Tuesday’s Tidbits

Rx coverage

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID treatment, COVID-19, Federal employment benefits, OPM, Rx coverage, Telehealth–
Photo by Patrick Fore on Unsplash

From Capitol Hill, we learn that “U.S. Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) today introduced their highly anticipated, bipartisan Cures 2.0 legislation that some leading health care organizations are calling a potential “game changer” in how the U.S. conducts biomedical research going forward.” Here’s a link\ to a Fierce Healthcare article on the bill.

From the Food and Drug Administration front —

  • The Wall Street Journal reports that “Pfizer said it asked U.S. health regulators to authorize its oral Covid-19 drug for use in high-risk patients, putting the pill on a path that could make it available for people to take at home by the end of the year.  Clearance from the U.S. Food and Drug Administration would give patients and doctors an easy-to-use treatment to keep people out of the hospital early in the course of the disease.” Moreover, “Pfizer Inc. is licensing its experimental Covid-19 antiviral to a global health organization in an effort to make the pill more readily available to people in low- and middle-income countries. Under the licensing agreement, the United Nations-backed Medicines Patent Pool will work with other drugmakers to manufacture the pill for use in 95 countries, including in sub-Saharan Africa, Pfizer and the nonprofit said Tuesday.”
  • The agency announced that authorizing “marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioral therapy and other behavioral methods to help with pain reduction in patients 18 years of age and older with diagnosed chronic lower back pain. “Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life,” said Christopher M. Loftus, M.D., acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “Pain reduction is a crucial component of living with chronic lower back pain. Today’s authorization offers a treatment option for pain reduction that does not include opioid pain medications when used alongside other treatment methods for chronic lower back pain.”

From the Delta variant vaccine mandate front, Reason informs us that

The ping-pong ball has been drawn, and the U.S. Court of Appeals for the Sixth Circuit is the winner. All of the various state, industry, and union challenges to the Occupational Safety and Health Administration’s Emergency Temporary Standard (ETS) mandating large employers to require vaccination or regular testing and masking of employees will be consolidated into a single proceeding in the Sixth Circuit.

Given that challenges had been filed in all twelve regional circuits, and there are over three-dozen parties, this will be one bear of a case. Red states and employer groups initially filed in the more conservative circuits, including the Fifth Circuit which issued a stay on Friday, arguing that OSHA’s action was unlawful. Blue states and progressive groups responded by filing challenges in more liberal circuits, alleging that OSHA’s ETS is too lax. Each side was trying to increase the chances that the case would be consolidated on favorable turf by increasing the number of favorable circuits in the lottery draw.

Today the Labor Department referred the case to the Joint Panel on Multidistrict Litigation which conducted the lottery. The Sixth Circuit’s case presenting the legality of the OSHA ETS is Kentucky v. OSHA, No 21-4031. Bloomberg adds that “Although the Fifth Circuit temporarily halted the rule before the case was transferred, the Sixth Circuit will have the authority to modify or lift that order.” The case ultimately is expected to be resolved at the Supreme Court.

From the Centers for Disease Control front

  • The CDC’s National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) has created a website full of “the links to access select information from NCCDPHP on health equity and racial/ethnic disparities.”
  • The CDC also has made available a pre-diabetes risk test for consumer use along with suggestions on how to deal with this condition.

From the federal employee benefits front, Federal News Network informs us

Some same-sex spouses of deceased federal employees and retirees will have another shot at earning survivor benefits from the federal government, the Office of Personnel Management announced this week.

A new notice, scheduled for publication in the Federal Register Wednesday, describes how widows or widowers who meet a specific set of criteria can apply for federal survivor benefits that they were previously ineligible for or, in some cases, denied.

OPM also has created an online “support center” for federal retirees. Check it out.

From the prescription drug pricing front, Healthcare Dive tells us that

Price hikes taken last year by AbbVie on its anti-inflammatory drug Humira increased U.S. healthcare spending by $1.4 billion, an amount unsupported by evidence showing any new health benefits, the Institute for Clinical and Economic Review said in a new report.

Humira, which treats rheumatoid arthritis and other diseases, was one of nine high-cost drugs singled out by ICER for large price increases without corresponding data proving greater effectiveness or new clinical uses.

Humira’s net price rose 9.6% in 2020, the watchdog group said in its report. The increase in net price, which reflects what insurers pay after rebates, actually exceeded AbbVie’s hike to the drug’s list price, a reversal of what usually happens during negotiations with drugmakers.

STAT news adds that

The findings, which appear amid ongoing national turmoil over the cost of prescription drugs, mark the third time that ICER has attempted to identify price hikes on big-selling drugs for which no new clinical evidence was offered. The exercise has underscored a debate over the value of medicines and the extent to which price hikes occur beyond medical inflation, even after rebates are counted.

At the same time, however, ICER also noted that overall net prices for prescription drugs in the U.S. market declined in the past several years, and even wholesale price increases have not exceeded the broader inflation rate. This helped restrain health insurance premiums, which benefited patients, although not necessarily in relation to specific medications.

Finally an intriguing telehealth tidbit from mHealth Intelligence

The number of outpatient visits after hospital discharges remained stable during the COVID-19 pandemic but telehealth use for these visits increased, suggesting that telehealth was a substitute for in-person care rather than an addition, a study published in JAMA Health Forum revealed.

Monday Roundup

David Ermer–CDC, Congress, COVID-19, Medicare, Rx coverage–
Photo by Sven Read on Unsplash

From the Capitol Hill front, Roll Call reports that an extension of the continuing resolution currently funding the federal government appears to be on tap.

Senate Democrats and Republicans are eyeing a two- to three-month continuing resolution that would punt final decisions on fiscal 2022 appropriations into February or March, according to sources familiar with the talks.

That decision, if blessed by House Democrats and the Biden administration, would decouple a complicated omnibus spending bill covering every federal agency from thorny negotiations over budget reconciliation and the debt limit.

