“Congress heads into a make-or-break week for avoiding a government shutdown, with leaders of the Republican-controlled House hoping they can persuade GOP holdouts to get on board with four full-year bills and a short-term funding patch.
“With a shutdown set for Oct. 1, unless Congress acts, the plan marks a last-ditch effort by Republicans to find a way forward. If no deal is reached, hundreds of thousands of federal workers are set to be furloughed.
“When it gets crunch time, people that have been holding off all this time blaming everybody else will finally hopefully move,” House Speaker Kevin McCarthy (R., Calif.) told reporters Saturday.
“McCarthy laid out the path forward in a GOP conference call. The House is expected on Tuesday to vote on a rule establishing the parameters for debate on a defense-spending bill, a bill funding the Homeland Security Department, one funding the State Department and another funding agricultural priorities.
“After that, McCarthy is expected to focus on a short-term spending deal ranging from two weeks to two months to keep the government funded while negotiations continue.”
The U.S. Supreme Court has posted its October 2023 Term calendar. The opening conference will be held on Tuesday, September 26. The first oral arguments will be held on October 2, 2023.
If history can be a guide, OPM will announce the 2024 FEHB premiums this week, along with the government contribution change.
“The drug colchicine has been used for more than 2,000 years to treat the fiery joint-pain ailment called gout. It also is a remedy for a genetic disorder called familial Mediterranean fever and for pericarditis, an inflammation of the sac around the heart.
“Now, colchicine may be set for a surprising new role. In June, the Food and Drug Administration approved a new low-dose version of the drug as the first-ever medicine to treat cardiovascular inflammation, marking a new approach to heart attack prevention.
“Several things could limit the adoption of colchicine by cardiologists, at least at first, including side-effect concerns and the emergence of several other new options for reducing the risk of heart attacks. But the drug’s approval provides fresh validation for a concept that has been gaining momentum in cardiology over the past 25 years—that inflammation is a key culprit in atherosclerosis, the artery-clogging disease, and that treating it can reduce the risk of a heart attack.
T”he bedrock strategy for heart-attack prevention has long been lowering LDL cholesterol with drugs called statins. Adding low-dose colchicine—which in one study reduced cardiovascular risk by 31% in patients already treated with statins and other preventive medicines—would enable doctors to simultaneously hit two biological targets that cause heart attacks.
“This is about combining therapies” that are both effective ways to reduce risk, says Dr. Paul Ridker, director of the Center for Cardiovascular Disease Prevention at Harvard-affiliated Brigham and Women’s Hospital, Boston. “They’re not in conflict; they’re synergistic.”
Cardiovascular Business identifies the best heart hospitals using a Newsweek survey. The top five are the following:
NPR Shots considers whether Ozempic causes mental health side effects.
The NY Times discusses the synthetic opioid epidemic plaguing many of the Nation’s large cities, like New York. This article focuses on “collateral damage.”
“The rising death toll comes as the city and the state have turned away from the aggressive law enforcement of low-level street drug activity that was common in the late 1990s. The shift has happened gradually over time, as a broader movement has pushed to reframe drug use as a public health crisis rather than as primarily a criminal issue.”
In Medicare news, Fortune Well tells us about 2024 Medicare changes and other relevant matters as we approach the Medicare open enrollment period, which begins on October 15, 2023.
In business news,
HR Dive points out, “Employers have 44 days on average to “make or break” a new hire, and first impressions make a lasting impression, according to a Sept. 20 report from BambooHR, a cloud-based human resources platform.”
“Creating a “buddy system” to pair new hires with experienced employees can make the onboarding experience stronger, according to a McLean & Co. report. The tenured employee can personalize the onboarding experience, serve as a contact person and provide advice about team processes or organizational culture.”
“The Department of Homeland Security (DHS) issued recommendations to Congress about how the federal government could improve critical infrastructure cyber incident reporting in a new report. Notable recommendations include streamlining the reporting process by establishing a single reporting web portal, as well as creating a model incident report form that federal agencies can adopt.
“The report, aptly titled “Harmonization of Cyber Incident Reporting to the Federal Government,” was a deliverable required by the Cyber Incident Reporting for Critical Infrastructure Act of 2022 (CIRCIA), signed into law in March of last year. CIRCIA enabled the creation of the Cyber Incident Reporting Council (CIRC), which took the lead on the report and represents leaders from 33 federal agencies.
“The report acknowledged ongoing challenges that stem from duplicative federal cyber incident reporting requirements. Currently, there are 52 cyber incident reporting requirements either in effect or proposed across the federal government.”
FEHBlog note – At least 53 cyber incident reporting requirements exist as the DHS report overlooks OPM’s requirements for FEHB plan carriers.
SUMMARY: The Office of the National Cyber Director (ONCD) invites public comments on opportunities for and obstacles to harmonizing cybersecurity regulations, per Strategic Objective 1.1 of the National Cybersecurity Strategy. ONCD seeks input from stakeholders to understand existing challenges with regulatory overlap, and explore a framework for reciprocity (the recognition or acceptance by one regulatory agency of another agency’s assessment, determination, finding, or conclusion with respect to the extent of a regulated entity’s compliance with certain cybersecurity requirements) in regulator acceptance of other regulators’ recognition of compliance with baseline requirements.
DATES: The original comment deadline for this RFI was 5 p.m. EDT September 15, 2023. ONCD has extended the deadline for comments to be received to 5 p.m. EDT October 31, 2023.
ADDRESSES: Interested parties may submit comments through www.regulations.gov
“FBI Director Christopher Wray urged private sector organizations to help the agency by coming forward with information regarding malicious cyber activity.
“Wray told attendees at Mandiant’s annual mWISE 2023 conference Monday that many of the agency’s successful cyber operations in recent years were accomplished with the assistance of private sector partners. He emphasized organizations would be treated properly as victims of malicious actors and not punished for their cooperation.
“We know the private sector hasn’t always been excited about working with federal law enforcement, but when you contact us about an intrusion, we won’t be showing up in raid jackets,” Wray told conference attendees. “Instead, we’ll treat you like the victims you are – just like we treat all victims of crimes.”
The U.S. has made significant progress towards developing a more resilient cybersecurity infrastructure after implementing about 70% the Cyberspace Solarium Commission’s recommendations, according to a report from CSC 2.0.
CSC co-chairs Sen. Angus King, I-Maine, and Rep. Mike Gallagher, R-Wisc., praised the launch and implementation of the National Cybersecurity Strategy during a presentation Tuesday in Washington D.C., but said more work needed to be done on deterrence.
Key gaps remain in the nation’s cybersecurity posture, including the need to create more resilient federal networks and strengthen key critical infrastructure sectors, such as healthcare, agriculture and water.
“Cisco reached a deal valued at $28 billion in cash, or $157 per share, to buy software observability firm Splunk, the companies announced Thursday. The deal, which marks Cisco’s largest-ever acquisition, is built around the “complementary capabilities” across AI, security and observability between Cisco and Splunk.
“Cisco expects the deal to become cash flow positive and gross margin accretive within the first fiscal year after the deal closes, which is expected in Q3 2024. The agreement, which has been unanimously approved by the board of directors at Cisco and Splunk, remains subject to regulatory approval.
“Splunk President and CEO Gary Steele will join the executive leadership team at Cisco, reporting directly to Chair and CEO Chuck Robbins.”
From the cybersecurity breaches and vulnerabilities front,
HHS’s Healthcare Sector Cybersecurity Coordination Center (HC3) released its August 2023 cybersecurity vulnerability bulletin.
“In August 2023, vulnerabilities to the health sector have been released that require attention. This includes the monthly Patch Tuesday vulnerabilities released by several vendors on the second Tuesday of each month, along with mitigation steps and patches. Vulnerabilities for August are from Microsoft, Google/Android, Cisco, Apple, Mozilla, Fortinet, VMWare, and Adobe. A vulnerability is given the classification as a zero-day if it is actively exploited with no fix available or is publicly disclosed. HC3 recommends patching all vulnerabilities, with special consideration given to the risk management posture of the organization.”
