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.
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.
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.
From Capitol Hill, Medpage Today suggests that prior authorization practices are under Congress’s spotlight.
From the Omicron and siblings front–
The Wall Street Journal offers an interesting report on the ups and downs of Omicron and its siblings.
Govexec tells us about recent Safer Federal Workforce changes to “its COVID-19 protocols to draw more distinctions between the policies for vaccinated and unvaccinated workers, including those related to travel and paid leave.”
From the federal employment front, the Society for Human Resource Management explains how the federal government is “struggling mightily to recruit, retain and develop the talent it needs to succeed and earn the reputation of being a “model employer.” Agencies and their HR leaders are working to upgrade antiquated systems and processes. The new-hire process currently takes an average of 100 days to complete, double that of the private sector.” Good luck.
From the Rx coverage front, Prime Therapeutics announced last week
Leading pharmacy benefit manager (PBM) Prime Therapeutics LLC (Prime) analyzed its real-world data to assess clinical outcomes and drug waste differences between medically integrated dispensing (MID) and central specialty pharmacy dispensing of oral cancer therapies. This study of a Prime pilot program showed a potential average savings opportunity of $1,800 per medication dose change at a MID pharmacy compared to a central fill specialty pharmacy. Results reinforced Prime’s position of the advantages of the MID model, on which its IntegratedRx™ program is based.
With the MID model, care providers – including doctors and pharmacists – have access to prescribing history, test results and other important patient information in the EMR. This coordination informs the care team earlier than the traditional model. This early look has potential to help lower the number of 30-day prescriptions going to waste.
Prime’s MID pilot program was implemented in early 2021 within three oncology practices and across three Blue Plans’ commercially insured lives to prove the potential care and cost advantages with this distinct model compared to a centralized specialty pharmacy model. Study participants were prescribed oral drugs that did not require dispensing and shipment from a payer-directed specialty pharmacy to the oncologist (aka white bagging).
From the studies department —
Health Payer Intelligence informs us “More consumers reported that their health plans are offering transparency tools and overall consumer awareness about the availability of transparency tools has grown, according to a study conducted on behalf of HealthSparq.”
MedPage Today discusses a study finding that weight loss, even when achieved by bariatric surgery, will reduce the risk of obesity-related cancer. The FEHBlog wonders if weight loss produced by the current, effective weight loss drugs would have a similar health impact.
mHealth Intelligence notes that “To reduce the amount of time spent in a virtual waiting room, researchers from the University of California San Diego conducted a pilot that used text messaging to provide patients with a meeting link when their provider was ready to see them, finding it to be a successful alternative.”
The New York Times reports on a GlaxoSmithKline “checkpoint inhibitor” drug trial conducted on eighteen rectal cancer patients. The drug wiped out the cancer in all of those patients. Quite amazing. According to the Times experts indicate that the trial needs to be replicated.
BioPharma Dive reports “Twenty-four years ago, a drug called Herceptin changed how doctors treat breast cancer. Its approval in 1998 made it possible to target the aggressive breast tumors tied to a gene called HER2. Other drugs quickly followed Herceptin and, over the years since, have substantially improved survival for people with the disease. A quarter of a century later, another shift in treatment could be on the horizon. At the American Society of Clinical Oncology meeting, AstraZeneca and Daiichi Sankyo are presenting results proving that, for the first time, a targeted medicine can help metastatic breast cancer patients whose tumors express only low levels of HER2. Clinical trial data revealed at ASCO and published in The New England Journal of Medicine Sunday show the drug, Enhertu, halved the risk of cancer progression compared to chemotherapy and reduced the risk of death by 36%.”
The Guardian tells us “Taller people have an increased risk of peripheral neuropathy, as well as skin and bone infections, but a lower risk of heart disease, high blood pressure and high cholesterol, according to the world’s largest study of height and disease. A person’s height raises and reduces their risk of a variety of diseases, according to the research led by Sridharan Raghavan of the Rocky Mountain Regional VA Medical Center in the US. The findings are published in the journal PLOS Genetics.”
From the potpourri department, check out this NIH Newsletter for June 2022.
Congress continues with its State / District work period for a second week. Congress resumes its work on Capitol Hill next week.
From the Omnicron and siblings front, the Wall Street Journal reports
In the latest phase of the Covid-19 pandemic, federal and local officials are telling people to decide for themselves how best to protect against the virus.
Health officials are leaving it up to people to assess if they need booster shots, whether to wear a mask and how long to isolate after a positive test. Businesses, schools and other entities are scaling back specific guidelines as they prepare for a return to normal.
The question of when older adults should get a second vaccine booster is the latest example of the government shifting decisions from broad-based community outreach to personal choice. People 50 years and older can get the additional booster at least four months after their first, but health authorities aren’t pushing those eligible to get the shots.
That’s sensible. Bloomberg’s Prognosis adds
Nearly a third of employers who previously required Covid-19 shots have dropped or plan to drop the requirement by the end of this year, according to a forthcoming survey from the consulting firm Willis Towers Watson. (Read the full story here.)
From the Social Determinants of Health front, Fierce Healthcare reports
Optum Ventures is investing in senior care startup DUOS to help fuel the company’s growth and build out its technology capabilities.
Launched in 2021, New York-based DUOS helps place expert personal assistants, called “Duos,” into the homes of seniors. The company works directly with consumers as well as with payer and provider organizations.