But it wasn’t yet clear Democrats across the Capitol were unified behind that strategy, with some pushing a much shorter stopgap measure running for two weeks, to Dec. 17. That would keep the pressure on for a spending deal before the winter holiday season and allow lawmakers to clear the decks for next year’s agenda.

Another possibility is lawmakers try out a stopgap bill to Dec. 17, see how much progress is possible, and then pass another CR, this time through the end of February or March.

From the Delta variant vaccine mandate front —

  • It’s worth noting that the Federal Acquisition Regulation Council is expected to consider a draft proposed rule implementing the mandate for federal government contractors this coming Wednesday November 17.
  • With regard to OSHA’s large business mandate, the Society for Human Resource Management tells us that “

OSHA stated that it “has suspended activities related to the implementation and enforcement of the ETS pending future developments in the litigation,” although it “remains confident in its authority to protect workers in emergencies.” OSHA noted that the court ordered it to take no steps to implement or enforce the ETS until further court order.

“OSHA’s course of action should give some comfort to employers taking a wait-and-see approach,” said Kyle Johnson, an attorney with Frost Brown Todd in Louisville, Ky., Jeff Shoskin, an attorney with Frost Brown Todd in Cincinnati, and Catherine Burgett and Anne Duprey, attorneys with Frost Brown Todd in Columbus, Ohio, in a firm legal update. “Because the future of the order is uncertain, employers should keep apprised of the status of the legal challenges ahead and have a plan to comply with the ETS should the order be modified or dissolved.” 

The Centers for Disease Control reminds us that Antibiotic Awareness Week begins this Thursday November 18. “USAAW is an annual observance that raises awareness of the threat of antibiotic resistance and the importance of appropriate antibiotic use.”

Following up on the large increase in Medicare Part B premiums for 2022, Healthcare Dive informs us that “CMS said the hike is mostly due to potential use of Biogen’s Aduhelm, a drug for Alzheimer’s disease that’s drawn criticism for carrying a high price tag despite unclear effectiveness, along with ongoing uncertainty from the coronavirus pandemic.” That’s puzzling as the Biogen drug has been a colossal sales flop. What’s more, STAT News broke the news tonight that

Al Sandrock, Biogen’s top scientist and the face of its years-long campaign to develop a treatment for Alzheimer’s disease, is leaving the company after more than two decades, STAT has learned.

The surprise departure of Sandrock, who oversees all of Biogen’s research and development, leaves a void in the company’s upper ranks. And it comes as Biogen is facing a worsening business outlook, saddled with a string of setbacks to its research pipeline and forced to defend its scientific integrity after the approval of the polarizing Alzheimer’s treatment Aduhelm.

STAT News also offers an interesting story about the two anti-viral drugs that could become Flonase for COVID. For example,

At the headline level, Pfizer’s pill reduced the risk of hospitalization and death by 89%,while Merck showed a reduction of 50%. But neither firm has disclosed detailed data from its pivotal studies, and the trials were not identically designed.

The studies enrolled similar populations — unvaccinated people with mild to moderate Covid-19 and at least one risk factor for severe disease — but they had slightly different measures of efficacy. Pfizer’s 89% figure comes from patients who started getting its pill, Paxlovid, within three days of their first Covid-19 symptoms. Merck’s 50% applies to patients who began treatment within five days. In the Paxlovid study, patients who started treatment within five days saw an 85% improvement in hospitalization or death versus placebo. Merck has not shared data on patients who got its drug within three days of symptom onset.

We will have to keep our fingers crossed while the Food and Drug Administration considers granting these drugs emergency use authorization.

Monday Roundup

David Ermer–COVID-19, COVID-19 testing, Federal employment benefits, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the FEHB Open Season front, consultant Tammy Flanagan reports on the new trend of FEHB plans to offer Medicare Part B premium reimbursement contingent upon joining a related Medicare Advantage plan.

From the Delta variant front, the American Hospital Association informs us that

The Food and Drug Administration Friday authorized another over-the-counter COVID-19 diagnostic test for emergency use. The iHealth COVID-19 Antigen Rapid Test delivers results in 15 minutes. The company anticipates producing 100 million tests per month, with capacity increasing to 200 million per month in early 2022, FDA said.

STAT News offers an interesting snapshot of the now diminishing Delta variant surge.

Chart comparing hospitalizations by vaccine status

The chart truly speaks for itself.

In the maternal health field, the Health and Human Services Department announced that “200+ hospitals that are participating in the HHS Perinatal Improvement Collaborative, a contract with Premier, Inc. This new network is focused on improving maternal and infant health outcomes by reducing disparities. Comprised of hospitals from all 50 states, the collaborative is the first to evaluate how pregnancy affects overall population health by linking inpatient data of newborns to their mothers.” A list of the participating hospitals may be found at the bottom of the HHS press release.

From the Rx coverage front, STAT News tells us

Nearly a dozen of the highest-rated hospitals in the U.S. charged commercial health insurers and cash-paying patients significantly more than what Medicare has recently paid for 10 infused medicines on which the government spends the most money, according to a new analysis.

Median prices exceeded the Medicare Part B payment limit by a low of 169% at Rush University Medical Center in Chicago, while the Mayo Clinic Hospital in Phoenix exceeded the payment limit by 344%. Among cash-paying customers, the prices ranged from 149% of the Medicare payment limit at Rush to 306% at Brigham and Women’s Hospital and Massachusetts General Hospital, both based in Boston.

The Part B infused medicines for which Medicare Part B spent the most money were Rituxan, Orencia, Enbrel, Prolia, Eylea, Opdivdo, Keytruda, Avastin, Lucentis, Neulasta, and Remicade, but the list did not include biosimilar versions. These medications are variously used to treat conditions including cancer, rheumatoid arthritis, and macular degeneration.

