FEHBlog

Monday Roundup

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From Washington DC,

  • The Office of Personnel Management issued a Benefit Administration Letter providing guidance about an Enrollee Decision Period for Federal Long Term Care Insurance Program enrollees. The Enrollee Decision Period started today and ends on November 9, 2023.
  • The Food and Drug Administration announced
    • “approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.”
  • Roll Call adds
    • “Advisers to the Centers for Disease Control and Prevention are scheduled to discuss on Tuesday recommendations for who should receive the vaccines and when, with CDC Director Mandy Cohen expected to sign off shortly thereafter. 
    • “Drugmakers say they’re ready to begin shipping the shots immediately in accordance with the CDC’s pending guidelines.”
  • STAT News tells us, “Sen. Bernie Sanders (I-Vt.) will hold a confirmation hearing next month for Dr. Monica Bertagnolli, President Biden’s nominee to run the National Institutes of Health, he said Friday.”

From the public health front,

  • MedPage Today reports
    • “Anesthesiologists are sharply divided over how to handle the growing number of surgical patients on GLP-1 receptor agonists, given that the drugs can raise the risk of aspiration during surgery.
    • “While the leading U.S. anesthesiology society suggests that patients stop taking injectable versions of the medications for 7 days ahead of surgeryopens in a new tab or window, some anesthesiologists are turning to alternative strategies such as intubating all at-risk patients, even for minor procedures.
    • “Other anesthesiologists are calling for patients to stay off the drugs for weeks, not days, or titrate down to lower doses.
    • “This topic is being heavily discussed in the anesthesia community right now, and it’s very polarizing,” Michael Gulak, MD, a resident anesthesiologist at the University of Toronto, told MedPage Today.”

From the U.S. healthcare business front,

  • Beckers Hospital Review informs us
    • “Nonprofit hospital expenses continued to grow last year while liquidity fell to pre-pandemic levels, according to Moody’s Investor Services. 
    • “In a Sept. 7 report, Moody’s outlined 2022 fiscal year trends based on data from 218 health systems. The report noted operating margins fell to”unsustainable levels” as median operating cash flow margin was 4.9 percent and median operating margin was -0.3 percent amid labor shortages and inconsistent patient volumes.
    • “While the industry shows signs of stabilizing in 2023, the labor environment will remain challenging,” the report states.”
  • Per Benefits Pro,
    • “Hospitals in the United States faced unprecedented challenges during the COVID-19 pandemic, and those challenges have left them floundering in the face of increased costs and workforce shortages. According to the most recent Costs of Caring report from the American Hospital Association, this combination of factors has resulted in a 17.5% increase in overall hospital expenses between 2019 and 2022. “Further exacerbating the situation is the fact that the staggering expense increases have been met with woefully inadequate increases in government reimbursement,” the report states, leading to consistently negative margins and over half of hospitals ending 2022 at a financial loss.
    • “Even so, hospital expenses per inpatient day have been steadily trending upwards for years in the U.S., whether for-profit, non-profit, or state/local government. Research from KFF shows that in 1999, the average adjusted expenses per inpatient day for state/local government hospitals was $1,004. Non-profits were at $1,139, and for-profits were at $999. As of 2021, state/local government stands at $2,742—a 173% increase. Non-profits are at $3,013 (164.5%) and for-profits at $2,296 (129.8%).”
  • MedCity News points out
    • While there are fewer rural residents enrolled in Medicare Advantage plans than micropolitan or metropolitan residents, MA enrollment in rural areas is growing much more rapidly, new research shows.
    • The KFF report, published Thursday [September 7], defines rural areas as having less than 10,000 people, micropolitan areas as having 10,000 to 50,000 people and metropolitan areas as having at least 50,000 people. The findings come when Medicare Advantage growth overall is on the rise, accounting for more than half of eligible Medicare beneficiaries in 2023.
  • Healthcare Dive relates
    • Walmart is considering buying a majority stake in value-based medical chain ChenMed, according to a Bloomberg report published Friday.
    • The retail giant is in discussions with ChenMed regarding a transaction that would value the Miami-based primary care clinic operator at several billion dollars, Bloomberg reported, citing sources familiar.
    • Terms of the deal aren’t finalized, and talks could fall through or a different buyer could emerge, Bloomberg’s sources said.
    • If a deal is announced, Walmart would become the latest retail operator to bag a primary care operator, following in the footsteps of rivals including CVS, Amazon and Walgreens.
    • ChenMed operates a network of more than 125 clinics for Medicare-eligible seniors in 15 states, according to the company’s website.

Weekend update

Photo by Dane Deaner on Unsplash

From Washington, DC,

From the public health front,

  • The New York Times reports
    • “A steady uptick in [COVID-19] cases since July and reports of worrisome new variants have fueled concern that the virus is poised to make a comeback this fall and winter. But in interviews, experts offered reassurances that the country will not see a return to the nightmarish scenarios of previous years.
    • “There is no evidence that any of the variants in circulation cause more severe disease or evade immunity adroitly enough to render vaccines ineffective. And although hospitalizations and deaths are increasing week by week, the numbers remain low, noted Gigi Gronvall, a biosecurity expert at the Johns Hopkins Center for Health Security.
    • “These increases are more alarming by statistics than in reality,” Dr. Gronvall said.” 
  • Roll Call tells us
    • “During the same week that naloxone — a nasal spray that reverses opioid overdoses — became available for purchase without a prescription, the nation’s top substance use officials called for greater availability and training for the drug, with five federal officials receiving training to administer it during a public demonstration at Health and Human Services headquarters Friday. 
    • * * * “While the Food and Drug Administration initially approved naloxone in 1971 as an injectable drug used in medical settings, it wasn’t until 2015 that the FDA approved a nasal spray version for prescription use. But the agency only approved the first over-the-counter versions of the drug this year. It became available without prescription this week, with Emergent BioSolutions’ 4 mg nasal spray selling for $44.99 for a two-dose product. Harm Reduction Therapeutics’s RiVive, is expected to become available in eBloomarly 2024.
    • “The price point has been a concern for some advocates who worry it could limit accessibility and use. In an interview, Rahul Gupta, director of the White House Office of National Drug Control Policy, said the administration is working to bring the price point down as part of a larger effort to reduce healthcare costs.
    • “We’re constantly working with manufacturers because we’ve got to make this accessible and affordable. So we’re on this, and we’re exploring every pathway working with HHS and our other government partners as well,” he said.
  • Bloomberg offers a fascinating article about Lyme Disease. This tick-borne disease first made its appearance in the 1990s. An effective vaccine was made available in 1998, but the ultimately discredited “vaccines cause autism” campaign killed the vaccine in its cradle. Pfizer is now developing a new Lyme Disease vaccine, which is expected to receive FDA approval in 2026.
  • NPR Shots offers a comic strip explaining how to take care of your ears.

