Midweek Update

Rx coverage

Midweek Update

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

The American Hospital Association informs us that

The Senate early this morning approved on a party line vote a $3.5 trillion budget resolution, which included reconciliation instructions which will provide the majority party with the means to pass a comprehensive reconciliation package with just 51 votes in the Senate, rather than the usual 60-vote hurdle. The House will reconvene on Aug. 23 to consider the budget resolution. Once the resolution has passed both chambers, the House and Senate majorities can proceed with the reconciliation process, a resolution to which is expected in the fall. 

Bloomberg adds

Translating the budget framework into law will require Biden and Democratic congressional leaders keeping their party’s moderate and progressive wings marching together.

Just hours after passage of the budget blueprint, Senator Joe Manchin, a Democrat from West Virginia, said he couldn’t support a social spending bill with a $3.5 trillion price tag. Senator Kyrsten Sinema, an Arizona Democrat, has said the same. One Democratic objection is all it would take to scuttle the package in the Senate.

Time will tell but we are talking about $3.5 trillion on top of the $1 trillion infrastructure bill and multi-trillion COVID-19 relief bills that Congress has passed in the last 18 months. It appears that Congress is trying to disprove the adage that money can’t solve all problems.

One of the initiatives in the budget reconciliation package is to add dental, vision, and hearing coverage to Medicare. Kaiser Health News discusses the issue here.

From the Delta variant front

  • The Centers for Disease Control’s Advisory Committee on Immunization Practice released a helpful report on COVID-19 adverse side effects which it summarized as follows

What is already known about this topic?

Rare serious adverse events have been reported after COVID-19 vaccination, including Guillain-Barré syndrome (GBS) and thrombosis with thrombocytopenia syndrome (TTS) after Janssen COVID-19 vaccination and myocarditis after mRNA (Pfizer-BioNTech and Moderna) COVID-19 vaccination.

What is added by this report?

On July 22, 2021, the Advisory Committee on Immunization Practices reviewed updated benefit-risk analyses after Janssen and mRNA COVID-19 vaccination and concluded that the benefits outweigh the risks for rare serious adverse events after COVID-19 vaccination.

What are the implications for public health practice?

Continued COVID-19 vaccination will prevent COVID-19 morbidity and mortality far exceeding GBS, TTS, and myocarditis cases expected. Information about rare adverse events should be disseminated to providers, vaccine recipients, and the public.

  • Forbes tells us that today “The Centers for Disease Control and Prevention encouraged anyone pregnant and breastfeeding to get vaccinated against coronavirus Wednesday, pointing to a growing amount of evidence that vaccines are safe and effective as new cases and hospitalizations linked to the virus surge across the country.” The Washington Post adds “Just 23 percent of pregnant women have received at least one shot of vaccine.”
  • Also from Forbes as schools begin to reopen “Vaccine rates among teenagers have remained lower than the U.S. population overall, with only 43% of 12- to 15-year-olds and 52.8% of 16- and 17-year-olds receiving at least a first dose as compared with 58.9% of the total population and 71.2% of adults.”
  • The Boston Globe discusses this teenage hesitancy issue — “The top reservation among parents of unvaccinated teens was the lack of information about the long-term effects of the shot, followed by concerns about side effects and fertility — despite conclusive evidence that the vaccine has no negative impacts on reproduction. Dr. Jill Kasper, a pediatrician at Cambridge Health Alliance, said she typically encounters ‘very little hesitancy’ from parents about routine adolescent vaccinations. That hasn’t been the case with COVID-19.”

The HHS Agency for Healthcare Quality and Research issued two noteworthy studies today. Here are the topline findings

  • #1 Overuse or low-value procedures may result in patient physical, psychological, or emotional harm. This study explored the association between eight low-value care procedures and length of stay (LOS) and cost. All eight procedures were associated with increased LOS and cost, particularly spinal fusion. Patients receiving low-value care may be exposed to increased risk of adverse events and hospital-acquired conditions.
  • #2 Medication administration errors made by parent or caregivers can result in medication errors at home. This systematic review found that 30% to 80% of pediatric patients experience a medication error at home, and that the risk increases based on characteristics of the caregiver and if a prescription contains more than two drugs.

Healthcare Dive informs us that

  • CVS Health said its Aetna unit will offer virtual primary care to self-funded employers nationwide in a move that underscores the growing popularity of telehealth services fueled by the COVID-19 public health emergency.
  • Using Teladoc Health’s physician-led care team model, the Aetna Virtual Primary Care service is intended to help strengthen the patient-doctor relationship and improve access to care, the vertically integrated company announced Tuesday. Members can receive health services remotely and in person.

Such support for primary care should be applauded.

In other healthcare news

  • STAT News reports that The Department of Veterans Affairs has decided not to cover a new Alzheimer’s drug from Biogen [Adulhelm], citing insufficient evidence of “a robust and meaningful clinical benefit” and concerns about safety. In a notice issued by the agency, the VA said it will make exceptions for “highly selected patients” and listed several hurdles that must be cleared before the medicine will be covered, such as requiring it to be prescribed by providers who specialize in treating dementia and ensuring patients had recently received MRI brain scans. * * * ‘Its bad news for Biogen,’ said Ira Loss of Washington Analysis, which tracks legislative and regulatory issues affecting the pharmaceutical industry for investors, who noted several private insurers have either declined or delayed coverage for the drug. ‘The VA is a big buyer of medicines. And you don’t like this kind of publicity, that’s for sure.’”
  • Fierce Healthcare continues to report from the HIMSS conference in Las Vegas. “Health IT giant Epic launched a new customer story-sharing website that lets Epic users share insights, tips and creative ideas around using health IT to improve their organizations and patient care. The site, EpicShare.org, combines insights from industry leaders, quick tips on improving outcomes and performance, in-depth case studies as well as a “Hey Judy” column from Epic founder and CEO Judy Faulkner.”

