Midweek update

Wellness

Midweek update

David Ermer–CDC, Medical / Rx research, Medicare, OPM, Rx coverage, Telehealth, U.S. Healthcare, Wellness–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The American Hospital Association (“AHA”) News tells us,
    • “The House Appropriations Committee July 10 voted 31-25 to approve legislation that would provide $185.8 billion in funding for the departments of Labor, Health and Human Services, and Education in fiscal year 2025, an 11% cut below the prior fiscal year. * * *
    • “The bill would also prohibit any funding from being used to implement or enforce the final rule issued by the Administration relating to minimum staffing levels for long-term care facilities.
    • “The full House may consider the bill in August.”
  • The AHA News also reports on several CMS/HHS rule makings that occurred today.
    • “The Centers for Medicare & Medicaid Services July 10 released its calendar year 2025 proposed rule for the physician fee schedule. The rule proposes to cut the conversion factor by 2.8%, to $32.36 in calendar year 2025, as compared to $33.29 in CY 2024. This reflects the expiration of the 2.93% statutory payment increase for CY 2024; a 0.00% conversion factor update under the Medicare Access and Children’s Health Insurance Program Reauthorization Act; and a .05% budget-neutrality adjustment.” * * *
    • “CMS will accept comments on the proposed rule through Sept. 9.” 
      • Here is a link to the CMS fact sheet on the proposed rule plus a link to the CMS fact sheet on proposed rule’s shared savings program.
      • Per Fierce Healthcare,
        • “In statements quickly released after the proposed rule dropped, frustrated physician and industry groups contrasted the “dangerous” baseline reimbursement cut against financial pressures weighing on practices.”
    • “The Centers for Medicare & Medicaid Services July 10 issued a proposed rule that would increase Medicare hospital outpatient prospective payment system rates by a net 2.6% in calendar year 2025 compared to 2024. This includes a proposed 3.0% market basket update, offset by a 0.4 percentage point cut for productivity.” * * *
    • “CMS will accept comments on the proposed rule through Sept. 9.” 
      • Here is a link to the CMS fact sheet on the proposed rule.
      • STAT News adds,
        • “The federal government will not modify regulations that dictate how hospitals publish their prices for consumers, ignoring pleas from patient advocates who have said hospitals still are not fully complying with the 3-year-old law.
        • “The Biden administration on Wednesday proposed an annual rule that sets payment rates for hospitals. This document is where the government has in the past rolled out changes to the so-called hospital price transparency rule, but the Biden administration did not address the issue in this edition.
      • Per Fierce Healthcare,
        • “In reaction statements, industry groups like the American Hospital Association (AHA) and hospital group purchasing organization Premier said that the “inadequate” pay update proposal and called for an upward adjustment in the final version of the rule.”
    • “The Department of Health and Human Services July 10 released a proposed rule designed to improve health information sharing and interoperability. The Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule includes two sets of certification criteria designed to enable health information technology for public health and payers to be certified under the Office of the National Coordinator for Health Information Technology’s Health IT Certification Program. The criteria would improve public health response, advance value-based care delivery and focus on standards-based application programming interfaces to improve end-to-end interoperability between health care providers and public health organizations or payers. 
    • The rule proposes a new set of certification criteria to support the technical requirements included in the Centers for Medicare & Medicaid Services’ Jan. 2024 Interoperability and Prior Authorization final rule to facilitate electronic prior authorization. The proposed rule also responds to patient, provider and other communities’ concerns about patient privacy and care access by expanding exceptions and clarifying the definitions of information blocking. HHS plans to publish the notice in the Federal Register with a 60-day comment period.
  • Following up on yesterday post about the FTC interim staff report on its PBM investigation, the Wall Street Journal reports,
    • “The Federal Trade Commission is preparing to sue the largest three pharmacy-benefit managers over their tactics for negotiating prices for drugs including insulin, after a two-year investigation into whether the companies steer patients away from less-expensive medicines. 
    • “The agency plans to file lawsuits taking aim at business practices related to rebates brokered with drug manufacturers, people familiar with the matter said. The FTC is also investigating the role that insulin manufacturers play in the negotiations, one of the people said.”
  • STAT News adds,
    • “The lawsuits are expected to focus on the controversial role of rebates, according to the source, who spoke on condition of anonymity. These are paid by drugmakers to PBMs to win favorable placement on formularies, which are the lists of medicines covered by health plans. In general, drugmakers argue they must raise prices to compensate for rebates, while PBMs maintain drug companies raise prices to boost profits.”
  • Bloomberg provides context to the situation by noting
    • “States and municipalities have also filed suits against both pharmacy benefit managers and drugmakers alleging that they drove up insulin costs for public-sector health plans. Many of those cases have been consolidated in a New Jersey federal court managing the litigation.”
  • Federal New Network digs into Fed Scope and discovers, among other things, that “Nearly half of all civilian feds are new hires since 2019. Agencies hired more than 1 million federal employees since October 2019, and it’s almost an even split between competitive and excepted service.”

From the public health and medical research front,

  • The New York Times reports,
    • “A 54-year-old New Jersey woman who was the second person to receive a kidney transplanted from a genetically modified pig, and who lived with the organ for 47 days, died on Sunday, surgeons at NYU Langone Health announced on Tuesday.
    • “The patient, Lisa Pisano, was critically ill, suffering from both kidney failure and heart failure. She received the pig kidney on April 12, just eight days after implantation of a mechanical heart pump.
    • “Surgeons were forced to remove the kidney on May 29 after it was damaged by inadequate blood flow related to the heart pump. After the explantation, Ms. Pisano resumed kidney dialysis but eventually was transitioned to hospice care.
    • “Ms. Pisano made medical history as the first person with a heart pump who is known to have also received an organ transplant. Patients with kidney failure are usually ineligible to receive a heart pump because of the high risk of dying.”
    • RIP, Ms. Pisano.
  • CNN tells us,
    • “An estimated 72 million women in the United States have skipped or delayed a recommended health screening, according to a new survey. This poll, conducted by Gallupfor medical technology company Hologic, found that 90% of women acknowledged the importance of regular health screenings — but more than 40% have skipped or delayed a test.
    • “Women have trouble prioritizing their own health, the survey found, with over 60% of women responding that it was hard to make their own health a priority. The numbers are particularly striking among younger women; 74% of women in Generation Z and 70% of millennials said it was hard to prioritize their health, compared with 52% of baby boomers and 39% of the Silent Generation.
    • The journalist also interviews CNN wellness expert Dr. Leana Wen about these findings.
  • Healio informs us,
    • “[R]esearchers utilized National Violent Death Reporting System (NVDRS) data to assess the number, circumstances and characteristics of violence-related deaths in 2021.
    • “Overall, there were 68,866 fatal incidents involving 70,688 deaths that occurred in 48 states and Washington, D.C. Among the deaths:
      • 58.2% were suicides;
      • 31.5% were homicides;
      • 8.2% were deaths of undetermined intent that could have been due to violence;
      • 1.3% were deaths due to “legal intervention,” like law enforcement using deadly force in the line of duty; and
      • less than 1% were unintentional firearm deaths.
    • “Nguyen and colleagues also found that 59.2% of deaths involved firearms.
    • “Among suicide victims, when the circumstances were known (84.4%), the suicide was often preceded by mental health conditions, as 49% of victims were currently diagnosed with a mental health problem and 29.2% experienced a depressed mood at the time of death.” * * *
    • “Violence is preventable and reducing deaths in communities is possible with evidence-based approaches,” the researchers wrote.
    • “They added that such interventions can include “social-emotional learning programs, enhanced parenting skills and family relationships, treatment for persons at risk for suicide, and treatment to prevent reattempts.”
  • and
    • “Patients with chronic kidney disease or transplant should have ongoing access to telehealth to help manage care, according to results of a qualitative meta-analysis. 
    • “One group in need of telemedicine services is chronic kidney disease (CKD) and transplant patients,” Christopher D. Manko, BS, of the Geisinger Commonwealth School of Medicine in Scranton, Pennsylvania, wrote with colleagues. They added, “[P]atients need frequent appointments to manage all related conditions. Similarly, transplant patients need close monitoring of the grafted organ and immunosuppressant therapy.” But Manko and colleagues noted that “prior systematic reviews focused on telehealth and eHealth interventions in dialysis patients have shown conflicting results with potential benefits [and] more adequately powered prospective studies are needed.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “Fourth time’s the charm? Sanford Health is hoping so.
    • “Less than a year after scrapping its proposed merger with a Minnesota health system— its third failed deal since 2019 — South Dakota’s Sanford is attempting a new, multibillion-dollar mashup. The $7 billion, 45-hospital system plans to absorb Marshfield Clinic Health System, a $3 billion system of 11 hospitals across Wisconsin and northern Michigan.
    • “The proposed deal would make Sanford Marshfield’s parent company, creating a 56-hospital system with Sanford’s name, CEO, and headquarters in Sioux Falls, S.D. The combined system would have about 56,000 employees, 4,300 doctors and advanced practice providers, two health plans with more than 425,000 members, specialty pharmacies, and research institutions. The systems said they plan to close the deal by the end of the year.
    • “Sanford CEO Bill Gassen told STAT in an interview that Sanford and Marshfield are a good fit not only from a regulatory perspective — they have no overlapping coverage areas — but more importantly, from a cultural one. He said both nonprofit systems strive to deliver world-class care in rural areas. They both want strong physician leaders. They both have big health plans. They both do research and train doctors.”
  • Bloomberg relates,
    • “Purdue Pharma LP secured a two-month window to negotiate a new pact with members of the Sackler family as the OyxContin maker and its owners brace for a potential wave of civil opioid lawsuits after the US Supreme Court scuttled an earlier $6 billion settlement.
    • “Judge Sean Lane said during a Tuesday court hearing in New York that he’d extend for 60 days an injunction that, for years, has paused opioid litigation against the billionaire family while Purdue, government authorities and victims lawyers attempted to effectuate the earlier settlement.
    • “Advisers who negotiated the earlier deal will attempt to cut a new agreement during the two-month window that complies with the Supreme Court’s ruling. Such a settlement, if successful, would likely compensate victims and provide billions of dollars to fund programs to combat the nation’s opioid addiction crisis.” 
  • Healthcare Dive lets us know,
  • and
    • offers more insights into the 2024 Medicare Advantage star rating changes that CMS made recently in response to court decision.
  • The New York Times points out that “In Constant Battle With Insurers, Doctors Reach for a Cudgel: A.I. As health plans increasingly rely on technology to deny treatment, physicians are fighting back with chatbots that synthesize research and make the case.”
  • ICD-10 Monitor asks us whether we are ready for the new ICD-10 diagnosis codes that take effect October 1, 2024.
  • Drug Channel peers into its crystal ball to project prescription drug spending in 2032.

