The 118th Congress Convenes

Mental health care

The 118th Congress Convenes

David Ermer–CMS, Congress, FDA, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From our Nation’s Capital, Roll Call informs us

A bloc of [twenty] Republican opponents Tuesday kept Kevin McCarthy from becoming speaker on three ballots, and the House adjourned to come back on Wednesday and try again to pick a leader.

McCarthy, R-Calif., had told his colleagues as the day began he would not back down, and his supporters said there would be repeated votes. After three votes, the last of which saw McCarthy lose one of his earlier supporters, a motion from McCarthy ally Tom Cole of Oklahoma to adjourn until noon Wednesday was adopted by voice vote.

Roll Call adds

The history-making chaos in the House drew most of the attention Tuesday, but longtime senators were making history of their own.

Sen. Patty Murray, D-Wash., was elected as the first woman to serve in the constitutional office of president pro tempore, while Senate Minority Leader Mitch McConnell eclipsed Montana Democratic Sen. Mike Mansfield’s record for length of service as a party floor leader. * * *

And not to be outdone, [Sen. Chuck] Schumer had some history of his own, becoming the longest serving senator from the state of New York.

STAT News reports

The nation’s health agencies already have a long to-do list for 2023.

Top officials have promised reforms in the food, drug, and public health departments as frustrations mount over the federal response to Covid-19 and last year’s widespread baby formula shortages. Biden administration appointees are racing to fix pandemic-exposed cracks in the systems for mental health care, addiction treatment, and health coverage, even as millions of people are likely to be kicked out of Medicaid, the federal program serving low-income people with few resources. There’s still no one leading the National Institutes of Health.

And while Congress delivered many of the president’s requests in the end-of-year spending package last month, it also dropped several provisions that would have given federal health regulators more authority. 

From the New Years predictions front, STAT News informs us

For almost three years, hospitals and health insurers have been riding the waves of the Covid-19 pandemic. Even though they can better predict what lies ahead in 2023, there remain several big unknowns. STAT’s business reporters will be paying attention to three trends in particular: the end of the public health emergency, how hospital price hikes will affect people’s paychecks, and Medicare Advantage’s explosive growth.

From the pricing transparency front, Kaiser Health News reminds us that

As of Jan. 1, health insurers and employers that offer health plans [including FEHB plans] must provide online calculators for patients to get detailed estimates of what they will owe — taking into account deductibles and copayments — for a range of services and drugs. * * *

So how will it work?

Patients, knowing they need a specific treatment, drug, or medical service, first log on to the cost estimator on a website offered through their insurer or, for some, their employer. Next, they can search for the care they need by billing code, which many patients may not have; or by a general description, like “repair of knee joint,” or “MRI of abdomen.” They can also enter a hospital’s or physician’s name or the dosage amount of a drug for which they are seeking price information.

Not all drugs or services will be available in the first year of the tools’ rollout, but the required 500-item list covers a wide swath of medical services, from acne surgery to X-rays.

Once the information is entered, the calculators are supposed to produce real-time estimates of a patient’s out-of-pocket cost.

Starting in 2024, the requirement on insurers expands to include all drugs and services.

This requirement was created by the 2020 Transparency in Coverage Rule issued under the 21st Century Cures Act and the 2021 No Surprises Act.

On a related note, Health Leaders Media tells us

According to the recent report by the OIG investigating instances of incorrect co-surgery and assistant-at-surgery modifier usage, 69 of 100 sampled procedural services did not meet federal requirements.

An additional review of 127 corresponding services found that 49% were noncompliant with federal requirements, as well.

The OIG reviewed a randomly selected sample of 100 services rendered by Part B providers between 2017 and 2019 with certain CPT procedural codes and a Medicare Physician Fee Schedule (MPFS) co-surgery indicator of 1 or 2. The reviewed procedures included spinal fusions, knee replacements, and endovascular repairs, among others.

That’s a big bowl of wrong.

From the pricing reforms front, Fierce Healthcare relates

Physician group practices participating in the Bundled Payments for Care Improvement (BPCI) Initiative garnered cost savings for the top five conditions that require medical intervention but did not save money for the top five surgical procedures.

On the other hand, hospitals participating in the BPCI initiative saved money for both categories, according to a study in JAMA Health Forum.  

Researchers at the University of Pennsylvania said their findings underscore the “suitability of hospitals to bundled payment models, specifically highlighting their relative advantage over group practices in achieving cost and potential quality outcomes for medical conditions.”

From the Rx coverage front —

  • Biopharma Dive offers us a look back at the FDA’s drug approvals in 2022 — “The agency’s main review office cleared 37 new medicines last year, its lowest total since 2016 and well below 2021’s mark of 50.” — and a look forward at ten clinical trials to watch in the first half of 2023 — “Highly anticipated study results are expected in Alzheimer’s, obesity and Huntington’s disease, while a pair of high-priced acquisitions could be put to the test.”
  • STAT News has questions stemming from the recent Congressional investigative report on the Aduhelm fiasco.
  • The New York Times reports “For the first time, retail pharmacies, from corner drugstores to major chains like CVS and Walgreens, will be allowed to offer abortion pills in the United States under a regulatory change made Tuesday by the Food and Drug Administration. The action could significantly expand access to abortion through medication. * * * Whether large pharmacy chains and local drugstores would opt to make the pills available was not immediately clear Tuesday. A spokesman for Walgreens, Fraser Engerman, said: “We are going to review the F.D.A.’s decision.”
  • The Wall Street Journal adds “Most abortions in the U.S. happen via the pill, according to the Guttmacher Institute. Several organizations that mail abortion pills, sometimes to women in states with abortion bans, have seen shipments increase since the Supreme Court’s latest abortion decision. * * * Also on Tuesday, the Justice Department issued an opinion saying that abortion pills can be sent through the U.S. mail, as long as the sender doesn’t intend them to be used unlawfully. The U.S. Postal Service and the Department of Health and Human Services had asked the Justice Department to clarify an 1873 law, which had been invoked by Mississippi’s attorney general in a lawsuit last year, that prohibits mailing items that can be used to produce abortions.”

From the mental healthcare front, the American Hospital Association places a spotlight on children and adolescent care.

Monday Roundup

David Ermer–Congress, COVID-19, FDA, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, STAT News reports

Leaders in Congress have reached a sweeping deal to ease Medicare pay cuts to doctors, make major changes to post-pandemic Medicaid policy, and to help prepare for future pandemics.

Lawmakers are aiming to pass a health care policy package along with legislation to fund the federal government by Friday. The details of the omnibus spending package were confirmed by two lobbyists and two congressional aides.

The bill’s text is not yet finalized, and the deal is still subject to changes.

Details may be found in the article.

Following up on last Friday’s post on emergency medical care, MedPage Today counters

The New York Times reported last week that a newly released federal government study believes that up to 250,000 people die in the U.S. annually due to misdiagnoses made in emergency rooms.

However, in a large document obtained by Inside Medicine that is not yet public, one expert contributing to an internal review of the report prior to its publication found a “fatal flaw” in the methodology behind some of the most crucial and eye-catching findings. Other major concerns were brought up by other reviewers and technical experts, which the study authors did not fully address prior to the release of the report. The technical expert concerned about the “fatal flaw” wrote that results were, “Headline grabbing, yes, but this is at best gravely misleading, given the concerns….”

Emergency medicine organizations have already pointed out major problems in the report. One thing not yet pointed out is that the magnitude of the findings fail every whiff test imaginable. If the findings of the report were somehow to be true, that would mean that 8.6% of all deaths in the U.S. — that is, 250,000 out of 2.9 million deaths (2019, the last pre-pandemic year) — are caused by mistakes and misses in ERs. That’s preposterous, on its face. * * *

This report seems unfamiliar with the idea that what we seek in medicine is net benefit. This report counts only the misses, but none of the saves ERs routinely make by following evidence-based medicine developed by emergency physicians, cardiologists, neurologists, and other experts working together. This report seems to think that abiding by the principle of balancing risks and harms is somehow synonymous with medical error. * * *

Here is the internal review and here is the link to the federal government’s report

In medical billing news, MedCity News informs us

Nearly 40% of Americans struggle to understand their medical bills, a recent survey showed. But the respondents also shared a few ways providers and insurers could step in to make bills less confusing.

The survey was released Friday by AKASA, an AI developer for healthcare operations. It was conducted online in March by YouGov and included responses from 2,026 U.S. adults. * * *

How can providers and insurers help? Survey respondents shared several ways:

  • About 27% said it would be beneficial to receive a call from the physician’s office or hospital staff before the medical procedure, explaining terms of payments and the payment plans available. 
  • Another 12% said they’d like an online calculator that can show cost ranges for procedures.
  • About 11% said it would be helpful to receive an email from their insurer that walks through the bill after they receive care.
  • About 9% said they’d like the payer to call and walk them through the bill.
  • Another 9% said they want access to live online customer service through their health plan’s website.
  • Additionally, 8% want a call from the physician’s office or hospital staff that explains the bill after receiving services.  

