Monday Roundup

Monday Roundup

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From the COVID-19 vaccine front

  • The New York Times reports that “The Food and Drug Administration warned on Monday that Johnson & Johnson’s coronavirus vaccine can lead to an increased risk of a rare neurological condition known as Guillain–Barré syndromeanother setback for a [one dose] vaccine that has largely been sidelined in the United States. Although regulators have found that the chances of developing the condition are low, they appear to be three to five times higher among recipients of the Johnson & Johnson vaccine than among the general population in the United States, according to people familiar with the decision. The warning was attached to fact sheets about the vaccine for providers and patients.”
  • USA Today offers a success story on AHIP’s Vaccine Community Connectors program. “Most important, this effort helped the industry home in on one specific strategy to accelerate health equity: better access to health care data that incorporates the social determinants of health.” Speaking SDOH data, Health IT Analytics informs us about the use of SDOH data in researching and managing Alzheimer’s Disease.
  • The American Hospital Association reminded folks today to keep its Vaccine Communications Resources website in mind.

Fierce Healthcare reports that

“The Biden administration has started to investigate whether Medicare should cover the extremely pricey Alzheimer’s drug aducanumab. The Centers for Medicare & Medicaid Services announced Monday it is opening a National Coverage Determination (NCD) analysis on the drug that will cost patients $56,000 a year. Advocates and experts have called for the agency to move quickly to decide whether to cover the drug. “We want to consider Medicare coverage of new treatments very carefully in light of the evidence available,” said CMS Administrator Chiquita Brooks-LaSure, in a statement Monday. “That’s why our process will include opportunities to hear from many stakeholders.”

Earlier press reports on Aduhelm, as well as common sense, indicate that commercial health plans likely will follow CMS’s lead on coverage of that drug.

Healthcare Dive tells us that “Telehealth use overall has stabilized at levels 38 times higher than before the COVID-19 pandemic, ranging from 13% to 17% of visits across all specialties, according to new data from McKinsey released roughly a year since the first major spike in COVID-19 cases.” * * * On the provider side, 58% of physicians continue to view virtual care more favorably than before the pandemic, though that’s down slightly from September, when 64% of physicians were in support. As of April this year, 84% of doctors were offering telehealth, and 57% said they’d prefer to continue offering it. However, that’s largely dependent on reimbursement: 54% of doctors said they wouldn’t provide virtual care if it was paid at a 15% discount to physical services.”

HR Dive discusses the President’s July 9 executive order provision “taking aim at” non-compete agreements.

Biden’s order leaves some questions unanswered. It does not ban or impact any existing employment agreement, Chris Marquardt, partner at Alston & Bird, told HR Dive in an email. “Employers will need to wait and see what the Federal Trade Commission does in response to the Executive Order before thinking about its potential impact,” he said.

Among other reasons, intellectual property and trade secrets have been cited as cause for use of non-competes. But the agreements have been the subject of criticism for potentially driving down wages in certain industries and geographic areas.

Govexec.com offers an interesting take on how the July 9 executive order seeks to use Federal procurement and regulations to promote competition 

Midweek Update

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In news from our Nation’s capital

  • Yesterday the House Appropriations Committee approved for House floor consideration the Fiscal Year 2022 Financial Services and General Government appropriations bill which includes OPM and FEHB Program funding. The vote was 33-24. Govexec adds that the Committee action “endorses President Biden’s proposal to give civilian federal employees an average 2.7% pay raise in 2022, despite efforts by some Democrats to provide a bigger increase.”
  • Amy Howe informs us that tomorrow will be the last day of the U.S. Supreme Court’s October 2020 term and the two remaining decisions are politically significant.
  • The Society for Human Resource Management reports that ​”The Equal Employment Opportunity Commission (EEOC) has extended the deadline for filing the EEO-1 form from July 19 to Aug. 23. Businesses with 100 or more employees and some federal contractors with at least 50 employees must submit an annual EEO-1 form, which asks for information from the previous year about the number of employees who worked for the business, sorted by job category, race, ethnicity and gender. The EEOC did not collect such data in 2020 due to the coronavirus crisis. Covered employers now have until the new deadline to submit both their 2019 and 2020 data.”
  • The Office of Management and Budget’s Office of Information and Regulatory Affairs has completed its work on HHS’s first interim final rule on implementing the No Surprises Act. Next step will be the Federal Register’s public inspection list.

From the COVID-19 front

  • The Centers for Disease Control has improved its COVID-19 data tracker website. Check out this fascinating new chart on the value of the COVID-19 vaccines.
  • The Wall Street Journal reports that “People who became infected with Covid-19 after getting a messenger RNA vaccine [Pfizer or Moderna] carried less virus and had shorter cases than unvaccinated people who became infected, a study by government health researchers found. * * * “Even when people get vaccinated and did get infected, they were less likely to have an illness that causes a fever,” said Mark Thompson, an epidemiologist at the U.S. Centers for Disease Control and Prevention who helped lead the study.”
  • The American Hospital Association informs us that “The Moderna COVID-19 vaccine produces neutralizing antibody titers against the Delta variant, although fewer than against the ancestral strain of the virus, the company announced yesterday. * * * “These new data are encouraging and reinforce our belief that the Moderna COVID-19 Vaccine should remain protective against newly detected variants,” said CEO Stéphane Bancel.