Friday Stats and More

David Ermer–COVID-19, COVID-19 vaccine, Federal employment benefits, OPM, 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 31st week of this year (beginning April 2, 2020, and ending August 4, 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 exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through August 4, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through August 24, 2021, which also uses Thursday as the first day of the week:

While COVID-19 cases are soaring, the number of deaths remains stable thanks to the high vaccination rates for Americans over age 65. It is also encouraging that the number of administered vaccinations also is increasing.

In other Delta variant news:

  • Surprisingly, according to STAT News, “with nearly 20% of all U.S. Covid cases last week recorded in children, the American Academy of Pediatrics and 11 other organizations put out a consensus statement this week calling on providers conducting sports physicals to ask about children’s Covid vaccination status and to use it as an opportunity to administer a vaccine, if possible.”
  • Fierce Pharma tells us that “In a trial of nearly 480,000 healthcare workers in South Africa, Johnson & Johnson‘s one-dose vaccine helped prevent severe disease from the Delta variant, Bloomberg reports. The trial is the first piece of large-scale evidence that shows the shot works against the variant, the news service stated. In fact, Glenda Gray, one of the leaders of the work, said the vaccine may provide better protection against Delta than the Beta variant.”
  • MedPage Today reports that “Unvaccinated adults who were previously infected with COVID-19 were twice as likely to be reinfected as those previously infected but also fully vaccinated, researchers found. A case-control study in Kentucky found a more than two times higher risk of COVID-19 cases among unvaccinated adults with prior infection compared with their fully vaccinated counterparts (OR 2.34, 95% CI 1.58-3.47), reported Alyson Cavanaugh, PhD, of the CDC, and colleagues, writing in an early edition of the Morbidity and Mortality Weekly Report.“
  • In related news Precision Vaccines tells us that “The World Health Organization (WHO) issued Influenza Update N° 399 on August 2, 2021, saying, ‘Globally, despite continued or even increased testing for influenza in some countries, influenza activity remained at lower levels than expected for this time of the year.'”

From the No Surprises Act (“NSA”) front, the FEHBlog discovered today that last Tuesday the tri-agencies and OPM submitted their second NSA interim final rule, which concerns the independent dispute resolution process, to OMB’s Office of Information and Regulatory Affairs for final review. OIRA already has two listening sessions concerning this rule making on its calendar. This indicates that the second interim final rule will be made public in early September, rather than on its October 1, 2021, due date.

From the federal employee front

  • Govexec brings us up to date on the development of the President’s mandatory vaccination program for federal employees. “The Safer Federal Workforce Task Force—a group President Biden created by executive order that is led by the White House, General Services Administration and Office of Management and Budget—confirmed in new guidance agencies would not initially ask for proof of vaccination, but they could follow up for documentation if they receive “a good faith allegation that strongly suggests” an employee lied on their attestation form. Those “certification of vaccination” forms will soon go out via email to all federal employees, with an Office of Management and Budget official saying that process will begin next week.  While agencies will initially rely on the honor system as it begins asking employees for their vaccination status, the administration made clear there could be consequences for lying.”
  • Govexec also discusses how Medicare Advantage plans are being integrated into FEHB plans. The trend started with HMOs and the APWU Health Plan picked it up for this year. Expect more plans to follow suit for 2022.  

In more news

  • Earlier this week, the FEHBlog noted a Reuters report that the Justice Department is preparing to file suit to block Optum’s acquisition of Change Healthcare. Fierce Healthcare reports today au contraire that “Change Healthcare President and CEO Neil de Crescenzo said Thursday he’s pleased with the company’s progress on regulatory review of its pending deal with Optum and is moving forward with plans for a successful integration. ‘We look forward to continuing to work diligently in coordination with UHG (UnitedHealth Group) to provide the necessary information requested by the DOJ (Department of Justice) and completing the transaction.'” Time will tell.
  • Medcity News informs us that “GoodRx struck a partnership with medication data giant Surescripts that would let healthcare providers access cash price information on medications. Arlington, Virginia-based Surescripts dominates the e-prescribing market, offering technology that routes clinicians’ electronic prescriptions directly to pharmacies. It’s owned by CVS Health and Express Scripts, and nearly 2 billion prescriptions were delivered through its software last year.”
  • mHealth Intelligence tells us that “While the pandemic prompted an unprecedented surge in telehealth to address healthcare needs, it also highlighted the gap between those who can access care and those who can’t. Now health systems, community health organizations, non-profits and philanthropic groups are moving to address those gaps with programs that use telehealth to extend care to those who can’t access or afford it. They’re fueling a surge in connected health charities and projects targeting the social determinants of health. Among those groups is Beam Up, an organization launched by telehealth company Beam Healthcare to address gaps in access to health food, quality education and healthcare services. Executives see a need for these services not only in other countries – a partnership with Tyto Care is equipping a handful of orphanages in Mexico with telemedicine technology – but in cities and rural regions across the United States.

Midweek Update

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

It turns out that OPM Director Kiran Ahuja held her first virtual press conference this morning.

  • The Federal Times discusses her conversation with reporters about implementing the President’s vaccination mandate and piloting an online retirement application for federal employees.
  • Federal News Network and FCW paint with broader brushes about Ms. Ahuja’s goals and challenges.

The FEHBlog noticed today that the OPM senior staff bios on its website provide a good picture of Director Ahuja’s team.