From the Rx coverage front, STAT News discusses current prescription drug shortages.

The Wall Street Journal adds

Medicines to lower fevers, clear congestion and ease aches and pains are in high demand this winter as the U.S. is experiencing a surge in pediatric cases of RSV, influenza and Covid-19. Parents and caregivers are struggling to find over-the-counter fever reducers such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil) as well as amoxicillin, an antibiotic prescribed to treat common childhood ailments such as ear or upper respiratory infections. Both CVS Health Corp. and Walgreens Boots Alliance Inc. announced they have imposed purchase limits on children’s cold and flu medicines. * * *

Manufacturers are producing at full capacity [in contrast to the baby formula shortage] and directing inventory to where it is most needed, the Consumer Healthcare Products Association, which represents producers of over-the-counter medications. “However, we understand it might be frustrating for parents to quickly locate these products from their usual pharmacy or retailer due to intermittent out-of-stocks,” the group said. A spokeswoman for Johnson & Johnson, whose brands include pain relievers Tylenol and Motrin, said that while some products might be less readily available, the company isn’t experiencing widespread shortages of children’s Tylenol or Motrin.

From the mental health care front —

  • The Department of Health and Human Services announced “the annual release of the Department’s National Plan to Address Alzheimer’s Disease: 2022 Update – PDF. Through the National Plan, HHS and its federal partners work to improve the trajectory of Alzheimer’s disease and related dementias (ADRD) research, support people living with dementia and their caregivers, and encourage action to reduce risk factors.”
  • HR Dive explains how employers can help resolve the “unspoken crisis” in men’s mental health.

From the fraud, waste, and abuse front, Fierce Healthcare reports

In a development in what’s being billed as one of the largest healthcare fraud schemes ever, a federal grand jury [on November 14] convicted the owner of a laboratory that performs sophisticated genetic tests of bilking Medicare out of hundreds of millions of dollars.

The crime involved telemarketers allegedly lying to Medicare recipients by ensuring them that they were covered for expensive genetic cancer tests, according to the Department of Justice (DOJ). * * *

The convicted individual—Minal Patel, 44, of Atlanta, the owner of LabSolutions LLC—personally pocketed $27 million of the $187 million that the scheme raked in from Medicare from July 2016 through August 2019.

Patient brokers, call centers and telemedicine companies also allegedly cashed in, as Patel paid them kickbacks and bribes after the Medicare beneficiaries agreed to take the tests, DOJ said. The patient brokers allegedly obtained signed doctors’ orders recommending the tests from telemedicine companies. Patel made the patient brokers sign contracts that misleadingly stated that the brokers were performing legitimate advertising services for LabSolutions.

At last week’s ABA Health Law Section Washington Health Law Summit, the FEHBlog learned about a recent federal anti-health care fraud law called the Eliminating Kickbacks in Recovery Act (“EKRA”). The law is directed at patient brokers, laboratories etc. in situations involving, for example, opioid misuse or this one. EKRA criminalizes fraud against private sector health plans as well as the federal treasury. Here’s a law firm’s article about EKRA if you are interested.

From the U.S. healthcare business front, Fierce Healthcare informs us

Two South [New] Jersey hospitals have signed a letter of intent to merge into a system of more than 10,000 employees and over $2.2 billion in annual revenues.

Camden, New Jersey-based Cooper University Health Care and Cape May Court House, New Jersey-based Cape Regional Health System said in a Wednesday announcement they’ll be working toward a definitive merger agreement in March and then regulatory approvals that “could take until the first quarter of 2024.”

Should the agreement come to pass, the joined system would comprise 900 licensed beds across the organizations’ two flagship hospitals, six urgent care centers and over 130 ambulatory locations across eight counties.

From the federal employment front, Federal News Network relates

Leaders in the Biden administration called for “major reforms” to the federal pay system, building on a not-so-new conversation around issues with the compensation system for much of the federal workforce.

The current structure for determining pay for the 1.5 million federal employees on the General Schedule is inherently flawed, the President’s Pay Agent said in its annual report to the president.

“As has been noted in earlier pay agent reports and discussed in other venues, we believe there is a need to consider major legislative reforms of the white-collar federal pay system, which continues to utilize a process requiring a single percentage adjustment in the pay of all white-collar civilian federal employees in each locality pay area without regard to the differing labor markets for major occupational groups,” the pay agent said in the Dec. 19 report. “The current pay comparison methodology used in the locality pay program ignores the fact that non-federal pay in a local labor market may be very different between different occupational groups. As currently applied, locality payments in a local labor market may leave some mission-critical occupations significantly underpaid while overpaying others.”

The pay agent, composed of Office of Personnel Management Director Kiran Ahuja, Labor Secretary Marty Walsh and Office of Management and Budget Director Shalanda Young, issued its annual report ahead of the planned 4.6% pay raisefor the federal workforce in 2023.

Weekend update

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 testing, Mental health care, Telehealth–

The House of Representatives and the Senate will be in session this week for limited Committee business and floor voting.

The Wall Street Journal explains

Lawmakers will return to the Capitol this week with a singular focus of passing a sweeping bipartisan spending bill to avert a shutdown and fund the government through September, despite opposition from many House Republicans.

The massive bill is expected to total around $1.7 trillion and could be released as early as Monday. It would fund government agencies and programs and allow those agencies to distribute grants and contracts to the private sector. 

Because it is the last piece of legislation that Congress will pass in this session, lawmakers have spent weeks lobbying to attach other bills, including funding for Ukraine, changes to tax policy and a measure to update how Congress deals with disputes over certifying presidential-election results. * * *

The Senate is expected to vote on the bill first. Senate Minority Leader Mitch McConnell (R., Ky.) has been part of the negotiations and set a deadline of Thursday to reach a deal—a day before the money runs out—but he said his patience was limited and that he wouldn’t allow talks to stretch past Christmas. 

From the Omicron and siblings front, NPR Shots provides insights on Paxlovid.

The Centers for Disease Control and Prevention recommends treatment for patients at risk of severe disease, hospitalization and death, which includes anyone who’s 50 and older (risk increases with age), people who are unvaccinated and people with certain medical conditions, such as obesity, chronic lung disease, heart disease or a weakened immune system.

But exceptions can be made. A colleague who is under 50 told her doctor she was feeling worse each day after her positive COVID test and had a history of pneumonia. The doctor wrote a Paxlovid prescription. * * *

[In addition to you doctor or pharmacist, t]he federal government has a “Test to Treat” locator to see where you can be tested for free and, if you test positive and are eligible, leave with the drug. Spots include community health centers and some pharmacies. 

Pharmacies may also send the pills to your home for prescriptions the doctor calls in. Walgreens just announced free Paxlovid delivery via Door Dash and UberEATS; CVS will send it the same day for a fee. * * *

Since Paxlovid has to be taken within five days of symptoms starting to work, you might contact your doctor’s office to find out what steps to take if you test positive and think you need the drug. * * *

Paxlovid is the best option for reducing the risk of severe disease. The last monoclonal antibody treatment for COVID-19 lost its FDA authorization last month because it is ineffective against currently circulating variants. That leaves Paxlovid; remdesivir, which requires an outpatient infusion over three days at a hospital or treatment center; and molnupiravir [the other pill], which studies put at only 30% effective in treating the virus. In addition, some doctors are treating immunocompromised patients with convalescent plasma.

Bloomberg Prognosis discusses expiration dates on at-home Covid tests.

The Food and Drug Administration has extended the shelf-lives of 14 brands of tests. Consumers can look up their specific brand and even the lot number to see the correct expiration dates. Brands including iHealth, from a subsidiary of Andon Health in China, Abbott Laboratories’ BinaxNow and ACON Labs Inc.’s Flowfex now last up to 12  months, 15 months and 21 months, respectively. The FDA advises against using at-home Covid tests past their expiration date.

Health plans and Medicare continue to provide at-home Covid tests at no cost, and the federal government resumes mailing out free at-home Covid tests tomorrow.

From the telehealth front —

mHealth Intelligence tells us

Implementing a telehealth navigator program helped improve video visit attendance, providing clinics with a positive financial return, according to a new study published in JAMA Network Open.

The COVID-19 pandemic dramatically drove up the use of telehealth. Like many other healthcare provider organizations, Boston-based Beth Israel Deaconess Medical Center implemented and scaled telehealth visits. But they found that technical issues could hamper video visits, prompting some video visits to be converted into audio-only visits via the telephone, according to the study authors.

The medical center implemented a patient navigator pilot program to reduce barriers to video visit attendance. Through the program, a patient navigator contacted patients one day before their video visit appointment to provide technical support. The navigator went through the steps required for the patient to connect to their visit and addressed frequently asked questions.

