Monday Roundup

Congress

Monday Roundup

David Ermer–CDC, Congress, COVID vaccine mandate, COVID-19, Medicare, OPM, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, Federal News Network discusses the federal employee pay raise angles presented by the House financial service and general appropriations bill which cleared the House Appropriations Committee last Friday. Federal News Network indicates that the bill leaves the door open for the Senate to also accept the President’s proposed 2023 4.6% pay raise for federal employees and the military.

From the Dobbs case front, Govexec.com reports

President Joe Biden announced two actions immediately after the ruling: one directing the Department of Health and Human Services to safeguard access to contraception and medication abortion, and another protecting travel for medical appointments.

To those ends,

  • Govexec tells us that OPM today confirmed that its policy allowing federal employees to apply sick time to travel out of state remains in effect after the high court struck down Roe v. Wade, and
  • The Department of Health and Human Services (HHS) announced that a meeting was held today between Affordable Care Act regulators, including the HHS and Labor Department Secretaries, and health plan executives to emphasize the importance of full compliance with the ACA’s contraceptive coverage with no cost-sharing mandate when delivered in-network. The ACA regulators also issued a letter to health plans making the same point.

The FEHBlog ran across this NPR Shots article which explains that the Plan B or morning-after pill is considered a contraceptive and not an abortion drug. The Wall Street Journal informs us

Some of the nation’s biggest retailers are rationing over-the-counter emergency contraceptive pills as demand spikes following the Supreme Court ruling overturning a constitutional right to abortion.CVS Health Corp.,  Walmart Inc., and Rite Aid Corp. were limiting purchases of the pills, which were in short supply or out of stock Monday morning on major retailer websites. CVS and Rite Aid were limiting purchases to three. Walmart had some pills available without limits, but only in cases where they wouldn’t ship until next month. Pills available this week were limited to four or six.

From the Omicron and siblings and monkeypox front

  • Govexec reports on a U.S. Court of Appeals for the Fifth Circuit decision order rehearing a federal employee vaccine mandate case which upheld the mandate on lack of plaintiffs’ standing to challenge the mandate. The mandate nevertheless has remained on hold while the case winds it way through the appellate court.
  • USA Today reports on when and how to access the monkeypox vaccine.

From the Medicare front, HHS announced

a new model aimed at improving cancer care for Medicare patients and lowering health care costs. CMS’ Center for Medicare and Medicaid Innovation (Innovation Center) designed the Enhancing Oncology Model (EOM) to test how to improve health care providers’ ability to deliver care centered around patients, consider patients’ unique needs, and deliver cancer care in a way that will generate the best possible patient outcomes. The model will focus on supporting and learning from cancer patients, caregivers, and cancer survivors, while addressing inequities and providing patients with treatments that address their unique needs.

From the reports and studies department —

  • The next issue of Health Affairs offers a bevy of articles on Type 2 diabetes and pre-diabetes which are available at this link.
  • The Congressional Budget Office has made available examples of the work performed by its Health Analysis Division.
  • HealthDay reports “More than 18 million Americans have now survived cancer, a new report shows. The American Cancer Society (ACS) and the U.S. National Cancer Institute collaborated on the report to estimate cancer prevalence and help public health officials better serve survivors.”
  • mHealth Intelligence calls our attention to a telehealth-oriented  Healthcare Experience Report: 2022 released by Zocdoc. The FEHBlog was pleased to read “Mental health continues to hold a place of dominance in telehealth. In May of 2020, 2021, and 2022, the percentage of mental health visits that occurred virtually was 74 percent, 85 percent, and 87 percent, respectively.” Hub and spoke telehealth, e.g, Teladoc, brings mental health care in-network thereby lowering benefit costs while improving access to care.

Weekend update

David Ermer–CDC, Congress, COVID-19, Electronic health records, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Capitol Hill —

The Senate is on a State work break for the next two weeks which encompasses Independence Day. The House of Representatives will be engaged in Committee business this week through Thursday. Then the House will be on District work break through the end of the following week.

The House Oversight and Reform Committee is holding a hearing tomorrow on an important topic: “Examining the 2022 National Drug Control Strategy and the Federal Response to the Overdose Crisis.”

On Friday, the House Appropriations Committee approved

the fiscal year 2023 Financial Services and General Government bill on a 31 to 22 vote. * * *

The following amendments to the bill were adopted by the full Committee:

Rep. Quigley – The manager’s amendment makes technical and noncontroversial changes to the bill and report. The amendment was adopted by voice vote.

Rep. Stewart #3 – This amendment prohibits the government’s use of cloud computing platforms unless they prevent child exploitation images. The amendment was adopted by voice vote.

A summary of the bill is here. The text of the draft bill is here. The bill report, before the adoption of amendments in full Committee, is here. 

This bill includes FEHB and OPM funding.

It occurred to the FEHBlog over the weekend that on Friday he did not explain how the Supreme Court’s Dobbs decision overruling Roe v. Wade impacts the FEHB Program. The short answer in the FEHBlog’s opinion is that it has no impact.

Under the Hyde Amendment whose requirements have been applied to the FEHB via annual appropriations bills for decades, FEHB Program coverage of abortions is limited to abortions in cases of rape, incest, or endangerment of the mother’s life. Federal courts of appeals uniformly have held that the Hyde Amendment preempts more restrictive State abortion limitations. E.g., Planned Parenthood Affiliates v. Engler, 73 F.3d 654 (6th Cir. 1996) (citing precedential authorities).

From the Omicron and siblings front —

Nature reports

The BA.4 and BA.5 subvariants are spiking globally because they can spread faster than other circulating variants — mostly BA.2, which caused a surge in cases at the beginning of the year. But so far, the latest Omicron variants seem to be causing fewer deaths and hospitalizations than their older cousins — a sign that growing population immunity is tempering the immediate consequences of COVID-19 surges.

Nature explores what the rise of BA.4 and BA.5 means for the pandemic.

The FEHB agrees that the complete Nature article is worth reading.