Thursday Miscellany

David Ermer–CDC, CMS, Medical / Rx research, Mental health care, NIH, Telehealth, U.S. Healthcare, Wellness–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Department of Health and Human Services announced,
    • Today the U.S. Department of Health and Human Services, through its Administration for Community Living, released “Aging in the United States: A Strategic Framework for a National Plan on Aging – PDF.” The report lays the groundwork for a coordinated effort – across the private and public sectors and in partnership with older adults, family caregivers, the aging services network, and other stakeholders – to create a national set of recommendations for advancing healthy aging and age-friendly communities that value and truly include older adults. The national plan on aging will advance best practices for service delivery, support development and strengthening of partnerships within and across sectors, identify solutions for removing barriers to health and independence for older adults, and more. Developed by leaders and experts from 16 federal agencies and departments working together through the Interagency Coordinating Committee (ICC) on Healthy Aging and Age-Friendly Communities, the report also reflects input from community partners and leaders in the aging services network.
  • The Assistant Secretary of Labor for Employee Benefit Security, Lisa Gomez, reminds us,
    • “May is Mental Health Awareness Month, reminding us of the critical need to prioritize mental well-being – especially in the workplace where many spend a significant portion of their time. Did you know that more than 1 in 5 adults in America live with a mental illness? Mental health issues can affect job performance, relationships and overall well-being. Understanding your rights and support systems can make a world of difference. 
    • “Here are three actions you can take to get the mental health care you deserve through your job-based health plan: 
    • “Use your benefits: * * * For more information, read our publication “Understanding Your Mental Health and Substance Use Disorder Benefits.”
    • “Don’t take no for an answer: * * * You also can look at our publication “Filing a Claim for Your Benefits” for steps to help navigate this process. 
    • “Contact the Department for help:  Know that support for your mental health journey is available – you don’t have to go through it alone. One source of support is found by contacting a benefits advisor with the Department’s Employee Benefits Security Administration at askebsa.dol.gov or by calling 1-866-444-3272 for assistance with any questions or problems you encounter when trying to use the mental health and substance use disorder benefits under your job-based health plan. The benefits advisors can help you understand your rights, your health plan and its appeal process.”
  • The American Hospital News lets us know,
    • “The Centers for Disease Control and Prevention May 29 published a blog co-authored by AHA, the National Institute for Occupational Safety and Health and the Agency for Healthcare Research and Quality, highlighting efforts by federal agencies and the hospital field to address the mental health and well-being of health care workers following incidents of workplace violence. The blog contains several resources, such as AHA’s Hospitals Against Violence Initiative, the Building a Safer Workplace and Community infographic, and information about #HAVhope Friday on June 7 * * *.
  • HR Dive informs us,
    • “Employers run afoul of federal law when they fire someone for not disclosing a disability during a job interview or for waiting until after they were hired to ask for an accommodation, the U.S. Equal Employment Opportunity Commission warned in a May 21 lawsuit.
    • “Per the complaint in EEOC v. All Day Medical Care Clinic, LLC, on her first day of work, a scheduling assistant for a Maryland-based healthcare provider notified the CEO she had a vision impairment and needed a magnifier and Zoomtext software as an accommodation. The CEO allegedly advised her that things would have been different if she’d mentioned her disability and accommodation needs during her interview and told her to leave, according to court documents.
    • “The EEOC sued the healthcare provider for allegedly violating the Americans with Disabilities Act. Under the ADA, “job applicants do not need to reveal their disabilities before being hired,” Debra Lawrence, regional attorney for the EEOC’s Philadelphia district office, explained in a press release. “When an employer penalizes an employee for not raising issues of disability and reasonable accommodation, it is requiring the employee to reveal information the employee legally does not have to divulge,” Lawrence said. All Day Medical Care did not respond to a request for a comment prior to press time.”

From the public health and medical research front,

  • The New York Times reports,
    • “A third farmworker in the United States has been found to be infected with bird flu, heightening concerns about an outbreak among dairy cattle first identified in March.”A third farmworker in the United States has been found to be infected with bird flu, heightening concerns about an outbreak among dairy cattle first identified in March.
    • “The worker is the first in this outbreak to have respiratory symptoms, including a cough, sore throat and watery eyes, which generally increase the likelihood of transmission to other people, federal officials said on Thursday.
    • “The other two people had only severe eye infections, possibly because of exposure to contaminated milk.
    • “All three individuals had direct exposure to dairy cows, and so far none has spread the virus to other people, Dr. Nirav Shah, principal deputy director of the Centers for Disease Control and Prevention, said at a news briefing.”
  • The National Institutes of Health announced,
    • “Using a combination of cutting-edge immunologic technologies, researchers have successfully stimulated animals’ immune systems to induce rare precursor B cells of a class of HIV broadly neutralizing antibodies (bNAbs). The findings, published today in Nature Immunology, are an encouraging, incremental step in developing a preventive HIV vaccine.”
  • The Institute for Clinical and Economic Review released,
    • “its revised Evidence Report assessing the comparative clinical effectiveness and value of ensifentrine (Verona Pharma) for the treatment of chronic obstructive pulmonary disease (COPD).”its revised Evidence Report assessing the comparative clinical effectiveness and value of ensifentrine (Verona Pharma) for the treatment of chronic obstructive pulmonary disease (COPD).
    • “COPD is a common cause of severe respiratory problems,” said ICER’s Chief Medical Officer, David Rind, MD. “People with COPD can experience persistent shortness of breath and fatigue that can significantly affect their daily activities. Current evidence shows that ensifentrine decreases exacerbations when used in combination with some current inhaled therapies and is well-tolerated by patients, but there are uncertainties about how much benefit it may add to unstudied combinations of inhaled treatments.” * * *
    • “Key Clinical Findings“Key Clinical Findings
      • “ICER does not have significant concerns about harms with ensifentrine. We have high certainty that ensifentrine added to maintenance therapy, compared with maintenance therapy alone, results in at least a small net health benefit, and may result in substantial net health benefit (“B+”). We have somewhat greater certainty in the benefits when ensifentrine is added to the regimens studied in the clinical trials than when added to optimized modern inhaler therapies for COPD.
    • “Key Cost-Effectiveness Findings
      • “Ensifentrine has not yet been approved by the FDA, and the manufacturer has not announced a US price if approved. ICER has calculated a health-benefit price benchmark (HBPB) for ensifentrine to be between $7,500 to $12,700 per year.”
  • The Centers for Medicare Services is contemplating moving coverage of PreExposure Prophylaxsis using Antiviral Therapy to prevent HIV infection from Medicare Part D to Medicare Part B.
  • The Wall Street Journal relates,
    • “Screens are inherently harmful to our sleep, right?
    • “It isn’t that black and white, some sleep experts now say.
    • “Spurred by recent research, sleep scientists and doctors are rethinking the conventional wisdom. In some cases, they are backing away from dogmatic approaches such as cutting out screens two hours before bedtime. And they are questioning how much the dreaded “blue light” actually delays sleep.
    • “It is becoming more evident that the tech in and of itself isn’t always the problem,” says Shelby Harris, a clinical psychologist specializing in behavioral sleep medicine in New York. “We need to figure out how to tailor the recommendations to the person.”
  • Mercer Consulting discusses “Help for opioid addiction: Some progress, much more to do.” 

