Tuesday’s Tidbits

HIPAA Privacy and Security Rules

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, HIPAA Privacy and Security Rules, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Federal Employee Benefits Open Season front, FedSmith provides advice to federal and postal employees and FedWeek provides guidance to all interested parties.

In the Federal Times, Reg Jones answers a reader’s question about whether an annuitant can suspend their FEHBP coverage.

From the Omicron and flu front –

MedPage Today expresses expert views that developing vaccines that prevent the spread of Covid require human challenge trials in which fully informed, vaccinated people are exposed to Omicron.

[M]any experts agree: we need new vaccines to limit the spread of the virus. The current generation of vaccines offers strong protection against serious illness and death, but their edge has dulled against new variants, and they do not always prevent infection and transmission of the virus.

The White House hosted a summit on the issue in July, showcasing the myriad ways researchers are going about developing new vaccines. There are hundreds of candidates in early stages around the world, but the resources devoted to COVID-19 vaccine research are a fraction of what they were 2 years ago. Human challenge trials can greatly speed the selection of the most promising in this field of candidates, providing scientific and economic benefits over uniform reliance on large field studies.

Time will tell.

The Wall Street Journal provides a background story of this year’s flu that compares the spread of the flu vs. the spread of Covid.

How contagious is flu?

Covid-19 is more contagious than influenza, doctors say. One reason is that most people have had flu multiple times and many have gotten multiple flu shots over the years. 

The most common calculation of a virus’s infectiousness is a measure called the R0 (pronounced “R naught”). This metric estimates how many people one contagious person will infect on average. The R0 of influenza is between one and two. R0 data for Covid-19 isn’t definitive, especially as the virus continues to mutate, but studies indicate the number for many Covid strains is higher than for flu. 

From the tidbits department

  • Healthcare Dive offers “five takeaways from the FDA’s list of AI-enabled medical devices. As the number of devices increases, the agency is looking to adapt its regulatory framework to the new technology, including faster approval of algorithm updates.”
  • The Patient-Centered Outcomes Research Institute (PCORI), which the Affordable Care Act requires health insurers and plans to fund, shares its strategic plan.
  • The Segal Company helpfully reminds cafeteria plan sponsors that “As part of COVID-19 relief, the Consolidated Appropriations Act, 2021 (CAA) permitted plan sponsors to immediately implement certain mid-year changes to their cafeteria plans during the 2020 and/or 2021 plan years without first having to adopt plan amendments. Employers that implemented such relief are required to adopt certain retroactive plan amendments by December 31, 2022.”
  • The Centers for Disease Control calls attention to its U.S. Diabetes Surveillance System website. Check it out.
  • Beckers Hospital Review lists the ten most expensive States for healthcare. The only state with a top 10 population included on Becker’s list is Florida.

Midweek Update

David Ermer–Congress, COVID-19, Federal employment benefits, HIPAA Privacy and Security Rules, OPM, U.S. Healthcare–

From Capitol Hill, Fierce Healthcare tells us

The House unanimously passed the Improving Seniors’ Timely Access to Care Act on Wednesday via a voice vote. The legislation, which has new transparency requirements for MA plans, now heads to the Senate.

Lawmakers behind the legislation said in a joint statement the bill will “make it easier for seniors to get the care they need by cutting unnecessary red tape in the healthcare system,” said Reps. Suzan DelBene, D-Washington, Mike Kelly, R-Pennsylvania, Ami Bera, M.D., D-California, and Larry Bucshon, M.D., R-Indiana.

It’s worth noting that traditional Medicare has no prior authorization requirements. Beckers Payer Issues adds

Enrollees in Medicare Advantage were less likely to receive low-value care than those enrolled in traditional Medicare, a new study published in JAMA Open Network found. 

The study, published Sept. 9, found Medicare Advantage enrollees received 9.2 percent fewer low-value services than their counterparts using traditional Medicare. 

Low-value care is services that provide little clinical benefit or cause more harm than benefits for a patient. 

The study’s authors, lead by researchers from Humana and Boston-based Tufts University School of Medicine, compared enrollees in a large, national Medicare Advantage plan to a random sample of 5 percent of traditional Medicare beneficiaries. 

The study found among Medicare Advantage enrollees, those who had HMO plans were less likely to receive low-value care than those with PPO plans.

Read the full study here.

Hopefully, Congress will not throw out the baby with the bath water.

From the federal employee benefits front, FedWeek informs us

OPM has issued a reminder to agencies of their authority to verify that family members being covered under the FEHB actually are eligible, including the process to be used and the documentation required.

The notice calls attention to a revision of the FEHB handbook section on family member eligibility reflecting several instructions of recent years, including one telling agencies to tighten scrutiny of those covered and another laying out procedures for removing those deemed ineligible. That is a response to several inspector general reports warning that ineligible persons are being insured under the program, raising premium costs to the government and to other FEHB enrollees.

That directive, now part of the handbook, lists agency responsibilities to verify eligibility of family members during initial enrollment of newly hired employees and when family members are being added to an existing enrollment due to a “qualifying life event” such as marriage.

In the middle of the last decade, OPM added a standard contract provision to FEHB contract requiring carriers to share the cost of any family member eligibility audit that OPM undertakes. OPM has not yet exercised that provision.

It turns out that for the past two weeks federal employee benefits expert Reg Jones has been writing in Fedweek about federal employee retirement benefits. Today’s he discusses survivor benefits which includes a squib about perhaps the most unique and valuable survivor benefit — FEHB coverage for the survivor’s life with the full government contribution as explained here:

If your spouse receives a survivor annuity and was covered under either the Self Plus One or Self and Family option of your Federal Employees Health Benefits plan when you died, he or she and all eligible children can continue that coverage. If the annuity amount is less than the premiums required, your spouse will be able to make payments directly to OPM to cover the cost.

From the Omicron and siblings front, we have two thoughtful pieces from MedPage Today

In other virus news, the American Hospital Association reports

The recent paralytic polio case in an unvaccinated adult in Rockland County, N.Y. and wastewater samples from communities near the patient’s residence meet the World Health Organization’s criteria for circulating vaccine-derived poliovirus, the Centers for Disease Control and Prevention announced yesterday. Genetic sequences from the virus in the patient and wastewater specimens have been linked to wastewater samples in Jerusalem and London, indicating community transmission, CDC said.
 
Thirty other countries have circulating vaccine-derived poliovirus, which is not caused by the polio vaccine but occurs when local immunity to poliovirus is low enough to allow prolonged transmission of the original weakened virus in the oral polio vaccine. Oral polio vaccine has not been used or licensed in the U.S. since 2000 but continues to be used in some countries. N.Y. Governor Kathy Hochul last week declared a state of emergency to help expand vaccination efforts and surveillance. 
 