The Wall Street Journal informs us

Pfizer Inc. and BioNTech SE vaccines modified to target the Omicron variant produced a significantly larger immune response than the companies’ currently available vaccine in a study, they said.

A modified booster shot targeting Omicron specifically increased neutralizing antibody levels 13.5 to 19.6 times higher than the current shot in study volunteers a month after administration, depending on the dose, the companies said Saturday. * * *

The results, coming after Moderna Inc. also found its Omicron-targeting booster produced a stronger immune response, suggest possible benefit to modifying the shots to improve protection against an evolving virus.

The Journal adds that the Food and Drug Administration is considering whether to give emergency use authorization to the Omicron-oriented boosters for fall 2022. Based on the Nature article, it appears that Omicron will still be with us then.

Fortune identifies seven things doctors who treat long Covid want people to know.

From the Monkeypox front, Bloomberg Prognosis tells us

The World Health Organization opted against calling the recent monkeypox outbreak a public health emergency of international concern.

The outbreak is “clearly an evolving threat,” the WHO said in a statement Saturday, though it doesn’t constitute an international public health emergency “at this moment.” An emergency committee convened on Thursday to discuss the outbreak.

“What makes the current outbreak especially concerning is the rapid, continuing spread into new countries and regions and the risk of further, sustained transmission into vulnerable populations including people that are immunocompromised, pregnant women and children,” according to the statement. “It requires our collective attention and coordinated action now to stop the further spread of monkeypox virus.”

NPR Shots expresses concern that U.S. testing program for this disease is inadequate.

For many of the [201] confirmed cases, health officials don’t know how the person caught the virus. Those infected haven’t traveled or come into contact with another infected person. That means the virus is spreading in some communities and cities, cryptically. 

“The fact that we can’t reconstruct the transmission chain means that we are likely missing a lot of links in that chain,” Jennifer Nuzzo, an epidemiologist at Brown University, says. “And that means that those infected people haven’t had the opportunity to receive medicines to help them recover faster and not develop severe symptoms. 

“But it also means that they’re possibly spreading the virus without knowledge of the fact that they’re infected,” she adds.

In other words: “We have no concept of the scale of the monkeypox outbreak in the U.S.,” says biologist Joseph Osmundson at New York University. “

NPR explains that the monkeypox testing process is much too cumbersome and the CDC hopes to have the process streamlined “sometime in July.”

Meanwhile, Precision Vaccines reports

New influenza vaccine effectiveness data presented at the U.S. CDC’s June 22, 2022 meeting of the Advisory Committee on Immunization Practices (ACIP) show flu shots worked better during 2021 – 2022 than initially reported.

Published on June 23, 2022, this ACIP data shows flu shots reduced the risk of influenza illness by about 35% among vaccinated people.

Data from October 4, 2021, through April 30, 2022, showed that flu vaccines reduced people’s risk of mild to moderate flu illness caused by H3N2 flu viruses—the most common flu viruses this season—by about one-third overall. * * *

Also, at the meeting, ACIP voted in favor of a preferential recommendation for certain flu vaccines over others for adults 65 years and older in the United States. 

The ACIP voted to preferentially recommend higher-dose flu vaccines (Fluzone High-Dose vaccine and Flublok recombinant vaccine) or adjuvanted flu vaccine (Fluad vaccine) over standard-dose unadjuvanted flu vaccines.

And if one of these vaccines is unavailable at the time of administration, people in this age group should get a standard-dose flu vaccine instead. 

From the health information technology front, Health Data Management calls out attention to the following

  • “In a [very sensible] letter to Department of Health and Human Services Secretary Xavier Becerra, several healthcare standards organizations are calling for streamlining and making more predictable the process for submitting attachments as well as modernizing existing rules to improve patient care and reduce burdens on clinicians.”
  • “New legal requirements for providers to give an estimated cost of patients’ medical services will be difficult to meet, particularly when multiple organizations are involved in a patient’s care, according to WEDI, the Workgroup on Electronic Data Interchange. Meeting the requirements of the No Surprises Act, which was included as part of a Consolidated Appropriations Act passed late in 2020, will be challenging because there is no standardized process to enable the exchange of cost information among facilities, WEDI notes.”
  • “While healthcare organizations see the prevailing trend of increasing patient consumerism, the ability to give patients opportunities to schedule their own appointments is lagging. Many organizations have adopted some capabilities for self-scheduling, according to new research from the Center for Connected Medicine (CCM), yet the use of these tools remains low [because] scheduling solutions lack the right algorithms and that organizations lack standardized scheduling templates across appointment types.”

In particular the second bullet strikes a chord with the FEHBlog as he has pointed out that Congress made a huge mistake by failing add the provider’s good faith estimate and the health plan’s advance explanation of benefits to the list of HIPAA standard transactions.

Friday Stats and More

David Ermer–Congress, COVID-19, Federal employment benefits, OPM, SCOTUS, U.S. Healthcare, Uncategorized–

Note — Unfortunately, Thursday’s post did not arrive on the E&S website until 9 am ET today, so it did not go out to subscribers this morning. Lo siento. Here is a link to yesterday’s post.

Onto today’s post —

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

The CDC’s weekly review of its Covid statistics states “As of June 22, 2022, the current 7-day moving average of daily new cases (97,430) decreased 5.6% compared with the previous 7-day moving average (103,175).”

Here’s the CDC’s weekly chart of new Covid hospital admissions:

The CDC’s weekly review states “The current 7-day daily average for June 15–21, 2022, was 4,375. This is a 1.0% increase from the prior 7-day average (4,329) from June 8–14, 2022.”

Here is the FEHBlog’s latest weekly chart of new Covid deaths:

The CDC’s weekly review states “The current 7-day moving average of new deaths (255) has decreased 10.4% compared with the previous 7-day moving average (285).”

The CDC’s weekly review also reports

As of June 23, 2022, there are 391 (12.1%) counties, districts, or territories with a high COVID-19 Community Level, 996 (30.9%) counties with a medium Community Level, and 1,830 (56.8%) counties with a low Community Level. This represents an increase (+1.9 percentage points) in the number of high-level counties, a slight increase (+1.6 percentage points) in the number of medium-level counties, and a corresponding decrease (−3.6 percentage points) in the number of low-level counties. 51 jurisdictions had high- or medium-level counties this week. Rhode Island is the only jurisdiction to have all counties at low Community Level. 

