CYBERSECURITY & HEALTHCARE
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Cyberattack Paralyzes Largest U.S. Health Care Payment System, Change Healthcare |
A severe cash squeeze is facing medical care providers - from large hospital networks to the smallest of clinics - in the aftermath of a cyberattack two weeks ago that paralyzed the largest U.S. billing and payment system in the country. The attack forced the shutdown of parts of the electronic system operated by Change Healthcare, a sizable unit of UnitedHealth Group, leaving hundreds, if not thousands, of providers without the ability to obtain insurance approval for services ranging from a drug prescription to a mastectomy - or to be paid for those services. In recent days, the chaotic nature of this sprawling breakdown in daily, often invisible transactions led top lawmakers, powerful hospital industry executives and patient groups to pressure the U.S. government for relief.
On Tuesday, HHS announced that it would take steps to try to alleviate the financial pressures on some of those affected: Hospitals and doctors who receive Medicare reimbursements would mainly benefit from the new measures. U.S. health officials said they would allow providers to apply to Medicare for accelerated payments, similar to the advanced funding made available during the pandemic, to tide them over. They also urged health insurers to waive or relax the much-criticized rules imposing prior authorization that have become impediments to receiving care. And they recommended that insurers offering private Medicare plans also supply advanced funding. Change Healthcare handles as many as one of every three patient records in the country. (https://www.nytimes.com/2024/03/05/health/cyberattack-healthcare-cash.html)
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FBI Warns U.S. Healthcare Sector of Targeted BlackCat Ransomware Attacks |
CISA, the FBI, and the Department of Human Services have released a joint advisory warning about the resurgence of BlackCat ransomware. Since December 2023, this group has compromised 70+ victims, the majority of which reside in the healthcare sector. The development comes after one of ALPHV BlackCat's administrators made a post encouraging affiliates to target hospitals after law enforcement's takedown of the ransomware group's infrastructure in early December 2023. As a way to help organizations defend against potential BlackCat attacks, the agencies recommend organizations to: - Routinely take inventory of assets and data to identify authorized and unauthorized devices and software. - Prioritize remediation of known exploited vulnerabilities. - Enable and enforce multifactor authentication with strong passwords. - Close unused ports and remove applications not deemed necessary for day-to-day operations. (CompTIA ISAO / https://thehackernews.com/2024/02/fbi-warns-us-healthcare-sector-of.html / https://www.cisa.gov/news-events/cybersecurity-advisories/aa23-353a)
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PHARMA NEWS
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First OTC Birth Control Pill in US Begins Shipping to Stores |
The first over-the-counter birth control pill will be available in U.S. stores later this month, allowing American women and teens to purchase contraceptive medication as easily as they buy aspirin. Manufacturer Perrigo said it has begun shipping the medication, Opill, to major retailers and pharmacies. A one-month supply will cost about $20 and a three-month supply will cost around $50, according to the company's suggested retail price. It will also be sold online. The launch has been closely watched since last July, when the FDA said the once-a-day Opill could be sold without a prescription. Ireland-based Perrigo noted there will be no age restrictions on sales, similar to other over-the-counter medications. (https://apnews.com/article/birth-control-pill-pharmacy-contraceptive-add40fec7589dae8ba26eb29bee36b8b)
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CVS & Walgreens Plan to Start Dispensing Abortion Pill Mifepristone Soon |
Drugstore chains CVS Health and Walgreens plan to start dispensing an abortion pill in a few states within weeks. CVS will start filling prescriptions for mifepristone in Rhode Island and neighboring Massachusetts "in the weeks ahead," spokeswoman Amy Thibault said. Walgreens will begin dispensing the medication within a week, spokesman Fraser Engerman said. The chain will start with some locations in California New York, Pennsylvania, Massachusetts, and Illinois. He said the company was starting in "in select locations to allow us to ensure quality, safety and privacy for our patients, providers and team members." Thibault said CVS will add states "where allowed by law, on a rolling basis." The moves come more than a year after the FDA finalized a rule change that broadened the availability of abortion pills to many more pharmacies, including large chains and mail-order companies. (https://apnews.com/article/cvs-walgreens-mifepristone-abortion-adaa5f92afa0f7b8ed5801e976932380)