On the Delta variant front

  • Kaiser Health News makes a convincing economic agreement for receiving a COVID-19 vaccination.
  • The New York Times reports that “With a new surge of coronavirus infections ripping through much of the United States, the Food and Drug Administration has accelerated its timetable to fully approve Pfizer-BioNTech’s coronavirus vaccine, aiming to complete the process by the start of next month, people familiar with the effort said. President Biden said last week that he expected a fully approved vaccine in early fall. But the F.D.A.’s unofficial deadline is Labor Day or sooner, according to multiple people familiar with the plan. The agency said in a statement that its leaders recognized that approval might inspire more public confidence and had “taken an all-hands-on-deck approach” to the work.”

On the 2nd quarter financial reports front, Healthcare Dive reports that

Returning utilization of health services and higher-than-expected COVID-19 care costs drove CVS Health’s net income in the second quarter down 7% year over year to $2.8 billion, the healthcare behemoth reported Wednesday.

The payer business, which includes Aetna, reported a medical loss ratio of 84.1%, up significantly from 70.3% the same time last year. The hike in MLR, which was higher than both internal and analyst forecasts, is especially acute compared to the second quarter of 2020, which saw a severe dip in utilization as COVID-19 lockdowns and elective procedure restrictions kicked into gear.

However, CVS beat Wall Street expectations for both earnings and revenue, with topline of $72.6 billion, up 11% year over year, driven mostly by growth in government products. The Woonsocket, Rhode Island-based company raised its full-year guidance following the results.

In legal news, Business Insurance informs us that “The U.S. Department of Justice is weighing a possible lawsuit to block UnitedHealth Group’s (UNH.N) nearly $8 billion deal to acquire health care analytics and technology vendor Change Healthcare (CHNG.O), the Information reported on Tuesday.”

From the federal employee benefits front, Reg Jones tells us in FedWeek that “One valuable feature of the Federal Long Term Care Insurance Program is its more generous rules regarding coverage in retirement, as compared with the FEHB health insurance and FEGLI life insurance programs.” Of course, the greater flexibility may be explained by the facts that FEHB and FEGLI coverage are government funded while FLTCIP is fully member funded. Still it’s useful information.

In other mid-week news

  • The Center for Medicare and Medicaid Innovation released its 2020 report to Congress today.
  • STAT News tells us that “For all the explosive controversy over the approval of the first treatment for Alzheimer’s disease in nearly 20 years, hardly any patients have actually gotten it yet. The drug’s eye-popping, $56,000 annual price and questionable benefit to patients have been a shock to the bureaucracy that makes the health care system run — and that’s having a clear effect on uptake. Some analysts estimated last month that fewer than 100 patients were dosed in the first weeks after the therapy was approved, though availability will likely ramp up over the coming months.”
  • Health Payer Intelligence discusses “five ways payers have tackled mental, hehavioral Healthcare in 2021. As the coronavirus pandemic becomes more manageable and vaccination rates increase nationwide, payers are channeling funds into mental and behavioral healthcare programs.” That’s a sound focus of attention.

Thursday Miscellany

David Ermer–COVID-19, COVID-19 vaccine, Rx coverage, Telehealth–

From the Delta Variant front

  • As explained in this White House fact sheet, President Biden announced, among other things, that “to help protect workers and their communities, every federal government employee and onsite contractor will be asked to attest to their vaccination status. Anyone who does not attest to being fully vaccinated will be required to wear a mask on the job no matter their geographic location, physically distance from all other employees and visitors, comply with a weekly or twice weekly screening testing requirement, and be subject to restrictions on official travel. * * * These rules should not only apply to federal workers and onsite contractors. President Biden is directing his team to take steps to apply similar standards to all federal contractors. The Administration will encourage employers across the private sector to follow this strong model.”
  • The FEHBlog was struck by the fact that President intends to apply the mandate to federal contractors which group includes all of the FEHB carriers. If President were to flow down the mandate to federal subcontractors, he would pick up a large chunk of the American economy. This mandate whatever its scope would be accomplished by an amendment to the Federal Acquisition Regulation or perhaps regulator interpretations of the FAR which already includes a lot of provisions on worker safety. Time will tell.
  • Govexec reports on federal employee union and organization responses to the vaccine mandate which has been mixed. The Wall Street Journal adds that “Two prominent business groups, the U.S. Chamber of Commerce and Business Roundtable, said they welcomed Mr. Biden’s actions.”
  • The Wall Street Journal reports on private sector employers that have implemented a vaccine mandate, including Morgan Stanley, Google and Facebook. These mandates have been tied to office reopenings.

In telehealth business news —

Healthcare Dive reports that

Teladoc Health saw its year-over-year total revenue more than double in the second quarter of this year, coming in above Wall Street expectations and hiking its full-year guidance for the second time this year after offering mild expectations in February.

Analysts noted, however, that membership numbers were stale and the hospital business was slower than expected for the quarter. Shares were down 6% in morning trading Wednesday.

In a call with investors Tuesday, executives tried to steer the conversation toward per-member revenue metrics and touted new contracts, including with major Blues payer HCSC and a primary care platform agreement in the works with an unnamed national payer.

Fierce Healthcare reports that “Amwell is acquiring two digital health companies for $320 million to expand its services beyond telehealth visits. The virtual care company is scooping up SilverCloud Health, a digital mental health platform, and Conversa Health, which offers automated virtual healthcare. The addition of the two companies’ technology will help to differentiate Amwell from other telehealth players, company executives said.”

In prescription drug news, STAT News tells us more about the interchangeable insulin biosimilar that the Food and Drug Administration approved for marketing yesterday. Of note

The agency endorsed Semglee, a copy of long-acting Lantus (insulin glargine), that it first approved last year. * * * But Lantus, which is sold by Sanofi (SNY), already faces competition from several other long-acting insulins. And the company that sells Semglee – Viatris (VTRS), which was created last year when Mylan merged with Pfizer’s Upjohn unit – faces the same challenges winning coverage from health insurers. * * *

The real impact rests with patients whose out-of-pocket costs are more closely tied to the wholesale price for Semglee, according to Sonia Oskouei, vice president of biosimilars at Cardinal Health, a large pharmaceutical wholesaler. Those who pay cash or have high deductible health insurance typically pay more than others, which is where the “market opportunity” exists, she explained.