Medicare Part B already sets Part B drug prices which tend to be injectables administered at facilities. Democrat legislators in Congress also want Medicare Part D to fix prices for certain drugs distributed by pharmacies. Government price fixing has never worked successfully in the American economy in the FEHBlog’s understanding.

Also from the healthcare pricing front, Health Payer Intelligence informs

Outcomes-based contracts continue to be popular for certain therapies as healthcare costs mount, an Avalere study found.

Avalere’s findings draw on survey responses from 51 insurers and pharmacy benefit managers. Altogether, the survey participants cover approximately 59 million members. The survey was fielded from September 27 to October 8, 2021 and it is Avalere’s fifth annual survey on the subject.

“OBCs typically include an agreement between health plans and drug or device manufacturers that ties product reimbursement to specific clinical, quality, or utilization outcomes,” Avalere researchers explained.

Let’s go.

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Federal employment benefits, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From the Delta variant front —

  • The Wall Street Journal reports “Federal officials said they would do more to get over-the-counter Covid-19 tests to consumers, after some manufacturers have struggled to meet demand after the Delta surge drove increased demand from individuals, schools and businesses.” Better late, etc. Here’s a link to the HHS press release.
  • The Journal also reports that “Moderna Inc.’s MRNA 7.05% Covid-19 vaccine was generally safe and induced the desired immune responses in children ages 6 to 11 in a clinical trial, according to the company. The Cambridge, Mass., company said Monday that it would submit the results to health regulators in the U.S., Europe and elsewhere in seeking authorization to widen the use of its shots to include this younger age group. The company announced the interim data in a press release, and results haven’t yet been published in a peer-reviewed medical journal. * * * An FDA decision on the Pfizer vaccine in children [ages 5 to 11] could come soon, following an advisory panel meeting scheduled for Tuesday. 
  • The Centers for Disease Control informs us in a newly issued study on Delta variant cases

What is already known about this topic?

The SARS-CoV-2 B.1.617.2 (Delta) variant is highly transmissible; however, whether it causes more severe disease in adults has been uncertain.

What is added by this report?

Analysis of COVID-NET data from 14 states found no significant increases in the proportion of hospitalized COVID-19 patients with severe outcomes during the Delta period. The proportion of hospitalized unvaccinated COVID-19 patients aged 18–49 years significantly increased during the Delta period.

What are the implications for public health practice?

Lower vaccination coverage in adults aged 18–49 years likely contributed to the increase in hospitalized patients during the Delta period. COVID-19 vaccination is critical for all eligible adults, including adults aged <50 years who have relatively low vaccination rates compared with older adults.

From the COVID vaccine mandate front

  • The Equal Employment Opportunity Commission released new FAQ guidance on “Vaccinations – Title VII and Religious Objections to COVID-19 Vaccine Mandates.”
  • The Senate today confirmed the President’s nominee, Douglas Parker as Assistant Secretary of Labor in charge of the Occupational Health and Safety Administration by a 50 to 41 vote. Govexec adds that “Douglas Parker, most recently chief of California’s Division of Occupational Safety and Health, [will lead] the workplace safety agency that has about 1,800 employees. Parker previously served as deputy assistant secretary for policy in the Labor Department’s Mine Safety and Health Administration under the Obama administration and was part of the Biden transition team on worker health and safety issues.” OSHA is responsible for the pending vaccination screening program rule applicable to private sector employers with 100 or more employees.

On a related note, Federal News Network tell us that

The federal workforce used just slightly more than half of the funds Congress set aside earlier this year for a special emergency leave program.

The American Rescue Plan Act, which Congress passed into law in March, created a $570 million emergency paid leave fund that allowed federal employees to take time off for a variety of pandemic-related reasons.

Employees were each eligible for 600 hours, or 15 weeks, of paid leave to quarantine, recover from a personal infection or care for a family member sick with COVID-19. They could also use the emergency paid leave to recover from adverse symptoms after receiving the COVID-19 vaccine.

The Office of Personnel Management was responsible for administering the fund on behalf of the executive branch and U.S. Postal Service. OPM formally launched the program at the end of April.

Eligible federal employees had until Sept. 30 to request emergency paid leave, per the sunset date in the American Rescue Plan, or earlier if the funds were exhausted before that date.

From the cost and frequency of healthcare front —

  • The American Hospital Association issued a report about the cost of healthcare over the past decade / the first decade of the Affordable Care Act, particularly the cost of hospital care versus health insurance premiums.
  • Fierce Healthcare reports that “Common elective surgeries are starting to recover volume lost during COVID-19 lockdown measures, according to a new study by Epic Health Research Network. No common elective surgery is back at pre-pandemic volumes, though some are nearing it, the study found.”

From the Rx coverage front —

  • Healthcare Dive informs us that “National employer group the Purchaser Business Group on Health is starting a new company to develop healthcare products for large employers, frustrated by unmet need and rising costs. The venture, called Emsana Health, launched on Monday with its first business unit, a pharmacy benefit manager called EmsanaRx. Emsana will develop products designed with and for PBGH member organizations, which include Walmart, Costco, Microsoft, Intel and Tesla, among others, but products will be available to outside companies as well, a PBGH spokesperson confirmed.”
  • Fierce Healthcare adds that “The Mark Cuban Cost Plus Drug Company PBC also launched its own PBM this week, The Wall Street Journal reported. Cuban’s company aims to sell generic drugs at a transparent, fixed rate, and to achieve this united manufacturing, distribution and pharmacy services under one roof, according to the article. Cuban, a billionaire investor, told the WSJ he agreed to back the venture after receiving a pitch via email from its now-CEO, Alex Oshmyansky M.D., Ph.D. The PBM will begin to bid for clients next year and aims to be fully up and running by 2023, Oshmyansky told WSJ. “The supply chain for distributing pharmaceuticals to patients is so cumbersome and broken,” he told the outlet. “We decided the only way to get our drugs to the people who need them is to build a parallel supply chain where we have control of all the intermediary players and ensure the same level of transparency at every level.”
  • Health Payer Intelligence reports that “Prescription digital therapeutics (PDTs) coverage remains nascent, as the adoption rate is only at 40 percent among the minority of payers who have familiarity with PDTs, according to a survey that Avalere conducted for Pear Therapeutics. A post from the Institute for Patient Access defined PDTs most succinctly. ‘Prescription digital therapeutics are software programs that physicians prescribe as a form of treatment,’ the post explained. ‘The software captures patients’ information about symptoms or progress that can then be shared or remotely accessed by their providers. The technology has been found to help patients adhere to their treatment plans.’”

