Midweek Update

Uncategorized

Midweek Update

David Ermer–Congress, End of the PHE, NE, NCQA, NIH, OPM, Rx coverage, Telehealth, Uncategorized–
Photo by Michele Orallo on Unsplash

From Capitol Hill —

Roll Call reports

  • “The White House and congressional leaders are discussing the duration of appropriations caps and a debt limit raise as staff talks get underway in advance of the next principals meeting on Friday.
  • “A two-year appropriations deal is under consideration, according to sources familiar with the talks, along the lines of three separate laws since 2015 that were paired with suspensions of the debt limit. 
  • “The White House and top Democrats are pushing for two years of debt limit breathing room, as in the 2019 deal cut with former President Donald Trump. That law contained two years of spending caps, which Speaker Kevin McCarthy pointed out as far back as January.
  • “Such an arrangement would, in theory, remove the threat of fiscal cliffs facing lawmakers and the economy until after the 2024 elections.”

Fierce Healthcare tells us,

  • “The Senate Health, Education, Labor and Pensions (HELP) Committee convened the heads of three big pharmas—Eli Lilly CEO David Ricks, Novo Nordisk CEO Lars Fruergaard Jørgensen and Sanofi CEO Paul Hudson—as well as the top brass at the three largest PBMs—CVS Health Executive Vice President and President of Pharmacy Services David Joyner, Express Scripts President Adam Kautzner and OptumRx CEO Heather Cianfrocco.
  • “The legislation on the docket for the HELP Committee aims to inject transparency into the pharmaceutical supply chain as well as increase access to generics. PBM reforms on the table include eliminating spread pricing models as well as clawbacks from pharmacies. * * *
  • “The HELP Committee will convene Thursday to mark up four bills that target drug pricing. Sanders said that while these measures are a priority, there’s more work to be done in addressing this issue. He added that issues with affording drugs are a broader part of the ongoing challenges around affordability in healthcare.”

Tomorrow is the last day of the Covid public health emergency, and today the Department of Health and Human Services posted a fact sheet on how the end of the PHE affects telehealth.

From the Rx coverage front, the Wall Street Journal points out

  • “Advisers to the Food and Drug Administration recommended making an oral contraceptive available without a prescription for the first time, potentially widening access to birth control for women across the country. 
  • “The panel of FDA advisers voted 17 to 0 on Wednesday that there was enough evidence for the agency to approve the medication’s sale over-the-counter. The FDA, which is expected to make a final decision this summer, doesn’t have to follow the expert panel’s advice, though it often does.
  • “The FDA approved the pill, called Opill, for prescription use in 1973. HRA Pharma, owned by Perrigo, a Dublin-based generic drugmaker, submitted its application to make Opill available over-the-counter last July. 
  • “The advisory panel said the benefits of making oral contraceptives available over-the-counter outweighed the risks.”

The cost curve is pointing down.

From the medical research front, the National Institutes of Health updates us on multiple mRNA vaccines that show promise for treating HPV-Related cancers.

From the healthcare quality front, NCQA informs us

  • “We launched our Race and Ethnicity Stratification Learning Network.
  • “The network is a free, interactive, online tool that offers data and best practices to help health plans improve how they collect race and ethnicity data on enrollees.
  • Improving data collection of race and ethnicity data is vital to improving health equity.
  • “The data available in this new resource summarize the care of 20 million people enrolled in 14 health plans that reported results on 5 HEDIS measures, stratified by race and ethnicity.
  • “Best practices we identify come from NCQA’s qualitative interviews of key staff at plans in the learning network.
  • “A report groups our findings in three areas.”

Check it out.

From the federal employment front, the Office of Personnel Management announced

  • released proposed regulations that would prohibit the use of previous salary history in setting pay for federal employment offers. Under the new proposed regulations, federal agencies would not be able to consider an applicant’s salary history when setting pay for new federal employees in the General Schedule pay system, Prevailing Rate pay system, Administrative Appeals Judge pay system, and Administrative Law Judge pay system.  
  • “These proposed regulations are a major step forward that will help make the federal government a national leader in pay equity,” said OPM Director Kiran Ahuja. “Relying on a candidate’s previous salary history can exacerbate preexisting inequality and disproportionally impact women and workers of color. With these proposed regulations, the Biden-Harris Administration is setting the standard and demonstrating to the nation that we mean business when it comes to equality, fairness, and attracting the best talent.” 

Cybersecurity Saturday

David Ermer–Cybersecurity, Uncategorized–

From the cyber breaches front, Health IT Security reports on the latest healthcare breaches.

