Monday Roundup

CMS

Monday Roundup

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Mental health care, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • Roll Call reports
    • “House Republicans unveiled a stopgap funding measure Sunday night that would avoid a partial government shutdown next month and provide border security measures sought by conservatives. But passage even in the GOP-controlled House was already in doubt as some hard-liners came out against the measure Sunday night while the ink on it was barely dry.
    • “The draft continuing resolution would extend current funding through Oct. 31, while cutting 8.1 percent from all nondefense accounts except for the Department of Veterans Affairs and disaster relief. That extension would give lawmakers an extra month to try to complete fiscal 2024 appropriations that are otherwise needed by Sept. 30. * * *
    • “The bill is set for floor consideration this week, along with the fiscal 2024 Defense spending bill that stalled last week when conservative detractors threatened to vote against the rule needed to take it up.”
  • Politico discusses where we stand with the proposed mental health parity rule changes.
    • “The Biden administration’s proposal substantially expands the law Bush signed. It would mandate that insurers analyze the outcomes of their coverage to ensure there’s equivalent access to mental health care and take action to comply if they’re falling short.
    • “Insurers respond: AHIP, the lobbying group for insurers, says the situation is more complicated than Biden makes out, and workforce shortages are behind barriers to access.
    • “For years, health insurance providers have implemented programs and strategies to expand networks and increase access,” AHIP spokesperson Kristine Grow said in a statement.
    • “The administration has set a deadline for comments on its proposed rules for early October; insurers and their allies are asking for more time to respond.
    • “The ERISA Industry Committee, which represents large employers’ benefit interests, joined AHIP, among other associations, employers and health plans, in writing to administration officials to ask that the comment period on the proposed rules be extended. They warned that the rules could create “unnecessary burdens” for providers, insurers and patients and “unintentionally” impede access to care.”
  • The Centers for Medicare and Medicaid Services (CMS) announced on its No Surprises Act website today:
    • “Federal IDR Process update: Certain functions of the Federal IDR Process are temporarily paused in response to the TMA III Court Order.  On September 5, 2023, the Departments directed certified IDR entities to resume making eligibility and conflict of interest determinations and encouraged disputing parties to continue engaging in open negotiations.  The Departments expect to direct certified IDR entities to resume issuing payment determinations for some disputes very soon.”
  • The Office of Management and Budget’s Office of Information and Regulatory Affairs has completed work on a regulation that will affect the FEHB:
    • AGENCY: HHS-CMS RIN: 0938-AT86 Status: Concluded
    • TITLE: Medicare Secondary Payer and Certain Civil Money Penalties (CMS-6061) Section 3(f)(1) Significant: No
    • STAGE: Final Rule Economically Significant: No
    • RECEIVED DATE: 03/01/2022 LEGAL DEADLINE: Statutory
    • REVIEW EXTENDED
    • COMPLETED: 09/11/2023 COMPLETED ACTION: Consistent with Change
  • The FEHBlog will be watching the Federal Register for this one.
  • CMS also “finalized a rule to streamline enrollment in the Medicare Savings Programs (MSPs), making coverage more affordable for an estimated 860,000 people.”

From the public health and medical research fronts,

  • Per Healthcare Dive, “New RSV vaccines can be powerful tools, but rollout poses test; The recently approved shots will slot in alongside vaccines for influenza and COVID-19 this fall, raising communication challenges for public health officials.” The article dives into the details, but health plans can help communicate new vaccines’ benefits to their members with young kids and members who have reached senior citizen status.
  • NPR reports,
    • “The mixture of stimulants like cocaine and meth with highly potent synthetic opioids is a fast-growing driver of fatal overdoses in the U.S.
    • “Since 2010, overdoses involving both stimulants and fentanyl have increased 50-fold, and now account for 32% of U.S. overdoses in 2021 and nearly 35,000 deaths, according to a study published Thursday in the scientific journal Addiction.
    • “We’re now seeing that the use of fentanyl together with stimulants is rapidly becoming the dominant force in the U.S. overdose crisis,” says Joseph Friedman, the lead author of the study and a researcher at UCLA’s David Geffen School of Medicine. “Fentanyl has ushered in a polysubstance overdose crisis, meaning that people are mixing fentanyl with other drugs, like stimulants, but also countless other synthetic substances.”
  • Healio points out that based on a recent research study,
    • “Consumption of added sugar, total sugar, total glucose equivalent and fructose from added sugar and juice were linked to a higher risk for coronary heart disease.
    • “Fructose from vegetables and fruits was not.”
  • The American Medical Association informs us, “What doctors wish patients knew about social isolation.”
  • Health Day notes based on a Swedish study,
    • “Chronic acid reflux — also known as GERD — has long been thought to boost a person’s risk of esophageal cancer
    • “A new study refutes that, finding that only patients with evidence of injury to their esophagus from reflux have a higher cancer risk
    • “Researchers downplayed a “very moderate” increased risk for women, saying that it remains “extremely low.'”
  • MedPage Today calls our attention to a different Swedish study,
    • “Bariatric surgery for obesity was associated with a reduced risk of hematologic cancers in a prospective Swedish study spanning more than three decades.”
  • Per NIH,
    • “Artificial intelligence (AI) and machine learning (ML) can effectively detect and diagnose Polycystic Ovary Syndrome (PCOS), which is the most common hormone disorder among women, typically between ages 15 and 45, according to a new study by the National Institutes of Health. Researchers systematically reviewed published scientific studies that used AI/ML to analyze data to diagnose and classify PCOS and found that AI/ML based programs were able to successfully detect PCOS.
    • “Given the large burden of under- and mis-diagnosed PCOS in the community and its potentially serious outcomes, we wanted to identify the utility of AI/ML in the identification of patients that may be at risk for PCOS,” said Janet Hall, M.D., senior investigator and endocrinologist at the National Institute of Environmental Health Sciences (NIEHS), part of NIH, and a study co-author. “The effectiveness of AI and machine learning in detecting PCOS was even more impressive than we had thought.”

