Voice of America’s Asian American Changemakers series premiered its final episode recently, featuring the work of the U.S. Office of Personnel Management and the leadership of Director Kiran Ahuja. Asian American Changemakers is a character-driven docuseries highlighting the lives and experiences of Asian Americans in the political and public arena. * * *
Watch the full Asian American Changemakers episode here and learn more about opportunities to serve at opm.gov.
OPM also informed FEHB carriers that “The recent opinion in Braidwood Management, Inc. v. Becerra, — F. Supp. 3d —, 2023 WL 2703229 (N.D. Tex.), in the U.S. District Court for the Northern District of Texas, pertains to the preventive services requirement under the Affordable Care Act; it does not impact the preventive services requirements for FEHB Carriers.” Regardless, and as the FEHBlog anticipated, writers in Health Affairs suggest sensible administrative law approaches to repairing the Braidwood management problem. For example, “the HHS Secretary could authorize the director of the Agency for Health Care Research and Quality or the CDC director to review and adopt the Task Force’s recommendations, which the CDC director now does before ACIP’s immunization recommendations become effective.” No wonder HHS appealed Braidwood Management to the Fifth Circuit without requesting a stay of the district court’s decision.
In other judicial news, the Washington Post reports
“A federal judge in Texas blocked U.S. government approval of a key abortion medication Friday, siding with abortion foes in an unprecedented lawsuit and potentially upending nationwide access to the pill widely used to terminate pregnancies.
“The highly anticipated ruling puts on hold the Food and Drug Administration’s approval of mifepristone, a medication first cleared for use in the United States in 2000. The ruling will not go into effect for seven days to give the government time to appeal.”
Later today, per the AP, “A federal judge in Washington state on Friday ordered U.S. authorities not to make any changes that would restrict access to the abortion medication mifepristone in 17 Democratic-led states that sued over the issue, countering a ruling by a judge in Texas on the same day that ordered a hold on federal approval of the drug.”
From the healthcare of the near future front —
Medscape relates
“US regulators may soon clear blood-based biomarker tests for colorectal cancer (CRC), expanding potential options for patients seeking more convenient forms of screening.
“Most recently, Guardant Health, Inc., announced the completion of its US premarket approval application for its Shield blood test to screen for CRC. Approval by the US Food and Drug Administration (FDA) would position Guardant to later secure Medicare coverage for its test.
“Rival companies, including CellMax Life, Freenome, and Exact Sciences, which already offers the stool-based Cologuard product, are pursuing similar paths in their development of blood tests for CRC.
I”f these companies succeed, clinicians and patients could have a choice of several FDA-approved tests in a few years.”
A Wall Street Journal essay digs into why “doctors are turning to artificial intelligence to help them make the best decisions for patients.
From the public health front –
Fierce Healthcare informs us “Black mothers living in the least vulnerable areas of the U.S. are more likely to die or have worse birth outcomes compared to white mothers living in the most vulnerable areas, a sweeping new study has found.”
Fierce Healthcare tells us “Reports of serious patient safety events among healthcare facilities in 2022 rose 19% from 2021 with falls, the most common such event, rising nearly 27%, according to data reported to The Joint Commission and released Tuesday.”
Today is National Employee Benefits Day, a celebration created by the International Foundation of Employee Benefit Plans.
From inside the Capital Beltway —
OPM issued a press release on its interim final rule concerning Postal Service Health Benefits Program implementation. That IFR was published in the Federal Register today.
Federal News Network reports that members of Congress are pressuring OPM to fix the consistent delays in processing federal employee retirement applications. The straightest path to solving the delay problem is reconfiguring or replacing the current Federal Employee Retirement System that replaced an even more complex Civil Service Retirement System prospectively in the mid-1980s. That is Congress’s responsibility.
Govexec tells us that “The Internal Revenue Service will bring on about 30,000 employees over the next two years as it begins spending the $80 billion in new funds Congress provided last year, the Biden administration said in an operational plan it unveiled on Thursday.”
On Thursday, President Biden signed an executive order to improve the effectiveness of the regulatory review process and regulatory analysis, which implements his Day One memo.
“Parts of the federal regulatory review process haven’t been updated since the 1990s, and since then, we’ve seen substantial advances in scientific and economic knowledge,” wrote Richard Revesz, administrator of the Office of Information and Regulatory Affairs, in a blog post. “These new steps will produce a more efficient, effective regulatory review process that will help improve people’s lives—from protecting children from harmful toxins and lowering everyday costs for families to improving rail safety and growing our economy from the middle out and bottom up.”
Health and Human Services’ highly publicized list of the first Medicare Part B prescription drugs hit with rebates under the Inflation Reduction Act discreetly dropped from 27 to 20, prompting critiques from the pharma lobby over the Biden administration’s swift implementation of the legislation’s drug controls.
As spotted by Endpoints, the press release and accompanying guidelines released by HHS were updated on March 30 with the removal of several previously listed drugs: Gilead’s Yescarta and Tecartus, Bausch + Lomb’s Xipere, Acrotech Biopharma’s Folotyn, Shionogi’s Fetroja, Kamada’s WinRho and Stemline Therapeutics’ Elzonris.
Abbott has initiated a recall for [4.2 million] reader [devices] for its FreeStyle Libre glucose monitoring systems, which are at risk of catching fire if improperly stored or charged, according to the Food and Drug Administration.
The agency categorized the recall as Class I, the most serious category of problems with medical devices, which can cause serious injury or death. Abbott noted that users do not need to send the devices back to the company but can continue to use them as long as they use chargers and cables supplied by Abbott with the device. * * *
The company has set up a special website with more information for people who use the FreeStyle glucose readers.
Abbott said that users can replace the reader with a smartphone app.
The FDA withdrew its approval of Makena, the only preterm birth drug greenlit by the agency, on April 6 after research showed the treatment did not work better than a placebo.
The repealed approval follows an FDA advisory panel voting in favor of removing Makena and the drugmaker announcing it would halt sales.
Mark Cuban Cost Plus Drug Co. now sells more brand-name drugs.
After breaking into the brand-name market in March — over a year since launching its online wholesaler company — Cost Plus Drugs offers three brand-name products made by Janssen, a Johnson & Johnson business. Cost Plus Drugs sells about 1,000 generics and four brand-name drugs.
The three products are Invokana (canagliflozin), Invokamet (canagliflozin-metformin HCl) and Invokamet XR (canagliflozin-metformin HCl), according to a Cost Plus Drugs tweet.
One of them, Invokana, is a Type 2 diabetes drug that typically costs more than $675, according to Cost Plus Drugs’ website. Mr. Cuban’s company’s price is $243.90.
In the first year of the COVID-19 pandemic, 2 US studies suggested that people hospitalized for COVID-19 had nearly 5 times the risk of 30-day mortality compared with those hospitalized for seasonal influenza.1,2 Since then, much has changed, including SARS-CoV-2 itself, clinical care, and population-level immunity; mortality from influenza may have also changed. This study assessed whether COVID-19 remains associated with higher risk of death compared with seasonal influenza in fall-winter 2022-2023.