The Wall Street Journal reports

Remote treatment of mental-health problems surged in the pandemic, as in-person treatment became difficult while pandemic-driven isolation increased anxiety and depression.

Digital mental-health companies plunged in, promising to provide millions with access to high-quality care by video, phone, and messaging.

Many of the businesses, however, put a premium on growth. Investor-backed, they deployed classic Silicon Valley tactics such as spending heavily on advertising and expansion while often using contractors instead of employees to control costs. A strategy designed for mundane businesses such as food delivery, the formula can be badly suited to the sensitive activity of treating mental-health problems.

No bueno. The article is focused on stand-alone telemental health services.

In the spirit of the Season, Bloomberg Prognosis tackles the question of “Eggnog Made With Raw Eggs Safe.”

“Eggnog may be safely made at home by using egg substitutes, whole, liquid or pasteurized eggs,” Darin Detwiler, a food-safety expert at Northeastern University, says. “These products need no further cooking to kill harmful bacteria.”

Pasteurized eggs are gently heated in their shells to a high-enough temperature to kill any bacteria without cooking the egg. They are pretty widely available, though the texture isn’t always exactly the same as an unpasteurized egg.  

If you are making eggnog the old-fashioned way, Detwiler has some advice for that, too.

“Cook the egg mixture to 160℉ and refrigerate it quickly in several small containers,” he says. “Then it will cool quickly.”

Jingle bells, all.

Friday Stats and More

David Ermer–CDC, COVID-19, Mental health care, OPM, Patient safety, Telehealth–
Photo by Sincerely Media on Unsplash

Based on the Centers for Disease Control’s Covid Data Tracker, the CDC’s weekly interpretation of those new cases, hospitalizations and death statistics shows across-the-board increases. Welcome winter.

New Cases

As of December 7, 2022, the current 7-day average of weekly new cases (65,569) increased 49.6% compared with the previous 7-day average (43,825). A total of 99,241,649 COVID-19 cases have been reported in the United States as of December 7, 2022.

Variant Proportions

CDC Nowcast projections* for the week ending December 10, 2022, estimate the proportion of lineages designated as Omicron with estimates above 1%: BA.5—and four of its sublineages (BQ.1, BQ.1.1, BF.7, and BA.5.2.6)—BA.4.6, and XBB. XBB is a recombinant of two BA.2 sublineages.

The two predominant Omicron lineages and the two that are increasing this week are BQ.1.1, projected to be 36.8% (95% PI 34.1-39.6%) and BQ.1, projected to be 31.1% (95% PI 29.0-33.4%) nationally. All other lineages (BA.5, BF.7, XBB, BN.1, BA.5.2.6, and BA.4.6) are decreasing in proportion this week compared to last.

New Hospitalizations

The current 7-day daily average for November 30–December 6, 2022, was 4,844. This is a 13.8% increase from the prior 7-day average (4,256) from November 23–29, 2022.

New Deaths

The current 7-day average of new deaths (426) increased 61.7% compared with the previous 7-day average (263). As of December 7, 2022, a total of 1,080,472 COVID-19 deaths have been reported in the United States.

CNN adds,

Hospitals are more full than they’ve been throughout the Covid-19 pandemic, according to a CNN analysis of data from the US Department of Health and Human Services. But as respiratory virus season surges across the US, it’s much more than Covid that’s filling beds this year.

More than 80% of hospital beds are in use nationwide, jumping 8 percentage points in the past two weeks.

Hospitals have been more than 70% full for the vast majority of that time. But they’ve been 80% full at only one other point: in January, during the height of the Omicron surge in the US. Back in January, about a quarter of hospital beds were in use for Covid-19 patients. But now, only about 6% of beds are in use for Covid-19 patients, according to the HHS data.

From the Omicron countermeasures front, the weekly interpretation tells us

As of December 7, 2022, 657.9 million vaccine doses have been administered in the United States. Overall, about 228.6 million people, or 68.9% of the total U.S. population, have completed a primary series.* More than 42.0 million people, or 13.5% of the U.S. population ages 5 years and older, have received an updated (bivalent) booster dose.

Medscape adds, “Getting at least one dose of a COVID-19 vaccine decreases the chances of having symptoms beyond 3 weeks or developing long COVID, a new analysis shows.”

The weekly interpretation usually encourages more Covid vaccinations. This week, the interpretation opens by touting the use of Paxlovid, to wit —

As we enter the holiday season, it’s important to take steps to protect yourself and others from serious illness with COVID-19, including staying up to date on COVID-19 vaccines and promptly talking to your healthcare provider about treatment options if you test positive for COVID-19.

If you have COVID-19 symptoms:

Test : Use a self-test, locate a test site, or find a Test to Treat location.

Talk: If you test positive, talk to a healthcare professional to determine if you are eligible for treatment, even if your symptoms are mild right now.

Treat: Start treatment within five days of developing symptoms.

Note to Readers: Paxlovid is not a replacement for COVID-19 vaccination. COVID-19 vaccination makes you much less likely to get very sick. Still, some vaccinated people, especially those ages 65 years or older or who have other risk factors for severe disease, may benefit from treatment if they get COVID-19. A healthcare provider will help decide which treatment, if any, is right for you.

That’s the full picture for most folks. Here’s the “real-world data” link if you are interested. Thank you CDC.

Here are the key points from this week’s CDC FluView:

  • Seasonal influenza activity is high across the country.
  • Of the influenza A viruses detected and subtyped during week 48, 76% have been influenza A(H3N2), and 24% have been influenza A (H1N1).
  • Seven influenza-associated pediatric deaths were reported this week, for a total of 21 pediatric flu deaths reported so far this season.
  • CDC estimates that, so far this season, there have been at least 13 million illnesses, 120,000 hospitalizations, and 7,300 deaths from flu.
  • The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 48 during every previous season since 2010-2011.
  • The number of flu hospital admissions reported in the HHS Protect system increased during week 48 compared to week 47.
  • The majority of influenza viruses tested are in the same genetic subclade as and antigenically similar to the influenza viruses included in this season’s influenza vaccine.
  • All viruses collected and evaluated this season have been susceptible to influenza antivirals.
  • An annual flu vaccine is the best way to protect against the flu. Vaccination helps prevent infection and can also prevent serious outcomes in people who get vaccinated but still get sick with the flu.
  • CDC recommends that everyone ages 6 months and older get a flu vaccine annually. Now is a good time to get vaccinated if you haven’t already.
  • There are also prescription flu antiviral drugs that can be used to treat flu illnesses. It’s very important that flu antiviral drugs are started as soon as possible to treat patients who are hospitalized with flu, people who are very sick with flu but who do not need to be hospitalized, and people with flu who are at higher risk of serious flu complications based on their age or health.
  • Multiple respiratory viruses are currently co-circulating with influenza.  Testing is important to determine the appropriate treatment.

From the FEHB front, the FEHBlog was bowled over to discover on reginfo.gov that on November 29, the Office of Personnel Management took a major step forward in implementing the Postal Service Health Benefits Program by submitting a draft interim final rule to OMB’s Office of Information and Regulatory Affairs for its review. This is the final step before the rule is published in the Federal Register. The statutory deadline for so promulgating this rule is April 8, 2023.

From the miscellany department

  • HR Dive discusses a Mercer report on how employers can impact the maternal mortality problem.
    • EBRI offers a useful analysis of telemedicine and its relationship with other healthcare services, enrollee health, and costs.
    • Chain Drug News reports that PCMA, the prescription drug manager trade association, has issued policy recommendations to accelerate patient biosimilar drug use.
    • The Wall Street Journal offers encouraging news about prison programs to resolve inmate addiction issues.

    Two-thirds of people entering prisons and jails have what the Department of Health and Human Services diagnoses as substance-use disorder. For years, the only treatment in all but a handful of detention centers was to detox.

    Some 630 of the roughly 5,000 jails and prisons nationwide now provide medication treatment for opioid use, according to the nonprofit Jail and Prison Opioid Project, up from about 20 in 2015. The drugs include buprenorphine, which tamps cravings for opioids, naloxone, which reverses their effects, and methadone, which eases withdrawal symptoms. Some are taken daily, others can be taken once a month in extended-release versions. The Biden administration said it wants medication available for every drug user in federal custody and at half of state prisons and jails by 2025.

    Midweek update

    David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Government Contracting, Mental health care, OPM, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–
    Photo by Manasvita S on Unsplash

    From Capitol Hill, the Wall Street Journal reports

    Senate Democrats celebrated their win in Georgia giving them 51 seats next year, a result that enhances their power by allowing them to more easily advance President Biden’s nominees while also providing slightly more flexibility on legislation.

    Sen. Raphael Warnock’s win in a runoff election over GOP challenger Herschel Walker comes after two years in which Vice President Kamala Harris provided a tiebreaking vote in the 50-50 Senate. * * *

    Since early 2021, the two parties have been operating under a power-sharing agreement with evenly divided committees, which has prevented Democrats from issuing subpoenas to witnesses without GOP support. When nominees have tied in a committee vote, Democrats have been forced to hold an extra procedural vote to finalize their nomination. The Warnock victory will give Democrats a narrow majority on each panel.