From the U.S. healthcare business and quality fronts,

  • Beckers Payer Issues reports
    • The National Committee for Quality Assurance has named the best-rated health plans of 2023 based on factors that include care quality, patient satisfaction and efforts to keep improving.
    • The ratings were released Sept. 15 and are based on 2022 data from commercial, Medicare, Medicaid and ACA plans that reported HEDIS and CAHPS results to the NCQA, which cover more than 200 million people. NCQA Accreditation status was also factored in. Plans were rated on a zero- to five-star scale, with five being the highest rating. In total, 1,095 plans received a rating. No Medicaid or Medicare plan received 5-stars this year.
    • Commercial plans that received a five-star rating:
      • Independent Health Association (New York)
      • Kaiser Foundation Health Plan of the Mid-Atlantic States (Washington D.C., Maryland, Virginia)
  • Per Healthcare Dive
    • ‘Hospitals have been required to post their prices for shoppable services online since 2021, but costs shared online rarely correlate to prices hospitals share with consumers on the phone, according to a new secret shopper survey.
    • ‘The study found wide variations when comparing hospitals’ online cash prices for childbirth and brain imaging with prices told to consumers who inquire over the phone.
    • ‘For example, researchers found five hospitals with online prices greater than $20,000 for vaginal childbirth but telephone prices less than $10,000. For a brain magnetic resonance imaging scan, two hospitals said the cost was more than $5,000 over the phone, but the price tag was $2,000 online.’
    • That’s a big bowl of wrong.
  • Reuters reports,
    • “Novo Nordisk (NOVOb.CO) has hired U.S. private contract manufacturer PCI Pharma Services to handle assembly and packaging of Wegovy, a source familiar with the matter said, as it races to boost output of the weight-loss drug to meet demand.
    • “Philadelphia-based PCI, which has 15 facilities in North America, Europe and Australia, is putting together the self-injection pens used to administer Wegovy, said the source, who declined to be named because the information is confidential.”
  • mHealth Intelligence tells us
    • The percentage of asynchronous telehealth claim lines for mental health conditions increased nationwide, with a particularly sharp rise in the Midwest, where it doubled between May and June, according to new telehealth usage data.
    • The data from FAIR Health’s Monthly Telehealth Regional Tracker represents the privately insured population, including Medicare Advantage and excluding Medicare Fee-for-Service and Medicaid. The tracker, launched in May 2020, uses data from FAIR Health to provide insights into month-to-month changes in the volume of telehealth claim lines and audio-only telehealth usage.
    • Nationally, telehealth remained stable at 5.4 percent of claim lines in May and June. In three US regions, telehealth use did not change during this period, but usage fell by 2.4 percent in the Midwest.

In general business news, HR Dive offers “A running list of states and localities that require employers to disclose pay or pay ranges.”

Thursday Miscellany

David Ermer–CDC, CMS, Congress, FDA, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC —

  • The American Hospital Association News tells us
    • “The House Energy and Commerce Committee today held a hearing on legislative proposals to prevent and respond to generic drug shortages. In comments submitted last month, AHA urged the committee to reject provisions in its draft legislation proposals that would limit patient access to 340B drugs and consider additional proposals that would protect the supply chain for essential medications.
    • “Witnesses at today’s hearing included representatives from Civica, the American Society for Health System Pharmacists, Healthcare Supply Chain Association, Healthcare Distribution Alliance, and Association for Accessible Medicines.”
  • STAT News adds,
    • “Although shortages are not new, the number of drugs in short supply has grown steadily for about two years. Shortages also have become more difficult to predict and are affecting drugs that are more critical.
    • “Most concerning are the shortages of cancer drugs, which until recently hadn’t been much of a problem for at least a decade. There are 15 cancer drugs currently in short supply, according to the Food and Drug Administration, though the White House this week said one of the key shortage chemotherapies, cisplatin, is nearly back to pre-shortage levels.
    • “Civica Rx members choose which drugs it brings to market. So far, the nonprofit contracts for cyclophosphamide, a chemotherapy that helps treat multiple cancers, and there’s a heightened urgency to determine whether to add more cancer drugs to the list.
    • “Given the drug shortage situation for cancer drugs, we have a working group now,” said Allan Coukell, senior vice president of public policy at Civica Rx. “We’re looking at what would a portfolio of those drugs be.”

