Tuesday’s Tidbits

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Tuesday’s Tidbits

David Ermer–AHRQ, CDC, COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, Telehealth, U.S. Healthcare–

From the Delta variant vaccination and treatment front, AHIP informs us that

The Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) held a meeting to discuss the safety and efficacy of the COVID-19 antiviral treatment molnupiravir, developed by Merck and Ridgeback Biotherapeutics. The oral treatment is the first COVID-19 therapy that could be taken outside a clinical setting. The Committee reviewed data by Merck and the FDA on molnupiravir’s toxicity, efficacy, and safety, and discussed concerns over treatment of pregnant persons and the potential effects of viral mutation and evolution. Initial data from Merck showed that molnupiravir reduced the hospitalization risk among high-risk patients by 48%, however data released November 26 suggests the reduction in hospitalizations may be closer to 30%.

The Committee voted 13-10 that the potential benefits of molnupiravir outweigh the known and potential risks when used for the treatment of mild-moderate COVID-19 in adult patients who are within 5 days of symptom onset and are at high risk of severe COVID-19, including hospitalization or death. Given concerns about the potential harmful effects on fetal development, Committee members further stressed the need for pregnancy testing prior to taking molnupiravir.

The FDA will review AMDAC’s conclusions and formally decide whether or not to grant emergency use authorization (EUA) to molnupiravir in the coming weeks. 

Acting Food and Drug Commissioner Dr. Janet Woodcock announced

The [Food and Drug Administration] is working as quickly as possible to evaluate the potential impact of this variant on the currently available diagnostics, therapeutics and vaccines. We are closely monitoring the situation and are committed to communicating with the public as we learn more. 

Historically, the work to obtain the genetic information and patient samples for variants and then perform the testing needed to evaluate their impact takes time. However, we expect the vast majority of this work to be completed in the coming weeks.

Healthcare Dive informs us that

The emergence of a new COVID-19 variant, named Omicron (B.1.1.529), is putting pressure on diagnostics manufacturers who test for the presence of SARS-CoV-2 to ensure its results are not impacted. Thermo Fisher Scientific, Qiagen and Lucira Health were quick to claim their tests can detect the emerging variant.    

The Wall Street Journal reports that

The Omicron variant of the Covid-19 virus could lead to more infections among vaccinated people, according to several scientists, but some said there were reasons to believe the shots would protect against severe disease.

While the new variant might evade the antibodies generated in reaction to the vaccines, the virus will likely remain vulnerable to immune cells that destroy it once it enters the body, said Ugur Sahin, co-founder of BioNTech SE, which sells a Covid-19 shot with partner Pfizer Inc.

“Our message is: Don’t freak out, the plan remains the same: Speed up the administration of a third booster shot,” Dr. Sahin said in an interview Tuesday.

In that regard, Govexec.com notes that “Pfizer/BioNTech are expected to apply for approval for their booster shots for 16 and 17 year olds and the FDA “could authorize extra shots within roughly a week,” The New York Times reported on Monday.”

In COVID vaccine mandate legal news, the FEHBlog was quite surprised to read in Govexec that

On Tuesday, a federal judge temporarily blocked the COVID-19 vaccine mandate for federal contractors in three states.

U.S. District Judge Gregory Van Tatenhove, who serves in the U.S. District Court for the Eastern District of Kentucky, issued a preliminary injunction for the vaccine mandate for federal contractors and subcontractors in all covered contracts in Kentucky, Ohio and Tennessee. Following President Biden’s issuance of the executive order on the mandate on September 9, there have been numerous legal challenges. 

“This is not a case about whether vaccines are effective. They are. Nor is this a case about whether the government, at some level, and in some circumstances, can require citizens to obtain vaccines. It can,” wrote Van Tatenhove. “The question presented here is narrow. Can the president use congressionally delegated authority to manage the federal procurement of goods and services to impose vaccines on the employees of federal contractors and subcontractors? In all likelihood, the answer to that question is ‘no.’”

The New York Times adds

A federal judge issued a preliminary injunction on Tuesday to halt the start of President Biden’s national vaccine mandate for health care workers, which had been set to begin next week. 

The injunction, written by Judge Terry A. Doughty, effectively expanded a separate order issued on Monday by a federal court in Missouri. The earlier one had applied only to 10 states that joined in a lawsuit against the president’s decision to require all health workers in hospitals and nursing homes to receive at least their first shot by Dec. 6 and to be fully vaccinated by Jan. 4.

“There is no question that mandating a vaccine to 10.3 million health care workers is something that should be done by Congress, not a government agency,” Judge Doughty of U.S. District Court for the Western District of Louisiana wrote. He added: “It is not clear that even an act of Congress mandating a vaccine would be constitutional.”

The plaintiffs, he added, also have an “interest in protecting its citizens from being required to submit to vaccinations” and to prevent the loss of jobs and tax revenue that may result from the mandate.

It looks like the vaccine mandates are creating more work Judicial Panel on Multidistrict Litgation.

From the HIV front —

  • The National Institutes of Health tells us that “Among people with HIV worldwide who are receiving antiretroviral therapy (ART), adults are getting closer to the global target of 95% achieving viral suppression, but progress among children and adolescents is lagging and long-term viral suppression among all groups remains a challenge. These findings of a study funded by the National Institutes of Health suggest that substantial efforts are needed to help people with HIV durably suppress the virus. The findings were published today in the journal The Lancet HIV.”
  • The Centers for Disease Control informs us that “Improving access to and use of HIV services for [men having sex with men] MSM, particularly Black MSM, Hispanic/Latino MSM, and younger MSM, is essential to ending the HIV epidemic in the United States.”
  • Here is a link to the CDC’s website on HIV treatment.

From the tidbits department —

  • Fierce Healthcare calls to our attention the fact that

The Business Group on Health has identified several trends in health and wellness to keep an eye on next year, which they say highlight the sense of “collective urgency” employers and their workforces feel.