From the U.S. healthcare business front,

  • The Washington Post reports
    • “Kroger, one of the nation’s largest supermarket chains, has agreed to pay more than $1 billion to settle lawsuits alleging it failed to monitor suspicious orders of addictive pain pills that fueled the nation’s opioid crisis.
    • “The company announced Friday it will pay up to $1.2 billion to states and local governments, and $36 million to Native American tribes over 11 years.
    • “The money adds to more than $50 billion in settlements obtained by state and local governments suing opioid-industry players alleged to have flooded the nation with addictive pills, despite red flags that they were being diverted to the black market.
    • “Governments aim to use the money to ease the opioid crisis and save lives. Among the ways: paying for drugs to reverse overdoses, bolstering addiction treatment services and creating education campaigns.”
  • KFF Health News is tracking the distribution of these opioid-related class action settlements across the fifty states and DC.

 

Cybersecurity Saturday

From the cybersecurity policy front,

  • We learn from Cybersecurity Dive that
    • Final work is underway for the Cyber Incident Reporting for Critical Infrastructure Act, which Cybersecurity and Infrastructure Security Agency Director Jen Easterly expects to be done by the end of this year or early 2024 at the latest, she said Wednesday at the Billington Cybersecurity Summit. The act, signed in March 2022, requires critical infrastructure providers to report major cyber incidents and ransomware payments to the agency.
    • “But until we have that in place, we need to make sure we are communicating around threats, realizing that a threat to one is a threat to many,” Easterly said. 
    • Easterly said the agency has made significant progress in building a collaborative model for sharing intelligence and gaining visibility into threats facing the nation, but said more work still needs to be done.
  • Per Fedscoop,
    • “New policy guidance is coming soon to help agencies comply with the Federal Risk and Authorization Management Program (FedRAMP) as the cloud landscape evolves, according to the federal government’s No. 2 IT official.
    • “Drew Myklegard, deputy federal CIO, said Thursday at FedScoop’s FedTalks that the forthcoming guidance comes as the federal cloud marketplace has evolved to be more dominated by software-as-a-service (SaaS) and platform-as-a-service (PaaS) offerings. 
    • “The landscape has changed. SaaS — and now it’s heavy, heavy SaaS — and a lot of PaaS providers really need access to the government and their mission. So now we’re pivoting and it takes a couple of years to do that, but we’re pivoting towards that market,” Myklegard said.
    • “He continued: “We’ve seen an exponential growth every couple of years of these SaaS providers and the tools. But what we haven’t seen is similar exponential growth in their adoption, at least like ATO-ed [authority to operate], secured and monitored by the CIOs out there of those types of products.”

From the cybersecurity breaches and vulnerabilities front,

  • The Wall Street Journal reports,
    • “A record year for cyberattacks on U.S. hospitals is putting patients in danger, as hospitals struggle to cope with disabled equipment and frozen data, an official from the American Hospital Association warned Thursday.
    • “Hackers, especially ransomware groups, are routinely taking down medical applications and internet connections, and freezing up patient and operations data, John Riggi, national adviser for cybersecurity and risk at the AHA, said, speaking at a meeting of the Healthcare Information and Management Systems Society. 
    • “Email and phones go down. Backup computers generally don’t work or have only about three days of data on them,” Riggi said. “We have seen this consistently,” he told the audience of healthcare technology and cyber leaders.”
  • The American Hospital Association adds,
    • “The U.S. Treasury Department, in coordination with the United Kingdom, Sept. 7 sanctioned 11 individuals who are part of the Russia-based Trickbot cybercrime group, whose targets have included hospitals and other critical infrastructure organizations. The Department of Justice also unsealed indictments against nine individuals in connection with Trickbot malware and Conti ransomware, including seven of the sanctioned individuals. According to the agencies, the Trickbot group in 2020 launched a wave of ransomware disruptions against U.S. hospitals and health care facilities, in one case deploying ransomware that disrupted computer networks and telephones at three Minnesota facilities and caused them to divert ambulances.”  
  • Last week, the Cybersecurity and Infrastructure Security Agency added one known exploited vulnerability to its catalog
  • Cybersecurity Dive points out
    • “A consumer signing key that caused security headaches for Microsoft earlier this year was exposed in an April 2021 crash dump, the company said Wednesday. A China-based threat group behind attacks later used the key to compromise more than two dozen customers, including U.S. State Department emails earlier this year. 
    • “Microsoft disclosed the crash dump, which redacts sensitive information, as part of an internal investigation into how the consumer signing key was left exposed. The threat group, which Microsoft calls Storm-0558, compromised the corporate account of a Microsoft engineer following the crash dump,
    • “The threat group stole sensitive emails from the State Department and reportedly U.S. Commerce Secretary Gina Raimondo.”
  • Per Krebs on Security, “Experts Fear Crooks are Cracking Keys Stolen in LastPass Breach.”

From the ransomware front,

  • Security Week reports,
    • “Cisco this week raised the alarm on a zero-day in Adaptive Security Appliance (ASA) and Firepower Threat Defense (FTD) software that has been exploited in Akira ransomware attacks since August.
    • “Tracked as CVE-2023-20269 (CVSS score of 5.0, medium severity), the issue exists in the remote access VPN feature of Cisco ASA and FTD and can be exploited remotely, without authentication, in brute force attacks. 
    • “This vulnerability is due to improper separation of authentication, authorization, and accounting (AAA) between the remote access VPN feature and the HTTPS management and site-to-site VPN features,” Cisco explains in an advisory.”

From the cybersecurity defenses front,

  • Cybersecurity Dive identifies the top five behaviors of successful CISOs thanks to Gartner Research.
  • Dark Reading discusses three strategies to defending against “resurgent info stealers.”
  • An ISACA experts explores using near-miss incidents are risk indicators.