From the Rx coverage front,

  • Forbes reports
    • “Despite misleading headlines, such as “Sudafed, Benadryl and most decongestants don’t work,” * * * [t]here are branded products that include the names Sudafed and Benadryl that do work as nasal decongestants. These contain the active ingredient pseudoephedrine. But because the dangerous illicit substance methamphetamine can be made in illegal laboratories with pseudoephedrine these products were placed behind the counter years ago. In 2005, Congress passed the Combat Methamphetamine Epidemic Act, which requires that pharmacies and other retail stores maintain purchase logs for products that include pseudoephedrine, and it limits the amount of those products an individual can purchase per day. Pseudoephedrine-based drugs are not affected by the FDA panel’s vote. They will remain available behind the counter.”
  • Per Healthcare Dive,
    • “GoodRx has notched a third partnership with a pharmacy benefit manager to integrate its drug coupons at the point of sale, further expanding GoodRx’s access to the commercially insured PBM market.
    • “For eligible members filling a generic medication starting in 2024, the new program will compare GoodRx’s discount price with their price through insurance and apply the lowest cost. The payment will be automatically applied to consumers’ deductibles.
    • “With MedImpact and existing deals with CVS Caremark and Cigna-owned Express Scripts, GoodRx now reaches more than 60% of insured lives through the partnerships, the company said Wednesday.”
  • The Institute for Clinical and Economic Research published an evidence report for gene therapy to treat Metachromatic Leukodystrophy.
    • “Currently available evidence provides greater certainty of substantial net health benefit in pre-symptomatic MLD; evidence also suggests that individuals with early symptomatic disease benefit from treatment —
      • “Using weighted analyses across all patient subpopulations, arsa-cel would achieve common thresholds for cost-effectiveness if priced between $2.3M – $3.9M —
      • “At the September 29 virtual public meeting, ICER’s independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate on the treatment’s comparative clinical effectiveness, other potential benefits, and long-term value for money.”

From the U.S. public health front,

  • Healio points out
    • Results from the American Association for Cancer Research’s annual Cancer Progress Report revealed that the age-adjusted overall cancer death rate in the U.S. fell by 33% between 1991 and 2020.
    • The report also detailed FDA approvals related to anticancer therapeutics over the past year, the impact of immunotherapy on cancer care in the 21st century and key challenges needed to overcome obstacles patients with cancer still face moving forward.
  • McKinsey notes” “Orthopedic care is among the largest categories in US healthcare; improvements could have far-reaching positive effects. We analyze care pathways to spot opportunities for better coordination.” Check it out.
  • Per Fierce Healthcare,
    • “Xylazine, a powerful veterinary tranquilizer, was detected in drug tests in 34 states from every region of the country, according to a new analysis.
    • “The analysis was conducted by national drug testing lab Millennium Health, looking at more than 160,000 de-identified urine drug test results from more than 73,000 unique patients collected between mid-April and mid-July 2023. 
    • “Xylazine, also known as “tranq,” is a sedative that prolongs and enhances the euphoric effects of illicit fentanyl. Xylazine-associated deaths are on the rise, and nearly all involve illicit fentanyl or fentanyl analogs. The Biden administration designated fentanyl combined with xylazine an emerging threat in April. “
  • and
    • “Loneliness can have major impacts on seniors’ health, worsening comorbidies and even driving mortality, according to a white paper by the Elevance Health Public Policy Institute.
    • “Loneliness in older adults increases the likelihood of depression and dementia as well as worsening outcomes for individuals with hypertension, heart disease and stroke, according to the white paper.
    • “In a survey, the researchers researchers found that:
      • About 28% of respondents had a mental health condition.
      • About 1 in 4 reported having both depression and another mental health condition.
      • Individuals with a mental health diagnosis were more likely to live alone.
      • Individuals with a mental health diagnosis cited limitations to social activities in the past month because of poor health.
    • “Elevance Health hired research and consulting company Health Management Associates to describe the characteristics of 16,000 Medicare beneficiaries with a mental health diagnosis using the 2018 Medicare Current Beneficiary Survey. Some beneficiaries were covered by traditional fee-for-service Medicare, others by Medicare Advantage (MA).”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Medical services provided in outpatient settings are notably pricier when delivered in hospital-owned departments compared with ambulatory surgery centers or physicians’ offices, according to a new analysis from a Blue Cross Blue Shield Association subsidiary.
    • “The report, based on data for 133 million Blues members found from 2017 to 2022, also found prices generally grew more rapidly at hospital outpatient departments than at non-hospital outpatient settings.
    • “Researchers said their data supports site-neutral proposals to make care costs the same regardless of where it’s provided. Momentum is building in Congress around the policies, but they face fierce opposition from hospital groups.”
  • and
    • “Out-of-network ground ambulance rides made up a larger percentage of total claim lines than in-network rides between 2018 to 2022, exposing patients to a higher risk of surprise bills, according to an analysis by Fair Health. 
    • “Out-of-network rides made up almost 64% of all ground ambulance claim lines in 2018, decreasing slightly to over 59% in 2022. 
    • “Advanced life support (ALS) services, which provide a higher level of care than basic life support (BLS), comprised a larger share of ground ambulance claims than basic life support services from 2018 to 2022 — another factor that could drive up costs, the research found. About 51% to 52% of ground ambulance claim lines were associated with ALS during the study period.”

