From Capitol Hill, the Senate Homeland Security and Governmental Affairs Committee will hold a full Committee hearing to examine cybersecurity risks to the healthcare sector. The hearing will occur on Thursday, March 16, 2023, at 10 am.
Among the topics at the hearing will be a serious cybersecurity breach at DC Health Link which runs the DC health marketplace under the Affordable Care Act (“Act”). In the Affordable Care Act (“ACA”) Congress shifted its health benefits coverage for its members and senior staffers from FEHB to the ACA marketplace. Of note, Congress was directly hit in the OPM breach and this new one.
A hacker who uses the pseudonym “Denfur” is selling a database they claim includes stolen sensitive data from at least 55,000 customers of D.C.’s health insurance marketplace, including members of Congress and their staffs.
DC Health Link, which confirmed the breach and dark web leaks in a statement, helps all city residents purchase health insurance, not just members of Congress.
What’s happening: Researchers at Check Point Research told Axios Thursday that a malicious hacker had posted the database for sale on the “biggest English-speaking dark web hacking forum.” The member claims the database includes sensitive data from thousands of customers, including Social Security numbers, birthdates and home addresses.
Denfur is now selling the stolen database for just “a few dollars,” researchers noted. Denfur signed off the post with “Glory to Russia!”
CyberScoop reports that a sample of the stolen data includes information about former defense officials and lobbyists, and the Associated Press reported it was able to authenticate data belonging to two victims in the set.
Axios has seen the dark web post, which was still live as of Friday morning.
A person using the moniker “IntelBroker” first posted the stolen data on March 6 to an online forum, where data breaches are publicized and data is either published for download or offered for sale. That post was subsequently pulled down, and “IntelBroker” is now listed permanently banned.
Three days later, on March 9, a second user going by the name “Denfur” — whose signature on the site reads “Glory to Russia!” — posted what they claimed was the full database, along with a sample that includes 200 entries. The full dataset includes 67,565 unique entries and about 55,000 “unique people,” Denfur claimed.
At about midday Thursday Denfur also claimed that “the intended target WAS U.S. Politicians and members of U.S. Government.” The quote appeared alongside a link to a news story about the incident quoting House of Representatives Chief Administrative Officer Catherine Szpindor as saying that the members of Congress were not the specific target of the attack.
From the cybersecurity risks / vulnerabilities front —
CrowdStrike, a cybersecurity firm that tracks the activities of global threat actors, reported the largest increase in adversaries it has ever observed in one year — identifying 33 new threat actors and a 95% increase in attacks on cloud architectures. Cases involving “cloud-conscious” actors nearly tripled from 2021.
“This growth indicates a larger trend of e-crime and nation-state actors adopting knowledge and tradecraft to increasingly exploit cloud environments,” said CrowdStrike in its 2023 Global Threat Report.
Besides the raft of new threat actors in the wilds that it pinpointed, CrowdStrike’s report also identified a surge in identity-based threats, cloud exploitations, nation-state espionage and attacks that re-weaponized previously patched vulnerabilities. * * *
Last week’s revelation of an attack on password manager LastPass, with 25 million users, says a lot about the difficulty of defending against data thieves entering either by social engineering or vulnerabilities not usually targeted by malware. The insurgency, the second attack against LastPass by the same actor, was possible because the attack targeted a vulnerability in media software on an employee’s home computer, releasing to the attackers a trove of unencrypted customer data.
The Cybersecurity and Infrastructure Security Agency (CISA) added three known exploited vulnerabilities to its catalog on March 7, 2023, and two more on March 10. Bleeping Computer provides its perspective here.
Tech Republic also highlights a cybersecurity report from the World Econonic Forum that is worth a gander.
From the ransomware front
Tech Republic informs us based on the CrowdStrike report that cybercriminals are shifting tactics from ransomware to data exfiltration and extortion like what happened at DC Health Link. “There was a 20% increase in the number of adversaries conducting data theft and extortion last year, by CrowdStrike’s reckoning.”
HHS’s Healthcare Sector Cybersecurity issued a threat alert on data exfiltration trends in the healthcare sector on March 9.
Here’s a link to Bleeping Computer’s The Week in Ransomware.
HHS, through the Administration for Strategic Preparedness and Response (ASPR), and the Health Sector Coordinating Council (HSCC) Cybersecurity Working Group released the Cybersecurity Framework Implementation Guide to help the healthcare sector manage cybersecurity risks amid an increasingly sophisticated threat landscape.
The guide aims to help healthcare organizations align their cyber programs with the National Institute for Standards and Technology (NIST) Cybersecurity Framework (CSF). * * *
The publication is not intended to replace other cybersecurity programs or provide a roadmap to compliance, the guide states. Rather, the voluntary guidance can help healthcare organizations bolster their existing programs and ideally reduce risk by aligning the healthcare sector with NIST’s robust framework.
Bank Info Security points out that “In addition to the new joint NIST cybersecurity framework toolkit, the Health Sector Coordinating Council and HHS are also close to completing an update of a joint 2019 publication, Health Industry Cybersecurity Practices.”
On Thursday, OPM Director Kiran Ahuja appeared at a hearing before the House Oversight and Accountability Committee for around three hours of questioning. Federal News Network tells us
This week, the Oversight and Accountability Committee held seven hearings in the span of just two days. Members are probing fraudulent payments of pandemic relief programs, advances in artificial intelligence (AI) and inflation, to name just a handful.
The FEHBlog listened to the hearing. Much of the questioning at the hearing stems from OPM’s struggles with federal retirement program administration. OPM must deal with an unnecessarily complicated retirement system that Congress created. Congress could solve OPM’s administration/customer service problem by simplifying federal employee retirement laws.
In FEHB news, Ms. Ahuja announced
OPM will issue the Postal Service Health Benefits Program (“PSHBP”) interim final implementation rule in April 2023. Bear in mind that the statutory deadline is April 6, 2023.
OPM expects to solve its FEHB eligibility issues by ending the current decentralized approach to FEHB enrollment under which federal agencies hold primary responsibility. Remember that half of the enrollment, the annuitants, already are centralized in the OPM annuitant payroll office. Nevertheless, OPM plans to roll out its new 100% centralized approach with the PSHBP for 2025 and subsequently extend it to legacy FEHB.
OPM works “hand in glove” with the Postal Service to implement the PSHBP.
