Friday Stats and More

COVID-19

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.

Midweek Update

David Ermer–ACA, COVID treatment, COVID-19, COVID-19 vaccine, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Delta variant vaccine front, the New York Times reports

The Food and Drug Administration is aiming to authorize booster doses of Pfizer-BioNTech’s coronavirus vaccine for all adults as early as Thursday, a move that would expand the number of Americans eligible for additional shots by tens of millions, according to people familiar with the agency’s plans.

The Centers for Disease Control and Prevention’s independent committee of vaccine experts has scheduled a meeting for Friday to discuss data on the booster dose’s efficacy and safety. If both the F.D.A. and the C.D.C. sign off this week, they will have acted strikingly quickly — a little more than a week after Pfizer asked for authorization of boosters for everyone 18 and older.

Under that scenario, any adult who received a second dose of the vaccine at least six months earlier would be officially eligible to get a booster as soon as this weekend. The F.D.A. is expected to rule without consulting its own expert panel, which has met frequently during the pandemic to review vaccine data and make a recommendation ahead of a regulatory decision.

Moderna is expected to soon submit its own request for the F.D.A. to broaden eligibility for its booster. But for now, every adult could get the Pfizer booster, according to people familiar with the planning.

From the Delta variant research front, the National Institutes of Health has announced that

Lung autopsy and plasma samples from people who died of COVID-19 have provided a clearer picture of how the SARS-CoV-2 virus spreads and damages lung tissue. Scientists at the National Institutes of Health and their collaborators say the information, published in Science Translational Medicine, could help predict severe and prolonged COVID-19 cases, particularly among high-risk people, and inform effective treatments.

From the Delta variant vaccine mandate front, Govexec tells us that

The White House will not back down from next week’s deadline for virtually all federal employees to prove they are vaccinated against COVID-19, despite calls for a delay.  The federal workforce has until Nov. 22 to provide documentation demonstrating they are inoculated or to request an exemption under an executive order issued by President Biden. 

From the opioid epidemic front, the Washington Post informs us that

The U.S. drug epidemic reached another terrible milestone Wednesday when the government announced that more than 100,000 people had died of overdoses between April 2020 and April 2021. It is the first time that drug-related deaths have reached six figures in any 12-month period. * * *

The new data shows there are now more overdose deaths from the illegal synthetic opioid fentanyl than there were overdose deaths from all drugs in 2016.

Fentanyl is many times more powerful than morphine, leading to more frequent fatal overdoses. It is increasingly laced into other drugs, such as cocaine, and counterfeit pills, killing some who consume it unknowingly.

During the worst of the pandemic, more users were alone, reducing the chances that other users or bystanders could call first responders in the event of an overdose, experts have said. * * *

The number of opioid prescriptions issued by health-care providers has declined sharply as the crisis continues.

Addiction preys on young and middle-aged adults, who make up the bulk of those with drug-related substance use disorder.

Compounding the problem is the fact as related by Sam Quinones in his recent book the Least of Us that while a lethal dose of heroin takes about 15 minutes to kill a person, a lethal dose of fentanyl will take a minute or two to do so. That’s hardly enough time to administer naloxone which can pull people back from the brink of death. The FEHBlog wishes that Pfizer and Merck could develop a pill to cure substance abuse.

From the Open Season front, Reg Jones in Fedweek offers thoughts on how to use the ongoing federal benefits open season to the readers’ advantage.

From the No Surprises Act front, Healthcare Dive reports that

A key sticking point [stemming from the tri-agencies’ independent dispute resolution interim final rule] is the arbitration process, and how the qualifying payment amount (QPA) — determined by a plan’s median in-network contracted rate for a geographic area — is used to arrive at rates for out-of-network providers.

The Association of Air Medical Services filed a lawsuit in federal [district] court [for the District of Columbia, No. 1:21-cv-03031] challenging the rules Tuesday, claiming reliance on a QPA strays from Congress’ intent when passing the law that “no single statutory factor receives special weight” in the arbitration process.