“Cisco Talos has published an open-source report regarding the North Korean state-sponsored actor, the Lazarus Group, reported to be targeting internet backbone infrastructure and healthcare entities in Europe and the United States. The attackers have been exploiting a vulnerability in ManageEngine products, which is tracked as CVE-2022-47966. This vulnerability was added to CISA’s Known Exploited Vulnerabilities Catalog in January 2023. Through this exploit, the attackers are deploying the remote access trojan (RAT) known as “QuiteRAT.” Security researchers previously identified this malware in February 2023, and it is reportedly the successor to the group’s previously used malware “MagicRAT,” which contains many of the same capabilities. Further analysis of this campaign has also shown that the group is using a new malware tool called “CollectionRAT,” which appears to operate like most RATs by allowing the attacker to run arbitrary commands among other capabilities. Both CISA and the FBI have previously warned that these types of vulnerabilities are common attack methods for malicious actors and can pose a significant risk to healthcare and public health organizations. HC3 strongly encourages organizations to update these systems.”
HC3 posted a PowerPoint on Chinese and North Korean cybercrime. In sum,
“Chinese and North Korean “cybercriminal groups” act as unique threats to the U.S. health sector.
“China and North Korea are significant cyber powers–China in absolute terms and North Korea in relative terms.
“Domestic politics in both organizations has created a unique cybercriminal ecosystem, where the only significant cybercriminals threatening the U.S. health sector are state-sponsored.
“Most significant criminal gangs (i.e., are financially motivated) have all the sophistication of many other cybercriminal gangs but also have the resources (technological, financial and diplomatic) of a state behind them.”
“They are state-backed criminals, and they target a number of industries, including the U.S. health sector.”
This week, CISA added eight known exploited vulnerabilities to its catalog on September 18, another on September 19, and one more on September 21.
“Apple’s announcement on Thursday [September 20] that its latest operating system updates patch three new zero-day vulnerabilities. Based on the previous work of the organizations credited for reporting the flaws, they have likely been exploited by a spyware vendor.”
From the ransomware front,
On September 20,
“The Federal Bureau of Investigation (FBI) and the Cybersecurity and Infrastructure Security Agency (CISA) released joint Cybersecurity Advisory (CSA) #StopRansomware: Snatch Ransomware, which provides indicators of compromise (IOCs) and tactics, techniques, and procedures (TTPs) associated with the Snatch ransomware variant. FBI investigations identified these IOCs and TTPs as recently as June 1, 2023.
“Snatch threat actors operate a ransomware-as-a-service (RaaS) model and change their tactics according to current cybercriminal trends and successes of other ransomware operations.
“Arika ransomware has continued to evolve since emerging as a threat in March, expanding its reach from initially targeting Windows systems to include Linux servers and employing a growing array of tactics, techniques, and procedures (TTPs).
“An in-depth report on Akira from LogPoint breaks down the “highly sophisticated” ransomware, which encrypts victim files, deletes shadow copies, and demands ransom payment for data recovery.
“The infection chain actively targets Cisco ASA VPNs lacking multifactor authentication to exploit the CVE-2023-20269 vulnerability as an entry point.
“As of early September, the group had successfully hit 110 victims, focusing on targets in the US and the UK.”
“Security has an underlying defect: passwords and authentication; Cyberattacks are fueled by the shortcomings of business authentication controls. Bad things happen when access falls apart and credentials land in the wrong hands.”
An ISACA expert discusses how to mitigate emerging technology risks.
The FEHBlog failed to hit publish last night, so Thursday Miscellany was not emailed Friday morning. To correct the problem, Friday Factoids will follow Thursday September 21’s post. Lo siento
“Faced with the House stalemate over a government stopgap funding bill, Senate Majority Leader Chuck Schumer (D-N.Y.) on Thursday set up a path for the Senate to move first on a bill to fund the government beyond Sept. 30.
“Schumer filed cloture on a motion to proceed to H.R. 3935, the House-passed bill to reauthorize the Federal Aviation Administration (FAA), which could serve as a legislative vehicle to pass a continuing resolution to fund the government through the Senate. * * *
“Senators will spend next week debating and voting on the legislation in hopes of sending it to the House by Wednesday or Thursday of next week.”
“The [new] plan [from the House of Representatives] is to ready more of the chamber’s 11 remaining full-year appropriations bills for votes, focusing on passing those to establish a firm negotiating position for talks with the bigger-spending Senate.”
Yesterday, the Affordable Care Act regulators extended the public comment deadline for the proposed mental health parity rule revisions from October 2 to October 17, 2023.
Today, the Centers for Medicare and Medicaid Services posted a new announcement on its No Surprises Act website:
“Effective September 21, 2023, the Departments have directed certified IDR entities to resume processing all single and bundled disputes already submitted to the IDR portal and assigned to a certified IDR entity. The ability to initiate new disputes involving air ambulance items or services as well as batched disputes for air ambulance and non-air ambulance items and services is currently unavailable. IDR portal functionalities related to previously initiated batched disputes are also unavailable. Disputing parties should continue to engage in open negotiation according to the required timeframes.”
CMS also updated its website with No Surprises Act rules and fact sheets.
“The FWCI competencies provide a common language for 214 occupational series. OPM has published 80 occupation-specific competency models representing work governmentwide that may be used for selection, evaluation, and training activities. The FWCI is a resource for agencies to leverage in their skills-based hiring practices.
“OPM will continue to support agencies and collect critical data that strengthens our workforce and enables us to deliver services for the American people,” said OPM Director Kiran Ahuja. “This update to the Federal Workforce Competency Initiative will help agencies hire the talent they need and expand opportunities for positions that do not require certain degrees.”
The Equal Employment Opportunity Commission posted its new strategic enforcement plan for 2024 through 2028.
From the public health front,
The American Medical Association identifies eight things doctors wish their patients knew about the flu shot.
“Poor oral hygiene is associated with an increased risk for myriad health problems, including heart disease, diabetes, cancer, rheumatoid arthritis and early death. The state of our teeth and gums, though, may be vital for our well-being beyond the mouth and body.
“Emerging evidence suggests that what goes on in our mouth can affect what goes on in our brain — and may even potentially affect our risk for dementia.
“People should really be aware that oral health is really important,” said Anita Visser, professor in geriatric dentistry at the University of Groningen in the Netherlands.”
“A recent CVS Health®/Harris Poll survey of Americans 18 years and older found that nearly one in five (18%) U.S. adults say they were plagued with suicidal thoughts in the past year.
“Other key findings from the survey include:
“More than a third of younger adults aged 18-34 (36%) say they had moments in the past year where they contemplated suicide.
“An overwhelming nine in ten (89%) U.S. adults deem suicide prevention efforts a major priority in our society.
“However, less than a third (32%) strongly agree they can recognize the warning signs of someone potentially at risk, and only four in ten (43%) are strongly aware of resources that offer support and information on suicide prevention.
“Nearly eight in ten (77%) U.S. adults believe healthcare providers have a crucial role in suicide prevention, and there is an opportunity for providers to have more discussions about suicide with patients.”
“The Federal Trade Commission is suing anesthesia provider U.S. Anesthesia Partners and private equity firm Welsh, Carson, Anderson and Stowe, alleging the two colluded to consolidate anesthesiology practices in Texas, driving up prices to boost their profits.
“Welsh Carson created USAP in 2012 before acquiring over a dozen anesthesia providers over the next decade to create a single dominant provider in the state, regulators allege. The PE firm and USAP also made price-setting agreements with independent anesthesiology practices while sidelining a potential competitor by striking a deal to keep them out of USAP’s market, the FTC said.
“The complaint filed Thursday in federal district court says the actions have cost Texans “tens of millions of dollars” more each year in anesthesiology services.”
MedCity News offers insights on value-based care from an executive at the HealthPartners HMO in Minnesota. “The commercial market has struggled to adopt value-based care, but HealthPartners has had some success, according to Mark Hansberry, senior vice president and chief marketing officer of the company. During a conference, he shared five rules for scaling value-based care, including creating trust and providing real-time data.”
“Nearly 1,900 U.S. physicians have applied to become certified in obesity medicine — a record number — according to data from the American Board of Obesity Medicine.