Kaiser Permanente has doubled its Thriving Communities Fund to $400 million, unlocking more money to build affordable housing and other value-based investments.
The nonprofit healthcare provider’s announcement Thursday comes as the Biden administration is pressing for the industry to tackle social risk factors such as food and housing insecurity. * * *
Insurer UnitedHealth Group earlier this month announced a $100 million investment in affordable housing, bringing its total housing investment to $800 million. The insurer has created more than 19,000 housing units as part of the initiative.
CVS also invested $114 million in affordable housing in 2020, hoping to also set aside certain units for the homeless and seniors.
The major investments in housing come as the healthcare industry is pressing to tackle social risk factors.
The payer will cover genetic testing through Blue Care Network, the company’s nonprofit health maintenance organization (HMO), which covers 840,000 members.
“Our first priority with the Blue Cross Personalized Medicine program is to ensure that a physician is able to provide the right medication, at the right dose, as early in the process as possible,” said Scott Betzelos, MD, chief medical officer and vice president of HMO strategy and affordability at Blue Care Network.
Cigna’s Evernorth is teaming with the Behavioral Health Center of Excellence (BHCOE) to more effectively measure the quality of care for people with autism.
The partnership will allow the two to collaborate on creating measures that will help people with autism and their caregivers track the efficacy of their treatment. The partners plan to start with measures for applied behavior analysis (ABA), which is the most well-researched and effective intervention for people with autism spectrum disorder.
The lack of common performance measures for ABA makes it hard to track outcomes among providers, according to the announcement.
The Secretary of Health and Human Services Xavier Becerra renewed the declaration of a public health emergency due to Covid for another 90 days from April 16. Roll Call provides background on this expected decision.
Beckers Hospital Review summarizes an interview the White House’s new COVID-19 response coordinator, Ashish Jha, MD, recently gave to NPR. The article describes Dr. Jha as optimistic.
Roll Call also offers its perspectives on the CDC’s Covid vaccination strategy.
Some experts question boosting with vaccines modeled on the original virus as new variants sweep the globe. The immune system responds most quickly to variants it has already encountered, and evidence has shown that people infected with a significantly different variant of a virus can potentially suffer worse reactions when a new wave hits.
But it’s not yet clear if this is the case with COVID-19 or whether the current vaccines have broad enough protection to neutralize this phenomenon, known as “original antigenic sin.”
“Theoretically, repeated exposure to an older variant formula may drive our immune system to concentrate too much on old features and not on new features,” Katelyn Jetelina, an assistant professor at University of Texas Health Science Center, wrote in her Substack newsletter. “But despite some truly surprising evolutionary leaps of the virus (like Omicron) we have not seen any convincing evidence of OAS among humans, which is great news.”
There’s also disagreement in the medical community about whether more COVID-19 shots of any kind are necessary for the broader public beyond the elderly and high-risk. The debate has muddled the message on already confusing booster recommendations.
“The FDA and CDC have kind of come out with, like, a lukewarm, ‘Yeah, you can do this,’ as opposed to, ‘Run and do it now.’ And you know, that’s going to leave most people confused,” said Jen Kates, Kaiser Family Foundation director of global health and HIV policy.
In this regard, the Wall Street Journal discusses “Why It Is Hard to Know Who Needs a Covid Booster: Mysterious T Cells: Vaccine experts aren’t certain who under 65 years should get a second booster–and when–because the response of T cells is poorly understood.”
Researchers and U.S. health officials measuring whether Covid-19 vaccines work have largely focused on the body’s first-line defense, called antibodies. The Food and Drug Administration recently cleared a second booster shot partly based on real-world research out of Israel showing the extra dose restored antibody levels that had waned and reduced risk of infections.
“You have T cells that are not waning to the same degree and are likely a big part of what’s going to keep you out of the hospital,” said John Wherry, director of the Institute for Immunology at the University of Pennsylvania.
The presence of T cells, vaccine experts say, might explain why many vaccinated people who tested positive for Covid-19 several months after their inoculations managed to avoid severe cases.
Lingering T cells might reduce the need for many healthy people to get a second booster dose within months of their first, some vaccine experts say. In fact, there might be diminishing returns from getting boosters over time if T-cell levels eventually plateau or slowly drop over timeas people get more shots, researchers say.
There is limited evidence to go on, however. * * * Dr. Wherry said his lab expects to publish data soon showing that T cells after the initial series of vaccinesremain in the body for at least nine to 12 months. “We are building the plane as we’re flying,” Dr. Wherry said.
From the Covid vaccine mandate for federal employees front, Govexec follows up on last week’s decision from the U.S. Court of Appeals for the Fifth Circuit lifting the preliminary injunction on that mandate. The FEHBlog noted earlier this week that the federal government has asked the Fifth Circuit to accelerate the effective date for that action. Govexec tells us that the plaintiffs’ attorneys have opposed the government’s motion and intend to petition the Court for a rehearing or a rehearing en banc.
The White House announced “Additional Actions in Response to Vice President Harris’s Call to Action on Maternal Health.” Of interest to FEHB carriers, the fact sheet explains
“Birthing-Friendly” Hospital Designation: CMS is proposing the “Birthing-Friendly” hospital designation to drive improvements in maternal health outcomes and maternal health equity. The “Birthing-Friendly” hospital designation would assist consumers in choosing hospitals that have demonstrated a commitment to maternal health. The Administration announced this new designation during the White House Maternal Health Day of Action Summit.