From the cybersecurity justice front —

The Washington Post informs us,

  • “Former Uber chief security officer Joe Sullivan avoided prison Thursday as he was sentenced for covering up the 2016 theft of company data on 50 million Uber customers while the company was being investigated by the Federal Trade Commission over a previous breach.
  • “Sullivan had been convicted in October of obstruction of justice and hiding a felony, making him the first corporate executive to be found guilty of crimes related to a data breach by outsiders.
  • “U.S. District Judge William Orrick sentenced Sullivan to three years of probation, noting his significant past work in protecting people from the sort of crime he later concealed. He also said that Sullivan’s steps had succeeded in keeping the stolen data from being exposed.
  • “Orrick said he felt former Uber chief executive Travis Kalanick was equally responsible for what he considered a serious offense, and he wondered aloud why Kalanick had not been charged. The judge also said he was influenced by the unprecedented nature of the case, warning that future offenders would be jailed, even if they were the pope.”

Cybersecurity Dive tells us,

  • “A New Jersey appellate court upheld a prior ruling in favor of Merck, a major pharmaceutical company embroiled in a closely watched case involving $1.4 billion in claims stemming from the 2017 NotPetyacyberattack.
  • “The court agreed Monday that insurers could not deny coverage under war exclusion language contained in the policies, saying the circumstances didn’t apply in the Merck case. 
  • “The decision is considered a major victory for companies seeking claims for cyberattacks at a time when hackers linked to rogue nation-states have stepped up threat activity through supply chain attacks, ransomware and other malicious threats.”

From the cyber vulnerabilities front, the Cybersecurity and Infrastructure Security Administration added three more known exploited vulnerabilities to its catalog.

Cybersecurity Dive points out “three areas of generative AI the NSA is watching in cybersecurity.
Generative AI is a “technological explosion,” NSA Cybersecurity Director Rob Joyce said. While it is a game-changing technology, it hasn’t delivered quite yet.”

From the ransomware front —

Cyberscoop relates that “Victims’ reluctance to report ransomware stymies efforts to curb cyberattacks, say federal officials. Federal officials say they need more victims to report when they’ve been hit by ransomware in order to better defend against the problem.”

Here is a link to Bleeping Computer’s latest Week in Ransomware.

  • “This week’s ransomware news has been dominated by a Royal ransomware attack on the City of Dallas that took down part of the IT infrastructure.
  • “The attack occurred early Monday, affecting the Dallas Police dispatch system and the public library’s computer network. Additional systems, including the City’s website, were shut down as time passed.
  • “On Wednesday, the City’s network printers began printing ransom notes from the attack. BleepingComputer obtained a screenshot of this note, allowing us to identify that the Royal ransomware operation was behind the attack.”

From the cyber defenses front, Cybersecurity Dive notes

  • “Google rolled out a feature Wednesday that allows account holders to create passkeys, part of a wider move to phase out passwords across the industry.
  • “Passkeys are stored on local computers or mobile devices, reducing the risk of credentials being hacked through a phishing attack. Passkeys allow users to sign into apps and sites the same way as they would access their devices, such as a face scan or fingerprint. 
  • “Dashlane separately announced a feature called passwordless login on Wednesday, which means users of the password manager will no longer need to create a master password to access the service.”

Friday Factoids

David Ermer–CDC, COVID-19, End of the PHE, NE, Mental health care, U.S. Healthcare, Uncategorized–
Photo by Sincerely Media on Unsplash

From Washington DC —

  • The Wall Street Journal reports
    • “Rochelle Walensky will be stepping down as director of the Centers for Disease Control and Prevention in June, the agency said Friday.
    • “Dr. Walensky decided to step aside, after more than two years in the job, as the Biden administration prepares to end the national health emergency around Covid-19 next week and just hours after the World Health Organization declared the crisis was over.
    • “Her departure is another indication the U.S. is moving into a new phase of its response to the virus, which health experts say is still a threat but not spreading like it had, and hospitalizations and deaths are nearing new lows.”
  • The Washington Post adds
    • “Neera Tanden will replace Susan Rice as head of President Biden’s Domestic Policy Council, the White House announced Friday, becoming the first Asian American to serve in the role.
    • “I am pleased to announce that Neera Tanden will continue to drive the formulation and implementation of my domestic policy, from economic mobility and racial equity to health care, immigration and education,” Biden said in a statement.
    • “Tanden, 52, has served as senior adviser and staff secretary to Biden since 2021, overseeing aspects of the president’s domestic, economic and national security teams. Tanden also held policy advising positions in the Clinton and Obama administrations, and was the former president of the Center for American Progress, a liberal think tank.”