“In October, 1,889 physicians will take the exam to become certified in the specialty area. That’s up from 1,001 exam candidates in 2020, marking an 88.7 percent jump. Physicians’ growing interest in the certification comes amid booming patient demand for GLP-1 receptor agonist drugs such as Ozempic and Wegovy. As of August, 2023, sales for Ozempic in the U.S. topped $3 billion.
“More than 6,700 physicians are certified in obesity medicine, a certification that first became available in 2012. For the upcoming exam in October, 38 percent of exam candidates are internal medicine physicians and 30 percent family medicine. To sit for the exam, physicians must have completed a minimum of 60 continuing medical education credits on the topic of obesity.”
The FEHBlog notes that if you build it, they will come.
Fierce Healthcare looks inside Walgreens’ pharmacy and primary care model.
“Novo Nordisk found bacteria in batches of the main ingredient for a diabetes pill that is a cousin to popular diabetes and weight-loss drugs and was made at a North Carolina plant earlier this year, according to a federal inspection report reviewed by The Wall Street Journal.
“The Food and Drug Administration inspected the Clayton, N.C., plant in July and issued a report saying that Novo Nordisk had failed to investigate the cause thoroughly and that the plant’s microbial controls were deficient.
“The plant makes the drug ingredient semaglutide, which is used in the diabetes pill Rybelsus. Semaglutide is also the main ingredient in Novo Nordisk’s popular injections Ozempic and Wegovy, but the company said the semaglutide for those products isn’t made at the same plant.
“The Danish company said the Clayton plant is still running and producing for the market and wouldn’t share details of its interactions with the FDA.
“The agency said Thursday that based on Novo’s responses to its inspection findings, the FDA isn’t aware of ongoing compliance issues that raise any concerns about the quality of drugs made at the plant.”
“A bipartisan bill led by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) to improve access to lifesaving organ donations became law today. The Securing the U.S. Organ Procurement and Transplantation Network Act will improve the management of the U.S. organ donation system by breaking up the contract for the Organ Procurement and Transplantation Network (OPTN) and encouraging participation from competent and transparent contractors. U.S. Sens. Ben Cardin (D-Md.), Todd Young (R-Ind.) and Bill Cassidy (R-La.) are original cosponsors of the legislation.”
“The lawmakers’ novel approach would aim to ensure Congress completes its work on all 12 appropriations bills needed to fund the government, without the threat of a shutdown that would furlough hundreds of thousands of federal workers and leave government contractors unpaid. Major government functions will stop on Oct. 1 at 12:01 a.m. unless Congress acts.
“The bill, co-sponsored by Sens. James Lankford (R., Okla.) and Maggie Hassan (D., N.H.), would set in motion 14-day continuing resolutions, which keep the government funded at the prior year’s levels, while Congress works exclusively on passing appropriations bills.”
“The threat of a massive tax is enough to push drugmakers such as Boehringer Ingelheim Pharmaceuticals, Inc. and Novartis AG to comply with the Biden administration’s landmark drug pricing law and negotiate with Medicare.
“Companies who manufacture the first 10 drugs selected to negotiate prices with Medicare have until Oct. 1 to officially agree to enter price talks. Under the Inflation Reduction Act, those who refuse to comply with the negotiations must pay a tax starting at 65% of the US sales of a product. The fines would increase by 10% every quarter, with a maximum of 95%.”
That’s a lot of leverage.
The Consumer Financial Protection Bureau has “announced it is beginning a rulemaking process to remove medical bills from Americans’ credit reports. The CFPB outlined proposals under consideration that would help families financially recover from medical crises, stop debt collectors from coercing people into paying bills they may not even owe, and ensure that creditors are not relying on data that is often plagued with inaccuracies and mistakes.” In the FEHBlog’s view, this approach is bound to backfire as lenders lose faith in credit reports.
From the public health and medical research front,
“Nearly half of U.S. states had an adult obesity prevalence at or above 35% in 2022, according to CDC.
“The 22 states that met this mark — a small jump from the 19 states just the year prior — included Alabama, Arkansas, Delaware, Georgia, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Nebraska, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Virginia, West Virginia, and Wisconsin.”
By an 11-1 vote, the Advisory Committee on Immunization Practices (ACIP) recommended that pregnant women receive a single dose of Pfizer’s prefusion F protein (RSVpreF) vaccine (Abrysvo) at 32 to 36 weeks gestation to prevent lower respiratory tract RSV infection in infants.
After decades without an option for protecting most infants against the annual respiratory scourge, providers now have two options: the maternal vaccine and the monoclonal antibody nirsevimab (Beyfortus), which the ACIP last month recommended for all infants younger than 8 months born during or entering their first RSV season.
STAT News adds, “The recommendation was accepted by CDC Director Mandy Cohen shortly after the conclusion of the panel’s meeting.”
“A new cancer drug developed by Daiichi Sankyo and AstraZeneca met one of its two main goals in a breast cancer trial, helping patients who had progressed on earlier-line treatments live longer than those receiving chemotherapy without their disease getting worse, the companies said Friday.
“The trial tested the drug, known as datopotamab deruxtecan, in HER2-low or -negative patients whose tumors were sensitive to hormone treatments before their cancer returned. AstraZeneca and Daiichi didn’t release detailed data and stated that the trial hadn’t gone on long enough to tell if patients given their treatment lived longer overall, the trial’s other main goal.
“The data suggest the companies’ drug could present a threat to Gilead’s similarly acting medicine Trodelvy, which gained approval in a similar setting earlier this year. HR-positive, HER2-negative breast cancer is the most common form of the disease.”
“A combination of cancer drugs from Seagen and Merck & Co. has shown early success in a large clinical trial, results that help confirm the pairing’s ability to treat a wide range of bladder cancer patients.”
“A clinical trial has launched to test whether early intensive immune modulation for hospitalized COVID-19 patients with relatively mild illness is beneficial. The placebo-controlled study, part of the global clinical trials consortium known as Strategies and Treatments for Respiratory Infections and Viral Emergencies (STRIVE), will enroll approximately 1,500 people at research sites around the world. It is supported by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) in partnership with NIH’s National Center for Advancing Translational Sciences (NCATS).
“Immune modulators—treatments for modifying the immune system to better respond to disease or illness—are lifesaving for certain hospitalized COVID-19 patients. However, the optimal timing for administering the medicines to achieve the best outcomes has not been defined.”
The Wall Street Journal poses ten questions about experimental drugs that can be made available to seriously ill patients.
“Catholic healthcare giant CommonSpirit Health has reported a $1.4 billion operating loss (-4.1% operating margin) and a net loss of $259 million for its 2023 fiscal year, which ended June 30, according to financial statements released Thursday.
“The nonprofit, which currently operates 145 hospitals across 24 states, had logged a $1.3 billion operating loss (-3.8% operating margin) and a $1.8 billion deficit of revenues over expenses during its prior fiscal year.
“This time around, the organization enjoyed patient volumes that “reached pre-pandemic levels in many of the health system’s markets” but was dragged by “private and government reimbursements [that] did not keep pace with increased costs of providing care to patients,” CommonSpirit said in a release accompanying the latest financial filings. The most recent year’s operating performance also included a $160 million adverse impact from a fall 2022 cybersecurity breach that affected numerous locations.”
The CMS is poised to crack down further on health insurers in the Medicare Advantage program, according to new comments from a top agency official.
MA plans — which now cover more than half of Medicare beneficiaries — have faced rising criticism over care denials and access, along with improper coding practices that inflate the program’s cost.
“You will see CMS in the future be a much tougher payer and much tougher regulator to ensure that, for every beneficiary and taxpayer who pay more for it, the value is there, the service is there and beneficiaries have full information for the choices that they’re making,” CMS Deputy Administrator Jon Blum said Thursday at the National Association of ACOs’ fall conference in Washington, D.C.
House Republicans appeared to be moving closer to an agreement Wednesday on an opening bid for stopgap funding legislation that would keep the lights on at federal agencies beyond Sept. 30 and pave the way for their chamber to take up its full-year appropriations bills.