    “It’ll be easier for Democrats to move forward with some of their nominees, particularly in the judiciary, and that makes it more difficult for us,” said Sen. Mitt Romney (R., Utah). 

    Roll Call informs us

    The newly minted defense authorization bill for fiscal 2023 [NDAA], made public Tuesday night, provides a shot in the arm to the U.S. defense budget but bars the military from discharging any more troops who refuse COVID-19 vaccine shots in their arms. * * *

    [This bill has been approved by a House-Senate conference committee.] The House is expected to vote on the NDAA as soon as Thursday and the Senate to soon follow suit, perhaps next week.  

    The bill would authorize a 4.6 percent across the board pay increase for military personnel and civilians. However, House and Senate negotiators removed a House-passed “inflation bonus” of an additional 2.4 percent for troops and Defense Department civilians making less than $45,000 a year. * * *

    Also of note, the bill would ban contractors across the government from using Chinese-made semiconductors, after a lengthy phase-in period, an aide with knowledge of the provision said Tuesday. Many federal contractors and other businesses say they are unclear how they will comply.

     Govexec offers two more insights on the NDAA

    Congressional negotiators on Tuesday night finally revealed a compromise version of the annual defense policy bill with the aim of passing it through both the House and Senate this week. But to some lawmakers, federal employee groups and good government experts’ chagrin, the measure did not include [Insight link] a provision aimed at blocking Republican-led efforts to strip potentially tens of thousands of federal employees of their civil service protections.

    and

    The authorization bill compromise text contains provisions [Insight link] that seek to increase transparency and accountability of investigations into Inspectors Generals [IG] and operations of the Council of Inspectors General on Integrity Efficiency (and its integrity committee, specifically); ensure IGs are only removed for justiciable and compelling reasons (and Congress is notified); and limit who can serve as acting IGs. There are also stipulations for notifying Congress when an agency doesn’t provide requested information or assistance to an IG and providing more training opportunities for IGs. 

    In an effort to address persistent watchdog job vacancies, the bill’s text states: “If the president fails to make a formal nomination for a vacant inspector general position that requires a formal nomination by the president to be filled within the period beginning on the later of the date on which the vacancy occurred or on which a nomination is rejected, withdrawn, or returned, and ending on the day that is 210 days after that date, the president shall communicate, within 30 days after the end of such period and not later than June 1 of each year thereafter, to the appropriate congressional committees.” 

    From the federal employee benefits front —

    FedWeek gives us last minute guidance on the Federal Employee Benefits Open Season that ends next Monday December 12.

    The Wall Street Journal offers ideas for use of flexible spending account dollars. The article make a point that was not on the FEHBlog’s radar screen:

    This year’s December FSA spending crunch could be worse than usual. While you’re meant to empty your FSA every year, during the pandemic the government relented on this rule, allowing FSA savers to roll over what they saved in 2020 and 2021, with some accounts swelling to more than $7,000. 

    That special treatment is set to end in 2022, meaning if you have been accumulating money in your FSA, you may need to empty our account by Dec. 31 or you risk losing it all. “Some people might be in for a rude surprise,” says Spiegel.

    Employers are permitted to give workers a little wiggle room—but not much. Some plans include a rollover provision that allows account holders to carry forward a small portion of their savings, although this amount is limited to $570 for 2022. Other plans may allow a spending grace period of up to 10 weeks.  

    From the infectious disease front —

    • The Wall Street Journal brings us up to date on Omicron treatments.
    • The Hill reports on the state of the flu and RSV surges. “Dr. Andrew Pekosz, a virologist and professor at Johns Hopkins Bloomberg School of Public Health, believes the U.S. is still in the “early stages” of a surge in influenza cases, he told Nexstar. * * * “With RSV we seem to be hitting a plateau,” said Pekosz. “Case numbers have not increased significantly for a couple of weeks, but they’re still at a very high level. So the burden of RSV is still great, but we may be closer to the peak there than we are with flu.”
    • Forbes relates, “A newly discovered immune response inside the nose could explain why respiratory illnesses like RSV, Covid, the common cold and flu thrive in winter, according to research published Tuesday in The Journal of Allergy and Clinical Immunology, a finding that challenges the conventional wisdom that infections spread because people are stuck indoors and signposts ways to develop new treatments.”

    From the Rx development and coverage front

    • MPR informs us “The Food and Drug Administration (FDA) has granted Fast Track designation to PH10 for the treatment of major depressive disorder (MDD). * * * Results showed that treatment with PH10 significantly reduced depressive symptoms as early as 1 week based on the 17-item Hamilton Depression Scale (HAM-D-17) scores compared with placebo (P =.022). The intranasal spray was found to be well tolerated, with no serious adverse events reported.”

    Touted by celebrities, raved about by TikTok users, and advertised by med spas, a new class of drugs for treating diabetes and obesity has exploded in popularity for its weight-loss effects, leading to rippling shortages across several of the medications.

    Amid the surge in demand, Eli Lilly and pharmacies have started to tighten access to the latest of this type of drug, tirzepatide, focusing on giving it to people with type 2 diabetes, the only population it’s authorized for so far. But that’s left another set of patients scrambling — people with clinical obesity who turned to the medication as one of their few options for treatment. * *

    There’s much overlap between the two conditions, said Beverly Tchang, an endocrinologist and assistant professor of clinical medicine at Weill Cornell Medicine. “Obesity can lead to diabetes, diabetes can lead to obesity,” she said. “They’re very much intertwined, and to treat one but not the other seems inequitable.” Tchang treats both types of patients and feels the drug shouldn’t be conserved for one group at the expense of the other.

    From the telehealth front, mHealth Intelligence explains

    FAIR Health’s Monthly Telehealth Regional tracker reported no change in telehealth usage in September compared with August and noted that COVID-19 fell in its rankings on top telehealth diagnoses lists in all regions and at the national level.

    The FAIR Health Monthly Telehealth Regional tracker is a complimentary service that analyzes how telehealth activity and use change monthly by tracking various factors such as claim lines, procedure codes, and diagnostic categories. It represents the privately insured population, including Medicare Advantage but excluding Medicare Fee-for-Service and Medicaid beneficiaries.

    From the public health front —

    • MedPage Today informs us “Drug overdose deaths in pregnancy or the postpartum period increased sharply in the U.S. in recent years, with the rise most pronounced at the start of the COVID-19 pandemic in 2020, researchers reported. * * * Jacob S. Ballon, MD, MPH, of Stanford University in California, noted that the study authors did not provide explanations for why the overdose-related death rate rose sharper among the pregnant and postpartum group during the study period, but said it will likely be the basis for further research. “[It’s] an interesting signal,” said Ballon, who was not involved with the study. “But now what do we do with that to explain it or make some sense of it?”
    • Healthcare Dive tells us
    • Increased delays in discharging patients who require additional care after a hospital stay could slow their recovery, potentially harming health outcomes and quality of life, the American Hospital Association cautioned in a report released Tuesday.
    • The inability to discharge patients is putting additional strain on hospitals operating with thin workforces, and health systems are bearing the cost of care for patients who stay excess days without appropriate reimbursement, the AHA said.
    • The association has urged Congress to help offset the costs of care for patients’ additional days in the hospital by creating a temporary per diem Medicare payment targeted to acute, long-term care, rehabilitation and psychiatric facilities.

    From the U.S. healthcare business front —

    Imagine going into your doctor’s office and facing not a staff of overworked doctors and nurses, but an inviting conversation. A talk with a healthcare professional who has plenty of time, isn’t in a hurry and is ready to listen to a recital of the different aches and pains of your life. Someone with expertise in medications dedicated to making your life easier and healthier. A professional who makes and then hands you a cup of coffee before you even start talking.

    With that conversation–easy, low stress–you can begin a level of trust with your doctor’s office that you might not have had before. And the person listening may, in conjunction with the doctors and nurses, find some better paths to helping you get healthier, even if you suffer from a chronic disease.

    That’s the vision that Fergus Hoban has for the American healthcare system. His company, UpStream, provides integrated services for primary care physicians, both independently and as part of networks or bigger healthcare systems. Centered around a prescribing pharmacist, a team of nurses and other professionals work with doctors to provide better care for Medicare patients while at the same time lowering costs.

    LHC Group and UnitedHealth Group have extended their merger agreement as the feds take a deeper look at the deal.

    The agreement was extended until March 28, 2023, and the two companies now expect the merger to close in the first quarter of 2023, according to a filing with the Securities and Exchange Commission.

    That the insurance giant intended to acquire LHC, a home health provider, was announced in March, and the deal is valued at about $5.4 billion. UnitedHealth said it plans to fold LHC into its Optum subsidiary as part of its provider arm, Optum Health, which is one of the country’s largest employers of physicians.

