Monday Roundup

Rx coverage

Monday Roundup

David Ermer–COVID-19, COVID-19 vaccine, Electronic health records, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

The Food and Drug Administration (“FDA”) announced today that the agency has “approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. Accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit. 

“Under the accelerated approval provisions, which provide patients suffering from the disease earlier access to the treatment, the FDA is requiring the company, Biogen, to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.”

The Wall Street Journal adds

Biogen priced the newly approved drug higher than analysts expected. The company said it would charge about $56,000 a year per patient.

A preliminary analysis conducted by the Institute for Clinical and Economic Review, a nonprofit research and advisory group, said the drug could be cost-effective at a per-patient price of $2,500 to $8,300 a year.

Alzheimer’s is a progressive degenerative disease that slowly robs people of their memory and the ability to care for themselves.

About six million people suffer from Alzheimer’s in the U.S. Of those, as many as 1.4 million could be eligible to take Aduhelm, according to estimates by Cigna.

What’s more, according to the Journal,

Cigna will likely cover the drug for people who match the patients studied in Biogen’s clinical trials—those with early-stage Alzheimer’s and amyloid buildup in their brains—said Steve Miller, Cigna’s chief clinical officer.

Most Alzheimer’s patients are covered by Medicare, and their out-of-pocket costs could be significant, depending on their coverage, because of so-called coinsurance payments that require patients to cover a percentage of certain health costs, Dr. Miller said.

“The out-of-pocket testing costs could be a real barrier for those patients who lack the financial means,” said Dr. Miller.

Cigna estimates that patients with traditional Medicare insurance could be on the hook for more than $10,000 a year in coinsurance and copayments for the drug and amyloid testing, Dr. Miller said. Additional costs for people with supplemental Medigap insurance or commercial coverage through Medicare Advantage could reach up to $4,000 annually.

Dr. Miller said patients may be eligible for financial assistance to cover the extra costs through nonprofit foundations, which are often funded by drugmakers.

Healthcare Dive offers a comprehensive article about the new drug that is not behind a paywall.

From the COVID-19 front

  • David Leonhardt in the New York Times reports on his takeaways from Britain’s recent, modest rise in new COVID-19 cases:

One, vaccines are still the most effective way, by far, to defeat this terrible pandemic. Nothing matters more than the speed at which shots go into arms — in Britain, in the U.S. and especially in poorer countries, where vaccination rates are still low.

Two, behavior restrictions can still play a role in the interim. If hospitalizations or deaths in Britain rise over the next two weeks, there will be a strong argument for pushing back the full reopening of activities. And that has obvious implications for the U.S., too. Restricting indoor activities for unvaccinated people is particularly important.

Three, caseloads are no longer as important a measure as they used to be. Before the vaccines were available, more cases inevitably meant more hospitalizations and deaths. Now, the connection is more uncertain. As a recent Times story put it, paraphrasing British scientists, “upticks in new infections are tolerable so long as the vast majority do not lead to serious illness or death.”

  • The Society for Human Resource Management discusses stepped-up employer efforts to encourage COVID-19 vaccinations and reduce employee tensions over COVID-19 masks and vaccination in the workplace.
  • Medscape offers suggestions for healthcare providers and possible health plans on how to target COVID-19 vaccine hesitancy.
  • The Massachusetts Institute of Technology’s Pandemic Technology Project reports on best community practices in closing COVID-19 vaccination gaps.

From the OPM front

  • Govexec informs us that OPM “on Monday moved to finalize new regulations making it easier for federal agencies to bring back former employees at a higher salary than when they left government. Currently, federal agencies have the authority to rehire former federal workers outside the competitive hiring process, but they can only offer them positions at the same pay grade they held before they left federal service. Under a final rule set to be published in the Federal Register Tuesday, effective July 8, agencies will be able to use that process to rehire former federal workers at higher salaries than when they left government, accounting for the experience and skills they gained through education and the private sector.”
  • Federal News Network informs us that “Federal retirement activity slowed across the board last month, from new claims to backlogged cases and even the time it takes to process them. The latest numbers from the Office of Personnel Management showed that 7,684 new claims were filed in May compared to 9,414 in April — an 18.4% decrease month over month but a 15.6% increase from the same time a year ago. The number of claims processed also dropped to 8,451 in May versus 11,396. That’s a 25.8% decline month other month, although April was unusually high for processed claims when compared to historical monthly totals. May’s processed claims were about even year over year. The retirement backlog decreased from 25,386 claims in April to 24,619 claims in May, but that represented a 35.4% increase from May 2020. In January of this year, the backlog, which has not met it’s goal of 13,000 claims for more than a year and a half, peaked at 26,968 claims and has slowly inched back down.” It’s the FEHBlog’s understanding that OPM’s issues stem from an unnecessarily complex federal retirement system that only Congress can fix.

In other news

  • Beckers Hospital Review reports that “Walmart Health’s primary care medical group has filed paperwork to expand virtual care in 16 more states, Insider reported June 7.”
  • Healthcare Dive informs us that even before the new information blocking rule’s effective date, “the majority of hospitals have allowed patients to view and download their health information via their own patient portal [in recent year] . However, hospitals allowing patients to use third-party apps to see their data increased sharply from 2018 to 2019, according to a new report from the federal agency that regulates U.S. health IT.”