In Social Security and Medicare news,

  • The Detroit Free Press reports,
    • “The odds moved up, based on the latest inflation data, that Social Security benefitscould see a 3.2% cost-of-living adjustment next year. Not sky high but a bit better than average.
    • “To be sure, we’ll need to see one more month of data before the exact inflation adjustment will be known. The next round of Consumer Price Index data for September will be released by the U.S. Bureau of Labor Statistics on Oct. 12.”
  • Per CNET,
    • “Starting in 2024, Medicare Premium costs will be changing — Medicare Part B costs are expected to get more expensive, while Medicare Part D prices are projected to decrease. We’ll tell you how much below. * * *
    • “Due to a new Alzheimer’s treatment coming to the market (Leqembi, from pharmaceutical companies Eisai and Biogen), Medicare beneficiaries are expected to pick up the cost. Therefore, Medicare Part B prices are expected to increase in 2024. The costs are projected to go up from the current $164.90 to $174.80, a nearly $10 increase per month. 
    • “While you may not see a huge difference in the amount you’re paying for Medicare Part D, it still could be slightly lower. The average total monthly Part D premium is projected to decrease from $56.49 in 2023 to $55.50 in 2024, according to the Centers for Medicare & Medicaid Services (CMS). That’s nearly $1 each month.” 

Midweek update

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Wall Street Journal reports, “House Speaker Kevin McCarthy laid out a map for passing legislation to keep the government funded past Oct. 1, but immediately ran into new roadblocks from spending hawks and fresh grumbling that he should be ousted from his post.” The FEHBlog anticipates that Congress will pass a continuing resolution before the end of the month.
  • The Centers for Medicare and Medicaid Services announced,
    • “the list of 34 prescription drugs for which Part B beneficiary coinsurances may be lower between October 1 – December 31, 2023. Some people with Medicare who take these drugs may save between $1 and $618 per average dose starting October 1, 2023, depending on their individual coverage.  * * *
    • “CMS has released information about these 34 Part B drugs and biological products in the quarterly Average Sales Price (ASP) public files, available here. A fact sheet is available here.”
  • Healthcare Dive informs us,
    • “Healthcare legislation being hashed out on the Hill is taking aim at pharmacy benefit managers, but the policies — while potentially worthwhile — are unlikely to have more than modest effects on the cost of prescription drugs in the U.S., experts say. us,
    • “Eliminating all PBM profits would only reduce total drug-related spending by “several percentage points,” since operating margins for the three biggest PBMs averaged roughly 4% of revenues last year, according to a new report from the Brookings Schaeffer Initiative on Health Policy.
    • “Lowering spending further would require “fundamental market changes” like changing drug patent protections or the way drug prices are regulated, the report says — measures sure to face heavy opposition from pharmaceutical companies.”
  • Per Becker’s Hospital Review,
    • “Cisplatin, a drug used for multiple types of cancer that’s been in a severe shortage for months, is close to returning to 100 percent of pre-shortage supply levels, the White House said Sept. 12. * * *
    • “In June and July, the FDA allowed China-based Qilu Pharmaceutical to temporarily import cisplatin. These lots have already been distributed, according to the FDA. The agency also worked with domestic drugmakers to increase their manufacturing capacity. 
    • “These actions brought the cisplatin supply back to nearly 100 percent of the pre-shortage levels and are greatly alleviating the shortages of carboplatin,” according to a post from the White House’s Office of Science and Technology Policy.”
  • The Federal Times writes about the impending premium increases in the Federal Long Term Care Insurance Program.