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Some Patients Are Losing Access to Weight-Loss Drugs as Employers Stop Coverage |
Employers that embraced paying for weight-loss drugs are now reckoning with their high costs, forcing growing numbers to dial back or cut off their reimbursement because they can't afford it. The companies are putting in place restrictions such as limiting use to workers with high body-mass indexes, or a $20,000 cap, while others have eliminated coverage altogether. They can't sustain the spending, they say, and question whether the medications are reaching the right patients. Weight-loss drugs such as Wegovy and Zepbound are among the hottest prescriptions in the U.S. But the drugs list for more than $1,000 a month. Employers budgeted a 5.2% increase in health-plan budget costs for 2024, in part due to demand for the medicines, according to a recent survey from health-benefits manager Mercer. Instead, the drugs had helped fuel an 8.4% bump in employer pharmacy-benefit costs in 2023. The added spending is proving too much for some businesses. (https://www.wsj.com/health/healthcare/weight-loss-drugs-employer-insurance-dbe19458)
MEANWHILE, More Than a Billion People Worldwide Are Obese, WHO Study Finds: More than a billion people globally are now considered obese, a condition linked to an increased risk of numerous serious health problems, according to updated estimates from the World Health Organization and an international group of researchers. Obesity is so prevalent it has become more common than being underweight in most nations, including many low and-middle income countries that have previously struggled with undernourishment. The findings, considered among the most authoritative of independent estimates, are based on data from more than 220 million people in more than 190 countries. Obesity rates for adults more than doubled between 1990 and 2022, and more than quadrupled among children and adolescents aged 5-19, the paper said. Over the same period, the proportion of girls, boys and adults considered underweight fell by a fifth, a third and half, respectively, the analysis found. (https://www.reuters.com/business/healthcare-pharmaceuticals/more-than-billion-people-worldwide-are-obese-who-study-finds-2024-02-29/)
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HEALTHCARE & GOVERNMENT
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CMS Issues Additional Guidance on Program to Allow Medicare Beneficiaries to Pay Out-of-Pocket Rx Costs in Monthly Payments |
CMS has released the second part of draft guidance for the Medicare Prescription Payment Plan that outlines requirements for Medicare Part D plan sponsors, including outreach and education requirements, pharmacy processes, and operational considerations, for the program's first year, 2025. The draft guidance is part of the implementation of President Biden's prescription drug law, the Inflation Reduction Act, which will help reduce the burden of high upfront out-of-pocket prescription drug costs for seniors and people with disabilities with Medicare prescription drug coverage by allowing them to spread out costs over the year rather than requiring they pay in one lump sum. (https://www.cms.gov/newsroom/press-releases/cms-issues-additional-guidance-program-allow-people-medicare-pay-out-pocket-prescription-drug-costs)
MEANWHILE, Medicare Advantage plans might need to get a little skimpier next year: The Medicare Advantage industry is contending with pressure on both cost, as seniors who held back on procedures during the pandemic rush back, and revenue, as the Biden administration curtails payments to plans. The more challenging financial picture means companies will need to make some tough decisions about their plans next year - either sacrifice profit margins to continue growing or pull back on benefits to boost profitability. While there are other factors at play, if the current trends continue, plans will have to be more cautious in their offerings going forward. (https://www.wsj.com/health/healthcare/your-medicare-plan-might-not-include-as-many-freebies-next-year-ee7cab0d?mod=hp_minor_pos21)
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Government Warns Medicare Advantage Insurers Not to Deny Care Based on AI |