From the FEHB Open Season front, OPM today released a spreadsheet identifying those FEHB plans for which the 2022 employee contribution for self and one coverage will be more than the 2022 employee contribution for self and family coverage. In all cases the total premium for self and family coverage is more the total premium for self plus one coverage. The employee contributions become upside down due to the vagaries of the government contribution formula. It was a Congressional mistake to add the self plus one tier to FEHB given the relatively small family size in FEHB plans.

Midweek update

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

From the Delta variant front —

The Boston Globe informs us that

U.S. regulators on Wednesday signed off on extending COVID-19 boosters to Americans who got the Moderna or Johnson & Johnson vaccine and said anyone eligible for an extra dose can get a brand different from the one they received initially. * * *

Specifically, the FDA authorized a third Moderna shot for seniors and others at high risk from COVID-19 because of their health problems, jobs or living conditions — six months after their last shot. One big change: Moderna’s booster will be half the dose that’s used for the first two shots, based on company data showing that was plenty to rev up immunity again.

For J&J’s single-shot vaccine, the FDA said all U.S. recipients, no matter their age, could get a second dose at least two months following their initial vaccination.

The FDA rulings differ because the vaccines are made differently, with different dosing schedules — and the J&J vaccine has consistently shown a lower level of effectiveness than either of the two-shot Moderna and Pfizer vaccines.

As for mixing and matching, the FDA said it’s OK to use any brand for the booster regardless of which vaccination people got first. The interchangeability of the shots is expected to speed the booster campaign, particularly in nursing homes and other institutional settings where residents have received different shots over time. * * *

The Food and Drug Administration’s decisions mark a big step toward expanding the U.S. booster campaign, which began with extra doses of the Pfizer vaccine last month. But before more people roll up their sleeves, the Centers for Disease Control and Prevention will consult an expert panel Thursday before finalizing official recommendations for who should get boosters and when.

The Wall Street Journal adds that

A panel of outside experts at the FDA is scheduled to review the data [on Pfizer’s modified COVID mRNA vaccine for children ages 5 to 11] Tuesday. Although the agency doesn’t have to follow the group’s recommendation, it typically does. The CDC’s independent advisory committee will meet on Nov. 2-3 to consider the vaccine. 

The White House said the administration has been coordinating with state and local leaders on plans to distribute the vaccines. If authorized, young children would receive two injections of the vaccine, three weeks apart, just like adolescents and adults do but at a lower dosage.

Mr. Zients said the doses will be shipped with all the supplies necessary to administer the shots, including smaller needles. The vaccines will also be shipped in smaller packages containing about 100 doses each, the White House said, and can be stored for up to 10 weeks at standard refrigeration temperatures and for 6 months at ultracold temperatures. * * *

[Furthermore,] the Biden administration is preparing to distribute shots to children at doctors’ offices, pharmacies and schools should federal regulators clear the inoculations for kids ages 5-11.

Also, Govexec reminds us that the Veterans Administration is acting as the guinea pig agency for the President’s vaccine mandate for federal employees. The VA initiated a mandate program while the President was still in the vaccination screening program stage so its discipline deadlines are occurring earlier.

The Veterans Affairs Department has begun disciplining employees who have not proven that they are vaccinated against COVID-19, sending an untold number into counseling following a deadline to turn over their documentation. 

Just 70% of the 380,000 employees at the Veterans Health Administration met the Oct. 18 deadline to show proof of vaccination, VA Secretary Denis McDonough said on Wednesday, leaving 114,000 workers who have yet to do so. VA previously reported that 88% of their health care workforce had said they were vaccinated, but that was based on data from self-reported “attestation forms.” Under stricter guidance the Biden administration has rolled out, VA employees must now submit paperwork to actually demonstrate that they have been inoculated.

From the third quarter financial results department —

Healthcare Dive reports that

  • Anthem’s medical costs during the third quarter beat Wall Street expectations despite the wave of COVID-19 hospitalizations and cases that were fueled by the delta variant during the quarter. The medical cost results are likely to ease investor fears, SVB Leerink analysts said in a Wednesday note.
  • On top of that, Anthem increased medical membership by nearly 6% over the prior-year quarter, ending the period with 45.1 million members. The largest membership gains were recorded in its government book of business, a continuing trend throughout the pandemic.
  • Anthem generated a $1.5 billion profit for the third quarter, a dramatic leap from the prior-year period when net income was $222 million. The payer again hiked its outlook for the remainder of the year on the results released Wednesday.

STAT News tells us that

Biogen made just $300,000 from the Alzheimer’s disease treatment Aduhelm in the first full quarter since its approval, a number far below Wall Street’s expectations and the company’s internal goals.

Aduhelm’s third-quarter sales, disclosed Wednesday, are nowhere near the roughly $14 million analyst consensus estimate, calculated by the investment bank Cowen. Last month, STAT reported that only about 100 patients had received a dose of Aduhelm between its June approval and Sept. 11. The final revenue number suggests Biogen failed to accelerate the drug’s commercial launch.

