Tuesday Tidbits

HIPAA Privacy and Security Rules

Tuesday Tidbits

David Ermer–AHRQ, CDC, CMS, Electronic health records, Federal employment benefits, HIPAA Privacy and Security Rules, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Healthcare Dive lets us know,
    • “President-elect Donald Trump has nominated Dr. Mehmet Oz, a physician, TV personality and former Republican candidate for Senate, to run Medicare and Medicaid as administrator for the CMS.
    • “America is facing a Healthcare Crisis, and there may be no Physician more qualified and capable than Dr. Oz to Make America Healthy Again,” Trump said in his announcement on social media platform Truth Social.
    • “The CMS oversees the healthcare coverage of more than 160 million Americans, or around half the U.S. population, through Medicare, Medicaid, the Children’s Health Insurance Program and Affordable Care Act plans.”
  • Per an HHS press release,
    • “Today, the Surgeon General released a new report on health disparities related to tobacco use, which finds that despite the nation’s substantial progress in reducing cigarette smoking and secondhand smoke exposure in the overall U.S. population, that progress has not been equal for all population groups. Disparities in tobacco use persist by race and ethnicity, income, education, sexual orientation and gender identity, occupation, geography, behavioral health status, and other factors. Additionally, cigarette smoking and secondhand smoke exposure continue to cause nearly half a million deaths a year in the United States—nearly one in five of all deaths.
    • “This report expands upon the 1998 Surgeon General’s report on tobacco use among U.S. racial and ethnic groups to include data and trends by additional demographic factors and their intersection. This report also summarizes research on factors that influence tobacco-related disparities, and outlines actions everyone can take to eliminate these disparities and advance health equity in the United States.” * * *
    • “For Surgeon General’s report information and resources, including the full report, a report executive summary, a consumer guide, and fact sheets, visit www.SurgeonGeneral.gov
      or www.CDC.gov/EndTobaccoDisparities“
  • FedManager offers its take on the ongoing Federal Employee Benefits Open Season while Serving Those Who Serve delves into Medicare Part D EGWPs participating in the FEHB and PSHB Programs.
  • HealthITBuzz reflects on a “Year of Movement in Pharmacy Interoperabiilty.” The more electronic health record interoperability, the better, after all.
  • The American Hospital Association News tells us,
    • Data released Nov. 18 by the University of Pennsylvania found that 15% of U.S. adults are familiar with the 988 Suicide and Crisis Lifeline, a 1% increase from last year. Those individuals from the survey reported that they knew the number and correctly stated it when asked in an open-ended format. One percent of respondents inaccurately reported the number was 911, an improvement from 4% in 2023. The 988 hotline launched in July 2022.”
    • The FEHBlog wonders if 911 operators transfer appropriate calls to 988 operators.
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), announced a $100,000 civil monetary penalty against Rio Hondo Community Mental Health Center (“Rio Hondo”) in California. The penalty resolves an investigation into Rio Hondo over a failure to provide a patient with timely access to their medical records. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule’s right of access provisions require that individuals or their personal representatives have timely access to their health information (within 30 days, with the possibility of one 30-day extension) and for a reasonable, cost-based fee. OCR enforces the HIPAA Privacy Rule, which establishes national standards to protect individuals’ medical records; sets limits and conditions on the uses and disclosures of protected health information; and gives individuals certain rights, including the right to timely access and to obtain a copy of their health records.” * * *
    • “The Notice of Final Determination may be found at: https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/rio-hondo/notice-final-determination/index.html“

From the public health and medical research front,

  • The New York Times reports,
    • “If I drew you a graph that showed the death rate among American kids, you would see a backward check mark: Fewer kids died over the last several decades, thanks to everything from leukemia drugs to bicycle helmets. Then, suddenly, came a reversal.
    • “I first noticed this in 2021 while poking around in mortality data from the virus-ridden year before. It looked bad. I knew that kids who contracted Covid tended to fare better than older people, but was the virus killing them, too?
    • “Nope. It wasn’t the virus. It was injuries — mostly from guns and drugs. From 2019 to 2021, the child death rate rose more steeply than it had in at least half a century. It stayed high after that. Despite all of the medical advances and public health gains, there are enough injuries [from firearms, traffic, drugs and drowning] to have changed the direction of the chart.”
  • Consumer Reports, writing in the Washington Post, informs us about “microplastics, phthalates, BPA and PFAS. We encounter these potentially toxic materials in everyday life. Here’s the difference among them.”
  • BioPharma Dive let us know,
    • “An experimental under-the-skin injection of Merck & Co.’s cancer immunotherapy Keytruda showed similar characteristics as the current intravenous formulation in a Phase 3 clinical trial, the company said Tuesday.
    • “The drugmaker plans to discuss data from the trial, which it didn’t disclose in full, with the Food and Drug Administration and other regulators. The intravenous form of Keytruda is expected to lose U.S. patent protection in 2028, which would open the door to biosimilar competitors.
    • “Rival Roche has already gained FDA approval for a subcutaneous version of its competing immunotherapy Tecentriq, while Bristol Myers Squibb is awaiting an FDA decision on an under-the-skin injection of Opdivo. Merck could be as much as a year or more away from approval of subcutaneous Keytruda.”
  • and
    • “An experimental pill developed by Johnson & Johnson and Protagonist Therapeutics significantly cleared skin in most people with moderate-to-severe plaque psoriasis who enrolled in a Phase 3 trial run by J&J.
    • “Treatment with the drug, called icotrokinra, led to clear or almost clear skin in about two-thirds of participants after four months of testing. Just under half experienced a 90% or greater reduction in their scores on another measure of psoriasis plaque coverage and severity. Only 8% and 4%, respectively, of study participants on placebo hit those same marks.
    • “Responses to icotrokinra improved further through six months and, according to a Monday statement from J&J, a similar percentage of participants in both trial groups experienced side effects. The company plans to present detailed results at an upcoming medical meeting.”
  • The National Institutes of Health offers information about “Weight-loss surgery in teens | Sugar intake and chronic disease risk | Mapping cancer formation and spread.”
  • Per an NIH press release,
    • “Experts convened by the National Institutes of Health (NIH) have identified five elements of a brain-based condition that has emerged as a leading cause of vision impairment starting in childhood in the United States and other industrialized nations. Known as cerebral (or cortical) visual impairment (CVI), some estimates suggest that at least 3% of primary school children exhibit CVI-related visual problems, which vary, but may include difficulty visually searching for an object or person or understanding a scene involving complex motion. Their report, based on evidence and expert opinion, was published today in Ophthalmology.
    • “Lack of awareness about CVI is a large factor leading to it to be misdiagnosed or undiagnosed, which can mean years of frustration for children and parents who are unaware of an underlying vision issue and don’t receive help for it,” said report co-author, Lotfi B. Merabet, O.D., Ph.D., associate professor of ophthalmology, Massachusetts Eye and Ear and Harvard Medical School, Boston.
    • “Clarifying the factors for suspecting CVI should help build awareness and help eye care providers identify children for further assessment so they can benefit from rehabilitation and accommodation strategies as early as possible,” said report co-author, Melinda Y. Chang, M.D., assistant professor of clinical ophthalmology at the University of Southern California, Los Angeles.”
  • The Institute for Clinical and Economic Review (ICER) announced,
    • ICER will assess the comparative clinical effectiveness and value of tolebrutinib (Sanofi) for the treatment of secondary progressive multiple sclerosis (SPMS).
    • The assessment will be publicly discussed during a meeting of the CTAF in June 2025, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • ICER’s website provides timelines of key posting dates and public comment periods for this assessment.
  • The U.S. Preventive Services Task Force opened a public comment period of its Grade A recommendation that all pregnant women undergo early screening for syphilis infection. This recommendation confirms an earlier decision made in 2018. The public comment period ends on December 23, 2024.