For example, the organization echoed an ongoing industry trend: virtual care isn’t going away following a massive increase in use during the pandemic. However, the Business Group argues that taking full advantage of its strengths will require integration with in-person offerings.

  • The Society for Human Resource Management, having lost respect for the Delta variant, discusses how the Omicron variant may impact the workplace.
  • AHRQ tells us that “Patients with retail medications to treat opioid use disorders spent on average 3.4 times more for out-of-pocket prescriptions than the rest of the U.S. population, according to an AHRQ-study published in the Journal of Substance Abuse and Treatment.” No bueno.
  • Also “AHRQ has released an updated Chartbook on Rural Healthcare that shows that people in rural areas face difficulty getting timely, high-quality, affordable healthcare. 
  • HHS’s Office for Civil Rights which enforces the HIPAA Privacy and Security Rules now has settled in OCR’s favor 25 complaints against healthcare providers for allegedly violating HIPAA’s individual right to access medical records.

Friday Stats and More

David Ermer–ACA, COVID treatment, COVID-19, COVID-19 vaccine, Telehealth, U.S. Healthcare–

Based on the Centers for Disease Control’s COVID Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s weekly chart of new COVID cases:

Here is a link to the CDC’s weekly chart of new COVID hospital admissions which trended up by 5.4% from last week. However, the FEHBlog’s weekly chart of new COVID deaths has begun to trend down again.

Here’s FEHBlog’s weekly chart of new COVID vaccinations distributed and administered.

The vaccinations administered line continues to trend up. The CDC’s COVID vaccinations site now displays vaccinations administered to the age 5 to 11 group. Nearly 70% of the over age 12 population is fully vaccinated, and 97.5% of the age 65+ population has received at least one dose of the COVID vaccine. That’s impressive.

In Delta variant booster news, the CDC informs us that over one quarter of the age 50+ has received the booster. AHIP informs us that

Today the Food and Drug Administration (FDA) amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines, authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. This amendment expands the use of booster doses of both vaccines to include all adults at least six months after completion of the primary vaccination series of the Moderna COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine or at least two months after completion of primary vaccination with the Janssen COVID-19 Vaccine.

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) also met today to discuss further clinical recommendations on the use of COVID-19 vaccine booster doses for adults. After reviewing the most recent safety and efficacy data of the Pfizer and Moderna booster doses, which showed the vaccines to be safe, the Committee unanimously (11-0) voted in favor of authorizing:

— A single COVID-19 vaccine booster dose is recommended for persons aged 18 and olderwho received an mRNA COVID vaccine primary series based on individual benefits and risks, at least 6 months after the primary series, under the FDA’s Emergency Use Authorization (EUA).

— A single COVID vaccine booster dose is recommended for persons aged 50 and older who received an mRNA COVID vaccine, at least 6 months after the primary series, under the FDA’s EUA.

Any FDA-approved or authorized COVID-19 vaccine can be used for a booster dose, regardless of vaccine received for a primary series.

The committee emphasized that the top priority continues to be vaccination of the unvaccinated, and that potential side effects of vaccination, such as incidence of myocarditis and pericarditis, need continual monitoring as more data becomes available.

Medscape adds that

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, signed off on a recommendation Friday evening to let all US adults get a COVID-19 booster shot.

The endorsement, following a unanimous vote by a panel of CDC advisors earlier in the day backing a third dose of a Moderna or Pfizer mRNA COVID vaccine, now means everyone over the age of 18 is eligible for a booster.

According the ACA FAQ 50, health plans now must covered vaccines administered to the expanded group.

Here is a link to the CDC’s weekly interpretation of its COVID statistics.

In other news / the “more”:

  • The Department of Health and Human Services announced today that “Today, the Biden-Harris Administration unveiled details about the establishment of a new federal advisory committee, the Ground Ambulance and Patient Billing (GAPB) Advisory Committee. As mandated through the No Surprises Act, the GAPB Advisory Committee will be charged with providing recommendations to the Secretaries of Health and Human Services (HHS), Labor, and Treasury on ways to protect consumers from exorbitant charges and balance billing when using ground ambulance services. * * * Learn more about the GAPB Advisory Committee and the Federal Register Notice – PDF.”
  • Beckers Hospital News reports that “Insurers need more evidence of the clinical benefit of Biogen’s controversial Alzheimer’s drug Aduhelm before they start paying for it, Bloomberg reported Nov. 18. Bloomberg surveyed 25 of the nation’s largest insurers, and none of them deemed the drug “medically necessary.” Most indicated they view the drug as experimental and said they needed to see more evidence on the drug’s ability to slow cognitive decline.”
  • Govexec tells us that “About 90% of NASA employees have received at least one dose of a COVID-19 vaccination, according to agency data, but about 1,150 workers are seeking an exemption to President Biden’s governmentwide mandate.”
  • mHealth Intelligence informs us that “The number of outpatient visits after hospital discharges remained stable during the COVID-19 pandemic but telehealth use for these visits increased, suggesting that telehealth was a substitute for in-person care rather than an addition, a study published in JAMA Health Forum revealed.”
  • The Wall Street Journal provides an overview of currently available and near future COVID treatments.

Thursday Miscellany

David Ermer–COVID-19, COVID-19 vaccine, Federal employment benefits, OPM, Telehealth–
OPM Headquarters a/k/a the Theodore Roosevelt Building

The FEHBlog discovered OPM’s Agency Financial Report for the 2021 fiscal year, dated November 2020, on its website tonight. The most interesting discussion of the FEHB begins at page 125, the start of OPM’s response to the Inspector General’s top management challenges paper.

From the Delta variant vaccine front, Politico reports tonight that

The Food and Drug Administration on Friday is expected to authorize Moderna’s Covid-19 booster shot for all adults — a move that would come in tandem with the clearance of Pfizer-BioNtech’s booster for widespread use, two people with knowledge of the matter told POLITICO.