    LHC Group would add 30,000 employees who provide more than 12 million home health services annually.

    • Health Payer Intelligence also tells us about positive provider and payer reactions to the CMS proposed rule to promote widespread use of electronic prior authorizations. As noted here yesterday, “[t]he proposed rule would require the implementation of Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) standard Application Programming Interface (API) and mandates that payers have to explain the specific reason behind a prior authorization denial. Expedited prior authorizations will have to occur within 72 hours and non-urgent prior authorizations will have to be turned around in seven calendar days.”

    Tuesday’s Tidbits

    David Ermer–CMS, Electronic health records, FDA, Medicare, Mental health care, NIH, Rx coverage, Telehealth, U.S. Healthcare–
    Photo by Patrick Fore on Unsplash

    From the Federal employee benefits front, Fedweek offers year-end benefits and tax guidance to federal and postal employees and annuitants.

    From the medical research and development front,

    STAT News reports, “A consensus may be emerging about how to prescribe the new Alzheimer’s drug lecanemab, according to remarks made by both a critic of other Alzheimer’s medicines and the CEO of the company that developed it.”

    The National Institutes of Health announced

    The protein apolipoprotein E (APOE) plays a key role throughout the body. It helps to transport cholesterol and other fatty molecules, or lipids. The gene that produces APOE comes in a few different varieties. The most common is called APOE3.

    The most notorious is APOE4, which has long been linked to an increased risk of dementia in Alzheimer’s disease. People who inherit one copy of the APOE4 gene have up to a fourfold greater risk of developing Alzheimer’s disease dementia. Inheriting two copies of APOE4 elevates the risk up to twelvefold. But despite years of study, scientists have little understanding of how APOE4 affects the human brain and boosts dementia risk. * * *

    [NIH] Researchers found evidence that the Alzheimer’s-related gene APOE4 disrupts cholesterol management in the brain and weakens insulation around nerve fibers.

    A drug that affects cholesterol led to improved learning and memory in mice with the gene, pointing to a potential new approach for treating dementia in Alzheimer’s disease.

    The Wall Street Journal reports

    New research has bolstered a once-gutsy idea: Bugs in the digestive system may play a role in depression.

    Two studies published Tuesday in the journal Nature Communications found a link between several types of bacteria in the gut and depressive symptoms. Trillions of microorganisms including bacteria, fungi and yeast live in the digestive tract. Research exploring whether they might affect an array of diseases has increased in recent years.

    The new studies, conducted among thousands of people in two cities in the Netherlands, are among the largest to date demonstrating potential associations between gut microbiota and mental health.

    “Ten years ago if you’d said there was something linking depression and the microbiome, you’d be carried out with a straitjacket,” said Jos Bosch, an associate professor of psychology at the University of Amsterdam who co-wrote both studies. “Now absolutely, it’s very clear there’s a link.”

    . . . Researchers who conducted the studies in the Netherlands called their findings a preliminary step toward identifying biological indicators and therapies for depression. The precise relationship between depression and microbes in the gut couldn’t be determined, they said. Depression can cause a person to eat less healthily, Dr. Bosch pointed out, which can lead to changes in the composition of microorganisms in the gut.

    “Causality is a bit up in the air,” he said. 

    From the mental healthcare front, Fierce Healthcare tells us

    While mental health and substance abuse issues have only grown thanks to the pandemic, a bright spot may be forming: The number of providers available to treat these concerns is increasing, a new study shows.

    The United Health Foundation, the philanthropic arm of insurance giant UnitedHealth Group, released its annual “America’s Health Rankings” report and in the analysis found that between 2020 and 2021, the number of people who reported that their mental health was poor in 14 of the last 30 days increased by 11%.

    In 2020, 13.2% reported frequent mental distress, and that rose to 14.7% in 2021, according to the report.

    At the same time, drug-related deaths spiked. The report found that deaths increased by 20% nationwide between 2019 and 2020, reaching 27.9 deaths per 100,000. This is the largest year-over-year increase in more than a decade, according to the report.

    The report also found that disparities within drug deaths increased in tandem. Such deaths increased by 45% among multiracial populations and by 43% among Black populations. Drug-related deaths were highest among American Indian/Alaskan Native populations, occurring at a rate nine times higher than the lowest group, Asian patients.

    However, the analysis found that the supply of mental health providers reached its highest levels since the report was first published in 2017. The number of mental health providers per 100,000 increased by 7% between 2021 and 2022 and has increased by 40% since the 2017 report.

    There are now 305 mental health providers per 100,000, according to the report.

    Health Payer Intelligence adds

    Having one or more outpatient behavioral health treatment (OPBHT) visits was associated with lower healthcare costs among patients with newly diagnosed behavioral health conditions, a JAMA Network Open study found.

    Adults with a behavioral health condition incur 2.8 to 6.2 times greater medical costs than those without one, and nearly a quarter of adults had a behavioral health condition as of 2018. However, behavioral health condition diagnoses are often delayed, and most individuals receive little or no treatment each year.

    From the Rx coverage front, STAT News tells us

    During 2021, drugmakers substantially raised prices on seven widely used medicines without any new clinical evidence to justify the increases, leading patients and health insurers in the U.S. to spend an additional $805 million last year, according to a new report.

    The drug for which spending increased the most due to a price increase was Xifaxan, which is used to treat both irritable bowel syndrome and a complication of cirrhosis. Salix Pharmaceuticals, a unit of Bausch Health, raised the wholesale price by 7.9%. The net price — after rebates and discounts — rose by 12%, most likely because the company offered fewer concessions than previously.

    Consequently, spending for this drug climbed by $174.7 million, according to the report issued by the Institute for Clinical and Economic Review, a nonprofit that assesses the cost effectiveness of medicines. The report noted that the manufacturer disputed the net price and budget impact, which was provided by the SSR Health market research firm, but did not provide corrected estimates.

    Of course, PBM formularies are designed to correct these issues.

    The Wall Street Journal adds

    Emergent BioSolutions Inc., maker of Narcan, a nasal-spray form of naloxone, said Tuesday that the U.S. Food and Drug Administration fast-tracked an application it submitted for an over-the-counter version of its widely used opioid-reversal nasal spray.

    The company said it had been working on the application for several months. Emergent said the FDA’s priority review gives the drug an expected approval date of March 29, 2023, putting it first in line for approval ahead of competitors that have announced their planned foray into the market. 

    The FDA has encouraged pharmaceutical companies to apply for approval for over-the-counter versions of overdose-reversal medications such as Narcan to help confront a swelling overdose crisis from bootleg versions of the powerful opioid fentanyl.

    Last week, FDA Commissioner Robert Califf said naloxone—which binds to opioid receptors to reverse the effects of opioids—should be as ubiquitous as defibrillators.

    From the fraud, waste, and abuse front, mHealth Intelligence reports

    As telehealth use exploded across healthcare programs provided by federal agencies, a report by a watchdog committee shows several program integrity risks linked to telehealth billing, including duplicate billing and ordering unnecessary durable medical equipment or laboratory tests.

    They found that approximately 37 million individuals used telehealth services from March 2020 through February 2021 in the selected programs administered by the six federal agencies. This represents a massive increase from the 3 million individuals in these programs who used telehealth services the year prior.  

    In most programs, telehealth was used primarily to access office visits with a primary care provider or specialist and for behavioral health services, like individual and group therapy and substance use disorder treatment.

    Overall, the agencies spent more than $6.2 billion on telehealth services, with Medicare accounting for the highest expenditure at $5.1 billion, followed by TRICARE and the Federal Employees Health Benefits Program, which together spent $1 billion.

    But the OIGs found several similar program integrity risks associated with billing for telehealth services across multiple programs. These included “upcoding” telehealth visits by billing for visits longer than they lasted, duplicate billing for the same service, ordering unnecessary durable medical equipment, supplies, or laboratory tests, and billing for services inappropriate or ineligible for telehealth.

    From the plan design front, Fierce Healthcare relates

    The Biden administration released a proposal which, if finalized, would mandate Medicare Advantage (MA), Medicaid managed care, Affordable Care Act (ACA) plans and state Medicaid agencies implement electronic prior authorization systems by 2026. 

    The proposed rule, released Tuesday by the Centers for Medicare & Medicaid Services (CMS), will require payers and states to streamline prior authorization processes and improve the electronic exchange of health data by 2026. It also contains incentives for hospitals and physicians to adopt electronic prior authorization.

    “The prior authorization and interoperability proposals we are announcing today would streamline the prior authorization process and promote healthcare data sharing to improve the care experience across providers, patients and caregivers,” CMS Administrator Chiquita Brooks-LaSure said in a statement. 

    It is the revised version of a Trump administration rule originally finalized in late 2020 but withdrawn after concerns about costs and a short deadline. That rule only applied to Medicaid managed care, the Children’s Health Insurance Program and ACA plans, while the new version would apply also to MA plans. 