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “UnitedHealth Group’s Optum Rx, CVS Health’s Caremark and Cigna’s Express Scripts have sued the Federal Trade Commission alleging the agency’s in-house case over insulin prices is unconstitutional.
    • “The companies, the three largest pharmacy benefit managers by market share, are suing to block the administrative proceedings, according to a complaint filed Tuesday in the U.S. District Court for the Eastern District of Missouri. The PBMs’ associated group purchasing organizations Emisar Pharma Services, Zinc Health Services and Ascent Health Services, respectively, are also plaintiffs in the case.” * * *
    • “The PBMs allege the FTC’s claims — which they deny — involve private rights that should be heard in a federal court and allege the administrative proceeding violates their due process rights under the Fifth Amendment.”
  • and
    • “Change Healthcare’s vital clearinghouse platform has been restored after a cyberattack on the UnitedHealth Group subsidiary caused unprecedented billing and payment disruptions for providers nationwide, the company announced on its status webpage.
    • “This is a big step for the technology company after its systems were taken offline following a February ransomware attack that caused widespread disruptions throughout the healthcare system. Change Healthcare operates as the largest clearinghouse for billing and payments in the U.S., processing 15 billion transactions annually and managing about one-third of patient records.” 
  • and
    • “CVS Health is the first company to earn a Health Equity Accreditation from URAC.
    • “The independent nonprofit accrediting organization said CVS was the first to apply to the program, which started in 2023.” * * *
    • “CVS’ social determinants of health dashboard — aimed at helping identify individuals who are at risk of poor outcomes and refer them to community-based programs and screening options — contributed to its accreditation, URAC said. The company’s work in addressing health-related cost and access barriers played a role too, according to URAC.”
  • Fierce Healthcare adds,
    • “Mike Pykosz, the former CEO of Oak Street Health, will leave CVS Health as part of the company’s latest leadership shake-up.
    • “CVS announced Tuesday that Sree Chaguturu, M.D., will step into the role of president for healthcare delivery alongside his existing title as chief medical officer. In the announcement, CEO David Joyner said that Pykosz let the company’s top brass know “earlier in the year that he planned to move on from the company and we appreciate him helping to lead a smooth transition.”
    • “As CMO, Chaguturu oversees CVS’ medical affairs organization and is responsible for clinical quality, patient outcomes, addressing access gaps and managing health costs across the enterprise. He was also previously the chief medical officer at CVS’ Caremark pharmacy benefit manager.”
  • Fierce Pharma identifies the 2024’s Fiercest Women in Life Sciences. Kudos to them!
  • KFF brings us up to date on the national IV fluid shortage created by Hurricane Helene.
    • “[H]ospitals are facing seasonal strains on their already limited IV fluid resources, said Sam Elgawly, chief of resource stewardship at Inova, a health system in the Washington, D.C., area.
    • “We’ve been very aggressive in our conservation measures,” Elgawly said, stressing that he does not believe patient care has been compromised. He told KFF Health News that across the system IV fluid usage has dropped 55% since early October.
    • “Elgawly called the shortage a crisis that he expects to have to continue managing for some time. “We are going to operate under the assumption that this is going to be the way it is through the end of 2024 and have adopted our demand/conservation measures accordingly,” he said.”
  • MedTech Dive tells us,
    • “The Food and Drug Administration alerted healthcare providers Friday about the safety and supply of Getinge/Maquet vessel harvesting devices.
    • “The letter to providers describes issues with Getinge/Maquet VasoView Hemopro Endoscopic Vessel Harvesting (EVH) Systems. Getinge recalled the devices in September after receiving 18 complaints about Hemopro 1.5 devices in four months, including reports of 17 serious injuries.
    • “The FDA letter addresses the injury reports and warns the removal of Hemopro 1.5 may interrupt the supply of EVH devices. The devices are now on the FDA’s device shortage list.”

Monday Roundup

David Ermer–CMS, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • American Hospital News reports
    • “The Centers for Medicare & Medicaid Services April 22 finalized minimum staffing requirements for nursing homes that participate in Medicare and Medicaid. As proposed in September, the final rule will require nursing homes to provide a minimum of 3.48 hours of nursing care per resident day, including 0.55 hours of care from a registered nurse per resident day and at least 2.45 hours of care from a nurse aide per resident day, as well as 24/7 onsite RN services. CMS slightly expanded the opportunity for facilities to seek exemptions from the requirements from its original proposal. AHA had urged CMS not to finalize the proposal but instead develop more patient- and workforce-centered approaches focused on ensuring a continual process of safe staffing in nursing facilities.”
  • KFF adds
    • “KFF estimates that 19% of nursing facilities would meet the minimum HPRD staffing standards under full implementation of the final rule with their current staffing levels (Figure 1). Nearly 60% of facilities would meet the interim requirement of an overall requirement of 3.48 HPRD, but fewer facilities would meet the RN and nurse aide provisions that are required when the rule is fully implemented (49% and 30% respectively; data not shown).”
  • HHS’s Office for Civil Rights announced a final amendment to the HIPAA Privacy rule concerning reproductive health. The final rule
    • “Prohibits the use or disclosure of PHI when it is sought to investigate or impose liability on individuals, health care providers, or others who seek, obtain, provide, or facilitate reproductive health care that is lawful under the circumstances in which such health care is provided, or to identify persons for such activities.
    • “Requires a regulated health care provider, health plan, clearinghouse, or their business associates, to obtain a signed attestation that certain requests for PHI potentially related to reproductive health care are not for these prohibited purposes.
    • “Requires regulated health care providers, health plans, and clearinghouses to modify their Notice of Privacy Practices to support reproductive health care privacy.
    • “The Final Rule may be viewed here – PDF.
    • “View The Final Rule Fact Sheet here.”
  • AHA News adds,
    • “The rule will take effect 60 days after publication in the Federal Register and require covered entities to comply within 240 days. As requested by the AHA, OCR plans to issue a model attestation form before the compliance date.”
  • HHS’s Office of the National Coordinator of Health IT announced that
    • “Common Agreement Version 2.0 (CA v2.0) has been released. The Common Agreement establishes the technical infrastructure model and governing approach for different health information networks and their users to securely share clinical information with each other – all under commonly agreed-to rules-of-the-road. The seven designated Qualified Health Information Networks™ (QHINs™) under the Trusted Exchange Framework and Common Agreement℠ (TEFCA℠) can now adopt and begin implementing the new version. Also published today is the Participant and Subparticipant Terms of Participation, which sets forth the requirements that each Participant and Subparticipant must agree to and comply with to participate in TEFCA.”Common Agreement Version 2.0 (CA v2.0) has been released.
    • “The Common Agreement establishes the technical infrastructure model and governing approach for different health information networks and their users to securely share clinical information with each other – all under commonly agreed-to rules-of-the-road. The seven designated Qualified Health Information Networks™ (QHINs™) under the Trusted Exchange Framework and Common Agreement℠ (TEFCA℠) can now adopt and begin implementing the new version. Also published today is the Participant and Subparticipant Terms of Participation, which sets forth the requirements that each Participant and Subparticipant must agree to and comply with to participate in TEFCA.
    • ?Notably, CA v2.0 includes enhancements and updates to require support for Fast Healthcare Interoperability Resources® (FHIR®) Application Programming Interface (API) exchange, which will allow TEFCA Participants and Subparticipants to more easily exchange information directly between themselves and will enable individuals to more easily access their own health care information using apps of their choice via TEFCA. These enhancements and updates mark a huge step forward for TEFCA as it meets the promise of seamless nationwide exchange at scale. Visit HealthIT.gov to view a list of key concepts that have evolved from Common Agreement v1.1 to v2.0.”
  • Federal News Network shared the results of survey of federal employee attitudes toward the push to return to office.
    • “Of the 6,300 survey respondents, about 30% said they work entirely remotely, 6% work entirely in-person and 64% were working on a hybrid schedule — a mix of in-person work and telework.
    • “Over half of employees said senior leadership at their agency had not clearly explained the purpose of returning to the office. More than a third were in strong disagreement.”
  • From MedTech Dive,
    • “The Food and Drug Administration approved Lumicell’s breast cancer imaging tool, the company said Thursday.
    • “Lumicell developed the Lumisystem imaging technology to enable surgeons to detect residual cancer in the breast cavity after performing a lumpectomy to remove the tumor.
    • “An FDA advisory committee voted in March that the benefits of Lumisystem outweigh the risks, with one expert predicting the system will have the biggest impact on surgeons who have higher re-excision rates.”