The decision comes just days after Moderna officially asked the FDA to green-light its booster for Americans 18 and older, and reflects the administration’s growing unease over the recent rise in Covid-19 cases across the nation.

The FDA had previously planned to authorize Pfizer’s booster shot this week, enabling the government to roll out shots to millions more people ahead of the Thanksgiving holiday.

But after Moderna filed a similar request on Wednesday, officials began debating whether to speed that authorization along as well, the people with knowledge of the matter said.

The FDA declined to comment.

From the Open Season front, Govexec discusses how to get the biggest bang for your buck in dental benefits if you are a federal or postal employee / annuitant.

From the telehealth front, Fierce Healthcare informs us that

In a report from Quest Diagnostics released Monday, 67% of the over 500 primary care physicians surveyed said they fear they missed signs of drug abuse in their patients during the pandemic.

And nearly all of them were prescribing those often-misused drugs—a whopping 97% reported prescribing opioids within 6 months of taking the survey.

Their concerns extend beyond the pandemic into telemedicine use today. Only 50% of physicians said they were confident they could recognize signs of drug misuse during telehealth visits, a far cry from the 91% that said the same of in-person patient interactions.

From the Rx coverage front, the Wall Street Journal reports that

CVS Health Corp. said Thursday it will close 900 stores over the next three years, nearly 10% of its U.S. locations, while adding more health services at remaining locations.

The largest U.S. pharmacy chain said it would close 300 stores a year while adding primary-care offices at certain sites as well as converting more stores into so-called health hubs with offerings such as diagnostic testing, mental-health services and hearing exams.

“The company has been evaluating changes in population, consumer buying patterns and future health needs to ensure it has the right kinds of stores in the right locations for consumers and for the business,” CVS said in a statement.

A CVS spokesman said the company doesn’t yet have a list of which stores are closing, a process that will begin early next year. 

From the strategy front, Federal News Network tells us that

The Biden administration on Thursday laid out the vision for its President’s Management Agenda, detailing three broad goals and four values that will drive a multi-year, multi-faceted effort throughout the government.

The initial vision is a roadmap that explains how the administration will build capacity within government agencies to make good on the president’s broader agenda, Jason Miller, deputy director for management at the Office of Management and Budget, said.

“The how matters. This president has been clear from day one that how we do things shapes what we can do,” Miller told reporters Wednesday evening.

To that end, the Biden administration said values of equity, dignity, accountability and results would drive its PMA priorities. Each priority has multiple underlying strategies.

Those priorities are:

Strengthening and empowering the federal workforce

Delivering excellent, equitable and secure federal services and customer experiences

Managing the business of government to “build back better”

“This simple, yet powerful three-part approach builds on lessons learned across administrations, while also repairing damage done over time to the federal government, by strengthening its capacity to deliver results,” Miller said.

The administration wanted to keep the PMA simple, and it explicitly wanted to avoid setting “dozens and dozens of new initiatives,” Miller added.

Meritalk adds

The Office of Personnel Management (OPM) and the Office of Management and Budget (OMB) are set to release their four-year strategic plan later this month, according to OPM Director Kiran Ahuja, who previewed what the Federal government can expect to see in that plan.

During an FCW event today, Ahuja said the four-year strategic plan is currently “in OMB’s hands and will be released fairly soon.” Ahuja also said the plan will focus on rebuilding the Federal workforce.

“We have an opportunity to remake it, both in the early career talent that we need to bring in, as well as the importance of professional development opportunities,” Ahuja said.

She went on to say the plan will also focus on the Federal workforce becoming “the model employer,” through both telework and remote work flexibilities, as well as “a whole range of efforts,” including providing support to the Federal workforce and leaning in to “a hybrid work environment and being an example there.”

It seems like yesterday that OPM released its last four year plan in 2018.

Tuesday’s Tidbits

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

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

From the Food and Drug Administration front —

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

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

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

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

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

From the Centers for Disease Control front

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

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

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

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

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

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

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

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

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

STAT news adds that

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

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

Finally an intriguing telehealth tidbit from mHealth Intelligence

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

Happy Veterans’ Day

David Ermer–COVID-19, HSA, OPM, Telehealth–
Thanks to Justin Casey for sharing their work on Unsplash.

Happy Veterans’ Day! Here’s a link to the OPM Director’s thoughts on this day as posted in OPM’s Medium channel.

Roughly 30 percent of the federal workforce has served our nation in uniform, and at OPM, we are working hard to welcome more. We are the guardians of the competitive hiring process, which includes ensuring that agencies are properly applying the Veterans’ preference rules. Much like in our recently expanded Military Spouse Hiring Authority, we recognize the unique leadership qualities on display in military households. We are eager to honor their contributions and match their skills with the needs of the American people.

From the Open Season advice front, Tammy Flanagan writes about FEHB high deductible health plans (“HDHP”), enrollment in which allows a federal or postal employee to contribute to a health savings account (“HSA”).

In 2022, for each month you are eligible for an HSA, you will receive a premium pass through, which is portion of your monthly health plan premium that is deposited to your HSA each month. You can make additional tax-free contributions to your HSA, as long as total contributions do not exceed $3,650 for an individual and $7,300 for a family.

In many of the FEHB HDHP plans, the premium pass through amount ranges from $75 to $100 per person per month, which can go a long way toward offsetting the high deductibles that are inherent to this kind of plan. There’s no time limit for withdrawing money from an HSA to pay for [healthcare ]expenses.

HSA contributions and related income are never federally taxed as long as the money is used for healthcare expenses. The trick is to grow the funding in an HSA before you hit high out of pocket medical spending for raising a family or in retirement.

It’s also worth noting that the alway informative Reg Jones has been writing about Open Season in FedWeek for the past three weeks.

In related news, Health Payer Intelligence discusses the Medicare Advantage open season also now underway.