At least a handful of conservative holdouts still maintained their opposition as of Wednesday night, which would be enough to sink a revised bill unless GOP leaders are able to change some minds in the next few days. Speaker Kevin McCarthy, R-Calif., is expected to keep the chamber in session on Saturday if necessary.
Even if GOP leaders’ new effort is successful, however, it was starting to look more like a bid to reopen the government after a brief shutdown, given the deadline is 10 days away and the Senate is likely to ping-pong a much different bill back to the House.
The FEHBlog notes that it would not be unusual for Congress to pass a brief continuing resolution next week to allow for the passage of a longer continuing resolution, thereby side stepping the partial government shutdown.
Fierce Healthcare offers details on the House Ways and Means Committee’s No Surprises Act hearing, while Healthcare Dive shares details on the House Oversight and Accountability’s PBM reform hearing. Both hearings were held yesterday.
Speaking of the No Surprises Act, the ACA regulators released a proposed rule increasing the government’s NSA arbitration fee from $50 per party to $150 per party next year. The FEHBlog has no idea why the government doesn’t ladder the fee based on the amount in dispute. The government also increased the maximum fee independent dispute resolution entities can charge the parties.
“FDA Approves GSK Myelofibrosis Med That Has Edge Over Others in Drug Class
“FDA approval of GSK’s Ojjaara in myelofibrosis introduces a new competitor to blockbuster Incyte drug Jakafi. Ojjaara was part of GSK’s $1.9 billion acquisition of Sierra Oncology last year.”
“FDA Rejects ARS Pharma’s Nasal Spray Alternative to Injectable Epinephrine
“ARS Pharmaceuticals frames its intranasal epinephrine spray as a needle-free alternative to products such as EpiPen. Though this spray won the backing of an FDA advisory committee, the agency is now requiring that ARS Pharma run another study to support a regulatory submission.”
From the public health and medical research fronts,
“The federal government is again offering free Covid-19 tests to Americans, providing a fifth round of free tests in part to meet current needs and in part to stimulate a domestic testing industry that has struggled with cratering demand for rapid diagnostics.
“The measure, announced Wednesday, will see rapid tests released from the Strategic National Stockpile. In addition, 12 domestic test manufacturers will receive investments totaling $600 million to help “warm-base” the U.S. capacity for rapid test production, both for Covid and future disease threats. * * *
“Households will be entitled to receive four free rapid tests apiece, with ordering at COVIDtests.gov opening on Sept. 25. O’Connell said test shipments are expected to start on Oct. 2.”
The FEHBlog thinks that the government is fighting the last pandemic. Why not incent the production of the FDA-approved (last February) at-home tests for Covid or the flu, not just Covid?
“Don’t throw out that seemingly outdated at-home rapid Covid-19 test just yet. It may still be good.
“The Food and Drug Administration has been extending expiration dates for some authorized at-home, over-the-counter Covid test kits, meaning some unused tests may still be viable. The agency’s updated list of expiration dates may be useful to those reaching for their stash of Covid-19 tests amid new variants and a recent bump in cases and hospitalizations.”
“A trial of a preventive HIV vaccine candidate has begun enrollment in the United States and South Africa. The Phase 1 trial will evaluate a novel vaccine known as VIR-1388 for its safety and ability to induce an HIV-specific immune response in people. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has provided scientific and financial support throughout the lifecycle of this HIV vaccine concept and is contributing funding for this study.”
“Is morning the best time of day to exercise? Research published Tuesday in the journal Obesity finds that early morning activity — between 7 a.m. and 9 a.m. — could help with weight loss.
“My cautious suggestion from this study is that if we choose to exercise in the early morning before we eat, we can potentially lose more weight compared to exercise at other times of the day,” said lead researcher Tongyu Ma, a research assistant professor at The Hong Kong Polytechnic University.”
“Ochsner Health is launching a pilot program this month that will use generative artificial intelligence to draft “simple” messages to patients.
“About a hundred clinicians across the New Orleans-based health system will participate in the first phase of the program, where AI will prepare responses to patient questions unrelated to diagnoses or clinical judgments. The messages will be reviewed and edited by providers before being sent to patients, according to a news release.
“Ochsner is part of an early adopter group of Microsoft’s Azure OpenAI Service, which integrates with the Epic electronic health record. The health system will test the messaging feature over three phases this fall, and Ochsner will collect patient feedback to improve the system.”
“Making sense of mountains of data continues to be an often elusive goal for most of the healthcare system, but Cambia Health Solutions said it hopes its latest effort will allow it to better corral useable information.
“Cambia and Abacus Insights, a data management company that tacklesthe challenge of making healthcare networks interoperable, launched a new data aggregating system that processes information for about 3.4 million members across four Blues plans.
“According to an Abacus case study (PDF), “Cambia recognized that to deliver care orchestrated around the unique needs of each individual, data must be actionable. To be actionable, case study data must be understandable, usable, timely, and have clinical utility.”
“House Republican leaders worked to salvage a short-term spending bill that sparked angry disagreements among the party’s rank-and-file, but they remained short of the support needed to pass the measure and show the party could unite to avert a government shutdown. * * *
“The effort to pass a short-term deal comes as Congress is working to pass the 12 annual appropriation bills that fund the government. Leaders of both parties in the House and Senate have thrown their support behind reaching a short-term deal that would give both chambers more time to negotiate a full-year spending agreement.
“Both McCarthy and Senate Minority Leader Mitch McConnell (R., Ky.) have warned of the political fallout for the GOP from a shutdown.
“I’ve seen a few of them over the years, they never have produced a policy change, and they’ve always been a loser for Republicans politically,” said McConnell to reporters.”
Govexec offers federal employees a “guide to pay and benefits during a shutdown.”
The House Ways and Means Committee held a No Surprises Act hearing today. Here are a link to the Chairman’s opening statement and a link to the AHIP witness statements.
“Enrollees in the Federal Long-Term Care Insurance Program (FLTCIP) are bracing for another big premium increase starting in 2024.
“The Office of Personnel Management, which runs the federal insurance program, announced plans to hike up premium rates for current enrollees. The changes will take effect on Jan. 1.
“Unlike the averages offered in past years, OPM declined to share an average percentage increase for FLTCIP premiums. An agency spokesperson said the percentage increases for enrollees were too variable for an average to accurately depict how much the rates are rising.
“But anecdotal experiences from program participants who spoke with Federal News Network and who shared their premium notification letters with the National Active and Retired Federal Employees Association (NARFE) show the increases are as large as 86%, if the enrollees choose to stick with their same coverage options. In a few other instances, enrollees received notice from OPM that their premiums will go up 77% and 49%, according to NARFE.”
The U.S. Preventive Services Task Force issued a revised Grade B recommendation today. “The USPSTF recommends screening for hypertensive disorders in [asymptomatic] pregnant persons with blood pressure measurements throughout pregnancy.”
“The recommendation made Tuesday by the U.S. Preventive Services Task Force broadens 2017 guidance to screen regularly only for preeclampsia, a dangerous and increasingly common condition that can arise in pregnancy. It involves high blood pressure along with kidney or liver trouble and other problems and is believed to occur when the placenta develops abnormally because of a problem with the blood vessels that supply it.
“The recommendation applies to other disorders marked by high blood pressure that, like preeclampsia, normally develop in the second half of pregnancy. They include gestational hypertension—high blood pressure without the other signs of preeclampsia—and eclampsia, which involves seizures and is life-threatening.”
Per Healthcare Dive
“Eighty-one percent of nursing home facilities nationwide and 90% of for-profit facilities would need to hire additional registered nurses or nurse aides to meet the minimum nursing staff hours standards proposed by the CMS earlier this month, according to a KFF estimate published Monday.”
“Doctors say they’re finding it increasingly difficult to distinguish Covid from allergies or the common cold, even as hospitalizations tick up.
“The illness’ past hallmarks, such as a dry cough or the loss of sense of taste or smell, have become less common. Instead, doctors are observing milder disease, mostly concentrated in the upper respiratory tract.
“It isn’t the same typical symptoms that we were seeing before. It’s a lot of congestion, sometimes sneezing, usually a mild sore throat,” said Dr. Erick Eiting, vice chair of operations for emergency medicine at Mount Sinai Downtown in New York City.”