From the U.S. healthcare business front,

  • Beckers Payer Issues shares the views of 32 payer executives about changes to healthcare delivery in the next ten years. For example,
    • Bruce Rogen, MD. Chief Medical Officer of Cleveland Clinic Employee Health Plan: Longitudinal patient records on each patient accessible by providers caring for the patient having a complete history of clinical data sourced from multiple EMRs and across payers and over time going back years if not decades.
    • AI platforms that are able to access the longitudinal patient record to engage the patient in preventive care, filling gaps in care, managing medication refills, enhancing medication compliance, and obtaining prior authorization from payers when indicated.
    • Teams of healthcare providers using the longitudinal patient record and the AI platforms to provide care anywhere and everywhere (hospital, post-acute, home care, remote, virtual) and focusing on prevention. The team includes physicians, nurses, navigators, care coordinators, pharmacists, social workers, behavioral health psychologists and counselors, community healthcare workers and home care workers.
    • Ilan Shapiro, MD. Chief Health Correspondent, Medical Affairs Officer and Senior Vice President at AltaMed (Los Angeles): In 10 years, healthcare delivery will likely be more patient-centric and value-based, with AI technology playing a crucial role in both treatment and prevention of illnesses. Patients will be incentivized for proactive wellness steps, fostering a culture of health promotion. Nationwide care coordination will be streamlined, reducing constraints and enhancing accessibility. This transformation will empower patients and healthcare teams, ensuring that care is brought back to the community level.
  • Per FierceHealthcare
    • “Well-being programs continue to be a central focus for employers, and they’re evolving the reach of these offerings into new areas such as the social determinants of health, according to a new survey.
    • “The Business Group on Health and Fidelity Investments released their annual look at employers’ strategies around wellness on Wednesday, and found nearly all of the 160 surveyed firms said they view well-being programs as a being key to their overall strategy. These employers said they intend to continue funding these programs at current levels.
    • “In addition, more than half (51%) said they plan to build out their well-being programs to tackle social needs in the next three to five years.”
  • The Wall Street Journal examines the connection between private equity investments and growing healthcare costs.
    • “Consolidation is as American as apple pie.
    • “When a business gets bigger, it forces mom-and-pop players out of the market, but it can boost profits and bring down costs, too. Think about the pros and cons of Walmart and “Every Day Low Prices.” In a complex, multitrillion-dollar system like America’s healthcare market, though, that principle has turned into a harmful arms race that has helped drive prices increasingly higher without improving care. 
    • “Years of dealmaking has led to sprawling hospital systems, vertically integrated health insurance companies, and highly concentrated private equity-owned practices resulting in diminished competition and even the closure of vital health facilities. As this three-part Heard on the Street series will show, the rich rewards and lax oversight ultimately create pain for both patients and the doctors who treat them. Belatedly, state and federal regulators and lawmakers are zeroing in on consolidation, creating uncertainty for the investors who have long profited from the healthcare merger boom.”
  • STAT News considers the lack of consensus over the meaning of value-based care. Sigh.
    • “Mai Pham, president of the Institute for Exceptional Care, said her benchmark for success is not how health care providers are feeling. It’s what is actually happening to the nation’s health, and the status quo in her view is unacceptable. Life expectancy among Americans has plateaued, and life expectancy for Americans in the prime years of their lives is falling. This trend, Pham noted, started before the Covid-19 pandemic, and it’s happening across races and geography.
    • “It’s difficult to say whether value-based care has been a success. Medicare has tried a broad range of programs and strategies, each of which has involved a broad range of organizations. Some have done well, others have not.
    • “So it’s not a binary answer,” Pham said. “What I would say is that it has not lived up to the hype.”
  • mHealth Intelligence tells us,
    • “Though telehealth use skyrocketed among United States adults with private health insurance during the COVID-19 pandemic, new research reveals that rural residents utilized telehealth less than their urban peers.
    • “The research, published by the AARP Public Policy Institute last week, examined changes in telehealth use from 2019 to 2021 among people younger than 65 enrolled in private, employer-sponsored health insurance plans.”

Midweek Update

David Ermer–Congress, COVID-19, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Obesity, Telehealth, U.S. Healthcare, Wellness–

From Washington, DC

  • Modern Healthcare tells us,
    • “Congress took the first step Wednesday to extend expiring telehealth rules, hospital at home services and other programs aimed at rural hospitals.
    • “The House Ways and Means Committee passed the Preserving Telehealth, Hospital, and Ambulance Access Act of 2024 by a vote of 31-0, setting it up for passage by the full House later this year. * * *
    • “One potentially controversial provision in the bill requires pharmacy benefit managers that work with Medicare Part D plans to de-link the compensationthey pay themselves from the rebates they secure based on drugs’ high list prices. Rep. Brad Schneider (D-Ill.) said the provision will save the government about $500 million, although official estimates were not yet available. The provision does not apply to the broader commercial market, though Schneider and Rep. Nicole Malliotakis (R-N.Y.) both called for expansion of the provision to the commercial market. Large PBMs oppose such provisions.”
  • Govexec lets us know,
    • “A new report from the Congressional Budget Office found that a gap between the combined pay and benefits of federal workers and their private sector counterparts has nearly disappeared between 2015 and 2022, raising new questions about President Biden’s proposed 2% average pay raise for the federal workforce in 2025.
    • “Federal policymakers generally rely on one of two reports comparing the compensation of federal and private sector workers. First is an annual analysis compiled by the Bureau of Labor Statistics for review by the Federal Salary Council, which compares only the wages of similar jobs, is the preferred citation of Democrats and federal employee unions. * * *
    • “CBO’s analysis, which is typically conducted every five years and is preferred by conservatives, compares “total compensation”—wages plus the cost of benefits like health care, paid leave and retirement—of federal and private sector employees with similar educational backgrounds. This model has traditionally concluded that the cost of federal employees’ pay and benefits is moderately higher than their counterparts in the private sector, although federal workers with master’s or professional degrees still tend to earn less.
    • “The latest version of CBO’s report, which was released last month, covers only 2022, rather than the traditional 2015-2020 period, due to the economic upheaval caused by the COVID-19 pandemic. It found that the total compensation gap between federal and private sector jobs cratered between 2015 and 2022, falling from 17% in its last analysis to just 5%.”
  • Per May 8 HHS press releases,
    • “The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), is announcing the Increasing Organ Transplant Access (IOTA) Model. The proposed model, which would be implemented by the CMS Innovation Center, aims to increase access to kidney transplants for all people living with end-stage renal disease (ESRD), improve the quality of care for people seeking kidney transplants, reduce disparities among individuals undergoing the process to receive a kidney transplant, and increase the efficiency and capability of transplant hospitals selected to participate. This proposed model would build on the Biden-Harris Administration’s priority of improving the kidney transplant system and the collaborative efforts between CMS and the Health Resources and Services Administration (HRSA) to increase organ donation and improve clinical outcomes, system improvement, quality measurement, transparency, and regulatory oversight.” * * *
    • “The proposed rule on the Increasing Organ Transplant Access Model can be accessed from the Federal Register at https://www.federalregister.gov/public-inspection/current. Standard provisions are included in the proposed rule that would be applicable to all Innovation Center model participants that begin participation in a model on or after January 1, 2025.
    • “View – PDF a fact sheet on the Increasing Organ Transplant Access Model.
    • “More information on the Increasing Organ Transplant Access Model is available on the model webpage.”
  • and
    • “The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced $46.8 million in notices of funding opportunities to promote youth mental health, grow the behavioral health workforce, improve access to culturally competent behavioral care across the country, and strengthen peer recovery and recovery support. President Biden made tackling the mental health crisis and beating the opioid epidemic key pillars in his Unity Agenda for the nation. Today’s announcement will help communities transform how they address behavioral health.”
  • Beckers Clinical Leadership notes,
    • “Starting this summer, rural health clinics seeking Medicare reimbursement can apply through a new accreditation program from The Joint Commission. 
    • “On May 7, The Joint Commission said it has received deeming authority from CMS for a new rural health clinic accreditation program, which is meant to support patient safety improvements by reducing variation and risks in the delivery of primary care and personal health services.” 

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “Geneoscopy received Food and Drug Administration approval for its Colosense noninvasive colorectal cancer screening test, the company said Monday.
    • “The stool-based test, which Labcorp will offer, is approved for screening people aged 45 years or older who are at average risk of developing colorectal cancer. The indication puts Geneoscopy in competition with Exact Sciences’ Cologuard test.
    • “Geneoscopy focused on the opportunity in people aged under 50 years in its statement about the approval. Around 2% of people in that cohort used a stool-based test in 2021, but Evercore ISI and TD Cowen analysts expect Colosense to have a limited impact on Exact.”
  • STAT News points out,
    • “The Apple Watch has secured a new qualification from the Food and Drug Administration that could make the smartwatch an appealing tool for medical device companies hoping to illustrate the benefits of a common heart procedure.
    • “Last week, the Apple Watch’s Atrial Fibrillation History feature became the first digital tool qualified under the Medical Device Development Tools (MDDT) program. Released in 2022, the feature estimates a user’s A-fib burden, or how much time they spend in atrial fibrillation, which is an irregular heart rhythm that can cause shortness of breath and fatigue, and is also linked to an increased risk of stroke.
    • “The qualification means that FDA has determined in advance that sponsors can use the feature as a secondary endpoint in clinical trials without having to do additional work. Specifically, the Apple Watch is qualified for use as a secondary endpoint in clinical trials for cardiac ablation devices, which reduce the electrical signals that cause A-fib by scarring the heart with extreme heat or cold energy. Pulsed field ablation is the latest version of the technology, using a controlled electric field to scar tissue rather than the riskier thermal energy.”
  • Regulatory Focus notes,
    • “The US Food and Drug Administration (FDA) is piloting a program to enhance communication between drugmakers, investigators, and its drug shortage team during inspections to prevent facilities from unnecessarily shutting down and potentially contributing to shortages of essential drugs, said Patrizia Cavazzoni, MD, director of the agency’s Center for Drug Evaluation and Research (CDER).
    • “Cavazzoni made these remarks during a webinar hosted by the Alliance for a Stronger FDA on Monday, during which, she said “we strongly encourage manufacturers not to stop manufacturing as the result of an inspection.” She added that manufacturers sometimes shut down production lines based on what they are hearing during the inspection, which she said could worsen shortages.”