[Based on an examination of Veterans Administration electronic health records] there were 8996 hospitalizations (538 deaths [5.98%] within 30 days) for COVID-19 and 2403 hospitalizations (76 deaths [3.16%]) for seasonal influenza (Table). After propensity score weighting, the 2 groups were well balanced (mean age, 73 years; 95% male).
The death rate at 30 days was 5.97% for COVID-19 and 3.75% for influenza, with an excess death rate of 2.23% (95% CI, 1.32%-3.13%) (Figure). Compared with hospitalization for influenza, hospitalization for COVID-19 was associated with a higher risk of death (hazard ratio, 1.61 [95% CI, 1.29-2.02]).
The risk of death decreased with the number of COVID-19 vaccinations (P = .009 for interaction between unvaccinated and vaccinated; P < .001 for interaction between unvaccinated and boosted). No statistically significant interactions were observed across other subgroups
The U.S. Preventive Services Task Force released its final research plan for “Vitamin D, Calcium, or Combined Supplementation for the Primary Prevention of Falls and Fractures in Community-Dwelling Adults: Preventive Medication.”
Community-Dwelling means “Community and primary care–relevant settings, including assisted and independent living facilities,” but not inpatient, SNF, or rehabilitation settings.
The average out-of-pocket spending per non-birth-related pediatric hospitalization was $1,313 for privately insured children, but spending varied depending on the time of the year, chronic condition prevalence, and plan generosity, a study published in JAMA Pediatrics found.
Non-birth-related pediatric hospitalizations occur 2.5 million times per year and can lead to high medical costs for privately insured families.
Researchers used claims data from 2017 to 2019 from the IBM MarketScan Commercial Database to assess out-of-pocket spending for these hospitalizations and which factors influence this spending.
findings showing more U.S. employers are looking to steer employees to affordable, quality care options as a way to combat rising medical costs and improve health outcomes.
Aon’s 2022 Health Care Survey outlines employer priorities in health and benefits strategies and shows how they are responding to looming health care inflation, which Aon forecasts to rise 6.5% this year to more than $13,800 per employee on average.
Data show employers are eager to steer participants toward high-quality, cost-effective hospitals and physicians using a combination of narrow network strategies, plan design, provider guidance services and financial incentives. Thirty-seven percent of employers said they were interested in using plan design to steer members to optimal providers, while 35% already have these plan design features in place.
Fierce Healthcare interviews a WTW expert about ways employers can control rising healthcare costs.
Last June, the major tracker of inflation—the Consumer Price Index—hit 9.1% but has been receding ever since. Employers should be aware that the healthcare industry will not see a similar reduction in prices and, in fact, should expect costs to rise substantially, according to an expert at Willis Towers Watson.
Tim Stawicki, a WTW senior health and benefits consultant, said in a recent blog post that a different dynamic will function in the healthcare industry because contracts lock in negotiated prices, usually for one to three years.
When those contracts end, providers will want to make up for profits they may feel that they missed out on, and that’s especially the case in the wake of the COVID-19 pandemic. * * *
Stawicki advised employers that they can avoid the worst of this fallout through better management of utilization and reviewing physician networks to make sure that they coincide with an employer’s coverage area that may have changed because of COVID-19. In addition, employers should try to improve the employee experience and implement more cost-effective points of care by steering individuals to urgent care centers or making it easier to use virtual care and choose provider networks based on their geographic footprint.
Govexec and the Federal Times report about yesterday’s release of OPM’s Postal Service Health Benefits Program interim final rule.
Fedweek offers interesting observations on the federal workforce demographics:
“For years, [federal agencies] focused on the “retirement wave”—or still more sweeping, the “retirement tsunami”—when the Baby Boom population hit retirement eligibility. That view continues today, with the constant repetition of statistics such as that 15 percent of the federal workforce is already eligible to retire, and that in five years 30 percent of current employees will be eligible.
“That wave never happened and there is no reason to believe it will.
“What has actually happened is that federal retirements have been a fairly steady flow at around 60,000 to 70,000 each year from agencies apart from the Postal Service (which accounts for about 40,000 more on average). That’s around 3 percent per year, so when it’s five years later, 15 percent or so already have retired and there’s still only 15 percent who are eligible.
“Since those first soundings about a retirement wave, the workforce actually has been increasing in age. The average is now 47—five years older than the overall U.S. workforce—with about 28.7 percent age 55 or above, up by a half-point just in the last six years. The percentage aged 60 and older—which more or less equates to retirement eligibility—rose from 9.4 to 14.5 percent over the last 15 years.”
This is the demographic challenge facing the FEHB Program which is ameliorated by the coordination of benefits with Medicare beginning at age 65. OPM improved the opportunities for coordination of benefits with Medicare by allowing carriers to integrate Medicare Part D prescription drug plans for 2024.
From the public health front —
Dana Farber Cancer Institute offers insights into which States have the highest cancer rates.
The Department of Human Services announced making progress in the “whole of government” response to long Covid.
STAT News tells us about the debate over universal infant screening for cytomegalovirus (CMV).
“[E]xperts say there is little public awareness about CMV compared to other viral infections that can infect a fetus in utero, such as HIV, Zika, and toxoplasmosis, all of which are far rarer than CMV infections. Professional societies recommend pre-pregnancy counseling and monitoring for HIV, butnot for CMV. And testing for the infection in newborns isn’t widespread.”[E]xperts say there is little public awareness about CMV compared to other viral infections that can infect a fetus in utero, such as HIV, Zika, and toxoplasmosis, all of which are far rarer than CMV infections. Professional societies recommend pre-pregnancy counseling and monitoring for HIV, butnot for CMV. And testing for the infection in newborns isn’t widespread.
“Through my entire career, it’s been so clear that this field is really lacking in progress,” said Laura Gibson, an infectious diseases physician at UMass Memorial Health. “It’s just been frustrating to all of us in the field over decades.”
“That is starting to change, as state public health committees and legislatures begin to debate whether to mandate doing more robust screening for CMV. In 2019, Ontario became the first region in the world to test every baby for CMV. This year, Minnesota followed suit.”
“Obesity and diabetes in mothers have traditionally been considered risk factors for the child to also develop obesity. But a new study suggests that more narrow measures of health during pregnancy could help better assess that risk.
“Researchers grouped pregnant women based on specific metabolic traits and found that insulin resistance was associated with the highest risk, compared with other traits such as high cholesterol and triglycerides, according to a study published in JAMA Network Open on Tuesday.
“The risk linked to insulin resistance was even higher than that associated with prepregnancy obesity, defined as a body mass index over 30, and with diabetes diagnosed in gestation, the study said.”
From the Rx coverage front —
AHIP offers a new resource that “highlights how biosimilars offer an effective, lower-cost alternative to a brand name biologic product. In the last 10 years, for example, $36 billion of biosimilar medication spending was associated with $56 billion in savings. And savings from biosimilars are expected to exceed $180 billion over the next 5 years — a more than 4-fold increase from the last 5 years.”