From the public health front —

  • The Wall Street Journal informs us,
    • “The World Health Organization declared an end to the Covid-19 emergency, signaling that one of the most deadly and economically devastating pandemics in modern history is receding as the disease that caused it becomes a routine illness. 
    • “Covid-19 is here to stay, but the pandemic has been in a downward trend for more than a year because people around the world have built up immunity to the virus, the WHO said on Friday. Mortality has decreased, and there is less pressure on health systems. The trends have enabled most countries to return to prepandemic life, even as Covid-19 continues to spread.
    • “It’s therefore with great hope that I declare Covid-19 over as a global health emergency,” said WHO Director-General Tedros Adhanom Ghebreyesus.
  • Here are links to the CDC’s Covid Data Tracker and Weekly Fluview which continue to support the ending of U.S. Covid public health emergency next Thursday, May 11.
  • U.S. News and World Report ranks U.S. states by mental health depression rates.
    • “Around 1 in 5 American adults have dealt with a form of depression, with data also indicating symptoms are most prevalent among young adults and women.
    • “According to the most recent survey data collected through the Behavior Risk Factor Surveillance System, which is administered by the Centers for Disease Control and Prevention, a median of about 21% of the U.S. adult population in 2021 had ever been told they have a form of depression. That’s the highest the share has been in comparative data collected since 2011.”
  • NBC News points out that
    • “Prolonged and unexplained bouts of diarrhea, stomachaches and spots of blood during bowel movements may be signs of early-onset colorectal cancer — a disease that’s increasingly found in young adults not old enough to qualify for colonoscopies.
    • “The most troubling early symptom is rectal bleeding, a possible sign of colon cancer that’s not comfortably discussed beyond the bathroom.
    • “It can be difficult or embarrassing to talk about,” said Dr. Matthew Kalady, the director of the division of colon and rectal surgery at the Ohio State University Comprehensive Cancer Center. “But the reality is everybody deals with something like this,” and it’s important to understand what’s normal and what’s not, he said.
    • “The new research from Washington University School of Medicine in St. Louis, published Thursday in the Journal of the National Cancer Institute, included 5,075 people with early-onset colorectal cancer.”

From the U.S. healthcare business front —

  • Healthcare Dive tells us,
    • “Cigna Group raised its full-year guidance for adjusted earnings per share, revenue and customer growth as it reported first-quarter results Friday, including total revenue up 6% year over year at $46.5 billion. The insurer’s net income, at $1.3 billion, increased from $1.2 billion in the year-ago period. 
    • “Cigna posted a medical loss ratio of 81.3%, down from 81.5% in the prior-year quarter and better than internal expectations. This was partly based on lower COVID-19 costs. Claims for COVID, flu and respiratory syncytial virus were lower than expected in the quarter while non-viral care needs were more normalized, executives said on a call with investors Friday. * * *
    • “In discussing pharmacy benefit management arm Express Scripts, executives said they are aware of public and political pressure to lower drug costs, but are prepared to adapt as needed. “We are confident in our ability to earn sustainable and attractive margins for our services under a variety of legislative scenarios,” [CEO David] Cordani said.”
  • Fierce Healthcare relates that
    • “Option Care Health, a provider of post-acute care and infusion services, will shell out $3.6 billion to acquire home health and hospice firm Amedisys.
    • “The deal will create a massive provider of post-acute care services encompassing more than 16,500 employees and 674 care centers in 46 U.S. states, with a projected $6.2 billion in annual revenue. The combination of the two will enable the companies to beef up capabilities and expand their footprints as care options increasingly move into patients’ homes.
    • “Combining Amedisys’ home health, hospice, palliative and high-acuity care services with Option Care Health’s home and alternate site infusion services will create a leading independent platform for home and alternate site care, according to the executives in a press release.”

Thursday Miscellany

David Ermer–CDC, COVID-19, Mental health care, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From the public health front —

  • MedPage Today tells us
    • “COVID-19 dropped to the fourth leading cause of death in 2022, down from third place in 2020 and 2021, according to provisional mortality data from the CDC.
    • “Taking its place was “unintentional injury,” which followed heart disease and cancer as the longstanding top killers, reported Farida B. Ahmad, MPH, and colleagues in Morbidity and Mortality Weekly Report (MMWR).”
  • The New York Time reports
    • “Births and pregnancies in the United States have been on a long-term decline. A new data analysis provides one reason: It’s becoming less common for women to get pregnant when they don’t want to be.
    • “The analysis, released Thursday in the journal Demography by researchers at the Guttmacher Institute, estimates the number of pregnancies in the United States — there is no single official count — and examines women’s feelings about the timing of their pregnancies.” 
  • The New York Times Morning column points out that state legislatures are embracing harm avoidance approaches to drug addiction. ” The approach focuses on mitigating the potential dangers of drugs, not necessarily encouraging users to abstain, e.g., legalizing fentanyl testing strips.”