Depending on the pharmacy, Semglee injector pens cost about $150 to $180 without insurance for a typical month’s supply, compared to $340 or more for the same supply of Lantus, according to the GoodRx web site.

Also STAT News informs us that “Emergent BioSolutions (EBS) plans to resume Covid-19 vaccine production at its Baltimore plant after getting the green light from the FDA, according to The Wall Street Journal. The Baltimore plant had been shut down after FDA inspectors determined there was severe contamination at the plant, which makes the Johnson & Johnson (JNJ) vaccine. While domestic demand for the J&J shot has dwindled in recent months, the Biden administration is seeking to export the vaccine to countries needing protection against Covid-19.” The loss of the Johnson & Johnson to the U.S vaccination campaign will be noted in histories as the one dose is effective with socially vulnerable communities.

Midweek update

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

From the Delta variant front:

  • The Wall Street Journal offers a helpful set of FAQs on the Delta variant of COVID-19.
  • The Journal also reports that “President Biden is expected to announce Thursday that his administration will require federal employees to get vaccinated or be regularly tested for Covid-19, according to a person familiar with the discussions. * * * The person familiar with the situation said no decision has been finalized, and the policy is still under review. The person said the administration is also strongly considering more stringent masking protocols for unvaccinated federal workers. Such policies could affect millions of workers, depending on which categories of employees were included.
  • Federal News Radio writes out a laundry list of “tricky legal questions” posed by the vaccine mandate, according members of the bar. The FEHBlog expects that the courts will resolve these questions in the government’s favor expeditiously.
  • Bloomberg reports that vaccinations rates are up sharply in the areas of the country where the Delta variant is running amuk. In the end you can count on common sense prevailing.
  • The Journal also informs us that “Protection against symptomatic Covid-19 from Pfizer Inc. and partner BioNTech SE’s vaccine diminished over time but remained strong after six months, according to data released by the companies Wednesday. The efficacy of the vaccine protecting against symptomatic disease dropped every two months, to 84% after six months from a peak of 96% within two months of vaccination, a decline that may add urgency to Pfizer’s push to administer an additional dose to maintain protection. The companies reported that cumulatively the vaccine was 91% effective at preventing symptomatic Covid-19 during the first six months, in line with the analysis that was first reported earlier this year.”

On the new drug / drug research front

  • The Food and Drug Administration today approved for marketing “the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog. Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S. for the treatment of diabetes. Approval of these insulin products can provide patients with additional safe, high-quality and potentially cost-effective options for treating diabetes.” Outstanding.
  • The National Institutes of Health (NIH) announced that “Researchers have identified a cellular defect common to familial and sporadic forms of ALS [/ Lou Gehrig’s Disease]. The NIH-funded study may point to possible therapeutic target for the disease.” Encouraging.

In other NIH news, the director of the National HEAL Initiative provides an update on the program’s efforts. She describes her program as follows:

HEAL’s mission is to find scientific solutions to help end addiction long-term. And although this goal is concrete, it’s not always simple. We recognize that people face real-world challenges accessing high-quality care for pain and addiction, and our research needs to take this into account. As I’ll describe in the post, HEAL is funding several studies to accelerate research to practice to improve health, as well as to prevent unnecessary loss of life from overdose.

Good luck with that worthy effort.

In FEHB news, Reg Jones has posted a Fedweek column on children’s benefits under the program.

Healthcare Dive continues to report on second quarter financial reporting from health insurers. Today, Humana reported. According to Healthcare Dive,

Non-COVID-19 medical use bounced back faster than expected during the second quarter, Humana executives told investors Wednesday. The insurer was able to post net income of $588 million as COVID-19 treatment costs for its members fell faster than anticipated, compared to $1.8 billion a year ago as patients deferred care amid the pandemic.

Humana, which insures a large portion of seniors through Medicare, did disclose that is has noticed COVID-19 admissions increasing in recent weeks, a potentially troubling sign.

The payer experienced robust membership growth in its Medicaid business while it reported declines in the fully-insured commercial segment. Overall, total medical membership was up slightly compared to the prior-year period.

Monday Roundup

David Ermer–COVID-19, COVID-19 testing, COVID-19 vaccine, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash
  • On the COVID-19 front, David Leonhardt in the New York Times provides valuable insights on how to think about COVID-19 cases that have broken through vaccinations. “

Different vaccinated people are going to make different decisions, and that’s OK. I find the risk of breakthrough infections to be small enough that I’m not going to make major changes to my behavior.

I would feel differently if I lived in a community with a lower vaccination rate — or if I lived with somebody who was vulnerable to Covid because of an immunodeficiency. And the current surge in cases has changed my thinking. I will again wear a mask sometimes when in close contact with strangers, even if it has little tangible effect. The main reason to do so, as Dowdy said, is to contribute to a shared sense that we have entered a worrisome new phase of the pandemic.