    Monday Roundup

    David Ermer–CDC, Congress, COVID-19, FDA, Federal employment benefits, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare–
    Photo by Sven Read on Unsplash

    From Capitol Hill, Roll Call reports the FY 2023 National Defense Authorization Act is expected to rescind the Defense Secretary’s 2021 Covid vaccine mandate for U.S. service members. “Congressional leaders are aiming to introduce the final compromise NDAA version as soon as Tuesday, with House floor action possible later in the week.”

    From the infectious disease front —

    • Bloomberg Prognosis tells about a study confirming the Paxlovid rebounds have been blown out of proportion.
    • Pfizer has asked the Food and Drug Administration for an emergency use authorization applicable to its bivalent Omicron vaccine designed for children at least six months old and not over four years old.
    • The Health and Human Services Secretary has confirmed reported plans to end the mpox public health emergency when the current declaration expires at the end of January 2023. “But we won’t take our foot off the gas – we will continue to monitor the case trends closely and encourage all at-risk individuals to get a free vaccine.”
    • MedPage Today interviews Demetre Daskalakis, MD, MPH, the deputy coordinator of the White House Monkeypox Response Team, about the course of the illness since it erupted in the summer

    Influenza hospitalizations this early in the season are higher than they have been in a decade, according to the CDC, with 14 pediatric deaths reported so far.

    “Since October 1, there have already been at least 8.7 million illnesses, 78,000 hospitalizations, and 4,500 deaths from flu,” said CDC Director Rochelle Walensky, MD, MPH, on a call with reporters on Monday, held in part to kick off National Influenza Vaccination Week. * * *

    This year, influenza vaccines are “well matched to the viruses currently circulating,” she added. The flu shots contain protection for two influenza A and two influenza B virus strains. Of influenza A viruses detected and subtyped this season, 79% have been A(H3N2) and 21% have been A(H1N1).

    The CDC recommends influenza vaccination particularly for children, immunocompromised individuals, pregnant women, and people 65 and over.

    It was not clear if the pediatric deaths reported so far this season involved unvaccinated children, but Fryhofer noted that previous data showed about 80% of influenza deaths occur in unvaccinated persons.

    Pregnant women who get the flu shot also protect their newborns, who are not eligible for vaccination before they are 6 months of age, Fryhofer said. “If you’re not doing it for you, do it for your baby.”

    • For context, here are the flu case and death statistics from the last flu season before Covid struck, October 2019 through March 2020.
    2019 – 2020 Winter CDC Fluview  3/28/20
    Flu Deaths                  24,000 
    Flu Cases             39,000,000 

    The flu is a highly contagious, dangerous disease.

    • NPR Shots offers consumer advice should they counter pharmacy shelves with a low or no supply of anti-fever drugs.

    From the telehealth front, Health Leaders Media tells us

    According to a survey commissioned by America’s Health Insurance Plans, almost 70% used telehealth in the past year because it’s more convenient than in-person care, and almost 80% say telehealth makes it easier to seek out care.

    Almost 50% used telehealth because they were unable to make an in-person appointment, while 24% said they wanted to save money.

    Some 36% used telehealth just once over the past year, while 53% used it between two and five times.

    From the mental healthcare front, Health Payer Intelligence reports

     CareFirst BlueCross BlueShield (CareFirst) is providing community-based organizations with nearly $8 million in grants to help improve behavioral healthcare access and quality for underserved youth.

    The COVID-19 pandemic exacerbated the mental and behavioral health crisis among children, adolescents, and families. In response, CareFirst is investing in 19 community-based organizations in Maryland, Washington, DC, and Northern Virginia.

    “CareFirst recognizes that behavioral health is an essential part of overall health, which includes a continuum of conditions ranging from severe mental health disorders to the emotional, psychological, and social factors that affect a person’s overall wellbeing,” Destiny-Simone Ramjohn, PhD, vice president of community health and social impact at CareFirst, said in the press release.

    Kudos

    From the Rx coverage front, Fierce Healthcare informs us

    Express Scripts, which is part of Cigna’s Evernorth subsidiary, said Monday that it will add biosimilars for Humira to its largest formularies as preferred products available for patients with inflammatory conditions. Like other major PBMs, Express Scripts sees significant potential in biosimilars to help address the massive costs associated with specialty drugs.

    Specialty drugs account for just 2% of prescriptions but drive half of drug spending.

    In October 2021, Express Scripts announced that it would put Semglee, the first Food and Drug Administration-approved interchangeable insulin biosimilar, on its National Preferred Formulary for 2022. The company estimates that this move generated $20 million in savings in the first year.

    From the federal government employee benefits front, Federal News Network relates

    The Office of Personnel Management plans to suspend applications for the Federal Long Term Care Insurance Program for two years beginning Dec. 19, in anticipation of a sizeable rate hike.

    OPM announced the unusual measure last month in the Federal Register, and noted that federal workers who submit their applications by the deadline will still be considered for enrollment. FLTCIP was created in 2002 and assists with health care costs for participants who need help with daily personal functions, or who have a severe cognitive illness, and covers home care, nursing home or assisted living benefits.

    “OPM is suspending applications for coverage in FLTCIP to allow OPM and the FLTCIP carrier to assess the benefit offerings and establish sustainable premium rates that reasonably and equitably reflect the cost of the benefits provided,” the agency wrote.

    The program will continue to operate normally for current enrollees, although they will not be able to apply to increase their coverage. There are currently around 267,000 federal workers and retirees participating in the insurance plan, and OPM typically receives only a few thousand applications to enroll per year.

    The decision to suspend applications for the program came after John Hancock Life and Health Insurance Co., the contractor that administers the program, informed OPM that it is likely that there will a premium increase sometime next year.

    Finally, the Wall Street Journal offers an interesting article about medical research that is “uncovering links between your ‘subjective age’ [as opposed to your chronological age] and your future health and longevity.”

    Weekend update

    David Ermer–AHRQ, Congress, Federal employment benefits, Medicare, Mental health care, OPM, Rx coverage, Uncategorized–
    Thanks to ACK15 for sharing their work on Unsplash.

    The House of Representatives and the Senate are in session this week for Committee business and floor voting.

    The continuing resolution funding the federal government expires at 11:59 pm on Friday December 16.

    The Federal Employee Benefits Open Season ends at 11:59 pm, in the location of the enrollee’s electronic enrollment system, on Monday, December 12, 2022.

    The Medicare Open Enrollment period ends this Wednesday, December 7.

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

    • A shortage in the weight loss drug Wegovy, “missing out on hundreds of millions of dollars in sales and squandering a head start before a rival could begin selling a competing product. * * * [Wegovy manufacturer’ Novo lists Wegovy at $1,349 a month. Some commercial insurers cover the drug.” OPM has encouraged FEHB carriers to offer coverage of this drug.
    • A CVS Health effort to improve pharmacy efficiency with “a system [currently being tested] that allows pharmacists to process prescriptions in part remotely, a move it said could improve store working conditions and the experience for customers as the company grapples with a shortage of pharmacists.”

    From the mental healthcare front, Health Payer Intelligence tells us

    Mental healthcare services utilization and network size have grown significantly since 2019 among Blue Cross Blue Shield of Massachusetts (“Blue Cross”) members, according to data from Blue Cross.

    Mental healthcare services utilization grew by 100 percent in the timeframe that Blue Cross examined. At the same time, Blue Cross’s mental healthcare network grew by 46 percent.

    “As the need for mental health services continues to grow, access to convenient and affordable care is critical,” said Andrew Dreyfus, president and chief executive officer of Blue Cross. “By expanding and diversifying our mental health network, we’re ensuring that our members are able to find and receive the high-quality care they need, when they need it.”

    The mental healthcare provider network swelled to a total of 18,000 clinicians. With the growth in utilization, Blue Cross plans to expand its network further. The payer will do this by working with national mental healthcare provider groups as well as expanding its virtual care mental health groups in 2023. * * *

    Blue Cross also shared that the health plan’s reimbursement for telehealth and virtual care services is at parity with in-person services. Receiving reimbursement at parity is not only a controversial issue for telehealth providers but also for mental and behavioral healthcare providers, who do not always receive reimbursement at parity with physical care providers.

    Kudos.

    Also worth reading is this Journal article about a 24-year-old military wife who went through drug addiction hell and came out a new person with help from her family, the Missouri prison where she was housed, and a fellow inmate. The article illustrates the importance of Blue Cross of Massachusett’s efforts to expand mental health coverage and various efforts to reduce drug addiction and overdose deaths.