“Polio vaccination is the safest and best way to fight this debilitating disease and it is imperative that people in these communities who are unvaccinated get up to date on polio vaccination right away,” said Dr. José R. Romero, director of CDC’s National Center for Immunization and Respiratory Diseases. “We cannot emphasize enough that polio is a dangerous disease for which there is no cure.”

From the No Suprises Act front, Beckers Hospital CFO Report relates

The No Surprises Act, which prevents patients from receiving surprise bills from out-of-network providers at emergency rooms, could lead to an increase in emergency department visits, a new study from the Agency for Healthcare Research and Quality found. 

The study, published Sept. 12 in The American Journal of Medical Care, compared emergency department visits rates in 15 states that implemented bans on balance billing between 2007 and 2018 to rates in 16 states where these bills were not banned. 

The study’s authors found that state-level bans reduced spending per emergency room visit by 14 percent but increased emergency room visits by 3 percentage points. These visits were 9 percent less urgent than before the balance billing ban, according to an emergency department severity index. 

Based on the state-level analysis, the study’s authors, led by AHRQ researcher William Encinosa, PhD, conclude that the No Surprises Act, which took effect this year, could result in 3.5 million more emergency room visits annually. 

“Because individuals will no longer have the fear of a possible catastrophic surprise ED bill not covered by their insurer, they may be more inclined to go to the ED in marginal, less severe cases,” the authors wrote. 

Read the full study here.

In the FEHBlog’s opinion, the No Surprises Act is working well, and he does not foresee a surge in ER visits because going to the emergency room is no picnic.

In preventive services news, MedPage Today reports

The jury is still out on whether asymptomatic children and adolescents should be screened for diabetes, the U.S. Preventive Services Task Force (USPSTF) said.

In a new recommendation statement published in JAMA, the task force concluded that there is insufficient evidence to weigh the benefits and harms of screening for type 2 diabetes in this pediatric population, despite rising rates of disease.

“[T]here is inadequate evidence that screening and early intervention lead to improvements in health outcomes such as renal impairment, cardiovascular morbidity, mortality, and quality of life,” wrote Carol M. Mangione, MD, MSPH, of the University of California Los Angeles, and colleagues.

From the miscellany department —

  • The Department of Health and Human Services announced that today HHS “Secretary Xavier Becerra formally swore in Melanie Fontes Rainer as Director of the Office for Civil Rights (OCR). Director Fontes Rainer previously served as the Acting Director and was officially appointed to the role last month.  OCR is responsible for enforcing federal civil rights; conscience protections; the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach Notification Rules; and the Patient Safety and Quality Improvement Act and Patient Safety Rule – which together protect individuals’ fundamental civil rights and medical privacy.”
  • The Justice Department announced “the establishment of three Strike Force teams created to enhance the Department’s existing efforts to combat and prevent COVID-19 related fraud. “These Strike Force teams will build on the Department’s historic enforcement efforts to deter, detect, and disrupt pandemic fraud wherever it occurs,” said Attorney General Merrick B. Garland. “Since the start of this pandemic, the Justice Department has seized over $1.2 billion in relief funds that criminals were attempting to steal, and charged over 1,500 defendants with crimes in federal districts across the country, but our work is far from over. The Department will continue to work relentlessly to combat pandemic fraud and hold accountable those who perpetrate it.” The Strike Force teams will operate out of U.S. Attorney’s Offices in the Southern District of Florida, the District of Maryland, and a joint effort between the Central and Eastern Districts of California.”

The good news is there’s a cure for hepatitis C. The bad news is how hard it is to bring that miracle cure to the people who need it. For years experts assumed the drug’s astronomical price was the biggest barrier. So in 2019, Louisiana and Washington state adopted the “Netflix model,” as in paying a lower price for abundant access to the drug. Just last week the White House jumped on board for a national version.

But STAT’s Nicholas Florko has found that neither state is near its goal. In Washington, the treatment rate for Medicaid patients is now lower than before the initiative began, even with a lower price. “The further you get out in the population … the more you start to hit this population that is harder — harder to identify, more costly to convert to treatment,” Rena Conti of Boston University told Nick. Read his investigation here.

  • The National Institute of Health’s HEAL Program offers ways to build opioid use disorder prevention into everyday life.
  • Govexec discusses OPM’s efforts to “highlight ways federal employees can contribute to the White House’s fight against hunger and to improve Americans’ health and nutrition, including through an event later this month.”

Tuesday Tidbits

David Ermer–ACA, CDC, COVID-19, HIPAA Privacy and Security Rules, No Surprises Act, OPM, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Omicron and siblings front, the Wall Street Journal reports

The Biden administration has completed plans for a fall Covid-19 booster campaign that would launch in September with 175 million updated vaccine doses provided to states, pharmacies and other vaccination sites.

The administration is procuring the doses, which drugmakers are updating to target the newest versions of the virus. The administration has also informed states, pharmacies and other entities they can begin preordering now through the end of August, according to the administration’s fall vaccination planning guide.

Vaccines would be shipped immediately following an expected authorization by federal drug regulators, who still must review and sign off on the shots, and recommendations from the Centers for Disease Control and Prevention, which still must review the data and sign off on administering the shots. 

Administration officials have expressed hope that the boosters would help head off a wave of serious illnesses and deaths in the fall and winter, when cases often increase as more people gather indoors.

Due to the 2021-22 Delta and original Omicron variants, I gave up on expecting herd immunity from Covid. However, MedPage Today points out that those perilous Covid surges combined with vaccinations and treatments like Paxlovid create herd safety from hospitalizations and deaths. We should build up vaccination levels, but the vaccination marketing campaign should be built on a sensible theory like herd safety and not on 2020-like hysteria.

From the No Surprises Act front, Fierce Healthcare offers provider and payer opinions on the final independent dispute resolution rule. Last Spring, CMS dethroned the Qualifying Payment Amount from its commanding position in the baseball arbitration process. That aspect of the final rule is not a change in current practice. The FEHBlog senses that the No Surprises Act is working well.

Today, the Office of Personnel Management posted its first FAQs on the Postal Service Health Benefits Program which will launch in January 2025.

From the medical research front, BioPharma Dive reports

Over the last decade, drugs based on multiple RNA technologies, known as RNA interference and antisense oligonucleotides, have made it to market. Yet, it took a historic pandemic to thrust RNA into the global spotlight. Equipped with new tools, scientists are now exploring how other types can be used to make therapies that last longer and treat, as well as prevent, more diseases.