  • Fierce Healthcare reports that “Dozens of healthcare professional organizations including the American Hospital Association, America’s Essential Hospitals and the Association of American Medical Colleges have released joint or individual statements calling for providers to implement mandatory COVID-19 vaccination policies for healthcare personnel.” The Wall Street Journal adds that “A significant uptick in Covid-19 cases across the U.S. is leading to new vaccination mandates for public employees, with the Department of Veterans Affairs on Monday becoming the first federal agency, California the first state, and New York the first major city to announce requirements for their workers. “epartment of Veterans Affairs Secretary Denis McDonough said healthcare personnel who work in or visit Veterans Health Administration facilities or provide direct care to people the VA serves would have eight weeks to get vaccinated. Officials in the state of California and New York City said Monday they would require their workers to either be vaccinated against Covid-19 or be tested at least weekly for the virus. California’s order, which also applies to those who work in healthcare settings, goes into effect in August. The New York City mandate begins after Labor Day.”
  • The Wall Street Journal also reports “The U.S. has purchased 200 million additional Covid-19 vaccine doses from Pfizer Inc. and partner BioNTech SE at a higher price than previous deals. The U.S. is paying about $24 a dose, according to Pfizer, up from the $19.50 that the government paid in its earlier deals to supply the country. The deal brings the total purchased from the U.S. to 1 billion doses. The companies said they expect to deliver 110 million of the additional doses by the end of the year, with the rest by the end of next April.  While demand has largely stalled in recent weeks, additional demand could open up if the vaccine is cleared for use in younger children. Pfizer is testing the vaccine in children under 12 years old, and has said it hopes to begin having data available before the end of the year.  The new agreement is in addition to the one announced last month for 500 million doses that the U.S. is scheduled to donate to the rest of the world.”
  • In this regard, the Washington Post reports that “Federal regulators have requested that vaccine companies expand their trials to test coronavirus shots in several thousand school-aged children before seeking [emergency use authorization] — a move intended to assess whether a rare inflammation of the heart muscle that has been seen in young adults shortly after vaccination is more common in younger age groups.”
  • STAT News provides its perspective on the current surge. STAT suggests that this surge is accelerating faster than last summer’s surge which is not surprising because the Delta variant is much more contagious that the variant in circulation last summer.
  • The Department of Health and Human Services (“HHS”) has announced that it ‘will invest more than $1.6 billion from the American Rescue Plan to support testing and mitigation measures in high-risk congregate settings to prevent the spread of COVID-19 and detect and stem potential outbreaks.’
  • Today, in commemoration of “the 31st anniversary of the Americans with Disabilities Act (ADA), (HHS) and the U.S. Department of Justice (DOJ) jointly published guidance on how “long COVID” can be a disability under the ADA, Section 504 of the Rehabilitation Act, and Section 1557 of the Affordable Care Act.  The guidance is on the HHS website and on the DOJ website.

Also today, HHS announced phase 2 of the HPV vaccination campaign for young adults.

Currently, only 40% of young adults in the United States have received one or more doses of the human papillomavirus (HPV) vaccine, and only 22% have completed the vaccine series.i The HHS Office of the Assistant Secretary for Health’s Office on Women’s Health is launching the second phase of the HPV VAX NOW campaign to address this gap. The initial campaign launched on January 6, 2021 to support healthcare providers who counsel young adults in Mississippi, South Carolina, and Texas by providing resources to promote effective HPV vaccine recommendations. The second phase of the campaign will target young adults ages 18–26 in the same three states, with the long-term goal of empowering all to complete the HPV vaccine series.

In health equity developments

  • The American Academy of Actuaries has released a paper on health equity from an actuarial perspective that is worth a gander.
  • Patient Engagement HIT discusses how “a new study [in the New England Journal of Medicine] revealing unequal opioid and pain medication prescription access between White and Black patients is calling into question the prevalence of implicit bias in medicine.” The researchers concluded that “We do not know whether or how these differences affect patient outcomes, because both opioid underuse and overuse can cause harm. We do know that skin color should not influence the receipt of pain treatment. “Our overall observations and system-specific reporting should prompt action by providers, health system administrators, and policymakers to explore root causes, consequences, and effective remediation strategies for racially unequal opioid receipt.”
  • In that regard, Kaiser Health News discusses the pros and cons of state and local government monitoring of opioid prescriptions.

When efforts to establish Missouri’s statewide monitoring program stalled, St. Louis County established one in 2017 that 75 local jurisdictions agreed to participate in, covering 85% of the state, according to the county health department. The county now plans to move its program into the state one, which is scheduled to launch in 2023.

Dr. Faisal Khan, director of the county department, said he has no doubt that the St. Louis program has “saved lives across the state.” Opioid prescriptions decreased dramatically once the county established the monitoring program. In 2016, Missouri averaged 80.4 opioid prescriptions per 100 people; in 2019, it was down to 58.3 prescriptions, according to the CDC.

Khan acknowledged that a monitoring program can lead to an increase in overdose deaths in the years immediately following its establishment because people addicted to prescription opioids suddenly can’t obtain them and instead buy street drugs that are more potent and contain impurities.

But he said a monitoring program can also help a physician intervene before someone becomes addicted. Doctors who flag a patient using the monitoring program must then also be able to easily refer them to treatment, Khan and others said.

“We absolutely are not prepared for that in Missouri,” said Winograd, of NoMODeaths. “Substance use treatment providers will frequently tell you that they are at max capacity.”

The FEHBlog would rather see expansion of treatment facilities that loosening standards on opioid prescribing.

Weekend update

David Ermer–Congress, COVID-19, Medicare, Rx coverage, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

Both Houses of Congress will be in session this week for Committee business and floor voting. It should be noted that for the next several weeks that FEHBlog will be writing from Austin, TX, way outside the Capital Beltway.

On the COVID-19 front

  • The American Medical Association offers an article on what doctors would like their patients to know about COVID-19 variants.
  • The Wall Street Journal reports on the efforts of Pfizer, Merck and the Japanese drugmaker Shionogi to develop a pill to treat COVID-19. “Drugmakers are looking for a pill that those who get a positive Covid-19 test could take at home while their symptoms are mild. Such medicines already exist for influenza, including Roche Holding AG’s Tamiflu and Shionogi’s Xofluza, although they don’t work for all patients and might be prescribed too late to do much good. Xofluza is marketed in the U.S. by Roche. ‘Our target is a very safe oral compound, like Tamiflu, like Xofluza,’ said Isao Teshirogi, Shionogi’s chief executive officer. He said Shionogi’s Covid-19 pill aims to neutralize the virus five days after a patient takes it.” In contrast to the convenience of pills, existing COVID-19 treatments must be administered by a doctor in a hospital or other healthcare facility.