From the public health and medical research front,

  • The New York Times asks and considers,
    • Bird Flu Is Infecting More Mammals. What Does That Mean for Us?
    • H5N1, an avian flu virus, has killed tens of thousands of marine mammals, and infiltrated American livestock for the first time. Scientists are working quickly to assess how it is evolving and how much of a risk it poses to humans. * * *
    • “I never let my kids go to a state fair or animal farm, I’m one of those parents,” Dr. Lakdawala said. “And it’s mostly because I know that the number of interactions that we increase with animals, the more opportunities there are.”
    • “Should H5N1 adapt to people, federal officials will need to work together and with their international counterparts. Nationalism, competition and bureaucracy can all slow down the exchange of information that is crucial in a developing outbreak.
    • “In some ways, the current spread among dairy cows is an opportunity to practice the drill, said Rick Bright, the chief executive of Bright Global Health, a consulting company that focuses on improving responses to public health emergencies. But the U.S. Agriculture Department is requiring only voluntary testing of cows, and is not as timely and transparent with its findings as it should be, he said.
    • “Dr. Rosemary Sifford, the department’s chief veterinarian, said the staff there were working hard to share information as quickly as they can. “This is considered an emerging disease,” she said.
    • “Government leaders are typically cautious, wanting to see more data. But “given the rapid speed at which this can spread and the devastating illness that it can cause if our leaders are hesitant and don’t pull the right triggers at the right time, we will be caught flat-footed once again,” Dr. Bright said.
    • “If we don’t give it the panic but we give it the respect and due diligence,” he added, alluding to the virus, “I believe we can manage it.”
  • MedPage Today discusses the ready availability of human vaccines for the H5H1 avian flu virus should the need arise.
  • Precision Vaccinations reminds us,
    • “In April 2024, the United States observes the 15th Annual Oral Cancer Awareness Month, which emphasizes the significance of preventing human papillomavirus (HPV)- related oral cancers [with HPV vaccines].
  • HealthDay tells us,
    • “The right diet may be the best medicine for easing the painful symptoms of irritable bowel syndrome (IBS), new research shows. 
    • “In the study, two different eating plans beat standard medications in treating the debilitating symptoms of the gastrointestinal disease. One diet was low in “FODMAPs,” a group of sugars and carbohydrates found in dairy, wheat and certain fruits and vegetables, while the second was a low-carb regimen high in fiber but low in all other carbohydrates.
    • “Published April 19 in the journal Lancet Gastroenterology and Hepatology, the findings suggest that patients should first try dietary changes before moving to drugs for relief.”
  • MedScape informs us,
    • “A new three-phase screening protocol that incorporates a PSA test, a four-kallikrein panel, and an MRI scan appears to improve the prostate cancer detection rate among men invited to participate in a single screening compared with those not invited, according to preliminary findings from the Finnish ProScreen randomized clinical trial.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “UnitedHealth’s results beat Wall Street expectations on an adjusted basis, with the company noting that overall care patterns in the first quarter were“consistent with the company’s expectations.” Nothing to worry about here, executives repeatedly told investors, who promptly sent UnitedHealth’s stock soaring and hospital shares tanking. Then on Thursday, Elevance offered more relief, saying that costs were running as expected while raising its full-year earnings guidance.
    • “Various monthly surveys are also showing a moderation in hospital volumes. TD Cowen’s survey, for instance, found that 305 hospitals reported only 1% year-over-year revenue growth in March, which was far weaker than 11% growth in February. Analysts led by TD Cowen’s Gary Taylor suggested that we could be at the start of a reversal of hospitals’ outperformance over managed care companies. 
    • “Investors will find out more this week as providers including Universal Health and HCA Healthcare, two large hospital chains, report earnings. HCA might still deliver solid results, as improvements in labor cost pressures and pricing should still positively influence earnings, notes UBS analyst A.J. Rice. 
    • And in any case, stabilization of healthcare utilization isn’t the same as a sharp drop-off. UnitedHealth and Elevance earnings may have signaled to investors that their views on providers were perhaps a bit too rosy, but they didn’t exactly demonstrate that cost pressures have eased. UnitedHealth noted that while it was no longer seeing the “aggressive acceleration” in medical utilization the industry saw in 2023, it hasn’t yet seen a major “step down.”
  • Per Fierce Healthcare,
    • “UnitedHealth Group provided an update late Monday on its analysis of the data accessed in the cyberattack on Change Healthcare, and said it identified files that contain personal and health information.
    • “The company said that the personal health information (PHI) and personally identifiable information (PII) found in the files “could cover a substantial proportion of people in America.” However, UHG said it has not yet uncovered evidence that full medical histories or doctors’ charts were among what was stolen.
    • “UnitedHealth added that with the complexity of the review, it will likely take months of further analysis to identify and notify impacted customers. In the meantime, it’s offering two years of credit monitoring and identity theft protection to anyone who has been effected by the breach.
    • “In addition, the company has also offered to make notifications and conduct required administrative steps on behalf of providers and customers.”
  • Per BioPharma Dive,
    • “Bristol Myers Squibb is turning to a manufacturing startup to help produce cancer cell therapies faster, announcing Monday a partnership with the South San Francisco, California-based Cellares.
    • “The deal, which reserves Cellares’ production capacity for Bristol Myers’ use, is worth up to $380 million in upfront and milestone payments. Cellares will handle technology transfer of certain Bristol Myers cell therapies to its automated manufacturing platform, dubbed the Cell Shuttle.
    • :Bristol Myers currently sells two so-called CAR-T cell therapies, Breyanzi for lymphoma and Abecma for multiple myeloma, and has several others in development. In a statement, Lynelle Hoch, head of the pharmaceutical company’s cell therapy unit, said the Cellares deal would help it meet demand for CAR-T therapies “now and in the future.”

Tuesday Tidbits

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, Electronic health records, FDA, Generative AI, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, U.S. Healthcare–
Photo by Maddy Weiss on Unsplash

Happy First Day of Spring!