At least 10 biotechnology startups are developing next-generation RNA drugs. Though years of research lie ahead, these companies have already raised hundreds of millions of dollars from venture capitalists, large pharmaceutical firms and other investment groups.

If their work pans out, it could provide new treatments for cancer, rare diseases, and chronic illnesses that affect organs, the nervous system and the immune system.

The article provides an overview of these RNA drug development efforts.

From the tidbits department —

  • MedPage Today reports that “For higher-risk adults without prior cardiovascular disease (CVD) events, the U.S. Preventive Services Task Force (USPSTF) continues to broadly recommend statins for primary prevention while differing from other American guidelines in certain key aspects. * * * Despite being consistent with the USPSTF’s 2016 recommendations on the subject, the latest update takes away language about the preferred low-to-moderate dosing of statins in people with no history of CVD. This could be attributed to a lack of data, as a review of the literature showed most statin trials tested a moderate-intensity statin.”
  • Axios reports “Life expectancy in the U.S. fell in all 50 states and the District of Columbia from 2019 to 2020 and fell nationally by 1.8 years, according to new Centers for Disease Control and Prevention data published Tuesday. The big picture: The decline nationally and in states was mostly due to the COVID-19 pandemic and increases in unintentional injuries, specifically drug overdose deaths.
  • The National Institutes of Health announced that “Poverty, combined with other types of adversity in early childhood, is associated with greater chances of premature death in adulthood, compared to other adverse childhood experiences, according to a study of more than 46,000 people by researchers at the National Institutes of Health.”
  • The NIH Director’s Blog features a fascinating description of the inside of the “amazing” human brain.
  • The HHS Office of Civil Rights reached a settlement with dermatology practice over an alleged HIPAA Privacy Rule violation for improper disposal of protected health information.

Thursday Miscellany

David Ermer–ACA, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, HIPAA Privacy and Security Rules, Medicare, OPM, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Capitol Hill, the Wall Street Journal reports that the Senate majority’s leadership is rallying the caucus to pass the Schumer – Manchin compromise reconciliation bill that would address climate and healthcare concerns while raising taxes. The goal is for the Senate to pass the bill next week which immediately precedes the Senate’s August recess.

The Hill adds that

A day after Sen. Joe Manchin (D-W.Va.) stunned Washington by endorsing hundreds of billions of dollars for President Biden’s domestic agenda, House Democrats are rallying behind the nascent package as a crucial — if incomplete — strategy for tackling the climate crisis and easing working class economic strains.

Both articles discuss the flies remain in the reconciliation ointment.

Govexec informs us

The odds that Congress would increase the average 4.6% pay raise planned for federal employees in 2023 got a little longer Thursday, after Senate appropriators revealed that they would effectively endorse President Biden’s pay increase proposal.” The Senate Appropriations Committee on Thursday revealed all of their initial versions of fiscal 2023 spending bills, including the package governing financial services and general government, which is the vehicle by which Congress weighs in on federal employee compensation. That bill makes no mention of changes to career federal employees’ pay, effectively endorsing the pay raise plan offered by Biden in his fiscal 2023 budget proposal.

Here is a link to the Senate Appropriations Committee’s press release unveiling those bills. What caught the FEHBlog’s eye is the statement in the press release that the Senate appropriations bills, like the House appropriations bills, do not include the Hyde amendments limiting federal funding of abortions to cases of rape, incest, or endangerment of the mother’s life. That tectonic change would draw the FEHBP into the post-Dobbs controversy.

From the Affordable Care Act front, Prof. Katie Keith does her usual outstanding job breaking down the proposed ACA Section 1557 individual non-discrimination rule in Health Affairs Forefront. In the FEHBlog’s view, the rule is unnecessarily complicated. It is the FEHBlog’s understanding that this HHS rule would not apply to FEHBP and that HHS would refer Section 1557 complaints involving FEHB plans to OPM. As the preamble points out, Section 1557 is a law that doesn’t need an implementing rule. Nevertheless, HHS recommends that other agencies with programs covered by Section 1557 adopt their own implementing rule using the HHS rule as a template.

The ACA regulators issued a 13-page long ACA FAQ 54 describing in detail the ACA rule requirements under which health plans must cover contraceptive drugs and services for women without cost sharing.

On a related note, Healthcare Dive tells us

Melanie Fontes Rainer is now acting director of HHS’ Office of Civil Rights. Fontes Rainer will replace Lisa Pino, who oversaw rulemaking related to patient safety, reproductive rights and other healthcare issues and issued policy regarding health equity, long COVID and firearm injury and death prevention, the agency said in an emailed statement.

From the federal employee benefits front, Fedweek explains the circumstances under which survivors of federal employees (as opposed to federal annuitants) are eligible for federal survivor benefits.

If you are an employee who was married when you die and you had at least 18 months of creditable civilian service, your spouse will be entitled to a survivor annuity.  * * * f you were enrolled in either the self plus one or self and family options of the Federal Employees Health Benefits program when you died, the person(s) on your enrollment could continue that coverage. If you weren’t enrolled in the program (or were enrolled but in the self only option), any otherwise eligible survivors would be out of luck.

From the Omicron and siblings front, the American Medical Association offers a helpful Q&A on Covid boosters.

From the monkeypox front, Reuters makes two reports

  • The United States has the capacity to conduct 60,000-80,000 tests for monkeypox virus per week, Health and Human Services Secretary Xavier Becerra said on Thursday. When the monkeypox outbreak began, the U.S. was able to conduct only 6,000 tests per week, Becerra told reporters during a telephone briefing.
  • The U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday it plans to make the rapidly spreading monkeypox disease a nationally notifiable condition. The designation, which is set to take effect on Aug. 1, updates criteria for reporting of data on cases by states to the agency and would allow the agency to monitor and respond to monkeypox even after the current outbreak recedes, the CDC said.

From the U.S. healthcare business front —

The American Hospital Association issued a report attacking the commercial health insurance industry, which in the FEHBlog’s view is akin to strangling the golden goose.

Healthcare Dive reports

Teladoc beat Wall Street expectations for revenue in the second quarter, with a topline of $592 million, up 18% year over year. Chronic care membership came in higher than analysts expected, while member utilization improved year over year.

But “all eyes” are on the vendor’s guidance for the rest of the year, which implies a third-quarter miss and a steep ramp-up for earnings in the fourth quarter, SVB Securities analyst Stephanie Davis wrote in a note on the results.

STAT News chimes in

Telehealth giant Teladoc is bracing for disappointing earnings this year as it faces headwinds that could also thwart competitors struggling to turn a profit — including increasingly frugal employers delaying or dropping contracts for virtual care.