 

Friday Factoids

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From Washington, DC —

  • The American Hospital Association informs us
    • “The 988 Suicide & Crisis Lifeline now offers American Sign Language services for people who are deaf and hard of hearing, the Department of Health and Human Services announced.
    • “This new service is one more critical step towards making mental health support more accessible and inclusive for all,” said Miriam Delphin-Rittmon, HHS assistant secretary for mental health and substance use.”
  • and
    • “A new Centers for Medicare & Medicaid Services fact sheet reviews how the agency selected the first 10 Part D drugs to include in the Medicare Drug Price Negotiation Program, its process for negotiating with the companies that make the drugs, opportunities for public input and key dates for implementation. CMS last week announced the first 10 drugs for the program and plans to publish the negotiated prices by next September, which would take effect in 2026.”
  • The Department of Health and Human Services announced
    • “new details of its agreement with Regeneron to extend its public-private partnership to develop life-saving monoclonal antibodies as part of Project NextGen enhancing our preparedness for COVID-19 strains and variants.
    • “The HHS is committed to lowering drug costs for all Americans. As part of that commitment, HHS and Regeneron announced an extension of their long-standing partnership to develop life-saving monoclonal antibodies. That modification to Regeneron’s contract with the Administration for Strategic Preparedness and Response’s (ASPR’s) Biomedical Advanced Research and Development Authority is valued at $326M and supports the advanced development of a next-generation monoclonal antibody for COVID-19 prevention under HHS’s Project NextGen.
    • “This agreement included a clause where Regeneron committed that if a new product is commercialized, its list price in the United States will be equal to or less than its retail price in comparable markets globally. Inclusion of this clause is the result of HHS’s and Regeneron’s shared interest in ensuring enduring and equitable access to therapeutics developed under public-private partnerships for all Americans.”

From the public health front,

  • The American Hospital Association tells us
    • “This season’s flu vaccines for the Southern Hemisphere have reduced the risk of being hospitalized for flu by 52%, based on mid-season data from five countries, suggesting the U.S. vaccines could provide similar protection if similar viruses continue to predominate, the Centers for Disease Control and Prevention reports. Both hemispheres used similar flu vaccine formations. The CDC recommends all Americans aged 6 months and older get the seasonal flu vaccine in September or October.”
  • Per Health Day,
    • “The mpox vaccine appears to show effectiveness against the virus, new research shows
    • “Among 37 gay and bisexual men who were either reinfected or had received their mpox vaccine, the disease was less severe
    • “The findings show that the vaccine is a valuable addition to treatments used for mpox infection.”
  • and
    • “Standard Pap tests may miss a deadly type of cervical cancer 
    • “A new screening tool could pick up more of those cancers as well as lesions that may progress into cancer, its developers say
    • “The findings must now be confirmed by clinical trials”
  • More details are available in the Health Day articles.
  • A Wall Street Journal reporter explains what he learned from trying to live a perfect life for a day based on expert advice.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “CVS Health shuffled responsibilities for its leadership bench on Thursday in a bid to better align business segments, as the retail health giant undergoes corporate restructuring following flagging earnings.
    • “CVS named CFO Shawn Guertin president of its health services segment, and said former Humana CFO Brian Kane will join this week as president of Aetna health benefits arm. CVS first announced Kane would be joining CVS in April.
    • “CVS’ care delivery businesses Oak Street Health and Signify Health will continue to operate under health services umbrella. Their respective heads, Mike Pykosz and Kyle Armbrester, will now report directly to Guertin.”
  • Beckers Payer Issues notes,
    • “AHIP has named its general counsel, Julie Simon Miller, to serve as interim CEO, effective Oct. 2.
    • “AHIP President and CEO Matt Eyles is stepping down from his role at the end of September, and the trade association is currently searching for a permanent chief executive, according to a Sept. 7 news release.
    • “Ms. Miller has served as general counsel since 2015 and has been with the association for more than 18 years.”
  • The Employee Benefit Research Institute points out,
    • “IRS Notice 2019-45 allows health savings account (HSA)-eligible health plans the flexibility to cover 14 medications and services used to prevent the exacerbation of chronic conditions prior to meeting the plan deductible. A 2021 Employee Benefit Research Institute (EBRI) survey of employers collected information on their response to the 2019 guidance and found that many employers added pre-deductible coverage as a result of the IRS notice. A recent EBRI report based on claims data from about 2 million HSA-eligible health plan enrollees confirmed the findings from the 2021 EBRI survey — fewer enrollees in HSA-eligible health plans have deductibles for services impacted by the IRS notice, and cost sharing has shifted from deductibles to copayments and coinsurance.”
  • Per Fierce Healthcare,
    • “Prior authorization will become less of a hassle for physicians in Blue Cross Blue Shield of Michigan’s network, BCBSM officials hope, as they roll out an effort to relax about 20% of prior authorization requirements.
    • “This is part of Blue Cross’ ongoing effort to improve healthcare quality, experience, access and affordability for members, while also reducing administrative tasks for clinicians,” BCBSM said in a press release.”

From the Rx coverage and research front,

  • BioPharma Dive reports,
    • “Seagen is committing $60 million to develop a new type of cancer drug, striking a multi-year alliance with biotechnology company Nurix that aims to combine their respective technologies.
    • “Per terms of the deal announced by Nurix Thursday, Seagen could pay as much as $3.4 billion more if certain research, development, regulatory and commercial milestones are met. Nurix retains an option to co-market and share profits on two products that emerge from the partnership.
    • “The companies plan to pair Seagen’s antibody expertise with Nurix’s protein degradation technology to create “degrader-antibody conjugates,” akin in some ways to Seagen’s approved antibody-drug conjugates. The collaboration comes as Pfizer works to close its $43 billion acquisition of Seagen.”
  • and
    • “Verge Genomics, a biotechnology company using artificial intelligence to develop therapies for diseases of the nervous system, announced on Friday a four-year partnership with AstraZeneca’s rare disease unit Alexion to identify new drug targets.
    • “As part of the agreement, Verge will receive up to $42 million in upfront, equity and near-term payments. The company also could receive as much as $840 million in milestone payments over the deal, along with royalties on any resulting products.
    • “The partnership seeks to find and validate new drug targets for uncommon neurodegenerative and neuromuscular diseases. The companies plan to do this by using Verge’s technology, which uses both AI and human tissue data to predict what drug targets are most likely to succeed in clinical testing.”