Initially, the designation would be awarded to hospitals based on attestation that the hospital has participated in maternity care quality improvement collaboratives and implemented best practices that advance health care quality, safety, and equity for pregnant and post-partum patients.
Data will be submitted by hospitals for the first time in May 2022, and CMS will post data for October to December 2021 in fall 2022. Criteria for the designation may be expanded in the future.
OPM’s call letter for 2023 benefit and rate proposals suggested that carriers keep an eye on this initiative.
Speaking of government initiatives, Federal News Network brings us up to date on the TEFCA initiative that would create a backbone for the country’s regional health data networks, among other data resources.
From the government reporting front, HR Dive informs us
The U.S. Equal Employment Opportunity Commission today opened 2021 data collection reporting for its Employment Information Report (EEO-1), Standard Form 100, Component 1. The filing deadline is May 17, 2022, EEOC said.
Generally, private employers with at least 100 employees must submit an EEO-1 Component 1 report. So must federal contractors with 50 or more employees.
The window for reporting has been shortened significantly compared to the last two years, with HR given a little over one month to complete the form.
Gee, the FEHBlog understood that the Covid public health emergency had been extended.
From the medical research from LifeSciences Intelligence reports
A major international study recently identified 75 genes associated with an increased risk of developing Alzheimer’s disease, including 42 new genes not previously discovered.
The study involving UK Dementia Research Institute researchers enrolled over 100,000 individuals with Alzheimer’s disease and over 600,000 healthy individuals across the UK, US, Australia, and Europe. Researchers studied the differences in their genetic makeup.
Notably, 60–80% of disease risk is based on genetics. Therefore, researchers must continue to uncover the biological causes and develop treatments for the millions of people affected globally.
From the mental healthcare front, Beckers Hospital Review offers a suicide rate of each U.S. state and the District of Columbia in 2020, according to a ranking Kaiser Family Foundation released on April 12. The national age-adjusted suicide rate was 13.5 per 100,000 people in 2020. Wyoming had the highest rate and the District of Columbia the lowest.
The House Appropriations Committee is tentatively planning to take up its fiscal 2023 spending bills in June, teeing up potential floor votes in July, according to people familiar with the schedule.
Subcommittees would mark up their 12 annual bills from June 13 to June 22. The full committee would hold its markups from June 22 through June 30.
The top four appropriators in the House and Senate, known as the “four corners,” are expected to meet shortly after the two-week recess this month to begin discussions aimed at reaching a bipartisan agreement on overall discretionary spending levels for the fiscal year that begins Oct. 1.
A bipartisan group of four key lawmakers unveiled a long-shot policy that aims to alleviate one of the American health care industry’s most embarrassing problems: mind-bogglingly high prices for insulin, a drug millions of Americans need to survive.
The policy outline released Monday is a reboot of a three-year-old bill introduced by Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine). It would dangle a carrot for drugmakers to lower their list prices. Insurers and middlemen wouldn’t get to keep fees for diabetes drugs — but only if drugmakers lower list prices for drugs back to 2006 levels. It would also make sure patients with Medicare or private insurance don’t pay more than $35 per month for their insulin, though it would not offer the same protection to the uninsured.
Federal News Radio follows up on last week’s Senate confirmation of Kristin Boyd to be the first Senate-confirmed OPM Inspector General in over six years.
From the Omicron and siblings front —
Fierce Healthcare calls attention to a Commonwealth Fund report on the efficacy of Covid vaccines
COVID-19 vaccinations have blunted the worst waves of the pandemic, preventing millions of deaths, limiting strain on the U.S. healthcare system and producing “substantial cost savings” in healthcare spending, according to new estimates published Friday by the Commonwealth Fund.
From the first authorizations in December 2020 through March 2022, COVID-19 vaccination was estimated to have averted roughly 2.3 million deaths and 66.2 million additional infections, per the analysis.
Further, the push for shots in arms was found to have prevented 17 million hospitalizations in the U.S. and saved the country’s healthcare system just shy of $900 million in total spending, notwithstanding the country’s savings related to workplace absences and deaths.
The risk of developing inflammatory heart conditions after Covid-19 vaccination is relatively low, two large studies found, especially when compared with the heart-related risks from Covid-19 disease itself and from vaccines against other diseases [such as the flu].
“The overall message is that you can never consider risk in isolation,” said Jason Perry Block, an associate professor at Harvard Medical School and a co-author of the CDC’s analysis.
Concerns over potential side effects from Covid-19 vaccines are one reason some eligible adults in the U.S. say they haven’t gotten the shots, according to public-opinion surveys. About 70% of eligible Americans have been fully vaccinated against Covid-19, according to the CDC.
In considering the cardiac risks associated with Covid-19 vaccines, Dr. Block said people “also have to consider the risk on the other hand. If you don’t get vaccinated and do get infected, the risk is higher of cardiac complications.”
From the Covid vaccine mandate front —
A federal district court in Georgia preliminarily enjoined the federal government’s vaccine mandate on its contractors. The federal government appealed to the U.S. Court of Appeals for the 11th Circuit. The appeal was argued before a panel of three judges last Friday. Federal News Network adds
A three-judge panel from the U.S. Court of Appeals for the 11th Circuit says it remains unclear whether the Biden administration has the authority to impose a COVID-19 vaccine mandate on federal contractor employees.