Like FedWeek (as discussed in FEHBlog posts earlier this week), Congress does not understand the FEHB’s hardcore transparent prescription drug pricing program for experience-rated carriers. Director Ahuja did not trumpet OPM’s game-changing decision to allow integrated Medicare Part D EGWPs for 2024.
It’s worth adding that the Federal Times has recognized that OPM has improved FEHB infertility treatment benefits for 2024 and that Govexec.com includes an article about the OPM call letter for 2024 benefit and rate proposals, which includes a misunderstanding of Medicare programs being integrated into FEHB for greater savings.
OPM is encouraging FEHB carriers to offer Medicare Advantage Prescription Drug Employer Group Waiver Plans, which are designed to maximize value to enrolled individuals under FEHB and Medicare. These are special plans more generous than standard Medicare Advantage plans.
In recent years, a growing number of FEHB carriers have offered such plans. They must provide benefits that are at least the same as those offered by other Medicare plans.
Over the past decade, FEHB plans have been integrating Medicare Advantage / Prescription Drug Plans. These are known as MAPDs. Annuitants with Medicare Part A and B coverage can opt into these MAPD plans and receive a Part B premium subsidy, among other benefits.
In a January 2023 carrier letter and the February 2023 call letter, OPM informed carriers of a new opportunity to offer Medicare Part D EGWPs. These “new to FEHB” Part D prescription drug plans, which can be integrated with FEHB Rx benefits, are open to all Medicare prime annuitants, including Medicare Part A only members.
With the current integrated MAPD plans, opting-in annuitant members must pay the Medicare Part B premium adjusted for the Plan subsidy. With the Part D PDPs / EGWPs, the Plan covers the Part D premiums for the participating members.
In regular Friday post news, here are links to the CDC’s Covid Data Tracker, which continues to show downward trends in new cases, hospitalizations and deaths, and the CDC’s weekly Fluview, which indicates, as folks know, that the flu epidemic is over.
The FEHBlog also suggests that readers listen to the 15-minute long, eye-opening Wall Street Journal podcast on fentanyl test strips.
From our Nation’s capital, the President presented his Fiscal Year 2024 budget to Congress today. Roll Call informs us
While spending would increase by $1.9 trillion over a decade, revenue would increase by $4.7 trillion, for over $2.8 trillion in a 10-year deficit reduction. But according to the Office of Management and Budget’s numbers, the budget shortfall would still total more than $17 trillion over the next decade even if Biden’s plans were fully implemented, which seems unlikely.
The Wall Street Journal adds, “Biden’s budget shows the rising cost of leaving Medicare and Social Security untouched. In the President’s blueprint, the two programs plus interest consume a sharply growing share of economic output.
The President’s proposed spending and tax increases will face an unfriendly reception among Republicans in Congress, as lawmakers gear up for a fight over the debt ceiling that could come before the Sept. 30 end of the fiscal year. GOP leaders in the House have called for unspecified spending cuts as a condition of raising the federal debt limit. But the president has said he won’t negotiate over raising the debt ceiling.
Republicans plan to release their own budget proposal in the coming months, though they haven’t agreed on a plan.
The President will make public more budget details over the next few days. Until then, it’s worth noting that the budget includes the following healthcare proposal
The budget proposes $11 billion for a five-year effort the White House hopes will eliminate hepatitis C in the U.S., said Dr. Francis Collins, the former National Institutes of Health director who is spearheading the initiative. Drugs to treat the disease have been on the market since 2013, but normally retail for about $24,000 per patient.
In related news, the American Hospital Association tells us,
“The Centers for Disease Control and Prevention [CDC] today recommended screening all U.S. adults at least once in their lifetime for hepatitis B using three laboratory tests. It also expanded risk-based testing recommendations to certain populations and activities with increased risk for the hepatitis B virus.”
The FEHBlog is unsure how this meshes with the ACA’s preventive services mandate because the current US Preventive Services Task Force recommendation is Grade B for “screening for hepatitis B virus (HBV) infection in adolescents and adults at increased risk for infection.” The CDC’s new recommendation is significantly broader.
The Office of Personnel Management released on March 7 “a new memorandum today detailing a vision for the future of the workforce: a Federal government with a workforce that is inclusive, agile and engaged, with the right skills to enable mission delivery.”
From the public health front —
The Kaiser Family Foundation notes ten numbers to mark the third anniversary of the Covid pandemic
The Dana Farber Cancer Institute highlights a comprehensive article about colon cancer in young adults.
The Food and Drug Administration “published updates to the mammography regulations to, among other things, require mammography facilities to notify patients about the density of their breasts, strengthen the FDA’s oversight and enforcement of facilities and help interpreting physicians better categorize and assess mammograms.
The New York Times reports, “A review of poisonings among children 5 and younger found that opioids contributed to nearly half of the deaths from 2005 to 2018, largely from accidental overdoses, according to new research. * * * The study, published on Wednesday in the journal Pediatrics, analyzed 731 poisoning-related deaths that occurred from 2005 to 2018 across 40 states.”
From weight loss drugs front —
STAT News continues its reporting on obesity drugs. The latest article concerns “‘Emotional hunger’ vs. ‘hungry gut’: The attempt to subtype obesity and tailor treatments.”
Medscape provides the account of a physician who took the new obesity drugs, specifically Ozempic. This article is particularly worth a gander.
From the SDOH front, Mercer Consulting lays out its latest “Must-Do Strategy: Lean in on Benefits Strategy to Support DEI Goals.”
From the miscellany department
Cigna offers its insights on how to choose among virtual care, urgent care centers, and emergency rooms.
“In a March 8 Twitter thread, the FDA acknowledged it’s aware of a potential drug supply disruption after Gurnee, Ill.-based Akorn Operating Co. closed in late February.
“The FDA clarified that the ongoing shortage is of a specific albuterol inhalation solution used in nebulizers, typically in hospitals, for patients having trouble breathing, not in inhalers at the consumer level. The agency said it is working with manufacturers to ease the shortage and “reiterated that outsourcing facilities may compound the specific product.”