The Wall Street Journal offers “A Game Plan for Timing Your Flu, Covid, and RSV Shots This Fall.”
“Doing puzzles, playing memory-boosting games, taking classes, and reading are activities that we often turn to for help keeping our brains sharp. However, research is showing that what you eat, how often you exercise, and the type of exercise you do can help lower your risk of dementia to a greater extent than previously thought.
“Although more studies are needed, “there’s a lot of data that suggests exercise and diet are good for the brain and can prevent or help slow down” cognitive changes, says Jeffrey Burns, co-director of the University of Kansas Alzheimer’s Disease Research Center in Fairway.
“And living a healthy lifestyle can produce brain benefits regardless of age.”
From the healthcare business front,
Fierce Health identifies the most influential minority executives in healthcare for 2023. Maazal tov to those execs.
“Elevance Health’s pharmacy benefit manager, CarelonRx, is launching a new integrated cost savings program to automatically offer members the lowest price for generic prescription drugs at their preferred pharmacy.
“We will automatically compare prices to emulate a comparative shopping experience, similar to when a member would use a discount card,” Michele Paige, vice president of product at CarelonRx, told Becker’s. “But now they don’t have to because it’s integrated within their benefits.”
“The new program, EnsureRx, is set to launch in February and will automatically compare prices for more than 50 generic medications against a variety of cash discount cards, with savings automatically applied. Ms. Paige shared that the list of generic medications covered will be constantly evaluated for potential additions.”
and
“Cigna Healthcare offers employers a supplemental benefit designed to help employees diagnosed with musculoskeletal conditions.
“The payer is adding musculoskeletal conditions to its Supplemental Health Critical Illness plans, according to a Sept. 18 news release. The program provides an annual payment of $3,000 to employees to help them cover out-of-pocket hospital costs or other expenses such as rent, childcare and groceries.
“Cigna offers similar benefits for cancer, heart attack and stroke.”
“House Republicans unveiled a stopgap funding measure Sunday night that would avoid a partial government shutdown next month and provide border security measures sought by conservatives. But passage even in the GOP-controlled House was already in doubt as some hard-liners came out against the measure Sunday night while the ink on it was barely dry.
“The draft continuing resolution would extend current funding through Oct. 31, while cutting 8.1 percent from all nondefense accounts except for the Department of Veterans Affairs and disaster relief. That extension would give lawmakers an extra month to try to complete fiscal 2024 appropriations that are otherwise needed by Sept. 30. * * *
“The bill is set for floor consideration this week, along with the fiscal 2024 Defense spending bill that stalled last week when conservative detractors threatened to vote against the rule needed to take it up.”
Politico discusses where we stand with the proposed mental health parity rule changes.
“The Biden administration’s proposal substantially expands the law Bush signed. It would mandate that insurers analyze the outcomes of their coverage to ensure there’s equivalent access to mental health care and take action to comply if they’re falling short.
“Insurers respond: AHIP, the lobbying group for insurers, says the situation is more complicated than Biden makes out, and workforce shortages are behind barriers to access.
“For years, health insurance providers have implemented programs and strategies to expand networks and increase access,” AHIP spokesperson Kristine Grow said in a statement.
“The administration has set a deadline for comments on its proposed rules for early October; insurers and their allies are asking for more time to respond.
“The ERISA Industry Committee, which represents large employers’ benefit interests, joined AHIP, among other associations, employers and health plans, in writing to administration officials to ask that the comment period on the proposed rules be extended. They warned that the rules could create “unnecessary burdens” for providers, insurers and patients and “unintentionally” impede access to care.”
The Centers for Medicare and Medicaid Services (CMS) announced on its No Surprises Act website today:
“Federal IDR Process update: Certain functions of the Federal IDR Process are temporarily paused in response to the TMA III Court Order. On September 5, 2023, the Departments directed certified IDR entities to resume making eligibility and conflict of interest determinations and encouraged disputing parties to continue engaging in open negotiations. The Departments expect to direct certified IDR entities to resume issuing payment determinations for some disputes very soon.”
The Office of Management and Budget’s Office of Information and Regulatory Affairs has completed work on a regulation that will affect the FEHB:
AGENCY: HHS-CMS RIN: 0938-AT86 Status: Concluded
TITLE: Medicare Secondary Payer and Certain Civil Money Penalties (CMS-6061) Section 3(f)(1) Significant: No
STAGE: Final Rule Economically Significant: No
RECEIVED DATE: 03/01/2022 LEGAL DEADLINE: Statutory
REVIEW EXTENDED
COMPLETED: 09/11/2023 COMPLETED ACTION: Consistent with Change
The FEHBlog will be watching the Federal Register for this one.
CMS also “finalized a rule to streamline enrollment in the Medicare Savings Programs (MSPs), making coverage more affordable for an estimated 860,000 people.”
From the public health and medical research fronts,
Per Healthcare Dive, “New RSV vaccines can be powerful tools, but rollout poses test; The recently approved shots will slot in alongside vaccines for influenza and COVID-19 this fall, raising communication challenges for public health officials.” The article dives into the details, but health plans can help communicate new vaccines’ benefits to their members with young kids and members who have reached senior citizen status.
“The mixture of stimulants like cocaine and meth with highly potent synthetic opioids is a fast-growing driver of fatal overdoses in the U.S.
“Since 2010, overdoses involving both stimulants and fentanyl have increased 50-fold, and now account for 32% of U.S. overdoses in 2021 and nearly 35,000 deaths, according to a study published Thursday in the scientific journal Addiction.
“We’re now seeing that the use of fentanyl together with stimulants is rapidly becoming the dominant force in the U.S. overdose crisis,” says Joseph Friedman, the lead author of the study and a researcher at UCLA’s David Geffen School of Medicine. “Fentanyl has ushered in a polysubstance overdose crisis, meaning that people are mixing fentanyl with other drugs, like stimulants, but also countless other synthetic substances.”
Healio points out that based on a recent research study,
“Consumption of added sugar, total sugar, total glucose equivalent and fructose from added sugar and juice were linked to a higher risk for coronary heart disease.
“Fructose from vegetables and fruits was not.”
The American Medical Association informs us, “What doctors wish patients knew about social isolation.”
“Chronic acid reflux — also known as GERD — has long been thought to boost a person’s risk of esophageal cancer
“A new study refutes that, finding that only patients with evidence of injury to their esophagus from reflux have a higher cancer risk
“Researchers downplayed a “very moderate” increased risk for women, saying that it remains “extremely low.'”
MedPage Today calls our attention to a different Swedish study,
“Bariatric surgery for obesity was associated with a reduced risk of hematologic cancers in a prospective Swedish study spanning more than three decades.”
“Artificial intelligence (AI) and machine learning (ML) can effectively detect and diagnose Polycystic Ovary Syndrome (PCOS), which is the most common hormone disorder among women, typically between ages 15 and 45, according to a new study by the National Institutes of Health. Researchers systematically reviewed published scientific studies that used AI/ML to analyze data to diagnose and classify PCOS and found that AI/ML based programs were able to successfully detect PCOS.
“Given the large burden of under- and mis-diagnosed PCOS in the community and its potentially serious outcomes, we wanted to identify the utility of AI/ML in the identification of patients that may be at risk for PCOS,” said Janet Hall, M.D., senior investigator and endocrinologist at the National Institute of Environmental Health Sciences (NIEHS), part of NIH, and a study co-author. “The effectiveness of AI and machine learning in detecting PCOS was even more impressive than we had thought.”
From the U.S. healthcare business and quality fronts,
The National Committee for Quality Assurance has named the best-rated health plans of 2023 based on factors that include care quality, patient satisfaction and efforts to keep improving.
The ratings were released Sept. 15 and are based on 2022 data from commercial, Medicare, Medicaid and ACA plans that reported HEDIS and CAHPS results to the NCQA, which cover more than 200 million people. NCQA Accreditation status was also factored in. Plans were rated on a zero- to five-star scale, with five being the highest rating. In total, 1,095 plans received a rating. No Medicaid or Medicare plan received 5-stars this year.