As the FEHBlog previously noted, the Texas Medical Association has filed a similar lawsuit in the Lone Star State.

Encouragingly, Healthcare Dive adds that

The rules guiding the arbitration process are a form of consumer protection, 63 organizations representing patients, consumers, unions and employers said in a Tuesday letter.

An over reliance on out-of-network charges, particularly among Wall Street-backed providers, extracts maximum costs from patients, employers and health systems, thus driving up premiums and contributing to ever-rising healthcare spending in America, they said.

“As outlined in the interim final rule, it is only by reinforcing the QPA as the overriding and primary factor for determining final payment that the No Surprises Act can achieve the $17 billion in cost savings outlined by the Congressional Budget Office,” the groups wrote.

Amen

Also from the NSA front, the tri-agencies and OPM released an interim final rule implementing NSA Section 204’s burdensome yet aggregated prescription drug and healthcare cost reporting requirements imposed on health plans. The accompanying fact sheet explains

Summary of the November 17, 2021 IFC

This IFC requires plans and issuers in the group and individual markets to submit certain information on prescription drug and other health care spending to the Departments annually, including:

General information regarding the plan or coverage;

Enrollment and premium information, including average monthly premiums paid by employees versus employers; 

Total health care spending, broken down by type of cost (hospital care; primary care; specialty care; prescription drugs; and other medical costs, including wellness services), including prescription drug spending by enrollees versus employers and issuers;

The 50 most frequently dispensed brand prescription drugs;

The 50 costliest prescription drugs by total annual spending;

The 50 prescription drugs with the greatest increase in plan or coverage expenditures from the previous year; 

Prescription drug rebates, fees, and other remuneration paid by drug manufacturers to the plan or issuer in each therapeutic class of drugs, as well as for each of the 25 drugs that yielded the highest amount of rebates; and 

The impact of prescription drug rebates, fees, and other remuneration on premiums and out-of-pocket costs.

The IFC provides that plan sponsors, issuers, and FEHB carriers generally will be required to submit this information aggregated at the state/market level, rather than separately for each plan. To ensure that the Departments and OPM are able to conduct meaningful data analysis and identify prescription drug trends, the IFC further provides uniform standards and definitions, including for identifying prescription drugs regardless of the dosage strength, package size, or mode of delivery.

Applicability Date and Comment Period

The CAA requires plans and issuers to begin submitting the required information to the Departments by December 27, 2021, and to submit this information by June 1 of each year thereafter. However, the Departments have announced that they will exercise discretion to provide temporary deferral of enforcement with regard to the December 27, 2021 and June 1, 2022 deadlines, and that they will not initiate enforcement action against a plan or issuer that submits the required information for 2020 and 2021 by December 27, 2022. OPM also will allow its FEHB carriers to report information for 2020 and 2021 by December 27, 2022.

Comments on this IFC are due at 5 p.m. on January 24, 2022.

Before long, health plans, and especially FEHB carriers, will be spending most of their time reporting data to the government.

Tuesday’s Tidbits

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

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

From the Food and Drug Administration front —

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

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

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

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

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

From the Centers for Disease Control front

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

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

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

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

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

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

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

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

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

STAT news adds that

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

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

Finally an intriguing telehealth tidbit from mHealth Intelligence

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

Monday Roundup

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

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

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

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

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

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

From the Delta variant vaccine mandate front —

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

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

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

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

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

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

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

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

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

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

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

Weekend Update

David Ermer–Congress, COVID-19, OPM, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

Both Houses of Congress are in session this week for floor voting and Committee business. The Hill summarizes what’s ahead for Congress over the next month and it’s a tough row to hoe indeed. The December 3 deadline on the current stop gap funding bill and the budget ceiling relief is looming.