Finally, following up on the FEHBlog’s message to Congress about FEHB prescription drug costs, OPM stated its position against carving out prescription drug coverage from FEHB carrier responsibilities in the agency’s FY 2018 annual financial report on page 123:
OPM does not concur with OIG’s suggestion that OPM continue to pursue efforts towards a prescription carve-out program. The Federal Employees Health Benefits (FEHB) Program is a market-based program that provides complete health benefits within each FEHB plan. The FEHB Program is not a self-funded plan and its statutory framework does not contemplate it to be the direct payer of benefits. Each FEHB Program plan offers comprehensive medical services including services provided by physicians and other health care professionals, hospital services, surgical services, prescription medications, medical supplies and devices, and mental health services. FEHB Program plans compete to offer all of these benefits in a high quality manner at the most competitive price possible.
Carving out pharmacy benefits or any of the other services normally covered under an FEHB Program contract and administering the benefit as a separate contract or program, could undermine the fundamental market-based nature ofthe FEHB Program. It would be disruptive and could lead to a reduction in plan participation, and limit the ability of FEHB carriers to focus on comprehensively improving the health of the population. There would likely be less effective
coordination of medical and pharmacy claims, and potentially less effective, one-size-fits-all pharmacy utilization and disease management programs. OPM is now assessing carrier performance on the basis of clinical quality measures that require tight coordination between medical and pharmacy benefits. A carved out pharmacy benefit is not consistent with or supportive of plan performance assessment, and may impair achievement of OPM’s long-term population health goals. As an example, carriers being held accountable for controlling diabetes and hypertension in the population they serve cannot do so readily if they do not have control over pharmacy benefit design and real time access to adherence data.
To control the cost of prescription drugs, OPM works with carriers to better manage pharmacy networks, focus on drug utilization techniques, coordinate coverage of specialty drugs between the medical and pharmacy benefit, optimize the prescription drug benefit via formulary design, and implement effective cost comparison tools for members and prospective enrollees. Additionally, OPM notes that the most recent drug trend reported by FEHB carriers showed a significantly slower rate of growth compared with previous years, in line with industry trends.
This statement continues to warm the FEHBlog’s heart.
American women are staging a return to the workforce that is helping propel the economy in the face of high inflation and rising interest rates.
Women have gained more jobs than men for four straight months, including in January’s hiring surge, pushing them to hold more than 49.8% of all nonfarm jobs. Female workers last edged higher than men on U.S. payrolls in late2019, before the pandemic sent nearly 12 million women out of jobs, compared with 10 million men.
The Society for Human Resource Management offers five ways employers can reduce gender disparities at work.
Following up on recent posts —
The Wall Street Journal brings us up to date on Lilly’s decision to offer its insulin products on the commercial market with a $35 copayment.
“Lilly comes out the winner of this saga, for now. It dealt PBMs a blow, avoided paying Medicaid rebates that were going to rise next year if its insulin products remained highly-priced, and received plaudits from President Biden. The move also complicates matters for upstarts such as Civica. But Allan Coukell, Civica’s senior vice president of public policy, says plans to introduce low-cost insulin as soon as next year are unchanged.”
Bloomberg offers an article on biological age testing that mentions Elysium Health, whose CEO spoke at the WSJ Health Forum on Monday.
Beckers Hospital Review tells us that the Amoxicillin shortage is continuing. Because Amoxicillin is one of several drug shortages, Pharma News Intelligence offers short-term and long-term management strategies to deal with them.
Last week, the Food and Drug Administration issued an emergency authorization for the first at-home Covid-19 and flu combination test. The news came just days after the test’s maker, Lucira, filed for bankruptcy, blaming the FDA’s “protracted” approval process for its financial problems.
“Now the FDA has released a rare comment clarifying what happened during its authorization process. The new details are raising hopes among other home-test manufacturers that the FDA is becoming more flexible about its requirements for approving at-home flu test kits.”
Beckers Payer Issues informs us,” Providers join payers in urging CMS to halt proposed 2024 Medicare Advantage rates.” Good news for AHIP. Healthcare Dive reviews insurer and trade association comments to CMS on this topic.
The Wall Street Journal highlights the growing backlog of No Surprises Act arbitrations. The silver lining in this cloud is that the litigation-related backup does not impact the law’s Open Negotiation Process. Providers and payers should work to resolve qualifying payment disputes through that effective process.
In other news
JAMA points out a recent CDC report documenting disparities in mental health-related emergency department care.
The Drug Channels blog lists the 15 largest U.S. pharmacies. (Trigger warning the link is principally a sales pitch for Drug Channels, but the information is useful.)
“Abbott received U.S. Food and Drug Administration clearance for what it said will be the first commercially available laboratory blood test to help evaluate traumatic brain injury (TBI), also known as concussion.
“The test offers a result in 18 minutes, allowing clinicians to quickly assess patients with concussion and triage them, the company said Tuesday. A negative test result can rule out the need for a CT scan, eliminating wait time at the hospital.
“The test runs on Abbott’s Alinity i laboratory instrument, making it widely available to U.S. hospitals, the Chicago area-based company said.”
NPR discusses efforts to right various healthcare debt collection wrongs:
“Dozens of advocates for patients and consumers, citing widespread harm caused by medical debt, are pushing the Biden administration to take more aggressive steps to protect Americans from medical bills and debt collectors.
“In letters to the IRS and the Consumer Financial Protection Bureau, the groups call for new federal rules that, among other things, would prohibit debt for medically necessary care from appearing on consumer credit reports.
“And the groups are pressing the IRS to crack down on nonprofit hospital systems that withhold financial assistance from low-income patients or make getting aid cumbersome, another common obstacle KHN documented.”
The House Oversight and Accountability Committee has started an investigation into the role of “pharmacy benefit managers” (PBMs), which act as a middleman between insurance carriers and pharmaceutical companies in healthcare programs, including the FEHB.
“Greater transparency in the PBM industry is vital to determine the impact PBM tactics are having on patients and the pharmaceutical market,” chairman Rep. James Comer, R-Ky., wrote to OPM. He asked for copies of the PBM contracts in the program and information on how they are carried out, as well as for information on the rebates, fees, or other similar charges received by PBMs and any efforts the agency has made to recoup overpayments to them.”
“The use of pharmacy benefit managers has been a long-running issue in the FEHB, with prior proposals—mainly sponsored by Democrats, unsuccessfully—to limit their role or even have OPM negotiate with pharmaceutical companies directly on a program-wide basis.