Weekend update

David Ermer–ACA, COVID-19, COVID-19 vaccine, OPM, Rx coverage–

The Senate will resume Committee work and floor voting this coming week while the House of Representatives will be limited to Committee business.

From the COVID-19 front

  • Bloomberg reports that “U.S. hospitalizations continue to fall, with 3.17% of beds occupied by Covid-19 patients on June 4, according to the U.S. Department of Health and Human Services. That percentage dropped from 3.67% on May 28 and is the lowest since March 14, 2020.”
  • The Advisory Board informs us its June 4, 2021, COVID-19 Roundup that “The World Health Organization (WHO) on Monday announced variants of the coronavirus will now be named after letters of the Greek alphabet, to simplify the variants’ names and avoid names that can be stigmatizing to a country. According to the new naming system, the variant B.1.1.7, which was first discovered in the United Kingdom, will now be called Alpha; the B.1.351 variant first discovered in South Africa will be called Beta; and the B.1.617.2 variant first discovered in India will be called Delta. Once all 24 letters of the Greek alphabet have been used, WHO said it will announce another naming system.”

Kaiser Health News tells us that

The Food and Drug Administration’s decision next week whether to approve the first treatment for Alzheimer’s disease highlights a deep division over the drug’s benefits as well as criticism about the integrity of the FDA approval process.

The agency said it will decide by June 7 the fate of Biogen’s drug aducanumab, despite a near-unanimous rejection of the product by an FDA advisory committee of outside experts in November. Doubts were raised when, in 2019, Biogen halted two large clinical trials of the drug after determining it wouldn’t reach its targets for efficacy. But the drugmaker later revised that assessment, stating that one trial showed the drug reduced the decline in patients’ cognitive and functional ability by 22%.

Some FDA scientists in November joined with the company to present a document praising the intravenous drug. But other FDA officials and many outside experts say the evidence for the drug is shaky at best and that another large clinical trial is needed. A consumer advocacy group has called for a federal investigation into the FDA’s handling of the approval process for the product.

A lot is riding on the drug for Biogen. It is projected to carry a $50,000-a-year price tag and would be worth billions of dollars in revenue to the Cambridge, Massachusetts, company.

The Department of Health and Human Services, last Friday, released

a new report that shows 31 million Americans have health coverage through the Affordable Care Act – a record.  The report also shows that there have been reductions in uninsurance rates in every state in the country since the law’s coverage expansions took effect. People served by the health Marketplaces and Medicaid expansion have reached record highs.  

The data shows those individuals currently enrolled in health coverage through the Health Insurance Marketplaces and Medicaid expansion under the ACA, including 11.3 million people enrolled in the ACA Marketplace plans as of February 2021 and 14.8 million newly-eligible people enrolled in Medicaid through the ACA’s expansion of eligibility to adults as of December 2020. 

In addition, there are one million people enrolled in the ACA’s Basic Health Program, and nearly four million previously-eligible adult Medicaid enrollees who gained coverage under expansion due to the ACA’s enhanced outreach, streamlined applications, and increased federal funding under the ACA. Today’s report shows the important role the ACA has played in providing coverage to millions of Americans nationwide.

The report also shows that between 2010 and 2016, the number of nonelderly uninsured adults decreased by 41 percent, falling from 48.2 million to 28.2 million. All 50 states and the District of Columbia have experienced reductions in their uninsured rates since the implementation of the ACA, with states that expanded Medicaid experiencing the largest reduction in their uninsured rate. California, Kentucky, New York, Oregon, Rhode Island, Washington, and West Virginia have reduced their uninsured rate by at least half from 2013 to 2019 through enrollment in Marketplace coverage and expansion of Medicaid to adult populations. To date, 37 states and the District of Columbia have expanded Medicaid to cover adults under the ACA. 

Healthcare Dive reports that

  • The nation’s largest commercial insurer is taking a closer look at whether visits to the emergency room by some of its members are necessary. Starting July 1, UnitedHealthcare will evaluate ER claims using a number of factors to determine if the visit was truly an emergency for its fully insured commercial members across many states, according to a provider bulletin. 
  • If UnitedHealthcare finds the visit was a non-emergency, the visit will be “subject to no coverage or limited coverage,” the provider alert states.
  • However, a statement provided to Healthcare Dive said the insurer will reimburse for non-emergency care according to the member’s benefit plan. In other words, the amount paid by UnitedHealthcare may be less if deemed a non-emergency.    

For what it’s worth, this plan designed to control healthcare resources makes sense to the FEHBlog.

Last week, the FEHBlog noted that OPM had a settled a lawsuit in the National Federation for the Blind alleged that the agency’s website was not adequately accessible to visually impaired FEHB members. To place the settlement in context, the FEHB calls attention to this NextGov article reporting that

Federal websites are not as accessible for those with disabilities as the law mandates they should be, according to a report released Thursday by the Information Technology and Innovation Foundation.

The report tested the 72 most popular federal websites and used a combination of automated tests and qualitative assessments to assess their compliance with Section 508 of the Rehabilitation Act. The law requires the General Services Administration to ensure federal websites are accessible to people with disabilities, including federal employees and the public.

According to the report, 30% of the most popular federal websites did not follow modern web accessibility standards on their homepages, and 48% failed a standard test on at least one of their three most popular web pages.