The administration told the court last Friday that federal contracting law gives the president broad authority to set the terms of the federal government’s contracts, including making sure contractors have enough healthy employees to complete their contracts with agencies on time.
The judges, however, repeatedly said during oral arguments that the federal government has a high bar to clear, in order for the court to overturn a lower court’s injunction barring the administration from enforcing the mandate.
The 11th Circuit likely will issue its opinion next month.
The Hill reports on the latest developments in the federal government’s vaccine mandate on its workforce.
The Biden administration on Monday asked a federal appeals court to clear a procedural hurdle that remained after a key legal victory last week and allow the administration to quickly resume enforcement of its COVID-19 vaccine mandate for federal employees.
The request to the U.S. Court of Appeals for the 5th Circuit, if granted, would effectively reinstate the public health policy after it was put on hold across the country in January by a federal judge in Texas.
* * *
The administration’s request Monday would move up the timeline for the panel’s judgment to take effect, which is currently not set to occur until May 31.
From the SDOH front, Health Payer Intelligence informs us
UnitedHealthcare announced that it will expand a program to advance maternal health equity in for minority communities in North Carolina.
“Access to quality maternal health care will help close the gap on health inequity in our state,” said Anita Bachmann, chief executive officer of UnitedHealthcare Community Plan of North Carolina. “We are honored to partner with Mountain Area Health Education Center and SistasCaring4Sistas of North Carolina to address disparities and outcomes with the expanded doula program.”
The payer partnered with the community-based organization SistasCaring4Sistas to expand access to the organization’s program, Doulas for Social Justice.
From the Aduhelm front, Fierce Healthcare reports on payers’ cheerful reaction to last week’s CMS Medicare coverage decision of that expensive drug only at the clinical trial level. “We appreciate that when these treatments receive an accelerated FDA approval, Medicare will cover for patients in [Food and Drug Administration] or [National Institutes of Health] approved trials,” according to a statement from insurance lobbying group AHIP.”
From the miscellany department
The Wall Street Journal reports about “New apps and telehealth services [that] are providing women in middle age more access to health expertise, education and support to help them during menopause [such as MenoLife].”
The Department of Health and Human Services shares Secretary Becerra’s remarks at the White House Medical Debt Event with Vice President Harris. Here is a link to the Administration’s fact sheet describing new actions to lessen the burden of medical debt and increase consumer protection. According to the fact sheet,
These actions will help:
Hold medical providers and debt collectors accountable for harmful practices;
Reduce the role that medical debt plays in determining whether Americans can access credit – which will open up new opportunities for people with medical debt to buy a home or get a small business loan;
Help over half a million of low-income American veterans get their medical debt forgiven; and,
Inform consumers of their rights.
Medpage offers an interesting account of how a doctor is trying to make sure that his patients get the medical screening tests that they need.
Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here are the FEHBlog’s weekly charts of new Covid cases and deaths from the 27th week of 2021, a low points of cases and death, and the 14th week of 2022, another lull but not quite as low.
The CDC’s Weekly Review of its COVID statistics issued today notes “The current 7-day daily average for March 30–April 5, 2022, was 1,406. This is a 10.3% decrease from the prior 7-day average (1,567) from March 23–29, 2022.”
Here’s the FEHBlog’s weekly chart of Covid vaccinations administered and distributed since the beginning of the Covid vaccination era through this week, again using Thursday as the first day of the week.
The administration of Covid vaccines popped us this week. Over 75% of the U.S. population aged 18 and older are fully vaccinated. Nearly half (48.6%) of that cadre is boostered. The Weekly Review’s commentary discusses the importance of vaccinating children.
COVID-19 vaccines have undergone—and continue to undergo—the most intensive safety monitoring in U.S. history, and adverse events are rare. Vaccinating children is the single best way to protect them from severe illness associated with COVID-19.
From Capitol Hill, the Wall Street Journal reports
Senators had also hoped to move forward on the coronavirus vaccines and treatments package, but progress quickly bogged down over Republican efforts to amend the bill to extend a pandemic-era immigration policy called Title 42—which allows Border Patrol agents to quickly turn away migrants at the southern border—with some Democrats siding with the GOP. Senators said they ran out of time, and the break could help end the logjam, even if it means the aid will need to wait at least several weeks.
“We’ll see where the discussions go, but my assumption is during the course of the break they’ll be some conversations between people who are interested in advancing it and see if we can make any headway on coming up with a process,” said Sen. John Thune (R., S.D.) on the Covid aid.
“I don’t think we’re leaving anything hanging up in the air that we’re not going to be able to continue to work with afterwards,” said Sen. Angus King (I., Maine), who caucuses with Democrats.
Congress is on State / District work periods for the next two weeks.
From the Rx coverage front, Health Affairs offers a fascinating article leading with an HHS Inspector General report on biosimilar drug use in the Medicare Part D program. The article blossoms into a broader look at biosimilar use in America. For example,
Last fall, two academics from the USC Schaeffer Center for Health Policy & Economics and the University of Chicago Harris School of Public Policy analyzed the available biosimiliars and found these were, on average, 30% less expensive than the underlying brand-name biologics. This represented a savings of about $665 off the average price.