From the public health and research front,

  • The American Medical Association released a letter supporting the CDC’s “universal recommendation for the 2023-2024 COVID-19, XBB.1.5 containing vaccine.”
  • The National Cancer Institute informs us
    • “Testing for the presence of cancer-causing types of the human papillomavirus (HPV) is now a standard part of screening for cervical cancer, sometimes with simultaneous Pap tests (known as co-testing). But cervical cancer screening is recommended to stop at age 65 in many places and, for a variety of reasons, many older adults stop getting screened for cervical cancer well before that age. 
    • “Results from a population-based study conducted in Denmark, however, suggest that it may be worthwhile for some individuals between ages 65 and 69 to get tested for HPV: those who haven’t had cervical cancer screening for at least 5 years.
    • “In the new study, about 62% of women who were invited to undergo this “catch-up” testing for HPV (intervention group) had a test within the next year. In a comparison group of women not invited for catch-up testing, only about 2% had either a Pap test or an HPV test over the next year.”
  • The Wall Street Journal reports
    • “The first artificial womb to gestate a human baby is fast approaching reality.
    • “Food and Drug Administration regulators will weigh next week how scientists should conduct the first human tests of bag-like wombs, meant to nurture babies born so premature that modern medicine struggles to keep them healthy. * * *
    • “Philadelphia-based Vitara Biomedical has said that it is working on an artificial womb and is close to human clinical trials. A company executive said at a biotech symposium last year that the firm is commercializing the research of one of two U.S. groups known to be testing the technology on lambs. The other U.S. group says it is still a few years off from human trials.”
  • Forbes notes, “The Marcus Autism Center in Atlanta has launched its biomarker-based device that has been authorized by the FDA to aid in the diagnosis of autism in children between 16 and 30 months of age.” 

From the U.S. healthcare business front,

  • BioPharma Dive tells us,
    • “After pulling off a biomedical triumph with its COVID-19 vaccine, Moderna on Wednesday put out a roadmap for investors that promises billions of dollars from new medicines.
    • “The company aims to launch as many as 15 new products in the next five years, including four by 2025. In 2027, Moderna expects $8 billion to $15 billion in respiratory product sales. And on Wednesday, it forecast another $10 billion to $15 billion in annual sales from new treatments for cancer and rare and latent diseases it hopes to introduce by 2028.”
  • Beckers Payer Issues points out,
    • “Humana, Aetna and Molina are not renewing their contracts with senior companionship company Papa following allegations of abuse against patients or company employees, Bloomberg reported Sept. 11.
    • “In May, Bloomberg Businessweek published a report detailing allegations of abuse against seniors and Papa employees based on 1,200 complaints submitted to the company. The complaints included allegations of sexual abuse and assault, harassment, or unsafe living conditions.
    • “A spokesperson for Papa declined to provide a comment to Bloomberg about specific contracts, but said the company has grown its client base this year and is selling programs for next year.” 

Tuesday Tidbits

David Ermer–CDC, CMS, COVID-19, COVID-19 vaccine, FDA, HSA, Medical / Rx research, Rx coverage, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The American Hospital Association News tells us
    • “As authorized yesterday by the Food and Drug Administration and recommended by its vaccine advisory committee, the Centers for Disease Control and Prevention today recommended a single dose of the updated Moderna and Pfizer COVID-19 vaccines for Americans aged 12 and older, and one or two doses of the updated vaccines for previously vaccinated children aged six months through 4, at least two months after receipt of their last dose. The agency also recommended three doses of the updated Pfizer vaccine and two doses of the updated Moderna vaccine for unvaccinated children under age 5, as authorized by the FDA and recommended by the committee. CDC anticipates the updated vaccines will be available later this week.
    • “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality,” said Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “We very much encourage those who are eligible to consider getting vaccinated.”
  • and
    • The Food and Drug Administration’s independent Nonprescription Drugs Advisory Committee Sept. 12, by unanimous vote, declared oral phenylephrine ineffective as a decongestant. Phenylephrine is a common active ingredient in over-the-counter medications sold under the Nyquil, Tylenol, Advil, Robitussin, Sudafed and Benadryl brands, to name a few. FDA is not bound to the committee’s recommendations, but the agency’s own analysis presented prior to the panel’s meeting concluded that oral phenylephrine formulations are safe but ineffective at standard or even higher doses. The vote paves the way for products containing oral phenylephrine potentially being pulled from shelves until reformulated versions are offered.
  • FEHBlog observation — The class action lawyers should be revving up the old turbobiller.
  • The U.S. Census Bureau announced
    • “The percentage of working-age adults ages 19 to 64 with health insurance coverage increased from 2021 to 2022, primarily driven by an increase in employment-based coverage. This resulted in uninsured rates dropping from 11.6% to 10.8% according to U.S. Census Bureau data released today [September 12]. 
    • “The Health Insurance Coverage in the United States: 2022 report shows that the share of working-age adults with coverage rose across many race and ethnic groups, regions and employment status.”
  • Beckers Hospital Review informs us
    • CMS fined two more hospitals for alleged price transparency violations Sept. 5, marking the third consecutive month the agency has levied fines on noncompliant hospitals.   
    • “According to CMS’ price transparency website:
      • Washington, D.C.-based Saint Elizabeths Hospital was fined $677,440. 
      • Silver Spring, Md.-based Holy Cross Hospital was fined $325,710.
      • Additionally, CMS’ Sept. 8 update of its price transparency website included information of another hospital fined Aug. 22 that was not previously uploaded to the site. Doctors’ Center Hospital Bayamón (Puerto Rico) was fined $102,200.
    • The hospitals have 30 days from the issuance date to appeal the fines. 
    • CMS has now fined 14 hospitals for price transparency violations. To date, three hospitals have appealed their penalties and are under review, according to CMS.”  
  • ICD Monitor relates
    • “To help improve the collection of the social determinants of health (SDoH) Z codes, the Centers for Medicare & Medicaid Services (CMS) Office of Minority Health last week released a new Z code infographic. 
    • “CMS’s goal is to assist providers with understanding and using SDoH terminology in their documentation that will allow for greater alignment for ICD-10-CM Z code capture.  As discussed, CMS believes that greater Z code capture will enhance quality improvement activities and provide further insights into the existing health inequities that hospitals and their community are facing.” 