From the Aduhelm front, STAT News tells us that
A majority of U.S. physicians disagree with the Food and Drug Administration’s approval of the Alzheimer’s drug from Biogen (BIIB) and believe the medicine should not be routinely used, according to a new survey from STAT and Medscape. Nearly two-thirds of the 200 primary care physicians and neurologists polled find the trial data unclear when it comes to benefits and risks of the drug. Consequently, only a small minority of these doctors think the medicine should be given to patients with early-onset Alzheimer’s.

The controversial new Alzheimer’s drug would only be cost effective if priced between $3,000 and $8,400, an 85% to 95% discount off the $56,000 list price, due to “insufficient” evidence the drug benefits patients, STAT says, citing a revised analysis. The assessment by the Institute for Clinical and Economic Review is very similar to an evaluation issued a month ago, before the FDA approved the medicine and issued a broad label. But Biogen has pledged to promote the drug only to a more specific patient population and the FDA is requiring fewer costly MRI scans to monitor patient safety.

With regard to the physician survey and with all due respect to that fine profession, the FEHBlog expects that the “If you build it they will come” principle could apply to Aduhelm.

In other healthcare news

  • Barron’s reports that “The nation’s largest retailer is now selling the first private-label insulin at prices more than 50% lower than brand names of the diabetes drug, which can cost thousands of dollars a year. Walmart pharmacies began filling prescriptions this week for the discount chain’s ReliOn NovoLog brand of insulin in vials and injector pens. The drug, made by major supplier Novo Nordisk (NVO), will be available by mid-July at the company’s Sam’s Club wholesale stores. “We know many people with diabetes struggle to manage the financial burden of this condition, and we are focused on helping by providing affordable solutions,” Cheryl Pegus, executive vice president of Walmart Health & Wellness, announced Tuesday.” 
  • Medscape informs us that “Families with private health insurance pay around $3,000 for newborn delivery and hospitalization, while adding neonatal intensive care can push the bill closer to $5,000, based on a retrospective look at almost 400,000 episodes. The findings suggest that privately insured families need prenatal financial counseling, as well as screening for financial hardship after delivery, reported lead author Kao-Ping Chua, MD, PhD, assistant professor and health policy researcher in the department of pediatrics and the Susan B. Meister Child Health Evaluation and Research Center at the University of Michigan, Ann Arbor, and colleagues. “Concern is growing regarding the high and rising financial burden of childbirth for privately insured families,” the investigators wrote in Pediatrics.”  Health plans may want to take a gander at their own members out of pocket spending on maternity care.
  • Employee Benefit News inquires whether a “subscription model can fix primary care.” The subscription model is offered by direct primary care companies like One Medical. According to the EBN article,

The appeal of these companies has grown as employers increasingly seek to address a shortage of high-quality primary care and reduce spending on the health of their workforce, said Ellen Kelsay, CEO and president of the Business Group on Health, which represents large employers.

Studies show a strong correlation between access to primary care and lower spending on expensive medical services such as ER visits, surgeries and hospital admissions. Yet in the United States, primary care accounts for only around 5% to 7% of total health spending, compared with 14% in the 36 member nations of the Organization for Economic Cooperation and Development.

The big bet of One Medical and companies like it is that greater spending on primary care will fatten their bottom lines while reducing overall health costs for their clients. [One Medical works with health plans as well as self-funded employers and patients.]

Midweek Update

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The Senate took no action on Kiran Ahuja’s nomination to be OPM Director today as Senators Booker and Peters remain out of pocket due to family illnesses.

On the hospital front —

  • The Advisory Board informs us about U.S. News and World Reports most recent rankings of children’s hospitals.
  • Axios reports that “Some of the hospitals with the highest revenue in the country also have some of the highest prices, charging an average of 10 times more than the actual cost of the care they deliver, according to new research by Johns Hopkins University provided exclusively to Axios.”

On the mental healthcare front, we have two articles on start- up companies from Katie Jennings in Forbes. One concerns Burlingame, Calif.-based Lyra Health and the other concerns “Lifestance Health Group, one of the nation’s largest outpatient mental health providers.” Check them out.

On the prescription drug front —

  • Healthcare Dive reports that “Anthem, one of the biggest U.S. payers, has joined an initiative to create low-cost generic drugs for hospital and retail pharmacies. The initiative CivicaScript, a subsidiary of hospital-owned nonprofit drugmaker Civica Rx, plans to initially develop and manufacture six to 10 common but pricey generic medicines that don’t have enough market competition to drive down cost, officials said Wednesday. The first generics could be available as early as 2022.”
  • Fierce Pharma informs us that “Antibody treatments have shown little success in helping COVID-19 patients with  severe disease. But a large [UK] study of hospitalized patients reveals that Regeneron’s antibody cocktail can reduce the chance of death in patients who haven’t produced their own antibody responses to the disease.”
  • STAT News interviews the Alzheimer Association’s CEO about the newly approved drug Aduhelm.