Commercial plans that received a five-star rating:
Independent Health Association (New York)
Kaiser Foundation Health Plan of the Mid-Atlantic States (Washington D.C., Maryland, Virginia)
‘Hospitals have been required to post their prices for shoppable services online since 2021, but costs shared online rarely correlate to prices hospitals share with consumers on the phone, according to a new secret shopper survey.
‘The study found wide variations when comparing hospitals’ online cash prices for childbirth and brain imaging with prices told to consumers who inquire over the phone.
‘For example, researchers found five hospitals with online prices greater than $20,000 for vaginal childbirth but telephone prices less than $10,000. For a brain magnetic resonance imaging scan, two hospitals said the cost was more than $5,000 over the phone, but the price tag was $2,000 online.’
“Novo Nordisk (NOVOb.CO) has hired U.S. private contract manufacturer PCI Pharma Services to handle assembly and packaging of Wegovy, a source familiar with the matter said, as it races to boost output of the weight-loss drug to meet demand.
“Philadelphia-based PCI, which has 15 facilities in North America, Europe and Australia, is putting together the self-injection pens used to administer Wegovy, said the source, who declined to be named because the information is confidential.”
The percentage of asynchronous telehealth claim lines for mental health conditions increased nationwide, with a particularly sharp rise in the Midwest, where it doubled between May and June, according to new telehealth usage data.
The data from FAIR Health’s Monthly Telehealth Regional Tracker represents the privately insured population, including Medicare Advantage and excluding Medicare Fee-for-Service and Medicaid. The tracker, launched in May 2020, uses data from FAIR Health to provide insights into month-to-month changes in the volume of telehealth claim lines and audio-only telehealth usage.
Nationally, telehealth remained stable at 5.4 percent of claim lines in May and June. In three US regions, telehealth use did not change during this period, but usage fell by 2.4 percent in the Midwest.
In general business news, HR Dive offers “A running list of states and localities that require employers to disclose pay or pay ranges.”
“Speaker Kevin McCarthy said on Sunday that he intended to resurrect a stalled Pentagon spending measure and try to push it to the House floor this week despite pledges by members of the far-right Freedom Caucus to oppose the move unless their sweeping demands on spending were met. * * *
“Other House Republican leaders joined Mr. McCarthy in saying that some progress had been made in weekend talks toward resolving their internal differences over their spending strategy, and that they hoped to break the logjam this week.
“We are working through this, and I’m optimistic that we will continue to move the appropriations process forward,” Representative Elise Stefanik, Republican of New York and a member of the leadership team, said in a separate interview on “Fox News Sunday.”
“The Office of Personnel Management on Friday announced that it is proposing new regulations aimed at hamstringing future administrations from reviving a controversial plan to strip tens of thousands of federal workers of their civil service protections, potentially accelerating a long-simmering battle between good government groups and conservative Republican activists. ***
“OPM’s newly proposed regulations, which will be published Monday in the Federal Register, seek to at least slow down a future administration from reviving Schedule F. It stipulates that when a federal employee’s job is converted from the competitive service to the excepted service, the employee retains “the status and civil service protections they had already accrued,” unless they voluntarily transfer into an excepted service position.”
“Women who live to age 90, 95 or even 100 experience what’s known as “exceptional longevity.” An analysis published last month found one factor linking those long lives: maintaining a stable body weight over decades.
“The study, published in the Journals of Gerontology: Series A, looked at data about 54,437 women from the Women’s Health Initiative, a long-term study that began in the 1990s. The women studied were born on or before Feb. 19, 1932, and the researchers looked at their weight when they began the program, in Year 3, and in Year 10 of the program, then followed up on their survival status as of Feb. 19, 2022.
“They found that the women whose body weight stayed stable over the years had 1.2 and 2 times the odds of surviving to 90 and beyond than those who lost weight.
“Women who lost 5 percent or more of their body weight over the first three years studied had 33 percent lower odds of surviving to 90, 35 percent lower odds of surviving to 95 and 38 percent lower odds of surviving to 100 than their counterparts whose weight remained stable.”
The new Covid shots and the flu vaccines will be available this week. The New York Times observes, and the FEHBlog agrees,
“Some experts believe that spreading out your shots might make sense if you can time them to just before each virus peaks. So while you may get the Covid vaccine this month, as cases rise in parts of the United States, you could consider waiting until later in the fall to get the flu shot. Flu cases typically peak between December and February; you can monitor flu activity in your state through the Centers for Disease Control and Prevention’s influenza surveillance reports for more detailed information. A doctor can also help you decide the best strategy, especially if you have a high risk of severe disease or are immunocompromised.”
“Does M&A work? The latest research says it’s a tossup.
“Business-school students are often taught that successful mergers and acquisitions are a long shot. One influential Harvard Business Review article, dating from 2011, says a range of studies show roughly 70% to 90% of deals fail to create value for the buyer.
And many investors worry that takeovers are more reliably lucrative for investment banks—which LSEG says earned some $13.1 billion in M&A fees in the first half of this year—than for the acquiring companies and their shareholders.
But more recent research from academics and consultants puts the success rate closer to even. Companies that do frequent smaller deals, as well as making bigger bets, tend to outperform, advisers say. That is because they hone their ability to identify targets, integrate those businesses and reap the intended financial benefits.
Companies should always weigh up deal making against alternative uses of funds, said Barry Weir, Citigroup’s co-head of European mergers and acquisitions.
“If the risk-adjusted return from M&A is higher than the benefits from returning cash to shareholders or some other lower-risk alternative, then it makes sense,” Weir said. “If it doesn’t meet this hurdle then you shouldn’t be doing M&A.”
HR Dive considers the occasions on which employees subject to the Fair Labor Standards Act are entitled to be paid for commuting to the office.
“An advisory committee to the Cybersecurity and Infrastructure Security Agency [CISA] delivered a long list of recommendations on Wednesday that encourage the agency to take measures to increase the cybersecurity expertise on corporate boards of directors, develop a national cybersecurity alert mechanism and better protect high-risk communities from surveillance.
“These policy measures were just a few of more than 100 recommendations made to CISA Director Jen Easterly, who called the findings “transformative.”
“Healthcare stakeholders have an opportunity to provide feedback to the Senate on improving health data privacy in the US, thanks to a request from US Senator Bill Cassidy (R-LA), a ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee.
“Cassidy issued a request for information (RFI) from stakeholders to gain insights into improving health data privacy and modernizing HIPAA. The deadline to submit feedback to Cassidy’s team is September 28.”
“The White House is looking to add oversight capabilities to strengthen cybersecurity for critical infrastructure. The administration has been working with various cabinet agencies to bolster cybersecurity in water, rail, aviation, energy and other sectors.
“However, Anne Neuberger, deputy national security advisor for cyber and emerging technology, speaking during the Billington Cybersecurity Summit in Washington D.C., raised the possibility of a letter grade rating that would hold key providers accountable for maintaining a certain level of cyber resilience.
“As good as public-private partnerships are, the administration sees additional enforcement ability as necessary.”
The Wall Street Journal offers its September 2023 cybersecurity regulatory update.
“In this quarter’s edition: updates on recently passed regulations from the U.S. Securities and Exchange Commission and the New York Department of Financial Services, new regulatory measures introduced by the California Privacy Protection Agency, the new cybersecurity strategy in New York state, and expert commentary on the draft regulations recently published by CPPA.”
From the cybersecurity breaches and vulnerabilities front,
“The dark web marketplaces dedicated to the trade of credentials and vulnerabilities boasts some big names in enterprise compromises, Flashpoint research released Tuesday [September 12] shows.
“Three reported purchases of vulnerability exploits on the dark web during the first half of the year included high profile, actively exploited CVEs, according to the threat intelligence firm.
“Flashpoint said its threat intelligence analysts observed a post expressing interest in the exploit on June 16, and another user offered help in response two days later.”
“A global cyber-espionage campaign conducted by the Iranian nation-state actor known as Peach Sandstorm (aka Holmium) has successfully plucked targets in the satellite, defense, and pharmaceutical sectors, Microsoft is warning.