Perhaps the biggest boost, though, will occur when biosimilar versions of Humira begin entering the U.S. market next year. This is expected to kick-start a wave of increased biosimilar usage between now and 2027, by which time the worldwide market should roughly double to $20 billion, according to Bernstein analyst Ronny Gal.
“The savings we identified with increased biosimilar use, while modest, could be significant once biosimiliar versions of Humira come on the market,” said [Melissa] Baker [from the HHS Office of Inspector Genera]. “Part D spending for Humira is in the billions of dollars.” The HHS OIG report noted that Humira and Enbrel accounted for more than $5 billion in Part D spending and nearly half of Part D spending on biologics in 2019.
From the Aduhelm front, Fierce Healthcare tells us
Leaders of the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) sought to present a united front a day after CMS approved narrow Medicare coverage of the Alzheimer’s disease drug Aduhelm.
FDA Commissioner Robert Califf, M.D., and CMS Administrator Chiquita Brooks-LaSure issued a joint statement Friday to address criticism of CMS’ decision that Medicare only cover Aduhelm and similar products for beneficiaries in a qualifying clinical trial. Critics have charged CMS is trying to undermine the FDA’s approval decisions as the agency cleared the drug last year via accelerated approval.
“The work of both of our agencies is critical to ensure that medical products are available to people across the country,” the agency leaders said in a statement.
From the mental healthcare front, Health Payer Intelligence informs us
CVS Health and its payer arm, Aetna, aimed to make strides in the healthcare industry in 2021 by delivering affordable healthcare services to members, increasing access to virtual and mental healthcare, and implementing initiatives to advance health equity, according to the payer’s 2021 Environmental, Social, and Governance (ESG) report. The report reflects data from January 1 to December 31, 2021.
Well done.
Finally, the FEHBlog ran across this helpful Kaiser Family Foundation preventive services tracker website.
The Affordable Care Act (ACA) requires new private health insurance plans to cover many recommended preventive services without any patient cost-sharing. For adults, the required services are recommended by the U.S. Preventive Services Task Force (USPSTF), the Advisory Committee on Immunization Practices (ACIP), and the Health Resources and Services Administration (HRSA) based on recommendations issued by the Institute of Medicine Committee on Women’s Clinical Preventive Services. As new recommendations are issued or updated, coverage must commence in the next plan year that begins on or after exactly one year from the recommendation’s issue date.
This tracker presents up-to-date information on the adult preventive services nongrandfathered private plans must cover, by condition, including a summary of the recommendation, the target population, the effective date of coverage, and related federal coverage clarifications.
From the Capitol Hill front, today, the Senate took the following action
PN1166: Krista Anne Boyd, of Florida, to be Inspector General, Office of Personnel Management– Considered by Senate.– Confirmed by the Senate by Voice Vote.
And just like that, OPM has a Senate-confirmed Inspector General for the first time in over six years. The FEHBlog wishes Inspector General Boyd good luck.
The President issued a statement on World Health Day, which was celebrated today.
From the Omicron and siblings front —
The Centers for Medicare Services released an updated Toolkit on Covid Vaccines for health insurers and Medicare Advantage plans.
A federal appeals court has reinstated President Biden’s COVID-19 vaccine mandate for the federal workforce, overturning a lower court’s nationwide pause that had been in effect since January.
The plaintiffs who brought their suit over Biden’s executive order did not have standing in the federal circuit, a panel of the U.S Court of Appeals for the Fifth Circuit said in a 2-1 opinion Thursday evening, and instead must pursue their appeals through the Merit Systems Protection Board or Office of Special Counsel as laid out in the Civil Service Reform Act. The court vacated the injunction and instructed the district court in Texas that issued it to dismiss the case upon remand.
Medicare on Thursday finalized its plan to restrict coverage for the controversial, pricey Alzheimer’s drug Aduhelm to patients participating in clinical trials.
The decision marks the end of an intense pressure campaign from drugmakers and some patient groups who wanted Medicare to reverse its initial proposal and pay for the drug for more patients. As clinical trials are usually run out of major medical centers, the decision will likely mean some interested patients won’t be able to access the drug. However, Medicare isn’t explicitly requiring that patients be treated at hospital-based clinics like the initial proposal.
The decision has implications beyond Aduhelm’s manufacturer, Biogen, as well. The coverage decision is not specific to Aduhelm, and applies to all drugs in the class, including a forthcoming treatment that Eli Lilly has begun to submit for FDA approval.
But in a major change from the initial proposal, Medicare officials created a sort of shortcut path for drugs that, unlike Aduhelm, demonstrate a clinical benefit for patients before they are approved. Medicare will cover those medicines for a broader group of patients.
They would still need to collect some data, but the possible design of the studies is much more flexible — a significant win for Lilly.
Here is a link to the CMS fact sheet on this decision.
U.S. News adds “Medicare said Thursday it’s considering a cut in enrollee premiums after officials stuck with an earlier decision to sharply limit coverage for a pricey new Alzheimer’s drug projected to drive up program costs.” Given Medicare’s shaky financial condition, one would expect the government to build up reserves with the additional cash and then adjust the premium for the following Medicare year, taking all considerations into account.
From the No Surprises Act front, AHIP released a new resource reflecting on the first 100 days of the NSA.