From the mental healthcare front —

  • The Department of Health and Human Service recognizes “this Mental Health Awareness Month, [by] bringing attention to mental health and how essential it is to overall health and wellbeing [via] a fact sheet providing a snapshot of various efforts made by HHS over the past year.
  • Per Govexec,
    • “The Office of Personnel Management encouraged agencies to highlight the variety of mental health resources available to federal employees, and highlighted a new interagency effort to connect feds with mental health-related tools and events.
    • “In a memo to agency heads marking the start of Mental Health Awareness Month, OPM Director Kiran Ahuja said protecting the physical and mental well-being of federal workers is a “top priority” for the administration.
    • “We encourage agency leaders to remind employees about the importance of cultivating healthy wellness habits, which include caring for one’s mental health on a proactive rather than reactive basis,” she wrote. “Initiating regular conversations surrounding mental and emotional well-being is instrumental in normalizing and destigmatizing receiving mental health treatment and fostering a healthier workforce.”
    • “Ahuja said a new interagency listserv called Mindful Fed will offer tools and activities that federal employees can use to maintain their mental health. * * *
    • “Federal workers seeking to join the new listserv can email Mindful-FED-subscribe-request@listserv.gsa.gov, Ahuja wrote.”

From the U.S healthcare business front —

Healthcare Dive informs us,

  • Hospital margins continued to stabilize in March, but remained razor thin as inflation drove up supply and drug costs, according to Kaufman Hall’s national hospital flash report.
  • Hospitals reported flat median year-to-date operating margins, an improvement from almost a year of negative margins, according to the report.
  • “While it appears that hospital finances are stabilizing, that doesn’t mean that all is well,” said Erik Swanson, senior vice president of Data and Analytics with Kaufman Hall, in a statement.
  • Expenses, driven by economic inflation, hampered hospitals and outpaced a 24% month-over-month increase in profitability and a 12% increase in revenue.

and

  • “U.S. telehealth use totaled 5.5% of medical claim lines in February, a drop of 6.8% from January, according to Fair Health’s monthly telehealth tracker.
  • “In February, telehealth use declined in the four U.S. census regions: It dropHelaped by 8.7% in the Midwest, 8.3% in the South, 6.2% in the West and 1.5% in the Northeast.
  • “COVID-19 dropped out of the top five telehealth diagnoses nationally. The top diagnosis on telehealth claim lines was mental health conditions.”

From the miscellany front —

  • Fierce Healthcare relates, “It’s official: Medicare Advantage (MA) enrollment accounts for just over half of all Medicare beneficiaries, according to a new analysis from the Kaiser Family Foundation.”
  • Healthcare Innovation tells us,
    • “A year ago, officials from the Center for Medicare and Medicaid Services unveiled a National Quality Strategy. In a May 1 update on the strategy, CMS officials discussed several goals, including annually increasing the percentage of digital measures used in CMS quality programs. CMS officials also said the organization would build one or more quality data systems that can receive data using the FHIR data standard by 2027.”
  • The Segal consulting firm offers a five step strategy for improving wellness programs.
  • Mercer Consulting delves into employer health benefit planning ideas for 2024.

Friday Factoids

David Ermer–CDC, Congress, COVID-19, FDA, Mental health care, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sincerely Media on Unsplash

From the public health front —

  • Here are links to the CDC’s Covid Daily Tracker and its Fluview. It turns out that the CDC is planning one more issue of its Covid statistics review on May 12. All signs continue to support ending the PHE on May 11.
  • ABC News reports on the latest results of the Youth Risk Behavior Survey, published Thursday by the Centers for Disease Control and Prevention.
  • The GAO issued a report on government efforts to curb antibiotic resistance. The Wall Street Journal adds
    • A bipartisan group of U.S. senators and representatives introduced legislation aimed at encouraging drugmakers to develop antibiotics and antifungal drugs to address a growing public health threat. 
    • Bills that lawmakers proposed in the House and Senate on Thursday would commit $6 billion to purchasing new drugs to treat drug-resistant bacteria and fungi that federal officials designate as critically important targets. 
    • Nearly three million people in the U.S. are infected each year with bacteria immune to many antibiotics, the Centers for Disease Control and Prevention said. Some 35,000 of them die. The manufacturers of some promising antibiotics have gone bankrupt because sales of drugs needed only in emergencies are small, public-health experts said. Many big pharmaceutical companies got out of the antibiotic business years ago. 
  • The Hill tells us,
    • A record-low number of adults reported cigarette use in 2022, while reported usage of electronic cigarettes rose among adults. 
    • Preliminary survey results from the Centers for Disease Control and Prevention (CDC) found just 11 percent of American adults — or about 1 in 9 — reported they are smokers, which is a drop from 12.5 percent reported in 2020 and 2021. 
    • The new data, which is based on responses from 27,000 adults, captured an uptick in e-cigarette use among adults, from 4.5 percent who reported use in 2021 to 6 percent in 2022.
  • Fierce Pharma informs us.
    • With its next-generation pneumococcal vaccine, Pfizer has been playing catch-up with Merck in the indication’s key age group—infants. Thursday, Pfizer got to the finish line 10 months after its rival, but with a shot that offers more protection.
    • The FDA approval of Prevnar 20 covers children ages 6 weeks to 17 years and gives Pfizer a chance to continue to control a market it has dominated for two decades.
    • Prevnar 20 is Pfizer’s follow-on to Prevnar 13, offering protection against seven additional serotypes. Merck’s next-gen shot, Vaxneuvance, is a 15-valent vaccine.
    • In the U.S., the seven additional serotypes covered by Prevnar 20 have shown to be associated with antibiotic resistance and heightened disease severity, according to Pfizer. In children five and younger, the seven serotypes account for 37% of the incidence of pneumococcal disease.
  • STAT News points out
    • “To equip both clinicians and patients with the tools to prevent these [maternal health] tragedies, a group of experts * * * have developed a new, evidence-based preventive care plan for those who are at moderate to high risk of preeclampsia, a pregnancy complication that can drive blood pressure dangerously high and is a leading cause of maternal and infant deaths. The care plan, published Friday in the American Journal of Obstetrics and Gynecology, recommends a range of interventions to lower a patient’s risk, including at-home blood pressure checks, treatments like low-dose aspirin, and continuing to take any other needed heart medication, which people are often wary to do when pregnant. The plan also includes lifestyle recommendations for patients like eating a Mediterranean diet, exercising, and getting at least 7 hours of sleep per night.”