Also from the Rx coverage front, Fierce Healthcare informs us that

Express Scripts will prefer the first Food and Drug Administration-approved interchangeable biosimilar product, a move it says will lead to millions in savings.

Semglee, which was developed by Viatris, was approved by the FDA in late July. Express Scripts will move the product to its National Preferred Formulary, which reaches 28 million members. By making the change, the pharmacy benefit manager estimates it could achieve $20 million in savings in 2022.

In addition, Express Scripts said Sanofi’s biologic insulin injection Lantus will be excluded from its National Preferred Formulary.

From the reports and studies front

  • The CMS Center for Medicare and Medicaid Innovation issued a strategic plan for its second decade.
  • NCQA and Grantmakers in Health released a valuable report on how federal action is needed to improve race and ethnicity data in federal public health programs such as Medicare and Medicaid.

Tuesday’s Tidbits

David Ermer–Congress, COVID-19, COVID-19 vaccine, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Delta variant front —

  • The Centers for Disease Control reported today on a study finding that “Among hospitalized U.S. patients aged 12–18 years, vaccine effectiveness of 2 doses of Pfizer-BioNTech vaccine against COVID-19 hospitalization during June–September 2021, was 93% (95% confidence interval = 83%–97%).”
  • The Wall Street Journal tells us that General Electric Co., Union Pacific Corp. and other large U.S. employers are imposing Covid-19 vaccine mandates for their workers to comply with a Dec. 8 deadline set by the Biden administration for companies that are federal contractors. The FEHBlog expects that these companies understandably are taking this approach without prodding from the government contracting officers in order to avoid the OSHA vaccination screening program.
  • David Leonhardt in this morning’s New York Times, wrote about the death of General Colin Powell, who was a great American leader. He points out that

Colin Powell’s death at 84 underscores the continuing risk that Covid-19 presents to older people — even if they are fully vaccinated, as Powell was. For vaccinated Americans in their 70s and 80s, Covid remains more dangerous on average than many other everyday risks, including falls, choking, gunshot wounds or vehicle accidents. * * *

If cases return to their low levels of the spring and early summer, deaths among older adults will probably plummet as well. 

He also encourage older folks to get the COVID booster, which is happening, and the country to expand rapid COVID tests. He concludes

For most Americans, vaccination makes the risk of a serious form of Covid extremely rare. And for children, Covid tends to be mild even without vaccination. But until caseloads decline more, the situation remains frightening for many older people.

From Capitol Hill, the Federal New Network discusses the Senate Budget Committee’s release of the majority’s appropriations bills yesterday.

For federal employees, the draft bills from Senate Democrats are noticeably silent on a pay raise for civilian workers next year.

In their silence, Senate appropriators have essentially deferred to the plan President Joe Biden presented to Congressearlier this year. That plan called for a 2.2% across-the-board pay increase for federal employees, with an additional 0.5% in locality adjustments to total, on average, a 2.7% raise for 2022.

Neither the House nor Senate appears interested in legislating their own federal pay raise for civilian employees next year, making Biden’s planned 2.7% increase all the more likely.

From the waste front, UPI reports that

Medicare spent nearly $600 million over a three-year period to pay for cancer care involving four drugs later found to provide no clinical benefit for some forms of the disease for which the Food and Drug Administration approved them, an analysis published Monday by JAMA Internal Medicine found.

More than $170 million of this spending was for products voluntarily withdrawn by their manufacturers after clinical trials showed that they did not improve overall survival in people with various types of cancer, including breast and lung as well as liver and urinary tract cancers, the data showed.

From the over the counter front, Healthcare Dive reports that

  • “FDA proposed a rule creating a new category of over-the-counter hearing aids, allowing the products to be sold directly to consumers in stores and online without a medical exam or being fitted by an audiologist.
  • “The agency’s proposal is meant to increase competition in the lucrative hearing aid market and improve access to the high-cost technology for millions of Americans through a safe, effective and more affordable OTC alternative. While the rule, if finalized, would more clearly define prescription hearing aids, FDA said it would not change the classification of existing device types.
  • “A Cowen analyst said in a Tuesday note the FDA’s proposed rule would effectively allow consumer electronics manufacturers to get into the hearing aid space that has been dominated by companies such as ReSound, Sonova and William Demant. The Wall Street Journal reported last week that Apple is studying ways to make its AirPods into a health device, including for enhancing hearing.”

Competition is good.

It’s worth noting that in contrast to FEHB and employer sponsored coverage generally, Medicare Part B rarely requires prior authorization for any prescribed course of treatment.

From the tidbits department, Fierce Healthcare is offering a series of articles from the ongoing HLTH 2.0 conference

Weekend update

David Ermer–Congress, Rx coverage, Telehealth, U.S. Healthcare–

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

From the telehealth front —

Fierce Healthcare discusses the state of the telehealth marketplace.

“Ten years ago, Doctor On Demand, MDLive and Amwell had the market onto themselves. Largely, in part, due to pandemic, but also with reimbursement policy changes and innovation and an emerging tech side of the market, this has all driven new entrants to what you think of as the classic telehealth space,” Jeff Becker, principal healthcare analyst at CB Insights, told Fierce Healthcare.

The competition is “coming from everywhere,” Becker said, noting that the incumbent telehealth players traditionally generated revenue from one-off urgent care, low-acuity care and primary care visits handled virtually.

“Now you have Heal and DispatchHealth sending clinicians to your house or workplace to compete for that same urgent care book of business. You have Forward and One Medical with direct primary care and they, with a lot of venture backing, are competing for that one-off primary care, urgent care telehealth book of business,” he said.

There are also startups providing remote patient monitoring and virtual chronic disease management with a focus on specialty conditions, such as Monogram Health for chronic kidney disease patients and Hinge Health, which focuses on musculoskeletal pain. And there are digital health companies like Hims & Hers and Ro that offer prescription drug delivery and telehealth visits.