“The inspector general’s office at OPM also has raised that issue, in a recent report saying that “the discounts and other financial terms differed significantly among carriers, with those that have higher enrollments receiving the best deals, reducing the likelihood that the FEHB is maximizing prescription drug savings.”
“That report recommended that OPM conduct a study on options to hold down prescription drug costs, which account for a quarter of all spending in the FEHB. OPM agreed in principle, although it said it does not have the needed funds to conduct such a study.”
OPM should inform Rep. Comer that
The FEHB Program’s experience-rated carriers, who cover 80% of the FEHB enrollment, are subject to the country’s strictest PBM price transparency arrangement, as far as the FEHBlog knows. Congress should evaluate that system to help the legislative body decide whether transparency should be expanded to ERISA and ACA marketplace plans.
In the late 2010s, OPM announced in a management report that the agency agreed with carriers that the FEHB Program saves money by allowing carriers to manage medical and pharmacy benefits under OPM’s oversight. FEHB plan carrier HealthPartners offers a useful examination of carve-in vs. carve-out Rx program management topics.
OPM has authorized FEHB carriers to offer prescription drug plans integrated with Medicare Part D beginning in 2024. This change will rapidly reduce the FEHB Program’s prescription drug spend to commercial plan levels. It’s not magic.
In sum, the FEHB Program remains a model employer-sponsored health program.
From our Nation’s Capital, Roll Call fills us in on the debt ceiling negotiations. Significantly,
Economists at Moody’s Analytics estimate that the Treasury Department will run out of borrowing room by mid-August if Congress doesn’t act to raise or suspend the statutory debt limit by then.
The “x date” after which Treasury may not be able to pay all of the federal government’s bills appears to be Aug. 18, specifically, according to Moody’s economists Mark Zandi, Christian deRitis and Bernard Yaros.
The trio laid out various scenarios and potential consequences of failure to lift the $31.4 trillion debt ceiling in a new paper this week, on a topic that was examined more closely Tuesday afternoon in a Senate Banking subcommittee hearing led by Sen. Elizabeth Warren, D-Mass. Zandi is among those slated to testify.
The propspect of a mid-August explosion may encourage Congress to suspend the debt ceiling suspension until the end of the federal fiscal year, September 30, and focus on negotiating the interrelated 2024 appropriations and the debt ceiling topics.
The President provided highlights of the Medicare proposals in his 2024 fiscal year budget. The American Hospital Association explains
The president’s fiscal year 2024 budget will propose policies to keep Medicare’s Hospital Insurance Trust Fund solvent for at least an additional 25 years by directing additional Medicare taxes and savings from prescription drug reforms to the HI Trust Fund, the White House announced today. According to the latest annual report by the Medicare Trustees, the fund currently has sufficient funds to pay full benefits until 2028.
Among other Medicare provisions, the president’s budget will propose to eliminate cost-sharing for three behavioral health visits per year; require parity between physical health and mental health coverage; lower out-of-pocket costs for drugs subject to price negotiation; and cap Part D cost-sharing for certain generic drugs, the White House said.
The president’s FY 2024 budget is expected to be publicly released on March 9, with additional detail on March 13. AHA members will receive additional information on the president’s budget as those details are released.
Congress shared the budget with the Congressional Budget Office to analyze whether this plan will work.
Federal News Network reports on a recent GAO report about OPM.
The Office of Personnel Management is at “significant risk” of being unable to help agencies address governmentwide skills gaps, if it can’t first do a better job of addressing its internal skills gaps, GAO said in a report published last week.
Persistent internal skills gaps “could compromise OPM’s ability to implement its strategic objectives related to closing governmentwide skills gaps,” GAO said in the Feb. 27 report.
Although OPM has made progress in some areas of workforce management, such as creating an internal committee to hire and train new staff members, the agency is struggling to clearly identify and address several skills gaps within its own staff. * * *
Ron Sanders, former chairman of the Federal Salary Council and former associate director for HR policy at OPM, said the results of the GAO report were “unsurprising,” but that the reason behind the challenges may be difficult to measure.
“I think the skills gaps and have more to do with intangibles than they do with specific functional specializations,” Sanders, current president and CEO of Publica Virtu LLC, said in an interview with Federal News Network.
Hang in there, OPM, which has a lot on its plate, as we all do.
The Federal Trade Commission will give the public an additional 30 days to comment on a sweeping proposal to ban employers from imposing noncompete contracts on their workers.
The agency said interested parties have requested an extension, though acknowledged others oppose the delay. The public now has until April 19 to comment on the proposed rule, the FTC said on Monday.
FTC Commissioner Christine Wilson said in a separate statement that she would have supported an even longer extension since the proposal is “a departure from hundreds of years of precedent.”
MedCity News writes about the state of No Surprises Act rulemaking. Of note,
What the industry really needs from the government agencies at this point is a road map, or, as the Workgroup for Electronic Data and Interchange (WEDI) said in a recent letter to the secretary of HHS, a “glide path” that explains how the industry and the government will develop standards and operating rules together. In the letter, WEDI asked for the government’s expectations on vetting and testing standards and an estimate on timelines for implementing NSA regulations.
The FEHBlog heartily agrees with WEDI. Congress should consider amending certain provisions, particularly the good faith estimate and advance explanation of benefit provisions which should be amendments to the HIPAA electronic transaction standards and narrowed in scope.
From the Food and Drug Administration front —
STAT News provides an interview with Food and Drug Commissioner Dr. Robert Califf. For example
FDA Commissioner Robert Califf said on Monday that it “bothers” him that Novo Nordisk, which makes an obesity medication, funded the development of obesity coursework for medical schools. But he also said he saw it as an example of a drug company filling the void left by health systems that aren’t teaching doctors and trainees how to use new medicines.
“I think it’s a shame that you would need to depend on a pharmaceutical company for an educational program about something that’s affecting half of Americans,” Califf said during a meeting with STAT reporters and editors.
But, he said, “we also live in a practical real world. You might argue that if health systems did their jobs, you would have no need for educational programs from drug companies. But talk to people who practice medicine who are part of these big health systems and ask them how much help they get and guidance on what to do from the health systems they work for. I say this being a card-carrying lover of academic health systems, but that’s not where the money goes in academic health systems.”
The FDA is set to decide whether to fully approve Leqembi, Eisai and Biogen’s Alzheimer’s treatment by July 6, CNBC reported March 6.