From the U.S. healthcare business front —

  • BioPharma Dive report
    • “AbbVie withstood the first months of U.S. copycat competition to its lucrative arthritis drug Humira about as Wall Street had expected, conceding on price to maintain insurance coverage in response to Amgen launching the country’s first biosimilar rival in January.
    • “U.S. Humira sales totaled nearly $3 billion, a decline of 26% from the same period one year ago and just over analysts’ consensus forecasts. AbbVie executives told investors on a Thursday conference call that most of that impact was driven by price changes.
    • “Amgen, which recorded $51 million in U.S. revenue for its biosimilar Amjevita, is selling its Humira rival at two different prices: a 5% discount to Humira’s nearly $90,000 annual list price, and a 55% discount. The approach is meant to address the unique demands of the U.S. healthcare system, in which insurers rely on manufacturers providing rebates off of a drug’s sticker price.”
  • Becker’s Health IT provides more details about this week’s Kaiser Permanente deal with Geisinger, while Beckers ASC Review explores Optum’s physician acquisition strategy.

Tuesday’s Tidbits

David Ermer–End of the PHE, NE, Medicare, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From the U.S. healthcare business front —

  • STAT News reports
    • “UnitedHealth Group has acquired Crystal Run Healthcare, a prominent physician group in New York.
    • “The deal for Crystal Run, a network of almost 400 doctors, nurse practitioners, and other clinicians, closed in late February. There was no fanfare. Neither company issued a press release. The deal only came to light from an email obtained by the Mid-Hudson News.
    • “The move brings yet another large group of providers into UnitedHealth, which had more than 70,000 employed clinicians at the end of 2022. UnitedHealth is most-known for its health insurance arm, UnitedHealthcare. But the company has made a concerted effort over the past several years to buy physician groups, surgery centers, and other outpatient providers, and then funnel its insurance members to those entities as a way to keep more of the insurance premiums.”
  • Health Payer Intelligence tells us “58% of Payers Use Outcomes-Based Contracts for Prescription Drugs; While 10 percent of payers had between two and five outcomes-based contracts in place in 2022, 35 percent had 10 or more contracts.”
  • Fierce Healthcare relates “Evernorth’s Accredo specialty pharmacy arm has rolled out a new program that aims to assist members and plan sponsors in better managing the cost and complexity of therapies for rare conditions.”
  • Health Payer Intelligence reports
    • “Aetna launched a partnership with a virtual care company to provide chronic disease management for members with digestive issues.
    • “Aetna’s partner offers a virtual care platform dedicated to digestive health called Oshi.
    • “Oshi’s virtual-first, integrated approach to GI care aligns with our mission to invest in companies that are improving health for more people,” said Vijay Patel, managing partner at CVS Health Ventures. “Our collaboration with Oshi is a powerful example of how our investments in high-potential, early-stage companies are helping to make consumer health care more accessible, affordable and simpler.”
  • STAT News helpfully delves into the topic of how much a Medicare increase do hospitals need for the next federal fiscal year? It’s an enlightening read.

Sermonette — The squib from the lead story about UHG’s acquisition of Crystal Run ends with a cheap shot at the profit motive. As the FEHBlog noted at the time the ACA imposed the medical loss ratio on insurers, insurers will find a way to circumvent the MLR with other products which are not so limited. In this case, UHG has pulled a page out of Kaiser Permanente’s successful and admirable approach of pairing a medical group with a health plan to improve healthcare quality over time. Both the profit motive and the achieving quality goals underlie these business combinations, which the ACA’s MLR and other features invented.