From the public health and medical research front

  •  The Washington Post reports that “Olive oil use [is] associated with lower risk of dying from dementia. An observational study has found that regular olive oil consumption may have cognitive health benefits.”
    • “Vasilis Vasiliou, a professor and the chair of the department of environmental health sciences at Yale School of Public Health, said the Harvard study “has been done very carefully,” and there is a broader effort to try to “find a mechanism” as to why olive oil, or other parts of the plant, could be beneficial to cardiovascular or cognitive health.”Vasilis Vasiliou, a professor and the chair of the department of environmental health sciences at Yale School of Public Health, said the Harvard study “has been done very carefully,” and there is a broader effort to try to “find a mechanism” as to why olive oil, or other parts of the plant, could be beneficial to cardiovascular or cognitive health.
    • “We don’t believe it’s one compound or two. The olive oil has the phenolic antioxidants, which are very important for protecting against oxidative stress,” Vasiliou said. “But there is a lot of other stuff that’s going on there.”
  • Per MedPage Today,
    • “Use of cannabis and nicotine together during pregnancy was associated with higher risks for infant death and maternal and neonatal morbidity compared with no exposure to either substance, with dual-use risk estimates higher than with either substance alone, a retrospective population-based cohort study.
    • “Compared with use of neither substance, the risk of infant death was more than twice as high with combined use in pregnancy after controlling for possible confounders (adjusted risk ratio [aRR] 2.18, 95% CI 1.82-2.62), reported Jamie O. Lo, MD, MCR, of Oregon Health & Science University in Portland, and colleagues.
    • “By comparison, risks were 65% higher with cannabis use only (aRR 1.65, 95% CI 1.41-1.93) and 62% higher with nicotine use only (aRR 1.62, 95% CI 1.45-1.80) versus no exposure, the researchers detailed in JAMA Network Open.
    • “Lo told MedPage Today in an email that she and her colleagues were surprised to see the increased infant death rate in the combined cannabis and nicotine users compared with those using each substance alone.
    • “We also did not expect so many maternal and neonatal/infant outcomes to be worse with combined cannabis/nicotine use,” she added.”
  • The National Cancer Institute posted its periodic cancer information highlights.
  • The National Institutes of Health announced,
    • The National Institutes of Health (NIH) will launch clinical trials to investigate potential treatments for long-term symptoms after COVID-19 infection, including sleep disturbances, exercise intolerance and the worsening of symptoms following physical or mental exertion known as post-exertional malaise (PEM). The mid-stage trials, part of NIH’s Researching COVID to Enhance Recovery (RECOVER) Initiative, will join six other RECOVER studies currently enrolling participants across the United States testing treatments to address viral persistence, neurological symptoms, including cognitive dysfunction (like brain fog) and autonomic nervous system dysfunction. The new trials will enroll approximately 1,660 people across 50 study sites to investigate potential treatments for some of the most frequent and burdensome symptoms reported by people suffering from long COVID.
    • “People 18 years of age and older who are interested in learning more about these trials can visit trials.RECOVERCovid.org(link is external) or ClinicalTrials.gov and search identifiers NCT06404047, NCT06404060, NCT06404073, NCT06404086, NCT06404099, NCT06404112.” 
  • BioPharma Dive reports,
    • “A profoundly deaf baby who received Regeneron’s experimental gene therapy was able to hear normally within six months, the company announced Wednesday.
    • “The data, presented at a medical conference, build on initially promising research released in October. The baby was dosed at 11 months of age, one of the youngest children in the world to receive gene therapy for genetic deafness, Regeneron said. A second patient, treated at age 4, also showed hearing improvements at a six-week assessment, the company said.
    • “Both children suffer from a type of deafness caused by mutations in a gene known as otoferlin. The initial research on Regeneron’s DB-OTO therapy is part of an ongoing Phase 1/2 trial known as CHORD enrolling infants and children in the U.S., U.K. and Spain.

From the U.S. healthcare business front,

  • MedCity News informs us,
    • “About a third of employers are integrating value-based care into their employer-sponsored insurance, according to a new survey. Another third of employers are determining the “best-fit strategies for their organization” when it comes to accountable care.
    • “The report was published Sunday by the Milken Institute with support from Morgan Health, a JPMorgan Chase healthcare unit for employer-sponsored insurance. The Milken Institute is a nonprofit think tank focused on financial, physical, mental and environmental health. The survey received responses from 72 employers of varying sizes and industry types.
    • “The researchers found that when making health benefit decisions, expanding preventive care, improving access to primary care and focusing on whole-person health are the top three tenets of accountable care. The lowest-ranked tenets are reducing health outcome disparities and increasing access to digital care.”
  • Fierce Healthcare adds,
    • “Employers are in a strong position to lead the charge in changing the conversation around obesity care, according to a new report from the Milken Institute.
    • “The group released a how-to guide employers of all sizes can use to push for obesity to be recognized as a chronic condition, driving a more multifaceted model for care and addressing the stigma that exists around weight.
    • “The guidebook notes that obesity and conditions related to it are having a major impact on healthcare costs, accounting for $425.5 billion in costs for the civilian workforce, according to a recent study. This includes higher medical costs for both employers and employees as well as costs related to absenteeism.
    • “Sarah Wells Kocsis, director of the Center for Public Health at the Milken Institute and one of the paper’s authors, told Fierce Healthcare that employers are starting to take notice of this issue and lead a conversation that’s “decades in the making.”
    • “We’re really at an inflection point,” she said. “Our goal here is to put this in writing and explain what a strong case there is to think about obesity as a chronic disease.”
  • HealthDay explains,
    • “Worries over health-related costs are plaguing the minds of older Americans of all backgrounds, a new poll suggests.
    • “Five of the six health-related issues that most people found very concerning had to do with health care costs, according to results from the University of Michigan National Poll on Healthy Aging. 
    • “And the sixth issue – financial scams and fraud – also had to do with money, results show.
    • “In this election year, these findings offer a striking reminder of how much health care costs matter to older adults,” Dr. John Ayanian, director of the University of Michigan Institute for Healthcare Policy and Innovation, where the poll is based, said in a news release. The poll is supported by AARP and Michigan Medicine, U-M’s academic medical center.
    • “Overall, 56% of people over 50 said they’re concerned about the cost of medical care for older adults, poll results show.”
  • Per mHealth Intelligence,
    • New research reveals that a text message and telephone-based virtual care approach can improve rates of screening, identification, and treatment of maternal mental health conditions.
    • Published in Health Affairs, the study assessed an intervention that addresses various barriers to adopting maternal mental health screening and referral to treatment. Medical University of South Carolina researchers noted that perinatal mental health disorders, perinatal substance use disorders (SUDs), and intimate partner violence are common during pregnancy and the postpartum year. According to data from the Mental Health Leadership Alliance, maternal mental health conditions affect 800,000 families each year in the United States.
  • BioPharma Dive offers a helpful database of patent expiration dates for thirty top-selling medicines.

Thursday Miscellany

David Ermer–ACA, CMS, Employee Wellness Programs, Mental health care, OPM, SDOH, U.S. Healthcare, Wellness–

As you may be able to tell, it’s a late FEHBlog post because the FEHBlog was returning home to Dripping Springs, TX, last night from our Nation’s capital.

In case, here are some highlights from Washington DC.