Medicare Advantage has seen a lot of growth in recent years and that trend is set to continue into 2022, as evident in the number of plan offerings for the Medicare Advantage 2022 open enrollment season, according to a Kaiser Family Foundation (KFF) issue brief.

“As Medicare Advantage enrollment continues to grow, insurers seem to be responding by offering more plans and choices to the people on Medicare,” the researchers explained. Payers are offering a total of more than 3,800 Medicare Advantage plans in 2022. Nearly nine out of ten of these health plans are Medicare Advantage-prescription drug plans. 

In FSAFeds news, the Internal Revenue Service announced its 2022 inflation adjustments to various and sundry tax matters. Rev. Proc. 2021-45. Of note,

For taxable years beginning in 2022, the dollar limitation under § 125(i) on voluntary employee salary reductions for contributions to health flexible spending arrangements is $2,850. If the cafeteria plan permits the carryover of unused amounts, the maximum carryover amount is $570.

These increases are not automatic, but rather are triggered by employer action to amend the underlying plan.

From the COVID vaccine mandate front —

  • The Safer Federal Workforce Task Force has updated its guidance and FAQs for federal contractors. The best guidance currently available to contractors is the Task Force’s guidance document supplemented by the FAQs.
  • Federal News Network brings us up to date on the federal employee lawsuits challenging the vaccine mandate imposed on them. The Courts have turned away the plaintiffs’ requests for stays / preliminary injunctions on the employee mandate based on failure to meet the high standards for that extraordinary relief.

From the telehealth front, Healthcare Dive tells us that

As the delta variant surged in the third quarter, virtual care giant Amwell saw its urgent care volumes spike, while specialty care and behavioral health visits came in below expectations. That’s a sharp turnaround from the first half of the year, when urgent care volumes, specialty care and behavioral health visits grew together, analysts noted.

Urgent care visits are cheaper, however, so the higher urgent care mix had an unfavorable impact on total revenue per visit. Amwell’s revenue was down less than 1% year over year to $62.2 million, lower than Wall Street expectations though the Boston-based telehealth vendor’s earnings squeaked in slightly above forecasts.

To account for expected decreases in visit volume and the shift in visit-type mix toward urgent care versus specialty due to delta, Amwell lowered its full-year revenue guidance.

Friday Stats and More

David Ermer–AHRQ, COVID treatment, COVID-19, COVID-19 testing, COVID-19 vaccine, Mental health care, OPM, Telehealth–

Based on the Centers for Disease Control’s COVID Data Tracker and using Thursday as the first day of the wee, here is the FEHBlog’s weekly chart of new COVID cases this year:

New cases plateaued this week. Weekly new COVID hospitalizations continue their down trend. For the latest week, the number of new admissions was 5,025 compared to a peak of 16,478 in the first week of 2021.

The number of COVID-related deaths continues it decline according the FEHBlog’s chart:

Distribution and administration of COVID vaccines was up sharply the past two weeks. At least one million doses were administered daily last week.

Here’s a link to the CDC’s weekly interpretation of its COVID statistics. Notably,

As of November 4, 2021, 426.7 million vaccine doses have been administered. Overall, about 222.6 million people, or 67% of the total U.S. population, have received at least one dose of vaccine. About 193.2 million people, or 58.2% of the total U.S. population, have been fully vaccinated.* About 21.5 million additional/booster doses in fully vaccinated people have been reported. As of November 4, 2021, the 7-day average number of administered vaccine doses reported (by date of CDC report) to CDC per day was 1,510,524, a 55.8% increase from the previous week.

The best news is Pfizer’s announcement of a successful trial of antiviral pill to tame early COVID.

  • PAXLOVID™ (PF-07321332; ritonavir) was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19
  • In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 deaths in patients who received placebo
  • Pfizer plans to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization (EUA) as soon as possible

The Merck pill that Great Britain approved this week and the FDA will consider this month had the following reporting efficacy in its trial —

  • At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-Treated Patients Who were Hospitalized or Died

The FEHBlog points this out to illustrate the strength of the Pfizer pill not to downplay the Merck pill.

The public health strategy for defeating COVID always has been a combination of testing, drugs, and vaccines. Nobody expected the vaccines to lead the pack, but the FEHBlog is grateful that testing and drugs finally are catching up to the wonderous vaccines. You combine these new drugs with rapid at home tests like the recently FDA approved FlowFlex on top of the vaccines, and you are left with endemic COVID in the FEHBlog’s view. As the FEHBlog is not a medical expert, let’s close this section with a squib from STAT News:

The development of oral medicines that can be used to treat Covid early on could blunt the impact of the pandemic.

Nahid Bhadelia, the founding director of the Center for Emerging Infectious Diseases Policy & Research at Boston University, called oral antiviral pills “incredibly important” because existing treatments such as monoclonal antibodies must be given intravenously or as shots.

“With an oral antiviral, patients have more time and greater access to a treatment that will keep them out of the hospital,” Bhadelia said. “But the promise of oral antivirals will only be recognized if they’re available at your local pharmacy, and you can afford it, and you can get the test that tells you that you’re positive for Covid, so you can actually take advantage of this drug. So, the promise is there, but the rest of the pieces need to come together.”

From the tidbits department —

Morning Consult reports that

  • 72% of U.S. adults who have used telehealth said they’ve accessed virtual care through their regular provider or health plan, while another 17% have gotten care through a direct-to-consumer platform and 11% have used both types of services.
  • 53% of U.S. adults said they’d rather use in-person health care than telehealth moving forward, but that share fell to 45% among those who have used telehealth in the past.
  • Among the challenges for on-demand telehealth is getting coverage for the services, as traditional payers and providers roll out their own virtual care options.