From the end of the public health emergency front, the American Hospital Association informs us

  • “HIPAA enforcement discretion implemented for the COVID-19 public health emergency will expire with the end of the PHE on May 11, but covered health care providers will have until Aug. 9 to comply with the HIPAA rules with respect to telehealth, the Department of Health and Human Services’ Office for Civil Rights announced today.”
  • “OCR is continuing to support the use of telehealth after the public health emergency by providing a transition period for health care providers to make any changes to their operations that are needed to provide telehealth in a private and secure manner in compliance with the HIPAA Rules,” explained OCR Director Melanie Fontes Rainer.
  • “OCR in 2020 implemented enforcement discretion policies under HIPAA and the Health Information Technology for Economic and Clinical Health Act for community-based testing sites; telehealth remote communications; use and disclosure of protected health information by business associates; and online scheduling for COVID-19 vaccination.”

Here is a link to the notice.

From the COB with Medicare front, here is a link to a March 29 CMS Webinar for group health plans on Section 111 compliance. Speaker notes can be found at the end of the slides.

Thursday Miscellany

David Ermer–CMS, COVID-19, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

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.”
  • Govexec further informs us that
    • 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.”

From the Rx and medical devices coverage front

  • Fierce Healthcare reports
    • 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.
  • MedTech Dive reports
    • 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. 
  • Beckers Hospital Review relates
    • 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. 
  • Beckers Pharmacy News tells us
    • 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. 

From the public health front —

  • JAMA announced the following study results
    • 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.

From the healthcare spending front —

  • Health Payer Intelligence reports
    • 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.
  • Aon released on April 5
    • 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.

Weekend Update

David Ermer–Uncategorized–
Bluebonnets / The Texas State Flower

The House of Representatives and the Senate are on District / State work breaks for the next two weeks.

OMB’s Office of Information and Regulatory Affairs concluded on March 29 its work on OPM’s Postal Service Health Benefits Program interim final implementation rule. The rule will be published in the Federal Register this week.

On Friday, the Justice Department noticed an appeal to the U.S. Court of Appeals for the Fifth Circuit from the Northern District of Texas’s ruling on the role of USPSTF in the ACA preventive services mandate provision. The motion to stay is stepping up the plate.

From the Omicron and siblings front, Fortune Well discusses a new Omicron variant.

XBB.1.16, dubbed “Arcturus” by variant trackers, is very similar to U.S. dominant “Kraken” XBB.1.5—the most transmissible COVID variant yet, Maria Van Kerkhove, COVID-19 technical lead for the WHO, said earlier this week at a news conference. 

But additional mutations in the virus’s spike protein, which attaches to and infects human cells, has the potential to make the variant more infectious and even cause more severe disease. For this reason, and due to rising cases in the East, XBB.1.16 is considered “one to watch,” Van Kerkhove says.

It’s a warning we’ve heard before about other Omicron spawn—XBB.1.5 in particular. The variant, which rose to prominence late last year and early this year, elicited warnings that it could cause more severe disease, based on new mutations it had developed. 

It was a fate that didn’t play out—though the variant certainly took the lead when it came to transmissibility. XBB.1.5 accounted for just under half of all globally sequenced cases in early March, according to the WHO.

Only time will tell when it comes to what, if any, differences in severity XB.1.16 will display. Mutations that seem concerning in theory aren’t always concerning in real life because of the highly complex nature of population immunity.

The FEHBlog does plan to lose sleep over XB1.16.

In other public health news, the American Medical Association identifies six things that doctors wish their patient knew about better nutrition.

From the end of the public health emergency front, Healthcare Dive is following the unwinding of the great Medicaid expansion that occurred during the pandemic.

In the U.S. healthcare business news, Healthcare Dive tells us

  • Uber Health is foraying deeper into healthcare with a new feature that allows providers to order prescriptions to be dropped off at patients homes same-day.
  • The same-day prescription delivery is meant to help patients adhere to a medication schedule, Uber said Thursday. The service is made possible through an integration of Uber Health’s dashboard with ScriptDrop, a tech platform connecting patients and pharmacies with couriers nationwide.
  • The company also said it expects to soon launch delivery of healthy food and over-the-counter medicine for patients, including Medicare Advantage and Medicaid beneficiaries.

In OPM news, the agency per Govexec “on Friday published new guidance tasking agencies with updating their policies to ensure that they afford a “non-discriminatory and inclusive” work environment to all employees, particularly transgender and other gender non-conforming workers.”

Midweek Update

David Ermer–Uncategorized–

This afternoon, the Affordable Care Act regulators issued FAQ 58 guiding health plans, including FEHB plans, on handling the end of the Covid public health emergency (PHE), which will happen on May 11.

Coverage of Covid diagnostic tests after May 11 (Bold items are the government’s, and italicized items are the FEHBlogs:

Section 6001 of the [Families First Coronavirus Relief Act] FFCRA requires plans and issuers to cover COVID-19 diagnostic tests that meet statutory requirements and certain associated items and services without imposing any cost-sharing requirements, prior authorization, or other medical management requirements. However, that requirement is applicable only to diagnostic tests and associated items and services furnished during any portion of the PHE beginning on or after March 18, 2020. Therefore, a plan or issuer is not required under section 6001 of the FFCRA to cover COVID-19 diagnostic tests and associated items or services furnished after the PHE ends.