From Washington, DC,

  • The Wall Street Journal reports,
    • “Lawmakers who are finishing writing six annual spending bills have resolved a last-minute roadblock over border funding, setting the stage for Congress to review and approve the legislation on a tight timeline that could take them to the brink of a partial government shutdown this weekend. 
    • “Congressional negotiators late Monday reached a deal on the provisions within the Department of Homeland Security’s funding bill. That bill got caught in an 11th-hour tangle with the White House over border spending, which has become a top issue in many swing states during the 2024 presidential-election year.
    • “In a statement Tuesday morning, Speaker Mike Johnson (R., La.) said an agreement has been reached on the Homeland Security funds, and House and Senate committees have begun drafting bill text to be “prepared for release and consideration by the full House and Senate as soon as possible.”
    • “President Biden said Tuesday that a path on the remaining funding legislation had been finalized and he would sign the measure immediately when it gets to his desk.”
  • Per a House Budget Committee press release,
    • “Today, the House of Representatives advanced House Budget Committee legislation, H.R. 766, the Dr. Michael C. Burgess Preventative Health Savings Act (PHSA), to the Senate by a voice vote. 
    • “The historic accomplishment marks the first time in history that a bipartisan bill with sole Budget Committee jurisdiction has been brought to the Floor under a suspension of the House rules. * * *
    • “One of the major barriers to deploying modernized and innovative policies that would unequivocally curb the cost of health care is the antiquated process used for calculating congressional cost estimates on proposed health care legislation.
    • “Congressional scorekeepers have traditionally focused solely only on the short-term valuation of a policy rather than capturing the long-term economic impact.
    • “But today, with passage of H.R. 766, that changes. This bill seeks to improve the methodology of Congress’ broken budgetary process by providing policymakers with a more accurate cost estimate of the long-term cost savings from preventive health care policies.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced a new voluntary model that empowers primary care providers in eligible Accountable Care Organizations (ACOs) to treat people with Medicare using innovative, team-based, person-centered proactive care. A key part of the Biden-Harris Administration’s efforts to further promote competition in health care, the ACO Primary Care Flex Model (ACO PC Flex Model) will provide a one-time advanced shared savings payment and monthly prospective primary care payments (PPCPs) to ACOs. The advanced shared savings payments provide ACOs with needed resources and flexibility to cover costs associated with forming an ACO (where relevant) and administrative costs for required model activities. PPCPs will be distributed by ACOs to primary care practices, giving them improved resources and flexibility to provide care that best suits individuals’ needs.” * * *
    • “The ACO PC Flex Model is a five-year voluntary model that will begin on January 1, 2025. CMS is planning to select approximately 130 ACOs to participate in the model. Organizations interested in participating must first apply — either as new ACOs or renewing ACOs — to the Shared Savings Program. Shared Savings Program Applications are open May 20, 2024 – June 17, 2024. The ACO PC Flex Model Request for Applications (RFA) is planned to be released in the second quarter of 2024.
    • “For Frequently Asked Questions about the Primary Care Flex Model, please visit: https://www.cms.gov/priorities/innovation/innovation-models/aco-primary-care-flex-model/faqs.
    • “For a fact sheet on the model, please visit: https://www.cms.gov/files/document/aco-pc-flex-fs.pdf – PDF.”
  • Yesterday, HHS’s Office for Civil Rights offered guidance to HIPAA covered entities and business associates about their use of online tracking technologies.
    • “Compliance with the Security Rule helps lower the risk of unauthorized access to ePHI collected through a regulated entity’s website or mobile app that could lead to harm to individuals. Therefore, OCR is prioritizing compliance with the HIPAA Security Rule in investigations into the use of online tracking technologies. OCR’s principal interest in this area is ensuring that regulated entities have identified, assessed, and mitigated the risks to ePHI when using online tracking technologies and have implemented the Security Rule requirements to ensure the confidentiality, integrity, and availability of ePHI. OCR investigations are fact-specific and may involve the review of technical information regarding a regulated entity’s use of any tracking technologies. OCR considers all of the available evidence in determining compliance and remedies for potential noncompliance.”
  • The U.S. Preventive Services Task Force issued the following final recommendation today:
    • “For children and adolescents younger than 18 years without signs and symptoms of or known exposure to maltreatment: The evidence is insufficient to assess the balance of benefits and harms of primary care interventions to prevent child maltreatment. [Grade I]”
  • Beckers Payer Issues discusses what fifteen insurers and trade associations explored with Biden Administration officials yesterday about the Change Healthcare situation.
    • During the meeting, stakeholders discussed how progress has been made in reestablishing claims processing systems, though small, rural and safety-net providers specifically are still reporting issues with cash flow.
    • Many healthcare organizations will require third-party certification of Change’s cybersecurity before reconnecting to its systems, in which UnitedHealth was urged to provide a timeframe around. Payers were also asked to analyze their internal data to determine which providers need more support and to engage with them directly.
    • According to Reuters, payers said they would accelerate payments to Medicare and Medicaid providers, along with providing loans to Medicaid providers.”
  • Here is a link to the HHS readout from this meeting.
  • The U.S. Postal Service reminded its retirees with Part A only about the opportunity to enroll for Medicare Part B with no late enrollment penalty during a special enrollment period beginning April 1, 2024. The Postal Service is picking up the late enrollment penalty cost. This is a good deal.
    • “The one-time PSHB SEP is from April 1, 2024, to Sept. 30, 2024. Individuals eligible for the PSHB SEP will receive notification by U.S. Mail™ in March 2024.
    • “All required information must be returned in the envelope provided and postmarked by Sept. 30, 2024.”
  • The Food and Drug Administration announced,
    • “On Monday, the FDA launched a new portal for patients, consumers and health care professionals to report potential drug shortage issues directly into CDER’s NextGen system without creating a NextGen account. 
    • “Since 2017, NextGen has been a way for regulated industry to communicate with the FDA, including submitting information on shortages, discontinuations, and anticipated supply disruptions. Non-industry stakeholders without a NextGen account previously reported information about potential shortages to the FDA’s Drug Shortages Staff by email. The new public portal allows anyone to submit shortage information through an online form directly into NextGen.  
    • “Expanding access to NextGen’s shortage reporting beyond regulated industry will allow for greater consistency and ease of reporting by outside stakeholders, and greater efficiency in tracking and responding to these reports.” 

From the public health and medical research front,

  • MedPage Today informs us,
    • “Investigation of an early signal for stroke associated with COVID-19 bivalent vaccines turned into suspicion of high-dose or adjuvanted flu shots instead, based on a large U.S. population-based study.
    • “When researchers inspected a large Medicare database, they found no evidence of a significantly elevated risk for stroke at 1-21 days or 22-42 days after vaccination with either of the mRNA COVID vaccines distributed for the 2022-2023 respiratory season when compared with the 43-90 day control window, reported researchers led by Yun Lu, PhD, a statistician of the FDA in Silver Spring, Maryland.
    • “There was a significant excess of nonhemorrhagic stroke for people with concomitant administration of Pfizer-BioNTech’s bivalent vaccine plus a high-dose or adjuvanted influenza vaccine during the 22-42 days risk window (risk difference of 3.13 out of 100,000 doses); and a significant excess of transient ischemic attack for people with concomitant administration of Moderna’s bivalent COVID vaccine plus a high-dose or adjuvanted influenza vaccine during the 1-21 days risk window (risk difference of 3.33 out of 100,000 doses).
    • “But the researchers found that people with administration of a high-dose or adjuvanted influenza vaccine alone (without concomitant COVID vaccination) had an elevated risk for the combined outcome of nonhemorrhagic stroke or transient ischemic attack in both the 1-21 days risk window (risk difference of 1.65 per 100,000 doses) and 22-42 days risk window (risk difference of 1.60 per 100,000 doses).
    • “This finding suggests that the observed association between vaccination and stroke in the concomitant subgroup was likely driven by a high-dose or adjuvanted influenza vaccination,” the investigators reported in JAMA.”
  • Medscape lets us know,
    • “The US Food and Drug Administration (FDA) has cleared the twiist automated insulin delivery (AID) system (Sequel Med Tech, LLC; Manchester, NH) for people aged 6 years or older with type 1 diabetes. 
    • “The system comprises a novel insulin pump developed by Sequel’s research and development partner DEKA and uses the FDA-cleared Tidepool Loop algorithmthat was originally developed through patient-led, open-source initiatives.
    • “The twiist AID system has the capacity to work interchangeably with different integrated continuous glucose monitors (iCGMs), and Sequel will announce their initial iCGM partner closer to market launch, Sequel CEO and co-founder Alan Lotvin, MD, told Medscape Medical News. 
    • “It is the first AID system that directly measures volume and flow of insulin delivery, which enables it to rapidly detect obstructions or occlusions, usually within about 20 minutes, Lotvin explained. “

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Elevance Health has inked a deal to acquire Kroger Specialty Pharmacy.
    • “The grocery chain announced Monday that an agreement is in place, saying it’s expected to close in the back half of 2024 pending regulatory approvals. Elevance intends to add Kroger Specialty Pharmacy to its CarelonRx business, which houses its pharmacy benefit management services.
    • “Financial terms of the sale were not disclosed.”
  • Per BioPharma Dive,
    • “AstraZeneca is the latest large pharmaceutical company to make a sizable bet on radiopharmaceutical drugs for cancer, agreeing on Tuesday to acquire longtime biotechnology partner Fusion Pharmaceuticals in a deal worth up to $2.4 billion.
    • “AstraZeneca will acquire all of Fusion’s shares for $21 apiece, or about $2 billion. The British drugmaker could add another $3 per share via a financial instrument known as a “contingent value right” if Fusion meets an unspecified regulatory milestone. Should Fusion hit that mark, the buyout would be worth $2.4 billion.” 
  • Beckers Health IT offers six takeaways from last month’s HIMSS conference.

Friday Factoids

David Ermer–Generative AI, HIPAA Privacy and Security Rules, HSA, OPM, Patient safety, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Govexec tells us, “The Office of Personnel Management on Friday proposed new regulations aimed at granting federal agencies greater flexibility in selecting new federal employees during the hiring process.” The public comment deadline is September 19, 2023.
  • Federal News Network offers a table of federal government return-to-office policies.
  • The Society for Human Resource Management informs us,
    • “The U.S. Citizenship and Immigration Services (USCIS) announced Friday a new Form I-9—which has been streamlined and shortened—that employers should use beginning Aug. 1, 2023.
    • “Employers may continue to use the older Form I-9 (Rev. 10/21/19)  through Oct. 31., 2023. After that date, they will be subject to penalties if they use the older form. The new version will not be available for downloading until Aug. 1.  
    • “Additionally, the U.S. Department of Homeland Security (DHS) issued a final rule that allows the agency to create a framework under which employers could implement alternative document examination procedures, such as remote document examination. The new form subsequently has a checkbox to indicate when an employee’s Form I-9 documentation was examined using a DHS-authorized alternative procedure.
    • “At this time, the final rule only allows employers using E-Verify to use alternative verification methods.”
  • Healthcare Dive notes
    • “The Federal Trade Commission and the HHS’ Office for Civil Rights are warning hospitals and telehealth companies about embedding online tracking technologies on their websites or apps, saying the trackers risk exposing consumers’ personal health data to third parties. 
    • “The trackers, like the Meta Pixel or Google Analytics, collect identifiable information about users and could reveal information about health conditions, diagnoses, treatments, frequency of visits and more, the agencies wrote in a letter to about 130 health systems and telehealth providers.
    • “The warning marks the latest move from regulators regarding the healthcare industry’s use of tracking technologies, which monitor user behavior on websites. Sharing consumers’ health data with third parties, like advertisers, has been a recent target of FTC oversight.”