Leqembi is an antibody treatment that targets brain plaque associated with Alzheimer’s. The drug is administered intravenously twice a month and in clinical trials has shown it can slow early Alzheimer’s disease by 27 percent; however, the deaths of three trial participants may be tied to brain swelling caused by the drug.
The FDA approved the drug on an expedited basis in January, but CMS has made it accessible to patients only in clinical trials. CMS plans to provide broader coverage if Leqembi is fully approved, according to CNBC.
Makena was the only drug approved by the Food and Drug Administration to reduce the risk of preterm birth in women with a history of early deliveries.
Covis said Tuesday it wants to work with the FDA to set a wind-down period for the drug so that patients aren’t abruptly taken off of it. The company said it was acting after experts advising the agency recommended it pursue Makena’s withdrawal from the market.
Eli Lilly and Company (NYSE: LLY) today [March 3] announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Verzenio® (abemaciclib), in combination with endocrine therapy (ET), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at a high risk of recurrence. High risk patients eligible for Verzenio can now be identified solely based on nodal status, tumor size, and tumor grade (4+ positive nodes, or 1-3 positive nodes and at least one of the following: tumors that are ≥5 cm or Grade 3).1 This expanded adjuvant indication removes the Ki-67 score requirement for patient selection.
“The first hospitals seeking CMS’ new rural emergency hospital designation have submitted their applications, Kaiser Health News reported March 6.
“Hospitals that convert receive a 5 percent increase in Medicare payments as well an average annual facility fee payment of about $3.2 million, according to the report. In return, the hospitals must close their inpatient beds and focus solely on outpatient and emergency care.”
“Regional health system Atrium Health [headquartered in Charlotte, NC] is partnering with tech retailer Best Buy to co-design hospital-at-home programming, bolster Atrium’s existing hospital-at-home program and sell to other hospital clients down the line.
The partnership, announced Tuesday, aims to combine Atrium’s hospital-at-home program and existing telemedicine infrastructure with Best Buy Health, the retailer’s healthcare vertical that includes care-at-home business Current Health, along with its home installation and supply chain capabilities.
“The Atrium and Best Buy partnership seeks to improve some aspects of hospital-at-home programs that can be particularly tricky for operators, like patient education and technology installation in the home.
Beckers Hospital Review tells us, “Mark Cuban Cost Plus Drug Co. has entered into an agreement with IBSA Pharma to sell Tirosint, a medication for hypothyroidism. It will be the first brand-name drug offered by Mr. Cuban’s pharmacy.”
From the medical and pharmaceutical research and studies front —
“Some doctors are urging patients to cut back their consumption of sugar substitutes as questions mount about their health effects.
“In the latest study, published February in the journal Nature Medicine, Cleveland Clinic researchers found that the commonly used zero-calorie sweetener erythritol was associated with an increased risk of heart attacks, strokes and death within three years.
“Erythritol, a sugar alcohol produced naturally in the body, is used as a sugar substitute in low-calorie and low-carb products, often in those marketed as keto-friendly, such as ice cream, baked goods and condiments. It is also often mixed with other sweeteners.
“As low-carb and ketogenic diets have grown popular, people have turned to nonsugar-sweetened products for a hit of sweetness with less sugar and carbs. Yet, researchers are warning that sugar substitutes might pose their own health concerns.”
Medscape considers whether Vitamin D is a viable prevention strategy for dementia.
The NIH Director’s Blog discusses the importance of dental/oral health care to overall health and well-being.
“Fully 73% of Generation Z employees and 74% of Millennial employees have utilized mental health benefits offered by their employers, while 58% of Generation X employees and 49% of Baby Boomer employees have used the benefits.
Additionally, while 65% of Generation Z and 60% of Millennial workers say it’s “very important” for their employers to provide mental wellness benefits, just 49% of Generation X and 45% of Baby Boomer workers say the same.”
“An experimental medicine for a rare blood vessel disorder [pulmonary arterial hypertension, or PAH, which is caused by a thickening of the blood vessels around the lungs] improved patients’ exercise capacity and potentially slowed the disease’s progression, according to detailed results from a late-stage clinical trial that were revealed on Monday.
“The drug, called sotatercept and owned by Merck & Co., was the principal prize of an $11.5 billion acquisition the pharmaceutical company negotiated more than a year ago.
“Researchers at the National Institutes of Health show the benefits of screening adult patients in remission from acute myeloid leukemia (AML) for the residual disease before receiving a bone marrow transplant. The findings, published in JAMA(link is external), support ongoing research aimed at developing precision medicine and personalized post-transplant care for these patients.
About 20,000 adults in the United States are diagnosed each year with AML, a deadly blood cancer, and about one in three live past five years. A bone marrow transplant, which replaces unhealthy blood-forming cells with healthy cells from a donor, often improves these chances. However, research has shown that lingering traces of leukemia can make a transplant less effective.
“Researchers in the current study wanted to show that screening patients in remission for evidence of low levels of leukemia using standardized genetic testing could better predict their three-year risks for relapse and survival. To do that, they used ultra-deep DNA sequencing technology to screen blood samples from 1,075 adults in remission from AML. All were preparing to have a bone marrow transplant. The study samples were provided through donations to the Center for International Blood and Marrow Transplant Research.
Journal reports interviewed health experts, such as Chelsea Clinton and Food and Drug Commissioner Dr. Robert Califf, as well as the chief executive officers of Moderna, Biogen, One Medical, and Mass General Brigham, among others
One session concerned aging. A reporter interviewed three experts, who argued among themselves. Death and taxes, right?
The FEHBlog enjoyed the opportunity to listen to the Health Forum. He continues to think that FEHBP plans who don’t try to connect their members with in-network primary care providers are missing the boat.
Also, from the public health front, the Washington Post reports
Diabetes and obesity are rising among young adults in the United States, an alarming development that puts them at higher risk for heart disease, according to a study of 13,000 people between 20 and 44 years old.
The authors of the study, published Sunday in a major medical journal, warn the trends could have major public health implications: a rising generation dying prematurely of heart attacks, strokes and other complications. And Black and Hispanic people, particularly Mexican Americans, would bear the brunt.
“We’re witnessing a smoldering public health crisis,” Rishi K. Wadhera, assistant professor of medicine at Harvard Medical School and one of the study authors, wrote in an email.