  • What’s more, on Friday October 15, Walmart, which also is engaged in the telehealth market, and Transcarent, which sells in the digital marketplace,

announced they would be working together as go-to-market partners for self-insured employers across the country. The agreement allows Transcarent, which offers employees and their dependents a new, different, and better health and care experience, to share Walmart’s everyday low-cost on pharmaceuticals and other services with self-insured employers and their employees for the first time.

The collaboration makes it easier for millions of employees and the families of self-insured employers to access high-value care – no matter where they live – at affordable prices. This new offering will allow employers of all sizes to leverage Walmart’s healthcare size and scale to more easily provide their employees convenient care and cost-effective health and wellness options.

  • mHealth Intelligence further informs us that

Several large health systems have formed a coalition to support strategies that use telehealth and remote patient monitoring to provide acute care for patients at home.

The Advanced Care at Home Coalition builds on both the surge in remote patient monitoring [RPM] programs during the pandemic and the Acute Hospital at Home Program, launched in late 2020 by the Centers for Medicare & Medicaid Services. That program, which now involves more than 100 hospitals and health systems across the country, offers CMS waivers for a home-based care management plan to treat patients who would otherwise require hospitalizations for a broad range of acute conditions, including asthma, congestive heart failure, pneumonia and chronic obstructive pulmonary disease (COPD). Treatment plans combine RPM and telehealth with in-person care.

The coalition was launched by the Mayo Clinic, Medically Home and Kaiser Permanente, and includes Adventist Health, ChristianaCare, Geisinger Health, Integris, Johns Hopkins Medicine, Michigan Medicine (the University of Michigan), Novant Health, ProMedica, the Sharp Rees-Stealy Medical Group, UNC Health and UnityPoint Health.

From the Rx coverage front, this coming Saturday October 23 is the latest Drug Enforcement Administration National Rx Take Back Day allowing consumers to conveniently and safely dispose of unused prescription and over the counter drugs.

From the medical research front, Health Payer Intelligence tells us that

Using predictive analytics, University of Chicago researchers have developed a method to determine an eventual diagnosis of autism spectrum disorder (ASD) in young children. The new computational approach gathers data using diagnostic codes from previous doctor’s visits, eliminating the need for blood work or procedures to make a diagnosis.

According to researchers, this method reportedly reduced the number of false-positive ASD diagnoses produced by traditional screening methods by half. ASD can be diagnosed as early as two years old. However, false positives flagged by the initial screens commonly used today can delay confirming a true diagnosis.

With the importance of early intervention and the limited number of trained professionals, tools that can potentially reduce the number of patients required to undergo the lengthy, multistep process to receive an official positive diagnosis can significantly impact patient care.

Thursday Miscellany

David Ermer–COVID-19, COVID-19 vaccine, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Delta variant front, AHIP informs us

Today, the Food and Drug Administration (FDA) Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted to unanimously (19-0) endorse a booster dose for the Moderna COVID-19 vaccine for persons:

  • 65 years of age and older;
  • 18 through 64 years of age at high risk of severe COVID-19; and
  • 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

The Moderna booster dose is 50 micrograms – half the dosage of each of the first two doses in the series.  Individuals who are immunocompromised will receive the larger dose as was administered for earlier doses, as the third dose is considered part of the original series rather than a booster. * * *

The VRBPAC will convene again tomorrow to discuss recommendations for booster doses of the Johnson & Johnson vaccine and NIH will present data on heterologous use of booster doses following primary series of the three currently authorized or approved vaccines.

The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss recommending the Moderna and Johnson & Johnson vaccine boosters on October 20-21

Yesterday, the Equal Employment Opportunity Commission updated its COVID 19 vaccine incentive and mandate FAQ guidance for employers. The EEOC enforces the Title VII, the Americans with Disabilities Act and the Genetic Information Non-Discrimination Act among other measures. No surprises, as far as the FEHBlog can tell. Search for 10/13/2021 to find the new FAQs.

In related news, Politico reports that “President Joe Biden is likely to nominate former Food and Drug Administration Commissioner Robert Califf to return to the top role at the sweeping regulatory agency, according to four people with knowledge of the situation. * * * Califf previously served as commissioner for nearly a year in Obama’s second administration after an overwhelming vote in his favor. The White House has not finalized its decision, and the people with knowledge cautioned the situation could still change. But nine months into its search for a permanent FDA chief, Califf is now viewed as the leading candidate for the job.

In healthcare business news —

Healthcare Dive tells us that

  • UnitedHealth Group expects its planned $13 billion acquisition of data analytics firm Change Healthcare that’s been held up by DOJ review to close “in the first part of 2022,” COO Dirk McMahon told investors on a Thursday morning call.
  • The news is likely to anger hospital groups, which have raised concerns — some direct to regulators — that the deal could lower health IT competition and give its payer arm UnitedHealthcare an unfair advantage in contract negotiations.
  • The news comes as the diversified healthcare [company] beat Wall Street expectations on both earnings and revenue in the third quarter, with a topline of $72.3 billion, up 11% year over year, due to double-digit percentage growth in both UnitedHealthcare and health services business Optum. Profit was $4.2 billion, up 29% compared to the third quarter last year. As a result, Minnetonka, Minnesota-based UnitedHealth bumped its full-year guidance.

The Wall Street Journal reports that

Walgreens Boots Alliance Inc. will pay $5.2 billion to acquire a controlling stake in primary-care network VillageMD as the pharmacy chain seeks to remodel itself as a healthcare provider.

VillageMD operates more than 200 clinics where it has acquired or hired its own physicians and medical staff. Walgreens said the investment will enable it to open doctors’ offices at 600 or more of its drugstore locations by 2025, and a further 400 by 2027.

The drugstore company already owns a stake in VillageMD after agreeing last summer to pay $1 billion in equity and debt over the three years in exchange for a 30% stake in the Chicago-based startup. Under the deal announced Thursday, Walgreens will hold a 63% stake in VillageMD.