The HHS Agency for Healthcare Quality and Research reports that

The Lehigh Valley Health Network (LVHN) used an AHRQ initiative to expand treatment for opioid use disorders in Pennsylvania. As a result, primary care physicians are now using medication-assisted treatment to care for their patients with opioid use disorders.  This new practice has been a success; as of fall 2021, 75 percent of patients who initiated treatment have returned in the following calendar month to continue treatment. With addiction treatment, this number of returning patients represents a major improvement, as most patients traditionally end treatment quickly.

With eight hospitals and numerous health centers, physician practices, rehabilitation locations, and other outpatient locations, LVHN serves patients in seven eastern Pennsylvania counties. LVHN used AHRQ resources to integrate treatment for opioid use disorder into primary care practice.

“In one visit, a patient can get his diabetes and blood pressure medications, plus his medication for opioid use disorder, without feeling the judgement of going to an addiction specialist,” noted Gillian A. Beauchamp, M.D., LVHN emergency physician. “When you’re sitting in a primary care waiting room, nobody knows why you’re there, so you don’t feel the stigma you might in another setting of care.”

Bloomberg tells us that

Even though the [COVID pandemic] upheaval increased risk factors for suicide like financial stress, the number of Americans who took their own lives decreased by 3% in 2020, the Centers for Disease Control’s statistical group reported this week

Suicides had increased steadily this century before peaking in 2018 with 48,000 annual deaths. That number declined slightly in 2019 and continued to drop in 2020, to less than 46,000, according to the CDC’s provisional data. In April, when shutdowns were most severe, the U.S. saw the lowest number of suicides in any month of 2020, 14% below the previous year’s total that month.

Federal News Network reports

In an ongoing effort to inject more young talent into the federal workforce, the Office of Personnel Management is out with yet another new hiring policy.

The latest policy, which OPM will publish as an interim rule Friday, is designed to help agencies more easily recruit and hire recent college graduates into administrative and professional positions in the federal government.

The new hiring policy means agencies can noncompetitively appoint qualified and eligible college graduates to permanent career positions at or below the General Schedule 11 level, OPM said. In a blog post on the new policy, OPM Director Kiran Ahuja said recent gradates have a chance to earn up to $72,000 a year under this new authority.

Tuesday Tidbits

David Ermer–CDC, COVID-19, COVID-19 vaccine, Medicare, Telehealth, U.S. Healthcare–

From the Delta variant vaccination front, AHIP informs us that

Photo by Patrick Fore on Unsplash

Today, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) met to discuss the safety, efficacy and clinical considerations for the Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years. The committee unanimously voted (14-0) to recommend the vaccine with the following statement:

“The Pfizer-BioNTech COVID-19 vaccine is recommended for children 5-11 years of age in the U.S. population under the FDA’s Emergency Use Authorization (EUA).”

During the meeting, representatives from Pfizer and the CDC presented data that showed the vaccine to be immunogenic and safe, with majority of adverse events documented as injection site pain. Data from Pfizer showed no correlation of the vaccine with incidence of multisystem inflammatory syndrome MIS-C, and the CDC will continue to monitor the long-term effects of myocarditis in this population. The CDC also noted the disparities in COVID-19 disease epidemiology, that Black, Hispanic, and American Indian/Native Alaskan children are at greater risk for hospitalization and disease severity.  * * *

Additionally, the American Academy of Pediatrics, American Academy of Family Physicians, National Association of Pediatric Nurse Practitioners, and the Pediatrics Infection Disease Society endorsed the COVID-19 vaccine’s administration in all eligible children as authorized by the FDA.

The Wall Street Journal adds that the CDC Director Dr. Rochelle Walensky has ratified the ACIP’s recommendation.

The endorsement * * * on Tuesday, was the last step before doctors, nurses and pharmacists could start giving the shots. Some sites could start administering the vaccine as early as Wednesday, though federal officials don’t expect vaccinations in the age group to be in full swing across the U.S. until next week.

Over 2/3rds of the vaccine eligible U.S. population (12 years and older) are fully vaccinated and a quarter of Americans over age 65 have received a booster according to today’s CDC update.

From the also busy Medicare front, the American Hospital Association tells us about three final Calendar Year 2022 rules released today:

— Hospital Outpatient Services (Part A): The Centers for Medicare & Medicaid Services late today issued a final rule that increases Medicare hospital outpatient prospective payment system rates by a net 2.0% in calendar year 2022 compared to 2021.  In addition, as urged by AHA, CMS finalized its proposals to reverse two policies finalized in CY 2021. The first policy halts the elimination of the inpatient only list and adds back to the IPO list almost all of the services removed in 2021. The second reinstates several patient safety criteria for adding a procedure to the ambulatory surgical center covered procedures list that were in place in CY 2020 and prior. The rule also removes 255 of the 258 surgical procedures that had been added to the ASC CPL in 2021.

— Hospital Price Transparency: CMS also finalizes as proposed a number of modifications to the hospital price transparency rule, including significant increases to the civil monetary penalty for noncompliance. * * * Currently, the CMP is set at a maximum amount of $300/day. CMS will scale up the CMP based on a hospital’s bed count, with a minimum of $300/day for small hospitals (30 or fewer beds) and an additional $10/bed/day for larger hospitals with a daily cap of $5,500. CMS also will prohibit specific barriers to accessing the machine-readable files, including through automated searches and direct downloads. CMS provides updated clarifications on the price estimator tools for those hospitals that choose to use them to fulfill the shoppable service requirement, including allowing patients to manually input their insurance information and permitting broad disclaimers, as appropriate.

— Home Healthcare Services (Part A): The Centers for Medicare & Medicaid Services today released its calendar year 2022 final rule for the home health prospective payment system. The rule finalized a net update of 3.2% relative to CY 2021. This includes a 2.6% market basket increase ($465 million), a 0.7% increase for high-cost outlier cases ($125 million), and 0.1% decrease to rural payments as required by law (-$20 million).