“The challenge that we’re seeing is in these times of economic uncertainty, all purchases are just getting a significantly higher level of scrutiny,” CEO Jason Gorevic said in an earnings call Wednesday.

Gorevic also noted that declining yield on advertising suggests that individual patients may start spending less on direct-to-consumer services like BetterHelp, the company’s mental health care offering. Those hurdles aren’t unique to Teladoc. Competitors like Amwell and Talkspace could also have to grapple with cutbacks.

Healthcare Dive also delves into Amazon’s planned acquisition of One Medical. “The deal fast-tracks Amazon’s ambitions in healthcare, while giving One Medical a cushion in today’s tricky economic environment.”

Yesterday, the FEHB wrote about the hospitals receiving five stars from Medicare. Today Becker’s Hospital Review lists the 192 hospitals receiving a single start from that program.

Finally STAT News lists the 41 best books and podcasts on health and science to check out this Summer.

Weekend update

David Ermer–Congress, COVID-19, COVID-19 testing, HIPAA Privacy and Security Rules, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

The House of Representatives and the Senate are in session this week for Committee business and floor voting. This is the House’s last week of scheduled floor voting before the August recess.

The Wall Street Journal reported last Friday evening

President Biden signaled he was prepared to support a narrow bill that lowered prescription drug costs and extended Affordable Care Act subsidies but left out climate provisions, as Senate Democrats grappled with whether to abandon their broader economic agenda after intraparty talks hit an impasse.

Mr. Biden said that if the Senate didn’t move forward with climate legislation, he would turn to executive action, calling clean energy and combating climate change urgent matters. On the prescription drug portion of the agenda, he said the Senate “should move forward, pass it before the August recess, and get it to my desk so I can sign it,” characterizing it as a major victory for American households.

The statement came a day after talks between Sen. Joe Manchin (D., W.Va.) and Senate Majority Leader Chuck Schumer (D., N.Y.) broke down. Mr. Manchin told Mr. Schumer that he would back a prescription-drug proposal but couldn’t yet commit to backing tax increases or climate provisions, citing inflation worries.

From the Omicron and siblings front, NPR tells us

The BA.5 omicron subvariant, which is now the most prevalent coronavirus strain in the United States, is four times more resistant to COVID-19 vaccines, according to a new study.

The strain, which is considered “hypercontagious,” according to the Mayo Clinic, is more defiant against messenger RNA vaccines, which include Pfizer and Moderna.

The BA.5 strain represented 65% of cases from July 3 to 9, according to data from the Centers of Disease Control and Prevention. 

It is contributing to increases in COVID-19 hospitalizations and admissions to intensive care units across the country. 

But vaccines still provide much better protection than going without the safeguards.

Bloomberg Prognosis adds

Bertha Hidalgo, a University of Alabama epidemiologist, was faked out by a variant that never truly got off the launchpad.

“A few weeks ago, I thought BA2.12.1 would drive the summer wave and it would be a small wave, with not too many infections, to be followed by a BA.5 wave when schools reopened,” she says.

Instead, the BA.5 omicron variant decided that the summer of 2022 was its time to shine. The variant is now dominant in the US, according to the Centers for Disease Control and Prevention. Combined with BA.4, it is also powering a surge of the virus in Europe. 

This week, World Health Organization chief Tedros Adhanom Ghebreyesus warned that “new waves of the virus demonstrate again that Covid-19 is nowhere near over.”

The good news is that we now know much more about what strategies are effective for reducing spread of the virus as we go about our lives in these very odd times.

Hidalgo shared her list of best practices:

* Get vaccinated and get all available boosters

* Wear a mask indoors (and outdoors if in crowded spaces)

* Make sure to get a good quality, good fitting mask, like a KN95 

* Use rapid tests before gathering with others, or at the sign of any questionable symptoms

* If gathering indoors, consider improving ventilation through measures like opening windows or running a central HVAC system

“All of these are layers of protection we can take advantage of that are preventive and can help reduce chances of infection and transmission,” she says.

Quite honestly, the FEHBlog relies on vaccines, including boosters, and rapid tests along with common sense.

HR Dive informs us

Employers must now justify mandatory coronavirus testing for workers, the U.S. Equal Employment Opportunity Commission said in a July 12 update to its technical assistance manual.

Until now, the commission took the position that the Americans with Disabilities Act standard for medical examinations always permitted employer worksite COVID-19 testing. 

Going forward, employers will need to assess whether current pandemic circumstances and individual workplace circumstances justify testing to prevent workplace transmission, the agency said. Specifically, an employer must show that testing is job-related and consistent with business necessity, as defined by the ADA.

From the unusual viruses front, Govexec brings us a CDC update on monkeypox. Here are links to

From the U.S. healthcare business front, Fierce Healthcare offers 21st Century advice on improving health plan call centers.

From the mental healthcare front, NPR takes a deep dive into the new 988 suicide and mental health crisis number.

From the HIPAA privacy and security rule enforcement front, HHS’s Office for Civil Rights announced “the resolution of eleven investigations in its Health Insurance Portability and Accountability Act (HIPAA) Right of Access Initiative, bringing the total number of these enforcement actions to thirty-eight since the initiative began.  OCR created this initiative to support individuals’ right to timely access their health records at a reasonable cost under the HIPAA Privacy Rule.” All of the chastised parties were healthcare providers.

This morning the FEHBlog was doing his weekly quality review of the FEHBlog. He noticed that last Thursday, he mentioned a new Kaiser Family Foundation report without providing a topic or a link for his readers. Lo siento. Here is the missing information:

Pregnancy is one of the most common reasons for a hospitalization among non-elderly people. In addition to the cost of the birth itself, pregnancy care also involves costs associated with prenatal visits and often includes care to treat psychological and medical conditions associated with pregnancy, birth, and the post-partum period.

This analysis examines the health costs associated with pregnancy, childbirth, and post-partum care using a subset of claims from the IBM MarketScan Encounter Database from 2018 through 2020 for enrollees in large employer private health plans. It finds that health costs associated with pregnancy, childbirth, and post-partum care average a total of $18,865 and the average out-of-pocket payments total $2,854. The analysis also examine how pregnancy, childbirth, and post-partum health spending among large group enrollees varies by the type of delivery.

The analysis can be found on the Peterson-KFF Health System Tracker, an information hub dedicated to monitoring and assessing the performance of the U.S. health system.

Childbirth also is one of the required out-of-pocket cost requirements for a health plan’s ACA summary of benefits and coverage template.