On the regulatory front

  • The American Hospital Association provides more background on the last week’s proposed Calendar Year 2022 Medicare Part B payment rule. The public comment deadline is September 17.
  • Kaiser Health News reports on Biogen’s rather aggressive response to criticism of its FDA approval Alzheimer’s Disease drug Aduhelm which was rolled out last week.

In other news —

  • AHIP discusses health insurer efforts to address provider burnout stemming from the pandemic.
  • Fierce Healthcare reports that UnitedHealthcare, the largest insurer in the country, will make Peloton’s fitness classes to nearly 4 million fully insured members at no cost through its app, beginning on Sept. 1, the company announced. Eligible members will have access to either a 12-month Peloton digital subscription or a four-month waiver for a Peloton All-Access Membership, the insurer said. All-Access members can take fitness classes through connected devices, such as Peloton’s bikes, and track their metrics, in addition to app access.”
  • Fierce Healthcare also informs us that “Anthem and Humana have signed on for a minority stake in a new joint venture that aims to reshape the claims management experience. DomaniRx, pending regulatory approval, will feature a cloud-native, API-driven claims adjudication platform, according to an announcement. SS&C Technologies, which provides services and software to the financial and healthcare industries, will have a majority stake in the venture. * * * The goal of the venture, according to the announcement, is to arm healthcare organizations with “end-to-end transparency and data analytics” to help them keep up with an ever-changing regulatory environment.”

Friday Stats and More

David Ermer–CDC, COVID-19, COVID-19 vaccine, Rx coverage, Telehealth–

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 28th week of this year (beginning April 2, 2020, and ending July 14, 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 materially exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through July 14, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through July 14, 2021 which also uses Thursday as the first day of the week:

As of today, according to the Centers for Disease Control, 160.7 million Americans are fully vaccinated against COVID-19, which figure represents 59.6% of the population eligible to be vaccinated (age 12 and up). 79.3% of the population over age 65 is fully vaccinated. That’s a key fact.

The American Hospital Association informs us that “Pfizer today said its COVID-19 vaccine will receive a priority review from the Food and Drug Administration, indicating that Pfizer has completed its rolling submission of its application for the vaccine’s full authorization. The company’s Biologics License Application, which is intended for individuals age 16 and older, is supported by clinical date from its phase 3 clinical trial.” That’s good news.

The Washington Post reports that “A federal advisory panel [the CDC’s Advisory Committee on Immunization Practices] is expected next week to consider whether health-care workers should be allowed to give additional coronavirus shots to patients with fragile immune systems, even as top U.S. health officials have said an additional dose of vaccine is not widely needed. * * * The advisory panel[on July 22] plans to focus on the 2 to 4 percent of U.S. adults who have suppressed immunity, a population that includes organ transplant recipients, people on cancer treatments and people living with rheumatologic conditions, HIV and leukemia.”

From the prescription drug front —

  • STAT News reports that “A prominent panel of medical experts [convened by the Institute of Clinical and Economic Review] unanimously voted that there is no evidence to suggest the recently approved Alzheimer’s drug offers patients any health benefits beyond the usual care. * * * After the voting, a roundtable discussion was held during which Mark McClellan, a former Centers for Medicare & Medicaid Administrator, said that access to Aduhelm “is going to be pretty limited at least until the nine-month period is over” and that we are “not going to see very big numbers in the near term.” This is likely because many payers will want to wait for Medicare to make its coverage decision in early 2022.”
  • Bloomberg reports that ” When a new obesity medication from the Danish drugmaker Novo Nordisk A/S began selling in the U.S. in June, it became the most effective weight loss drug on the market. Wegovyhelps patients lose an average of about 15% of their body weight, almost double the rates demonstrated by other prescription treatments, according to study results. That translates to a loss of about 20 to 70 pounds for eligible patients. Only costly and invasive bariatric surgery has shown the ability to eliminate more pounds. With more than 100 million people categorized as obese, the U.S. is a potentially huge market for Wegovy, which costs $1,350 for four weekly injections and is being pitched as a long-term therapy. * * * Insurance companies, pharmacy benefit managers, and employers determine whether health plans cover weight loss drugs, and which ones. Today only about half the clients of Cigna Corp.’s Express Scripts unit and Prime Therapeutics LLC, two major pharmacy benefit managers, reimburse for weight loss drugs. Express Scripts recently added Wegovy to its largest formulary, covering about 24 million people. Insurers Anthem Inc. and CVS Health Corp.’s Aetna don’t typically cover weight loss drugs, but both have indicated Wegovy will likely get some coverage. Others have yet to decide. Although “it’s not for everyone,” Wegovy has a role to play in treating obesity, says Amy Bricker, president of Express Scripts. She says she’s optimistic that treating obesity will lower costs for Express Scripts’ health plans.”

HealthTech Magazine offers a useful article on integrating virtual care into a healthcare organization’s overall delivery strategy. During the NCQA / HL7 Digital Quality Measure conference this week more than one doctor remarked that no one has found the Goldilocks level for virtual care, but at least study appears underway.