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington, DC

  • Federal News Network offers its periodic update on the bills pending before Congress of interest to federal employees.
  • American Hospital Association News tells us that today
    • “The Department of Health and Human Services’ Office for Civil Rights released a proposed rule intended to update and clarify requirements under Section 504 of the Rehabilitation Act that prohibit discrimination on the basis of disability in programs receiving financial assistance from the department, including health care. According to HHS, the proposed rule would ensure that medical treatment decisions are not based on biases or stereotypes about individuals with disabilities; prohibit the use of value assessment methods that place a lower value on life-extension for individuals with disabilities when used to limit access or to deny aids, benefits and services; establish enforceable standards for accessible medical diagnostic equipment; and clarify obligations for accessible web and mobile applications and obligations to provide services in the most integrated setting appropriate to an individual’s needs. The rule will be published in the Sept. 14 Federal Register, with comments accepted for 60 days.”
  • The Federal Times points out
    • “The Office of Personnel Management received a small surge of retirement claims in July and August after applications had been falling steadily for months since January.
    • “The time it took the government to process retirements increased sharply in July to 85 days before falling back down to 74 days in August, according to data kept by OPM.
    • “Overall, the agency is sitting on an inventory of nearly 18,000 cases after it reduced its working caseload to new lows this year. About this time last year, there were 29,000 pending cases.
    • “Still, despite efforts to dispatch focus teams to address backlogs, the agency is failing to hit its target time or inventory goals, leaving retirees to wonder whether their case will be one that ends up sitting in limbo for longer. Ideally, retirement applications are processed in 60 days or fewer.”
  • CMS released its 2022 report on covered entity compliance with the HIPAA electronic transactions.
    • The transaction types experiencing the most violations during the 2020 and 2021 compliance reviews were specific to 835 [the claim transaction], 271 [Health Care Eligibility Response], and 277 [Claim Status Response] transactions. This changed slightly in 2022 as the most common transaction types experiencing violations are now 835, 271, and 834 [EOB] transactions.
    • CMS is sharing updated 2022 violation findings insights to inform and educate the industry, encourage widespread compliance, and assist covered entities with preparing for compliance reviews.
  • The Society for Human Resource Management relates,
    • The U.S. Equal Employment Opportunity Commission (EEOC) has released an updated deadline for employers to submit their demographic data. The EEO-1 Component 1 data collection for 2022 will start on Oct. 31, and the deadline for employers to file their EEO-1 reports is Dec. 5.
    • All private employers that have at least 100 employees are required to file the EEO-1 form annually, detailing the racial, ethnic and gender composition of their workforce by specific job categories.
    • Likewise, federal government contractors and first-tier subcontractors with 50 or more employees and at least $50,000 in contracts must file EEO-1 reports. State and local governments and public school systems are exempt.
  • KFF reports
    • “Over the past two years, the federal government has provided about $1 billion from the American Rescue Plan and Bipartisan Safer Communities Acts to launch the number, designed as an alternative to 911 for those experiencing a mental health crisis. After that infusion runs out, it’s up to states to foot the bill for their call centers.
    • “We don’t know what Congress will allocate in the future,” said Danielle Bennett, a spokesperson for the federal Substance Abuse and Mental Health Services Administration, which oversees 988. “But the hope is that there will be continued strong bipartisan support for funding 988 at the level it needs to be funded at and that states will also create funding mechanisms that make sense for their states.”
    • “Only eight states have enacted legislation to sustain 988 through phone fees, according to the National Alliance on Mental Illness, which is tracking state funding for the system. Others have budgeted short-term funding. But many predominantly rural states, where mental health services are in short supply and suicide rates are often higher than in more urban states, have not made long-term plans to provide support.”
  • MedPage reports,
    • When pseudoephedrine moved “behind-the-counter” nearly 20 years ago, it left oral phenylephrine (with brands including Sudafed PE and Suphedrine PE) as the only nasal decongestant available without pharmacy assistance. But there’s one big problem: phenylephrine doesn’t work, the FDA has finally determined.
    • FDA reviewers released the results of their long-running review of the evidence this week as background for a meeting of the Nonprescription Drugs Advisory Committee to be held on September 11 and 12.
    • The article explains the conundrum this finding creates for the FDA.

From the public health front,

  • MedPage reports that “the global incidence of early-onset cancer has increased by 79% over the past three decades, researchers reported.
    • “In a comment posted on Science Media Centre, Dorothy C. Bennett, MA, PhD, of St. George’s, University of London, cautioned that the increase in new cases of early-onset cancer is based on absolute numbers, rather than age-standardized rates.
    • “The world human population increased by 46% between 1990 and 2019, which explains part of the increase in total case numbers,” she said, adding that the increase in numbers of cancer deaths in this age group (28%) was notably lower than the number of new diagnoses, “which is below the increases in total population and case numbers, indicating a fall in the average cancer death rate in this group.”
  • Per the American Heart Association,
    • Obesity-related cardiovascular disease deaths tripled between 1999 and 2020 in the U.S.
    • Such deaths were higher among Black individuals (highest among Black women) compared with any other racial group, followed by American Indian/Alaska Native people.
    • Black adults who lived in urban communities experienced more obesity-related cardiovascular disease deaths than those living in rural areas, whereas the reverse was true for all other racial groups.
  • McKinsey Health offers a podcast about getting to the bottom of the teen health crisis.