Midweek update

David Ermer–ACA, CDC, COVID treatment, COVID-19, COVID-19 vaccine, HIPAA Privacy and Security Rules, Rx coverage, SDOH, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From the Omicron and siblings front —

The Wall Street Journal reports

The Biden administration has agreed to pay $3.2 billion for 105 million doses of Pfizer Inc.’s Covid-19 vaccine.

The deal would provide supplies for the federal government’s planned fall booster campaign, which administration officials are devising to blunt a potential wave in cases, possibly driven by variants of the Omicron strain now spreading across the U.S.

Under the deal, the federal government would have the option to buy 195 million additional doses, the Health and Human Services Department said Wednesday. Pfizer, which developed and makes the vaccine with partner BioNTech SE, would make whatever type of vaccine federal health regulators decide should be featured in the fall campaign.

The American Hospital Administration informs us

The Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response and Food and Drug Administration this week extended the shelf life for certain refrigerated lots of the COVID-19 combination monoclonal antibody therapies REGEN-COV and Evusheld. They extended the shelf life for REGEN-COV from 24 months to 30 months and the shelf life for Evusheld from 18 months to 24 months. FDA last year authorized the therapies for emergency use to prevent COVID-19 in certain adults and children. REGEN-COV is not currently authorized in any U.S. region because it is unlikely to be effective against the omicron variant and subvariants.

Health IT Analytics tells us “The National Institutes of Health’s (NIH) All of Us Research Program has announced that health data from 20,000 people who have had SARS-CoV-2 is now available to researchers in the US, expanding the program’s dataset to encourage the study of long COVID, social determinants of health (SDOH), and health disparities.”

Also, from the SDOH front, MedPage Today informs us

Maternal mortality rates substantially increased during the COVID-19 pandemic, according to a study using data from the National Center for Health Statistics.

After March 2020, maternal deaths increased by 33.3%, which was higher than the 22% overall excess death estimate expected to result from the pandemic, reported Marie Thoma, PhD, of the University of Maryland in College Park, and Eugene Declercq, PhD, of Boston University.

The rate of maternal deaths before the pandemic was 18.8 per 100,000 live births, which increased to 25.1 per 100,000 live births during the pandemic, the authors noted in a research letter published in JAMA Network Open. * * *

The largest increases were seen in Hispanic and Black women, which was in line with maternal mortality rates before the pandemic. Hispanic women saw a relative change of 74.2% (8.9 deaths per 100,000 live births), and Black women saw a 40.2% relative change (16.8 deaths per 100,000 live births), while white women saw a 17.2% relative change (2.9 deaths per 100,000 live births).

From the monkeypox front, the Department of Health and Human Services announced

an enhanced nationwide vaccination strategy to mitigate the spread of monkeypox.  The strategy will vaccinate and protect those at-risk of monkeypox, prioritize vaccines for areas with the highest numbers of cases, and provide guidance to state, territorial, tribal, and local health officials to aid their planning and response efforts.

Under the strategy, HHS is rapidly expanding access to hundreds of thousands of doses of the JYNNEOS vaccine for prophylactic use against monkeypox in areas with the highest transmission and need, using a tiered allocation system. Jurisdictions can also request shipments of the ACAM2000 vaccine, which is in much greater supply, but due to significant side effects is not recommended for everyone.  * * *

The Advisory Committee on Immunization Practices currently recommends vaccination for those at high risk following a confirmed monkeypox exposure. Given the large number of contacts and difficulty in identifying all contacts during the current outbreak, vaccine will now be provided to individuals with confirmed and presumed monkeypox exposures. This includes those who had close physical contact with someone diagnosed with monkeypox, those who know their sexual partner was diagnosed with monkeypox, and men who have sex with men who have recently had multiple sex partners in a venue where there was known to be monkeypox or in an area where monkeypox is spreading.

The American Hospital Association adds

CDC yesterday activated its Emergency Operations Center to monitor and coordinate the emergency response to monkeypox and mobilize additional CDC personnel and resources. The agency has expanded testing capacity for the virus since May 18, when the first U.S. case in the global outbreak was confirmed, to include up to 78 state public health laboratories and five commercial laboratory companies. As of June 28, 306 U.S. monkeypox cases have been reported. 

From the Dobbs case front

  • CNBC reports “CVS is removing its earlier purchase limit on emergency contraceptive pills. The chain said that ‘sales have since returned to normal and we’re in the process of removing the purchase limits.'”
  • HHS’s Office for Civil Rights announced “new guidance to help protect patients seeking reproductive health care, as well as their providers.”

In general, the guidance does two things:

1. addresses how federal law and regulations protect individuals’ private medical information (known as protected health information or PHI) relating to abortion and other sexual and reproductive health care – making it clear that providers are not required to disclose private medical information to third parties; and

2. addresses the extent to which private medical information is protected on personal cell phones and tablets, and provides tips for protecting individuals’ privacy when using period trackers and other health information apps.

According to recent reports, many patients are concerned that period trackers and other health information apps on smartphones may threaten their right to privacy by disclosing geolocation data which may be misused by those seeking to deny care. * * *

The guidance on the HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care may be found at https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/phi-reproductive-health/index.html.

The guidance on Protecting the Privacy and Security of Your Health Information When Using Your Personal Cell Phone or Tablet may be found at https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/cell-phone-hipaa/index.html.

From the FDA front, BioPharma Dive identifies five FDA decisions to watch in the third quarter of 2022 which starts on Friday.

From the Affordable Care Act front, the Internal Revenue Service released a draft of the 2022 Form 1095-B which FEHB and other health plans offering minimum essential coverage must make available to their enrollees.

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 vaccine, HIPAA Privacy and Security Rules, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Omicron and siblings front, the Wall Street Journal reports

A Covid-19 vaccine developed by Sanofi SA and GSK PLC to target the Beta strain of the virus produced a stronger antibody response against variants of Omicron when given as a booster compared with certain first-generation shots, two studies have found.

The results are the latest indication that tweaking vaccines can nudge antibody responses in the direction of new variants, possibly helping to shore up immunity as the virus mutates. The study results may also provide an opportunity for Sanofi and GSK, two vaccine giants that were late to develop Covid-19 immunizations, to play a role in providing booster shots.

What’s more, according to the Journal

A panel of advisers to the Food and Drug Administration is set to meet Tuesday [June 14] to consider whether use of Moderna Inc.’s Covid-19 vaccine should be expanded to include children ages 6 through 17.

The advisory committee is expected to vote Tuesday afternoon on whether the benefits of vaccinating children in this age group outweigh the risks. The FDA will consider the vote in making a final decision on whether to clear the vaccine for use in children 6 years and older.