Sequence is a subscription service that offers telehealth visits with doctors who can prescribe the drugs. WeightWatchers, which has long promised to help customers lose weight through food-tracking and lifestyle changes, is moving to also offer customers a medical weight-loss approach.
STAT News notes
The obesity revolution is just getting started. Long framed as a failure of willpower and the price of poor lifestyle decisions, obesity is now more often viewed as a biological disease — one that new drugs can treat. But as people clamor for Ozempic and Mounjaro, conceived to treat diabetes, concern is rising that in the rush to prescribe them, the root causes of obesity may be overlooked, including environmental factors. And eating-disorder experts worry people’s body images could be further stigmatized.
This is a moment reminiscent of other pharma turning points, such as when Valium and Prozac changed how people perceived anxiety and depression. But both the social media buzz and pharma’s marketing — including attempts to shape medical school curricula, STAT has learned — raise fears that treating obesity could be taken too far, draining health care dollars along the way. Read more from STAT’s Elaine Chen and Matthew Herper in the first of a series.
Lilly decided to reduce its insulin prices to avoid Inflation Reduction Act penalties.
Eli Lilly would’ve had to pay Medicaid about $150 for each vial of insulin used in the program if it hadn’t dramatically cut the list prices for some of its older products this week.
The company was about to run into a Medicaid penalty for hiking the price of its drugs faster than the rate of inflation. Now that it plans to lower the list price of the insulin Humalog 70%, it won’t trigger that penalty. Lilly also is lowering the price of Lispro, a biosimilar of Humalog, to $25 a vial.
More than a quarter of Americans over 40 take medications to lower their cholesterol, most of them statins. But not everyone can tolerate statins or wants to.
Now a new study confirms that bempedoic acid, approved in 2020, not only lowers cholesterol but also reduces the risk for heart attack and stroke.
Statins will remain the first therapy patients are given to lower cholesterol. But the news means more people will likely be prescribed a once-daily pill of bempedoic acid.
Bempedoic acid is sold under the brand name Nexletol from Esperion Therapeutics of Ann Arbor, Michigan. It is sold with another drug, ezetimibe as Nexlizet.
From the U.S. healthcare business front, Healthcare Dive informs us
Transcarent, a healthcare platform for self-insured employers, has agreed to acquire the majority of on-demand virtual care platform 98point6, including its almost 100-clinician physician group, in a deal worth up to $100 million.
Transcarent will get 98point6’s self-insured employer business, affiliated physician group and a software license, while the remaining 98point6 will rebrand as 98point6 Technologies and focus on licensing its software to third-party providers.
Seattle-based 98point6 bills itself as an artificial intelligence-enabled chatbot that collects patient information and summarizes it for a physician, who continues the conversation. The transaction is expected to close by the end of March.
McKinsey & Co. offers “insights to discover why it’s impossible to experience good health alone, and what shifts you can make now to strengthen your social world” in order to combat loneliness.
Fortune Well discusses “[a] ‘super strain’ of an antibiotic-resistant stomach bug [XBR Shingella] that is on the rise in the U.S.” Fortunately, the CDC offers ways to prevent a Shingella infection:
Carefully washing your hands with soap and water before sexual activity, eating or preparing food, and after going to the bathroom, changing a diaper, or cleaning up after someone who went to the bathroom;
Throwing away diapers in a covered, lined garbage can;
Cleaning up mess from diapers thoroughly and promptly;
Avoid swallowing water from lakes, ponds, and swimming pools and
Refraining from sex when you have diarrhea, and for two weeks after diarrhea resolves.
For years, people with Type 2 diabetes who needed to take drugs to lower their blood-sugar levels started with an old medicine called metformin. New guidelines now recommend patients can start with one of the newer diabetes medicines, which can also reduce weight and protect the heart and kidney.
The goal of the changes was to make treatment more specific to the patient rather than focused on the drug, said Dr. Nuha Ali El Sayed, an endocrinologist at the Joslin Diabetes Center in Boston who is vice president of healthcare improvement at the American Diabetes Association.
MedPage Today offers doctors ways to handle the current Adderall shortage.
From the worldwide healthcare front (and many FEHB plans (particularly nationwide plans) offer worldwide coverage), Beckers Hospital Review discusses “Newsweek‘s 2023 list of top 250 global hospitals.”
From the plan design front, Financial Advisor points out an EBRI report on health savings accounts.
The New York Times Morning Column considers a renewed interest in workplace personality tests.
“Covid has opened our eyes to the fact that there are different ways in which we can work,” said David Noel, a human resources executive at Scotiabank, a Toronto-based bank with 90,000 employees. Partly for that reason, Scotiabank has begun to put more weight on personality tests, and less weight on résumés, when it makes hiring decisions.
In the post-pandemic era, personality tests seem to have a new relevance. They can help determine who will thrive in which work arrangements and what personality mix can maximize a team’s chance of success. Some advocates of the tests argue that they can also increase the diversity of a company’s work force by reducing the focus on standards that have traditionally benefited white men. Since Scotiabank began using personality tests more heavily in its campus hiring program, the share of its new employees who are Black has risen to 6 percent, from 1 percent.
The Biden administration said it would pursue laws to establish liability for software companies that sell technology that lacks cybersecurity protections, concluding that market forces alone aren’t sufficient to guard consumers and the nation.
Free markets and a reliance on voluntary security frameworks have imposed “inadequate costs” on companies that offer insecure products or services, according to a national cybersecurity strategy released Thursday. It says the administration would work with Congress and the private sector to create liability for software vendors, sketching out in broad terms what such legislation should entail. * * *
In addition to making a forceful call for expanded liability, the plan reiterates several top priorities that have frequently been listed by various senior cybersecurity officials in recent years, such as urging more collaboration and threat-intelligence sharing with the private sector, forging international partnerships to develop cyber norms, and modernizing federal technology. While much of it is consistent with the goals of past administrations, the focus on liability and mandates on critical infrastructure largely depart from President Biden’s predecessors.
The strategy also emphasizes the need for persistent use of offensive cyber capabilities, such as those housed at the U.S. Cyber Command, to disrupt and dismantle cyber threats to the U.S. The strategy’s language effectively endorses steps taken during the Trump administration to allow the military to be more active with offensive cyber weapons. Mr. Biden’s strategy replaces one issued by former President Donald Trump in 2018.