“The cyber offensive has been active since February, according to a blog post from Microsoft Threat Intelligence, which concluded that the campaign used masses of password spray attacks between February and July to authenticate to thousands of environments and exfiltrate data, all in support of Iranian state interests.
“The password spray method of attack is a type of brute-force method used by hackers to gain unauthorized access to user accounts and systems. Password spraying involves attempting to access multiple accounts using common passwords, reducing the risk of account lockouts.”
“Apple has released emergency security updates for the flaws found in macOS, iOS, iPadOS, and watchOS used in the BLASTPASS exploit chain. As Bleeping Computerreports, Citizen Lab has warned Apple customers to apply the updates immediately and consider turning on Lockdown Mode if they suspect they’re particularly vulnerable to being targeted by sophisticated hackers. CISA has added the flaws to its catalog of known exploited vulnerabilities, saying that they pose “significant risks to the federal enterprise” and ordered all federal agencies to patch against them by October 2, 2023.”
“Deepfake is a term used to describe synthetic media — typically fake images and videos. Deepfakes have been around for a long time, but advancements in artificial intelligence (AI) and machine learning (ML) have made it easier and less costly to create highly realistic deepfakes.
“Deepfakes can be useful for propaganda and misinformation operations. For example, deepfakes of both Russia’s president, Vladimir Putin, and his Ukrainian counterpart, Volodymyr Zelensky, have emerged since the start of the war.
“However, in their new report, the FBI, NSA and CISA warn that deepfakes can also pose a significant threat to organizations, including government, national security, defense, and critical infrastructure organizations.”
“Your security solutions might stave off a LockBit infection, but you might still end up with encrypted files: according to Symantec’s threat researchers, some affiliates are using the 3AM ransomware as a fallback option in case LockBit gets flagged and blocked.”
The Healthcare Sector Cybersecurity Coordination Center provides us with a sector alert on Akira Ransomware.
“Akira is a Ransomware-as-a-Service (RaaS) group that started operations in March 2023. Since its discovery, the group has claimed over 60 victims, which have typically ranged in the small- to medium-size business scale. Akira has garnered attention for a couple of reasons, such as their retro 1980s-themed website and the considerable demands for ransom payments ranging from $200,000 to $4 million. Akira has been observed obtaining initial malware delivery through several methods, such as leveraging compromised credentials and exploiting weaknesses in virtual private networks (VPN), typically where multi-factor authentication (MFA) is not being used. Like many ransomware groups, they employed the double-extortion technique against their victims by exfiltrating data prior to encryption. It is also believed that the group may contain some affiliation with Conti due to observed overlap in their code and cryptocurrency wallets. The group has targeted multiple sectors, including finance, real estate, manufacturing, and healthcare.”
Here is a link to the latest Bleeping Computer Week in Ransomware, which features an attack on Las Vegas.
The Office for Civil Rights (OCR) and the Office of the National Coordinator for Health Information Technology (ONC) announce[ing] the release of version 3.4 of the Security Risk Assessment (SRA) Tool, further enhancing the user experience and helping covered entities navigate risk assessment requirements under the HIPAA Security Rule.
“OCR and ONC developed the SRA Tool to help small- and medium-sized healthcare providers identify and assess risks and vulnerabilities to electronic protected health information (ePHI). The tool is a software application that organizations can download at no cost.”
Check out the 405(d) Post, which offers “Five Key Insights from The Healthcare Cybersecurity Benchmarking Study.”
An ISACA expert explores risk assessment in a rapidly changing threat landscape.
CSO offers “Ten principles to ensure strong cybersecurity in agile development.”
Key Senate panels have reached a bipartisan deal on a bill that aims to bolster primary care.
“The package would invest more than $26 billion into primary care programs as well as initiatives to grow the healthcare workforce. The bill is cosponsored by Sen. Bernie Sanders, I-Vermont, who chairs the Senate Health, Education, Labor and Pensions committee, and Sen. Roger Marshall, R-Kansas, the ranking member of the Subcommittee on Primary Health and Retirement Security.”
Under a policy statement that the commission approved Thursday, the Federal Trade Commission will “use its full legal authority” against drugmakers that impede competition by improperly listing patents in a government database that controls how generic manufacturers can enter the market.
According to FTC Chair Lina Khan, pharma companies can “weaponize” the database, called the Food and Drug Administration Orange Book, because any generic maker that applies for approval of a drug with a listed Orange Book patent can be sued by the branded manufacturer and blocked from entry for 30 months.
The policy statement highlights the antitrust regulator’s tightening scrutiny of drugmakers’ marketing, patent and acquisition practices. The FTC recently slowed Amgen’s $27.8 billion acquisition of Horizon Therapeutics until Amgen agreed to safeguards against the “bundling” of drugs in the combined company. The agency is also carefully reviewing Pfizer’s planned $43 billion takeout of Seagen.
“The CMS agency that tests value-based payment models hopes to announce two new behavioral health and maternal health models later this year, according to Liz Fowler, director of the Center for Medicare and Medicaid Innovation.
“Both upcoming models have “a heavy role” for the Medicaid program, Fowler said Thursday during a Health Affairs policy briefing. The behavioral health model, which is currently going through clearance, will also involve Medicare.
“The CMMI is also working on strategies to better integrate specialty care with primary care, a priority Fowler called “a hard nut to crack.”
“The research is the final trial conducted by MAPS Public Benefit Corporation, a company that is developing prescription psychedelics. It plans to submit the results to the Food and Drug Administration as part of an application for approval to market MDMA, the psychedelic drug, as a treatment for PTSD, when paired with talk therapy.
“If approved, “MDMA-assisted therapy would be the first novel treatment for PTSD in over two decades,” said Berra Yazar-Klosinski, the senior author of the study, which was published in Nature Medicine, and the chief scientific officer at the company. “PTSD patients can feel some hope.”
Healio interviews “Kevin C. Oeffinger, MD, professor in the department of medicine and a member of the Duke Cancer Institute (DCI), founding director of the DCI Center for Onco-Primary Care and director of the DCI Supportive Care and Survivorship Center.” Check it out.
AHIP discusses health insurers’ efforts to improve access to mental health care providers.
“A recent AHIP survey of health insurance providers offering commercial health insurance coverage found that there is meaningful access to a wide range of professionals who deliver mental health support within plan networks. This survey also showed that the number of in-network mental health providers has increased by 48% in three years among commercial health plans.”
From the U.S. healthcare business front,
Following up on the news about the FDA’s issues with certain over the counter decongestants, Reuters points out,
“Procter & Gamble (PG.N), Walgreens (WBA.O) and Johnson & Johnson’s (JNJ.N) former consumer business are among several companies accused in lawsuits of deceiving consumers about cold medicines containing an ingredient that a unanimous U.S. Food and Drug Administration advisory panel declared ineffective.
Proposed class actions were filed on Wednesday and Thursday, after the panel reviewed several studies and concluded this week that the ingredient phenylephrine marketed as a decongestant was essentially no better than a placebo.”
“Over a 6-year period 25 percent of U.S. health visits were conducted by a non-physician, according to Harvard Medical School researchers.
“Advanced care delivered by nurse practitioner and physician assistant roles first emerged in the 1960s, and now, in 2023, nurse practitioner is the fastest growing career nationwide, according to the Bureau of Labor Statistics. Physician assistants also landed on the list of the nation’s fastest-growing careers, taking the 17th spot.
“For the study, which was published Sept. 14 in the British Medical Journal, researchers analyzed data from 276 million patient visits between 2013 and 2019 and found that during this time frame, there was an 89 percent increase in visits conducted by nurse practitioners and a 60 percent increase in visits conducted by physician assistants.”
“Ascension closed out its 2023 fiscal year with a $2.66 billion net loss, according to financial disclosures for the period ended June 30.
“The St. Louis-based nonprofit health system’s tough year, which ended June 30, came from a combination of high expenses, “sustained revenue challenges” and a one-time non-cash impairment loss of almost $1.5 billion, management wrote in the filing.
“Ascension’s operating loss for the year came in at $3.04 billion, or $1.55 billion (-5.6% margin) without the impairment losses.