From the public health and medical research front,

  • The Wall Street Journal has updated its report on the fall vaccination season.
  • MedTech Dive lets us know,
    • A prospective study published in the journal Lancet Digital Health found that an AI tool paired with a double reading by one radiologist was as good at detecting breast cancer as a double reading by two radiologists, the current standard of care.
    • Researchers at the Capio Sankt Göran Hospital in Stockholm, Sweden, and the Karolinska Institute said the results suggest that AI “has potential for controlled implementation, which would include risk management and real-world follow-up of performance.” 
    • The study used the Insight MMG system for breast cancer detection, made by Seoul, South Korea-based Lunit. The company helped fund the research, in addition to grants from the Swedish Research Council, the Swedish Cancer Society, and Region Stockholm.
  • The American Hospital Association News reports,
    • “The U.S. infant mortality rate was essentially unchanged in 2021, but the number of deaths rose 2% to 19,928, the Centers for Disease Control and Prevention reported Sept. 12. The mortality rate increased for infants of Asian women and declined for infants of Dominican women. Infants of Black women had the highest mortality rate by race at 10.55 per 1,000 live births, while infants born before 28 weeks of gestation had the highest rate by age (353.76). The five leading causes of death were unchanged from 2020, with declines for disorders related to short gestation and low birth weight. Infant mortality rates by state ranged from a low of 2.77 in North Dakota to a high of 9.39 in Mississippi. The U.S. infant mortality rate has generally trended downward since 1995 and has declined 21% since 2005, the most recent high (6.86).”
  • STAT News is now offering a new generation weight loss drug tracker.
    • “STAT has created a new database to track the significant obesity drugs that are on the market and in development. The tracker, which will be updated with developments each quarter, gives a sense of what new mechanisms could hit the market, how they would be taken and how often, and which companies are running the most trials.
    • “A related article details the strategies and challenges of some of these companies.”
    • Roughly seventy drugs are on the tracker currently.

From the U.S. healthcare business front,

  • Fierce Healthcare tells us, “Shareholders in home health company Amedisys have approved its $3.3 billion union with Optum, even as the feds take a closer look at the deal.”
  • Per Healthcare Dive,
    • “Walgreens is partnering with startup Pearl Health to help primary care physicians manage value-based care, in a bid to expand its reach with community-based providers.
    • “The partnership announced Tuesday [September 12] marries Pearl’s provider enablement technology with Walgreens’ care delivery assets and pharmacy services in an attempt to make it easier for clinical teams to provide the personalized treatment necessary in value-based arrangements, according to the companies.
    • “Walgreens and Pearl will help doctors manage value-based care in traditional Medicare’s accountable care organization program, called ACO REACH, starting in 2024. The two plan to eventually expand to Medicare Advantage and potentially commercial payers and Medicaid down the line.”
  • Per Employee Benefits News,
    • “Saving for retirement is a life-long challenge, and one that seems to be harder for women. While they live on average five years longer than men, they’re saving less.
    • “Bank of America analyzed 565,000 health savings accounts (HSAs), looking at utilization trends across genders and generations. Women’s HSA balances are 15% lower than men’s, with women more likely to spend their HSA savings before retirement and contribute less to their accounts. Overall, men’s average net HSA savings was $128 higher in 2022, and over the years that gap begins to add up.” * * *
    • “Lisa Margeson, managing director of retirement research and insights at Bank of America,  advises employers to at the very least educate their employees on the power of HSAs and how they can use them as retirement savings vehicles. Employer HSA contributions, caregiving benefits and flexibility will also help ensure women can maintain successful careers and save for their future. 
    • “As for women, Margeson encourages them to start their HSAs early, try to put at least a little aside each month and eventually invest that money according to their bank’s capabilities. For those who are uncomfortable with a high-deductible health plan, Margeson points to emergency savings accounts or an interest-bearing savings account as a companion to their retirement plans.”
  • The Society for Human Resource Management offers a breakdown of compensation expenses over the second quarter of this year.
    • “According to the latest Employer Costs for Employee Compensation report, released September 12 by the U.S. Bureau of Labor Statistics (BLS), employers spent just 0.59 percent more on wages and benefits in June 2023 compared to March 2023.
    • “Total employer compensation costs for private-industry workers averaged $41.03 per hour worked. Wages and salaries averaged $28.97 per hour worked, accounting for 70.6 percent of employer costs, while benefits costs averaged $12.06 per hour worked, accounting for the remaining 29.4 percent, according to the report.”