Following up on the tornado that struck a Pfizer factory in Rocky Mount, NC, STAT News reports

  • “Pfizer says a tornado that ripped through a key manufacturing plant in North Carolina does not appear to have caused “any major damage” to areas that produce medicines.
  • “The company reported most damage from the storm occurred at a warehouse that stores raw materials, packaging supplies, and finished medicines awaiting release by quality assurance personnel. As a result, it remains unclear about the extent to which destruction at the facility — which produces nearly 8% of all sterile injectables used in U.S. hospitals — will exacerbate a growing shortage of prescription drugs across the country.”

The Food and Drug Administration also issued a report on the incident.

From the medical malpractice front, STAT News points out

  • “A new study published this week in BMJ, * * * estimates that “371,000 people die every year following a misdiagnosis, and 424,000 are permanently disabled — a total of 800,000 people suffering “serious harm,” said David Newman-Toker, the lead author of the paper and a professor of neurology at Johns Hopkins School of Medicine and director of its Center for Diagnostic Excellence. Settling on an exact number is hard because many cases of misdiagnosis go undetected, he said. It could be fewer than his study identified or more — between half a million and a million — though in any event, it would be the most common cause of death or disability due to medical malpractice. 
  • “He likens the issue of misdiagnosis to an iceberg, saying cases leading to death and disability are but a small fraction of the problem. “We focused here on the serious harms, but the number of diagnostic errors that happen out there in the U.S. each year is probably somewhere on the order of magnitude of 50 to 100 million,” he said. “If you actually look, you see it’s happening all the time.” 
  • “But misdiagnoses typically don’t lead to severe consequences because, most times, people aren’t visiting the doctor with a serious condition. “The risk level just walking through the door in the doctor’s office that something horrible is going to happen to you because of a diagnostic error is actually quite low,” said Newman-Toker.”

In related news “[The American Hospital Association] AHA today released its quarterly Health Care Plan Accountability Update, featuring the latest news on AHA efforts to hold commercial health insurers accountable for policies that can delay care for patients, burden health care providers and add unnecessary costs to the health care system. READ MORE.”

From the factoid front —

  • HealthEquity suggests three ways to drive health savings account plan adoption.
  • Beckers Payer Issues points out how seven payers are using artificial intelligence.
  • MedTech Dive reports, “Intuitive Surgical posted strong robotic volume growth in the second quarter and raised its full-year procedure outlook but said patient interest in new weight-loss drugs is curbing demand for bariatric surgeries.”

Midweek update

David Ermer–Congress, HIPAA Privacy and Security Rules, Medical / Rx research, Mental health care, Rx coverage–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From our Nation’s capital —

  • STAT News reports
    • “Senators are slightly delaying their latest legislative push on health care, but as they do, a clearer picture is emerging about what’s in — and out — of the mix.
    • “The Senate health committee was expected to mark up legislation related to generic drugs, pharmacy benefit managers, and some leftovers from the Food and Drug Administration’s user fee agreements next week, but leaders are planning to reschedule the meeting, several sources told STAT.
    • “But 17 health care industry lobbyists and Senate staffers said Democratic leadership is targeting relatively low-hanging fruit that is bipartisan, and already has established history in legislation [i.e., a $35 copay on insulin in the commercial market]”.
  • Beckers Payer Issues tells us that “the Justice Department has decided to seek a stay pending appeal of a Texas federal judge’s ruling that struck down an ACA provision requiring insurance companies to provide coverage for preventive services, CNN reported April 11.”
  • The Department of Health and Human Services proposed a HIPAA privacy rule change “to strengthen its protections by prohibiting the use or disclosure of protected health information (PHI) to investigate, or prosecute patients, providers, and others involved in the provision of legal reproductive health care, including abortion care.” The public comment period will end sixty days after April 17, 2023, the day on which the proposed rule will be published in the Federal Register.

From the public health front —

  • MedPage Today informs us
    • Fentanyl adulterated with xylazine is an “emerging drug threat” in the U.S. and requires immediate action, the Biden administration warned.
    • “This is the first time in a nation’s history that a substance is being designated as an emerging threat by any administration,” said Rahul Gupta, MD, director of the White House Office of National Drug Control Policy (ONDCP), during a phone call with reporters late Tuesday afternoon. “And it couldn’t come at a more critical time.”
  • ABC News reports
    • The number of sexually transmitted infections (STIs) in the United States shows “no signs of slowing,” new federal data shows.
    • A total of 2.53 million cases of chlamydia, gonorrhea and syphilis were recorded in 2021, according to a new report published Tuesday from the Centers for Disease Control and Prevention.
    • That’s a 5.8% increase from the 2.39 million cases reported in 2020 and a 7% increase from five years ago when 2.37 million STIs were recorded in 2017.
    • “I’d like people to understand that this data actually impacts them whether they think it does or not and it’s because STIs happen to everyone, regardless of socioeconomic, religious, political lifestyle,” Dr. Kameelah Phillips, an OBGYN in New York City, told ABC News. “I’d like them to really understand that routine testing at their health care office is super important … gonorrhea doesn’t care who you are.”
    • While certain STIs did not reach pre-pandemic levels, others — such as syphilis — are recording the highest numbers seen in more than 70 years.

From the mental healthcare front —

  • Benefits Pro highlights a survey finding that
    • 21% of workers at ‘high mental health risk’ and unaware of available [employer sponsored] counseling.
    • Employees often do not know the range of resources available to them in their benefits packages and are often unaware of counseling included in the company’s employee assistance program, according to a TELUS survey.

Federal agencies and the Postal Service sponsor EAPs, but the FEHBlog is unaware of OPM creating a connection between those programs and the FEHBP.

From the Rx coverage front —

  • Drug Channels offers a report on specialty pharmacies which informs us that “Drug Channels Institute (DCI) estimates that in 2022, retail, mail, long-term care, and specialty pharmacies dispensed about $216 billion in specialty pharmaceuticals prescriptions. That’s an increase of 12% from the 2021 figure.”  
  • The Institute for Clinical and Economic Research released
    • a Protocol outlining how we will conduct our third annual assessment of how well major insurers’ prescription drug coverage policies align with a set of fair access standards developed by ICER with expert input from patient advocates, clinician specialty societies, payers, pharmacy benefit managers, and life science companies, and
    • a Draft Evidence Report assessing the comparative clinical effectiveness and value of exagamglogene autotemcel (“exa-cel”, Vertex Pharmaceuticals and CRISPR Therapeutics) and lovotibeglogene autotemcel (“lovo-cel”, bluebird bio) for sickle cell disease.  The draft report represents the midpoint in ICER’s eight month long review process.

From the medical research developments front

  • STAT News reports, “A Parkinson’s ‘game changer,’ backed by Michael J. Fox, could lead to new diagnostics and, someday, treatments.” It’s a heartening medical research story about Mr. Fox’s productive efforts.
  • Medscape reports
    • Phototherapy is a safe, effective, noninvasive, and inexpensive way of boosting cognition for patients with dementia, new research suggests. It may be “one of the most promising interventions for improving core symptoms” of the disease.
    • A new meta-analysis shows that patients with dementia who received phototherapy experienced significant cognitive improvement compared to those who received usual treatment. However, there were no differences between study groups in terms of improved depression, agitation, or sleep problems.