Thursday Miscellany

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

The FEHBlog realized today that he had neglected to provide this link to Prof. Katie Keith’s comprehensive Health Affairs Blog article on the first No Surprises Act interim final rule. AIS offers the following expert takes on that rule:

Industry experts’ perspectives:

Loren Adler, an associate director at the USC-Brookings Schaeffer Initiative for Health Policy, says that the QPA formula could lock in high rates for providers in some regions, particularly areas where there is a paucity of certain types of providers. He interprets the QPA calculation in the IFR as “a pretty provider-friendly definition.
Ge Bai, Ph.D., an associate professor at Johns Hopkins University’s Carey Business School and Bloomberg School of Public Health, says that it’s important to remember the larger picture — the No Surprises Act could reduce physicians’ revenue in some cases. She says that it could exacerbate physician shortages in areas that pay lower rates than others as physicians move to more lucrative locations.
Going forward, it’s hard to say whether the law and IFR will have inflationary effects on health care prices overall, Adler says. “The biggest piece of that, the determinant, will be the arbitration process,” he adds. He’s waiting to see what happens when the law actually comes into effect and arbitrations begin to take place.

The FEHBlog hopes that this law will not encourage providers to leave health plan networks.

On the COVID-19 front

  • David Leonhardt in the New York Times informs us about “Hopeful News on Delta. The Delta variant is more contagious. It does not appear to be more severe.” “If a new variant is not actually more severe, it doesn’t present a greater threat to a typical person who contracts Covid. Vaccinated people would remain protected. For children too young to be vaccinated, serious Covid symptoms would still be exceedingly rare — rarer than many other everyday risks, like riding in a car — and still concentrated among children with other health problems.”
  • U.S. Surgeon General Dr. Vivek Murthy issued “the first Surgeon General’s Advisory of this Administration to warn the American public about the urgent threat of health misinformation. Health misinformation, including disinformation, have threatened the U.S. response to COVID-19 and continue to prevent Americans from getting vaccinated, prolonging the pandemic and putting lives at risk, and the advisory encourages technology and social media companies to take more responsibility to stop online spread of health misinformation.

On the Aduhelm front:

  • The Wall Street Journal reports that “A pair of large hospitals are declining to administer Biogen Inc.’s new Alzheimer’s treatment, Aduhelm, the latest rupture to emerge from the Food and Drug Administration’s controversial approval of the drug last month. The Cleveland Clinic and Mount Sinai Health System in New York said they wouldn’t administer Aduhelm, which is also called aducanumab, to patients amid a debate about the drug’s effectiveness and whether the FDA lowered its standards in approving the medicine.”
  • Healthcare Dive informs us that “On a morning call with investors [today], UnitedHealth leadership said they were waiting on more information before making a coverage decision regarding Aduhelm, Biogen’s expensive new drug for Alzheimer’s disease priced at an average cost of $56,000 per year.”
  • STAT News tells us that

Normally, if a drug gets FDA approval, that means it has some benefit to patients. But the FDA decided to greenlight Biogen’s controversial drug Aduhelm without that guarantee.

That decision leaves patients, clinicians, and insurance companies in the dark. Under by far the most pressure is Medicare [and FEHB is a close second because FEHB carriers are on the hook for Medicare eligible annuitants drug coverage (see Wednesday’s post)}, since most patients eligible for the pricey drug have insurance through the taxpayer-funded program. Officials with the program just this week started the process for figuring out how Medicare will cover the drug, which will take months.

Some experts and stakeholders, including the influential Alzheimer’s Association, have called on Medicare to activate a rarely used regulatory tool to get more data about how well the drug works. (The FDA has also said Biogen must study whether Aduhelm slows down patients’ cognitive decline, but the drug maker has said it doesn’t have to report its results for another nine years.)

The tool, called a Coverage with Evidence Development, would mean Medicare would only cover Aduhelm for patients who enroll in clinical studies. The process has the potential to create real-world data that could help patients, physicians, and payers navigate unprecedented and difficult decisions.

In miscellaneous news

  • Healthcare Dive reports that “UnitedHealth Group handily beat Wall Street expectations for earnings and revenue in the second quarter, reporting revenue up 15% year over year to $71.3 billion, leading the Minnesota-based healthcare behemoth to increase its full-year guidance following the results.”
  • The Department of Health and Human Services announced that “more than two million people have signed up for health coverage during the Biden-Harris Administration’s 2021 Special Enrollment Period (SEP), which opened on February 15, 2021 as the country grappled with the pandemic, and will conclude on the extended deadline August 15, 2021.” * * * “The report also shows that of the new and returning consumers who have selected a plan since April 1, 1.2 million consumers (34%) have selected a plan that costs $10 or less per month after the American Rescue Plan’s (ARP) premium reductions.” The President wants Congress to make permanent this two year long premium reduction program.
  • Fierce Healthcare adds that “Senate Democrats announced late Tuesday the framework for a $3.5 trillion infrastructure package that will expand Medicare to offer dental, hearing and vision benefits.”

Midweek update

David Ermer–Federal employment benefits, OPM, Rx coverage, Telehealth, U.S. Healthcare–

At the top of FEHB news today is the release of the Congressional Budget Office’s report on the Postal Service Health Benefit (“PSHB”) Program provisions of the Postal Reform bill.

CBO expects that PSHB premiums would be lower than those for FEHB plans because Medicare would cover most of the health care costs for Medicare-eligible enrollees in PSHB plans. CBO estimates that USPS spending on health insurance premiums for active workers and their dependents would decrease by roughly $2.5 billion over the 2021-2031 period; those amounts are recorded as off-budget. CBO also estimates that federal spending for health insurance premiums for USPS annuitants and their dependents would decrease by $2.5 billion over that same period; those amounts are recorded as on-budget. * * *

FEHB premiums would rise slightly after those enrollees moved to the PSHB program, CBO expects. Over time, as USPS workers and annuitants enroll in a PSHB plan rather than in an FEHB plan, CBO expects that FEHB premiums would decrease because non-USPS enrollees in FEHB would have lower expected health care costs, on average, than enrollees joining the PSHB program. The federal government’s share of payments for health insurance premiums for non-USPS annuitants is recorded as on-budget direct spending. CBO estimates that spending for such annuitants would decrease by $61 million over the 2021-2031 period.