  • The GAO released a troubling report on our country’s fiscal health this week. Here’s a link to a Wall Street Journal Opinion Watch podcast about the report. The podcast is about 20 minutes long, and it may make your hair stand on edge.
  • Mercer Consulting discusses changes to the RxDC reports due annually on June 1.
    • “CMS released instructions for the third prescription drug data collection (RxDC) reports due June 1, 2024 – and they may cause plan sponsors to reconsider whether they need to make “plan level” submissions, instead of relying on their vendors to make “aggregate” submissions on their behalf. The good news is that the instructions largely mirror prior versions, so plan sponsors should be able to build off prior RxDC reporting efforts. However, for the first time, CMS plans to enforce the “aggregation restriction”—a provision in the 2021 regulations that CMS suspended for the first two reporting cycles. As explained [in the article], the reinstated aggregation restriction may cause headaches for some plan sponsors, who find that they can no longer rely on their PBM’s aggregate submission of pharmacy data but must instead submit plan level data. Other plan sponsors may welcome the opportunity to do a plan level submission so they can obtain otherwise unavailable prescription drug data.”
  • Per Govexec,
    • “With federal budget talks still unresolved less than a month away from Congress’ latest deadline, the Office of Personnel Management said Friday that the decade-long pay freeze for senior political appointees like Vice President Kamala Harris and others will remain in effect.
    • “In a Feb. 9 post, OPM Director Kiran Ahuja said that under January’s continuing resolution that extended federal funding to agencies until March 1 and 8, certain senior political appointees will continue to see their payable pay rates remain at current levels at least through the latter budget deadline, when Congress will have to decide whether it will continue to fund the federal government. 
    • “Future Congressional action will determine whether the pay freeze continues beyond March 8, 2024,” Ahuja said. “Until such time, the OPM guidance issued on Dec. 21, 2023, regarding the pay freeze for certain senior political officials continues to be generally applicable in applying the pay freeze in 2024.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “There isn’t a silver bullet to maintaining mental acuity or warding off dementia [as we age], scientists of aging say. But a combination of genetics, healthy lifestyle habits and factors such as cleaner air and good education have been linked to prolonged mental agility.  * * *
    • “Genetics is thought to play a role in brain maintenance, as does diet, exercise and a person’s risk of vascular disease. More education, mental stimulation and social connectivity have been associated with improved cognitive reserve.
    • “Better brain maintenance and cognitive reserve might help keep symptoms of dementia at bay. Almost 50% of people 40 and older think they will likely develop dementia, according to a 2021 AARP survey. The actual number of U.S. adults 65 and older with dementia is closer to 10%, a 2022 study found. * * *
    • “Sleeping too little—or too much—can also lead to cognitive problems. Activities including yoga and tai chi, the Chinese martial art, could help improve cognitive function, research suggests. 
    • “Hearing loss is a risk factor for dementia, too. Lost hearing might cause the brain to atrophy more quickly and can make people more isolated, said Dr. Dung Trinh, chief medical officer of the Healthy Brain Clinic. Hearing aids can help preserve mental fitness.”
  • AHA News adds,
    • “About half of U.S. health care workers have witnessed racial discrimination against patients and say discrimination against patients is a crisis or major problem, according to a survey released Feb. 15 by the Commonwealth Fund and African American Research Collaborative. Younger workers and workers of color were more likely than their older or white counterparts to say they witnessed discrimination, as were workers at facilities with more patients of color. About six in 10 Black health care workers and four in 10 Latino, Asian American and Pacific Islander workers say they have been discriminated against because of their race or ethnicity. 
    • “While most health care workers see positive efforts from employers to address discrimination, a majority of Black, Latino, and AAPI workers worry about retaliation if they raise discrimination concerns. When asked about potential solutions, more than two-thirds of health care workers thought the following could help: providing an easy way to anonymously report situations involving racism or discrimination; creating opportunities to listen to patients and health care professionals of color; examining treatment of non-English-speaking patients; and training health care staff to spot discrimination.” 
  • Employee Benefit News offers three suggestions on how employers can help employees hold cancer at bay with preventive screenings.
    • “A new report from healthcare platform Color Health shows that although 80% of employers are concerned by rising cancer costs and 96% of benefits leaders agree early detection is the best solution, the majority of focus is devoted to post-diagnosis treatment, rather than evidence-based screenings. 
    • “According to the report, three out of four employers say they are placing more emphasis on screening, early detection and risk prevention efforts, but they are going to have to go beyond their current benefits setup: Only a quarter believe their current health plans meet the screening needs of their workforce, and three-quarters say employees are not being adequately screened by their primary care provider. Leaders report that 40% of employees are not compliant with screenings in general, and for the most deadly forms of cancer — lung and bronchus — the American Lung Association reports that only 6% of people eligible get screened. 
    • “The assumption [has been that] if we cover mammograms and colonoscopies and lung CTs, then people will actually get them, and that’s turned out to be false,” says Othman Laraki, Color Health’s CEO. “The big driver for that is that for non-acute care services, availability is not the same thing as access.” 

Happy New Year!

David Ermer–Congress, COVID-19, Medical / Rx research, Obesity, SCOTUS, U.S. Healthcare, Wellness–

From Washington, DC

Congress returns to legislative and Committee business next week.

The Hill discusses four ways the Fiscal Year 2024 appropriations issues can play out in January.

The Chief Justice, Hon. John Roberts, released his year-end report on the federal judiciary. The report focuses on generative artificial intelligence.

From the public health and medical research front,

  • Fortune Well considers the reigning Omicron subvariant JN.1 or Pirola.
    • “As always, it’s impossible to distinguish COVID from the flu, RSV, and other common winter illnesses like rhinoviruses, enteroviruses, and parainfluenza viruses by symptoms alone. Even with the new, highly mutated COVID variant “Pirola” JN.1, now globally dominant, this remains true. What’s more, it’s possible to have two or more infections at the same time.
    • “As always, testing—at a health care facility or at home, in the case of COVID—is the only true way to determine the source of your illness. And while you should consult your health care provider, if your symptoms are mild and you don’t have other health conditions, the cause may not matter.”
  • The article wades into Pirola specifics.
  • The Washington Post shares what’s known about long Covid.
    • “An analysis of nearly 5 million U.S. patients who had covid, based on a collaboration between The Washington Post and research partners, showed that people infected with the coronavirus’s omicron variant are less likely to develop symptoms typical of long covid than those who had covid earlier in the pandemic. Patients exposed to the coronavirus during the first wave of pandemic illness — from early 2020 to late spring 2021 — were most prone to develop long covid, with 1 in 12 suffering persistent symptoms, the study showed.”
  • The Post points out,
    • “Although HDL helps remove cholesterol from people’s arteries, the researchers wrote that, at very high levels, HDL’s structure and actions change, and it “may become deleterious to health” in various ways.
    • “For more than six years, they tracked 18,668 study participants, all 65 or older and all physically and cognitively healthy at the start of the study. In those years, cognitive dementia was diagnosed in 850 participants (4.6 percent).
    • “Those with very high HDL levels were more likely to have developed dementia than were those with more optimal HDL levels. For instance, the oldest participants with high HDL levels (those 75 or older) were 42 percent more likely to have developed dementia than those with normal HDL levels, and overall, anyone with high HDL levels had a 27 percent increased risk for dementia.”
  • and also offers exercise-based strategies for people experiencing trouble standing up or lying down.
  • Medscape tells us
    • “Researchers made important gains in 2023 in the fight against cardiovascular disease (CVD), according to the American Heart Association’s (AHA’s) annual list of key scientific developments in the field.
    • “Every year, we compile an overview of scientific research that advances our understanding of how to prevent, treat, and manage heart disease and stroke,” Mariell Jessup, MD, AHA chief science and medical officer, said in a news release.
    • “Whether the science points to new ways to treat long-known health conditions, disparities in care, or how to prevent some of our most pressing problems, such as high blood pressure, diabetes, or obesity, the findings help people, healthcare professionals, policymakers, and others make better informed healthcare decisions,” Jessup added.
    • “[The article provides] a brief summary of some of the year’s most noteworthy developments, according to the AHA.”
  • The Wall Street Journal informs us,
    • “One of the best strategies for good health in the new year: Reduce the amount of sugar you eat.
    • “Sugar sneaks into our diet in surprising ways, from coffee drinks you don’t realize are sugar bombs to small amounts that add up in bread or sauces. Looking more closely at nutrition labels and little tricks like putting a few cookies onto a plate rather than eating them straight from the bag can help.
    • “It’s worth the effort, nutrition researchers say. Studies have found that diets high in added sugars are linked to a higher risk of obesity and Type 2 diabetes. 
    • “U.S. guidelines recommend that Americans limit their consumption of added sugars to 10% of daily calories. The American Heart Association recommends a limit of 6% of calories. While overall sugar consumption has decreased in recent years, Americans still get an average of about 13% of their daily calories from added sugars, according to federal data. 
    • “Still, there’s an important distinction between added sugars—which are found in processed foods such as soda, cereal and yogurt, as well as honey and sugar itself—and sugar that occurs naturally in foods like fruit and dairy products. Foods that naturally contain sugar provide nutrients that people need and most Americans aren’t eating enough of them, nutrition researchers say.”

From the U.S. healthcare business front,

  • Medscape reports,
    • “Drugmakers including Pfizer, Sanofi and Takeda Pharmaceutical plan to raise prices in the United States on more than 500 drugs in early January, according to data analyzed by healthcare research firm 3 Axis Advisors.
    • “Excluding different doses and formulations, more than 140 brands of drugs will have their prices raised next month, the data showed. * * *
    • “More drug prices are likely to be announced over the course of January – historically the biggest month for drugmakers to raise prices.
    • “In 2023, drugmakers raised prices on 1,425 drugs, down from 2022, when they raised prices on 1,460 drugs, according to data published by 46brooklyn.
    • “While drugmakers have pared back their price increases for established drugs, prices for newly launched drugs have hit record levels.
    • “In 2022, the price of newly launched drugs topped $220,000 from around $180,000 in the first six months of 2021 suggesting a more than 20% increase. That’s in line with a JAMA-published study on drug prices which showed that between 2008 and 2021 U.S. drug launch prices grew 20% annually.”

Thursday Miscellany

David Ermer–Congress, COVID-19, Federal employment benefits, HSA, Telehealth, Wellness–
Photo by Josh Mills on Unsplash

From Capitol Hill, STAT News reports

The Senate Judiciary Committee on Thursday passed legislation to prevent drug companies from gaming the patent system to delay competition from cheaper generics, but members in both parties said they still have concerns about the reforms.

It’s unclear when the bills might advance in either chamber. 

The Congressional Research Service released an analysis of healthcare coverage spending in 2021.

Meanwhile, the Health Affairs Council on Healthcare Spending and Value updates us on the recommendations proposed in its 2018 Road Map for Action.

From the Omicron and siblings front —

The Department of Health and Human Services (HHS) announced that its Secretary Xavier Becerra had given the States 90 days advance notice of the end of the Covid public health emergency on May 11, 2023.