To check your COVID-19 Community Level, visit COVID Data Tracker. To learn which prevention measures are recommended based on your COVID-19 Community Level, visit COVID-19 Community Level and COVID-19 Prevention.

The weekly statistics generally are stable and moving in the right direction.

The American Hospital Association adds

The Centers for Disease Control and Prevention last night endorsed Moderna’s COVID-19 vaccine for children aged 6-17, as its advisory committee recommended, creating an alternative to Pfizer’s COVID-19 vaccine for this age group. The Food and Drug Administration authorized the Moderna vaccine for children and adolescents last week.

Before ACA FAQ 50 issued October 4, 2021, the period for covering COVID vaccines with no cost sharing began 15 days after the CDC’s action. The FEHBlog, who is not errorless, thought that FAQ 50 eliminated the 15 day waiting period, but upon further review, FAQ 50 requires immediate no cost sharing coverage of Covid vaccines filing the FDA’s approval, usually an emergency use authorization. The FEHBlog doesn’t think this makes any practical difference because the Covid vaccines aren’t distributed without CDC approval.

From the Capitol Hill, the American Hospital Association provide us with this encouraging news:

The House of Representative today voted 234-193 to pass and send to the President for his signature bipartisan legislation to help reduce gun violence in communities. Approved by the Senate last night, the AHA-supported package includes behavioral health provisions, including funding for school safety resources, school-based supportive services and expanded access to telehealth for mental and behavioral health services. 

From the Supreme Court, the Court decided today that the right to an abortion is a matter controlled by state law, not the U.S. Constitution. The Wall Street Journal sums it up as follows “In upholding a Mississippi law banning the procedure after 15 weeks of pregnancy, the court’s conservative majority said the Roe decision was egregiously wrong in recognizing a constitutional right to abortion.” In response

Reproductive health care, including access to birth control and safe and legal abortion care, is an essential part of your health and well-being. While Roe v. Wade was overturned, abortion remains legal in many states, and other reproductive health care services remain protected by law. The U.S. Department of Health and Human Services (HHS) is committed to providing you with accurate and up-to-date information about access to and coverage of reproductive health care and resources. Our goal is to make sure you have appropriate information and support.

  • Health Payer Intelligence discusses health insurer reaction to the decision. “Payers and healthcare leaders are responding to the Supreme Court’s decision to overturn Roe v Wade, the case which protected abortion rights at the federal level, and while the repercussions remain uncertain many healthcare leaders are voicing their commitment to helping women navigate the impacts.”
  • The Wall Street Journal discusses employer reaction to the decision. “Businesses with health plans covering abortion now are weighing whether and how to pay for employees to travel to a state where the procedure is legal.”

From the OPM front

  • Federal News Network reports on OPM Director Karen Ahuja’s press conference held yesterday, the first anniversary of her swearing in as OPM Director.
  • FedWeek tells us that “OPM has said it is working to improve features for federal employees and annuitants to compare FEHB plans, although it does not project having those improvements in place until late next year—potentially in time for that year’s open season for selecting coverage in 2024.”

From the nicotine front, the Wall Street Journal reports

A federal appeals court on Friday granted Juul Labs Inc. a temporary stay of the Food and Drug Administration’s order for the vaping company to pull its e-cigarettes off the U.S. market.

A panel of judges from the U.S. Court of Appeals for the D.C. Circuit on Friday afternoon granted Juul’s request to delay the FDA’s ban, according to court documents. The temporary stay gives the court time to hear arguments and wasn’t a ruling on the merits of the case, the judges wrote.

Finally, HR Dive brings us a roundup of happenings at this week’s Society for Human Resource Management conference.

Happy First Day of Summer 2022

David Ermer–AHRQ, CDC, Congress, COVID-19, Electronic health records, Rx coverage, SCOTUS, SDOH, Telehealth, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

From Capitol Hill, the Hill reports

The Senate voted 64 to 34 Tuesday evening to advance an 80-page gun safety bill to strengthen background check requirements for gun buyers under 21, provide funding to states to administer red flag laws and to provide billions of dollars in new federal funding for mental health services.  * * *

Senate Majority Leader Schumer (D-N.Y.) said a successful initial procedural vote would set the bill up to pass by the end of the week.  

Last week, a House Appropriations subcommittee approved the Fiscal Year 2023 Financial Services and General Government Appropriations bill, which funds OPM and the FEHB Program. The accompanying bill summary points out

  • Office of Personnel Management (OPM) – The bill includes $448 million, an increase of $75 million above the FY 2022 enacted level, for OPM to manage and provide guidance on Federal human resources and administer Federal retirement and health benefit programs.
  • Fosters equality for women and men: Eliminates provisions preventing the FEHBP from covering abortion services.

The House Appropriations Committee will mark up this bill at a meeting scheduled for Friday, June 24.

The U.S. Supreme Court today issued a 7-2 decision holding that the Medicare Secondary Payer law does not permit healthcare providers to make disparate impact claims against health plans. This decision protects ERISA and FEHB Program plans against costly litigation. Fierce Healthcare and Health Payer Intelligence also report on the decision.

From the Omnicron and siblings front —

MedPage Today informs us

Most people who have been infected with COVID-19 in the U.S. in the past couple of months likely had the BA.2 or BA.2.12.1 variant, both lineages of the original Omicron strain of SARS-CoV-2.

Now, BA.4 and BA.5 are here, and they’re starting to make up a larger proportion of U.S. cases.

So if someone was recently infected with a BA.2 lineage, are they mostly protected against reinfection with BA.4 or BA.5?

Probably not, infectious disease experts say.

“It’s expected that there’s probably not much cross-protection between them,” Amesh Adalja, MD, an infectious disease physician at the Johns Hopkins Center for Health Security in Baltimore, told MedPage Today.