STAT News reports on cancer drug shortages that have plagued our country for years.
From the telehealth front, mhealth intelligence informs us that “According to the FAIR Health Monthly Telehealth Regional tracker, telehealth use increased [7.3%] across the country in January, with rates rising at the national level and in all US Census regions.” My word, telehealth use increased in the winter?!?
Finally, in Medicare Advantage and Part D News, CMS lowered the boom on Medicare Advantage and Part D plans with a new final rule to “strengthen Medicare Advantage and hold health insurance companies to higher standards for America’s seniors and people with disabilities by cracking down on misleading marketing schemes by Medicare Advantage plans, Part D plans and their downstream entities; removing barriers to care created by complex coverage criteria and utilization management; and expanding access to behavioral health care.” This action follows a payment policy and risk adjustment rule compromise last week.
Last Friday, OPM released to FEHB carriers its technical guidance supporting its call letter for 2024 benefit and rate proposals.
Federal News Network offers a long look at OPM’s process to implement the Postal Service Health Benefits Program.
OPM and AHIP will hold their annual conference for FEHB carriers on Wednesday and Thursday this week. The agenda can be found here. The 2024 call letter and PSHBP implementation are agenda topics.
Millions of diabetes cases may be missed under the current U.S. screening guidelines, especially among Asian Americans, according to a new study. A better way to test for the condition would be to leave body weight out of it, the researchers suggest.
Current guidelines from the U.S. Preventive Services Task Force recommend screening adults ages 35-70 who are considered overweight or obese (having a body mass index over 25).
However, racial and ethnic minority groups, especially Asian people, tend to develop diabetes at lower BMIs, so to identify more people with the condition across groups, all adults ages 35-70 regardless of their weight should be screened, researchers said in a study Friday in the American Journal of Preventive Medicine.
NPR Shots also invites us to meet the amazing “glass-half-full girl” whose brain was rewired as an infant after losing the left hemisphere.
In most people, speech and language live in the brain’s left hemisphere. Mora Leeb is not most people.
When she was 9 months old, surgeons removed the left side of her brain. Yet at 15, Mora plays soccer, tells jokes, gets her nails done, and, in many ways, lives the life of a typical teenager.
“I can be described as a glass-half-full girl,” she says, pronouncing each word carefully and without inflection. Her slow, cadence-free speech is one sign of a brain that has had to reorganize its language circuits.
Yet to a remarkable degree, Mora’s right hemisphere has taken on jobs usually done on the left side. It’s an extreme version of brain plasticity, the process that allows a brain to modify its connections to adapt to new circumstances.
Because it’s Sunday, here are two opinion pieces
The New York Times shares expert opinions on preparedness for the next pandemic.
Three professors of surgery at the University of California Medical Center defend the current United Network for Organ Sharing (UNOS).
As a private, nonprofit organization under contract with the federal government to manage the national organ transplant system, UNOS spearheads the complex, multidisciplinary organ procurement, matching, and delivery processes. With its contract up for renewal this spring, UNOS has come under heavy scrutiny, including in a recent guest column published in the New York Times, in which UNOS and other system organizations’ performances were blamed for the death of a kidney transplant candidate. This is just one example in a series of accusations made across news media, social media, and even in Congress.
Painting with such a broad and biased stroke creates an unfair representation of our highly nuanced organ transplant system and the people who run it. As transplant surgeons with a long history of involvement with the system — including one of us (Roberts) serving as a past Board President of UNOS/Organ Procurement and Transplantation Network (OPTN) — we have intimate knowledge of both its successes and its shortcomings. While UNOS has room to improve operationally — and is working to do so — we clearly see the organization’s life-changing results in our operating rooms and offices. More work lies ahead, however, such as addressing the fact that a rising number of organs are recovered but not transplanted.
Fedweek reports on Postal Services Health Benefit Program developments. The headline is that OPM expects “lots of questions” about the new program, which will launch in 2025. The good news for OPM and everyone effect affected is that the law requires the Postal Service to stand up a PSHBP education program this summer, which includes PSHBP navigators similar to the approach taken with the ACA marketplace.
FedWeek also tells us that the U.S. Court of Appeals for the D.C. Circuit rejected on procedural grounds a federal employee challenge to the Biden Administration’s Covid vaccine mandate for federal employees. The mandate has been blocked by a preliminary injunction in another federal judicial circuit. In any event, the vaccine mandates will end on May 12, the day after the Covid public health emergencies end.
A key Senate committee advanced legislation to ban pharmacy benefit manager tactics, such as spread pricing and clawback fees, and heighten transparency of the industry.
The Senate Commerce Committee passed the PBM Transparency Act of 2023 by a vote of 18 to 9 on Wednesday, advancing the reform legislation to the full Senate. Lawmakers said the legislation is meant to address a source of unfair and deceptive practices that increase drug prices.
Senators Chuck Grassley (R Iowa) and Maggie Hanson (D NH) have “introduced the Healthy Moms and Babies Act to improve maternal and child health care. The United States has a maternal health crisis that particularly affects women of color and those living in rural America. The Healthy Moms and Babies Act would achieve its goal by
Coordinating and providing “whole-person” care, supporting outcome-focused and community-based prevention, and supporting stillbirth prevention activities and expanding the maternal health workforce.
Modernizing maternal health care through telehealth to support women of color and women living in rural America.
Reducing maternal mortality and high-risk pregnancies including C-section births, and improving our understanding of social determinants of health in pregnant and postpartum women.
The future of Alzheimer’s treatments and coverage hung heavily over lawmakers’ Wednesday [March 22 Senate Finance Committee] hearing with Health and Human Services Secretary Xavier Becerra.
Dotted throughout the hearing room for Becerra’s testimony on the president’s proposed health care budget for 2024 were purple-clad advocates for Alzheimer’s disease treatments, who Democrats and Republicans alike acknowledged repeatedly throughout the hearing. But while senators from both parties pushed for speedy approvals and Medicare coverage of new drugs for the disease, they unsurprisingly diverged on how to manage the costs.
At the center of discussions was a controversial Medicare decision, last year, not to cover Biogen’s Aduhelm except through clinical trials, a decision later extended to Eisai’s Leqembi. The Food and Drug Administration approved both via the accelerated pathway, with limited data on either drug’s effectiveness. The drugmakers are required to follow up with more extensive data proving each medicine’s benefit.
CMS expects to revisit this Medicare decision publicly this summer.
For about an hour and a half on March 22, four pharmaceutical supply experts outlined ideas to lawmakers to reform the nation’s slippery access to critical drugs.
The FDA reports 130 drugs are currently in shortage; the American Society of Health-System Pharmacists says there are 302. Recently, the availability of vital drugs for cancer patients and emergencies has shrunk, and the closure of a U.S. drugmaker could put more out of stock.