The deal is the first major strategic move under Walgreens Chief Executive Rosalind Brewer, who came to the company from Starbucks in January.

Also Thursday, Walgreens said it would acquire a majority stake in CareCentrix Inc., a Hartford, Conn.-based home health benefits manager. Walgreens said it derives 85% of its revenue from some 35 million customers who have chronic conditions such as diabetes or heart disease.

Finally, STAT News reports that

Five months ago, weight loss company Noom announced $540 million in funding, dwarfing its previous investments. With locked-down users flocking to its app, revenues in 2020 had surged to $400 million, and the company made an ambitious pitch: It would spend the money to expand its behavioral change approach to other conditions, including diabetes, hypertension, and sleep.

Now, Noom is taking its first big step toward becoming a diversified digital health company with Noom Mood, a smartphone wellness app targeted toward people with daily stress and anxiety. Like the company’s weight loss program, Mood — which the company first rolled out as a beta program last year — primarily draws on concepts from cognitive behavioral therapy. “It was kind of a no-brainer,” said Andreas Michaelides, Noom’s chief of psychology. “These concepts are really what we consider to be the gold standard with psychology.”

Midweek update

David Ermer–COVID-19 vaccine, Federal employment benefits, Rx coverage, Telehealth, U.S. Healthcare–

From the COLA front, FedWeek informs us that

  • A federal retirement COLA of 5.9 percent will be paid in January to those retired under CSRS and 4.9 percent to those retired under FERS who are eligible for COLAs, increases that have been neared in recent decades only twice.
  • The announcement follows completion of the count toward that adjustment with release of the September inflation figure on Wednesday (October 13), which was up 0.4 percent. * * *
  • A 5.9 increase also will be paid on Social Security benefits. That’s primarily of interest to FERS retirees, for whom Social Security is a basic part of the retirement benefit, but also of interest to CSRS Offset retirees who have Social Security coverage as part of their benefit. Also, some “pure” CSRS retirees qualify for Social Security through from military service or earnings covered under that system before, after—and in some cases from outside earnings during—their CSRS working years. In many cases those benefits are reduced by the “windfall elimination provision” however. * * *
  • Congress appears to be on track to accept a raise payout by default of President Biden’s recommendation for a 2.7 percent average raise, with 2.2 percentage points to be paid across the board and the funds for the remainder divided up as locality pay.

From the Delta variant front, MedPage Today offers an interesting article on the efforts of primary care providers to convince their reluctant patients to receive a COVID vaccine.

[Australian social psychologist Matthew] Hornsey [observed] that in a world where the institutional memory of pandemics has been lost, only the perception of vaccine risk remains. With adverse effects making headlines daily, even in mainstream outlets, it’s hard to promote a message of safety.

David M. Oshinsky, PhD, a Pulitzer Prize-winning author and professor of medicine at NYU Grossman School of Medicine in New York City, noted the sense of euphoria with the polio vaccine, dubbed at the time as “the peoples’ vaccine.”

Well put.

Also, the Food and Drug Administration (FDA) staff today released their vaccination advisory committee briefing book on the one dose Johnson & Johnson vaccine. According to the Wall Street Journal’s report

A booster of Johnson & Johnson’s Covid-19 vaccine showed signs of significantly bolstering the immune defenses of study subjects, federal health regulators said Wednesday.  The regulators cautioned, however, that data was limited and that they had to rely on J&J’s own analysis for some of the study findings, rather than conducting their own.

The committee will take up the Modern booster tomorrow and the Johnson & Johnson vaccine as well as the topic of mixing and matching different COVID boosters on Friday.

From the telehealth front, Employee Benefit News reports that

Telehealth providers have found that their platforms are uniquely suited to address gaps in pediatric behavioral healthcare and are expanding their services to adolescents. Brightline, launched just before the pandemic, offers an “on-ramp” to behavioral health services, Allen says. The platform does an intake assessment and then provides education and 30-minute coaching services for parents and their children.

“Kids are actually more resilient using technology than we expected, and now there’s a strong preference for virtual first behavioral healthcare, because of the privacy and the comfort of delivering care in your home,” Allen says. “If Brightline hired every single pediatric therapist in the entire United States, we would still have a national shortage, so we instead use these tools to figure out what’s an appropriate care pathway and measure whether they’re working.”

From the Rx coverage front, STAT News informs us that Pfizer is backing up one of its expensive lung cancer drugs Xalkori with a insurance company backed warranty.

“In reality, this is for Medicare patients,” said Susan Raiola, president of Real Endpoints, an advisory and analytics firm that tracks reimbursement issues. Why? Medicare co-pays are used toward the so-called donut hole, the term used to describe a temporary limit on what Medicare will pay to cover a drug. The co-pays can add up, though, making refunds more desirable. * * *

To what extent warranties may become commonplace remains to be seen. But the concept may find takers among drug makers marketing high-priced treatments that cost $1 million or more, because winning reimbursement is challenging, according to Emad Samad, president of Octaviant Financial, a firm that is promoting the use of warranties in the pharmaceutical industry.

“So far, no one else has done this,” Samad said of the Pfizer program. “But where warranties will really come into play will be with high-cost treatments, such as gene and cell therapies. These companies will have to change commercial paths with these $1 million to $3 million drugs. They need tools – such as even more innovative warranty structures – so that payers can get comfortable with the varied outcomes potentially transformative therapies could have.”

From the medical devices front, Healthcare Dive informs us that the “FDA has awarded the latest crop of breakthrough device designations, granting regulatory privileges to investigational products including liquid biopsy tests for Alzheimer’s disease and bladder cancer. Check out the list.