    From the medical research front, the Wall Street Journal offers an essay about breast cancer written by a medical historian and breast cancer patient Dr. Lindsey Fitzharris. What grabbed the FEHBlog’s eye is the article’s conclusion:

    The cofounders of BioNTech recently announced that vaccines targeting cancer may be available before the end of the decade. Researchers at Duke University are already developing a vaccine that targets mutations commonly arising in people with certain types of advanced breast cancer. Using the same mRNA technology deployed against Covid-19, these types of vaccines would not be administered prophylactically but, rather, used as a treatment to trigger a stronger immune response in patients with locally recurrent or metastatic disease. When it comes to conquering breast cancer, future medical historians will have plenty to write about.

    From the innovation front, Senior Living explains how to use Apple AirPods as hearing aids. MedTech Dive adds

    • Apple AirPods Pro earbuds have the potential to be a hearing aid for adults with mild to moderate hearing loss, according to a paper published in iScience. 
    • Researchers found the earbuds meet four of the five standards for personal sound amplification products and perform comparably to hearing aids in terms of speech perception in quiet environments.
    • The study suggests that some consumer earbuds can function as hearing aids to potentially further lower the cost and address the stigma associated with the technology.

    It’s also worth calling attention to the HHS Agency for Healthcare Quality and Research’s Effective Health Care Program’s website.

    The Effective Health Care (EHC) Program improves the quality of health care by providing the best available evidence on the outcomes, benefits and harms, and appropriateness of drugs, devices, and health care services and by helping health care professionals, patients, policymakers, and health care systems make informed health care decisions. The EHC Program achieves this goal by partnering with research centers, academic institutions, health professional societies, consumer organizations, and other stakeholders to conduct research, evidence synthesis, evidence translation, dissemination, and implementation of research findings.

    Friday Stats and More

    David Ermer–CDC, COVID-19, FDA, Medicare, Mental health care, OPM, U.S. Healthcare–
    Photo by Sincerely Media on Unsplash

    From the Omicron and siblings front, the Centers for Disease Control’s weekly interpretative summary of its Covid statistics explains

    Cases

    As of November 30, 2022, the current 7-day average of weekly new cases (43,300) decreased 1.2% compared with the previous 7-day average (43,837). A total of 98,777,220 COVID-19 cases have been reported in the United States as of December 30, 2022.

    Variant Proportions

    CDC Nowcast projections* for the week ending December 3, 2022, estimate the proportion of lineages designated as Omicron with estimates above 1%: BA.5—and four of its sublineages (BQ.1, BQ.1.1, BF.7, and BA.5.2.6)—BA.4.6,and XBB. XBB is a recombinant of two BA.2 sublineages.

    New Hospital Admissions

    The current 7-day daily average for November 23–29, 2022, was 4,201. This is a 17.6% increase from the prior 7-day average (3,572) from November 16–22, 2022.

    Vaccinations

    As of November 30, 2022, 655.3 million vaccine doses have been administered in the United States. Overall, about 267.3 million people, or 80.5% of the total U.S. population, have received at least one dose of vaccine. About 228.4 million people, or 68.8% of the total U.S. population, have completed a primary series.

    Of those who have completed a primary series, about 114.8 million people have received a booster dose,* and more than 39.7 million people have received an updated (bivalent) booster dose. But 48.3% of the total booster-eligible population has not yet received a booster dose. Learn more about who is eligible.

    Deaths

    The current 7-day average of new deaths (254) decreased 32.4% compared with the previous 7-day average (376). As of November 30, 2022, a total of 1,077,303 Covid-19 deaths have been reported in the United States

    The CDC also released an encouraging report about Paxlovid’s efficacy.

    Summary

    What is already known about this topic?

    Nirmatrelvir-ritonavir (Paxlovid) is an outpatient antiviral medication recommended for adults with mild-to-moderate COVID-19 who have elevated risk of severe illness.

    What is added by this report?

    Among U.S. adults diagnosed with COVID-19, including those with previous infection or vaccination, persons who were prescribed Paxlovid within 5 days of diagnosis had a 51% lower hospitalization rate within 30 days after diagnosis than those who were not prescribed Paxlovid.

    What are the implications for public health practice?

    Paxlovid should be offered to eligible adults irrespective of vaccination status, especially in groups with the highest risk for severe COVID-19 outcomes, such as older adults and those with multiple underlying health conditions.

    Also from the public health front, the CDC’s Fluview tells us

    • Seasonal influenza activity is high and continues to increase across the country.
    • Of influenza A viruses detected and subtyped this season, 79% have been influenza A(H3N2) and 21% have been influenza A(H1N1).
    • Two influenza-associated pediatric deaths were reported this week, for a total of 14 pediatric flu deaths reported so far this season.
    • CDC estimates that, so far this season, there have been at least 8.7 million illnesses, 78,000 hospitalizations, and 4,500 deaths from flu.
    • The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 47 during every previous season since 2010-2011.
    • The number of flu hospital admissions reported in the HHS Protect system during week 47 almost doubled compared with week 46.
    • The majority of influenza viruses tested are in the same genetic subclade as and antigenically similar to the influenza viruses included in this season’s influenza vaccine.
    • All viruses collected and evaluated this season have been susceptible to influenza antivirals.
    • An annual flu vaccine is the best way to protect against flu. Vaccination helps prevent infection and can also prevent serious outcomes in people who get vaccinated but still get sick with flu.
    • CDC recommends that everyone ages 6 months and older get a flu vaccine annually. Now is a good time to get vaccinated if you haven’t already.
    • There are also prescription flu antiviral drugs that can be used to treat flu illness; those need to be started as early as possible.

    The Wall Street Journal offers a helpful overview of the tripledemic situation.

    From the Alzheimer’s Disease front —

    STAT News reports

    Scientific meetings about Alzheimer’s disease can be funereal affairs, with researchers from around the world gathering in hopes that the latest in a long line of negative clinical trials might light the path to a long-awaited success.

    This year was different. Nearly 2,000 people showed up to the Clinical Trials in Alzheimer’s Disease meeting, a conference record, to hear about lecanemab, a drug from Eisai and Biogen that appears to have broken the decades-long cycle of disappointment.

    A packed audience repeatedly burst into applause during Eisai’s lecanemab presentation on Tuesday — with onlookers clapping even when they learned that the results had been concurrently published in the New England Journal of Medicine. Supplemental figures don’t usually don’t draw cheers, but the warm reception underscored how overjoyed researchers were to have any kind of success against Alzheimer’s, even a modest one. * * *

    Several researchers compared this moment in Alzheimer’s research to the early days of cancer therapy or HIV treatment — the first drugs aren’t smash hits, but they’re something for scientists and doctors to build on and learn from.

    “It’s not like you’ve won the war with lecanemab,” said Eric Siemers, chief medical officer of Acumen Pharma. “We’ve got a lot of work to do. But this is an inflection point. There’s no question about it.”

    In that regard, BioPharma Dive points out lessons learned from testing a Roche drug similar to lecanermab.

    After one year of treatment, [the Roche drug] gantenerumab reduced amyloid burden in patients only half as well as the trials’ designers had expected based on previous research, said researcher Randall Bateman, a neurology professor at Washington University in St. Louis who helped lead the studies.

    Moreover, around half as many gantenerumab patients as predicted tested negative for amyloid over the course of the trial. Almost none tested negative after one year of treatment, and only around a quarter did after more than two years, researchers revealed.

    Data for lecanemab and donanemab presented at CTAD, meanwhile, showed stronger amyloid clearance, helping boost confidence in those drugs.

    Bateman also pointed to a post-study analysis researchers conducted of Roche’s trials that hinted at better outcomes for trial participants who had higher reductions in amyloid, although this finding wasn’t statistically conclusive.

    Taken together with data from other trials, gantenerumab’s results should help researchers as they try to optimize available therapies and develop new ones, Bateman said.

    “I see this as one of the missing essential pieces of the puzzle of figuring out how to optimally treat along this pathway for amyloid removal,” he said.

    Meanwhile, the New York Times tells us about “A Promising Trial Targets a Genetic Risk for Alzheimer’s
    Preliminary results offer hope that gene therapy can protect people with a version of the brain disease driven by a particular gene variant.”

    From the U.S. healthcare business front, Healthcare Dive reports

    Advocate Aurora Health and Atrium Health announced Friday the two providers have closed their merger deal, becoming the nation’s fifth-largest nonprofit health system by revenue.

    The new system, Advocate Health, will generate revenue of more than $27 billion and operate 67 hospitals and more than 1,000 sites of care in six states. The system expects to treat nearly 6 million patients each year. * * *

    The two systems do not have any geographic overlap, an aspect that has tripped up prior hospital mergers.

    Instead, economists told Healthcare Dive, the FTC is likely to examine insurer overlap in the case of Advocate Health. The combined entity operates in Illinois, Wisconsin, Georgia, North Carolina, South Carolina and Alabama.

    From the federal employment front —

    Govexec informs us

    The Biden administration will allow agencies to hire employees in certain positions on a temporary basis for up to 10 years, more than doubling the current cap limiting the assignments for those workers.