The hearing waded through causes of shortages — including manufacturing delays and opaque supply data. Some members on the Senate Committee on Homeland Security and Governmental Affairs pushed back on some pitched solutions, such as changing FDA practices and working to control drug prices.
In 2022, the number of new drug shortages increased by 30 percent, according to a report released by the Senate Committee on Homeland Security and Governmental Affairs hours before the hearing began.
“Colleagues and other hospitals have asked me to respond to the never-ending game of drug shortage Whac-A-Mole,” Andrew Shuman, MD, chief of the clinical ethics service center for bioethics and social sciences in medicine for the University of Michigan Medical School in Ann Arbor, said during the hearing.
The House Ways and Means Committee’s Health subcommittee held a hearing yesterday on healthcare costs. The American Hospital Association submitted a letter to the subcommittee that “shared how rising labor and other costs for hospitals and health systems are exacerbating workforce shortages and delaying patient access to care.”
Looking forward, Mercer Consulting identifies innovation in cancer treatment and prevention as the next frontier and McKinsey and Co. explores the pharmacy of the future.
“Use of nirmatrelvir-ritonavir (Paxlovid) in older adults with risk factors for severe disease was associated with a roughly 25% lower risk of a post-COVID condition (PCC), a retrospective study of Veterans Affairs data showed.
“In the cohort of over 280,000 patients with a confirmed COVID case, 13% of those prescribed nirmatrelvir-ritonavir went on to develop a PCC over the following 6 months compared with 18% of those who were not prescribed the antiviral (relative risk [RR] 0.74, 95% CI 0.72-0.77), Ziyad Al-Aly, MD, of the VA St. Louis Health Care System in St. Louis, and colleagues reported.” Fehblog observation: Go Paxlovid!
42% of adults in the U.S. are living with obesity, meaning they have a body mass index of 30 or higher, according to an analysis from NORC at the University of Chicago.
Researchers used 2013 to 2021 data from the CDC’s Behavioral Risk Factor Surveillance System to estimate obesity rates at the national and state level. To account for any reporting biases in the BMI measure, NORC adjusted BMI distribution to that of the National Health and Nutrition Examination Survey for corresponding time periods. NORC also created an interactive map to present its findings.
The article lists estimated state obesity rates for 2019 to 2021, ranked from highest (Mississippi – 51%) to lowest (Colorado 34%). FEHBlog observation At least one-third of every state’s population is morbidly obese, and yet we wonder why the life expectancy of Americans is dropping.
For women who are overdue for cervical cancer screening, mailing self-sampling kits for high-risk human papillomavirus (HPV) is a cost-effective means of increasing screening uptake, reveals an analysis of a large US trial.
The finding comes from a randomized trial in almost 20,000 women, which compared women who received a mailed HPV testing kit with those who did not. The results show that mailing was most cost-effective in women aged 50-64 years and in those who were only recently overdue for cervical screening.
The study was published by JAMA Network Open on March 22.
“These results support mailing HPV kits as an efficient outreach strategy for increasing screening rates in US health care systems,” say the authors, led by Rachel L. Winer, PhD, MPH, Department of Epidemiology, University of Washington School of Public Health, Seattle, Washington. (FEHBlog observation: Good idea.)
From the OPM front, Federal News Efforts lays out the OPM issues raised by the House Oversight Accountability Committee, including an FEHB improper payments issue.
The Federal Employees Health Benefits (FEHB) Program came under scrutiny during the committee hearing. Several members pointed to a report from the Government Accountability Office showing that OPM spends about $1 billion annually on ineligible FEHB members.
Without a monitoring mechanism to identify and remove ineligible members from FEHB, GAO said these costs will keep accruing.
“GAO’s report suggests OPM has been aware of this problem for years but has consistently failed to address it effectively. As GAO recounts, OPM acknowledged the possibility of a problem when it issued regulations in 2018 allowing agencies and participating insurers to request proof of eligibility for federal employees’ family members. OPM did not, however, actually require proof of eligibility,” Chairman James Comer (R-Ky.) said in a Jan. 23 letter to Ahuja.
In response to the concerns, Ahuja said during the hearing that OPM is working on creating a master enrollment index (MEI) — essentially a roster of FEHB subscribers and family members. The creation of an MEI has been in the works in OPM’s FEHB department for at least the last couple of years.
“We have been focused on this issue,” Ahuja said. “It’s a very decentralized health benefits program. We’ve been working with agencies and carriers to be able to ensure that we manage any ineligibility.”
Ahuja said the index will help clear up discrepancies in FEHB enrollment between both agencies and health carriers.
“That’s going to be a way forward,” she said.
With all due respect to the Director, the key problem is that OPM has never provided FEHB carriers with an enrollment roster that ties individuals to premiums paid for (and by) them. Until carriers can reconcile premiums with enrollment, the Master Enrollment Index remains flawed
HIPAA offers a widely used “820” electronic transaction standard for this purpose. In a perfect world, OPM would have rolled out the use of the 820 transactions to allow carriers to clean their enrollment records. It’s not too late, and doing so should be prioritized over the family member issue and centralization.
Family member eligibility is a secondary issue because 48% of FEHB enrollment is self-only, and the FEHB Program family member size averages under three people. The family member eligibility issue can be addressed with surveys based on statistical sampling rather than the entire enrollment of eligible family members.
The private sector uses the HIPAA 820, and randomized family member eligibility audits to keep enrollment records accurate.
From the CMS front, the American Hospital Association tells us that following up on U.S. District Judge Jeremy Kernodle’s February 6, 2023, revisions to the No Surprises Act’s (NSA) independent dispute resolution/arbitration rule:
The Centers for Medicare & Medicaid Services today instructed certified independent dispute resolution entities to resume making payment determinations for disputes involving items or services furnished on or after Oct. 25, 2022. Updated guidance to disputing parties regarding disputes involving items and services furnished on or after Oct. 25, 2022 is posted here. CMS also announced that starting March 17, disputing parties will begin receiving a majority of their payment determination notices from the IDR portal, specifically from auto-reply-federalidrquestions@cms.hhs.gov. Disputing parties are advised to make note of this email address.
The FEHBlog finds it mysterious that this guidance is coming from CMS when Medicare and Medicaid are exempt from the NSA.
In other CMS news
The Centers for Medicare & Medicaid Services will make whole health care providers impacted by lowered coinsurance on 27 Medicare Part B prescription drugs. The reduced coinsurance rates, which are required by the Inflation Reduction Act, take effect April 1 and will remain in effect through June 30. CMS in a fact sheet says it will pay impacted health care providers the difference between the full and reduced adjusted beneficiary coinsurance (in addition to their usual payment), after applying the Part B deductible and prior to sequestration, if applicable.
That’s good news because other FEHB and other plans providing secondary coverage would be picking up that cost.
In conference news, Fierce Healthcare discusses policy presentations from HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-Lasure at an AHIP conference and health and medtech presentations from the South by Southwest conference in Austin.