Security experts and former officials said establishing liability for software manufacturers was the most significant—if hardest to achieve—element of the strategy.
Security Week offers insider observations on the new strategy.
The document is divided into five pillars, representing key focus areas: defend critical infrastructure, disrupt and dismantle threat actors, shape market forces to drive security and resilience, invest in a resilient future, and forge international partnerships to pursue shared goals.
Each pillar has significant implications for critical infrastructure entities, including those in the healthcare sector. Namely, the National Cybersecurity Strategy highlights the need to further prioritize Internet of Things (IoT) device security and to transfer some cyber responsibilities away from software users and onto vendors.
“We must make fundamental changes to the underlying dynamics of the digital ecosystem, shifting the advantage to its defenders and perpetually frustrating the forces that would threaten it,” the document states.
“Our goal is a defensible, resilient digital ecosystem where it is costlier to attack systems than defend them, where sensitive or private information is secure and protected, and where neither incidents nor errors cascade into catastrophic, systemic consequences.”
Cybersecurity Dive discusses the path to implementing this strategy.
From the cyber breaches front, Security Week points out four recent healthcare sector data breaches.
Nearly one-third of companies lost money following a phishing attack in 2022, Proofpoint research found.
The 76% year-over-year increase in phishing attacks resulting in a wire transfer or invoice fraud reflects threat actors’ resolve to narrow their scope and steal money more quickly, according to Proofpoint’s annual State of the Phish report released Tuesday.
“We saw a significant jump in the direct financial loss,” said Sara Pan, team manager of product marketing at Proofpoint. “What that really implies is that we’re seeing attackers being more impatient and really wanting to claim their trophy right after a successful phishing attack.”
The Cybersecurity and Infrastructure Agency (CISA) added one more known exploited vulnerability to its catalog.
From the ransomware front —
Bank Info Security reports on an FBI report on ransomware attacks against critical infrastructure in 2022.
Based on known ransomware attacks, security researchers say the volume of such attacks seems to have remained constant in recent years. Ransomware incident response firm Coveware and cryptocurrency intelligence firm Chainalysis last month reported that blockchain analysis revealed a notable decline of 40% in the dollar volume of ransom being paid to criminals.
Coveware ascribed the decline directly to the FBI, which has “subtly but effectively shifted strategy from pursuing just arrests to putting a focus on helping victims, and imposing costs to the economic levers that make cybercrime so profitable.” Making a particular impact, Coveware says, is FBI agents quickly landing on-site to assist, including by helping senior executives and boards of directors understand their options.
The FBI and CISA issued an alert on Royal Ransomware.
Today [March 2, 2023], the Federal Bureau of Investigation (FBI) and the Cybersecurity and Infrastructure Security Agency (CISA) released joint Cybersecurity Advisory (CSA) #StopRansomware: Royal Ransomware to provide network defenders tactics, techniques, and procedures (TTPs) and indicators of compromise (IOCs) associated with Royal ransomware variants. FBI investigations identified these TTPs and IOCs as recently as January 2023.
Royal ransomware attacks have spread across numerous critical infrastructure sectors including, but not limited to, manufacturing, communications, healthcare and public healthcare (HPH), and education.
CISA encourages network defenders to review the CSA and to apply the included mitigations. See StopRansomware.gov for additional guidance on ransomware protection, detection, and response.
The Bleeping Computer’s Week in Ransomware is back!
Today [February 28, 2023], CISA released a Cybersecurity Advisory, CISA Red Team Shares Key Findings to Improve Monitoring and Hardening of Networks. This advisory describes a red team assessment of a large critical infrastructure organization with a mature cyber posture. CISA is releasing this Cybersecurity Advisory (CSA) detailing the red team’s tactics, techniques, and procedures (TTPs) and key findings to provide network defenders proactive steps to reduce the threat of similar activity from malicious cyber actors.
As detailed in the advisory, the CISA red team obtained persistent access to the organization’s network, moved laterally across multiple geographically separated sites, and gained access to systems adjacent to the organization’s sensitive business systems. This cybersecurity advisory highlights the importance of early detection and continual monitoring of cyber assets.
CISA encourages critical infrastructure organizations to apply the recommendations in the Mitigations section of this CSA to ensure security processes and procedures are up to date, effective, and enable timely detection and early mitigation of malicious activity.
The Cybersecurity and Infrastructure Security Agency is urging critical infrastructure providers to harden their defenses and enable phishing resistant multifactor authentication, after conducting a red team assessment of a large organization over a three-month period in 2022.
During the voluntary assessment, a CISA red team was able to gain access to workstations at separate geographic locations using spearphishing emails. The red team leveraged that access to move laterally around the network, gaining root access to multiple workstations adjacent to specialized servers.
The organization largely failed to detect multiple actions by the red team, including lateral movement, persistence and command and control activity. However, the use of strong service account passwords and MFA prevented the red team from accessing a sensitive business system.
“This highly detailed and technical report is an excellent guide to help implement specific cybersecurity tools that will help detect a cyberattack in the early stages and significantly reduce its spread and impact,” said John Riggi, AHA’s national advisor for cybersecurity and risk. “The ‘red team’ or penetration test used a common combination of voice and email social engineering techniques to gain trust of the end users and compromise their credentials, which reaffirms government and AHA cybersecurity guidance that relatively low-cost basics such as establishing phishing-resistant multi-factor authentication are essential to reduce cyber risk. I would strongly encourage hospitals and health systems to explore the possibility of leveraging CISA’s authority and capacity to provide free technical assistance, including red team penetration testing.”
Also, an ISACA expert explains why “LastPass Hack Highlights Importance of Applicable Acceptable Use Policies.”
Here are links to the CDC’s Covid Data Tracker and its last weekly interpretative review of those statistics. From now until the interpretative review ends, the interpretative review will be offered every other week, except when that Friday is the beginning of a federal three-day weekend. Good timing for this change because we just started the three-day weekend drought, which ends with Memorial Day.
The summary notes, “At this point in the pandemic, COVID-19 cases, hospitalizations, and deaths have been decreasing for several weeks, and much of the country has protection against circulating strains either through vaccination, previous infection, or a combination of both.” Nevertheless, the CDC urges folks to be vaccinated or stay current on vaccinations because the virus can change.