— Physician Services (Part B): The Centers for Medicare & Medicaid Services late today released its calendar year 2022 final rule for the physician fee schedule. The rule cuts the conversion factor to $33.59 in CY 2022, as compared to $34.89 in CY 2021, which reflects the expiration of the CY 2021 3.75% payment increase, a 0.00% conversion factor update, and a budget neutrality adjustment. The rule also finalizes several policies to expand access to telehealth for mental health services, including, in certain instances, covering audio-only services. In addition, as urged by the AHA, CMS finalized a delayed implementation of the payment penalty phase of the Appropriate Use Criteria program to the later of Jan. 1, 2023, or the Jan. 1 that follows the end of the COVID-19 public health emergency. Currently, the penalty phase is set to begin Jan. 1, 2022.   “The AHA applauds today’s ruling by CMS to delay the proposed enforcement of the Appropriate Use Criteria (AUC) program as well as to expand access to telehealth for behavioral health services,” said AHA Executive Vice President Stacey Hughes. 

Speaking of telehealth, Healthcare Dive calls attention to its finding that ‘While women are more likely than men to visit doctors and consume healthcare services in general, telehealth seems to be uniquely attractive to women.” Moreover, [t]he data also suggests female physicians offer virtual care services at higher rates than their male counterparts.”

In the tidbits department, we find

  • Healthcare Dive reports that “The median change in operating margins for hospitals fell 18.2% in September compared to August, according to the latest monthly report from Kaufman Hall, a hospital consultant group. Patient volumes declined in almost every key category, including emergency room visits and operating room minutes, potentially signaling that the rise in the delta variant caused some to once again defer care out of concern over contracting the coronavirus. Outpatient revenues declined, too, further underscoring this potential trend. Although fewer patients were admitted, patients were sicker and stayed longer. The average length of stay is also trending above pre-pandemic levels.”
  • MedPage Today offers an interesting story on Chicago’s Rush Medical Center “journey to health equity” using social determinants of health data, among other tools.
  • Federal Times reports that “The Partnership for Public Service held its annual Samuel J. Heyman Service to America awards Nov. 1, honoring nine federal employees and their associated teams out of 29 nominees for making a significant impact through their public service.” Congratulations to all of the nominees and thanks for your service to our country.

Weekend update

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, Telehealth, U.S. Healthcare–
Thanks to ACK15 for sharing their work on Unsplash.

Happy Halloween!

The U.S. House of Representatives and the Senate will be engaged in floor voting and Committee business this coming week. The Hill brings us up to date on Democrat Congressional leadership negotiations over the social spending budget reconciliation bill. Bloomberg adds

While the $500 billion infrastructure bill has already passed the Senate, the larger economic package will have to return there for another vote. Some Democratic Senators are signaling they may seek changes to what is passed in the House, possibly adding further delays. 

From the Open Season front, the ACA marketplace open season resumes tomorrow. The Federal Employee Benefits Open Season begins a week from tomorrow. OPM’s 2022 online FEHB Plan Comparison Tool is now available.

From the Delta variant front, the Wall Street Journal tells us that

The Food and Drug Administration is delaying a decision on Moderna Inc.’s application to authorize use of its Covid-19 vaccine in adolescents to assess whether the shot leads to a heightened risk of myocarditis, the company said.

The FDA notified Moderna on Friday evening that an analysis may not be completed until January of next year while the agency reviews recent international data on the risk of myocarditis after vaccination, the company said Sunday.

The Wall Street Journal reported earlier this month that the FDA was delaying a decision on Moderna’s application for authorization in 12- to 17-year-olds after several Nordic countries limited use due to myocarditis reports. 

Moderna also said it would delay asking the FDA to authorize use of a lower dose of its shot in even younger children, ages 6 to 11, while the agency continues to review its request to clear the shots in adolescents.

From the CMS front, Medicare offers coverage for those under age 65 who are afflicted with End Stage Renal Disease (“ESRD”). On Friday, CMS finalized its ESRD prospective payment rule for calendar year 2022. In its announcement CMS explained that

Through the ESRD Prospective Payment System (PPS) annual rulemaking, CMS is making changes to the ESRD Quality Incentive Program (QIP) and the ESRD Treatment Choices (ETC) Model, and updating ESRD PPS payment rates. The changes to the ETC Model policies aim to encourage dialysis facilities and health care providers to decrease disparities in rates of home dialysis and kidney transplants among ESRD patients with lower socioeconomic status, making the model one of the agency’s first CMS Innovation Center models to directly address health equity.

“Today’s final rule is a decisive step to ensure people with Medicare with chronic kidney disease have easy access to quality care and convenient treatment options,” said CMS Administrator Chiquita Brooks-LaSure. “Enabling dialysis providers to offer more dialysis treatment options for Medicare patients will catalyze better health outcomes, greater autonomy and better quality of life for all patients with kidney disease.”

That makes sense to the FEHBlog.

From the healthcare network front, the Yale School of Public Health (YSPH”) informs use that “a new survey analysis from a researcher at the YSPH suggests that privately insured adults are significantly more likely to rate their mental health provider network as inadequate compared to their medical provider network.” With due respect to Yale, this finding is hardly surprising given the fact that relative few mental health therapists join a health plan network because they don’t need patient referrals. That’s why it so important for the hub and spoke telehealth services to offer ongoing mental health care over their networks.

From the OPM front, Federal News Network reports that

As agencies contemplate and continue to plan for the future of work, the Office of Personnel Management is trying to let agencies know they have some help — and some new resources — to guide them through the unknown.

The agency is preparing to release more guidance on telework and remote work “very soon,” OPM Director Kiran Ahuja said in an interview with Federal News Network.

It’s all part of an effort to help agencies establish themselves as model employers that can meet the moment — and part of OPM’s own plans to reestablish itself as a human capital resource for the rest of government. They’re priorities Ahuja set in the early days since becoming OPM director, and they’ll continue well into 2022 and beyond, she said.