From the healthcare business front, Fierce Healthcare informs us
[Blue Cross of California and Walgreen] are launching new Health Corners in 12 Walgreens stores in the San Francisco Bay area and Los Angeles County.
At the Health Corner locations, Blue Shield members and customers will be able to connect with health advisers who can offer simple in-store care as well as assistance with preventive screenings, chronic care management and medications. The health advisers have clinical backgrounds, such as pharmacists or nurse practitioners.
The partnership seemed a natural fit, D.D. Johnice, vice president of the Health Transformation Lab at Blue Shield of California, said in an interview. * * * Some 80% of people in California live within five miles of a Walgreens store, she said, so the Health Corners could be a valuable tool for reaching people who live in healthcare deserts, or more specifically, Blue Shield network deserts.”
Michael F. Neidorff, who as chief executive officer of Centene Corp. transformed a tiny medical insurance firm serving three counties in 1996 into a nationwide giant in government-backed health coverage, died Thursday after what his family described as a long illness. He was 79.
Mr. Neidorff recently took medical leave and had signaled last year a plan to retire in 2022 from the CEO job he held for more than 25 years. Centene announced in March the appointment of Sarah London, who had been vice chairman, to succeed him as CEO.
St. Louis-based Centene is the biggest company in managed Medicaid, contracting with states to provide coverage to people enrolled in the program for lower-income Americans.
Centene offers FEHB HMO coverage through its Health Net subsidiary. RIP.
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.
A long-awaited reform bill that would save the Postal Service more than $100 billion (H.R. 3076) is headed to President Joe Biden’s desk.
The Senate on Tuesday passed the Postal Service Reform Act, which would, among other things, eliminate a 2006 mandate from Congress to pre-fund retiree health benefits.
Postmaster General Louis DeJoy supports the bill, as do postal unions and associations, who say it will address USPS’s long-term financial challenges.
The bill will create a Postal Service Health Benefits Program (PSHBP) within the FEHBP effective January 1, 2025. A recently added feature of the bill creates a transitional Open Season in the fall of 2024. Any Postal employee or annuitant who fails to switch to a PSHBP plan will be added to the rolls of their current carrier’s PSHBP plan. However, the non-selecting Postal employees and annuitants whose current carrier is not participating in the PSHBP will wind up on the rolls of the PSHBP option with the lowest premium that is not a high deductible health plan and does not charge membership dues.
Another new feature of the bill requires the Postal Service to create a Health Benefits Education Program in mid-2023. That HBEP will include ACA navigators. It will be interesting to see, for example, whether the ACA Navigators can hold down the number of non-selecting Postal employees and annuitants in the transitional Open Season.
P.S. For fun, the FEHBlog reviewed the summary of H.R. 3076’s earliest antecedent which was S. 1789 from the 112th Congress titled the 21st Century Postal Service Act of 2012. According to the bill’s summary, this first shot also called for an HBEP. The 2022 twist is the ACA navigator feature in H.R. 3076. More accurately, the FEHBlog should describe these folks as ACA-like navigators.
For perspective on this clarification, NPR Shots discusses the good works of patient navigators in the State of Delaware. These folks have been improving the rates of cancer screenings in underserved communities which in turn has lower cancer mortality rates.
Congressional leaders spent Tuesday afternoon negotiating potential late add-ons to the fiscal 2022 omnibus spending bill, including cybersecurity legislation and a bipartisan deal to revive lapsed Violence Against Women Act authorities, with an eye on releasing final text later that day.
“Republicans and Democrats are very, very close to finalizing the agreement,” Senate Majority Leader Charles E. Schumer, D-N.Y., told reporters Tuesday after Democrats’ early afternoon caucus lunch. “I expect there will be text released in a few hours. And we’re working very hard on a few last-minute issues: cyber and VAWA.”
The schedule leaders are eying would have the House vote on the omnibus Wednesday morning and the Senate clear the measure before stopgap funding expires at midnight Friday. GOP objections to a unanimous consent agreement to speed consideration in the Senate could delay final passage into the weekend, lawmakers warned, but both sides expect the process to be complete in time to avoid a partial government shutdown when federal agencies open Monday.
Lawmakers say they are close to an agreement to provide billions in new coronavirus relief, set to be tied to a massive government funding bill [which step would improve its chances of passage].
Congress is expected to include at least $15 billion in response to the Biden administration’s request for new funding for COVID-19 vaccines, treatments and testing.
Also from Capitol Hill, Congressional Research Service released a report on Health Reimbursement Arrangements, a tool which the Internal Revenue Service created in the early 2000s shortly before Congress added high deductible plans with health savings account to the toolbox in the Medicare Modernization Act of 2003. Nevertheless, HRAs remain handy tools for designing employer sponsored health plans such as those in the FEHBP.
From the Omicron front, the Department of Health and Human Services released a fact sheet about the Administration’s new test to treat program which is launching on a limited basis this week. Here’s a link to the fact sheet. It is evident that these sites will not be using a health department standing order to dispense the Covid medication. Instead
Are pharmacists themselves able to prescribe the oral antiviral pills (Paxlovid and Molnupiravir)?
No. The Test to Treat initiative includes sites that have health care providers available to provide timely and thorough assessment and discussion relevant to oral antiviral treatment option(s) , consistent with FDA requirements regarding these drugs. The Test to Treat initiative does not change existing requirements for a qualified health care provider to write the prescription.