The American Hospital Association tells us

More than 1 million prescriptions for the COVID-19 antiviral pills Lagevrio and Paxlovid were dispensed between late December 2021 and May 2022, but dispensing rates were lowest in the most socially and economically disadvantaged communities, according to a study released today by the Centers for Disease Control and Prevention. In a separate study of electronic health records from Kaiser Permanente Southern California over the period, fewer than 1% of patients aged 12 and older who received Paxlovid to treat mild-to-moderate COVID-19 had a COVID-19-related hospitalization or emergency department visit in the next five to 15 days. CDC said the studies “highlight the importance of ensuring access to oral antiviral medicine in treating COVID-19, a key strategy in preventing hospitalization and death.”

Speaking of hospitals, Beckers Hospital Review reports

Healthgrades has recognized 399 hospitals as recipients of its 2022 Outstanding Patient Experience Award, the organization said June 21. This represents the top 15 percent of hospitals in the U.S. for patient experience.  * * * Healthgrades has recognized 399 hospitals as recipients of its 2022 Outstanding Patient Experience Award, the organization said June 21. This represents the top 15 percent of hospitals in the U.S. for patient experience.  * * * View the full list of recipients here. 

From the Rx coverage front —

  • The Food and Drug Administration released one of its news roundups today.
  • Per Stat News, a group of researchers writing in the Annals of Internal Pharmacy used Mark Cuban’s online pharmacy pricing to puncture Medicare Part D’s pricing on generic drugs.
  • Per Fierce Healthcare, CVS Health is expanding its Project Health program to Richmond, Virginia and Las Vegas. “The healthcare giant announced Tuesday that it will hold 72 events dedicated to seniors and children this year. It is also adding four new mobile units in 2022.”
  • Per Healthcare Dive, Walgreens “has partnered with managed care company Buckeye Health Plan in Ohio to open new Health Corner locations in five of the state’s northeast neighborhoods this summer. * * * About 2.3 million patients will have access to Health Corner services across 60 locations in Ohio, California and New Jersey by the summer’s end, Walgreens said on Tuesday. By the end of this year, Walgreens expects to increase the number of Health Corners from 55 to about 100, including the new Ohio locations.”

From the interoperability and telehealth fronts

  • Epic, the largest purveyor of electronic health record systems in the U.S., announced “its plan to join a new health information exchange framework to improve health data interoperability across the country. The Trusted Exchange Framework and Common Agreement (TEFCA) will bring information networks together to help ensure that all people benefit from complete, longitudinal health records wherever they receive care. In the future, TEFCA will expand to support use cases beyond clinical care, such as public health.” That’s a big boost for TEFCA, which will serve as the backbone for the nation’s EHR systems.
  • AHRQ offers research on telehealth for women’s preventive healthcare services.

Finally, STAT News reports

President Biden will soon nominate Arati Prabhakar, a physicist and former DARPA director, to serve as his next top science adviser, the White House announced on Tuesday.

If confirmed by the Senate, Prabhakar would replace the genomics researcher Eric Lander, who resigned as the head of the White House science office in February amid a workplace-bullying scandal.

The new post would be Prabhakar’s third tour as head of a federal science office. She ran DARPA, the high-stakes military research agency, from 2012 to early 2017, and served as director of the National Institute of Standards and Technology in the 1990s.

Weekend update

David Ermer–CMS, Congress, COVID-19, COVID-19 vaccine, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

Happy Juneteenth and Fathers’ Day!

Following the observance of Juneteenth tomorrow, the Senate and the House of Representatives will be in session for floor voting and Committee business this week.

The Washington Post reports “A congressional deal for billions of dollars in additional coronavirus funding appeared all but dead Thursday [June 16] after Senate Republicans accused the White House of being dishonest about the nation’s pandemic funding needs.” The FEHBlog expects we have not heard the end of this issue.

From the Omnicron and siblings front —

The Wall Street Journal reports

The Centers for Disease Control and Prevention recommended that children as young as 6 months receive newly authorized Covid-19 shots, the final step to making the vaccines available.

The CDC said Saturday that the young children should receive either the two-dose series from Moderna Inc. or the three-dose series made by Pfizer Inc. and partner BioNTech SE.

As soon as Monday, children under 5 years, who haven’t been able to get vaccinated during the pandemic, could start getting inoculated.

The Journal also offers articles about what parents with younger kids should know about the new Covid vaccines and — what everybody wants to know — whether researchers can develop a Covid vaccine that “lasts.” On the latter point, “New variants have weakened the protection of the current shots, which require unpopular boosters. Scientists and the White House are exploring options for more durable protection, but success could take years.”

On a related note, Precision Vaccinations tells us

The U.S. Centers for Disease Control and Prevention (CDC) reported today the number of pneumonia-related fatalities continues to outpace both COVID-19 and Influenza. * * *

In the USA, common causes of viral pneumonia are influenza, respiratory syncytial virus, and SARS-CoV-2 viruses. A common cause of bacterial pneumonia is Streptococcus pneumoniae.

The good news is pneumonia is a vaccine-preventable disease, and the U.S. FDA has approved two types of pneumococcal vaccines, PCV13, and PPSV23. * * *

Unfortunately, the CDC’s data shows that in 2020, the percentage of adults who received a pneumococcal vaccination was just 25.5%.

FEHB plans may want to focus on this issue given the Program’s demographics.

From the U.S. healthcare front, the American Medical Association provides background on its freshly inaugurated President, Dr. Jack Resneck, Jr., and gives an account of Dr. Resneck’s inaugural address. Good luck, Dr. Resneck.

Thursday Miscellany

David Ermer–Congress, COVID-19, Federal employment benefits, NIH, Rx coverage, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, Roll Call reports

The Senate on Thursday took a major step toward broadening America’s commitment to take care of sick veterans, passing a bill to offer new health care and tax-free disability benefits to as many as 3.5 million veterans on an 84-14 vote.