The report finds that

Overall, our assessments reveal a large amount of variation in how agencies are meeting Section 508 requirements. Some agencies that have a large footprint—such as the Internal Revenue Service, the Census Bureau, the Department of Defense, and the Department of Education’s office of Federal Student Aid—scored low in our accessibility test of their websites, indicating that people with disabilities may have difficulty accessing essential government services or information about these services online. * * *

Notably, the White House and the Centers for Disease Control and Prevention earned a perfect score in our accessibility test of all three of their pages, and also performed well in our qualitative assessment. The Biden administration has committed to adhering to WCAG 2.1 Level AA criteria on the White House website—a step above Section 508’s requirements, which use WCAG 2.0.19

Memorial Day Update

David Ermer–CMS, COVID-19, COVID-19 vaccine, Rx coverage, U.S. Healthcare–
Thanks to Justin Casey for sharing their work on Unsplash.

On this second (and hopefully last) Memorial Day of the COVID-19 pandemic, let’s take a look at recent reports on the nation’s COVID-19 vaccination campaign —

  • The Wall Street Journal reports that while vaccination rates in the Southeastern states have been relatively low, COVID-19 transmission has been slowed in those states by a combination of vaccinations supplemented by people engaging in open air activities.

Health officials in warm-weather states have launched public-information campaigns to encourage residents to spend as much time outside as possible and are pushing for more vaccinations at outdoor sites such as state parks and minor league baseball parks, as a way of heading off another potential summer surge this year.

“Vaccination and people spending time outdoors are the two biggest factors” in why cases have been relatively low this spring, said Brannon Traxler, an epidemiologist who heads South Carolina’s public-health division.

Encouraging people to spend time outside is a high priority, but the even bigger priority is the focus on vaccination, Dr. Traxler said: “If we can get folks vaccinated, then the weather and where and how people congregate becomes less of a problem.”

  • The Centers for Disease Control reports on Patterns in COVID-19 Vaccination Coverage, by Social Vulnerability and Urbanicity from December 2020 through April 2021:

What is already known about this topic?

Counties with higher levels of social vulnerability have been disproportionately affected by COVID-19.

What is added by this report?

Disparities in county-level vaccination coverage by social vulnerability have increased as vaccine eligibility has expanded, especially in large fringe metropolitan (areas surrounding large cities, e.g., suburban) and nonmetropolitan counties. By May 1, 2021, vaccination coverage among adults was lower among those living in counties with lower socioeconomic status and with higher percentages of households with children, single parents, and persons with disabilities.

What are the implications for public health practice?

Outreach efforts, including expanding public health messaging tailored to local populations and increasing vaccination access, could help increase vaccination coverage in counties with high social vulnerability.

  • The San Francisco Chronicle reports that “Hope builds that COVID vaccine boosters won’t be needed for a year – or much long.” “’I expect we will have to be revaccinated eventually, but I don’t think it’s going to be in a year-or-two time frame,’ said Dr. Joel Ernst, an infectious disease expert at UCSF. ‘Obviously we don’t have a long period of observation, because we haven’t had the vaccines that long. But so far I’m reassured that the vaccine-induced immunity seems to be pretty durable.’”

In other news

  • Healthcare Dive informs us that “The Mayo Clinic reported turning a profit in the first quarter of the year, although its expenses rose significantly compared to the first quarter of 2020, which was mostly completed before the COVID-19 pandemic became a significant issue. * * * [M]ost patient volumes returned to pre-pandemic levels. Outpatient visits for the quarter matched 2019 numbers, while surgical volumes exceeded those of 2019, although inpatient days were down.”
  • Kaiser Health News tells us that “The Biden administration said Friday it has no timeline on whether it will allow states to import drugs from Canada, an effort that was approved under President Donald Trump as a key strategy to control costs.  Six states have passed laws to start such programs, and Florida, Colorado and New Mexico are the furthest along in plans to get federal approval.  The Biden administration said states still have several hurdles to get through, including a review by the Food and Drug Administration, and such efforts may face pressures from the Canadian government, which has warned its drug industry not to do anything that could cause drug shortages in that country.” Smart move by the Administration. Our country’s population dwarfs Canada’s.
  • The Wall Street Journal reports that “Genetically altered mosquitoes target deadly Dengue fever and ZikaIn pioneering test, insects with a gene primed to interrupt breeding are flying in the Florida Keys. Go get em. One pandemic is enough.

Memorial Day Weekend update

David Ermer–CDC, Congress, Congress, COVID-19, OPM, Rx coverage, SCOTUS, U.S. Healthcare–
Thanks to Justin Casey for sharing their work on Unsplash.

Congress is on a State / district work break this coming week. The Supreme Court has over thirty cases to decide, including the latest Affordable Care Act constitutionality case, before adjourning for the summer in late June / early July.

The federal employee news organizations have highlighted portions of the President’s fiscal year 2022 budget proposal which was released last Friday.

  • The Federal Times reports that “President Joe Biden’s fiscal year 2022 budget anticipates a more than 50,000 full-time-equivalent employee increase to the federal payrolls next year, as part of concerted efforts to attract young and expert workers to federal service. * * * ‘The Federal workforce continues to become older on average. Almost 30 percent (635,397) of employees are older than 55, while 8.1 percent (176,805) of employees are younger than 30. By comparison, in the private sector, 23 percent of the workforce is younger than 30. Every single agency has fewer employees younger than 30 today than they had in 2010,’ the budget proposal’s analytical perspectives state.
  • Govexec informs us that “President Biden on Friday formally proposed an average 2.7% pay increase for federal civilian employees in 2022 as part of his fiscal 2022 budget proposal. * * * It was unclear Friday how Biden’s proposal would be divvied up between an across-the-board boost to basic pay and increases in locality pay. In recent years, pay raise provisions have included a 0.5% average increase in locality pay, although it was frozen at 2020 levels this year. * * * The proposal also marks a return to the principle of pay parity between the civilian and military workforce, as service members would also receive a 2.7% pay raise in 2022. 