From the vaccine mandate front, Govexec reports that

The COVID-19 vaccine mandate for federal contractors “has been a very challenging thing to navigate,” as shown by the “evolution of guidance,” as well as the lawsuits attempting to challenge it, Justin Chiarodo, partner in and chair of the government contractors practice group at the law firm Blank Rome LLP, told Government Executive earlier this week. Chiarodo and his firm’s clients have concerns about how the mandate could impact the supply chain crisis and labor shortages. He also pointed out that on November 17, the Federal Acquisition Regulatory Council is poised to submit a report on its rule that will amend contracts to incorporate the vaccine mandate. * * *

The union that represents 7,500 employees at the Environmental Protection Agency announced on Tuesday [November 9] it entered into a Memorandum of Understanding with agency management on implementation of the vaccine mandate. “The [memorandum] ensures that Council 238 bargaining unit employees requiring exceptions to the mandate will receive due process as provided under the Council’s Master Collective Bargaining Agreement while at the same time protecting the safety and health of the overall bargaining unit,” said a statement from American Federation of Government Employees Council 238. Joyce Howell, Council 238 chief negotiator for the future of work negotiations, said that over 90% of the bargaining unit is fully vaccinated. 

The U.S. Postal Service said in a recent financial filing that the Occupational Safety and Health Administration’s new vaccine rule “will be extremely challenging to implement and administer during the height of our peak season, particularly given its expedited schedule,” Reuters reported on Wednesday [November 10]. The report noted: “Compliance, the USPS warned, ‘could result in labor challenges and high levels of absenteeism.’ Some employees could opt to leave, which ‘could cause significant business disruptions, and could adversely impact service performance and result in lower mail volume and revenue.’” 

The Postal Service, among other businesses affected by the OSHA rule, will be please to learn that late Friday, according to Reason,

The U.S. Court of Appeals for the 5th Circuit extended its stay on the Biden administration’s COVID-19 vaccine mandate for private employers, which the unanimous three-judge panel called “fatally flawed” and “staggeringly broad.” The stay * * * says OSHA shall “take no steps to implement or enforce the Mandate until further court order.” It is officially a preliminary pause “pending adequate judicial review of the petitioners’ underlying motions for a permanent injunction.” But the court left little doubt that it would grant those motions, saying “petitioners’ challenges to the Mandate show a great likelihood of success on the merits.”

The federal government can ask the U.S. Supreme Court to review the Fifth Circuit’s stay order. Reason adds

In a concurring opinion, Judge Duncan emphasizes that courts “expect Congress to speak clearly when authorizing an agency to exercise powers of ‘vast economic and political significance.'” He thinks “whether Congress could enact such a sweeping mandate under its interstate commerce power would pose a hard question.” But “whether OSHA can do so does not.”

From the medical device front, Fierce Healthcare tells us that

The Biden administration has repealed its predecessor’s last-minute rule granting expedited Medicare coverage of breakthrough devices.

The Centers for Medicare & Medicaid Services (CMS) had finalized the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule Jan. 14, just days before President Joe Biden was sworn into office.

If implemented, the rule would provide devices that received the Food and Drug Administration’s breakthrough-device designation up to four years of Medicare coverage once the product received or cleared the agency’s market authorization. CMS said at the time that its goal was to remove the gap between regulatory authorization and Medicare coverage determination, which in some cases could take up to a year. * * *

The repeal is a win for the insurance industry, which had warned the faster timetable could lead to premature coverage of unproven devices. Medical device manufacturers, on the other hand, generally saw the pathway as an incentive to take more risks in their pursuit of innovative technologies.

From the OPM front, Federal News Network reports that

Agencies are treading carefully into a new era, one that contemplates what public and private sector experts are calling, “the future of work.”

To help them make those decisions, agencies got more advice from the Office of Personnel Management, which released a new telework and remote work guide on Friday.