An FDA authorization could come within days. It would open the use of Moderna’s vaccine to children for the first time in the U.S., and give anyone still intending to inoculate their children 6 years and older against Covid-19 a second option.

Moderna’s vaccine has been authorized for use in adults 18 years and older since late 2020, while use of the other leading Covid-19 vaccine, from Pfizer Inc. and BioNTech SE, was expanded to anyone 5 and older last year.

From the FTC investigation front, FierceHealthcare updates us on the recently launched FTC investigation of the six largest PBMs. In other FTC news, Healthcare Dive tells us

** UnitedHealth and LHC Group have been hit by a request for additional information on their acquisition from the Federal Trade Commission, as regulators take an increasingly active role in overseeing healthcare M&A.

** The second request extends the waiting period the FTC has to challenge the deal. UnitedHealth agreed to acquire home health and hospice provider LHC for $5.4 billion in March.

** https://www.healthcaredive.com/news/regulators-unitedhealth-lhc-request-merger/625343/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202022-06-13%20Healthcare%20Dive%20%5Bissue:42394%5D&utm_term=Healthcare%20DiveIn a filing with the SEC on Friday, the companies said they have been complying with regulators and will continue to do so.

Speaking of home health care, Home Health News discusses Aetna’s interest in the topic.

Aman Gill, Aetna’s director of product strategy and innovation, told Home Health Care News last month that a home health acquisition was “on the table” for the company. 

This past week, at HHCN’s VALUE event, Aetna CMO Dr. Kyu Rhee reiterated the company’s commitment to the home as a setting of care. He also explained how care delivery has changed over the course of the last few years.

“We’ve been committed to home health and virtual care during the pandemic,” Rhee said. “And in our Medicare program, we’ve delivered tens of thousands of healthy at-home visits as well. … So my challenge to us as we think about the opportunity we have now and the next stage of this pandemic is: Are we going to persist in those values and make sure that the system delivers on those values, that hopefully we’ve learned over the last couple of years?”

From the Rx coverage front, the Food and Drug Administration announced

the [agency approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the U.S. each year. Today’s action marks the first FDA approval of a systemic treatment (i.e. treats the entire body rather than a specific location) for alopecia areata.

“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, M.D., director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”

The drug initially was FDA-approved for the treatment of rheumatoid arthritis in 2018.

From the HIPAA Privacy Rule front, the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), announced

issuing guidance on how covered health care providers and health plans can use remote communication technologies to provide audio-only telehealth services when such communications are conducted in a manner that is consistent with the applicable requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules, including when OCR’s Notification of Enforcement Discretion for Telehealth – PDF is no longer in effect. * * *

The Guidance on How the HIPAA Rules Permit Health Plans and Covered Health Care Providers to Use Remote Communication Technologies for Audio-Only Telehealth may be found at: https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/hipaa-audio-telehealth/index.html.

Midweek update

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, HIPAA Privacy and Security Rules, Telehealth, U.S. Healthcare–

The Postal Service Health Benefits Program was born today as the President signed into law the Postal Reform Act of 2022 (H.R. 3076). Here is a link to the President’s remarks made at the bill signing.

The PSHBP will become operational on January 1, 2025. OPM’s implementing rules must be finalized by April 6, 2023.

Govexec adds

The U.S. Postal Service is once again seeking to raise its rates by historically unusual amounts, announcing the increases on the same day President Biden signed into law a bipartisan bill to erase much of the agency’s debts and allow it to pursue new lines of revenue.  * * *

The new prices, which are set to go into effect July 10, would raise rates for regular, First-Class mail by 6.5% and by 8.5% for package services. A standard stamp would go from $0.58 to $0.60. The large increases were made possible under new authority the Postal Service’s regulator granted it in 2020 and which USPS employed for the first time last year. DeJoy promised as part of his 10-year business plan to use his authority to raise rates above inflation “judiciously,” but predicted USPS would generate between $35 billion and $52 billion by 2031 by raising prices.

From the Capitol Hill front, Roll Call reports “A bipartisan $10 billion COVID-19 supplemental is stuck in the Senate amid a dispute over a tangential pandemic-related border control policy, with both parties at a loss on how the impasse will be resolved.”

In other Omicron (and siblings) news

The Food and Drug Administration’s Vaccine and Biological Products Advisory Committee met today for a general discussion of Covid vaccines. The Wall Street Journal reports

A top U.S. health regulator said that asking people to frequently get Covid-19 boosters wasn’t sustainable because of vaccine fatigue and that authorities needed to develop a long-term strategy for protecting the public from the virus as it evolves.

Dr. Peter Marks, who heads the Food and Drug Administration’s vaccines division, said that last week’s authorization of a second booster dose for people 50 years and older and for people 12 and older with weakened immune systems was a stopgap.

STAT News offers a play-by-play account of that meeting here.

The American Hospital Association informs us

Medicare and Medicaid will cover a second Pfizer or Moderna COVID-19 booster at no cost to eligible enrollees, the Centers for Disease Control and Prevention announced today. Health care providers participating in the Centers for Disease Control and Prevention’s COVID-19 Vaccination Program also must provide authorized COVID-19 vaccines at no cost to recipients.

The FEHBlog discovered from reading an AHA squib that CDC Director Rochelle Wolensky approved the FDA’s March 29 second booster recommendation last week. That joint recommendation permits adults aged 50 and older to receive a second Pfizer or Moderna COVID-19 vaccine booster dose at least four months after an initial booster dose. In addition, those agencies authorized and recommended a second Moderna booster dose for certain immunocompromised adults and a second Pfizer booster dose for certain immunocompromised individuals aged 12 or older.”

What’s odd is that the ACA FAQ 50 indicates that the CDC advisory committee’s recommendation triggers the health plan to cover a particular use of a Covid vaccine with no member cost-sharing. Given that CMS has given the green light and the advisory committee reports to the CDC Director, the FEHBlog concludes that health plans also should step up to the plate and provide no cost-sharing coverage for these second boosters.

STAT Health tells us that

A new survey by STAT and The Harris Poll finds six in 10 Americans have already decided they will get another booster if it’s recommended for them.

Just under one-quarter of U.S. adults indicated they will only receive a second booster shot if a new variant arises or there is a surge in Covid-19 cases in their area, and 18% have no plans to get a booster at all, according to the survey, which polled 2,028 U.S. adults between March 25 and 27.

America has spoken.