From the U.S. healthcare business front,

  • Fierce Healthcare notes, “Employers’ health benefits costs are set to rise 5.4% next year, but this spike isn’t as high as may have been feared given inflationary pressures in the broader economy, according to a new analysis from Mercer.”
  • STAT News interviews “Amazon’s chief medical officers on where the company’s health care bets are headed next.”
  • Healthcare Dive informs us,
    • “Telehealth sessions comprised 5.4% of claim lines in June, the same amount as the prior month, according to Fair Health’s Monthly Telehealth Regional Tracker.
    • “Mental health conditions continued to top the list of Fair Health’s five most common telehealth diagnoses for June. The median allowed amount billed for a one-hour psychotherapy visit was $103.
    • “But Fair Health’s tracker showed regional variations. Although telehealth use decreased overall by 2.4% in the Midwest, asynchronous telehealth claim lines for mental health conditions more than doubled in the region from 15.9% in May to 36% in June. In asynchronous telehealth, providers collect data or medical images for review, instead of meeting with a patient in real time.” 
  • Per Health Affairs,
    • “Intensive care units (ICUs) are increasingly used for hospital care, yet out-of-pocket spending for ICU hospitalizations remains poorly understood, particularly among the nearly half of the US population with commercial health insurance. Using 2008–19 MarketScan data, we compared 1,441,810 hospitalizations involving ICU services with 13,011,208 hospitalizations that did not involve ICU services.
    • “Average cost sharing, adjusted for patient and admission factors, increased from $1,137 per hospitalization in 2008 to $1,539 in 2019, or a 34 percent increase. This was driven by increasing deductibles, which rose by 163 percent.
    • “Across twenty clinical conditions whose hospitalizations commonly occurred in both ICU and non-ICU settings, ICU admission was associated with $155 higher cost-sharing (13.0 percent higher) relative to cost sharing in non-ICU hospitalizations.
    • “Patients with high-deductible plans faced the highest cost-sharing relative to those with other plan types.
    • “Patients who received out-of-network hospital care encountered higher cost-sharing relative to those admitted to in-network hospitals with in-network clinicians.”

Midweek Update

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From Washington, DC

  • The American Hospital Association informs us,
    • “Republicans on the House Energy and Commerce, Ways and Means, and Education & Workforce Committees have released a summary of draft legislation the committees could introduce as soon as this week. The Lower Costs, More Transparency Act includes provisions focused on health care price transparency, site-neutral payment cuts, and extending certain funding set to expire Sept. 30 for Community Health Centers, the National Health Service Corps and the Teaching Health Centers Graduate Medical Education Program. The bill also would delay for two years the start of Medicaid Disproportionate Share Hospital cuts scheduled to take effect on Oct. 1.”
  • CMS changed its No Surprises Act announcement to read
    • Effective September 5, 2023, the Departments have directed certified IDR entities to proceed with eligibility determinations for single and bundled disputes submitted on or before August 3, 2023.  All other aspects of Federal IDR process operations remain suspended. Disputing parties may continue to engage in open negotiation. 
  • The FEHBlog noticed on reginfo.gov that the following two No Surprises Act proposed regulations were submitted for Office of Information and Regulatory Affairs review on August 29:
    • AGENCY: HHS-CMS RIN: 0938-AV15 Status: Pending Review
    • TITLE: Independent Dispute Resolution Operations (CMS-9897)
    • STAGE: Proposed Rule SECTION 3(f)(1) SIGNIFICANT: Yes
    • RECEIVED DATE: 08/29/2023 LEGAL DEADLINE: None
    • and
    • AGENCY: HHS-CMS RIN: 0938-AV39 Status: Pending Review
    • TITLE: Federal Independent Dispute Resolution Process Fees (CMS-9890)
    • STAGE: Proposed Rule SECTION 3(f)(1) SIGNIFICANT: Yes
    • RECEIVED DATE: 08/29/2023 LEGAL DEADLINE: None
  • The first Interested party meetings with OIRA are scheduled for September 8.

From the public health front,

  • The American Hospital Association tells us
    • “The Centers for Disease Control and Prevention Sept. 5 alerted clinicians to a recent increase in respiratory syncytial virus in the Southeastern U.S., which could signal the beginning of the 2023-2024 RSV season nationally. CDC encourages clinicians to prepare to implement prevention options, including the new long-acting monoclonal antibody to protect infants and some young children at higher risk for severe disease and two new vaccines to protect older adults from severe disease.”
  • Per STAT News
    • “More older adults have been hospitalized for COVID-19 over the past several weeks, according to internal data reviewed by health insurance giant Humana.
    • “Humana, which mostly provides health insurance to those 65 and older and who are therefore more vulnerable to the worst effects of Covid, expected more Covid cases and hospitalizations this year. But it didn’t expect the uptick to come during the waning summer months.”
  • BioPharma Dive reports,
    • Moderna said that an updated COVID shot it’s developing can protect against a form of the coronavirus known as BA.2.86, or Pirola, adding to early evidence the emerging variant may not be as troublesome as scientists had feared.
    • The data, delivered in a press release on Wednesday, show that the vaccine helped spur an immune response in humans against Pirola. It follows an announcement by Moderna last month that the same vaccine appears protective against other currently circulating strains known as Eris and Formax.
    • The Food and Drug Administration is currently reviewing the booster shot, with a decision expected shortly.
  • MedPage Today explains how to navigate the fall vaccine season for COVID-19, the flu, and RSV.

From the U.S healthcare business front,

  • Health Payer Intelligence points out four essential components of chronic disease management strategies.
  • Healthcare Dive relates,
    • Salt Lake City-based Intermountain Health last week reported $184 million in operating income for the first half of 2023, a 35% decrease from the prior-year period when the health system posted an operating income of $285 million. 
    • Expenses climbed to a total of $7.4 billion, offsetting a 22% year-over-year increase in revenue. Intermountain logged nearly $8 billion of revenue for the first six months of the year. 
    • The nonprofit operator still inked nearly $1.1 billion in net gain in the first half of the year, driven by investment income of $909 million.
  • Per MedTech Dive,
    • “Abbott reached an agreement to acquire Bigfoot Biomedical, a company that makes smart insulin pen caps that can sync with continuous glucose monitors to provide dose recommendations.
    • “The companies did not disclose the price of the acquisition, but plan to close it in the third quarter, they said in a Tuesday announcement. 
    • “The planned purchase would be Abbott’s first insulin delivery technology, adding to its position as one of the top CGM makers.” 

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington DC,

  • Govexec.com offers an interview with OPM’s Deputy Director Rob Shriver.
  • The American Hospital Association informs us
    • “The Centers for Medicare & Medicaid Services will select up to eight states to participate in a new voluntary all-payer model that aims to curb health care cost growth, improve population health, and advance health equity by reducing disparities in health outcomes. CMS plans to detail requirements for the States Advancing All-Payer Health Equity Approaches and Development Model in a funding opportunity notice this fall. Participating states will receive up to $12 million each to implement the model during one of three start dates, with the model concluding in December 2034. CMS expects to begin the pre-implementation period for the first cohort next summer. The model will build on best practices from the Maryland Total Cost of Care model, the Pennsylvania Rural Health Model, and the Vermont All-Payer ACO Model.