It replaces guidance OPM originally published on these topics back in 2011, when the original Telework Enhancement Act was less than a year old. * * *

The latest guide builds on prior guidance from OPM and the Biden administration — and provides perhaps the most comprehensive tool to date for agencies interested in building or expanding remote work programs. OPM also has a new website with future of work resources.

In a statement, [OPM Director Kiran] Ahuja said the new guide should serve as a model for both the public and private sectors to follow.

Friday Stats and More

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

Based on the CDC’s COVID Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s current weekly chart of new COVID cases for 2021:

Here is a link to the CDC’s weekly chart of new COVID related hospital admissions, and here is the FEHBlog’s current weekly chart of new COVID deaths:

Finally here is the FEHBlog’s current weekly chart of COVID vaccinations distributed and administered:

As of today, 86% of the U.S. population over age 65 has been fully vaccinated and 1/3 of that cadre has received a COVID booster.

Here’s a link to the CDC’s weekly interpretation of its COVID statistics. The CDC points out that “Starting the week of November 8th, vaccines [for children aged five through 11] will be available at pediatricians’ offices, pharmacies, Federally Qualified Health Centers, and more. To find vaccine near you, visit vaccines.gov; text your ZIP code to 438829 (GETVAX); or call 1-800-232-0233.”

The CDC’s Fluview informs us that “Seasonal influenza activity in the United States remains low, but the number of influenza virus detections reported by public health laboratories has increased in recent weeks.”

The best summary of where we stand with COVID is found in today’s New York Times column by David Leonhardt on whether it’s time to start back to returning to normalcy on COVID. His theme struck a chord with the FEHBlog:

“Among the Covid experts I regularly talk with, Dr. Robert Wachter is one of the more cautious. He worries about “long Covid,” and he believes that many people should receive booster shots. He says that he may wear a mask in supermarkets and on airplanes for the rest of his life.””

“Yet Wachter — the chair of the medicine department at the University of California, San Francisco — also worries about the downsides of organizing our lives around Covid. In recent weeks, he has begun to think about when most of life’s rhythms should start returning to normal. Increasingly, he believes the answer is: Now.

“This belief stems from the fact that the virus is unlikely to go away, ever. Like most viruses, it will probably keep circulating, with cases rising sometimes and falling other times. But we have the tools — vaccines, along with an emerging group of treatments — to turn it into a manageable virus, similar to the seasonal flu.”

In other news —

The Centers for Medicare and Medicaid Services finally announced 2022 Medicare Medicare Parts A and B premiums and cost sharing.

  • The Part A inpatient hospital deductible will increase from $1484 to $1556.
  • The Part B calendar year deductible will increase from $203 to $221.
  • The monthly standard Part B premium will increase from $148.50 to $170.10.

All of the changes and the income based Part B premium adjustments for high income beneficiaries is available here.

STAT News informs us that

Robert Califf, President Biden’s new pick to lead the Food and Drug Administration, doesn’t have much to show for his first tenure at the agency.

His grand plans for modernizing the way drug makers and the FDA collect patient data were shelved in 2017 after he left the agency’s top spot. His efforts to ban flavored tobacco products were foiled by the Obama White House. Even his push to finally fix the FDA’s hiring woes still hasn’t been fully implemented.

Now Califf, who Biden formally tapped on Friday to retake the FDA’s top job, will have another shot at delivering on those promises.

Health Payer Intelligence tells us that

More than eight out of ten survey participants in UnitedHealthcare’s sixth annual Consumer Sentiment Survey indicated that they are ready to choose a health plan during 2022 open enrollment season.

“Most Americans said they are prepared to select a health plan during this year’s open enrollment season, while the COVID-19 pandemic continues to spur interest in virtual care for medical services and digital fitness apps to help people pursue at-home fitness routines,” the press release shared.

UnitedHealthcare fielded the survey from September 10 through September 12, 2021 and received 1,013 responses from individuals 18 years old and older.