Improving the mental health workforce shortage is one of the Substance Abuse and Mental Health Services Administration’s top priorities right now, said Miriam Delphin-Rittmon, assistant secretary for mental health and substance use at HHS and the administrator of SAMHSA. To tackle this, the organization has several resources and grant programs in place to recruit more providers and support primary care physicians in treating mental health.
Each of these conferences was held this week.
From the public health front, CMS’s biweekly review of its Covid statisticstells us
As we mark three years of the COVID-19 pandemic, cases, deaths, and hospitalizations have all been decreasing steadily. Much of the U.S. population has some form of immunity, either through vaccination or previous infection. In addition, CDC’s 2023 Child and Adolescent Immunization Schedule now includes COVID-19 primary vaccine series and links to the latest guidance on booster dose vaccination in all populations.
The Wall Street Journal offers former CDC Director Tom Frieden view on the past three pandemic years.
The CDC’s Fluview continues to report “Seasonal influenza activity remains low nationally.”
The New York Times highlights a recent breakthrough in stroke treatment. The article reports that this breakthrough allowed John Fetterman to be a U.S. Senator from Pennsylvania. Here’s the catch.
There’s a number that floats around in medicine: It takes, on average, 17 years for a new treatment or technique, or some other form of research breakthrough, to filter down into widespread clinical practice. But the actual timeline varies widely from case to case. “What everybody’s trying to do is speed up that process,” says Dr. Sharon Straus, the director of the Knowledge Translation Program at St. Michael’s Hospital in Toronto. (“Knowledge translation” is one of several terms for a young, multidisciplinary field that aims to better understand and improve the medical research-to-practice pipeline.) “Some things do take off more quickly.”
That number of years is sobering. Good luck, Dr. Straus.
In FSAFeds news, the Internal Revenue Service issued FAQs addressing “whether certain costs related to nutrition, wellness, and general health are medical expenses under section 213 of the Internal Revenue Code (Code) that may be paid or reimbursed under a health savings account (HSA), health flexible spending arrangement (FSA), Archer medical savings account (Archer MSA), or health reimbursement arrangement (HRA).”
The Wall Street Journal reported this morning that maternal mortality cases in the U.S. spiked in 2021, rising from around 850 to 1200 nationwide. From examining Journal reader comments, the FEHBlog ran across a helpful breakdown of maternal deaths per U.S. state. The lowest maternal death rate is in California, and the highest maternal death rate is in Louisiana. The breakdown points out what the States with the lowest rates are doing right and what the States with the highest rates are doing to remedy the problem. Healthcare is local.
The FEHBlog also was directed to this article from the T.H. Chan public health school at Harvard:
October 21, 2022 – Women in the U.S. who are pregnant or who have recently given birth are more likely to be murdered than to die from obstetric causes—and these homicides are linked to a deadly mix of intimate partner violence and firearms, according to researchers from Harvard T.H. Chan School of Public Health.
Homicide deaths among pregnant women are more prevalent than deaths from hypertensive disorders, hemorrhage, or sepsis, wrote Rebecca Lawn, postdoctoral research fellow, and Karestan Koenen, professor of psychiatric epidemiology, in an October 19 editorial in the journal BMJ.
The U.S. has a higher prevalence of intimate partner violence than comparable countries, such violence is often fatal, and it frequently involves guns, Lawn and Koenen noted. They cited one study that found that, from 2009–2019, 68% of pregnancy-related homicides involved firearms. That study also found that Black women face substantially higher risk of being killed than white or Hispanic women.
I also located the CDC’s website on keeping new mothers alive.
This evening the Journal discussed why our country’s maternal mortality rate is so high.
Finally, STAT News reports that this afternoon the Centers for Disease Control announced preliminary 2022 maternal mortality figures.
Deaths of pregnant women in the U.S. fell in 2022, dropping significantly from a six-decade high during the pandemic, new data suggests.
More than 1,200 U.S. women died in 2021 during pregnancy or shortly after childbirth, according to a final tally released Thursday by the Centers for Disease Control and Prevention. In 2022, there were 733 maternal deaths, according to preliminary agency data, though the final number is likely to be higher.
Officials say the 2022 maternal death rate is on track to get close to pre-pandemic levels. But that’s not great: The rate before Covid-19 was the highest it had been in decades.
The CDC counts women who die while pregnant, during childbirth, and up to 42 days after birth. Excessive bleeding, blood vessel blockages, and infections are leading causes.
Covid-19 can be particularly dangerous to pregnant women, and experts believe it was the main reason for the 2021 spike. Burned out physicians may have added to the risk by ignoring pregnant women’s worries, some advocates said.
In 2021, there were about 33 maternal deaths for every 100,000 live births. The last time the government recorded a rate that high was 1964.
What happened “isn’t that hard to explain,” said Eugene Declercq, a long-time maternal mortality researcher at Boston University. “The surge was Covid-related.”
The FEHBlog’s goal is to provide perspective on this vital issue.
From the Omicron and siblings front, MedPage Today informs us
An FDA panel recommended the agency grant full approval to nirmatrelvir-ritonavir (Paxlovid) for treating high-risk COVID-19.
By a vote of 16-1 on Thursday, the Antimicrobial Drugs Advisory Committee said the totality of evidence supports the traditional approval of the oral antiviral, which has been widely used since late 2021 under an emergency use authorization to reduce the risk of hospitalization or death in outpatients at risk for severe outcomes.
“Besides oxygen, Paxlovid has probably been the single most important treatment tool in this epidemic, and it continues to be,” said Richard Murphy, MD, MPH, of the White River Junction VA Medical Center in Hartford, Vermont.
The Mercer consulting firm considers employer approaches to coverage of Covid tests following the end of the public health emergency.
Employers have some important decisions to make over the next two months before the COVID Public Health Emergency (PHE) comes to an end on May 11. One is how to handle cost-sharing for PCR and other COVID tests and related services provided by a licensed healthcare or otherwise authorized provider. Under the PHE, group health plans had to cover testing received either in- or out-of-network at no cost to participants.
We recently polled recipients of our New Shape of Work newsletter to ask whether they planned to impose cost-sharing requirements once allowed. Of the more than 1,000 readers who responded, about half indicated that their organization will not make any change when the PHE ends: 22% will continue to cover PCR testing at 100% both in- and out-of-network, and 29% say that they require COVID testing at their worksites and provide it at no cost. Only about a fourth (26%) will now require cost-sharing from participants even when they use an in-network facility for testing; about another fourth (23%) will add a cost-sharing requirement only for out-of-network services.
Personally, the FEHBlog would opt for restoring a cost-sharing requirement only for out-of-network services.
From the Rx coverage front
STAT News tells us, “Following the lead of its rivals, Sanofi will cut the price of its most widely prescribed insulin in the U.S. by 78% and also place a $35 cap on out-of-pocket costs for commercially insured patients who take the treatment, which is called Lantus. The moves will go into effect on Jan. 1, 2024.”
The Mercer consulting firm offers its perspective on coverage of the new era of weight loss drugs, e.g., Ozempic.