The CDC’s Fluview says, “Seasonal influenza activity remains low nationally.”
From the Rx coverage, Ed Silverman writing in STAT News comments
Now that Eli Lilly slashed the price for some of its insulin products, the moves raised questions about what will happen to other efforts to provide low-cost insulin, Kaiser Health News explains. Civica, a nonprofit, plans to begin selling biosimilar insulin for roughly $30 per vial by 2024 — $5 more than the new price of Lilly’s generic insulin. And the Mark Cuban Cost Plus Drug Co. plans to sell low-cost insulin. But drug pricing experts predict Lilly’s moves will not undercut those efforts. And these other initiatives to bring lower-cost insulin to market, in turn, would put pressure on Lilly to keep its prices down.
The FEHBlog agrees with these comments. Cost curve down.
From the U.S. healthcare business front, Healthcare Dive informs us
VillageMD, the clinical network majority owned by Walgreens, has acquired a medical group in Connecticut that operates more than 30 locations across the state.
On Friday, VillageMD said it snapped up Starling Physicians, which operates primary care and multi-specialty practices, for an undisclosed sum.
The acquisition expands VillageMD to more than 700 medical centers, as Walgreens continues to invest in expanding its clinical footprint.
Tammy Flanagan, writing in Govexec, points out irrevocable benefits decisions, e.g., FEHBP, that a federal or postal employee must make at the time they decide to take a CSRS or FERS retirement
From Capitol Hill, the Wall Street Journal reports that “Sen. Joe Manchin, who has been a crucial vote in shaping major pieces of President Biden’s agenda, urged Democratic colleagues to hold talks with Republicans on cutting federal spending, ahead of a summer deadline to reach a deal on raising the country’s debt ceiling.”
A larger share of people are being diagnosed with colorectal cancer at a younger age and at a more dangerous stage of the disease, a report showed. Doctors aren’t sure why.
The American Cancer Society said Wednesday that about 20% of new colorectal cancer diagnoses were in patients under 55 in 2019, compared with 11% in 1995. Some 60% of new colorectal cancers in 2019 were diagnosed at advanced stages, the research and advocacy group said, compared with 52% in the mid-2000s and 57% in 1995, before screening was widespread.
Cases and death rates for colorectal cancer have continued a decadeslong decline overall thanks to screening, better treatments and reductions in risk factors such as smoking, the ACS report’s authors said. But the shift of the burden toward younger people and diagnoses at more advanced stages has oncologists on alert.
“The improvements have slowed, and they’ve slowed because of this opposite trend we’re seeing in young people,” said Kimmie Ng, director of the Young-Onset Colorectal Cancer Center at Dana-Farber Cancer Institute in Boston. “More and more are getting diagnosed with cancer that might not be curable.”
The U.S. Preventive Serves Task Force is routinely reevaluating its 2018 grade A recommendation to screen pregnant women/persons for syphilis.
The number of remote patient monitoring (RPM) reimbursement claims hit a new high in 2022, according to a report by Definitive Healthcare.
By November, the volume of claims across the 10 Centers for Medicare & Medicaid Services’ codes for RPM was already 27% above the total for all of 2021, adding to the growth seen since the start of 2019.
Cardiologists are the main users of RPM devices, with blood pressure diagnoses accounting for more than half of all claims made in 2021. Diabetes, which accounts for 16% of claims, is the next most active area.
Medicare will cover continuous glucose monitors for a broader group of patients, starting in April, according to an updated policy published by the Centers for Medicare and Medicaid Services.
The policy change included broader language and also came earlier than expected, making it a “welcome surprise,” and could double the market for the devices, J.P. Morgan analyst Robbie Marcus wrote in a research note. * * *
In an earlier draft of coverage guidelines, CMS had suggested covering the devices for people with diabetes who take daily insulin, or who have a history of problematic hypoglycemia. Now, the policy includes people withnon-insulin treated diabetes and a history of recurrent level 2 or at least one level 3 hypoglycemic event.
From the Rx coverage front, the Congressional Research Service issued an “In Focus” report about “Selected Issues in Pharmaceutical Drug Pricing.”
From the healthcare quality front, NCQA posted slides and a recording from its latest Future of HEDIS webinar on February 28.
The Cleveland Clinic reported a $1.2 billion net loss for 2022 as expenses climbed from the prior year. Expenses ticked up in every key category in 2022, including salaries and wages, supplies and pharmaceuticals, Cleveland Clinic’s latest financial report shows.
Cleveland Clinic grew 2022 revenue roughly 5% to $13 billion from the prior year, but didn’t outpace expenses as costs increased nearly 14% to $12.4 billion before interest, depreciation and amortization.
Investment income helped pull the Midwest provider into the red as non-operating losses totaled $1 billion.
Oak Street Health’s losses grew in 2022 to almost $510 million as the value-based primary care company, which is pending an acquisition by CVS Health, continued to aggressively pursue growth.
In comparison, Oak Street, which operates a network of clinics for seniors on Medicare, reported a loss of $415 million in 2021.
The company opened 40 new centers over 2022 and ended the year with 169 facilities in 21 states, serving some 224,000 patients.
In what may well be the latest fad in hospital consolidation, two not-for-profit health systems located across the country from one another are seeking to link up — this time, to create a system with roughly $11 billion in revenue.
UnityPoint Health and Presbyterian Healthcare Services announced Thursday they’ve inked a letter of intent to explore a merger. Hospital mergers often involve partners in the same region so they can gain leverage with insurers, but in this case, UnityPoint is in the Midwest, whereas all nine of Presbyterian’s hospitals are several states away in New Mexico.
The deal illustrates not only health systems’ insatiable desire to get bigger in a tough operating environment, but their evolving strategy for doing so. Antitrust regulators have sunk deals involving partners they said would command too much market share in a given region, so hospitals are doing the next-best thing: seeking partners in far-flung states.
Walmart plans to expand its network of medical centers in 2024, including a launch into two new states, as retail health giants race to build out their primary care footprints.
The company announced Thursday it plans to open 28 new Walmart Health centers in 2024, bringing its number of total locations to more than 75.
Walmart Health will open clinics in Missouri and Arizona for the first time, while deepening its presence in Texas by expanding in the Dallas area and growing into Houston, according to the announcement.
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