From Harrisburg, PA,

  • The Pennsylvania Department of State announced,
    • “Starting Sept. 5, 2023, registered nurses and licensed practical nurses from other states who hold multistate licenses through the Nurse Licensure Compact m(NLC) will be able to provide in-person and telehealth services to PA patients. * * * Pennsylvania nurses will be able to apply for a multistate license once the compact has been fully implemented.”
  • Here is a link to nurse.org’s “Compact Nursing States List 2023,” which now includes forty states, Guam, and the Virgin Islands.
  • This type of licensing flexibility should help with nursing shortages.

From the Affordable Care Act front, Beyond the Basics provides an updated guide to minimum essential coverage.

From the generative AI front, STAT News now provides a tracking service that serves as a guide to health systems and companies driving the adoption of this important new technology.

Speaking of technology,

  • BioPharma Dive reports
    • Beam Therapeutics has begun human testing in the U.S. of a first-of-its-kind gene editing medicine for cancer, the company said Tuesday.
    • “Beam, a pioneering developer of a precise gene editing technique known as base editing, said in a short statement that it’s dosed its first patient in a study of the treatment, called BEAM-201. The trial involves patients with an aggressive form of blood cancer known as T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma, or T-ALL/T-LL. It will eventually enroll about 100 participants, according to a federal database.
    • “The study’s start makes BEAM-201 the first base editing therapy to enter clinical testing in the U.S., and marks the first time patients have received a cell therapy made by “multiplex editing,” in which several genes are edited. The edits are designed to eliminate expression of four genes known as CD7, TRAC, PDCD1 and CD52.
    • “Beam claims this approach could lead to a more powerful and durable treatment. In its statement, the company noted BEAM-201’s potential to sidestep a variety of issues associated with cell therapies, like propensity for the modified cells to kill one another, or become weaker as time goes on.
    • “Beam also believes the simultaneous edits could yield a more potent donor-derived, or “off the shelf,” cell therapy. Such allogeneic treatments would be more convenient than the personalized CAR-T therapies on the market, but results to date haven’t proven they’re more powerful at killing cancer cells.”
  • Very Buck Rogers.

From the telehealth front,

  • Per Healthcare Dive,
    • “Approximately one-third of behavioral health patients seeking therapy or medication visits said their clinicians did not offer both telehealth and in-person care, according to a study from nonprofit research organization Rand.
    • “The study, published on Tuesday in Health Affairs, revealed that 45% of behavioral health patients did not believe their clinicians considered their preferences for virtual or in-person care. In addition, 32% of respondents said they did not receive their preferred method of treatment.
    • “Despite the lack of choice offered by providers, many patients undergoing behavioral health therapy preferred in-person visits due to the personal nature of the treatment, the ability to build a rapport with providers, and fears around data security and privacy, the report found.”
  • Such reports explain why hub and spoke telemental services are not a solution for mental health parity.

From the human resources front,

  • The Society for Human Resource Management advises,
    • Even though [last week’s] proposed overtime rule is likely to be challenged in court after it is finalized, employers should start examining how it will affect their workplaces, legal experts say.
    • “I don’t think businesses should act now and make concrete changes,” said Jeff Ruzal, an attorney with Epstein Becker Green in New York City. “A preliminary injunction is likely” after the rule is finalized, he said, but employers “should study and audit the workplace” and prepare for the rule to possibly take effect. They should analyze who is exempt and nonexempt and plan for complying “without jeopardizing the business or payroll.” 

Happy Labor Day!

Way back in the day, OPM routinely would announce the next year’s FEHB premiums around Labor Day. The announcement was known as OPM’s Labor Day press release. Currently, the announcement is made in the last week of September.

Tammy Flanagan writes in Govexec about federal employee benefit issues confronting couples who both work for Uncle Sam, specifically

  • “Should we carry two self only plans under the Federal Employees Health Benefits program or one self plus one plan if we don’t need to cover children?
  • “Do we need to provide survivor annuities for each other?”

Check it out.

The Senate returns from its August State work break tomorrow for a shortened week of Committee business and floor voting. The House of Representatives returns to the Nation’s Capital next Tuesday.