For plans covering weight-loss medications, adding prior authorization criteria can help manage cost growth. These include requirements such as a certain body mass index (BMI), co-morbid conditions, enrollment in a behavior modification program, and/or reduced calorie diet. Upon initiation of therapy, patients and clinicians should partner to create a comprehensive plan to achieve goals and use the medication purposefully alongside a targeted and managed lifestyle program. The plan should include a discussion regarding medication discontinuation when/if goals are met to prevent relapse and weight regain/ weight cycling. Medical nutrition therapy (MNT) with a registered dietitian should be covered; ideally 14 in-person or telenutrition sessions.
Cognitive-behavioral therapy, self-monitoring, motivational interviewing, structured meal plans, portion control and goal setting are recommended interventions. Ideally, patients would progress from dietary intervention (covered MNT or weight management solution), to weight loss medications, and then, potentially, to bariatric surgery.
In recognition of Patient Safety Awareness Week, the Partnership to Fight Infectious Disease announced, making March 18 a day of action to raise awareness of the need to #squashsuperbugs so that we can all do our part to prepare and perhaps even prevent a future pandemic due to antibiotic resistance.
From the No Surprises Act front, Fierce Healthcare reports
An “astronomical” number of surprise billing arbitration dispute cases is impacting the Centers for Medicare & Medicaid Services (CMS), a top agency official said.
Education and communication are integral to an “orderly transition” in the handling of independent dispute resolutions for out-of-pocket charges, the official said. The agency has grappled with legal issues and implementation hiccups surrounding a controversial process for settling feuds between payers and providers on out-of-network charges.
“We are seeing more than expected number of disputes getting to that last stopgap part, which is the independent dispute resolution part,” said Ellen Montz, director of CMS’ Center for Consumer Information and Insurance Oversight. Montz spoke during a session Wednesday at the AHIP Medicare, Medicaid, Duals & Commercial Markets Forum in Washington, D.C.
The agency is also seeing a lot of ineligible cases that don’t qualify for the dispute resolution process, which requires a third party to choose between out-of-network charges submitted by the payer and provider.
These ineligible cases require “a lot of casework, phone calls and back and forth to determine eligibility,” Montz said.
The group that advises Congress on Medicare policy is recommending updating base physician payment rates by 1.45% for 2024, according to its annual March report out Wednesday.
The Medicare Advisory Payment Commission, or MedPAC, did not make recommendations for ambulatory surgery center payment updates or for Medicare Advantage plans.
The commission did note concern with MA plan coding intensity, and said Medicare now spends more on MA enrollees than it would have spent had those enrollees remained in fee-for-service plans.
The FEHBlog doubts that this MedPAC report made anyone happy.
From the federal employee benefits front, FedWeek reminds folks that while the dependent care flexible spending accounts available to federal employees typically are used for child care, they also can be used for senior care in certain circumstances.
From the federal employment front, Govexec tells us
The Biden administration is looking to add 82,000 employees in fiscal 2024, a 3.6% increase that would bring civilian federal rolls to their highest levels since World War II.
Nearly every federal agency would receive a funding boost in President Biden’s fiscal 2024 budget, and all but one major agency is anticipating adding staff as a result. Some of the hiring is still aimed at making up for losses sustained during Obama-era budget caps and Trump-era targeted reductions, though much of it is for implementing major new initiatives Biden has ushered into law like the Inflation Reduction Act and the bipartisan infrastructure measure Congress approved in 2021.
“As we release the President’s FY 2024 Budget, we are proud of the mission-driven investments it makes in the federal government’s most important asset—our people,” Office of Management and Budget Deputy Director for Management Jason Miller and Office of Personnel Management Director Kiran Ahuja said in a [Performance.gov] blog post Monday.
From the end of the public health emergency front, Health Payer Intelligence reports
NORC used the Urban Institute’s public health emergency Medicaid coverage loss estimates and historic data from the Current Population Survey (CPS) Annual Social and Economic Supplement (ASEC).
The researchers recategorized the data, taking into account respondents’ coverage type in year one and year two of the transition, supplementing data for smaller states, and applying a hierarchy of coverage types to distribute respondents with multiple coverage sources. When respondents had multiple coverage types, the researchers prioritized first employer-sponsored coverage, then uninsurance, CHIP, nongroup coverage, and other public coverage, respectively.
When the researchers blended these two data sources, the study found that individuals who lose their Medicaid coverage after the end of the public health emergency will transition into employer-sponsored health plans in most states.
More than half of the beneficiaries who lose Medicaid coverage will transition to employer-sponsored health plan coverage in every state except for Georgia (48.9 percent), according to the dashboard associated with the report. The state with the highest share of beneficiaries going into employer-sponsored health plans after the public health emergency was Delaware (57.1 percent).
Because FEHB-eligible annuitants and family members must be on Medicaid, OPM may want to consider sharing information with federal agencies about how this cohort can shift from Medicaid to FEHB and when to apply.
From the Medicare front —
CMS today trumpeted that Medicare Part D members can receive vaccinations without cost sharing. CMS doesn’t mention that commercial plans, including FEHB plans, have offered this opportunity under the Affordable Care Act since 2011. For example, the FEHBlog received a shingles vaccination with no-sharing (in-network) before he went on Medicare (because his company has under 20 employees). He got hit with a $400 Medicare Part D copay when he received the updated shingles shots in 2019. Better late than never because the FEHBlog needs a TDap booster next year.
While Congress emptied this bowl of wrong, Medicare beneficiaries still face a pre-existing condition limitation (except in certain states) if they try to enroll in a Medicare supplement plan after the first opportunity.
CMS announced “27 prescription drugs for which Part B beneficiary coinsurances may be lower from April 1 – June 30, 2023. Thanks to President Biden’s new law to lower prescription drug costs, some people with Medicare who take these drugs may save between $2 and $390 per average dose starting April 1, depending on their individual coverage.” One CMS fact sheet explains how this program works, and another CMS fact sheet lists the 27 drugs, which include Humira. This will reduce FEHB Program spending as a secondary payer for annuitant and eligible family members with primary Part B. In the FEHBlog’s opinion, this program will not generate a dollar-for-dollar cost shift from Medicare to the FEHB cohort without primary Part B due to how the new program is structured.
Looking forward, CMS released its “Initial Guidance for Historic Medicare Drug Price Negotiation Program for Price Applicability Year 2026.” Thanks to OPM’s decision to allow FEHB plans to offer Part D EGWPs in 2024, the FEHB will be advantaged by the Part D savings.
From the public health front, the Alzheimers Association issued
Alzheimer’s Disease Facts and Figures, an annual report released by the Alzheimer’s Association, reveals the burden of Alzheimer’s and dementia on individuals, caregivers, government and the nation’s health care system.
The accompanying special report, The Patient Journey in an Era of New Treatments, examines the importance of conversations about memory at the earliest point of concern, as well as a knowledgeable, accessible care team to diagnose, monitor disease progression and treat when appropriate. This is especially true now, in an era when treatments that change the underlying biology of Alzheimer’s are available.