To help you and your communities in your preparations for the end of the COVID-19 PHE, I have attached a fact sheet to this letter that includes information on what will and will not be impacted by the end of the COVID-19 PHE.2 In the coming days, the Centers for Medicare & Medicaid Services (CMS) will also provide additional information, including about the waivers many states and health systems have adopted and how they will be impacted by the end of the COVID-19 PHE. I will share that resource with your team when available.

MedPage Today informs us,

Early treatment with a single dose of pegylated interferon lambda in a highly vaccinated population of COVID-19 outpatients decreased the risk for hospitalization and emergency department (ED) visits lasting more than 6 hours, the phase III TOGETHER trial found.

Among nearly 2,000 participants with acute COVID symptoms and a risk factor for severe illness, 2.7% of those who received pegylated interferon lambda within a week of symptoms required hospitalization or ED visits, as compared with 5.6% of those given placebo (relative risk [RR] 0.49, 95% Bayesian credible interval [CrI] 0.30-0.76), reported Gilmar Reis, MD, PhD, of McMaster University in Hamilton, Ontario, and colleagues.

Results were similar regardless of vaccination status (over 80% were vaccinated), and the treatment effect with the long-acting form of interferon lambda-1 was more pronounced in those who received the subcutaneous injection with 3 days of their symptoms.

From the miscellany department —

HHS released initial guidance for Medicare’s Prescription Drug Inflation Rebate Program created by last year’s Inflation Reduction Act.

Under the Medicare Prescription Drug Inflation Rebate Program, drug companies who raise prices faster than the rate of inflation will be required to pay rebates to the Medicare Trust Fund. Below is a timeline of key dates for implementing the Medicare Prescription Drug Inflation Rebate Program:

  • October 1, 2022: Began the first 12-month period for which drug companies will be required to pay rebates to Medicare for raising prices that outpace inflation on certain Part D drugs.
  • January 1, 2023: Began the first quarterly period for which drug companies will be required to pay rebates for raising prices that outpace inflation on certain Part B drugs.
  • April 1, 2023: People with Traditional Medicare and Medicare Advantage may pay a lower coinsurance for certain Part B drugs with price increases higher than inflation.
  • 2025: CMS intends to send the first invoices to drug companies for the rebates.

The law has a circular aspect because the government needs a much lower general inflation index to get the full bang for the buck from this program. The notice also poses issues for public input.

The International Foundation of Employee Benefit Plans tells us,

The International Foundation has been tracking fertility and family-forming benefits over the past seven years. According to Employee Benefits Survey: 2022 Results, 40% of U.S. organizations currently offer fertility benefits (an increase from 30% in 2020).
Overall:

  • 28% cover fertility medications (8% covered in 2016, 14% in 2018, 24% in 2020)
  • 30% cover in vitro fertilization (IVF) treatments (13% in 2016, 17% in 2018, 24% in 2020)
  • 16% cover genetic testing to determine infertility issues (11% in 2018, 12% in 2020)
  • 17% cover non-IVF fertility treatments (6% in 2016, 11% in 2018, 11% in 2020).

In 2016, only 2% of organizations covered egg harvesting/freezing services. That jumped to 6% in 2018, 10% in 2020 and even higher in 2022, with 14% reporting that they cover the benefit.

Healthcare Dives points out, “National telehealth utilization increased 1.9% month-over-month among the privately insured population in November 2022, following one month of decline, according to a new analysis from Fair Health’s monthly tracker.” The bump is attributable to the tripledemic.

Fierce Healthcare relates, “UnitedHealthcare is rolling out a new wearables-based rewards program for members and their spouses. In UnitedHealthcare Rewards, eligible members can earn up to $1,000 per year by using wearable devices to complete health goals and activities, the insurance giant announced Wednesday.”

Health Payer Intelligence notes that “High deductible health plan (HDHP) enrollment hit a record high in 2021, with nearly six out of ten employer-sponsored health plan members enrolled in a high deductible health plan, according to a ValuePenguin survey.”

Benefits consultant Tammy Flanagan writing in Govexec, explains how federal employees can get the full advantage out of the Thrift Savings Plan, which is part of the Federal Employees Retirement System.

Friday Factoids

David Ermer–Congress, COVID-19, COVID-19 vaccine, Electronic health records, FDA, Rx coverage, U.S. Healthcare, Wellness–
Photo by Sincerely Media on Unsplash

From Capitol Hill, Fierce Healthcare tells us

Two top senators have reintroduced legislation that would introduce several reforms to pharmacy benefit managers, including prohibiting clawbacks of pharmacy payments. 

Sens. Maria Cantwell, D-Washington, and Chuck Grassley, R-Iowa, reintroduced on late Thursday the Pharmacy Benefit Manager Transparency Act and the Prescription Pricing for the People Act. The move shows the lawmakers are not backing down from going after PBMs in the latest Congress. 

Congress is a piker compared to OPM, which has been successfully “going after PBM’s” for over a decade.

From the public health front

  • All of the Omicron metrics are trending down. “As of January 25, 2023, there are 118 (3.7%) counties, districts, or territories with a high COVID-19 Community Level, 855 (26.6%) with a medium Community Level, and 2,242 (69.6%) with a low Community Level.”
  • Overall, about 268.9 million people or 81% of the total U.S. population, have had a single dose of Covid vaccine, “About 229.6 million people, or 69.2% of the total U.S. population, have completed a primary series.* More than 41.6 million people, or 19.9% of the eligible U.S. population ages five years and older, have received an updated (bivalent) booster dose.”
  • The CDC’s Weekly FluView again headlines, “Seasonal influenza activity continues to decline across the country.”
  • Turning to our longest-standing public health emergency, the U.S. Drug Enforcement Administration informs us

Illicitly-used xylazine is most often reported in combinations with two or more substances present, such as fentanyl, cocaine, or heroin, and can increase the potential for these drugs to cause fatal overdoses.

While scientists have not conducted much research on its effects, anecdotal reports suggest that users experience symptoms similar to those encountered via opioids, namely depression of the central nervous system. More specifically, effects associated with xylazine use include dry mouth, drowsiness, hypertension, respiratory depression, and even coma. Users can develop a physical dependence to xylazine, reporting withdrawal symptoms more serious than from heroin or methadone, such as sharp chest pains and seizures.

Note: Since xylazine is not an opioid, naloxone does not reverse its effects.

  • The Food and Drug Administration proposed changing from “time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV. This proposal is in line with policies in place in countries like the United Kingdom and Canada.”
  • Bloomberg relates, “Americans aren’t exercising enough.  Less than a third of US adults meet suggested benchmarks for aerobic and muscle-building activities set out by health officials, according to a new study released on Thursday.”

From the Rx coverage front, STAT News reports, “After months of anticipation, the first biosimilar version of Humira will become available next week — a pivotal moment in the long-running debate about whether cheaper copies of pricey biologics can lower soaring U.S. health care costs.” Time will tell.

From the electronic health records front —

  • MedCity News identifies five ways to inject intelligence into the prior authorization process.
  • Fierce Healthcare points out that

“A new report from the Georgetown University Center for Children and Families seeks to make several reforms to the Transparency in Coverage rule to ensure the data are more usable and accessible by researchers. The goal is to ensure that the data can be used to help regulators and lawmakers target policies that can boost coverage affordability. 

“’The good news is that many of the access and usability problems stem from the technical specifications provided by the Centers for Medicare & Medicaid Services [CMS],’ the report said. ‘Most can be fixed through administrative action and better enforcement, with minimum cost burdens for the plans and issuers.’”

From the U.S. healthcare business front —

  • MedCity News informs us that health insurers continue to receive a C grade from Leapfrog.
  • Fierce Healthcare tells us, “The Minnesota attorney general’s office has formally asked Sanford Health and Fairview Health Services to postpone the March 31 closing date of their proposed merger as it seeks more information on the repercussions of the deal, Chief Deputy Attorney General John Keller said during a public meeting held Wednesday evening. The Midwest nonprofit health systems had announced their 58-hospital merger plans in November, saying at the time that joining together would expand care quality and access across their rural and urban markets. The resulting organization would employ nearly 80,000 people.”
  • Healthcare Dive reports, “In a lawsuit filed Thursday, Cigna alleged that Amy Bricker’s appointment to chief product officer of CVS’s consumer segment places the payer’s trade secrets at risk and violates her noncompete agreement.” 
  • The Wall Street Journal reports that CVS and Walmart pharmacies will follow Walgreen’s lead by reducing their retail pharmacy hours. “CVS, in a recent notice to field leaders, said most of its reduced hours will be during times when there is low patient demand or when a store has only one pharmacist on site, which the company said is a “top pain point,” for its pharmacists.” Walmart will be closing its pharmacy at 7 pm rather than 9 pm.

Midweek Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, NIH, Wellness–

Happy First Day of Autumn!

From Capitol Hill, Roll Call discusses the Senate Majority Leader’s plans for successfully passing the continuing resolution funding the federal government through December 16, 2022.

[I]n theory the tentative plan to start the process this Thursday could lead to a final Senate vote by next Friday, when the current fiscal year expires. It might even enable the House to take up the Senate-passed bill and clear it in time to beat the midnight deadline.

All that assumes everything goes according to plan and that there’s an acceptable stopgap funding package that can pass in both chambers. None of those details have been released, but top appropriators and other lawmakers said Wednesday there’s no talk yet of a very short-term CR to buy more time.