From the public health front,

  • The Washington Post reports
    • “The Centers for Disease Control and Prevention on Friday [September 1] issued a national alert warning health-care professionals to watch out for infections of Vibrio vulnificus, a rare flesh-eating bacteria that has killed at least 13 people on the Eastern Seaboard this year.
    • “Although infections from the bacteria have been mostly reported in the Gulf Coast, infections in the eastern United States rose eightfold from 1988 to 2018, the CDC said. In the same period, the northern geographic range of infections has increased by 30 miles every year. This year’s infections came during a period of above-average coastal sea surface temperatures, the agency said.
    • “Up to 200 people in the United States every year report Vibrio vulnificus infections to the CDC. A fifth of the cases are fatal, sometimes within one or two days of the onset of illness, according to the agency.”
  • The Wall Street Journal tells us
    • “A two-decade decline in [prostate cancer] death rates has stalled. Some doctors worry deaths could rise in coming years.
    • “We’re finding them with disease not contained in the prostate but also in the bones, in the lymph nodes,” said Dr. James Porter, a urological surgeon in Seattle. “That’s a recent phenomenon.” 
    • “The pendulum swing hits at a fundamental problem in screening for all cancers: Testing too many people leads to more invasive procedures some patients don’t need. Testing too few misses opportunities to catch cases while there is a better chance treatment will work.
    • “Groups including the American Cancer Society are reviewing their own guidance for prostate-cancer screening. Many doctors want to better target the test, limiting screening for some men while encouraging high-risk groups including Black men or those with a strong family history to get testing earlier. 
    • “PSA recommendations have been ping-ponging back and forth, and what’s been lost in that is the high-risk people,” said Dr. Heather Cheng, director of the Prostate Cancer Genetics Clinic at Fred Hutchinson Cancer Center in Seattle. She is helping to review the American Cancer Society’s prostate-cancer screening guidelines. 
    • “Cheng and other doctors working to better calibrate screening said the risks of overdiagnosis have declined. More doctors now monitor low-risk tumors for growth before rushing a man into surgery or radiation. Better imaging tools have reduced biopsies.”
  • In other words, the problem is not necessarily the screening test; rather the problem may be the reaction of the medical community to screening results.  
  • NPR Shots informs us,
    • “The idea of food as medicine dates back to the ancient Greek doctor Hippocrates, and a new study adds to the evidence that a diet full of fruits and vegetables can help improve heart health. The research comes amid an epidemic of  diet-related disease, which competes with smoking as a leading cause of death.
    • “Researchers evaluated the impact of “produce prescriptions,” which provide free fruits and vegetables to people with diet related diseases including diabetes, obesity and hypertension. The study included nearly 4,000 people in 12 states who struggle to afford healthy food. They received vouchers, averaging $63 a month, for up to 10 months, which could be redeemed for produce at retail stores or farmers markets, depending on the location. 
    • “Health care providers tracked changes in weight, blood pressure and blood sugar among the participants. “We were excited to see improvements,” says study author Kurt Hager, an instructor at UMass Chan Medical School.
    • “Among adults with hypertension, we saw that systolic blood pressure decreased by 8 mm Hg and diastolic blood pressure decreased by about 5 mm Hg, which could have a meaningful impact on health outcomes,” Hager says.
    • “Among people with uncontrolled diabetes, their A1C levels, which is a 2-3 month average of their blood sugar, also declined significantly, by about .6 percent. “The reductions we saw in blood sugar were roughly half of that of commonly prescribed medications, which is really encouraging for just a simple change in diet,” Hager says.” 
  • Fortune Well explains how to deal with the uncertainty that serves as the root of anxiety.
    • “Uncertainty is life’s promise to us all. For more than twenty years, I have watched people rise from unspeakable pain to venture again into a future that withholds all certainty. I work with people who have endured shocking traumas and, predictably, our early conversations are filled with interrogative pleas for a certain safety: “How can I be absolutely sure nothing like this will ever happen again?” they ask me.
    • “The answer is: they cannot.
    • “After many years, the thing that still takes my breath away is the grace and courage of people who accept this truth and say: I rise again not because I know for sure, but because I hope anyway.”
  • The New York Times offers a reminder about how to use at home COVID tests effectively. Bear in mind that Paxlovid should be taken within five day after showing Covid symptoms.

Cybersecurity Saturday

From the cybersecurity vulnerabilities and breaches front,

  • Cyberscoop reports
    • “An international law enforcement operation disrupted the Qakbot botnet and associated malware that has been connected with countless cyberattacks and nearly $60 million in losses from victims around the world, the U.S. Department of Justice announced Tuesday. 
    • “The operation that included the FBI, DOJ and authorities in France, Germany, the Netherlands, Romania, Latvia and the United Kingdom — is “one of the largest U.S.-led disruptions of a botnet infrastructure” used by criminals to facilitate ransomware, financial fraud and other cyber-enabled criminal activity, the FBI said in a statement.
    • “There were no arrests in connection with the operation but the investigation remains ongoing, a senior FBI official told reporters Tuesday.
    • “Qakbot, also known as Qbot or Pinksipbot, is malware first detected in 2008 that has been associated with hundreds of millions of dollars in losses to individuals and businesses in the U.S. and around the world, according to the FBI. The malware has been an initial entry mechanism for a variety of ransomware groups over the years. Groups such as Conti, ProLock, Egregor, REvil, MegaCortex and Black Basta have been known to use it. Between October 2021 and April 2023, the FBI said, Qakbot administrators have received fees corresponding to approximately $58 million in ransoms paid by victims.
  • Cybersecurity Dive adds
    • “The FBI was able to redirect botnet traffic toward servers it controlled and disrupt the operation. More than 200,000 computers in the U.S. alone were found to be infected. Authorities also seized $8.6 million in illicit cryptocurrency as part of the takedown. ***
    • “The FBI and Dutch National Police have set up website links where stolen credentials can be accessed to find out if they were used.” 
  • Here are links to the related CISA announcement and Security Week’s report on industry reaction to this news.
  • Krebs on Security informs us,
    • “Domain names ending in “.US” — the top-level domain for the United States — are among the most prevalent in phishing scams, new research shows. This is noteworthy because .US is overseen by the U.S. government, which is frequently the target of phishing domains ending in .US. Also, .US domains are only supposed to be available to U.S. citizens and to those who can demonstrate that they have a physical presence in the United States.
    • “.US is the “country code top-level domain” or ccTLD of the United States. Most countries have their own ccTLDs: .MX for Mexico, for example, or .CA for Canada. But few other major countries in the world have anywhere near as many phishing domains each year as .US.
    • “That’s according to The Interisle Consulting Group, which gathers phishing data from multiple industry sources and publishes an annual report on the latest trends. Interisle’s newest study examined six million phishing reports between May 1, 2022, and April 30, 2023, and found 30,000 .US phishing domains.
    • “.US is overseen by the National Telecommunications and Information Administration(NTIA), an executive branch agency of the U.S. Department of Commerce. However, NTIA currently contracts out the management of the .US domain to GoDaddy, by far the world’s largest domain registrar.”
  • Go figure.
  • Cybersecurity Dive tells us last Monday
    • “The blast radius from the mass exploit of a zero-day vulnerability in the MOVEit file transfer service reached another milestone in its destructive spread: more than 1,000 organizations are impacted, according to Emsisoft and KonBriefing Research.
    • “The number of organizations hit by the wide-scale attack increased nearly 40% last week, underscoring the scope of impact and challenge organizations are encountering as they work to determine potential exposure.
    • “The pool of victims from Clop’s attack spree, which was discovered Memorial Day weekend, continues to grow as downstream victims, which lead to more downstream victims, are identified via public disclosures and the threat actor’s website.
  • Health IT Security adds
    • “This week, Singing River Health System in Mississippi is actively facing system downtime as it investigates a cyberattack on its network. What’s more, Prospect Medical Holdings, which operates 16 hospitals and more than 165 clinics across Southern California, Rhode Island, Pennsylvania, and Connecticut, is still experiencing a systemwide outage that began on August 9.
    • “As these incidents continue to develop, other entities have continued to report confirmed data breaches to HHS, as exemplified in this week’s data breach roundup. Third-party data breaches continue to dominate breach notifications, causing breaches across the country.”
    • The article goes on to highlight recent breach announcements. 