CBO also explains that the PSHB savings results from a cost shift to Medicare. Because FEHB and PSHB premiums are calculated for a combined risk pool of plan members, the Medicare savings will redound to the benefit of the Postal Service and all of the PSHB members. The lower premiums will encourage enrollment in the PSHB.

If OPM simply allowed all FEHB plans to integrate their prescription drug benefits with Medicare Part D (known as Part D EGWPs), then FEHB plan members and federal and postal employers, all of whom pay Medicare taxes, will receive lower premiums, thereby avoiding the unnecessary balkanization of the FEHB. The decision is OPM’s to make as Congress in 2003 expressly permitted FEHB plans to adopt Part D EGWPs.

In related new, CalPERS Board of Administration, which manages the the California state employees health benefit program, “approved health plan premiums for calendar year 2022, at an overall premium increase of 4.86%.” This suggests that we are in store for a sizable FEHB premium increase for 2022.

As the FEHBlog mentioned yesterday, he has been attending the NCQA’s virtual Digital Quality Summit which has been focusing on health equity, a worthy goal. During last year’s virtual DQS, the FEHBlog came up with the idea of adding the Census Bureau’s racial and ethnic identifiers to the ICD-10 code set which would allow health care providers to readily share that important data with health plans. Today the FEHBlog pushed the idea forward with the patient centered track. Time will tell.

Similarly, Govexec informs us that “Top diversity officials at four major agencies said on Tuesday that obtaining and using better data will be crucial to advancing diversity, equity, inclusion and accessibility in the federal workforce.”

In sad news, the Washington Post reports that

Deaths from drug overdoses soared to more than 93,000 last year, a staggering record that reflects the coronavirus pandemic’s toll on efforts to quell the crisis and the continued spread of the synthetic opioid fentanyl in the illegal narcotic supply, the government reported Wednesday. The death toll jumped by more than 21,000, or nearly 30 percent, from 2019, according to provisional data released by the National Center for Health Statistics, eclipsing the record set that year.

The Post adds

There are some signs that the Biden administration and Congress are preparing to renew efforts to address what was the nation’s most serious public health crisis before the pandemic. President Biden on Tuesday nominated former West Virginia public health official Rahul Gupta to be his drug czar. Gupta has cited the shift from in-person care during the pandemic as one of the contributors to increased addiction-related public health problems.

In prescription drug news

  • The Drug Channels blog discusses 2020 PBM drug trend reports. Top line: “[D]rug spending continues to grow more slowly than every other part of the U.S. healthcare system. Spending growth at CVS and Express Scripts was somewhat higher in 2020 compared to the 2019 figures, due primarily to faster utilization growth.”
  • The Boston Globe reports that “At least half-a-dozen private health insurers in some of the nation’s largest states are balking at covering Biogen’s controversial drug for Alzheimer’s disease, saying it is an experimental and unproven treatment despite being approved by the federal government one month ago. Six affiliates of Blue Cross and Blue Shield in Florida, New York, Michigan, North Carolina, and Pennsylvania indicated in policies posted online they will not cover the Cambridge biotech’s drug, Aduhelm, because they consider it ‘investigational’ or ‘experimental’ or because “a clinical benefit has not been established.” Aduhelm, which is priced at $56,000 a year, is intended to slow cognitive decline in patients with early Alzheimer’s symptoms, regardless of their age. * * * James Chambers, an associate professor of medicine at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, said that insurers have occasionally opted not to cover expensive specialty medicines for rare diseases, but that he’s never seen firms refuse to pay for an approved drug that could be prescribed to millions of people. ‘This is unprecedented,’ said Chambers, who has spent seven years studying how private insurers decide which drugs to cover. ‘Maybe it’s not entirely surprising given the controversy surrounding the drug’s approval, but it’s not something I’ve seen before.’” The FEHBlog expects that this is a prudent shot across the manufacturer’s bow. The FEHBlog is amazed that Biogen has not yet backed off on the $56,000 price annually per patient. In a STAT News interview, the acting FDA Commissioner Janet Woodcock remarked “The accelerated approval was based on very solid grounds,” she said. “I do believe that will play out over time, as people see that was a very appropriate use of that authority and the right thing to do for patients.”
  • Bloomberg reports on a recent Senate hearing on drug prices. Topics included patent reform and pay for delay deals.

In other news

  • The federal government’s principal healthcare fraud and abuse report for the last federal fiscal year was released. “During Fiscal Year (FY) 2020, the Federal Government won or negotiated more than $1.8 billion in health care fraud judgments and settlements,2 in addition to other health care administrative impositions. Because of these efforts, as well as those of preceding years, almost $3.1 billion was returned to the Federal Government or paid to private persons in FY 2020. * * * In FY 2020, the Department of Justice (DOJ) opened 1,148 new criminal health care fraud investigations. Federal prosecutors filed criminal charges in 412 cases involving 679 defendants. A total of 440 defendants were convicted of health care fraud related crimes during the year. Also, in FY 2020, DOJ opened 1,079 new civil health care fraud investigations and had 1,498 civil health care fraud matters pending at the end of the fiscal year. Federal Bureau of Investigation (FBI) investigative efforts resulted in over 407 operational disruptions of criminal fraud organizations and the dismantlement of the criminal hierarchy of more than 101 health care fraud criminal enterprises.”
  • Becker’s Hospital Review tells us about the telehealth provisions of the CMS proposed 2022 Medicare Part B physician payment rule which would preserve the status quo through 2023.