In a recent memo, CMS clarified that Medicare Advantage organizations may use algorithms, artificial intelligence, and related technologies to assist in making coverage determinations, but these technologies may not override standards related to medical necessity and other applicable rules for how coverage determinations by MA organizations are made. The memo states that "an algorithm that determines coverage based on a larger data set instead of the individual patient's medical history, the physician's recommendations, or clinical notes would not be compliant." For example, insurers may not use AI to determine whether to cover an inpatient hospital admission without considering factors specific to each patient. (https://www.aamc.org/advocacy-policy/washington-highlights/cms-addresses-use-ai-medicare-advantage-plans#)
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U.S. Health Officials Drop 5-Day Isolation Time for COVID-19 |
Americans who test positive for COVID-19 no longer need to stay in isolation for five days, U.S. health officials announced March 1. The CDC changed its longstanding guidance, saying that people can return to work or regular activities if their symptoms are mild and improving and it's been a day since they've had a fever. The change is an effort to streamline recommendations so they are similar to longstanding recommendations for flu and other respiratory viruses. Many people with a runny nose, cough or other symptoms aren't testing to distinguish whether it's COVID-19, flu, or something else, officials say. Most people have some degree of immunity to the coronavirus from past vaccinations or from COVID infections. And many people are not following the five-day isolation guidance anyway, some experts say. There is no change to guidelines for nursing homes and health care facilities, however. (AP / https://www.aol.com/news/u-health-officials-drop-5-180642391.html)
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Lawmakers Agree to Hike Medicare Doctor Pay By 1.68% |
Doctors will get a 1.68% pay hike in Medicare starting March 9 under a recent deal to fund part of the government. The pay bump is among multiple Medicare payment policies that now will run until the end of December. That year-end deadline lines up with the expiration of telehealth pay policies, setting the stage for a large health legislative package and giving Congress another shot at aligning hospital and doctor office payments and reforming the business practices of drug middlemen. (https://www.statnews.com/2024/03/03/doctors-medicare-pay-increase-congress/) (https://kffhealthnews.org/morning-breakout/lawmakers-agree-to-hike-medicare-doctor-pay-by-1-68/)
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CMS Updates Guidance to Permit Texting of Patient Information and Orders |
On February 8, 2024, CMS issued a memorandum to State Survey Agency Directors updating its prior 2018 guidance on the use of texting of patient information and orders among members of the care team within a hospital or Critical Access Hospital. The 2018 guidance explained that texting patient orders from a provider to a member of the care team would not be compliant with the Medicare Conditions of Participation (CoPs), citing concerns relating to record retention, privacy, confidentiality, and security. Under CMS's latest guidance, however, texting patient information and the texting of patient orders among members of the health care team is now permissible, so long as it is done through a HIPAA compliant secure texting platform and the CoPs are otherwise satisfied. (https://kslawemail.com/128/11043/pages/article-1.asp?sid=eec46fec-d82e-4bee-ab97-b49da75cdb1a)
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Medicare Generally Paid for Evaluation & Management Services Provided via Telehealth During First 9 Months of COVID-19 PHE That Met Medicare Requirements |
On February 13, 2024, OIG issued a report finding that physicians and other practitioners that provided evaluation and management (E/M) services via telehealth generally complied with Medicare requirements. OIG's audit covered $1.4 billion in Medicare Part B payments for more than 19 million E/M claim line services that were billed with place of service codes or modifiers indicating telehealth was used to provide the service during the audit period. Unallowable payments identified during the investigation resulted primarily from clerical errors or the inability to access records. (King & Spalding Health Headlines Feb. 19, 2024 / https://oig.hhs.gov/oas/reports/region1/12100501.asp)
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Medicare Price Negotiations: All Drugmakers Have Sent in Counteroffers |