From the miscellany department –
Forbes informs us that “the U.S. government is suing Rite Aid — accusing the drugstore chain of “knowingly” filling unlawful prescriptions for controlled substances — only adds to the financial and operational woes of the embattled drugstore chain.”
AHIP has added details to the March 29-30 OPM AHIP FEHB Carrier Conference agenda.
The Wall Street Journal reports on yesterday’s abortion pill hearing before a federal judge in Amarillo, Texas. “A federal judge on Wednesday questioned the government about its approval of a medication used in more than half of the abortions in the U.S. but also asked whether there was any precedent for a court blocking sales of a drug long after it had been allowed on the market.” The FEHBlog expects the Court to rule in the federal government’s favor because no such precedent exists.
A ChatGPT update released March 14 has been stunning physicians with its ability to deliver sound medical advice, The New York Times reported.
Anil Gehi, MD, a cardiologist and associate professor of medicine at Chapel Hill, N.C.-based UNC Health, described the health history of a patient, using advanced medical terminology, to the artificial intelligence chatbot and asked it how he should treat the person, according to the March 14 story.
“That is exactly how we treated the patient,” he said of ChatGPT’s answer.
Experts told the newspaper the new GPT-4 technology is more precise, accurate and descriptive than its predecessor, which OpenAI released in November. However, the chatbot is still prone to “hallucination” and making things up.
From our Nation’s capital, OPM released its Fiscal Year 2024 Congressional Budget Justification document, which is part of the federal budget process. Of interest to the FEHBlog is this OPM goal:
Improve customer experience by making it easier for Federal employees, annuitants, and other eligible persons to make a more informed health insurance plan selection.
By September 30, 2023, complete user-centered design and develop a minimum viable product for a new, state-of-the-art Decision Support Tool that will give eligible individuals the necessary information to compare plan benefits, provider networks, prescription costs, and other health information important to them and their families.
Federal News Network tells us about a related Office of Management and Budget analytical perspective on federal workforce issues.
The Office of Management and Budget, in one of its analytical perspectives supplementing the Biden administration’s 2024 budget request, said federal workers’ pay is “increasingly hamstrung” by statutory requirements “that curb the ability of agencies to reward talent, including for specialized occupations, in a national competitive job environment.”
Eisai Co.’s new Alzheimer’s disease drug Leqembi will be covered by the U.S. Department of Veterans Affairs, the first major insurer to agree to pay for the drug since its approval by U.S. regulators earlier this year.
Eisai said Monday veterans with the early stages of Alzheimer’s would get the drug covered under criteria set by the VA.
An estimated 167,954 veterans receiving care through the VA have Alzheimer’s dementia, according to government estimates. To qualify for Leqembi, patients must be over 65, have early-stage symptoms and elevated brain amyloid, sticky protein fragments, which the drug is designed to remove.
STAT News describes the VA’s step as “unexpected,” which is an understatement because CMS does not plan to issue a Medicare national coverage decision until mid-year. STAT News adds
The [VA] published a guide on its formulary saying coverage will extend to any veteran who meets specified criteria, including an MRI scan within the previous year, amyloid PET imaging consistent with Alzheimer’s and a staging test indicating mild Alzheimer’s dementia. There is also a long list of criteria that would exclude veterans.
The agency can negotiate prices for drugs, but the price it will pay for Leqembi was not listed and the Eisai spokesperson did not offer a cost. Leqembi has an annual wholesale price of $26,500, although the Institute for Clinical and Economic Review recently said the treatment should cost between $8,900 and $21,500 per year to be considered cost effective.
Under federal law, the VA can bill other health plans (including FEHB but not Medicare) for non-service related care such as this drug. For this reason, this VA action opens the back door to FEHB coverage of Leqembi.
From the end of the public health emergency front —
The Society for Human Resource Management offers its take on how employers should prepare for the end of the PHE, now less than two months away.
The American Hospital Association points out
The Food and Drug Administration will end 22 COVID-19-related policies when the public health emergency ends May 11 and allow 22 to continue for 180 days, including temporary policies for outsourcing facilities compounding certain drugs for hospitalized patients and non-standard personal protective equipment practices for sterile compounders not registered as outsourcing facilities, the agency announced. FDA plans to retain 24 COVID-19-related policies with “appropriate changes” and four whose duration is not tied to the PHE, including its recently revised policy for COVID-19 tests.
Pfizer has agreed to buy Seattle-based Seagen for $43 billion in a blockbuster deal that would unite the pharmaceutical giant with a biotechnology company that pioneered a new type of tumor-killing medicine.
The acquisition is the largest Pfizer has attempted since its 2009 purchase of Wyeth, and is the most sizable in the drug industry by value since AbbVie’s $63 billion buyout of Allergan in 2019.
Acquiring Seagen gives Pfizer control of the top-selling lymphoma medicine Adcetris as well as a pipeline of cancer treatments that’s yielded three new drug approvals in the past three years. Seagen specializes in a type of cancer therapy known as an antibody-drug conjugate, and has steadily improved on the technology since its founding in 1997.
Sanofi said Monday that it is acquiring Provention Bio, makers of a diabetes treatment, for $2.9 billion.
The Provention drug at the centerpiece of the deal, called TZield, was approved in the U.S. last November as the first and only treatment to prevent the onset of symptomatic Type 1 diabetes. Sanofi was already co-marketing the drug under a prior licensing deal signed between the two companies.
The French pharma giant will now own TZield outright, paying $25 per share to acquire Provention — a 273% premium over Friday’s closing stock price.
In recognition of Patient Safety Awareness Week
The HHS Agency for Healthcare Quality and Research’s Director Robert O. Valdez, Ph.D., M.H.S.A. explains how AHRQ is sharpening its focus on diagnostic safety.
The pediatric mental health crisis is the most pressing patient safety concern in 2023, the Emergency Care Research Institute said on March 13.
The ECRI, which conducts independent medical device evaluations, annually compiles scientific literature and patient safety events, concerns reported to or investigated by the organization, and other data sources to create its top 10 list.
Here are the 10 patient safety concerns for 2023, according to the report:
1. The pediatric mental health crisis
2. Physical and verbal violence against healthcare staff
3. Clinician needs in times of uncertainty surrounding maternal-fetal medicine
4. Impact on clinicians expected to work outside their scope of practice and competencies
5. Delayed identification and treatment of sepsis
6. Consequences of poor care coordination for patients with complex medical conditions
7. Risks of not looking beyond the “five rights” to achieve medication safety
8. Medication errors resulting from inaccurate patient medication lists
9. Accidental administration of neuromuscular blocking agents
10. Preventable harm due to omitted care or treatment
The U.S. Department of Labor announced on March 10
The crowdsourcing will focus on four areas of concern for people with mental health conditions, including benefits policies that meet their needs, access to workplace care and supports, the reduction of related social stigmas, disparities faced by people in underserved communities, shortages of behavioral health professionals, and the establishment of state resource systems.