Federal News Network offers three brief stories on the U.S. Postal Service

The Postal Service sent its first reduction in force notices to non-union management employees Friday [no indication of how many notices were sent out], and is planning to set higher prices on its mail products well above the rate of inflation [first class stamp would increase by 5% from 55 cents to 58 cents].

The Senate, meanwhile, voted [by unanimous consent] to confirm [Anton Hajjar] President Joe Biden’s third nominee to serve on the USPS Board of Governors. The board is now fully staffed for the first time since 2010, and will help the agency get its 10-year reform plan off the ground.

Thus the Senate has confirmed all three of the President’s Postal Governor nominees who shared a confirmation hearing with OPM Director Kiran Ahuja while Ms. Ahuja waits for a confirmation vote.

In healthcare news —

  • Bloomberg tells us that “The U.S. reported the lowest level of infection since the early days of the pandemic and welcomed back sports fans to stadiums. The Indianapolis 500 was run before 135,000 fans, the largest crowd for a sporting event since the pandemic began [but 1/3 of capacity].  * * * The world needs the cooperation of the Chinese government to trace the origins of Covid-19 and prevent future pandemic threats, two leading U.S. disease experts said Sunday.
  • NPR reports that “For children in particular, the risk of serious consequences from COVID-19 is the same magnitude as the risk they face from the flu, she says. But many parents seem more worried about the new and less familiar disease. * * * [E]xperts urge parents to try not to worry too much.
  • Because many FEHB plans provide hypertensive members with at home blood pressure monitor, the FEHBlog wants to share the American Medical Association’s views on what doctors wish their patients knew about home blood pressure measurement.

Finally, the FEHBlog’s eyes were drawn to the weekend Wall Street Journal’s Heard on the Street column which discusses the efforts of Walmart and Amazon to enter the healthcare business.

Friday Stats and More

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Rx coverage, U.S. Healthcare–

Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 21st week of this year (beginning April 2, 2020, and ending May 26, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):

and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases significantly exceeds new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through May 26, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through May 26, 2021 (five months) which also uses Thursday as the first day of the week:

The Centers for Disease Control observes that “COVID-19 cases and deaths in the United States have dropped to their lowest levels in nearly a year, and the number of people vaccinated continues to grow. As of May 27, 2021, nearly 133 million people in the U.S. are fully vaccinated, and the national percentage of COVID-19 tests that came back positive over the last 7 days was less than 3%”

Also on the COVID-19 vaccine front, Healthcare Dive reports that

Federal equal employment opportunity laws do not prohibit policies requiring that all employees who physically enter a workplace receive a COVID-19 vaccination, so long as such policies comply with the reasonable accommodation provisions of the Americans with Disabilities Act and Title VII of the Civil Rights Act as well as other applicable laws, according to technical assistance from the U.S. Equal Employment Opportunity Commission updated May 28.

Title VII and the ADA require employers to provide reasonable accommodations for employees who, because of a disability or a sincerely held religious belief, practice, or observance, do not get vaccinated for COVID-19, unless providing an accommodation would pose an undue hardship on the operation of the employer’s business, EEOC said. Employers with such a requirement also may need to respond to allegations that the requirement has a disparate impact on, or disproportionately excludes, an employee based on protected characteristics including age, race, color, religion, sex and national origin.

Employers also may offer incentives to employees to voluntarily show documentation or confirmation that they have received a COVID-19 vaccine, but the agency outlined some limits in the event that employers are incentivizing employees to voluntarily receive a vaccine administered by an employer or its agent. An employer may offer an incentive to employees to provide documentation or other confirmation from a third party not acting on the employer’s behalf, such as a pharmacy or health department, that employees or their family members have been vaccinated.

In other news —

  • Today, the President released his Fiscal Year 2022 U.S. budget. Here is a link to the Office and Management and Budget’s fact sheet. OPM’s budget information may be found beginning on page 1211 of the Appendix.
  • Yesterday, the Milliman consulting firm released its 2021 Medical Index. Peering into its crystal ball, Milliman states that “We project healthcare costs will grow by approximately 8.4% for the MMI family from 2020 to 2021. This rate, driven by a forecasted rebound in healthcare utilization, is higher than historical healthcare cost increases and gross domestic product (GDP) growth over the past five years.”
  • Healthcare Dive informs us that “Despite the financial turmoil COVID-19 wrought on U.S. medical practices over the past year, physician income has remained relatively steady, according to a new survey by the Medical Group Management Association. The survey — which included 185,000 providers among more than 6,700 physician-owned and hospital-owned practices — concluded they experienced flat or modest income growth in 2020. While compensation for primary care physicians — traditionally one of the lowest-paid specialties — grew, most specialist physicians either experienced small bumps or decreases in their income. Many medical specialties also experienced a decrease in patient encounters last year — a nearly inevitable outcome after many elective procedures were postponed in order to keep hospital capacity low enough to treat COVID-19 patients. However, the MGMA survey concluded that most practices saw patient volumes return to normal by mid-summer of 2020. Analysts predict the trend will continue to grow in 2021.” Agreed.
  • Recycle Intelligence informs us that “Hospital revenue, volumes, and margins increased in April 2021 both year-to-date and year-over-year, but have a long way to go in terms of COVID-19 recovery, according to a report by health care consulting firm Kaufman Hall. Despite the increases, hospital financial performance is down compared to last month.”
  • Last but not least, the Wall Street Journal reports that “A pathbreaking pill for lung cancer from Amgen Inc. was approved by the U.S. Food and Drug Administration, adding a new potential blockbuster to the biotech giant’s aging stable of drugs. The drug, called Lumakras, was approved Friday to treat a portion of lung cancer patients with a particular genetic mutation who have already tried other therapies. The mutation, known as KRAS, is among the most common found in cancers, but researchers struggled for so many years to find a medicine that can treat it that the mutation came to be considered ‘undruggable.’” Bravo. The Journal adds that “The company will charge $17,900 a month for the drug in the U.S., an Amgen spokeswoman said. Analysts project the drug could eventually ring up more than $1 billion in annual sales.”