Friday Factoids

David Ermer–CDC, CMS, HSA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC —

  • The American Hospital Association informs us
    • “The 988 Suicide & Crisis Lifeline now offers American Sign Language services for people who are deaf and hard of hearing, the Department of Health and Human Services announced.
    • “This new service is one more critical step towards making mental health support more accessible and inclusive for all,” said Miriam Delphin-Rittmon, HHS assistant secretary for mental health and substance use.”
  • and
    • “A new Centers for Medicare & Medicaid Services fact sheet reviews how the agency selected the first 10 Part D drugs to include in the Medicare Drug Price Negotiation Program, its process for negotiating with the companies that make the drugs, opportunities for public input and key dates for implementation. CMS last week announced the first 10 drugs for the program and plans to publish the negotiated prices by next September, which would take effect in 2026.”
  • The Department of Health and Human Services announced
    • “new details of its agreement with Regeneron to extend its public-private partnership to develop life-saving monoclonal antibodies as part of Project NextGen enhancing our preparedness for COVID-19 strains and variants.
    • “The HHS is committed to lowering drug costs for all Americans. As part of that commitment, HHS and Regeneron announced an extension of their long-standing partnership to develop life-saving monoclonal antibodies. That modification to Regeneron’s contract with the Administration for Strategic Preparedness and Response’s (ASPR’s) Biomedical Advanced Research and Development Authority is valued at $326M and supports the advanced development of a next-generation monoclonal antibody for COVID-19 prevention under HHS’s Project NextGen.
    • “This agreement included a clause where Regeneron committed that if a new product is commercialized, its list price in the United States will be equal to or less than its retail price in comparable markets globally. Inclusion of this clause is the result of HHS’s and Regeneron’s shared interest in ensuring enduring and equitable access to therapeutics developed under public-private partnerships for all Americans.”

From the public health front,

  • The American Hospital Association tells us
    • “This season’s flu vaccines for the Southern Hemisphere have reduced the risk of being hospitalized for flu by 52%, based on mid-season data from five countries, suggesting the U.S. vaccines could provide similar protection if similar viruses continue to predominate, the Centers for Disease Control and Prevention reports. Both hemispheres used similar flu vaccine formations. The CDC recommends all Americans aged 6 months and older get the seasonal flu vaccine in September or October.”
  • Per Health Day,
    • “The mpox vaccine appears to show effectiveness against the virus, new research shows
    • “Among 37 gay and bisexual men who were either reinfected or had received their mpox vaccine, the disease was less severe
    • “The findings show that the vaccine is a valuable addition to treatments used for mpox infection.”
  • and
    • “Standard Pap tests may miss a deadly type of cervical cancer 
    • “A new screening tool could pick up more of those cancers as well as lesions that may progress into cancer, its developers say
    • “The findings must now be confirmed by clinical trials”
  • More details are available in the Health Day articles.
  • A Wall Street Journal reporter explains what he learned from trying to live a perfect life for a day based on expert advice.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “CVS Health shuffled responsibilities for its leadership bench on Thursday in a bid to better align business segments, as the retail health giant undergoes corporate restructuring following flagging earnings.
    • “CVS named CFO Shawn Guertin president of its health services segment, and said former Humana CFO Brian Kane will join this week as president of Aetna health benefits arm. CVS first announced Kane would be joining CVS in April.
    • “CVS’ care delivery businesses Oak Street Health and Signify Health will continue to operate under health services umbrella. Their respective heads, Mike Pykosz and Kyle Armbrester, will now report directly to Guertin.”
  • Beckers Payer Issues notes,
    • “AHIP has named its general counsel, Julie Simon Miller, to serve as interim CEO, effective Oct. 2.
    • “AHIP President and CEO Matt Eyles is stepping down from his role at the end of September, and the trade association is currently searching for a permanent chief executive, according to a Sept. 7 news release.
    • “Ms. Miller has served as general counsel since 2015 and has been with the association for more than 18 years.”
  • The Employee Benefit Research Institute points out,
    • “IRS Notice 2019-45 allows health savings account (HSA)-eligible health plans the flexibility to cover 14 medications and services used to prevent the exacerbation of chronic conditions prior to meeting the plan deductible. A 2021 Employee Benefit Research Institute (EBRI) survey of employers collected information on their response to the 2019 guidance and found that many employers added pre-deductible coverage as a result of the IRS notice. A recent EBRI report based on claims data from about 2 million HSA-eligible health plan enrollees confirmed the findings from the 2021 EBRI survey — fewer enrollees in HSA-eligible health plans have deductibles for services impacted by the IRS notice, and cost sharing has shifted from deductibles to copayments and coinsurance.”
  • Per Fierce Healthcare,
    • “Prior authorization will become less of a hassle for physicians in Blue Cross Blue Shield of Michigan’s network, BCBSM officials hope, as they roll out an effort to relax about 20% of prior authorization requirements.
    • “This is part of Blue Cross’ ongoing effort to improve healthcare quality, experience, access and affordability for members, while also reducing administrative tasks for clinicians,” BCBSM said in a press release.”