Health Payer Intelligence also discusses a Humana program for employer sponsored plans in which “Humana is partnering with a type 2 diabetes reversal vendor [Virta] that uses remote patient monitoring and nutrition to help members manage and improve their type 2 diabetes.”

The article included this interesting tidbit on diabetes treatment

Diabetes is one of the top chronic conditions in the US that drive healthcare spending, alongside conditions such as cancer, heart disease, and obesity. As such, payers have heavily targeted this condition with various chronic disease management strategies.

It was not until August 2021, however, that the American Diabetes Association (ADA) officially determined that the phrase “diabetes reversal” was often more clearly identified as “remission,” Humana pointed out in its press release.

“Remission strikes an appropriate balance, noting that diabetes may not always be active and progressive yet implying that a notable improvement may not be permanent. It is consistent with the view that a person may require ongoing support to forestall relapse, and regular monitoring to allow intervention should hyperglycemia recur,” ADA decided. 

“The term reversal is used to describe the process of returning to glucose levels below those diagnostic of diabetes, but it should not be equated with the state of remission.”

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.

Midweek update

David Ermer–COVID-19, COVID-19 testing, U.S. Healthcare–
Thanks to ACK15 for sharing their work on Unsplash.

Timely observation from Forbes

Consumer prices are rising at the fastest pace in 30 years, as the Covid-19 pandemic and supply chain bottlenecks and staffing shortages reverberate around the globe. Data from the Bureau of Labor Statistics shows inflation rose 6.2% in October, with energy, cars and beef leading the way with increases of more than 20%.

However, some healthcare services seemed to buck the trend. Health insurance prices were down 6.4%. But it’s important to note that the index doesn’t directly price insurance policies — it tracks the movement of insurance premium holding the quality of the plan as constant (which isn’t how things tend to play out in the real world, especially with the rise of high deductible plans). The index shows eyeglasses and eyecare services saw only a 0.4% bump, while dental services were up 2.2%. Hospital and doctor services were up around 4%.

Until this year, healthcare prices have outpaced general inflation for more than a decade, explains healthcare analyst and Forbes contributor Joshua Cohen. “This is partly a function of the consumer price index being historically low during this period; often under 2%, in fact!” While it appears there may be a reversal, it won’t be official for many more months, as the confirmed data lags behind by several quarters, says Cohen. Plus, there are some holes. For example, the index doesn’t take into account the launch prices of new drugs, it only takes into account “increases of prices of existing products.” Stay tuned as to whether the decline in prices is an anomaly or a trend…

The observation is timely because at this time of year the federal employee press typically is complaining the FEHB premiums are increasing faster than the cost of living. That’s not the case for 2022.

From the Delta variant front, the Department of Health and Human Services announced that

To support access to [rapid at home COVID testing], HHS will use [$650 million of American Rescue Plan] funds to ramp up U.S. domestic manufacturing capacity. By strengthening our ability to produce these tests in the United States, we will minimize our reliance on imports from overseas, and sustain robust long-term manufacturing throughout 2022. The funding will also support purchasing raw materials and finished tests to increase our domestic supply of diagnostic tests.

This initiative builds on recent efforts by the Biden-Harris Administration to strengthen testing and make tests more available nationwide. President Biden recently announced $3 billion in new investments in rapid testing. These resources will grow the supply of rapid tests, including quadrupling the supply of at-home tests by the end of the year. HHS also recently announced a series of actions to help reduce costs, make tests more available, and support bringing more over-the-counter tests to market in the U.S.

Fierce Healthcare reports

Express Scripts is launching a new option for employers to cover over-the-counter COVID-19 tests under the pharmacy benefit.

Beginning Jan. 1, members who can access the benefit can visit an in-network pharmacy to purchase an applicable COVID-19 test. Members can then show their Express Scripts member card at checkout, which will process the purchase through their benefit.

Plans can set the copayment for the test at either a discounted rate or a $0 copay, Express Scripts said.