Thursday Miscellany

David Ermer–COVID-19, COVID-19 vaccine, OPM, Rx coverage–
OPM Headquarters a/k/a the Theodore Roosevelt Building

Federal News Network reports

The Office of Personnel Management is reshuffling current senior leadership and reorganizing a few of its offices as it waits for the arrival of its new director.

“OPM is making staff and organizational updates in order to better serve the agency’s mission,” the agency told Federal News Network. “These staff and organizations updates will help us to increase efficiency, better leverage our incredible internal talent and build back the agency for the future.”

Dennis Coleman, the agency’s current chief financial officer, will be the new chief management officer, OPM announced Thursday.

Margaret Pearson, OPM’s deputy chief financial officer, will be the acting CFO until the agency fills the job permanently. It will conduct a national search to find a new permanent CFO, OPM said.

From the COVID-19 vaccine front

  • The Wall Street Journal informs us that “The Food and Drug Administration and vaccine maker Johnson & Johnson expect to announce as early as Friday that contamination problems at a Covid-19 vaccine plant in Baltimore are resolved, clearing the way for millions more doses to become available.”
  • The New York Times tells us that “Immunity to the coronavirus lasts at least a year, possibly a lifetime, improving over time especially after vaccination, according to two new studies. The findings may help put to rest lingering fears that protection against the virus will be short-lived. Together, the studies suggest that most people who have recovered from Covid-19 and who were later immunized will not need boosters. Vaccinated people who were never infected most likely will need the shots, however, as will a minority who were infected but did not produce a robust immune response.”
  • A Bloomberg op-ed write opines (accurately in the FEHBlog’s opinion) that “The news that some employers have started handing out cash rewards to workers who are vaccinated against Covid-19 warms my libertarian heart. Yes, the idea is controversial; yes, there are legal implications. But providing incentives to get people to do what others think they should is almost always superior to punishing them for defying those wishes.” To that end, CVS Health announced that “beginning June 1, eligible customers who received or plan to receive a COVID-19 vaccination through CVS Health may choose to enter the #OneStepCloser sweepstakes for an opportunity to win one of over a thousand fun and exciting prizes through weekly drawings and grand prizes over a six-week period.” (Regrettably the FEHBlog got his vaccinations at a Maryland mass vaccination flight.)
  • Fierce Biotech reports that “Sanofi, GlaxoSmithKline kick-start phase 3 COVID-19 vax test as the pair targets variants, Q4 approval.”

From the prescription drug front —

  • Fierce Pharma informs us that “Within hours of granting emergency use approval to a COVID-19 antibody drug by GlaxoSmithKline and Vir, the United States has restricted the use of another COVID antibody treatment, this one from Eli Lilly. The FDA has halted the distribution of Lilly’s combination of bamlanivimab and etesevimab in Arizona, California, Florida, Indiana, Oregon and Washington––all states where coronavirus variants from Brazil and South Africa account for more than 10% of those with the disease. The antibody combo had previously been paused in Illinois and Massachusetts.  Providers in those states should use Regeneron’s antibody treatment of casirivimab and imdevimab, the FDA says. Lab studies have shown that option is more effective against the Brazilian (P.1) and South African (B.1.351) strains, according to the agency.’
  • Fierce Healthcare reports that CMS delays for six months [until July 1, 2022] a [complex] requirement for drugmakers to offer multiple best prices for Medicaid value-based deals. Also “The Pharmaceutical Research and Manufacturers of America, a top drug lobbying group, sued CMS in federal court on May 21 over another section of the Dec. 31, 2020, final rule. The drug industry wants a federal judge to ditch a requirement for manufacturers to factor in copay assistance into the Medicaid best price.”
  • Business Insider tells us that “Amazon is considering options for creating a physical retail-pharmacy presence in the US, three people familiar with the matter told Insider. It’s part of a plan to win over a larger slice of the prescription-drug industry. There is not a concrete plan to do so, and the talks are mostly exploratory, the people said. They were not authorized to speak to the press. Any meaningful rollout of stores could take more than a year, one of them said.” The FEHBlog watched a Bloomberg TV interview of Amazon’s CEO Jeff Bezos. The interview asked Mr. Bezos how he fills his workdays. He responded that he and his direct reports think about the future so this makes sense.
  • Virta Health, which offers diabetic treatments, announced a free webinar on Thursday June 17 at 2 pm to discuss a new potentially blockbuster Novo Nordisk anti-obesity drug. Here’s the skinny so to speak —

Obesity rates continue to soar, but earlier this year we were met with intriguing news. Early 2021, Novo Nordisk released phase 3 data for their diabetes drug, Semaglutide, in which the outcomes which were described as “breakthrough” and “game-changing” Patients on average lost 33.7 pounds after 68 weeks, more than 1.5 higher than the next best obesity drug. Experts predict the record-breaking efficacy rates could unleash the obesity drug market, which has historically lingered at a low <1% penetration rate. 