    The Office of Personnel Management issued the rule on Thursday, finalizing a proposal first put forward by the Trump administration. The rule will enable federal agencies to appoint employees in STEM jobs for a decade. OPM said the change would give agencies more flexibility when tackling long-term science, technology, engineering and mathematics projects. Previous regulations required agencies to get special permission from OPM to keep any term employee on staff for longer than four years.

    Viet Tran, an OPM spokesman, said the rule showed the administration’s “commitment to STEM hiring.” He added it would allow for more federal, rather than outsourced, hiring. 

    “With this final rule, agencies have more flexibility and support (and less administrative burden) to hire employees—rather than contractors—for non-permanent STEM positions that agencies expect from the outset to last longer than 4 years but not more than 10 years,” Tran said. “This is another tool to help agencies better compete for talent.”

    As the FEHBlog has explained, federal employees can expect a 4.6% pay raise for 2023 with 4.1% of the increase being distributed across the GS schedule and the remaining 0.5% allocated to locality pay. As it turns out, the Society for Human Resource Management tells us

    Employers in the U.S. plan to boost salaries an average of 4.6 percent in 2023, up from 4.2 percent this year, according to a new study.

    Employers say inflationary pressures and the ongoing challenges of finding and keeping workers are the main reasons for the higher projected increases. Indeed, 3 in 4 of the 1,550 U.S. employers in the latest Salary Budget Planning Report by consultancy WTW say they continue to experience problems attracting and retaining workers. The survey was conducted from Oct. 3 to Nov. 4, 2022.

    From the plan design front, a recent Kaiser Family Foundation report explains the growing use of all sizes of employers to provide retiree health benefits through Medicare Advantage plans.

    This analysis uses data from the 2022 KFF Employer Health Benefits Survey to examine the extent to which large private and non-federal public employers that offer retiree health benefits are turning to Medicare Advantage and why they are making this shift. However, the Survey does not include information about union-administered benefits. For additional information about methods, see Survey Design and Methods.

    Based on the Survey, we find:

    • Half (50%) of large employers offering retiree health benefits to Medicare-age retirees offer coverage to at least some retirees through a contract with a Medicare Advantage plan, nearly double the share in 2017 (26%).
    • About 44% of large employers that offer Medicare Advantage coverage to their retirees do not give retirees a choice in coverage options. 
    • Among larger employers with 1,000 or more workers that offer retiree health benefits through a Medicare Advantage plan, the most commonly cited reason they elected this option was the lower cost.

    FEHB plans also are implementing integrated Medicare Advantage plans as a cost-saving measure.

    From the HHS front, “Today, the U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra marked the one-year anniversary of HHS’s Overdose Prevention Strategy (Strategy) by announcing the progress the nation has made since the release of the Strategy, showing expanded treatment capacity, lives saved from an overdose, and commitment to long term recovery supports.” Kudos. Here is the fact sheet.

    Tuesday’s Tidbits

    David Ermer–CDC, Congress, COVID-19, FDA, Mental health care, NIH, U.S. Healthcare–
    Photo by Patrick Fore on Unsplash

    From Capitol Hill, Roll Call reports

    Congressional leaders and top appropriators are set to meet as early as Wednesday to work through differences on a potential omnibus spending agreement, Senate Majority Leader Charles E. Schumer said Tuesday.

    President Joe Biden and Vice President Kamala Harris, along with a few top White House aides, met with Speaker Nancy Pelosi, House Minority Leader Kevin McCarthy, Senate Minority Leader Mitch McConnell and Schumer earlier Tuesday to discuss the lame-duck agenda.

    Schumer said the leaders had a “productive discussion” about funding the government, and said all four leaders aim to come together to pass an omnibus.

    “We all agreed that it should be done this year, we all agreed we have to work together and everyone has to give a little bit,” he said. “We also…said we would all work toward getting an omnibus as opposed to a CR.”

    The prospects of a lame duck omnibus remain murky as Republicans and Democrats have not reached a topline spending agreement. The current continuing resolution runs out Dec. 16, though lawmakers have discussed a stopgap extension of perhaps a week to buy extra time.

    The FEHBlog sees these developments as a good sign.

    From the Omicron and siblings front, MedPage Today informs us

    What happens to people who get reinfected with SARS-CoV-2, the virus that causes COVID-19? A recent paper in Nature Medicinehas been misinterpreted by some as providing evidence that repeat infections are somehow worse than first-time infections.

    Here’s the actual situation: second infections are far less dangerous than first infections, with respect to severe, critical, and fatal COVID-19. This is true regardless of vaccination status.

    Health Payer Intelligence offers three interesting survey findings about health insurance in our country

    • “Health insurance coverage disruptions were associated with higher mortality risks for people with private and public insurance, a JAMA Health Forum study found.”
    • “In two-adult families with and without children, the majority of members had the same type of health insurance coverage, whether they had group plans, non-group plans, or Me,dicaid” according to a brief from the Employee Benefit Researcher Institute (EBRI).

    From the public health front, the FEHBlog ran across The PCORI Health Care Horizon Scanning System identifies and monitors developing innovations with potential to change health care. This database can be used by patients, care partners, and others to track advancements in care options.

    The Wall Street Journal reports

    The rate of gun deaths in the U.S. reached a 28-year high in 2021 after sharp increases in homicides of Black men and suicides among white men, an analysis of federal data showed.

    A record 48,953 deaths in the U.S., or about 15 fatalities per 100,000 people, were caused by guns last year, said the analysis published Tuesday in the journal JAMA Network Open. Gun deaths declined in the 1990s, but have been rising steadily over the past decade and skyrocketed during the Covid-19 pandemic, said researchers who conducted the analysis.

    Gun-related deaths of women and children have risen, the analysis said, but men remain far more likely to die from guns.

    “The disparities are so marked,” said Chris Rees, a co-author of the study and an assistant professor of pediatrics and emergency medicine at Emory University School of Medicine.

    On a related note, Federal News Network relates

    The Pentagon is looking to hire hundreds of clinicians and mental health professionals in the coming months, as part of the initial cohort of its worldwide suicide prevention workforce.

    Deputy Defense Secretary Kathleen Hicks, speaking Tuesday at a Washington Post Live event, said DoD is building up a “first of its kind” suicide prevention workforce that will eventually reach an end strength of 2,000 personnel.

    Hicks said hiring, onboarding and training the suicide prevention workforce is “at the top of the list” of priorities for Defense Secretary Lloyd Austin. This DoD workforce, she added, is expected to outpace any similar effort led by universities or state governments.

    “This prevention workforce will be a first of its kind, and we’re going to do it right here in the United States military, because that’s what we owe our people and their families,” Hicks said.

    From the medical research and development front, the Wall Street Journal reports

    Researchers released new details from a study of a closely watched drug for Alzheimer’s disease on Tuesday, shedding more light on the drug’s risks and benefits as U.S. health regulators weigh approving it. 

    Eisai Co. and Biogen Inc.’s drug, called lecanemab, slowed cognitive decline by 27% compared with a placebo over 18 months in a study of more than 1,700 people with early-stage Alzheimer’s, researchers reported in the New England Journal of Medicine on Tuesday. 

    The drug’s effect was moderate, and was associated with swelling and bleeding in the brain, the researchers said. They recommended further, longer study of the drug.

    Some 17.3% of patients taking lecanemab had signs of brain bleeding, compared with 9% in the placebo group. Brain swelling occurred in 12.6% of people getting the drug, versus 1.7% who got placebos. 

    The study data have been eagerly anticipated by Alzheimer’s researchers since Eisai disclosed high-level results in September, raising the hopes of doctors and patients that a new treatment proven to help Alzheimer’s patients is on the horizon.

    The companies have asked the U.S. Food and Drug Administration to conditionally approve lecanemab based on an earlier study showing that the drug reduced levels of a protein in the brain called amyloid associated with Alzheimer’s. The agency is expected to make a decision by Jan. 6. 

    Eisai, which is leading the development of lecanemab, has said it plans to seek full approval using the new study data. 

    The NIH DIrector’s Blog tells us about the NIH clinical center doctors who are testing 3D-printed miniature, single-use ventilators. Cool.

    Healthcare Dive informs us

    Google’s health division has inked its first commercial agreement to use its mammography AI research model in real-world clinical practice, with the goal of improving breast cancer screening, Google Health announced Monday.

    Google Health has partnered with cancer detection and therapy medtech iCAD on the 5-year deal. Under the agreement, iCAD will work to validate and incorporate Google’s mammography AI — which Google has been building and testing for several years — into its products for use in clinical practices.

    From the U.S. healthcare business front, the Wall Street Journal reports

    Apoorva Mehta, a co-founder of Instacart Inc., is working on his next act after saying earlier this year that he would step down as executive chairman from the startup he built into a grocery delivery giant once it goes public.

    Mr. Mehta earlier this month raised $30 million for Cloud Health Systems, a new healthcare startup aiming to offer consumers medical consultations and other health-related services, according to people familiar with the matter. 

    Good luck.