Friday Stats and More

David Ermer–CDC, COVID-19, HIPAA Privacy and Security Rules, Patient safety–

From the Centers for Disease Control’s Covid data tracker and its weekly interpretative summary of its Covid statistics:

  • New Cases totaled 455.556 this week, down 2.7% from last week.
  • Variants BQ.1.1 and BQ.1 are estimated to represent 78% of Covid / Omicron cases
  • New Hospitalizations averaged 5,010 this week, up 2.3% from last week.
  • New Deaths totaled 2,703, down 13.2% from last week.
  • “As of December 14, 2022, 660.4 million vaccine doses have been administered in the United States. About 228.8 million people, or 68.9% of the U.S. population, have completed a primary series.* More than 44.2 million people, or 14.1% of the U.S. population ages 5 years and older, have received an updated (bivalent) booster dose.”

The CDC reports good news about the efficacy of the bivalent booster here and here.

Pfizer announced the sale $2 billion worth of Paxlovid pills (3.7 million courses) to the federal government and its ongoing research on developing combined mRNA Covid and flu vaccine.

From CDC’s Fluview — “Seasonal influenza activity remains high but appears to be declining in some areas.”

Health Affairs brings us up to date on mpox.

Looking forward, Healthcare Dive reports

  • Leaders at hospitals and health systems across the country are anticipating a potentially turbulent operating environment in the coming year, according to a survey from Deloitte.
  • Among health system leaders, 85% said staffing challenges would have a major impact on their 2023 strategy and 76% said inflation is a significant factor. Other expected headwinds include affordability issues for patients, shrinking margins and continual supply chain disruptions.
  • Deloitte also polled health plan executives and found they face challenges related to inflation and a tight labor market, though are generally in a better financial position than hospitals and health systems.

Speaking of hospitals, Fierce Healthcare informs us

The care given in emergency departments came under fire yesterday with the release of a government study saying that 250,000 Americans die every year due to misdiagnoses.

The findings spurred an immediate response from the president of the American College of Emergency Physicians (ACEP), who questions the study’s veracity and methodology.

Christopher S. Kang, M.D., president of the ACEP, said in a statement that “in addition to making misleading, incomplete and erroneous conclusions from the literature reviewed, the report conveys a tone that inaccurately characterizes and unnecessarily disparages the practice of emergency medicine in the United States.”

One of the authors of the study—David Newman-Toker, M.D., Ph.D., a neurologist at Johns Hopkins University—vehemently defends the methodology and told Fierce Healthcare that “high levels of variation in care (across conditions, across hospitals, across demographic groups) tells us that these errors do not need to be thought of as ‘the price of doing business.’ It tells us that there are already probably ways to get it right.”

The study, conducted by Johns Hopkins for the Agency for Healthcare Research and Quality, states that among 130 million ED visits in the U.S. per year, 7.4 million patients are misdiagnosed. In addition, 2.6 million suffer an adverse event, and about 370,000 suffer serious harm from diagnostic errors.

The teenage daughter of CNN reporter Jake Tapper writes in CNN about her frightening ER experience. The FEHBlog joined his wife at a Dripping Springs TX knitting store holiday event. He mentioned the Alice Tapper story to two nurses who were horrified. In the FEHBlog experience, nurses are the best judge of hospital care across facilities.

In HIPAA news, the American Hospital Association tells us

The Department of Health and Human Services yesterday proposed a standard format for attachments to support electronic health care claims and prior authorization transactions under the Health Insurance Portability and Accountability Act. The standard would apply to all health plans, health care clearinghouses, and providers, who currently lack an efficient and uniform method of sending attachments, which can lead to provider burnout, slow down processing and delay payments or patient care.

“The AHA supports establishing a standard for attachments to reduce the administrative burdens facing clinicians, and we look forward to providing robust commentary after analyzing the rule’s specifics,” said Terrence Cunningham, AHA’s director of administrative simplification policy.

Comments on the rule are due March 21. 

Monday Roundup

David Ermer–CDC, COVID-19, Federal employment benefits, HIPAA Privacy and Security Rules, NIH, OPM, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Federal Employee Benefits Open Season front, Federal News Network is offering a free e-book on this timely topic.

Fierce Healthcare adds

When many people are looking to enroll in health benefits, they turn to Google as a source of key information on eligibility, the application process and in-network providers.

In this spirit, the Google Search team has quietly rolled out multiple features for its search engine that aim to make it easier for users to access key information about obtaining Medicaid and Medicare benefits, as well as which doctors locally accept those types of coverage.

The article offers more details on these new Google tools.

From the Omicron and siblings front

  • Beckers Hospital Review informs us “The CDC has begun tracking omicron subvariant XBB, which is now estimated to account for 3.1 percent of U.S. cases”[, somewhat higher in New York, New Jersey and New England states]. * * * Health experts anticipate the U.S. will see an increase in COVID-19 cases in the winter months as a collection of omicron subvariants circulates, though they have remained optimistic it will be less severe than last winter’s omicron surge.”
  • The National Institutes of Health discusses its research on the ability of the human body’s immune system to remember a previous Covid infection or vaccination to help ward off, or minimize symptoms during, a future infection.
  • Fierce Healthcare reports “The U.S. came in dead last compared to 20 other countries when it came to preventing deaths from COVID-19 as well as all-cause deaths, and it appears that relatively low vaccination rates might have played a part in those poor showings, a new study finds. * * * The U.S. continued to experience significantly higher COVID-19 and excess all-cause mortality compared with peer countries during 2021 and early 2022, a difference accounting for 150,000 to 470,000 deaths,” authors of the research letter published in JAMA Network wrote. ‘This difference was muted in the 10 states with highest vaccination coverage; remaining gaps may be explained by greater vaccination uptake in peer countries, better vaccination targeting to older age groups, and differences in health and social infrastructure.’”

From the public health front

  • Axios tells us “The RSV season normally runs from December to April, peaking in February and March, but this year has seen an earlier onset. [Dr.] Fauci noted that both the RSV and flu seasons have arrived earlier than usual this year.  Asked by [Meet the Press host Margaret] Brennan whether the U.S. is “in the worst of it” right now, Fauci replied, “I hope so.”
  • The American Hospital Association relates “The World Health Organization today recommended a new name for monkeypox that is intended to mitigate a rise in related racist and stigmatizing language associated with the ailment. The WHO’s newly recommended preferred term is “mpox.” The organization recommends a one-year transition period to mitigate confusion that could be caused by the change and allow for ICD and publication updates. The Biden administration voiced its support for the change, stating, ‘We welcome the change by the World Health Organization. We must do all we can to break down barriers to public health, and reducing stigma associated with disease is one critical step in our work to end mpox.’” The FEHBlog also will begin to refer to chickenpox as cpox.

From the regulatory front, MedPage Today informs us

In an effort to enhance care coordination for patients with substance use disorder (SUD), HHS, acting through its Office for Civil Rights and in collaboration with the Substance Abuse and Mental Health Services Administration, proposed changes to “Part 2” rules to better align privacy measures with those of HIPAA on Monday.

If implemented, the proposed rule would allow Part 2 programs to use and share patients’ records following a single signed consent by the patient “for all future uses and disclosures for treatment, payment, and healthcare operations.”

The proposal also aims to strengthen protections around disclosure of SUD treatment records to guard against discrimination and stigma.

The changes were initially called for in the CARES Act of 2020, provisions of which required the HHS secretary to better align the 42 CFR part 2 rule, better known as “Part 2,” with HIPAA’s Privacy, Security, Breach Notification, and Enforcement Rules.

“This proposed rule would improve coordination of care for patients receiving treatment while strengthening critical privacy protections to help ensure individuals do not forego life-saving care due to concerns about records disclosure,” said HHS Secretary Xavier Becerra in a press release.

HHS adds

From the medical research front, we learn from STAT News that

A drug developed by Axsome Therapeutics significantly reduced a common side effect of Alzheimer’s disease — agitation — the company announced Monday.

The therapy, AXS-05, met its primary goal of delaying time to relapse and preventing patients from relapsing. Patients taking the drug had a 3.6-fold lower risk of relapse overall, compared to placebo.

People with Alzheimer’s disease can get restless, upset, or even aggressive as the disease gets worse. Axsome’s trial also showed an improvement on a scale commonly used to measure overall agitation.