Any plan or issuer that provides coverage for COVID-19 diagnostic testing furnished after the PHE ends, including over-the-counter (OTC) COVID-19 diagnostic tests purchased after the PHE ends, is not prohibited from imposing cost-sharing requirements, prior authorization, or other medical management requirements for those items and services under section 6001 of the FFCRA. However, plans and issuers are encouraged to continue to provide this coverage, without imposing cost sharing or medical management requirements, after the PHE ends

The Departments do not explain the closing sentence.

Coverage of approved Covid vaccines post-PHE

On May 12, approved Covid vaccines will be subject to the Affordable Care Act’s preventive services mandate. Consequently, they remain fully covered with no cost sharing when delivered in-network. Out-of-network coverage depends on the plan brochure (FEHB) or SPD (ERISA) language.

HSA, HRA, and FSA reimbursement of Covid testing and treatment is unaffected by the end of the PHC

Notice to members

The Departments encourage plans and issuers to notify participants, beneficiaries, and enrollees of key information regarding coverage of COVID-19 diagnosis and treatment, including testing. This includes the date when the plan or issuer will stop coverage if the plan or issuer chooses to no longer cover COVID-19 diagnostic tests or when the plan or issuer will begin to impose cost-sharing requirements, prior authorization, or other medical management requirements on COVID-19 tests, to the extent applicable under the plan or coverage. The Departments also encourage plans and issuers to continue covering benefits for COVID-19 diagnosis and treatment and for telehealth and remote care services after the end of the PHE.

The Departments then provide specific guidance to ERISA plans concerning notice, COBRA, etc. Nevertheless, the FEHBlog suggests that FEHB plans treat this as a requirement in the absence of OPM guidance.

In other top news of relevance to the FEHBP:

  • The Food and Drug Administration gave Narcan nasal spray over-the-counter status. Narcan’s manufacturer expects that OTC Narcan, which can save the lives of people struck down by an opioid overdose, will appear on pharmacy shelves in September, according to the Wall Street Journal.
  • Beckers Hospital News tells us,
    • “UnitedHealthcare, Aetna and Cigna are moving to trim their prior authorization programs, which providers have criticized as burdensome, The Wall Street Journal reported March 29. 
    • “Starting in the third quarter of 2023, UnitedHealthcare will remove several procedures and medical devices from its list of services requiring prior authorization, according to the report. It also said it would eliminate many prior authorization requirements for gold-card doctors and hospitals beginning next year. 
    • “We’re not deaf to the complaints out there,” Philip Kaufman, UnitedHealthcare’s chief growth officer, told the Journal. “We’ve taken a hard look at ourselves and this process.”
    • “The payer processes about 13 million prior authorization requests a year out of about 600 million claims, according to the report. Officials said the changes are projected to reduce the number of prior authorization to about 10 million per year. 
    • “Cigna said it has been removing prior authorization requirements for about 500 services and devices since 2020, according to the report. Aetna said it is working to automate and simplify the prior authorization process. 
    • “American Medical Association President Jack Resneck Jr., MD, told the Journal he is cautiously optimistic about UnitedHealthcare’s changes but wants to see the details to be sure they will bring meaningful improvements.”
  • FedWeek points out the OPM Inspector General issued an evaluation report on telehealth utilization during the pandemic earlier this month.
    • “In a sampling of telehealth claims, auditors found more than 2,000 related to services that “could not be performed via telehealth”—including for laser surgery, anesthesia, injections and colonoscopies—and billing for procedures incompatible with the provider’s specialty.
    • “However, OPM management disagreed with the IG’s recommendations in those areas, for example pointing out that telehealth is a well-established concept. 
    • “The IG in turn disagreed, saying that “While telehealth is not a new offering in the FEHB, the variety of services offered and the technologies utilized have increased. When combined with the overall increase in telehealth utilization, we believe increased scrutiny and increased protections are both warranted moving forward.”

In U.S.healthcare business news, Healthcare Dive informs us

CVS closed its $8 billion acquisition of Signify on Wednesday. In a statement, CVS CEO Karen Lynch said the transaction will advance the company’s value-based care strategy by enhancing its presence in the home.

CVS and Signify will work on care delivery and engagement particularly for Medicare Advantage customers, according to a release on the deal’s close.

In conference news, Fierce Healthcare continues to report from the ViVE 2023 healthcare tech conference here and here. The FEHBlog will summarize his thoughts on the OPM carrier conference in Thursday’s post.