From the COVID vaccine mandate department —

Federal News Network reports

The largest federal employee union has asked the White House to push back the Nov. 22 deadline that executive branch workers currently have to comply with the federal vaccine mandate.

The American Federation of Government Employees said Tuesday federal workers should have the same Jan. 4 deadline that the Biden administration recently extended for contractors to receive their vaccine doses.

In a letter to the White House, Office of Management and Budget and the Office of Personnel Management, the union urged the Biden administration to harmonize federal vaccine mandate deadlines for government employees and contractors.

From the surveys department —

  • Health Affairs tells us about the Kaiser Family Foundation’s 2021 benchmark survey on employer sponsored healthcare in the U.S.
  • Healthcare Dive reports on the latest Leapfrog hospital patient safety grades. “Among 2,901 facilities scored by the Leapfrog Group, 32% received A grades this fall. Another 26% of hospitals received B grades while 35% scored a C. * * * Only 7% of hospitals received D grades, and less than 1% received an F.” The grades were in line with pre-pandemic scoring.

The International Foundation of Employee Benefit Plans reminds us that November is Men’s Health Awareness Month.

You’re probably already familiar with No-Shave November and Movember, movements created to encourage conversations about cancer awareness among men. These events encourage participants to put down their trimmers for 30 days and think about donating their monthly hair-maintenance expenses to the cause. Many cancer patients lose their hair during diagnosis and treatment, and one way to show empathy and support is to grow awareness while growing mustaches, beards and full heads of hair. For more ideas on getting your organization involved, click here.

From the healthcare business front, Health Payer Intelligence and Healthcare Dive each provide wrap up reports on 3rd quarter financial reporting from health insurers.

What’s more, Fierce Healthcare tells us that

Health IT industry veteran Donald Rucker, M.D. is joining the leadership team at interoperability startup 1upHealth.

Rucker, who served as the National Coordinator for Health Information Technology under the Trump administration, is jumping on board 1upHealth as its new chief strategy officer. The Boston-based company, founded in 2017, structures claims and clinical data to make it easier for organizations to share information.

As CSO, Rucker will help set the direction for 1upHealth’s ongoing innovations in Fast Healthcare Interoperability Resources (FHIR)-enabled computing and help healthcare organizations meet the evolving clinical, technical and reimbursement demands for modern data, according to the company.

From the encouraging research front, the National Institutes of Health informs us that

  • Sixty hours of a therapy called [Constraint induced movement therapy] CIMT led to significant improvements in hand and arm function among children with cerebral palsy in a randomized trial.
  • The findings suggest that intense treatment with CIMT has greater benefit than conventional forms of therapy.

From the Open Season advice department, Federal News Network alerts us that next Monday ‘November 15, 2021 on ForYourBenefit, our hosts Bob Leins, CPA®, and Tammy Flanagan, Senior Benefits Director NITP, will talk about Open Season.” Here’s a link to the show’s website which discloses that the show has been covering Open Season for the past three weeks. Check it out.

Tuesday’s Tidbits

David Ermer–CMS, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, U.S. Healthcare–

From the Open Season advice front, here are recent articles from FedSmith and Govexec .

From Capitol Hill, FedWeek reports that last Wednesday Nov. 3

The Senate Homeland Security and Governmental Affairs Committee has approved:

HR-2662, to give agency IGs authority to subpoena former federal employees; require an administration to provide a “substantive rationale, including detailed and case-specific reasons” prior to removing an IG; limit the use of administrative leave for IGs, including during the 30 days following the removal announcement; require acting IGs to be selected from among senior-level employees within the watchdog community; and require regular training to IG employees on their whistleblower rights.

The House already has passed the HR 2662. The Senate Committee amended the House bill before voting to sending the “favorable” substitute bill to the Senate floor for a vote.