Under the legislation written by Veterans’ Affairs Chairman Jon Tester, D-Mont., and ranking member Jerry Moran, R-Kan., the Department of Veterans Affairs would consider a veteran with any of 23 conditions, ranging from brain cancer to hypertension, who was deployed to a combat zone during the wars in Iraq or in Afghanistan automatically eligible for care at government cost, based on the presumption that exposure to toxic chemicals in the war zone caused the ailments.

The House must now pass the revised bill before President Joe Biden can sign it, which seems likely. The legislation largely mirrors, and slightly expands on, a House bill by Veterans’ Affairs Chairman Mark Takano, D-Calif., that passed 256-174 in March. Biden issued a statement at the time saying he supported the measure.

Under current law, veterans who believe toxic exposure during their service caused them to develop a disease can have trouble proving it, even when the linkage is known. So it’s likely that many veterans are denied care and disability benefits they deserve, advocates say. The new law, at a projected cost of $278.5 billion over 10 years, shifts the calculus, meaning the government will now pay for the care of veterans whose sickness is tied to their service, as well as others whose ailments might not be.

Because the federal government employs many veterans, this bill will reduce benefits costs for the FEHB Program once it becomes law.

From the Omicron and siblings front, the Wall Street Journal informs us

Many people are embarking on a summer of vacations, concerts and weddings put off during the height of the pandemic. Covid-19 is still finding ways to disrupt some of those plans.

Covid-19 isn’t causing acute illness and death on the scale it once did, thanks in part to protection built up by vaccines and prior infections.  * * *

The U.S. is logging some 100,000 known cases a day, and many more are being detected via at-home tests health departments don’t track. This is a stark difference from a year ago, when U.S. cases sank below 12,000 a day, the lowest level since the first surge, as vaccinations rose and many hoped the virus was in retreat.

The era of 12,000 cases a day was over when Delta and then Omicron arrived and will remain around until Omicron departs.

From the Rx coverage front —

STAT News tells us

In a notable move, the Federal Trade Commission put drugmakers and pharmacy benefit managers on notice that the agency will “ramp up enforcement” of any “illegal bribes and rebate schemes” that make it harder for patients to access lower-cost medicines.

The new policy statement noted the FTC plans to scrutinize rebates and assorted fees for signs that these payments are violating antitrust and consumer protection laws. As part of that effort, the agency expects to monitor lawsuits and file its own legal briefs in cases where it can provide assistance in analyzing illegal practices that may raise prescription drug prices.

“Today’s action should put the entire prescription drug industry on notice: when we see illegal rebate practices that foreclose competition and raise prescription drug costs for families, we won’t hesitate to bring our full authorities to bear,” said FTC Chair Lina Khan in a statement. “Protecting Americans from unlawful business practices that are raising drug prices is a top priority for the Commission.”

While the end of Omicron is not in the offing, the end of prescription drug rebates appears to be getting closer. However, the federal government should not put the kibosh on rebates unless the drug manufacturers agree to maintain the economic equities by offering price reductions equivalent to the rebates.

In other FTC news, BioPharma Dive reports

Drugmaker acquisitions of all sizes could receive closer scrutiny in the future if the Federal Trade Commission follows the advice of experts who spoke at a two-day agency meeting on market concentration and anticompetitive conduct.

The experts, mostly economists and other antitrust regulators, warned that some drugmakers have gained unfair market power due to the breadth of their product portfolios, allowing them to negotiate for preferred or even exclusive status on insurers’ coverage lists and thereby squeeze out competitors.

Taken together with the FTC’s plans to investigate the practices of pharmacy benefit managers, the meeting signals the Biden administration may take a tougher line on monopolistic practices in an effort to spark competition and target drug pricing.

From the Food and Drug Administration front, BioPharma Dive notes that

An experimental and closely followed drug for Alzheimer’s disease has failed a key clinical study, dealing yet another blow to the prevailing theory on how to treat a neurodegenerative illness that affects millions of people.

The drug’s developer, Roche, along with Banner Alzheimer’s Institute, the Phoenix-based organization helping lead the study, announced the negative results Thursday. After years following a family believed to be genetically predisposed to the disease, researchers found no significant difference in cognition or the ability to store and retrieve new memories between participants who received the drug and those who got placebo.

The failure is an upset not only to Roche, which hopes to follow its rival Biogen in getting an Alzheimer’s therapy approved for market, but also to the wider Alzheimer’s research field. For years, a protein called beta amyloid has been at the center of efforts to treat the disease. But every drug designed to block this protein, including Biogen’s, has faced setbacks. Roche’s announcement may therefore add to concerns that this protein isn’t the best research target.

In other drug research news, Walgreens announced “the launch of its clinical trial business to redefine the patient experience and increase access and retention in sponsor-led drug development research. Walgreen’s flexible clinical trial model combines the company’s vast foundation of patient insights, partner-enabled health and technology capabilities and in-person and virtual care options to break through barriers to engaging broader and more diverse communities.”

In U.S healthcare news, the American Medical Association completed its annual meeting. The AMA offers highlights from the session here.

Also, the Commonwealth Fund released its 2022 Scorecard on State Health System Performance.

Hawaii and Massachusetts top the 2022 State Scorecard rankings, based on overall performance across 56 measures of health care access and quality, service use and cost, health disparities, and health outcomes during the COVID-19 pandemic in 2020. The lowest-performing states were Mississippi, Oklahoma, and West Virginia.

The National Institutes of Health disclosed

From 2000-2019 overall life expectancy in the United States increased by 2.3 years, but the increase was not consistent among racial and ethnic groups and by geographic area. In addition, most of these gains were prior to 2010. This is according to a new study funded by the National Institutes of Health that examined trends in life expectancy at the county level. The study was led by researchers at the Institute for Health Metrics and Evaluation at the University of Washington’s School of Medicine, Seattle, in collaboration with researchers from NIH and published on June 16th in The Lancet.

MedCity News reports “Online healthcare marketplace Sesame closed a $27 million Series B funding round on Tuesday, bringing its total funding to $75 million. David Goldhill, CEO of the New York City-based startup, said the company is ‘an Expedia for medical care’ because patients can buy the care they want directly online, without the middleman of an insurance company.”