From the cybersecurity defenses front,

  • Per Cybersecurity Dive,
    • “Organizations are facing more obstacles obtaining or renewing cyber insurance coverage,  according to a survey of 300 organizations conducted by Censuswide, on behalf of Delinea. Organizations also face strict requirements to get a claim covered.
    • “The majority of organizations, 4 in 5,  said their insurance rates went up when they submitted a new application or applied for policy renewals, with two-thirds reporting premium hikes of between 50% and 100%. 
    • “It is also taking organizations longer to obtain new coverage. The process for 20 of those surveyed, roughly 7%, took six months or longer.”
  • The Healthcare and Public Sector Critical Infrastructure Security and Resilience Partnership released an updated version of its Health Industry Cybersecurity Tactical Crisis Response Guide.
  • An ISACA expert discusses “Contending with Artificially Intelligent Ransomware.”
  • HHS’s 405(d) group released a cyber-hygiene poster oriented toward healthcare providers. Nevertheless, it can be adapted for health plan use.
  • Forbes identifies ten “captivating” cybersecurity conferences being held in Fall 2023.

Friday Factoids

Photo by Sincerely Media on Unsplash

From Washington, DC

  • The Wall Street Journal reports
    • Nursing homes will have to maintain minimum staffing levels under a Biden administration proposal despite furious lobbying from the industry, which says it will be too onerous amid a continuing labor shortage.
    • “Biden administration officials said the first-ever national staffing rule would require nursing homes that participate in Medicare and Medicaid to provide a minimum of 0.55 hours of care from a registered nurse per resident a day, and 2.45 hours of care from a nurse aide per resident a day. A registered nurse would be required to be on-site at all times and nursing-home care assessments would be strengthened under the proposal.
    • “The Centers for Medicare and Medicaid Services estimates that about 75% of nursing homes would have to strengthen staffing in their facilities under the proposal. The proposed staffing standard exceeds those existing in nearly all states.”
  • and
    • “The Federal Trade Commission said Friday it had agreed to end its legal challenge of drugmaker  Amgen’s $27.8 billion deal to buy  Horizon Therapeutics, averting a trial that was to have started this month.
    • “The pact also dismisses the antitrust claims of six states that joined the FTC in May seeking to block the deal over concerns that Amgen would illegally bundle its products with Horizon’s medicines for thyroid eye disease and gout. Amgen agreed in the proposed settlement not to bundle the Horizon treatments and swore off conditional rebates or other tactics that could entrench the monopoly position of Horizon’s products.”
  • HHS Secretary Xavier Berra made a statement recognizing National Suicide Awareness Month.
    • “The Biden-Harris Administration is deeply committed to tackling the mental health crisis facing America, particularly the alarming rates of suicide. Recognizing the urgency of this issue, SAMHSA continues to support the Suicide Prevention Resource Center and consistently invests millions in suicide prevention initiatives. In fact, SAMHSA will award nearly $12 million to the Zero Suicide in Health Systems program next week. This ambitious program aims to comprehensively integrate the Zero Suicide intervention and prevention model across various health systems with the express aim of reducing suicide ideation, suicide attempts, and deaths due to suicide.
    • “But no program exemplifies our work to prevent suicide better than 988, the three-digit Suicide & Crisis Lifeline, which HHS launched in collaboration with the states in 2022. The Biden-Harris Administration has invested close to $1 billion in 988, and, thanks to 988, Americans are now connected with trained counselors who offer real support in times of crisis. Since the July 2022 launch, 988 has received more than 5.5 million calls, texts, and chats, and this July, text and chat were made available in Spanish.”
  • Per Fierce Healthcare,
    • Enforcement of information blocking penalties for health IT entities [went] into effect on Friday, opening the door to penalties of up to $1 million per violation.
    • The breakdown of how exactly the Department of Health and Human Services (HHS) Office of Inspector General (OIG) will prioritize what it expects to be a deluge of information-blocking complaints was posted by the regulator in late June.

From the public health front,

  • The Wall Street Journal discusses “Covid This Fall: What’s the Same, What’s Different and What to Know.”
  • The Hill adds
    • “COVID-19 hospitalizations have steadily increased over the past few weeks, reaching 15,067 for the week ending Aug. 19 — an 18.8 percent increase from the week prior, according to CDC data. But at this time last year, the U.S. averaged over 84,000 hospitalizations per week. More than 96 percent of U.S. counties are experiencing low COVID-19 hospitalization levels, at less than 10 new COVID-19 hospital admissions per 100,00 people.”
  • Per Beckers Hospital Review,
    • “The CDC updated its risk assessment on distant omicron relative BA.2.86 on Aug. 30, saying the strain — which has concerned experts over the large number of mutations it carries — has been detected in at least four states. 
    • “CDC continues to track the presence of the BA.2.86 [COVID-19] variant,” the update said. “Since CDC’s initial risk assessment, this variant has been identified in additional countries from both human and wastewater specimens.” 
    • “In the U.S., BA.2.86 cases have been detected in Virginia, Michigan, Ohio and New York either through human samples or wastewater samples. Separately, Houston Methodist in an Aug. 31 statement emailed to Becker’s said it has identified Texas’ first reported instance of BA.2.86 through genomic sequencing. The hospital’s COVID-19 sequencing team continues to sequence all positive specimens.” 
  • The New York Times Morning column provides an overview of Fall 2023 Covid, flu and now RSV vaccines. Of note, at least to the FEHBlog,
    • “This year’s flu vaccine shots are now available at drugstores, hospitals, doctor’s offices and elsewhere. You may want to wait until late September or October to get one, though. The heaviest parts of flu season tend to occur between December and February. If you wait, the shot’s protection against severe illness will still be near its strongest level during those months.”

From the U.S. healthcare business front,

  • Healthcare Dive relates,
    • “Walgreens chief executive Rosalind Brewer is stepping down as CEO and a member of the board effective immediately, the retail pharmacy giant announced Friday.
    • Brewer’s departure comes less than three years after she joined the Illinois-based retailer. The parting was a mutual decision between Brewer and Walgreens’ board, according to a release. Walgreens’ lead independent director Ginger Graham will serve as interim CEO while the company looks for a permanent replacement.”
  • STAT News discusses the “curious case of J&J’s Stelara, the unluckiest drug on Medicare’s list” of ten drugs subject to CMS “price negotiation.” Bad beat.