All of the manufacturers whose drugs were chosen for the federal government's Medicare price negotiation program have sent back counteroffers for what they consider to be a maximum fair price, the White House recently announced. All companies are continuing to engage in the negotiation process, despite the host of legal battles to block the program, according to President Biden. On Feb. 1, the CMS sent out initial offers of a maximum fair price for the first 10 drugs chosen for Medicare negotiations. These include medications of Eliquis, Jardiance, Xarelto, Januvia and Farxiga. Talks are expected to go through Aug. 1, when negotiations officially end, per CMS guidance. The maximum fair prices are scheduled to be published Sept. 1 and are set to go into effect at the start of 2026. (https://thehill.com/policy/healthcare/4506575-all-drugmakers-send-in-counteroffers-in-medicare-price-negotiations/)
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ENABLING OTHER HEALTH TRENDS
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Hospital CIOs Weigh 5G as Digitized Medicine Pushes Wi-Fi to Its Limits |
A profusion of connected devices and data-intensive processes in healthcare is forcing hospital CIOs to evaluate alternatives to their existing Wi-Fi networks, which are pushing ever closer to their limits. For years, hospitals have relied on Wi-Fi, where connectivity depends on the amount and strategic placement of networking hardware. It's a setup chief information officers say can be difficult to scale at the pace of galloping bandwidth demands. Taking a page from newly automated warehouses and factories, some hospital CIOs are testing and evaluating private networks that run on high-speed 5G wireless cellular technology and other hybrid private-public 5G systems, which they say could be expanded more quickly across hospital campuses than traditional Wi-Fi. (https://www.wsj.com/articles/hospital-cios-weigh-5g-as-digitized-medicine-pushes-wi-fi-to-its-limits-9567955b?mod=hp_minor_pos4)
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To Combat Nursing Shortage, University of New England Offering 12-Month, Accelerated Nursing Bachelor's Degree |
The University of New England has launched a 12-month Accelerated Bachelor of Science in Nursing degree program intended to meet student demand and ease growing shortages in the nursing workforce. The program is a response to the growing demand for a more efficient and focused path into the nursing workforce, offering students the opportunity to become skilled and competent nurses in a shorter timeframe. According to the American Hospital Association, the U.S. will need to hire 200,000 nurses per year - compounded with a projected shortage of 124,000 over the next 10 years - to meet demand. (https://www.une.edu/news/2023/une-now-offering-12-month-accelerated-nursing-bachelors-degree)
MEANWHILE, HHS Announces a Multi-Pronged Effort to Strengthen Direct Care Workforce: HHS, through the Administration for Community Living (ACL), announced several new initiatives and resources from ACL's Direct Care Workforce (DCW) Strategies Center to address the dire shortage of professionals who provide the services many older adults and people with disabilities need to live in the community. These include two technical assistance opportunities to help states strengthen their systems for recruiting, retaining, and developing direct care workers; a national hub to connect states, stakeholders, and communities to best practices and other resources related to the direct care workforce; and a webinar series for states and stakeholders focused on a range of direct care workforce topics. More information: https://www.hhs.gov/about/news/2024/02/27/hhs-announces-multi-pronged-effort-strengthen-direct-care-workforce.html
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Food As Medicine a Burgeoning Area for Digital Healthcare |
Digital health players, grocers, and even government leaders are placing bets on the power of nutritional guidance and food delivery services to contribute to preventative healthcare, mitigate chronic conditions, and address food deserts. Instacart, a partner in several big-name food as medicine programs, has even attracted some recent acquisition rumors. The umbrella term "food as medicine" encompasses many different types of digital programs, which range from "scripts" for dietician appointments, to medically-tailored meals, to subsidized groceries and food deliveries. Funding for these programs varies too. Some programs rely on nonprofit dollars or Medicaid waivers, while others help customizers utilize their benefits from health plans (especially MA plans) or sign up for SNAP. But the details of these funding mechanisms may change - which means that food as medicine players will likely have to adopt multiple payment strategies, rather than putting all of their eggs in one basket. (Rock Health's Rock Weekly, Feb. 12, 2024)
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