Tuesday’s Tidbits

David Ermer–Uncategorized–
Photo by Patrick Fore on Unsplash

In FEHB news, Federal News Network interviews Kevin Moss, editor of Consumers’ Checkbook Guide to Health Plans for Federal Employees, about OPM’s approving the use of Medicare Part D EGWPs in FEHB plans for 2024. Mr. Moss shares the FEHBlog’s excitement about this cost-saving development. Two nifty features of Medicare Part D EGWPs in contrast to Medicare Advantage Prescription Drug plans are that Medicare Part A only annuitants can enroll in them and the Plan’s prescription drug benefits can gap fill them. However, Mr. Moss indicates for 2024 and beyond, the gaps in Part D coverage are fewer. In addition, the OPM AHIP carrier conference, which begins tomorrow, will feature a session on Medicare Part EGWPs.

The carrier conference also provides a session on Social Determinants of Health. In addition, the Agency for Healthcare Quality and Research reminded us today about the availability of its October 2022 National Healthcare Quality and Disparities Report.

From the public health front —

  • WebMD tells us
    • “Good news and bad news on the long COVID front: Certain groups of people – like women, smokers, and those who had severe COVID-19 infections – are at a higher risk of long COVID, a review of more than 800,000 patients has found. 
    • “That’s the bad news. Yet, researchers also found that patients who had at least two doses of the COVID vaccine had a significantly lower risk of getting long COVID down the line.”
  • The NIH Directors Blog discusses using a whole-person approach to lifting the burden of chronic pain from service members and veterans. This approach is currently in use at VA facilities.
  • Healio tells us about a retrospective atrial fibrillation (AF) diagnosis study.
    • “In a retrospective study, Turakhia and colleagues analyzed patient information from five U.S. medical claims data sets from 2012 to 2017. Researchers estimated undiagnosed AF based on the observed incidence of ischemic stroke, systemic embolism and AF incidence after a stroke or systemic embolism.
    • “The estimated U.S. prevalence of AF (diagnosed and undiagnosed) in the third quarter of 2015 was 5,628,000 cases, of which 11% were undiagnosed. 
    • “The assumed 2‐year undiagnosed AF prevalence was 23% of the total prevalent patients with AF. Compared with diagnosed patients, those who remained undiagnosed tended to be women, to be older, to have more comorbidities and to have higher CHA2DS2‐VASc scores.” 
    • “Together with the known burden of AF, this expanding unmet need underscores the critical importance of early detection. Our data can support both disease surveillance and future research and policy initiatives aimed at addressing this diagnostic gap.”

From the U.S. healthcare business front —

  • The American Hospital Association reports
    • “Hospital operating margins dipped again in February to -1.1% and continue to remain negative, though with less month-to-month variation, according to the latest report on hospital finances from Kaufman Hall. Costs of goods and services are now increasing faster than labor, with both labor and non-labor expenses per adjusted discharge 21% higher than in February 2020.
    • “Due to external economic factors, relatively flat margins are likely to continue in the near term,” the report states.”
  • STAT News notes
    • “The tech-forward insurer Oscar Health has tapped former Aetna CEO Mark Bertolini to be its new chief executive, a move to jump-start the business as it seeks to win new customers and become profitable.
    • “Bertolini, 66, is a progressive thinker in the use of technology to deliver health services and has already been advising Oscar for the past 18 months. His appointment gives him an opportunity to put a stamp on the future of digital services and analytics in the industry he has served for four decades.
    • “I’m returning to the health care industry because I believe there is still work to be done,” Bertolini said during a conference call to announce his appointment on Tuesday. He said Oscar presents a unique opportunity to challenge the status quo in the industry and accelerate the shift toward a more “consumer-oriented” business model.”
  • Fierce Healthcare is covering the 2023 ViVE conference currently being held in Nashville, TN, here and here. “Focused on digital health innovation, the conference, sponsored by HLTH and the College of Healthcare Information Management Executives (CHIME), had 5,000 attendees in 2022,” its inaugural year, and 7,500 attendees this year.
    • “On Monday morning, a heavily armed attacker entered a Christian school in Nashville and fatally shot three 9-year-old children and three adults.
    • In a joint statement from conference co-organizers CHIME and HLTH, the organizations said they have committed to a combined $50,000 donation “on behalf of ViVE for the victims and their families of today’s tragic Covenant School shooting.”
  • STAT News offers a special report on the wisdom of using artificial intelligence to replace medical transcription.

In a noteworthy legal development, the American Hospital Association informs us

The AHA and AHIP today filed a [joint] friend-of-the-court brief in a False Claims Act case before the U.S. Supreme Court, arguing that the federal government’s erroneous construction and expansion of the FCA threatens the legitimate business activities of every government contractor, hospital, health care provider, health insurance provider and grant recipient in the nation.

In a separate statement, the organizations said, “While AHA and AHIP may not always share the same opinion on matters of litigation and policy, we agree that the current regulatory landscape and construction of the False Claims Act (FCA) creates an untenable situation for health care providers and health insurance providers. “If the government’s argument is accepted, our members will be forced to spend more on litigation and less on patient care.”

“We urge the Supreme Court to adopt an interpretation of the FCA that does not undermine the ability of our members to ensure that Americans have access to high-quality, affordable health care.”

Amen to that.