Despite what looks like a promising turn of events at the surface, there is growing concern that we’re at a tipping point for a healthcare cost crisis. With an estimated list price per patient of $13,000, semaglutide could take a huge hit on employers and payers who are already struggling to control growing medication and healthcare costs. 

Midweek Update

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

The Wall Street Journal reports that

A monoclonal antibody drug to treat early Covid-19 infections has been authorized by the U.S. Food and Drug Administration, said Vir Biotechnology Inc.and GlaxoSmithKline PLC, makers of the drug.

The drug, called sotrovimab, is the third antibody medicine authorized to treat patients early in the course of disease who are at high risk of developing severe cases.

Vir and Glaxo said in March that a study of the drug had been stopped early because it was shown to be highly effective, reducing hospitalizations or death by 85%, compared with a placebo. * * *

It is unclear what near-term role the drug will play in the U.S., where new infections are falling and there remains a glut of unused antibody drugs made by Eli Lilly & Co. and Regeneron Pharmaceuticals Inc.

Having a Plan B usually is a prudent step.

Speaking of prescription drugs, Healthcare Dive informs us that

  • “The Institute for Clinical and Economic Review, a nonprofit and frequent critic of drugmakers for excessively high drug prices, now plans to assess how health insurance policies harm patient access to care, the group announced Tuesday. This follows research by the group that argued cost-sharing should not be structured to shift healthcare costs to patients when they have no medically appropriate lower cost option.
  • “ICER’s review will not, however, look at whether cost-sharing should be reduced for drugs on which payers receive large rebates or whether payers should be asked to demonstrate how their policies on drug access save overall healthcare costs.
  • “Drugmakers have repeatedly tried to shift the blame for high out-of-pocket costs and limited access to drugs by pointing to the design of insurance plans. ICER’s review suggests a new emphasis by the group on examining the role insurers play alongside pharmaceutical companies in determining patient access and costs.”

Fedweek features Reg Jones’ latest missive on the relationship between federal employment benefits and life events. This report concerns the coverage of children under FEHB and FEGLI.

The FEHBlog has been tracking developments in the implementation of the No Surprises Act. In the course of doing so today, he found several letters from healthcare trade associations to federal regulators on this topic. Because it can be helpful to look over the fence, here are implementation comments from American Association of Orthopedic Surgeons, the American College of Radiology, the National Association of Free Standing Emergency Centers, the American Association of Medical Colleges, and the American College of Emergency Physicians. What’s more the Workgroup for Electronic Data has helpfully collected links to a bevy of expert analyses of the law. It’s a heavy lift.

In healthcare business news

  • Healthcare Dive tells us that “Hospital operator HCA Healthcare is linking up with Google Cloud on a new data analytics platform to support provider decision-making, the companies announced Wednesday. The deal between the 186-hospital system and the technology behemoth will build on HCA’s existing use of technology to streamline both clinical and non-clinical operations, and represents “significant investments” in the system’s mobile functions, the companies said. The goal is to give doctors and nurses workflow tools, analysis and alerts on their mobile devices for real-time updates on patients’ conditions, while also improving workflows such as supply chain, human resources and physical plant operations.”
  • Fierce Health reports that “The combined company of Grand Rounds Health and Doctor On Demand has expanded yet again to include a care concierge platform for the LGBTQ+ community. The virtual care companies announced Wednesday they signed a definitive agreement to acquire Included Health to improve health outcomes and address the health challenges facing communities including lesbian, gay and transgender patients as well as black, indigenous and people of color (BIPOC), the companies said in a press release.” Terms of the agreement were not disclosed

Weekend update

David Ermer–Congress, Medicare, Rx coverage, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

The House of Representatives will be conducting Committee business this week and is not expected to resume floor voting until June 14. The Senate will be conducting Committee business and floor voting this week. Tomorrow the Senate will begin the voting process for confirmed President Biden’s nominee for Centers for Medicare and Medicaid Services Administrator, Chiquita Brooks-LaSure.

The Supreme Court will hold another opinion day tomorrow which may be the occasion for the release of the California v. Texas Affordable Care Act constitutionality decision. Lexology discusses the fallout from the Surpreme Court’s December 2020 opinion in Rutledge v. PCMA narrowing the scope of ERISA preemption with respect to prescription benefit manager law. State legislatures have jumped on the opportunity created by the Rutledge opinion.

In 2021 alone, at least eight states have enacted some sort of PBM reform legislation, including Alabama, Arizona, Arkansas, Mississippi, New York, North Dakota, West Virginia and Wisconsin. PBM reform regulation has passed both the state house and senate in Texas and is on its way to the governor. These bills run the gamut of regulating the PBM industry, from prohibiting PBMs from charging pharmacies fees during and after the claims adjudication process, prohibiting PBMs from reimbursing their own affiliated pharmacies at a higher level than independent pharmacies to banning PBM discrimination against pharmacies participating in the Federal 340B medication discount program. This trend is likely to continue with almost 100 bills introduced across 39 states similarly aimed at regulating the PBM industry

Cost curve up. ERISA decisions like this one impact FEHB preemption because courts have interpreted the two preemption laws as generally analogous in scope.