NPR Shots offers more information on the program here.
Biden administration officials say [in the fact sheet] they’ll be launching a “one-stop shop” website later this month, where people will be able to find test-to-treat locations, along with sites where they can get free masks, tests and vaccines.
The test to treat program comes at a time when coronavirus cases are falling steeply in the U.S., and the supply of Pfizer’s Paxlovid pill is ramping up. These are good trends, but it’s not a time to be complacent, says Dr. James Hildreth, president and CEO of Meharry Medical College: “The virus is not done with us yet, right? And, if we do have another surge, having a system like this in place could have a huge impact on controlling it.”
Hildreth says the program holds a lot of promise — so long as it expands its outreach to rural communities, indigenous groups, and other marginalized high-risk people that need it the most.
The National Institutes of Health discusses an NIH funded research finding that the immune response from Covid vaccines improves for months after vaccination.
Govexec tells us “A federal appeals court on Tuesday appeared open to reinstating President Biden’s COVID-19 vaccine mandate, suggesting a lower court’s pause may have been overly broad.” Govexec based its view on the oral argument held before a panel of judges from the U.S. Court of Appeals for the Fifth Circuit in case calling into question the nationwide scope of the injunction created by the district court. The panel should issue its decision later this month.
Two key topics have dominated the industry conversation amid the COVID-19 pandemic: health equity and the role of technology.
But these are not distinct entities, insurance executives said Monday at the inaugural ViVE Conference in Miami, and it’s necessary to find the intersection, or “techquity.” It’s critical, they argued, that technology be viewed through an equity lens to ensure that access is fair and that the tools on offer are working for a diverse array of patients.
The national conversation about disparities, however, has helped enshrine equity as a key part of the technology conversation, said U. Michael Currie, senior vice president and chief health equity officer at Optum and UnitedHealth Group, on a panel at the conference.
and
Health tech veteran Jennifer Schneider, M.D., helped build up chronic condition management startup Livongo, then helped lead the company through a massive IPO and the industry’s largest merger with Teladoc.
Schneider and other Livongo veterans are reuniting and taking on their next challenge—improving rural healthcare.
The executive team, including Amar Kendale, former chief product officer at Livongo, and Bimal Shah, M.D., former chief medical officer at Livongo, announced Monday the launch of Homeward, a startup focused on improving access to high-quality, affordable primary and specialty care in rural communities.
George Washington was born in Virginia on February 11, 1731, according to the then-used Julian calendar. In 1752, however, Britain and all its colonies adopted the Gregorian calendar which moved Washington’s birthday a year and 11 days to February 22, 1732.
Americans celebrated Washington’s Birthday long before Congress declared it a federal holiday. The centennial of his birth prompted festivities nationally and Congress established a Joint Committee to arrange for the occasion.
Washington’s Birthday was celebrated [as a federal holiday] on February 22nd [from 1879] until well into the 20th Century. However, in 1968 Congress passed the Monday Holiday Law to “provide uniform annual observances of certain legal public holidays on Mondays.” By creating more 3-day weekends, Congress hoped to “bring substantial benefits to both the spiritual and economic life of the Nation.”
One of the provisions of this act changed the observance of Washington’s Birthday from February 22nd to the third Monday in February. Ironically, this guaranteed that the holiday would never be celebrated on Washington’s actual birthday, as the third Monday in February cannot fall any later than February 21.
Contrary to popular belief, neither Congress nor the President has ever stipulated that the name of the holiday observed as Washington’s Birthday be changed to “President’s Day.”
Average daily COVID-19 cases and hospitalizations are continuing to fall in the U.S., providing a signal that the Omicron variant is receding across the country.
* * *
Deaths are also beginning to decline, with an average of about 2,100 daily, according to the data tracker from The New York Times. More than 2,500 daily deaths were being reported in early February.
The Omicron sublineage BA.2, which raised alarms because of its transmission advantage, accounts for just 4% of cases in the U.S., and experts suggested it’s not likely to reverse the current downward trend of cases overall.
BA.2 has certainly increased in prevalence, but its been a slow trajectory, according to CDC data. BA.1.1, another Omicron sublineage, actually became the dominant strain in the U.S. in mid-January, the agency reported, with the original lineage, B.1.1.529, currently accounting for about 23% of U.S. cases.
“The BA.2 Omicron variant is increasing in prevalence slowly in both CDC and private data,” tweeted Scott Gottlieb, MD, former FDA commissioner and current Pfizer board member. “While it may become a dominant strain in time, it appears increasingly unlikely that it will cause a significant change in the downward trajectory of the current epidemic wave.”
That has certainly been the case for South Africa, where BA.2 accounts for nearly 100% of cases, according to Tulio de Oliveira, PhD, of the Centre for Epidemic Response & Innovation in Stellenbosch.
“This comes on a background of decreasing infections,” de Oliveira tweeted. The country now has a 7-day average of about 2,500 daily infections, down from a peak of about 23,000 in mid-December.
“At present, the Omicron BA.2 is not of great concern in South Africa,” he tweeted. “But our network is following very close and is alerted to its emergence.”