The guide will offer, in some detail, advice for agencies on making the shift to remote and hybrid work.

“We want to support what’s involved in our lives around flexibilities and child care but also knowing that we can be really productive,” Ahuja said. “We have this guide coming out. We’re also pulling together trainings and information around how to manage in a hybrid work environment and how to operate well in a work environment, as well as a new website focused on future of work.”

Thursday Miscellany

David Ermer–ACA, Congress, Federal employment benefits, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

The FEHBlog was particularly struck by an in-depth article in the Wall Street Journal about a lower income man in his sixties who emptied his retirement plan to pay for hospital bills for his wife who was stricken with cervical cancer. How does this happen in the Affordable Care Act world. The FEHBlog is not blaming the law. Rather the FEHBlog believes that people from the hospital, the insurance company, etc. dropped the ball when they had a chance to help this now broken man. The woman’s adult daughter, presumably the man’s step daughter, created a Go Fund Me page. Isn’t that a red flag?

The Journal also reports from Capitol Hill that the President’s Hail Mary pass to score a legislative victory with the billion dollar infrastructure bill fell short.

The Mercer consulting company is offering a report on furious state legislative efforts this year to regulate prescription benefit managers in the wake of last December’s U.S. Supreme Court decision on ERISA preemption and such laws, which was favorable to the state legislatures. The laws in the FEHBlog’s view while well intentioned mainly raise administrative costs.

Govexec in an Open Season related article discusses the No Surprises Act provisions that take effect on January 1, 2022, for enrollees with primary FEHB coverage in the United States. The FEHBlog does expect that this law will achieve its objective of getting patients out of the middle of billing disputes between out of network providers and health plans in emergency care, ancillary care at hospitals and surgicenters and air ambulances. The article notes that “The new rules don’t apply to people with coverage through programs such as Medicare, Medicaid, the Indian Health Service, the Veterans Affairs health system or TRICARE, because these programs already have other protections against high medical bills.”

From the third quarter financial reporting front / telehealth front, Healthcare Dive tells us that

  • “Teladoc plans to take on financial risk for its offerings in the future, including its virtual-first primary service, in a bid to expand revenue per member, the CEO of the New York-based virtual care giant said Wednesday.
  • The telehealth vendor made that program, called Primary360, available nationwide earlier this month, and it will be available through CVS Health-owned payer Aetna and Centene’s marketplace plans in Michigan, Mississippi, South Caroline and Texas early next year. And Teladoc is also beginning to talk with health systems about using Primary360 as a white-labeled digital front door to care for their populations, CFO Mala Murphy told investors on a call.
  • In its third quarter financial results also released Wednesday, Teladoc beat Wall Street expectations on earnings and revenue, with a topline of $522 million, up 81% year over year due to strength in multi-product sales and behavioral health, management said. The 19-year-old vendor saw 3.9 million visits in the quarter, representing 37% year-over-year growth.”

From the Affordable Care Act front, Kaiser Health News reports that

The federal government’s effort to penalize hospitals for excessive patient readmissions is ending its first decade with Medicare cutting payments to nearly half the nation’s hospitals.

In its 10th annual round of penalties, Medicare is reducing its payments to 2,499 hospitals, or 47% of all facilities. The average penalty is a 0.64% reduction in payment for each Medicare patient stay from the start of this month through September 2022. The fines can be heavy, averaging $217,000 for a hospital in 2018, according to Congress’ Medicare Payment Advisory Commission, or MedPAC. Medicare estimates the penalties over the next fiscal year will save the government $521 million. Thirty-nine hospitals received the maximum 3% reduction, and 547 hospitals had so few returning patients that they escaped any penalty.

Here is a link to KHN’s online tool to look up hospitals to find out whether the hospital was assessed a 2022 penalty.

From the reports and studies department —

  • The Kaiser Family Foundation released its COVID vaccine monitor for October 2021.
  • The American Medical Association discusses a study concluding that, notwithstanding a tremendous amount of consolidation between health systems and providers, private practices continue to play a “big part” in primary care, which the FEHBlog finds reassuring.
  • Health Payer Intelligence informs us

From the beginning, it was clear that seniors’ lives would be turned upside down as a result of the coronavirus pandemic, but Humana’s survey of over 1,000 seniors reveal the severe toll the pandemic has taken on senior mental health and social health.

“Health plans should take particular notice, since it is critical to understand all the evolving needs of seniors – health, social and behavioral – as the industry increasingly moves toward models of ‘whole health’ senior care and coverage,” said Kathy Driscoll, senior vice president and chief nursing officer at Humana.

The survey reached 1,003 Americans ages 64 and older, nationwide. Kelton Global fielded the survey from September 14 to September 21, 2021.

One of the most striking results of the survey was that, despite the rise in mental and behavioral healthcare needs and the expanded access to telemental and telebehavioral services that the pandemic brought, only three percent of seniors had accessed mental healthcare.

The results run parallel with a separate Anthem study which found that mental healthcare claims dropped even though mental healthcare demand rose during the coronavirus pandemic.

However, the low rate of telehealth utilization for these specific demands does not mean that seniors were as hesitant to use telehealth for other health-related purposes. Seniors were far more likely to use telehealth in order to access wellness programming (84 percent) and a third of seniors used telehealth to connect with their providers.

Midweek Update

David Ermer–COVID treatment, COVID-19, Telehealth, U.S. Healthcare–

From the Delta variant front —

STAT News offers an in-depth report on the Delta plus (AY.4.2) variant that has shown up in the United Kingdon. The article concludes

It’s possible that whatever transmission advantage AY.4.2 has over Delta is so narrow that it will take a while for it to start to gain on its parent strain in places beyond the United Kingdom. Also, there’s a lot of randomness when a new form of a pathogen gets introduced into an area — many imported cases simply die out without setting off a transmission chain. If AY.4.2 has just a small edge over Delta, then probability dictates it would require more imported cases for some to take off than if something much more transmissible arrived.