From the federal employee benefits front, Govexec delves into the impact of cost of living adjustments on federal employee retirement benefits.

Midweek update

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 vaccine, HSA, SCOTUS, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Capitol Hill, Medtech Dive reports

The Senate Committee on Health, Education, Labor and Pensions voted Tuesday to send a bill to the Senate that would reauthorize the Food and Drug Administration to collect user fees from device- and drug-makers for the next five years. 

A provision would require the FDA to finalize guidance that would create a category of over-the-counter hearing aids within a month of the bill’s passage. The FDA last issued a proposed guidance in October.

Committee Ranking Member Sen. Richard Burr, R-N.C., questioned on Tuesday whether the FDA should have that expanded authority, despite co-sponsoring legislation that would change how diagnostic tests are regulated, including laboratory-developed tests.

Fierce Healthcare adds

The American Hospital Association (AHA) penned a last-ditch letter to congressional leaders pleading for Medicare sequester cuts slated to take effect July 1 to be halted in light of the financial strain many of the nation’s hospitals are expected to face throughout 2022.

Congress had initially paused the 2% payment cut as part of the CARES Act when the COVID-19 pandemic began to threaten providers’ bottom lines. Sequestration cuts were continually punted downfield until last December, when a bill was signed to resume a 1% cut in April and the full 2% in July.

With half a month to go, AHA Executive Vice President Stacey Hughes warned majority and minority leaders Tuesday that financial relief from the pending cut is necessary for hospitals “to maintain access to care for the patients and communities they serve.”

From the Supreme Court, the American Hospital Association gleefully informs us

The U.S. Supreme Court today ruled unanimously in favor of the AHA and others, reversing a 2020 [U.S.] court of appeals decision upholding the authority of the Department of Health and Human Services to significantly cut payments to certain hospitals that participate in the 340B Drug Pricing Program, and thereby threatening access to care for patients.

The Supreme Court held that “HHS’s 2018 and 2019 reimbursement rates for 340B hospitals were contrary to the statute and unlawful.” Noting that “340B hospitals perform valuable services for low-income and rural communities but have to rely on limited federal funding for support,” the Supreme Court observed that “this case has immense economic consequences, about $1.6 billion annually.”

Despite those serious practical impacts, the Supreme Court concluded that “[u]nder the text and structure of the statute,” the case is “straightforward” as a matter of law: “Because HHS did not conduct a survey of hospitals’ acquisition costs, HHS acted unlawfully by reducing the reimbursement rates for 340B hospitals.”

From the Omicron and siblings front —

The Wall Street Journal reports

Health experts advising U.S. health regulators backed giving Covid-19 vaccines from Pfizer Inc. and BioNTech SE and from Moderna Inc. to children as young as 6 months old. 

The panel voted 21 to 0 in a pair of votes on Wednesday in support of expanding access to the vaccines.

The positive recommendations will likely lead soon to expanding the U.S. Covid-19 vaccination campaign to the 19.6 million children from 6 months to under 5 years of age, one of the last groups of people in the U.S. waiting for shots.

The Food and Drug Administration, which doesn’t have to follow the panel’s recommendations but usually does, is expected to authorize the shots within days. Vaccinations could begin as early as June 21, according to the Biden administration.

and

Moderna Inc. is planning to test its Covid-19 vaccine in babies 3 months to 6 months old, the youngest age group studied to date.

The Cambridge, Mass., company said Wednesday it is in the final stages of planning the study, to be called BabyCove and expected to begin enrolling as many as 700 babies in September.

BabyCove would be the first study of Moderna’s vaccine in infants younger than 6 months.

STAT News adds

Pfizer said Tuesday that a much-watched study of its antiviral Paxlovid in patients who have Covid but don’t have risk factors for severe disease failed to show a benefit in speeding alleviation of Covid symptoms, but did seem to prevent doctor’s visits and hospitalizations.

Additionally, because of the small number of hospitalizations overall in the study, it failed to produce a statistically significant finding on whether patients who had previously been vaccinated against Covid were hospitalized less often if they received Paxlovid.

The data in no way invalidate earlier results that show that Paxlovid prevents hospitalizations and saves lives in patients at high risk of severe Covid. But the results, published in a press release, are likely to take time for experts to digest and understand.

From the unusual viruses front, the American Hospital Association explains

The Centers for Disease Control and Prevention yesterday [June 14] updated its guidance to help clinicians evaluate and test patients with relevant history, signs and symptoms for monkeypox. Over 1,800 monkeypox or orthopoxvirus cases have been reported globally this year, including 72 in the United States. According to CDC, the virus does not spread easily between people without close contact, so the risk to the general population remains low.

The World Health Organization plans to change monkeypox’s name next week.

From the healthcare business front

Anthem will officially become Elevance Health on June 28, and, as part of its corporate rebrand, it’s also launching new brands for two of its subsidiaries.

The insurer will consolidate its healthcare services businesses under one umbrella, called Carelon. Carelon is a combination of the word “care” with the suffix “lon,” which means full or complete, representing the company’s ambition to offer an end-to-end care experience.

Carelon will include Anthem’s in-house pharmacy benefit manager Ingenio Rx as well as recent acquisitions such as Beacon Health Options, a behavioral health provider, and myNEXUS, a home healthcare company. Carelon will serve 1 in 3 people in the U.S., according to the announcement.

and

Humana is moving its pharmacy brands under the CenterWell umbrella.

Humana Pharmacy and Humana Specialty Pharmacy will now operate as CenterWell Pharmacy and CenterWell Specialty Pharmacy, respectively, the insurer announced. Enclara Pharmacia and Humana Pharmacy Solutions, the company’s pharmacy benefit management arm, will maintain their original branding.

“The CenterWell brand symbolizes our ongoing and strong commitment to keeping members, customers and patients at the center of everything we do,” said Scott Greenwell, Humana Pharmacy Solutions president, in a statement.

  • Morning Consult discusses how CVS Health and Walgreens retained “high customer trust” in 2021.