In other news and opinions:

  • Medpage Today offers an op-ed about the importance of primary care. The FEHBlog agrees that “Patients need support for mental and physical health all in one place” and accordingly health plans should encourage the use of primary care.
  • Fierce Healthcare reports that “There was a significant increase in pharmacy fraud and abuse under the pandemic, analysts at OptumRx say. The pharmacy benefit manager giant recovered $300 million in fraud, waste and abuse spend in 2020 and documented the largest ever increase in fraudulent claims, which were up 300% compared to 2019. In addition, Optum’s investigative audits led to an increase of 135% in fraud recoveries last year from 2019. The average audit recovery per case was also 70% higher in 2020 than in 2019, Optum found. Optum found the fraudulent behavior concentrated among independent pharmacies and rarely found similar activity among retail chains, [Optum analysts] said. Due to the findings, the PBM axed 112 pharmacies from its network.
  • Kaiser Health News informs us that “Colorado health officials so abhor the high costs associated with free-standing emergency rooms they’re offering to pay hospitals to shut the facilities down. The state wants hospitals to convert them to other purposes, such as providing primary care or mental health services. At least 500 free-standing ERs have set up in more than 20 states in the past decade. Colorado has 44, 34 owned by hospitals. The trend began a decade ago with hopes these stand-alone facilities would fill a need for ER care when no hospital was nearby and reduce congestion at hospital ERs. But that rarely happened. Instead, these emergency rooms — not physically connected to hospitals — generally set up in affluent suburban communities, often near hospitals that compete with the free-standing ERs’ owners. And they largely treated patients who did not need emergency care, but still billed them and their insurers at expensive ER rates, several studies have found.” Good luck Colorado as this approach also may reduce surprise billing issues.

Friday Stats and More

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

Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 20th week of this year (beginning April 2, 2020, and ending May 19, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):

and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases greatly exceed new deaths. Accordingly here is a chart of new weekly COVID-19 deaths over the period April 2, 2020, through May 19, 2021:

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through May 19, 2021, which also uses Thursday as the first day of the week:

With respect to COVID-19 vaccinations, Medscape reports that

The COVID-19 vaccines authorized for use in the United States and Europe offer protection against the four main coronavirus variants known to exist, a World Health Organization official says. “All COVID-19 virus variants that have emerged so far do respond to the available approved vaccines,” WHO European Regional Director Hans Kluge said Thursday at a news conference.

In sum, from the COVID-19 stats front, the Centers for Disease Control states

COVID-19 cases, hospitalizations, and deaths are going down, and the number of people vaccinated continues to go up, providing a sense of optimism as summer approaches. As of May 20, 48.4% of the U.S. population ages 18 years and older is fully vaccinated, and 60.5% have received at least one dose of a COVID-19 vaccine. Additionally, as of last week, millions more are now eligible to receive a COVID-19 vaccine. These trends and new CDC evidence-based guidance on masking provide encouragement that we are making progress toward returning to a sense of normalcy.

As you look ahead to summer, consider how COVID-19 is spreading in your community when choosing activities. Outdoor activities and visits are safer than those indoors, but fully vaccinated people can participate in most indoor activities without much risk. If you are not yet vaccinated, you should continue to practice prevention strategies such as wearing a well-fitted mask, practicing physical distancing, avoiding crowds, and washing your hands. 

In the “and more” category

Health Affairs discusses five keys to realizing health equity in U.S. health plans. To wit

“The five major priorities (and the achievements that will result from these priorities) for health equity leadership in health plans are:

  • Prioritizing Prevention and Wellness: Benefits and care delivery redesign
  • Prioritizing Communities: Engagement and investments
  • Prioritizing Innovation: Population and digital health
  • Prioritizing Education, Research, and Workforce Development: Academic-community collaborations
  • Prioritizing Action and Accountability: Data-driven improvement.”

mHealth Intelligence reports that “GAO tells Congress to wait on expanding telehealth coverage past the pandemic.
A new report and testimony from the Government Accountability Office says the full effect of CMS waivers on telehealth coverage during the pandemic isn’t yet known, and more study is needed. That conclusion won’t make the American Medical Association happy.

Reuters informs us that “CVS Health Corp., best known for its national chain of drugstores, said on Thursday it had started offering clinical trial services to support drug developers with tasks like patient enrollment. CVS said it had already collaborated with drug developers to help facilitate clinical trials for investigational COVID-19 vaccines and treatments, which the new business will now expand.”

Speaking of clinical investigations, Medscape reports that

The novel Galleri blood test (GRAIL, Inc.), which claims to detect up to 50 different cancers from single blood draw, is about to make its clinical debut in the United States. However, an expert cautions that this test should be considered as being under clinical investigation. Providence Health System, based in Renton, Washington, will be the first health system in the US to offer access to the Galleri test, where it will be available as a complement to recommended single-cancer screening tests.

On its website, GRAIL notes that the Galleri blood test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. It is intended to detect cancer signals and to predict where in the body the cancer signal is located. However, it does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. It is “intended to be used in addition to, and not replace, other cancer screening tests,” [GRAIL’s Leslie] Strope emphasized.