From the medical research front, the National Institutes of Health announced that “A commonly available oral diuretic pill approved by the U.S. Food and Drug Administration may be a potential candidate for an Alzheimer’s disease treatment for those who are at genetic risk, according to findings published in Nature Aging. The research included analysis showing that those who took bumetanide — a commonly used and potent diuretic(link is external) — had a significantly lower prevalence of Alzheimer’s disease compared to those not taking the drug.” Fingers crossed.

Midweek Update

David Ermer–Congress, COVID-19, COVID-19 testing, Mental health care, OPM, Rx coverage, U.S. Healthcare–

From Capitol Hill, the Wall Street Journal reports that

Senate Democrats were poised to accept a GOP proposal to defer the showdown over the debt ceiling until later this year, lawmakers said, as administration officials and corporate executives issued dire warnings about the dangers of a possible government default.

The proposed agreement would extend the debt ceiling into December, provided that Democrats affix a dollar amount to the debt level. A deal could pave the way for a procedural vote in the Senate soon, to be followed by final passage sometime later this week. The House will still have to pass the legislation, which is expected to be signed into law by President Biden.

OPM Director Kiran Ahuja was interviewed today for a Washington Post Live online event. Ms. Ahuja principally discussed implementing the COVID vaccine mandate for the federal workforce and implementing the President’s June 2021 executive order on enhancing diversity, equity and inclusion in the federal workforce.

From the Delta variant front, David Leonhardt in the New York Times posted another column on the need for more rapid COVID tests in our country.

If you wake up with a runny nose or scratchy throat, you should be able to grab a Covid-19 test from your bathroom shelf and find out the result within minutes. The tests exist. They are known as antigen tests and are widely available not only in Britain but also France, Germany and some other places. Rapid tests can identify roughly 98 percent of infectious Covid cases and have helped reduce the virus’s spread in Europe.

In the U.S., by contrast, rapid tests are hard to find, because the Food and Drug Administration has been slow to approve them. F.D.A. officials have defended their reluctance by saying that they need to make sure the tests work — which they certainly do. But many outside scientists have criticized the agency for blocking even those antigen tests with a demonstrated record of success in other countries. * * *

[At long last,] The F.D.A. announced Monday that it would allow the sale of an antigen test known as Flowflex. The test has been available in Europe but not here, even though the company that makes it — Acon Laboratories — is based in San Diego.

The decision suggests that the F.D.A. has become willing to approve other rapid tests too, Alex Tabarrok, an economist at George Mason University and an advocate of expanded testing, told me. Separately, the Biden administration plans to announce an expansion of rapid testing today, a White House official told me last night. It will be a $1 billion government purchase of tests, meant to accelerate their production, on top of other money the administration has already dedicated to rapid tests.

[I]t is not too late for rapid tests to improve day-to-day life. The Biden administration finally seems to be taking significant steps in that direction.

From the health equity front, Becker’s Payer Issues tells us that

United Health Foundation’s “America’s Health Rankings 2021 Health of Women and Children Report” report cites an increase in maternal mortality and a decrease in women and child physical activity.

The annual report from the UnitedHealth Group’s philanthropic arm, shared in an Oct. 6 announcement, called out a range of physical and behavioral health trends among women and children.

Among key findings is a 16 percent spike in average maternal mortality, shifting from 17.4 deaths per 100,000 births to 20.1 deaths. Florida was the state with the highest jump, up 70 percent to 26.8 deaths per 100,000 births.

Physical activity in children and women is also down, with only 20.6 percent of children and 21.5 percent of women meeting federal physical activity standards, according to the report. 

The report’s executive summary also pointed to rising mental health burdens on youths, including a 1.6 percentage point increase in childhood anxiety. Teen suicide is up 26 percent over 2014-2016 numbers to 11.2 deaths per 100,000 adolescents. 

Women also experienced 14 percent increased mental distress over 2016-2017 numbers

Health Affairs digs deeper into the maternal mortality issue and finds using data from fourteen state Maternal Mortality Review Committees (MMRCs) over the period 2008–17 that

Among 421 pregnancy-related deaths with an MMRC-determined underlying cause of death, 11 percent were due to mental health conditions. Pregnancy-related mental health deaths were more likely than deaths from other causes to be determined by an MMRC to be preventable (100 percent versus 64 percent), to occur among non-Hispanic White people (86 percent versus 45 percent), and to occur 43–365 days postpartum (63 percent versus 18 percent). Sixty-three percent of pregnancy-related mental health deaths were by suicide. Nearly three-quarters of people with a pregnancy-related mental health cause of death had a history of depression, and more than two-thirds had past or current substance use. MMRC recommendations can be used to prioritize interventions and can inform strategies to enable screening, care coordination, and continuation of care throughout pregnancy and the year postpartum.

From the Rx front, MedPage Today reports that

A national antibiotic stewardship program at ambulatory care centers was associated with reduced antibiotic prescribing during the pandemic, both overall and for acute respiratory infection (ARI) cases, researchers found.

In an analysis involving nearly 300 practices who took part in the Agency for Healthcare Research and Quality’s (AHRQ) program for improving antibiotic use, there were nine fewer antibiotic prescriptions for every 100 visits by the end of the intervention (95% CI -10 to -8), as well as 15 fewer prescriptions for every 100 ARI-related visits (95% CI -17 to -12), reported Sara Keller, MD, MPH, MSPH, of Johns Hopkins University in Baltimore. * * *

AHRQ’s Safety Program for Improving Antibiotic Use is a national program that involves presentations, webinars, patient handouts, and other educational tools (including the Four Moments of Antibiotic Decision Making tool) and emphasizes three key areas for clinicians: developing and improving antibiotic stewardship; learning strategies for discussing antibiotic prescribing with colleagues, patients, and their families; and best practices for diagnosing and managing common infectious syndromes, as well as allergies to antibiotic.

Fierce Healthcare informs us about a recently established prescription drug manager “Prescryptive Health, a blockchain-powered prescription data platform.”