From the benefit design front, Employee Benefits News offers the case for health savings accounts. The FEHBlog is already sold.

Weekend update

David Ermer–Congress, COVID-19, Rx coverage, U.S. Healthcare–
Mount Rushmore

From the Capitol Hill front, the House of Representatives and the Senate will be in session this week for floor voting and Committee business.

Roll Call reports

A bipartisan group of senators announced an agreement Sunday on significant updates to the nation’s gun laws, and the Senate majority leader said it ​​would be put on the floor once legislative text is ready.

The agreement, announced by 10 Republicans and 10 Democratic caucus members, certainly will not go as far as many Democrats would have hoped, but the scale of the GOP support suggests it could get the all-important 60 votes to overcome the filibuster rule that kept derailing the last bipartisan attempt to change gun laws, in 2013.

The agreement, which is not yet in legislative language, is the product of discussions led by Sens. Christopher S. Murphy, D-Conn., and John Cornyn, R-Texas, in the wake of recent mass shootings, including at an elementary school in Uvalde, Texas.

“Our plan increases needed mental health resources, improves school safety and support for students, and helps ensure dangerous criminals and those who are adjudicated as mentally ill can’t purchase weapons,” the 20 senators said in a statement. “Most importantly, our plan saves lives while also protecting the constitutional rights of law-abiding Americans.”

From the Omicron and siblings front —

MedPage Today discusses the latest Omicron siblings — BA.4 and BA.5. “Generally, BA.4 and BA.5 variants cause mild disease but spread in large numbers potentially because, unlike the Wuhan strain, which settles in the lungs, these newer strains seem to attach to the more benign upper nasal passages.”

Bloomberg Prognosis answers a reader’s question about whether to get a fourth Covid booster now.

Moderna said just this week that a new version of its Covid vaccine led to a better antibody response against omicron compared with its current mRNA shot. It plans to submit data to the US Food and Drug Administration in the coming weeks and hopes the shot will be available as soon as late summer. That shot is what’s called a bivalent vaccine, meaning it contains mRNA coding for the spike protein of both the original strain of the virus and omicron. 

Pfizer should also have updated mRNA vaccines available as soon as the fall, says Monica Gandhi, an infectious disease expert at the University of California, San Francisco. The FDA will hold an advisory committee meeting later this month to address whether fall shots should be modified, and if so what strains they should include.

But while currently available boosters are less effective against omicron, Gandhi points out, they still do offer some protection. So, she says, that answer to whether to get boosted now depends on a few factors. 

”I would advise — depending on case rates in your area and your age— getting the fourth dose now,” she says. “And then deciding what to get in the fall.”

MedPage Today also explains why “the [Novovax Covid] technology is quite innovative and has potential to enhance protection against” the disease.

From the healthcare business front, the Wall Street Journal reports on a

A philanthropic organization founded by the ex-energy trader [John Arnold] and his wife Laura is providing financial backing to three lawsuits against giant hospital systems in Wisconsin, Connecticut and North Carolina, alleging the systems used their market power to squash competition and illegally inflate prices. The systems say the lawsuits from employers and consumers are baseless. * * *

The financing from Arnold Ventures is supporting the work of Fairmark Partners LLP, the law firm behind the lawsuits. Fairmark secured its funding from the philanthropy after filing its first lawsuit, one of the founders said. The firm’s founders say the backing is key to a targeted effort to reshape hospital markets through the courts, and that it received money from other philanthropies it declined to identify. 

While the FEHBlog is not a fan of litigation, this strikes him as a worthy effort.

From the medical research front —

  • Kaiser Health News summarizes recent drug research developments.
  • NPR Shots reports on efforts to connect human nerve systems to prosthetic devices.
  • Fierce Healthcare tells us

Researchers at CVS studied the relationship between total cost of care and the use of National Comprehensive Cancer Network (NCCN) guidelines to direct care and found savings among both breast cancer and colon cancer patients. The studies, released at the American Society of Clinical Oncology’s meeting earlier this month, build on a similar analysis among lung cancer patients.

In both studies, the researchers found that using NCCN guidelines drove significant declines in total cost of care.

“Evidence-based medicine does result in improvement in quality of life,” Shirisha Reddy, M.D., senior medical director at CVS Health and an author on both studies, told Fierce Healthcare. “There’s a lot of external data that supports that.”

The first study included 937 patients with colon cancer. Among Medicare beneficiaries, concordance with NCCN guidelines was linked to a 33% reduction in total cost per care per member per month. The results were less significant among commercially insured patients.

In the second study, the researchers retrospectively looked at 315 patients with breast cancer. They found total cost of care reductions for patients treated in ways consistent with NCCN across multiple insurance types, including 25% among fully insured commercial patients, 28% among self-insured commercial patients and 43% in Medicare.

This included notable decreases in administered chemotherapy spend as well as outpatient care between Jan. 1, 2019, and Dec. 31, 2020.

Thursday Miscellany

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

From our Nation’s capital, the New York Times reports,

White House officials said on Wednesday that they would have to repurpose federal Covid-19 funds meant for coronavirus tests and protective equipment in order to supply more antiviral pills and vaccines, after so far failing to persuade Congress to pass a new pandemic relief package.

Roughly $10 billion from Department of Health and Human Services funds will be rerouted, around half of it to purchase vaccines for Americans ahead of a possible fall or winter wave of virus cases, when an updated shot may be needed, according to one White House official. The other half will go mostly to purchasing 10 million courses of Paxlovid, the antiviral treatment made by Pfizer that has been shown to substantially reduce the severity of Covid-19 in high-risk people, the official said. Around $300 million will be spent on another kind of treatment, monoclonal antibodies.

Also from the Omnicron and siblings front, a friend of the FEHBlog, journalist Theresa Defino, points out

Today and tomorrow NIH’s Advisory Committee to the Director is holding its first of two annual meetings. Today Dr. Fauci gave a presentation on Covid and Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, spoke on recovery from Covid.

The most interesting comments Dr. Fauci made begin on page 45. Dr. Koroshetz’s talk was about NIH’s efforts to understand long COVID. Lots of trials are going on. He also mentioned this website on Covid recovery which is worth a look. 