* * *

The Food and Drug Administration has granted Axsome breakthrough therapy status for AXS-05 in Alzheimer’s agitation, which could help the company secure an accelerated, additional approval. Company officials said they plan to wait to see data from another Phase 3 trial called ADVANCE-2 before filing a drug application, according to a third-quarter earnings call transcript from Sentieo.

and

Dr. Thomas Perls has for decades studied so-called super agers, people who live deep into their 90s and beyond, essentially unburdened by the typical diseases of old age. He is convinced that the secret to this remarkable longevity is buried in people’s genes and passed down through generations.

But which genes harbor this power? And if researchers pinpoint the right genes amid thousands in a person’s body, could that knowledge be harnessed to develop drugs that mimic those genes and allow more people to enjoy longer, healthier lives?

That’s the premise behind an ambitious new trial, the SuperAgers Family Study, (superagersstudy.org) that aims to enroll 10,000 people who are 95 years old or older and their children.

From the benefit design front, Beckers Payer Issues offers more insights from a recent AHIP study of prior authorization practices:

Gold-card programs give providers exemptions from certain prior authorization requirements, but providers who have discontinued these programs have found them administratively difficult to implement, according to a Nov. 14 America’s Health Insurance Plans survey.  * * *

Here are the top three reasons insurers said they discontinued gold card programs, according to the report:

1. Administratively difficult to implement: 75 percent

2. Reduced quality/patient safety: 50 percent 

3. Higher costs without improved quality: 25 percent

From the healthcare business front, Healthcare Dive reports

[Telehealth vendor] Amwell is in advanced discussions to acquire online therapy app Talkspace for roughly $200 million, according to a report from Israeli business publication Calcalist.

The telemedicine company is in talks to pay $1.50 per share for Talkspace, Calcalist reported on Sunday. The price tag would represent a 150% premium over Talkspace’s share price at Friday’s close.

The reported transaction reflects a sharp decline in Talkspace’s value since the therapy company went public last summer at a $1.4 billion valuation.

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, HIPAA Privacy and Security Rules, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Federal Employee Benefits Open Season front, FedSmith provides advice to federal and postal employees and FedWeek provides guidance to all interested parties.

In the Federal Times, Reg Jones answers a reader’s question about whether an annuitant can suspend their FEHBP coverage.

From the Omicron and flu front –

MedPage Today expresses expert views that developing vaccines that prevent the spread of Covid require human challenge trials in which fully informed, vaccinated people are exposed to Omicron.

[M]any experts agree: we need new vaccines to limit the spread of the virus. The current generation of vaccines offers strong protection against serious illness and death, but their edge has dulled against new variants, and they do not always prevent infection and transmission of the virus.

The White House hosted a summit on the issue in July, showcasing the myriad ways researchers are going about developing new vaccines. There are hundreds of candidates in early stages around the world, but the resources devoted to COVID-19 vaccine research are a fraction of what they were 2 years ago. Human challenge trials can greatly speed the selection of the most promising in this field of candidates, providing scientific and economic benefits over uniform reliance on large field studies.

Time will tell.

The Wall Street Journal provides a background story of this year’s flu that compares the spread of the flu vs. the spread of Covid.

How contagious is flu?

Covid-19 is more contagious than influenza, doctors say. One reason is that most people have had flu multiple times and many have gotten multiple flu shots over the years. 

The most common calculation of a virus’s infectiousness is a measure called the R0 (pronounced “R naught”). This metric estimates how many people one contagious person will infect on average. The R0 of influenza is between one and two. R0 data for Covid-19 isn’t definitive, especially as the virus continues to mutate, but studies indicate the number for many Covid strains is higher than for flu. 

From the tidbits department

  • Healthcare Dive offers “five takeaways from the FDA’s list of AI-enabled medical devices. As the number of devices increases, the agency is looking to adapt its regulatory framework to the new technology, including faster approval of algorithm updates.”
  • The Patient-Centered Outcomes Research Institute (PCORI), which the Affordable Care Act requires health insurers and plans to fund, shares its strategic plan.
  • The Segal Company helpfully reminds cafeteria plan sponsors that “As part of COVID-19 relief, the Consolidated Appropriations Act, 2021 (CAA) permitted plan sponsors to immediately implement certain mid-year changes to their cafeteria plans during the 2020 and/or 2021 plan years without first having to adopt plan amendments. Employers that implemented such relief are required to adopt certain retroactive plan amendments by December 31, 2022.”
  • The Centers for Disease Control calls attention to its U.S. Diabetes Surveillance System website. Check it out.
  • Beckers Hospital Review lists the ten most expensive States for healthcare. The only state with a top 10 population included on Becker’s list is Florida.

Midweek Update

David Ermer–Congress, COVID-19, Federal employment benefits, HIPAA Privacy and Security Rules, OPM, U.S. Healthcare–

From Capitol Hill, Fierce Healthcare tells us

The House unanimously passed the Improving Seniors’ Timely Access to Care Act on Wednesday via a voice vote. The legislation, which has new transparency requirements for MA plans, now heads to the Senate.

Lawmakers behind the legislation said in a joint statement the bill will “make it easier for seniors to get the care they need by cutting unnecessary red tape in the healthcare system,” said Reps. Suzan DelBene, D-Washington, Mike Kelly, R-Pennsylvania, Ami Bera, M.D., D-California, and Larry Bucshon, M.D., R-Indiana.

It’s worth noting that traditional Medicare has no prior authorization requirements. Beckers Payer Issues adds

Enrollees in Medicare Advantage were less likely to receive low-value care than those enrolled in traditional Medicare, a new study published in JAMA Open Network found. 

The study, published Sept. 9, found Medicare Advantage enrollees received 9.2 percent fewer low-value services than their counterparts using traditional Medicare. 

Low-value care is services that provide little clinical benefit or cause more harm than benefits for a patient. 

The study’s authors, lead by researchers from Humana and Boston-based Tufts University School of Medicine, compared enrollees in a large, national Medicare Advantage plan to a random sample of 5 percent of traditional Medicare beneficiaries. 

The study found among Medicare Advantage enrollees, those who had HMO plans were less likely to receive low-value care than those with PPO plans.

Read the full study here.

Hopefully, Congress will not throw out the baby with the bath water.

From the federal employee benefits front, FedWeek informs us

OPM has issued a reminder to agencies of their authority to verify that family members being covered under the FEHB actually are eligible, including the process to be used and the documentation required.

The notice calls attention to a revision of the FEHB handbook section on family member eligibility reflecting several instructions of recent years, including one telling agencies to tighten scrutiny of those covered and another laying out procedures for removing those deemed ineligible. That is a response to several inspector general reports warning that ineligible persons are being insured under the program, raising premium costs to the government and to other FEHB enrollees.

That directive, now part of the handbook, lists agency responsibilities to verify eligibility of family members during initial enrollment of newly hired employees and when family members are being added to an existing enrollment due to a “qualifying life event” such as marriage.

In the middle of the last decade, OPM added a standard contract provision to FEHB contract requiring carriers to share the cost of any family member eligibility audit that OPM undertakes. OPM has not yet exercised that provision.

It turns out that for the past two weeks federal employee benefits expert Reg Jones has been writing in Fedweek about federal employee retirement benefits. Today’s he discusses survivor benefits which includes a squib about perhaps the most unique and valuable survivor benefit — FEHB coverage for the survivor’s life with the full government contribution as explained here:

If your spouse receives a survivor annuity and was covered under either the Self Plus One or Self and Family option of your Federal Employees Health Benefits plan when you died, he or she and all eligible children can continue that coverage. If the annuity amount is less than the premiums required, your spouse will be able to make payments directly to OPM to cover the cost.

From the Omicron and siblings front, we have two thoughtful pieces from MedPage Today

In other virus news, the American Hospital Association reports

The recent paralytic polio case in an unvaccinated adult in Rockland County, N.Y. and wastewater samples from communities near the patient’s residence meet the World Health Organization’s criteria for circulating vaccine-derived poliovirus, the Centers for Disease Control and Prevention announced yesterday. Genetic sequences from the virus in the patient and wastewater specimens have been linked to wastewater samples in Jerusalem and London, indicating community transmission, CDC said.
 
Thirty other countries have circulating vaccine-derived poliovirus, which is not caused by the polio vaccine but occurs when local immunity to poliovirus is low enough to allow prolonged transmission of the original weakened virus in the oral polio vaccine. Oral polio vaccine has not been used or licensed in the U.S. since 2000 but continues to be used in some countries. N.Y. Governor Kathy Hochul last week declared a state of emergency to help expand vaccination efforts and surveillance. 
 