In miscellaneous news

  • The Wall Street Journal reportsApple Inc. Chief Executive Tim Cook has said the company’s greatest contribution to mankind will be in health. So far, some Apple initiatives aimed at broadly disrupting the healthcare sector have struggled to gain traction, according to people familiar with them and documents reviewed by The Wall Street Journal.”
  • Healthcare Dive tells us that “A University of Pennsylvania study that tracked Medicare claims for about 1.35 million beneficiaries who had joint replacement surgery found that hospitals participating in bundled payment programs spent less on the hip and knee joint procedures than hospitals receiving traditional fee-for-service payments. Spending, however, did not differ between hospitals that voluntarily joined bundling programs and those whose involvement was mandatory, according to the findings, which were published in a JAMA research letter. The results failed to validate assumptions that voluntary participants tend to achieve greater savings because they choose programs for the opportunity to reduce spending. The findings come as the head of the Center for Medicare and Medicaid Innovation, Elizabeth Fowler, suggested the agency would look to shift away from voluntary arrangements in favor of more mandatory models.”
  • Fierce Healthcare informs us that “The Centers for Disease Control and Prevention (CDC) released new interim guidance late Monday for healthcare providers treating patients with post-COVID conditions—an umbrella term the agency is using to capture a wide range of physical and mental health issues that sometimes persist four or more weeks after an individual’s COVID-19 infection. Sometimes referred to as “long COVID,” the conditions can present among COVID-19 patients regardless of whether they were symptomatic during their acute infection, the agency wrote in the guidance.”

Tuesday’s Tidbits

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Govexec reports that “the Senate voted 81-13 on Tuesday to confirm Jason Miller to be deputy director for management for the Office of Management and Budget. Miller is a former Obama administration economic adviser and most recently a nonresident senior fellow at the Brookings Institution and CEO of the Greater Washington Partnership, a nonprofit civic alliance.”

Julie Appleby of Kaiser Health News writes on the gradual rollback of COVID-19 treatment coverage with no member cost sharing in 2021.

Anthem, for example, stopped them at the end of January. UnitedHealth, another of the nation’s largest insurers, began rolling back waivers in the fall, finishing up by the end of March. Deductible-free inpatient treatment for covid through Aetna expired Feb. 28.

A few insurers continue to forgo patient cost-sharing in some types of policies. Humana, for example, has left the cost-sharing waiver in place for Medicare Advantage members, but dropped it on Jan. 1 for those in job-based group plans.

Not all are making the changes.

For example, Premera Blue Cross in Washington and Sharp Health Plan in California have extended treatment cost waivers through June. Kaiser Permanente said it is keeping its program in place for members diagnosed with covid and has not set an end date. Meanwhile, UPMC in Pittsburgh planned to continue to waive all copayments and deductibles for in-network treatment through April 20.

 Healthcare Dive reports

U.S. hospitals continue to struggle under the ongoing weight of the pandemic and its financial pressure, reporting a mixed performance in March, according to a new report from Kaufman Hall.

Volumes continued to decline, while revenues and expenses generally rose compared to the same time last year. Margins increased on both a year-to-date and year-over-year basis, but that’s largely due to measuring performance this year with last March, when hospitals were hit hard by the effects of state lockdowns and a pause in non-essential procedures, the consultancy said.

Researchers expect continued margin and revenue gains in the next few months, especially in comparison to record-poor performance in the first few months last year. Some gains are due to returning patient volumes, but the report warns the impacts of COVID-19 on providers are far from over.

Here is a link to today’s Centers for Disease Control’s “Interim Public Health Recommendations for Fully Vaccinated People.” The AP reports that “Some experts portrayed the relaxed guidance as a reward and a motivator for more people to get vaccinated — a message President Joe Biden sounded, too.” The FEHBlog honestly see the new guidance as too complicated and he will maintain his current mask wearing practices for a couple more months.

From the government contracting front

  • Here is a link to the President’s executive order raising the minimum wage on federal contracts for services and construction to $15 per hour. FEHB contracts do not fall into these classifications in the FEHBlog’s opinion.
  • The Equal Employment Opportunity Commission is revving up the EEO-1 reporting process. “The EEO-1 Component 1 report is a mandatory annual data collection that requires all private sector employers with 100 or more employees, and federal contractors with 50 or more employees meeting certain criteria, to submit demographic workforce data, including data by race/ethnicity, sex and job categories. * * * After delaying the opening of the 2019 EEO-1 Component 1 data collection because of the COVID-19 public health emergency, the EEOC has announced that the 2019 and 2020 EEO-1 Component 1 data collection is NOW OPEN.  Eligible employers have until Monday, July 19, 2021 to submit two years of data.”