Some variants also don’t circulate everywhere — a lot depends on what other versions of the virus are out there, and what the local environment looks like. The Alpha and Delta variants were so much more transmissible than the other iterations of the virus that were present when they emerged and encountered so many susceptible people that they became dominant. The Beta and Gamma variants, however, only caused issues in the regions where they emerged; there were cases detected elsewhere, but they never drove outbreaks globally.

At this point, it’s too early to say what impact, if any, AY.4.2 will have in the United States. It takes higher levels of population immunity to slow more transmissible pathogens, but between vaccinations and past infections, the country has a big wall of protection out there, with vulnerable pockets interspersed. For now, U.S. modeling still indicates a continued ebbing of the epidemic.

In other encouraging news, the Wall Street Journal informs us that

A widely available antidepressant holds promise as a treatment for Covid-19, according to a new study. Covid-19 patients who received fluvoxamine were significantly less likely to require hospitalization than those who didn’t, in the largest clinical trial evaluating the antidepressant’s effect on Covid-19 to date.

Fluvoxamine belongs to a class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs. It is commonly used to treat obsessive compulsive disorder and is also prescribed for depression. In use for decades, fluvoxamine has been shown to be safe and costs about $4 for a 10-day course, said Edward Mills, one of the study’s lead researchers and a professor of health sciences at McMaster University in Hamilton, Ontario. He said fluvoxamine’s low cost and wide availability make it a compelling alternative to other Covid-19 therapies including monoclonal antibody treatments, which are costly and require an infusion. Another treatment, Merck & Co. and Ridgeback Biotherapeutics LP’s experimental molnupiravir pill, will cost the U.S. government around $700 per course in the U.S.

“For both poor countries and even wealthy countries, it’s a great option,” Dr. Mills said of fluvoxamine. * * *

“This is exciting data,” said Daniel Griffin, chief of infectious disease at healthcare-provider network ProHealth New York, who wasn’t involved in the study. “There are several other trials that are in progress and if they confirm this finding, this may end up being standard of care.”

In related good treatment news, STAT News tells us that “In a notable bid to widen access to Covid-19 remedies, Merck has agreed to license its widely anticipated antiviral pill to the Medicines Patent Pool, which in turn can now strike deals with other manufacturers to provide versions of the drug to 105 low and middle-income countries.”

From the gene therapy front, the National Institutes of Health (NIH) announced that the “U.S. Food and Drug Administration, [NIH], 10 pharmaceutical companies and five non-profit organizations have partnered to accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease. While there are approximately 7,000 rare diseases, only two heritable diseases currently have FDA-approved gene therapies. The newly launched Bespoke Gene Therapy Consortium (BGTC), part of the NIH Accelerating Medicines Partnership (AMP) program and project-managed by the Foundation for the National Institutes of Health (FNIH), aims to optimize and streamline the gene therapy development process to help fill the unmet medical needs of people with rare diseases.

In a more practical development,

Aetna®, a CVS Health® company, announced the launch of its designated Gene-based, Cellular, and Other Innovative Therapies™ (GCIT) network. This network is designed to enable members’ access to new therapies that treat and potentially cure rare genetic diseases, while helping to manage the high cost of these therapies. Aetna’s national GCIT network includes access to more than 75 designated GCIT service providers that have demonstrated quality and value in the delivery of GCIT services.

Beginning January 1, 2022, Aetna’s designated GCIT network will provide three gene therapy services, including Luxturna, Spinraza and Zolgensma for the treatment of inherited retinal disease and spinal muscular atrophy. The GCIT network is included as a standard medical benefit in all Aetna fully insured plans and is also available to self-insured plans.  

From the reports and studies front

NIH released

Part two of the latest Annual Report to the Nation on the Status of Cancer [which] finds that cancer patients in the United States shoulder a large amount of cancer care costs. In 2019, the national patient economic burden associated with cancer care was $21.09 billion, made up of patient out-of-pocket costs of $16.22 billion and patient time costs of $4.87 billion. Patient time costs reflect the value of time that patients spend traveling to and from health care, waiting for care, and receiving care, according to the report.

The report, appearing October 26, 2021, in JNCI: The Journal of the National Cancer Institute, is the most comprehensive examination of patient economic burden for cancer care to date and includes information on patient out-of-pocket spending by cancer site, stage of disease at diagnosis, and phase of care. While this analysis is about the costs that are directly incurred by patients, which are critical to patient finances, the total overall costs of cancer care and lost productivity in the United States are much larger.

The Patient Centered Outcomes Research Institute (PCORI) announced its adoption of “five National Priorities for Health, which serve as ambitious long-term goals to guide PCORI’s funding of patient-centered comparative clinical effectiveness research (CER) and other engagement, dissemination and implementation, and research infrastructure initiatives. The adopted National Priorities for Health are:

  • Increase Evidence for Existing Interventions and Emerging Innovations in Health 
  • Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research 
  • Advance the Science of Dissemination, Implementation, and Health Communication 
  • Achieve Health Equity, and
  • Accelerate Progress Toward an Integrated Learning Health System”

From the substance use front, “Health and Human Services Secretary Xavier Becerra today announced the release of the new HHS Overdose Prevention Strategy, designed to increase access to the full range of care and services for individuals who use substances that cause overdose, and their families.  This new strategy focuses on the multiple substances involved in overdose and the diverse treatment approaches for substance use disorder. * * * For more information on the new Overdose Prevention Strategy, visit: www.hhs.gov/overdose-prevention/.  Read the full issue brief here: https://aspe.hhs.gov/reports/overdose-prevention-strategy“

From the teleheath front, Healthcare Dive takes “a look at Teladoc’s primary care strategy from its head of US group health. Kelly Bliss teased upcoming clients for a new virtual-first primary care product and parsed out Teladoc’s growth strategies for 2022 and beyond.” Enjoy.