From the Delta variant front Medscape informs us that

Pfizer and its European partner BioNTech have asked the US Food and Drug Administration (FDA) to expand emergency authorization of its COVID vaccine to allow everybody 18 and older to get a booster dose.

If it goes through, the broader use of Pfizer boosters would be a step toward President Joe Biden’s goal of boosters for all adults. He announced the goal last August but backed off to let the regulatory process by the FDA and the Centers for Disease Control and Prevention (CDC) play out.

Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to a company news release.

This would be Pfizer’s second bite at the FDA apple for this approach to its booster.

Govexec informs us from the Delta variant vaccine mandate front that

VA Secretary Denis McDonough spoke at the National Press Club in Washington, D.C. on Tuesday afternoon, which came after the October 8 deadline for health care employees to get vaccinated but before the November 22 deadline for the rest of the federal workforce. 

“We’re still getting all of our data together,” he said. As of this morning, about 91% of the health care professionals at VA “have uploaded their data,” which could be proof of vaccination or requests for one of the exemptions. This is up from about 70% about two and a half weeks ago. 

“We’re not going to question the legitimacy of anyone’s individual declaration of a religious exception,” McDonough said. However, “we may find ourselves in a situation where, for example, in an oncology department or in a spinal cord injury facility or in an intensive care unit…or community living center[s], we may have so many people who have claimed a religious exemption that we can’t safely provide care to our veterans in those vulnerable situations, in which case we reserve the right to deny religious exemptions.” 

Fedweek cautions that “Both supporters and opponents of the Coronavirus vaccine mandate expect it to increase turnover among federal employees, although it is hard to say how large that increase will be and how much of it will be involuntary versus voluntary.”

From the No Surprises Act (NSA) front, the FEHBlog noticed that the Centers for Medicare and Medicaid Services has created a public NSA website. Posted on the site is an October 25, 2021, CMS letter announcing required federal government website and contact information to be included in the consumer notice about the NSA and other NSA related documents.

Website: https://www.cms.gov/nosurprises/consumers. Note, consumer and provider functionality for complaints inquiry and triage will not be operational until January 2022.

Phone number for information and complaints: 1-800-985-3059.

We ask regulated entities not to include the above phone number in any plan documents for any plan or policy years that begin before January 1, 2022.

In other healthcare news

Per Fierce Healthcare, here are the 10 most cost-efficient hospitals in the U.S., according to the Lown Institute: 

  1. Pinnacle Hospital (Crown Point, Indiana)
  2. Saint Mary’s Regional Medical Center (Reno, Nevada)
  3. Mercy Medical Center Dubuque (Dubuque, Iowa)
  4. Encino Hospital Medical Center (Encino, California)
  5. Park Ridge Health (Hendersonville, North Carolina)
  6. Oroville Hospital (Oroville, California)
  7. Saint Michael’s Medical Center (Newark, New Jersey)
  8. UnityPoint Health – Meriter (Madison, Wisconsin)
  9. East Liverpool City Hospital (East Liverpool, Ohio)
  10. Maple Grove Hospital (Maple Grove, Minnesota)

“Overall, if all hospitals performed as well as the most cost-efficient hospitals, Medicare would save $8 billion each year.”

Healthcare Dive informs us that

Nonprofit health giant Kaiser Permanente’s operating margin continued to shrink in the third quarter as expenses grew faster than revenue, spurred by labor unrest and surging COVID-19 patients, the Oakland, California-based integrated health system said.

Kaiser reported $38 million in operating income in the quarter, on $23.2 billion in revenue. That’s a 0.2% operating margin — exceedingly low compared to a margin of 2.1% same time last year. 

The 39-hospital system’s expenses in the third quarter grew 7.5% year over year to $23.1 billion, while revenue only increased 5.5%. Kaiser said the expense growth was due to higher costs from COVID-19 patients and workforce requirements, as — like other hospital operators — Kaiser has had to pay more for travel nurses and other contract labor to meet rising patient levels during the pandemic.