“The numbers follow what was a difficult fiscal 2022, in which Ascension logged an $879 million operating loss and a $1.84 billion net loss. * * *
“Ascension is among the country’s largest health systems with 140 hospitals and 40 senior living facilities. The Catholic giant employs roughly 134,000 people across 19 states and the District of Columbia and reported $28 billion in total revenue during its 2022 fiscal year.
“Higher volumes and expenses have been a recurring takeaway in other nonprofit systems’ recent quarterly financial statements. Providence, a fellow Catholic nonprofit aiming to dig its way out of last year’s losses, reported last month that it had managed to trim its six-month operating losses from $424 million to $202 million thanks to returning patients and operational restructuring.”
“The House Energy and Commerce Committee today held a hearing on legislative proposals to prevent and respond to generic drug shortages. In comments submitted last month, AHA urged the committee to reject provisions in its draft legislation proposals that would limit patient access to 340B drugs and consider additional proposals that would protect the supply chain for essential medications.
“Witnesses at today’s hearing included representatives from Civica, the American Society for Health System Pharmacists, Healthcare Supply Chain Association, Healthcare Distribution Alliance, and Association for Accessible Medicines.”
“Although shortages are not new, the number of drugs in short supply has grown steadily for about two years. Shortages also have become more difficult to predict and are affecting drugs that are more critical.
“Most concerning are the shortages of cancer drugs, which until recently hadn’t been much of a problem for at least a decade. There are 15 cancer drugs currently in short supply, according to the Food and Drug Administration, though the White House this week said one of the key shortage chemotherapies, cisplatin, is nearly back to pre-shortage levels.
“Civica Rx members choose which drugs it brings to market. So far, the nonprofit contracts for cyclophosphamide, a chemotherapy that helps treat multiple cancers, and there’s a heightened urgency to determine whether to add more cancer drugs to the list.
“Given the drug shortage situation for cancer drugs, we have a working group now,” said Allan Coukell, senior vice president of public policy at Civica Rx. “We’re looking at what would a portfolio of those drugs be.”
“Despite misleading headlines, such as “Sudafed, Benadryl and most decongestants don’t work,” * * * [t]here are branded products that include the names Sudafed and Benadryl that do work as nasal decongestants. These contain the active ingredient pseudoephedrine. But because the dangerous illicit substance methamphetamine can be made in illegal laboratories with pseudoephedrine these products were placed behind the counter years ago. In 2005, Congress passed the Combat Methamphetamine Epidemic Act, which requires that pharmacies and other retail stores maintain purchase logs for products that include pseudoephedrine, and it limits the amount of those products an individual can purchase per day. Pseudoephedrine-based drugs are not affected by the FDA panel’s vote. They will remain available behind the counter.”
“GoodRx has notched a third partnership with a pharmacy benefit manager to integrate its drug coupons at the point of sale, further expanding GoodRx’s access to the commercially insured PBM market.
“For eligible members filling a generic medication starting in 2024, the new program will compare GoodRx’s discount price with their price through insurance and apply the lowest cost. The payment will be automatically applied to consumers’ deductibles.
“With MedImpact and existing deals with CVS Caremark and Cigna-owned Express Scripts, GoodRx now reaches more than 60% of insured lives through the partnerships, the company said Wednesday.”
The Institute for Clinical and Economic Research published an evidence report for gene therapy to treat Metachromatic Leukodystrophy.
“Currently available evidence provides greater certainty of substantial net health benefit in pre-symptomatic MLD; evidence also suggests that individuals with early symptomatic disease benefit from treatment —
“Using weighted analyses across all patient subpopulations, arsa-cel would achieve common thresholds for cost-effectiveness if priced between $2.3M – $3.9M —
“At the September 29 virtual public meeting, ICER’s independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate on the treatment’s comparative clinical effectiveness, other potential benefits, and long-term value for money.”
Results from the American Association for Cancer Research’s annual Cancer Progress Report revealed that the age-adjusted overall cancer death rate in the U.S. fell by 33% between 1991 and 2020.
The report also detailed FDA approvals related to anticancer therapeutics over the past year, the impact of immunotherapy on cancer care in the 21st century and key challenges needed to overcome obstacles patients with cancer still face moving forward.
McKinsey notes” “Orthopedic care is among the largest categories in US healthcare; improvements could have far-reaching positive effects. We analyze care pathways to spot opportunities for better coordination.” Check it out.
“Xylazine, a powerful veterinary tranquilizer, was detected in drug tests in 34 states from every region of the country, according to a new analysis.
“The analysis was conducted by national drug testing lab Millennium Health, looking at more than 160,000 de-identified urine drug test results from more than 73,000 unique patients collected between mid-April and mid-July 2023.
“Xylazine, also known as “tranq,” is a sedative that prolongs and enhances the euphoric effects of illicit fentanyl. Xylazine-associated deaths are on the rise, and nearly all involve illicit fentanyl or fentanyl analogs. The Biden administration designated fentanyl combined with xylazine an emerging threat in April. “
“Loneliness can have major impacts on seniors’ health, worsening comorbidies and even driving mortality, according to a white paper by the Elevance Health Public Policy Institute.
“Loneliness in older adults increases the likelihood of depression and dementia as well as worsening outcomes for individuals with hypertension, heart disease and stroke, according to the white paper.
“In a survey, the researchers researchers found that:
About 28% of respondents had a mental health condition.
About 1 in 4 reported having both depression and another mental health condition.
Individuals with a mental health diagnosis were more likely to live alone.
Individuals with a mental health diagnosis cited limitations to social activities in the past month because of poor health.
“Elevance Health hired research and consulting company Health Management Associates to describe the characteristics of 16,000 Medicare beneficiaries with a mental health diagnosis using the 2018 Medicare Current Beneficiary Survey. Some beneficiaries were covered by traditional fee-for-service Medicare, others by Medicare Advantage (MA).”
“Medical services provided in outpatient settings are notably pricier when delivered in hospital-owned departments compared with ambulatory surgery centers or physicians’ offices, according to a new analysis from a Blue Cross Blue Shield Association subsidiary.
“The report, based on data for 133 million Blues members found from 2017 to 2022, also found prices generally grew more rapidly at hospital outpatient departments than at non-hospital outpatient settings.
“Researchers said their data supports site-neutral proposals to make care costs the same regardless of where it’s provided. Momentum is building in Congress around the policies, but they face fierce opposition from hospital groups.”
“Out-of-network ground ambulance rides made up a larger percentage of total claim lines than in-network rides between 2018 to 2022, exposing patients to a higher risk of surprise bills, according to an analysis by Fair Health.
“Out-of-network rides made up almost 64% of all ground ambulance claim lines in 2018, decreasing slightly to over 59% in 2022.
“Advanced life support (ALS) services, which provide a higher level of care than basic life support (BLS), comprised a larger share of ground ambulance claims than basic life support services from 2018 to 2022 — another factor that could drive up costs, the research found. About 51% to 52% of ground ambulance claim lines were associated with ALS during the study period.”
“The odds moved up, based on the latest inflation data, that Social Security benefitscould see a 3.2% cost-of-living adjustment next year. Not sky high but a bit better than average.
“To be sure, we’ll need to see one more month of data before the exact inflation adjustment will be known. The next round of Consumer Price Index data for September will be released by the U.S. Bureau of Labor Statistics on Oct. 12.”
“Starting in 2024, Medicare Premium costs will be changing — Medicare Part B costs are expected to get more expensive, while Medicare Part D prices are projected to decrease. We’ll tell you how much below. * * *
“Due to a new Alzheimer’s treatment coming to the market (Leqembi, from pharmaceutical companies Eisai and Biogen), Medicare beneficiaries are expected to pick up the cost. Therefore, Medicare Part B prices are expected to increase in 2024. The costs are projected to go up from the current $164.90 to $174.80, a nearly $10 increase per month.
“While you may not see a huge difference in the amount you’re paying for Medicare Part D, it still could be slightly lower. The average total monthly Part D premium is projected to decrease from $56.49 in 2023 to $55.50 in 2024, according to the Centers for Medicare & Medicaid Services (CMS). That’s nearly $1 each month.”
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