From the No Surprises Act front, the AHA notes

The Centers for Medicare & Medicaid Services has released a new FAQ for health care providers on the No Surprises Act’s requirements and prohibitions, and the independent dispute resolution process; and a new FAQ on providing good faith estimates to uninsured and self-pay patients. CMS plans to launch next week the online portal through which uninsured and self-pay patients may initiate the dispute resolution process.

The CMS FAQs are worth reviewing by health plans because they go beyond the out-of-network bill consumer protections to address the NSA good faith estimate, continuity of care, and provider directory accuracy provisions. For example, the good faith estimate discussion on page 6 is quite informative.

From the Health Affairs front

  • Jane Zhu and a team of fellow experts wrote an article on Trends in Outpatient Mental Health Services Use before and during the pandemic. Here are excerpts from the abstract which is quite pro-telemental care.

In-person mental health encounters were reduced by half in the early months of the pandemic, with rapid recovery of service delivery attributable to telehealth uptake (accounting for 47.9 percent of average monthly encounters). We found variation in the degree to which telehealth use increased across groups: People with schizophrenia made up a lower proportion of telehealth encounters relative to in-person visits (1.7 percent versus 2.7 percent), whereas those with anxiety and fear-related disorders accounted for a higher proportion (27.5 percent versus 25.5 percent). These findings highlight the importance of broadening access to services through new modalities without supplanting necessary in-person care for certain groups.

  • Joshua Liao and Amol Navathe wrote an article in the Health Affairs Forefront describing a new Accountable Care Organization model designed to improve health equity.

From the healthcare business front —

Optum continues its buying spree and has picked up Kelsey-Seybold Clinic, a large, multi-specialty group practice based in Houston, Texas, Axios reported Monday.

With more than 500 physicians, Kelsey-Seybold Clinic operates multi-specialty care centers, a cancer center, a women’s health center, two ambulatory surgery center locations, and a specialized sleep center with more than 30 locations in the Greater Houston area. Kelsey-Seybold partners with major insurers to offer value-based commercial health plans. Kelsey-Seybold partners with major insurers to offer value-based commercial health plans. The organization partners with payers to offer value-based commercial health plans also owns its own Medicare Advantage plan for seniors, KelseyCare Advantage.

Intermountain Healthcare and SCL Health completed their merger, creating one of the nation’s largest nonprofit health systems, the two organizations announced Tuesday.

The new system, which will use the Intermountain name to reflect the parent entity, will operate 33 hospitals and hundreds of clinics across seven states and insure 1 million people in Utah and Idaho.

Colorado’s attorney general signed off on the merger last week after conducting a review, concluding the tie-up will not result in a material change to the charitable purposes of nonprofit SCL Health, based in Colorado, and that SCL assets will not leave the state.

  • Business Wire tells us “Millennium Trust Company, LLC (“Millennium Trust”), a leading provider of retirement and financial services for employers, institutions, advisors, and individuals, today announced it has signed a definitive agreement to acquire PayFlex Holdings, Inc. (“PayFlex”), a provider of health savings accounts (HSAs) and consumer-directed benefit administration services, from CVS Health Corporation (“CVS Health”).

In HIPAA Privacy and Security Rule News, the Department of Health and Human Services announced issuing

a Request for Information (RFI) seeking input from the public on two requirements of the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), as amended in 2021.  The growing number of cybersecurity threats are a significant concern driving the need for enhanced safeguards of electronic protected health information (ePHI).  This RFI will enable OCR to consider ways to support the healthcare industry’s implementation of recognized security practices. The RFI also will help OCR consider ways to share funds collected through enforcement with individuals who are harmed by violations of the HIPAA Rules.

* * *

Individuals seeking more information about the RFI or how to provide written or electronic comments to OCR should visit the Federal Register to learn more: https://www.federalregister.gov/documents/2022/04/06/2022-07210/considerations-for-implementing-the-health-information-technology-for-economic-and-clinical-health

Please note that comments must be submitted by June 6, 2022 in order to be considered.

Interestingly, the HHS seeks public input on developing the safe harbors created by the 2021 law.

Midweek update

David Ermer–COVID vaccine mandate, COVID-19, Electronic health records, HIPAA Privacy and Security Rules, Mental health care, No Surprises Act, U.S. Healthcare–

From the FEHB front, the Office of Personnel Management released the 2023 call letter for benefit and rate proposals and the related technical guidance letter.

OPM is to be congratulated for releasing the two letters simultaneously. Historically, OPM has released the call letter weeks or months before the technical guidance letter. As a result, carriers cannot start preparing their benefit and rate proposals, due May 31, until they receive both letters.

From the Omicron (and sibling) front, the American Medical Association informs us

The New York Times (3/15, Mandavilli) reports about “17 million Americans received the Johnson & Johnson Covid vaccine, only to be told later that it was the least protective of the options available in the United States.” However, “new data suggest that the vaccine is now preventing infections, hospitalizations and deaths at least as well as the Pfizer-BioNTech and Moderna vaccines.” The reasons are unclear, “and not all experts are convinced that the vaccine has vindicated itself.” Still, “the accumulating data nonetheless offer considerable reassurance to recipients of the vaccine and, if confirmed, have broad implications for its deployment in parts of the world.”

From the mental health care front, the American Hospital Association tells us

The Substance Abuse and Mental Health Services Administration yesterday released a toolkit to help health care providers and others prepare for the July 16 launch of 988, the new phone number for anyone experiencing suicidal thoughts or a mental health or substance use crisis to speak, text or chat with a trained crisis counselor. Authorized by the National Suicide Hotline Designation Act of 2020, the three-digit number will operate through the National Suicide Prevention Lifeline’s network of over 200 crisis centers.

“In the longer term, our vision is to build a robust crisis care response system across the country that links callers to community-based providers who can deliver a full range of crisis care services, if needed (like mobile crisis teams or stabilization centers),” SAMHSA notes.

To access the toolkit and other suicide prevention resources, visit SAMHSA’s new 988 website. 

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

The long-term shift from hospital-based care toward more treatment delivered in the home and ambulatory centers picked up pace during the COVID-19 pandemic and is expected to continue to gain momentum, pressuring revenue growth and margins in the hospital sector, according to new research from Moody’s Investors Service.

Reimbursement changes, risk-sharing, investment in outpatient services including ambulatory surgery centers, advances in drugs and medical devices and greater use of at-home acute care services are among the forces driving the movement away from more expensive hospital inpatient care.

Medicare telehealth visits increased 63-fold during 2020, Moody’s said, citing HHS data. Although hospitals are reporting that telehealth use is receding as more patients return to in-person physician visits, it will likely remain above pre-COVID levels, the ratings agency said.

Kaiser Health News looks at the No Surprises Act from the patient’s perspective. It’s an important article because health plans should help their members keep the new law’s billing protections in perspective.