From the Omicron and siblings’ front —

  • Fierce Healthcare tells us about the possible blossoming of another Omicron variant BF.7
  • The Wall Street Journal reports on the rollout of nasal Covid vaccines in Asia “though just how effective they are remains to be seen.” These are adenovirus, not mRNA-based, vaccines. Nonetheless

Delivering a vaccine through the nose has the potential to build up a type of immune response known as mucosal immunity, or immunity in the upper airway tract, said David Curiel, professor of radiation oncology at Washington University School of Medicine who co-developed the Bharat vaccine. That is important because mucosal immunity could more effectively block infection and transmission of the coronavirus than the type of immunity induced by injected vaccines, he said.

In other virus news, Forbes offers an illuminating article by Gayle Smith, the CEO of the ONE Campaign, which fights to end extreme poverty and preventable disease. Ms. Smith writes on the emergence of polio.

The re-emergence of polio is worrisome, particularly considering the politicization of and uneven response to the Covid-19 pandemic. Panic, however, is unwise. What is needed is vigilance and vaccination coverage. Fortunately, there are millions of people who are living proof that polio vaccines work.

This is a moment when the world can do the right thing and eradicate a preventable disease. Since the mid-1950s, a concerted global effort has confined endemic polio to only two countries and proven that this is a virus we can defeat. 

Going all the way is a moonshot and a win for the world. It is not without its challenges, of course. But it is far easier right now than defeating Covid, or malaria, or AIDS. One can only hope that ridding the world of a disease known as “infantile paralysis” might be something we can all agree on — if not for ourselves then for the children whose lives continue to be at risk.

Also, from the public health front, the National Institutes of Health helpfully informs us

In a large clinical trial that directly compared four drugs commonly used to treat type 2 diabetes, researchers found that insulin glargine and liraglutide performed the best of four medications approved by the U.S. Food and Drug Administration to maintain blood glucose levels in the recommended range. Blood glucose management is a key component of keeping people with type 2 diabetes healthy. All four medications evaluated were added to treatment with metformin, which is the first-line drug to treat type 2 diabetes. The trial was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health.

More than 37 million Americans have diabetes, and approximately 90 to 95% of them have type 2 diabetes. People with diabetes who keep their blood glucose levels in the near-normal range generally have a much lower risk of developing diabetes complications such as nerve, kidney, and eye diseases. Most people with type 2 diabetes require more than one medication to control blood sugar levels over time. 

While there is general agreement among health care professionals that metformin combined with diet and exercise is the best early approach in diabetes care, there is no consensus on what to do next to best keep high blood glucose in check.

From the wellness front, Fierce Health relates that United Healthcare is expanding its relationship with exercise machine marker Peleton. As a result, UHC will be making Pelton’s fitness services available to as many as 10 million of its members.

From the federal compensation and benefits front

  • Govexec reports on locality pay developments, and Social Security changes that Congress may approve this year.
  • Reg Jones writing in FedWeek provides a personal story about federal survivor benefits worth a gander.

Monday Roundup

David Ermer–Congress, COVID-19, Rx coverage, U.S. Healthcare, Wellness–

From Capitol Hill, Govexec informs us that

Congress is looking to fund federal agencies at their current spending levels through mid-December, with momentum growing for a 10-week stopgap bill to avoid a government shutdown on Oct. 1. 

Lawmakers must clear several hurdles before voting on a continuing resolution to kick off fiscal 2023, but they could act as soon as this week. Senate Majority Leader Chuck Schumer, D-N.Y., said last week he would work with Republicans to “avoid even a hint of a shutdown,” though several disagreements remain. Negotiations appear to have settled on a CR that would fund agencies through approximately Dec. 16, but lawmakers have yet to determine exactly which provisions will be added to it. 

From the federal appointment front, STAT News reports

President Joe Biden on Monday appointed longtime biologist and former government scientist Renee Wegrzyn as the first director of the nascent Advanced Research Projects Agency for Health.

Biden’s announcement comes as ARPA-H advocates debate where the multibillion-dollar agency should be headquartered and which elusive disease areas should be prioritized. The president officially launched the agency in March with $1 billion in initial funding allotted by Congress, but the search for its inaugural director has taken months.

Wegrzyn, 45, currently works at Boston-based Ginkgo Bioworks, a company focused on biological engineering, but has prior experience in two government agencies Biden has said he hopes to emulate with ARPA-H — the Pentagon’s Defense Advanced Research Projects Agency and the Intelligence Advanced Research Projects Activity.

Good luck, Dr. Wegryzn.

From the omicron and siblings front

The American Hospital Association tells us

Insured and uninsured Americans can receive the new bivalent Pfizer or Moderna COVID-19 booster and other COVID-19 vaccines at no cost as long as the federal government continues to purchase and distribute them, the Centers for Medicare & Medicaid Services announced today.

The Centers for Disease Control and Prevention this month recommended Pfizer’s updated COVID-19 vaccine booster for Americans aged 12 and older and Moderna’s updated COVID-19 vaccine booster for Americans aged 18 and older at least two months after completing a primary COVID-19 vaccine series or booster. Authorized by the Food and Drug Administration, the updated boosters are bivalent, meaning they help protect against the most recently circulating omicron variants as well as the original virus strain.

Americans can find local sites administering the new COVID-19 vaccine booster here. For more on provider requirements and payment, visit the CDC COVID-19 Vaccination Program and CMS toolkit.

The Wall Street Journal reports

Illness caused by Covid-19 shrank the U.S. labor force by around 500,000 people, a hit that is likely to continue if the virus continues to sicken workers at current rates, according to a new study released Monday.

Millions of people left the labor force—the number of people working or looking for work—during the pandemic for various reasons, including retirement, lack of child care and fear of Covid. The total size of the labor force reached 164.7 million people in August, exceeding the February 2020 prepandemic level for the first time. The labor force would have 500,000 more members if not for the people sickened by Covid, according to the study’s authors, economists Gopi Shah Goda of Stanford University and Evan J. Soltas, at the Massachusetts Institute of Technology.

“If we stay where we are with Covid infection rates going forward, we expect that 500,000-person loss to persist until either exposure goes down or severity goes down,” said Mr. Soltas. That assumes that some of those previously sickened eventually return to work.

The authors “provide the most credible evidence to date about labor-market impacts for a large set of workers,” said Aaron Sojourner, an economist at the W.E. Upjohn Institute for Employment Research, who wasn’t involved in the study.

From the U.S. healthcare business front —

Healthcare Dive relates

Escalating costs for labor, drugs, supplies and equipment are adding to the long-term pressures facing rural hospitals, raising the risk of more closures that could jeopardize patient access to care, the American Hospital Association warned in a new report. 

Many hospitals were already in difficult financial positions before the COVID-19 pandemic began, due to challenges including low patient volume and reimbursement, geographic isolation, staffing shortages and aging infrastructure, the AHA said. From 2010 through 2021, 136 rural hospitals closed, according to data from the University of North Carolina’s Cecil G. Sheps Center for Health Services Research. In 2020, when the pandemic hit, a record 19 rural hospitals closed.

The public health emergency put additional pressure on margins and patient volumes. “While rural hospitals were partially buoyed by the Provider Relief Fund and other sources of COVID-19 assistance that limited closures in 2021, the financial outlook for many rural hospitals moving forward is precarious,” the AHA said.

Revcycle Intelligence reports

Private equity acquisition of physician practices in dermatology, gastroenterology, and ophthalmology was associated with increased healthcare spending and utilization, according to a study published in JAMA Health Forum. * * *

Following a private equity acquisition, physician practices saw consistent growth in spending during the next eight quarters. Acquired practices saw a mean increase of $71 in charges per claim or a 20.2 percent increase. In addition, practices saw an increase of $23 in the allowed amount per claim—an 11 percent increase.

Patient utilization of healthcare services grew as well after practices underwent acquisitions.

Across the eight post-acquisition quarters, the mean number of unique patients increased by 25.8 percent. This increase was mainly driven by more new patient visits, which rose by 37.9 percent. The number of encounters grew by 16.3 percent and the number of evaluation and management (E/M) visits increased by 37.1 percent.

The increase in patient visits may reflect changes in management and practice operations or overutilization of profitable services and low-value care, the study suggested. This could lead to higher healthcare spending without corresponding benefits.

Additionally, researchers said the growing number of visits was consistent with private equity firms’ common strategy to maximize revenue through a fee-for-service delivery system.

Ruh roh on both counts.

Healthcare Finance adds

Quality can go a long way in determining if a consumer is willing to pay more for their healthcare, as indicated by new survey responses published by revenue cycle company AKASA.

Out of more than 2,000 respondents, the survey found that 57% would pay more for a higher quality of care. Out of all categories in the survey, care quality was the only area in which a majority said they would be willing to pay more.

Forty-seven percent said they would pay more for the ability to work with the care team of their choice. Forty-one percent said they would pay more for the ability to work with hospitals of their choice, while the same percentage said they’d pony up more cash for better location proximity or convenience.

In public health news, the American Hospital Association celebrates the fact that

The United Network for Organ Sharing, which serves as the nation’s transplant system under contract with the federal government, Friday reported its millionth U.S. organ transplant. UNOS and the Organ Donation and Transplantation Alliance credited the organ donation and transplantation community, including transplant hospitals, with making the historic milestone possible. The first successful transplant took place at Peter Bent Brigham Hospital (now Brigham and Women’s Hospital) in Boston in 1954.