From the Covid vaccination mandate front, the Society for Human Resource Management reports that the U.S. Court of Appeals for the Fifth Circuit ordered the lower court to reconsider whether United Airlines vaccination mandate offered sufficient protection under Tittle VII to religious objectors.
From the No Surprises Act front, the American Hospital Association tells us
The Centers for Medicare & Medicaid Services will host a conference call for health care providers Feb. 23 at 2 p.m. ET on the No Surprises Act’s continuity of care, provider directory and public disclosure requirements. To participate in the Special Open Door Forum, dial 888-455-1397 and reference passcode 5109694. Slides for the call are available here. Participants may email questions in advance to Provider_Enforcement@cms.hhs.gov. A recording will be available after the call through Feb. 25 by dialing 866-373-4993.
The cost of being transported by ground ambulance has increased steadily over the past five years, according to a new report from nonprofit Fair Health, threatening patients with few protections from balance billing in disputes between insurers and ambulance providers.
More ambulance trips are billing payers for advanced life support ( ALS), denoting a higher level of care (and reimbursement) than basic life support (BLS) services. Private insurers’ average payments for those trips increased 56% between 2017 and 2020, from $486 to $758, according to the analysis. Before accounting for discounts negotiated with payers, the rate that ambulance operators charged for trips jumped 23% in the same time period and now average almost $1,300.
However, the average reimbursement for advanced life support ambulance rides climbed by 5% for patients covered by Medicare, from $441 to $463, suggesting the government program is keeping a lid on rising costs.
Although at this point only air ambulance charges are subject to the No Surprises Act, this type of report could lead Congress to expand the law to include ground ambulance charges.
From the medical research front, Biopharma Dive informs us
Eli Lilly is again upping its investment in genetic medicine, announcing Tuesday plans to establish a Boston research center that will use RNA- and DNA-based technologies to develop new drugs.
The Lilly Institute for Genetic Medicine will take up 334,000 square feet in Boston’s Seaport neighborhood, with occupancy slated to begin in 2024. Lilly, which has earmarked around $700 million for the project, expects the institute to grow from 120 employees to 250 within five years. Roles will include data scientists, chemists and research biologists with expertise in genetic medicine.
Alongside drug development, the institute will take a page from another Lilly venture — Lilly Gateway Labs — and offer shared lab and office space to support biotechnology startups in the area. Use of the shared space, Lilly said, could create as many as 150 additional new jobs once it’s fully occupied.
Women who had ever experienced sexual violence in their lifetime — including sexual assault and workplace sexual harassment — were more likely to develop high blood pressure over a seven-year follow-up period, according to findings from a large, longitudinal study of women in the United States. The research, funded by the National Institutes of Health and published in the Journal of the American Heart Association, indicated that sexual violence was a common experience, affecting more than 20% of the women in the sample.
“Our results showed that women who reported experiencing both sexual assault and workplace sexual harassment had the highest risk of hypertension, suggesting potential compounding effects of multiple sexual violence exposures on women’s cardiovascular health,” said Rebecca B. Lawn, Ph.D.(link is external), of the Harvard T. H. Chan School of Public Health, Boston, lead author on the study.
From the healthcare initiative front, the Centers for Disease Control detailed its Million Hearts 2027 initiative.
From the virtual care front, Healthcare IT News tells us
The American Medical Association, in conjunction with Manatt Health, published a report this week exploring the ways that virtual care and other digital tools can accelerate the adoption of the integrated delivery of behavioral and physical healthcare.
In the report, the organizations note that behavioral health integration is essential for solving the country’s dire need for access to services.
“The demand for behavioral health services is significant and rising, but so is the potential for digital technology to support the integrated delivery of physical and behavioral health services,” said AMA President Dr. Gerald Harmon in a statement.
Moreover, in Health Affairs, the National Coordinator for Health Information Technology Micky Tripathi discusses delivering on the promise of health information technology in 2022.
From the healthcare business front, Healthcare Finance reports
The Department of Justice has until Saturday, February 27 to block the merger between UnitedHealth Group and Change Healthcare, according to a Securities and Exchange Commission filing on February 17.
The filing, by Change, was done in accordance with a timing agreement made with the DOJ. In November 2021, the two companies agreed not to consummate their merger before February 22.
The timing agreement provides the DOJ with 10 days’ notice to sue to block the deal.
“Effective February 17, 2022, UnitedHealth Group and the Company provided such notice to the DOJ,” Change said in the filing. “Accordingly, the DOJ now has until February 27, 2022 to initiate litigation to block the consummation of the merger.”
The DOJ is preparing the lawsuit to block UnitedHealth from purchasing Change, according to Seeking Alpha.
From the awards front
STAT News released its inaugural STATUS List which “recongizes standout individuals in health, medicine, and science. And although there are countless contenders to choose from, we’ve selected just 46 — an homage to the number of chromosomes in human DNA.”
OPM “announceda call for nominations for the 2022 Presidential Rank Awards (PRAs). A Presidential Rank Award is one of the most prestigious awards in the federal career civil service, and these awards are critical to recognizing the hard work and important contributions of dedicated civil servants in the American federal workforce. The awards – which recognize exceptional performance by members of the career Senior Executive Service (SES) and Senior Career Employees – reflect the Biden-Harris Administration’s commitment to supporting the federal workforce and recognizing federal employees who serve with distinction.” The nomination deadline is March 25, 2022.
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