From the provider of the future front, mHealth Intelligence reports

Though a majority (63 percent) of clinicians worldwide expect most of their consultations to be remote within the next decade, 51 percent believe that telehealth will negatively impact their ability to demonstrate empathy with their patients, a new report revealed.

Developed by Elsevier Health and Ipsos, the Clinician of the Future report includes a quantitative survey, qualitative interviews, and roundtable discussions with nearly 3,000 practicing physicians and nurses worldwide. Of the total number of respondents, 434 were from the US. * * *

Empathy from physicians is becoming increasingly important for patients. A vast majority of clinicians (82 percent) surveyed said that soft skills like listening and displaying empathy have become more critical in the last decade. In the US, 76 percent of clinicians agreed with this statement.

Though the importance of soft skills has grown, the report notes that technical skills will be key in the future.

From the HIMSS Conference in Orlando, Florida, Healthcare Dive holds an interview concerning the FEHBlog leading interoperability innovation of 2022, TEFCA:

Healthcare Dive caught up with Mariann Yeager to talk TEFCA at the HIMSS annual healthcare conference in Orlando on Monday. Yeager is CEO of the Sequoia Project, a nonprofit that was selected in 2019 to serve as the recognized coordinating entity (RCE) charged with developing, updating and maintaining the common agreement and overseeing QHINs.

Yeager shared more details on the timeline of TEFCA implementation, why organizations should join the voluntary framework and how the Sequoia Project and the Office of the National Coordinator for Health IT are at the beginning of a long process of monitoring and modernizing a living document that, given uptake, could shape the future of health data exchange for decades into the future.

“We’re really proud of the work that we’ve done,” Yeager said.

Check out the full interview.

Thursday Miscellany

David Ermer–Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, HIPAA Privacy and Security Rules, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Delta variant front, AHIP informs us that

Today, the Center for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) convened its final day of a scheduled meeting to discuss and vote on recommendations for booster doses of the Moderna and Janssen (Johnson & Johnson) COVID-19 vaccines, and to review data from the National Institutes of Health on mix-and-match booster doses.

The Committee unanimously voted (15-0) to approve the use of a single COVID-19 vaccine booster dose as follows:

1. Single booster dose of Moderna COVID-19 vaccine to be administered at least 6 months after completion of the primary series for individuals:

2. Single booster dose of the Janssen COVID-19 vaccine to be administered at least 2 months after completion of the primary regimen to individuals 18 years and older

3. Use of each of the available COVID-19 vaccines can be used as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine

Data presented by Moderna showed a slow decline in neutralizing antibodies generated from the primary series over time.  Data from Janssen showed lower overall vaccine effectiveness compared to those who received an mRNA vaccine, and that evidence is not sufficient to determine if vaccine effectiveness is waning.

ACIP evaluated the benefits and risks of a booster dose for both the Moderna mRNA vaccine and for the Janssen vaccine.  The booster dose for the Moderna vaccine is half the dosage of the primary series shots, while those receiving a Janssen booster will receive the same dosage as the primary series.  CDC recommends that people receiving a booster dose receive the same vaccine as the primary series unless unavailable or another product is preferred.  Today’s vote created the pathway for heterologous booster doses for all vaccines, following FDA authorization yesterday.

The Committee also reviewed updates on the safety of all approved COVID-19 vaccines regarding incidences of myocarditis, pericarditis, and thrombocytopenia (TTS) and found no increased rates of these serious adverse events following additional booster doses of the vaccines. The data indicated that serious side effects for all vaccines are extremely rare. More research needs to be done on the safety of heterologous vaccine administration.

The final stop for these recommendations is the CDC Director Rochelle Walensky. The Wall Street Journal reports that Dr. Walensky approved the Committee’s recommendations this evening.

STAT News points out

When the [COVID] shots arrived late last year, the message from health officials was simple: Get vaccinated when you become eligible, and get whichever jab is offered to you. But with boosters becoming available for select groups of people, and a lower-dose shot for young children expected shortly, the campaign is moving from a simple set of instructions to more of a messy flow chart for people organizing and delivering the jabs. * * *

Sorting all this out will fall to pharmacies, immunization programs, pediatricians, and vaccine administrators, many already stretched thin, who will also have to track inventory and try to minimize waste. It will be a quick turnaround, as well: As soon as the CDC checks the final box for boosters with its recommendations, people will start demanding them.

Under ACA FAQ 50 issued October 4, 2021, health plans must immediately begin to cover administration of these boosters without member cost-sharing.

From the vaccine mandate front, Federal News Network reports that

A memo released by the Defense Department states that civilian [employees] will ultimately be fired from their jobs if they are not fully vaccinated. DoD wants all of its civilians to get the shot and go through the required waiting period for antibodies to flourish by Nov. 22.

DoD civilians who refuse to get the shot will go through “progressive enforcement actions,” the first of which is a five-day counseling and education period.

If an employee is still recalcitrant, they will be suspended without pay for less than 14 days. If the refusal continues, DoD will then terminate the employee for “failing to follow a direct order.”

The memo states that DoD will designate officials to handle the disciplinary process and “ensure consistent application of disciplinary measures.”

There are some exceptions to the rule. DoD will provide waivers to those who cannot get the vaccine due to medical conditions or for religious reasons. Further guidance will be available soon on the exceptions and DoD is currently not taking any action on exemption requests.

From the FEHB Open Season front, OPM made the following edit to its FEHB 2022 Significant Events chart:

StateFEHB CarrierPlan NameTerminatingOptions (endof 2021)TerminatingCodes (end of2021)Automatic EnrollmentOption and Codes for2022
IndianaHumana Health Plan,Inc.Humana Health Plan,Inc.HighLouisvilleMetropolitan areaMH1, MH3, MH2StandardLouisville Metropolitanarea – MH4, MH6, MH5
IndianaHumana Health Plan of Ohio, Inc.Humana Health Plan of Ohio, IncHighA61, A63, A62BasicW61,W63,W62
KentuckyHumana Health Plan of Ohio, Inc.Humana Health Plan of Ohio, Inc.HighA61, A63, A62Basic W61,W63,W62

From the federal employment benefits front, Reg Jones in Fedweek discusses death benefits available to surviving beneficiaries following a federal annuitant’s post-retirement death.

From the HLTH2.0 conference, Healthcare Dive provides more Amazon Health news and Fierce Healthcare discusses how to attract younger health plan members.

From the the Capitol Hill front, Healthcare IT News explains that why this may be the year that Congress finally restores funding for a HIPAA patient identification number. Fingers crossed.