The FEHBlog strongly recommends this week’s episode of the Econtalk podcast (three strong weekly episodes in a row) in which

Podcaster and author Julia Galef talks about her book The Scout Mindset with EconTalk host Russ Roberts. Galef urges us to be more rational–to be open-minded about what we might discover about the world–rather than simply defend what we already believe, which she calls the soldier mindset. The conversation is a wide-ranging discussion of our biases and the challenges of viewing the world objectively.

Weekend update

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

FEHBlog opening note — The FEHBlog goofed by posting this May 7 COVID-19 charts in the May 14 Friday Stats and More post. The FEHBlog corrected his error on Saturday after the Friday post email went out. You can check out the website if you want to see the May 14 charts which are encouraging. In contrast, check out the Wall Street Journal’s charts on the COVID-19 situation in India which is still struggling with virus. Whereas 37% of the U.S. population is fully vaccinated, less than 5% of the much larger and younger Indian population has reached that status. In this regard, the Rome (N.Y.) Sentinel offers an Excellus Blue Cross consulting pharmacist’s valuable guidance on why people in the age 18 to 34 bracket should received the COVID vaccination.

Q: Katie [Abbott, Pharm.D.], you are in that age group. Why did you choose to get vaccinated? 

I trust the science behind the vaccines and believe they will help bring us back to how life was before the pandemic.

Q: Some, or most cases of COVID-19 in younger people are not severe. Why would a younger person get vaccinated if younger people aren’t really dying from COVID-19?

The younger population may not be seeing as many severe cases or deaths, but they are still at high risk of long COVID. Long COVID is when those who have recovered from COVID-19 experience lasting effects, including a range of symptoms such as fatigue, brain fog, chest pain, shortness of breath, cough, joint or muscle pain, depression, anxiety, and so much more. Long COVID can develop weeks or months after infection. It can happen to anyone who has had COVID, even if they had mild or no symptoms. Getting the vaccine remains a safe way to protect yourself, along with your community, family members, and those who cannot be vaccinated.

Returning to the regular weekend update, both Congress will be in session this week for Committee work and House and Senate floor votes. The House Oversight and Reform Committee will hold its third recent hearing on prescription drug costs on Tuesday morning. It’s worth noting that although the House Oversight and Reform Committee approved the Postal Reform bill (HR 3076) last week, the House Energy and Commerce and Ways and Means Committees also have jurisdiction over the bill. So we don’t know right now, when the bill may reach the House floor.

In OPM news, the Federal Times reports that

In anticipation of more employees returning to the office and in the spirit of May’s Mental Health Awareness Month, the Office of Personnel Management issued a tip sheet for agency human resource staff to better support employees at a vulnerable time. * * * In addition to communicating with employees about the usual resources available to them – such as the Employee Assistance Program and mental health treatments offered through Federal Employee Health Benefit plans – OPM encouraged agency work-life coordinators and HR professionals to be as communicative as possible about office safety procedures and available work schedule adjustments to ease any potential employee anxiety.

In other healthcare news,

  • mHealth Intelligence discusses the work of University of West Virginia researchers who are seeking to determine the best mix of in-person and virtual care. “With telehealth use skyrocketing over the past year and a half due to the coronavirus pandemic, some have wondered if there’s a limit to its effectiveness. Is there a certain number of virtual visits that a patient – especially one with a chronic condition – should get, after which the technology outlasts its value? The answer, according the researchers at the University of West Virginia, is … uncertain.” While that outcome is surprising to the FEHBlog, the researchers have gone back to the drawing board.
  • Fierce Healthcare reports that “GoodRx, a telehealth and drug-pricing comparison software company, acquired competitor RxSaver for $50 million in cash. The company closed the deal in late April, GoodRx reported during its first-quarter 2021 earnings call Thursday. RxSaver, which was owned by Vericast Corp., the payment and marketing company controlled by billionaire Ronald Perelman, operates a price comparison platform to provide discount offerings through partnerships with pharmacy benefit managers (PBMs). The acquisition will expand GoodRx’s business capabilities and consumer reach, particularly with respect to its prescription offering, the company said in its first-quarter 2021 earnings report.”
  • Health Payer Intelligence informs us that ” To help combat racial care disparities in communities of color, Blue Shield of California (Blue Shield) provided $300,000 to 12 different nonprofit organizations in California that promote the mental health and well-being of youths in their communities.   This act supports the health equity strategy of Blue Cross Blue Shield Association (BCBSA), Blue Shield’s parent company, as it seeks to improve racial care disparities by collaborating with local community leaders. By contributing $25,000 to each organization, Blue Shield is providing opportunities for youths of color that can improve their mental health.”
  •  Healthcare Dive reports that “Piedmont Healthcare signed a non-binding letter of intent to acquire Augusta, Georgia-based University Health Care System, which operates three hospitals as well as skilled nursing facilities and urgent care clinics along Georgia’s eastern border with South Carolina. * * * Just last week, the 11-hospital system announced plans to buy four additional hospitals from HCA Healthcare for $950 million. The sale is expected to close in the third quarter of this year. The hospitals in the HCA deal circle the outskirts of the Atlanta region. * * * Altogether, the two most recent deals would give Piedmont a total of 18 hospitals in Georgia, in addition to more ancillary services.” Healthcare Dive adds that the two deals are likely to face regulatory scrutiny.