From the unusual viruses report, Becker’s Hospital Review brings us up to date on roughly 700 cases of acute hepatitis of unknown etiology infecting young children in 34 countries, including our own. “The U.S. has reported 274 probable hepatitis cases in 39 states and jurisdictions as of June 8, according to the CDC.”

From the maternal health front, the American Hospital Association informs us

The Health Resources and Services Administration has released a report evaluating the Rural Maternity and Obstetrics Management Strategies Program, which completed its first year last August. The program uses a network approach to coordinate and improve maternal health care from preconception to postpartum; telehealth services to increase access to care in rural areas; potential aggregation of low-volume rural obstetric services; and payment structures that promote financial sustainability for access to high-quality maternal care. The cohort includes networks in Missouri, New Mexico and Texas that provided prenatal, delivery and postpartum care to 3,101 rural mothers. Participants said hiring patient navigators emerged as an early success strategy. The networks also laid the groundwork for expanding telehealth.

From the Rx coverage front, STAT News offers an interesting article about the drug pricing reform debate ongoing in Congress using an AMA Journal report showing skyrocketing launch prices for newly approved drugs.

Health Payer Intelligence tells us that “AHIP has subscribed to the Institute for Clinical and Economic Review’s (ICER) cloud-based analytics platform, providing [its] health plan members with access to benchmark reports, cost-effectiveness data, and policy recommendations.” Good idea, AHIP.

From the federal employee benefits front, a financial planner discusses how divorce may affect FEHB and FEGLI benefits at the My Federal Retirement website.

From the HIPAA standard transactions front, the CMS National Standards Group has released an updated Compliance Review Program Findings report identifying the most common violations of those standard and operating rules from compliance reviews.

Midweek Update

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

From Capitol Hill, Roll Call reports that FY 2023 appropriations work is gearing up.

From the Omicron and siblings front

The Wall Street Journal reports the following good news

Moderna Inc. said a modified [mRNA based] Covid-19 booster shot provided a stronger immune response than the company’s original vaccine against the Omicron variant in a new study. 

The Cambridge, Mass., company said Wednesday it will submit preliminary data from the study to U.S. health regulators in the coming weeks with the hope of making the modified booster shot available in late summer.

Researchers found that the levels of neutralizing antibodies against Omicron among people getting the modified shot were 1.75 times higher than in people who received a booster shot of the original vaccine, Moderna said.

and

AstraZeneca PLC said a study found its Covid-19 antibody treatment cut the risk of severe disease when given soon after symptoms develop, paving the way for its broader use.

The development comes at a time when the use of antibody treatments—once a mainstay for patients at high risk of developing severe Covid-19—has been complicated by the rise of the Omicron family of variants, which are less susceptible to some of the treatments. The treatments also face fierce competition from the more-convenient antiviral pills.

AstraZeneca’s antibody drug, called Evusheld, was found in its latest clinical trial to ward off severe disease in people who had already developed symptoms, according to results published late Tuesday in the Lancet Respiratory Medicine. The trial was conducted prior to the rise of the Omicron variant, but AstraZeneca has said that laboratory testing shows the antibody continues to work against the highly infectious strain.

The Food and Drug Administration released a revised checklist for prescribing the Pfizer Covid pill Paxlovid. While the checklist is intended for healthcare provider reference, it could be helpful to patients and health plans as well.

From the unusual virus front, STAT News offers an interesting article on how the hard lessons of the AIDS virus is shaping the U.S. response to monkeypox. The article notes

  • “[T]he monkeypox strain now in circulation is infinitesimally milder than HIV — zero fatalities have been reported out of the more than 1,000 cases so far.”
  • “Monkeypox isn’t transmitted sexually but by close contact with the disease’s hallmark pustules.”

From the Rx coverage front, Medpage Today informs us

The combination GIP and GLP-1 receptor agonist tirzepatide (Mounjaro [manufactured by Eli Lilly]) could soon be the next new treatment option for people with overweight or obesity, researchers reported.

In the 72-week, phase III SURMOUNT-1 clinical trial, people with obesity, but without diabetes, on 15 mg of the once-weekly injectable had a mean percentage change in weight of -20.9% (95% CI -21.8 to -19.9%) versus -3.1% (95% CI -4.3 to -1.9) with placebo, according to Ania M. Jastreboff, MD, PhD, of the Yale University School of Medicine in New Haven, and colleagues.

and

An open-source automated insulin delivery (AID) system — also known as a do-it-yourself system — was both safe and effective for patients with type 1 diabetes, according to the CREATE trial.

Over 24 weeks, users of the AID system spent more time in target glucose range (70 to 180 mg/dL) — an average of 14% longer — than those who were using sensor augmented pump therapy without automation, reported Martin de Bock, PhD, of the University of Otago in Christchurch, New Zealand, during a presentation at the American Diabetes Association (ADA) annual meeting.

The open-source AID system consists of the OpenAPS algorithm from a version of AndroidAPS implemented in a smartphone, paired with the DANA-i insulin pump and Dexcom G6 continuous glucose monitor. The researchers previously published additional information on the ins and outs of the algorithm in the Journal of Diabetes & Metabolic Disorders.

“Open-source AID, despite not being [FDA] regulated … is safe and efficacious in children and adults with type 1 diabetes compared to sensor augmented pump therapy,” de Bock noted. 

The American Diabetes Association offers more details on this significant development here.

From the transparency front, the Wall Street Journal tells us

Two Georgia hospitals on Wednesday were hit with federal financial penalties for failing to disclose their prices, marking the first such enforcement action taken under federal rules that have met with uneven compliance since taking effect in January 2021.

The Centers for Medicare and Medicaid Services (CMS), which is responsible for enforcing the rules, levied fines on Northside Hospital Atlanta and Northside Hospital Cherokee. The two hospitals, which are owned by Northside Hospital, together face penalties totaling roughly $1.1 million.

Perfect timing; right before the enforcement period for the transparency in coverage rule applicable to health plans begins on July 1.