“Polio vaccination is the safest and best way to fight this debilitating disease and it is imperative that people in these communities who are unvaccinated get up to date on polio vaccination right away,” said Dr. José R. Romero, director of CDC’s National Center for Immunization and Respiratory Diseases. “We cannot emphasize enough that polio is a dangerous disease for which there is no cure.”

From the No Suprises Act front, Beckers Hospital CFO Report relates

The No Surprises Act, which prevents patients from receiving surprise bills from out-of-network providers at emergency rooms, could lead to an increase in emergency department visits, a new study from the Agency for Healthcare Research and Quality found. 

The study, published Sept. 12 in The American Journal of Medical Care, compared emergency department visits rates in 15 states that implemented bans on balance billing between 2007 and 2018 to rates in 16 states where these bills were not banned. 

The study’s authors found that state-level bans reduced spending per emergency room visit by 14 percent but increased emergency room visits by 3 percentage points. These visits were 9 percent less urgent than before the balance billing ban, according to an emergency department severity index. 

Based on the state-level analysis, the study’s authors, led by AHRQ researcher William Encinosa, PhD, conclude that the No Surprises Act, which took effect this year, could result in 3.5 million more emergency room visits annually. 

“Because individuals will no longer have the fear of a possible catastrophic surprise ED bill not covered by their insurer, they may be more inclined to go to the ED in marginal, less severe cases,” the authors wrote. 

Read the full study here.

In the FEHBlog’s opinion, the No Surprises Act is working well, and he does not foresee a surge in ER visits because going to the emergency room is no picnic.

In preventive services news, MedPage Today reports

The jury is still out on whether asymptomatic children and adolescents should be screened for diabetes, the U.S. Preventive Services Task Force (USPSTF) said.

In a new recommendation statement published in JAMA, the task force concluded that there is insufficient evidence to weigh the benefits and harms of screening for type 2 diabetes in this pediatric population, despite rising rates of disease.

“[T]here is inadequate evidence that screening and early intervention lead to improvements in health outcomes such as renal impairment, cardiovascular morbidity, mortality, and quality of life,” wrote Carol M. Mangione, MD, MSPH, of the University of California Los Angeles, and colleagues.

From the miscellany department —

  • The Department of Health and Human Services announced that today HHS “Secretary Xavier Becerra formally swore in Melanie Fontes Rainer as Director of the Office for Civil Rights (OCR). Director Fontes Rainer previously served as the Acting Director and was officially appointed to the role last month.  OCR is responsible for enforcing federal civil rights; conscience protections; the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach Notification Rules; and the Patient Safety and Quality Improvement Act and Patient Safety Rule – which together protect individuals’ fundamental civil rights and medical privacy.”
  • The Justice Department announced “the establishment of three Strike Force teams created to enhance the Department’s existing efforts to combat and prevent COVID-19 related fraud. “These Strike Force teams will build on the Department’s historic enforcement efforts to deter, detect, and disrupt pandemic fraud wherever it occurs,” said Attorney General Merrick B. Garland. “Since the start of this pandemic, the Justice Department has seized over $1.2 billion in relief funds that criminals were attempting to steal, and charged over 1,500 defendants with crimes in federal districts across the country, but our work is far from over. The Department will continue to work relentlessly to combat pandemic fraud and hold accountable those who perpetrate it.” The Strike Force teams will operate out of U.S. Attorney’s Offices in the Southern District of Florida, the District of Maryland, and a joint effort between the Central and Eastern Districts of California.”

The good news is there’s a cure for hepatitis C. The bad news is how hard it is to bring that miracle cure to the people who need it. For years experts assumed the drug’s astronomical price was the biggest barrier. So in 2019, Louisiana and Washington state adopted the “Netflix model,” as in paying a lower price for abundant access to the drug. Just last week the White House jumped on board for a national version.

But STAT’s Nicholas Florko has found that neither state is near its goal. In Washington, the treatment rate for Medicaid patients is now lower than before the initiative began, even with a lower price. “The further you get out in the population … the more you start to hit this population that is harder — harder to identify, more costly to convert to treatment,” Rena Conti of Boston University told Nick. Read his investigation here.

  • The National Institute of Health’s HEAL Program offers ways to build opioid use disorder prevention into everyday life.
  • Govexec discusses OPM’s efforts to “highlight ways federal employees can contribute to the White House’s fight against hunger and to improve Americans’ health and nutrition, including through an event later this month.”

Tuesday Tidbits

David Ermer–ACA, CDC, COVID-19, HIPAA Privacy and Security Rules, No Surprises Act, OPM, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Omicron and siblings front, the Wall Street Journal reports

The Biden administration has completed plans for a fall Covid-19 booster campaign that would launch in September with 175 million updated vaccine doses provided to states, pharmacies and other vaccination sites.

The administration is procuring the doses, which drugmakers are updating to target the newest versions of the virus. The administration has also informed states, pharmacies and other entities they can begin preordering now through the end of August, according to the administration’s fall vaccination planning guide.

Vaccines would be shipped immediately following an expected authorization by federal drug regulators, who still must review and sign off on the shots, and recommendations from the Centers for Disease Control and Prevention, which still must review the data and sign off on administering the shots. 

Administration officials have expressed hope that the boosters would help head off a wave of serious illnesses and deaths in the fall and winter, when cases often increase as more people gather indoors.

Due to the 2021-22 Delta and original Omicron variants, I gave up on expecting herd immunity from Covid. However, MedPage Today points out that those perilous Covid surges combined with vaccinations and treatments like Paxlovid create herd safety from hospitalizations and deaths. We should build up vaccination levels, but the vaccination marketing campaign should be built on a sensible theory like herd safety and not on 2020-like hysteria.

From the No Surprises Act front, Fierce Healthcare offers provider and payer opinions on the final independent dispute resolution rule. Last Spring, CMS dethroned the Qualifying Payment Amount from its commanding position in the baseball arbitration process. That aspect of the final rule is not a change in current practice. The FEHBlog senses that the No Surprises Act is working well.

Today, the Office of Personnel Management posted its first FAQs on the Postal Service Health Benefits Program which will launch in January 2025.

From the medical research front, BioPharma Dive reports

Over the last decade, drugs based on multiple RNA technologies, known as RNA interference and antisense oligonucleotides, have made it to market. Yet, it took a historic pandemic to thrust RNA into the global spotlight. Equipped with new tools, scientists are now exploring how other types can be used to make therapies that last longer and treat, as well as prevent, more diseases.

At least 10 biotechnology startups are developing next-generation RNA drugs. Though years of research lie ahead, these companies have already raised hundreds of millions of dollars from venture capitalists, large pharmaceutical firms and other investment groups.

If their work pans out, it could provide new treatments for cancer, rare diseases, and chronic illnesses that affect organs, the nervous system and the immune system.

The article provides an overview of these RNA drug development efforts.

From the tidbits department —

  • MedPage Today reports that “For higher-risk adults without prior cardiovascular disease (CVD) events, the U.S. Preventive Services Task Force (USPSTF) continues to broadly recommend statins for primary prevention while differing from other American guidelines in certain key aspects. * * * Despite being consistent with the USPSTF’s 2016 recommendations on the subject, the latest update takes away language about the preferred low-to-moderate dosing of statins in people with no history of CVD. This could be attributed to a lack of data, as a review of the literature showed most statin trials tested a moderate-intensity statin.”
  • Axios reports “Life expectancy in the U.S. fell in all 50 states and the District of Columbia from 2019 to 2020 and fell nationally by 1.8 years, according to new Centers for Disease Control and Prevention data published Tuesday. The big picture: The decline nationally and in states was mostly due to the COVID-19 pandemic and increases in unintentional injuries, specifically drug overdose deaths.
  • The National Institutes of Health announced that “Poverty, combined with other types of adversity in early childhood, is associated with greater chances of premature death in adulthood, compared to other adverse childhood experiences, according to a study of more than 46,000 people by researchers at the National Institutes of Health.”
  • The NIH Director’s Blog features a fascinating description of the inside of the “amazing” human brain.
  • The HHS Office of Civil Rights reached a settlement with dermatology practice over an alleged HIPAA Privacy Rule violation for improper disposal of protected health information.