UNOS and the Alliance encourage the transplant community to join Living It Forward, a national initiative to commemorate the achievement and accelerate the path forward to the next million transplants. They also encourage members of the public to register as organ donors, noting that each donor can save up to eight lives and help up to 75 people through tissue donation. Over 100,000 people remain on the transplant waitlist.

From the Rx coverage front, BioPharma Dive tells us that

The Food and Drug Administration on Friday approved Bristol Myers Squibb’s psoriasis pill Sotyktu, the first medicine of its type and the last of three potential blockbuster drugs the company sought to bring to market this year.

Sotyktu will compete with biologic drugs like AbbVie’s Humira and Amgen’s Enbrel, but as a pill could be more attractive to patients who don’t want to inject themselves regularly. Importantly, Sotyktu’s labeling doesn’t require patients to first try biologic drugs, giving doctors an opportunity to prescribe it widely.

Approval came after Phase 3 testing in which the pill, also known as deucravacitinib, was tested against a placebo as well as another oral therapy, Amgen’s Otezla. In patients with moderate-to-severe plaque psoriasis, Sotyktu outperformed both on two commonly used measures for assessing skin clearing: PASI and sPGA.

“All in all, the overall efficacy and safety profile as a new first-in-class agent for plaque psoriasis bodes well for it becoming the standard of care,” said Samit Hirawat, Bristol Myers Squibb’s chief medical officer, setting a high bar for his company’s commercial expectations.

In wellness news, Healio informs us that

Widespread adoption of simple lifestyle changes, including switching to a well-known eating plan, could reduce risk for CV events and death for millions of adults with stage 1 hypertension, researchers reported.

“Millions of working-age people are walking around with elevated BP, which is symptomless but is also a leading preventable cause of disability and death,” Kendra D. Sims, PhD, MPH, a postdoctoral fellow at the University of California, San Francisco (UCSF) School of Medicine who presented the findings at the American Heart Association Hypertension Scientific Sessions, told Healio. “Our study found that 27,000 CVD events and 2,800 deaths could be prevented during the next 10 years if people with elevated BP follow through with recommended lifestyle changes. We would then save $1.6 billion in associated health care costs. The largest benefit comes from eating more fruits and vegetables and less salt, as outlined in the Dietary Approaches to Stop Hypertension (DASH) diet.

Midweek Update

David Ermer–ACA, CDC, Congress, COVID-19, OPM, Rx coverage, U.S. Healthcare, Wellness–
Photo by Manasvita S on Unsplash

From Capitol Hill, Roll Call reports

Democrats may need to make some changes to the tax portion of their budget reconciliation package to earn the support of Arizona Sen. Kyrsten Sinema, including possible removal of a tax increase on investment fund managers and softening a new minimum tax on the biggest corporations.

The bill could also undergo other tweaks as Senate Parliamentarian Elizabeth MacDonough continues her review of the bill. Changes to the prescription drug pricing provisions are already in the works, but many pieces of the package have yet to go through the formal “Byrd bath” to determine whether the language complies with budget rules.

Despite all the work still underway, several Democratic senators said they anticipated voting on the motion to proceed to the reconciliation package as soon as Thursday and beginning the “vote-a-rama” process, in which senators can offer unlimited amendments to the measure, as soon as this weekend. 

“As soon as possible, but don’t count on going home on the weekend,” Michigan Sen. Debbie Stabenow, a member of Democratic leadership, said. “We’re probably going to be here all weekend, so get lots of sleep.

From the OPM front, Federal News Digest tells us

The Office of Personnel Management is getting a second in command.

President Joe Biden nominated Rob Shriver to be the OPM deputy director on Aug. 3. * * *

Shriver is a political appointee already, having been the associate director for employee services since January 2021.

If confirmed by the Senate, Shriver would be OPM’s first deputy director since Michael Rigas, who held the job from March 2018 to January 2021, but worked in other administration positions from March 2020 until January 2021.

From the Omicron and siblings front —

Bloomberg informs us

[Israeli] Hospital workers who got a fourth dose of Pfizer Inc.’s messenger RNA vaccine were far less likely to get Covid than triple-vaccinated peers in a study. 

The findings published Tuesday in the American Medical Association’s open access journal are the latest to confirm the benefits of a second booster against breakthrough infections caused by omicron. The study’s authors pointed to an extra dose as a tool to prevent medical staff shortages and spare health systems in times of strain.  * * *

Doctors, nurses and other health-care workers who got a fourth mRNA shot in January showed a 7% rate of breakthrough infections. Those with three doses — the third having been administered by the end of September — saw an infection rate of 20%.  

The Department of Health and Human Services released two reports on long Covid to support patients and further research.

From the monkeypox front

  • Beckers Hospital Review explains that the Centers for Disease Control have released isolation guidance “as cases near 6,000.”

The New York Times delves into various aspects of the disease, including what people can do the stay safe.

From the U.S. healthcare business front

Healthcare Dive reports

CVS Health raised its full-year guidance in its second quarter earnings report despite a $77 million decrease in adjusted operating income primarily due to declines in its retail segment.

The company’s Aetna subsidiary boosted earnings with reported gains of 922,000 covered lives compared to the second quarter of last year and growth in all product lines contributing to a nearly 11% rise in revenues year over year.

Adjusted operating income was 9.1% lower in its retail division compared to the year prior due to a decrease in coronavirus vaccinations, “continued pharmacy reimbursement pressure” and the lack of an antitrust legal settlement gain that was recorded in the second quarter last year, according to the earnings report. * * *

In its race to add more primary care services, the executive team further teased acquisition plans, with [CVS Health CEO Karen] Lynch adding that the company could take the “next step on this journey” by the end of this year.

“We can’t be in … primary care without M&A. We’ve been very clear about that,” Lynch said.

[Larry] McGrath [CVS Health senior vice president of business development and investor relations] added that the company has been active in evaluating a wide range of assets around the care delivery space. CVS also signaled that it could potentially pursue multiple acquisitions, adding that there was “no one and done asset” in the market.

Biopharma Dive informs us

Gilead’s cell therapy business outperformed Wall Street expectations during the second quarter. The unit — which currently consists of two products, Yescarta and Tecartus, used to treat various blood cancers — generated $368 million in the three-month period, an increase of 68% year over year, earnings numbers released Tuesday show.

Key to that growth was a recent, first-of-its-kind approval from the Food and Drug Administration. In April, the agency cleared Yescarta as a so-called second line therapy for large B-cell lymphoma that resists or returns within a year of initial treatment with chemoimmunotherapy. Before, Yescarta was used only when patients either relapsed after or hadn’t responded to at least two other kinds of therapies.

Fierce Healthcare adds

CivicaScript’s first product is hitting the market.

The public benefits company and sister to Civica Rx is making its first generic available: 250-mg abiraterone acetate tablets. The drug is used in combination with the steroid medication prednisone as a treatment for prostate cancer that has spread to other parts in the body.

CivicaScript will make the drug available to pharmacies at $160 per bottle of 120 tablets, a typical one-month supply. The company suggests pharmacies sell it to patients at no more than $171 for each bottle. This price is about $3,000 less per month than the average cost for people enrolled in Medicare Part D, which is the largest portion of patients with this type of cancer.

Using CivicaScript’s abiraterone will lead to significant savings for patients both in the deductible phase and in the Part D “donut hole,” where they face the highest out-of-pocket costs, the company said in an announcement (PDF). * * *

“We’re proud the first lower-cost generic drug of our partnership with CivicaScript is entering the market,” said Kim Keck, president and CEO of BCBSA. “This is an important milestone in our shared commitment to help make prescription drugs more affordable for millions of Americans. No one should have to face breaking the bank from buying a life-saving medication.”

From the Affordable Care front, Prof. Katie Keith takes a deep dive into last week’s ACA FAQ 54 on mandated contraceptive coverage under that law.

From the research front —

Benefits Pro points to

A survey of nearly 2,500 U.S. healthcare consumers by PYMNTS.com offered more proof that this remains a barrier to consumer trust of the healthcareThe survey revealed that many consumers continue to under budget for their health care –probably because most have little idea about the cost of various procedures and appointments. * * *

For instance, nearly 20% of those surveyed said they “experienced financial distress due to health care costs because they spent more than they could afford in the past 12 months.” A quarter of respondents who said their advance notice cost estimates were accurate said they still spent more than they could really afford. Not surprisingly, 43% of those who received inaccurate cost estimates said they spent more than they could afford. system. PYMNTS.com, a provider of data, news and insights on innovation in payments and the payment-related, conducted the survey to learn how many respondents fell into the unexpectedly high and inaccurate estimate category, and what the outcome for them was in the aftermath. * * *

Medscape reports

Regular exercise, regardless of intensity level, appears to slow cognitive decline in sedentary older adults with mild cognitive impairment (MCI), new research from the largest study of its kind suggests.

Topline results from the EXERT trial showed patients with MCI who participated regularly in either aerobic exercise or stretching/balance/range-of-motion exercises maintained stable global cognitive function over 12 months of follow-up — with no differences between the two types of exercise.

“We’re excited about these findings, because these types of exercises that we’re seeing can protect against cognitive decline are accessible to everyone and therefore scalable to the public,” study investigator Laura Baker, PhD, Wake Forest University School of Medicine, Winston-Salem, North Carolina, said at a press briefing.

The topline results were presented at the Alzheimer’s Association International Conference (AAIC) 2022.