Part of the department’s ePolicyWorks initiative, the dialogues will remain open until April 3. Input received will inform the next meeting of the Mental Health Matters: National Task Force on Workforce Mental Health Policy
Healthexec calls attention to FDA recalls of certain eyedrops.
From the value-based care front, Health Payer Intelligence notes
CareFirst BlueCross BlueShield (CareFirst) has formed a strategic alliance with Aledade, Inc. (Aledade), offering independent primary care physicians tools and resources to improve healthcare affordability and effectiveness, supporting CareFirst member physicians in achieving value-based care goals.
Through this value-based relationship, CareFirst member physicians can leverage specialists, including onsite business support for physician practices, a technology platform that works with more than 100 different EHRs, and healthcare regulatory and policy expertise.
From the medical debt front, Healthcare Dive reports
Hospitals are a prime source of medical debt in America that hits underserved populations hardest, despite charity care programs and financial assistance policies, according to a new analysis from the Robert Wood Johnson Foundation.
Of the 15% of U.S. adults with past-due medical debt, almost two-thirds owe some or all of that debt to hospitals, according to research from the Urban Institute. That medical debt disproportionately affects underserved populations, such as low-income individuals and people with disabilities, researchers found.
While medical debt remains a persistent financial burden in the U.S., a new analysis from the Urban Institute highlights how targeting hospital billing could ameliorate the problem.
American women are staging a return to the workforce that is helping propel the economy in the face of high inflation and rising interest rates.
Women have gained more jobs than men for four straight months, including in January’s hiring surge, pushing them to hold more than 49.8% of all nonfarm jobs. Female workers last edged higher than men on U.S. payrolls in late2019, before the pandemic sent nearly 12 million women out of jobs, compared with 10 million men.
The Society for Human Resource Management offers five ways employers can reduce gender disparities at work.
Following up on recent posts —
The Wall Street Journal brings us up to date on Lilly’s decision to offer its insulin products on the commercial market with a $35 copayment.
“Lilly comes out the winner of this saga, for now. It dealt PBMs a blow, avoided paying Medicaid rebates that were going to rise next year if its insulin products remained highly-priced, and received plaudits from President Biden. The move also complicates matters for upstarts such as Civica. But Allan Coukell, Civica’s senior vice president of public policy, says plans to introduce low-cost insulin as soon as next year are unchanged.”
Bloomberg offers an article on biological age testing that mentions Elysium Health, whose CEO spoke at the WSJ Health Forum on Monday.
Beckers Hospital Review tells us that the Amoxicillin shortage is continuing. Because Amoxicillin is one of several drug shortages, Pharma News Intelligence offers short-term and long-term management strategies to deal with them.
Last week, the Food and Drug Administration issued an emergency authorization for the first at-home Covid-19 and flu combination test. The news came just days after the test’s maker, Lucira, filed for bankruptcy, blaming the FDA’s “protracted” approval process for its financial problems.
“Now the FDA has released a rare comment clarifying what happened during its authorization process. The new details are raising hopes among other home-test manufacturers that the FDA is becoming more flexible about its requirements for approving at-home flu test kits.”
Beckers Payer Issues informs us,” Providers join payers in urging CMS to halt proposed 2024 Medicare Advantage rates.” Good news for AHIP. Healthcare Dive reviews insurer and trade association comments to CMS on this topic.
The Wall Street Journal highlights the growing backlog of No Surprises Act arbitrations. The silver lining in this cloud is that the litigation-related backup does not impact the law’s Open Negotiation Process. Providers and payers should work to resolve qualifying payment disputes through that effective process.
In other news
JAMA points out a recent CDC report documenting disparities in mental health-related emergency department care.
The Drug Channels blog lists the 15 largest U.S. pharmacies. (Trigger warning the link is principally a sales pitch for Drug Channels, but the information is useful.)
“Abbott received U.S. Food and Drug Administration clearance for what it said will be the first commercially available laboratory blood test to help evaluate traumatic brain injury (TBI), also known as concussion.
“The test offers a result in 18 minutes, allowing clinicians to quickly assess patients with concussion and triage them, the company said Tuesday. A negative test result can rule out the need for a CT scan, eliminating wait time at the hospital.
“The test runs on Abbott’s Alinity i laboratory instrument, making it widely available to U.S. hospitals, the Chicago area-based company said.”
NPR discusses efforts to right various healthcare debt collection wrongs:
“Dozens of advocates for patients and consumers, citing widespread harm caused by medical debt, are pushing the Biden administration to take more aggressive steps to protect Americans from medical bills and debt collectors.
“In letters to the IRS and the Consumer Financial Protection Bureau, the groups call for new federal rules that, among other things, would prohibit debt for medically necessary care from appearing on consumer credit reports.
“And the groups are pressing the IRS to crack down on nonprofit hospital systems that withhold financial assistance from low-income patients or make getting aid cumbersome, another common obstacle KHN documented.”
The House Oversight and Accountability Committee has started an investigation into the role of “pharmacy benefit managers” (PBMs), which act as a middleman between insurance carriers and pharmaceutical companies in healthcare programs, including the FEHB.
“Greater transparency in the PBM industry is vital to determine the impact PBM tactics are having on patients and the pharmaceutical market,” chairman Rep. James Comer, R-Ky., wrote to OPM. He asked for copies of the PBM contracts in the program and information on how they are carried out, as well as for information on the rebates, fees, or other similar charges received by PBMs and any efforts the agency has made to recoup overpayments to them.”
“The use of pharmacy benefit managers has been a long-running issue in the FEHB, with prior proposals—mainly sponsored by Democrats, unsuccessfully—to limit their role or even have OPM negotiate with pharmaceutical companies directly on a program-wide basis.
“The inspector general’s office at OPM also has raised that issue, in a recent report saying that “the discounts and other financial terms differed significantly among carriers, with those that have higher enrollments receiving the best deals, reducing the likelihood that the FEHB is maximizing prescription drug savings.”
“That report recommended that OPM conduct a study on options to hold down prescription drug costs, which account for a quarter of all spending in the FEHB. OPM agreed in principle, although it said it does not have the needed funds to conduct such a study.”
OPM should inform Rep. Comer that
The FEHB Program’s experience-rated carriers, who cover 80% of the FEHB enrollment, are subject to the country’s strictest PBM price transparency arrangement, as far as the FEHBlog knows. Congress should evaluate that system to help the legislative body decide whether transparency should be expanded to ERISA and ACA marketplace plans.
In the late 2010s, OPM announced in a management report that the agency agreed with carriers that the FEHB Program saves money by allowing carriers to manage medical and pharmacy benefits under OPM’s oversight. FEHB plan carrier HealthPartners offers a useful examination of carve-in vs. carve-out Rx program management topics.
OPM has authorized FEHB carriers to offer prescription drug plans integrated with Medicare Part D beginning in 2024. This change will rapidly reduce the FEHB Program’s prescription drug spend to commercial plan levels. It’s not magic.
In sum, the FEHB Program remains a model employer-sponsored health program.
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