year.

The annual inflation-adjusted limit on HSA contributions for self-only coverage will be $3,850, up from $3,650 in 2022. The HSA contribution limit for family coverage will be $7,750, up from $7,300. The adjustments represent approximately a 5.5 percent increase over 2022 contribution limits, whereas these limits rose by about 1.4 percent between 2021 and 2022.

In Revenue Procedure 2022-24, the IRS confirmed HSA contribution limits effective for calendar year 2023, along with minimum deductible and maximum out-of-pocket expenses for the HDHPs with which HSAs are paired.

Here is that 2023 deductible and OOP max information:

For calendar year 2023, a “high deductible health plan” is defined under § 223(c)(2)(A) as a health plan with an annual deductible that is not less than $1,500 for self-only coverage or $3,000 for family coverage [Self-only: +$100 Family: +200 from 2022], and for which the annual out-of-pocket expenses (deductibles, co-payments, and other amounts, but not premiums) do not exceed $7,500 for self-only coverage or $15,000 for family coverage [Self-only: +$450 Family: +$900 from 2022].

From the Medicare Part D front, Fierce Healthcare reports

CMS is giving Part D plans a little extra time to prepare to funnel price concessions to the member at the point of sale.

The Centers for Medicare & Medicaid Services on Friday finalized a rule with the price concession changes as well as a slew of updates for Medicare Advantage plans.

The agency said in a fact sheet on the regulation that beginning Jan. 1, 2024, it will define the negotiated price for a drug in Part D as the baseline, or lowest possible, payment to a pharmacy to ensure that price concessions are felt at the point of sale by beneficiaries.

“This policy reduces beneficiary out-of-pocket costs and improves price transparency and market competition in the Part D program,” CMS said.

The bell for prescription drug rebates is beginning to toll.

From the healthcare business front, Healthcare Dive tells us

Molina Healthcare in the first quarter recorded its highest COVID-19 costs since the start of the pandemic, CEO Joe Zubretsky said Thursday.

However, those costs were almost entirely offset by members cutting back on healthcare visits, a common trend throughout the pandemic, he said on a call with investors.

After costs peaked in January, they quickly declined in the subsequent months. “When I say [COVID-19 costs] subsided during the quarter, it did so dramatically,” Zubretsky added.   

HR Morning discusses a recent Willis Towers Watson survey on how employers are dealing with rising health care costs. To make healthcare more affordable for employees.

Fifty-five percent said their plan is to improve quality and outcomes to lower overall cost. Adding or enhancing low- or no-cost coverage for specific benefits is the plan for 41%. And 32% will be making changes to employees’ out-of-pocket costs, while 21% said they’ll alter their health plan payroll contributions.

From the preventive services front, the U.S. Preventive Services Task Force made a final grade D recommendation against initiating low-dose aspirin use for the primary prevention of CVD in adults 60 years or older. “For adults aged 40 to 59 years with an estimated 10% or greater 10-year cardiovascular disease (CVD) risk:  The decision to initiate low-dose aspirin use for the primary prevention of CVD in this group should be an individual one.” This is a Grade C recommendation.