From the Rx coverage and research front,

  • BioPharma Dive reports,
    • “Seagen is committing $60 million to develop a new type of cancer drug, striking a multi-year alliance with biotechnology company Nurix that aims to combine their respective technologies.
    • “Per terms of the deal announced by Nurix Thursday, Seagen could pay as much as $3.4 billion more if certain research, development, regulatory and commercial milestones are met. Nurix retains an option to co-market and share profits on two products that emerge from the partnership.
    • “The companies plan to pair Seagen’s antibody expertise with Nurix’s protein degradation technology to create “degrader-antibody conjugates,” akin in some ways to Seagen’s approved antibody-drug conjugates. The collaboration comes as Pfizer works to close its $43 billion acquisition of Seagen.”
  • and
    • “Verge Genomics, a biotechnology company using artificial intelligence to develop therapies for diseases of the nervous system, announced on Friday a four-year partnership with AstraZeneca’s rare disease unit Alexion to identify new drug targets.
    • “As part of the agreement, Verge will receive up to $42 million in upfront, equity and near-term payments. The company also could receive as much as $840 million in milestone payments over the deal, along with royalties on any resulting products.
    • “The partnership seeks to find and validate new drug targets for uncommon neurodegenerative and neuromuscular diseases. The companies plan to do this by using Verge’s technology, which uses both AI and human tissue data to predict what drug targets are most likely to succeed in clinical testing.”

Thursday Miscellany

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Government Contracting, OPM, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Federal News Network offers its periodic update on the bills pending before Congress of interest to federal employees.
  • American Hospital Association News tells us that today
    • “The Department of Health and Human Services’ Office for Civil Rights released a proposed rule intended to update and clarify requirements under Section 504 of the Rehabilitation Act that prohibit discrimination on the basis of disability in programs receiving financial assistance from the department, including health care. According to HHS, the proposed rule would ensure that medical treatment decisions are not based on biases or stereotypes about individuals with disabilities; prohibit the use of value assessment methods that place a lower value on life-extension for individuals with disabilities when used to limit access or to deny aids, benefits and services; establish enforceable standards for accessible medical diagnostic equipment; and clarify obligations for accessible web and mobile applications and obligations to provide services in the most integrated setting appropriate to an individual’s needs. The rule will be published in the Sept. 14 Federal Register, with comments accepted for 60 days.”
  • The Federal Times points out
    • “The Office of Personnel Management received a small surge of retirement claims in July and August after applications had been falling steadily for months since January.
    • “The time it took the government to process retirements increased sharply in July to 85 days before falling back down to 74 days in August, according to data kept by OPM.
    • “Overall, the agency is sitting on an inventory of nearly 18,000 cases after it reduced its working caseload to new lows this year. About this time last year, there were 29,000 pending cases.
    • “Still, despite efforts to dispatch focus teams to address backlogs, the agency is failing to hit its target time or inventory goals, leaving retirees to wonder whether their case will be one that ends up sitting in limbo for longer. Ideally, retirement applications are processed in 60 days or fewer.”
  • CMS released its 2022 report on covered entity compliance with the HIPAA electronic transactions.
    • The transaction types experiencing the most violations during the 2020 and 2021 compliance reviews were specific to 835 [the claim transaction], 271 [Health Care Eligibility Response], and 277 [Claim Status Response] transactions. This changed slightly in 2022 as the most common transaction types experiencing violations are now 835, 271, and 834 [EOB] transactions.
    • CMS is sharing updated 2022 violation findings insights to inform and educate the industry, encourage widespread compliance, and assist covered entities with preparing for compliance reviews.
  • The Society for Human Resource Management relates,
    • The U.S. Equal Employment Opportunity Commission (EEOC) has released an updated deadline for employers to submit their demographic data. The EEO-1 Component 1 data collection for 2022 will start on Oct. 31, and the deadline for employers to file their EEO-1 reports is Dec. 5.
    • All private employers that have at least 100 employees are required to file the EEO-1 form annually, detailing the racial, ethnic and gender composition of their workforce by specific job categories.
    • Likewise, federal government contractors and first-tier subcontractors with 50 or more employees and at least $50,000 in contracts must file EEO-1 reports. State and local governments and public school systems are exempt.
  • KFF reports
    • “Over the past two years, the federal government has provided about $1 billion from the American Rescue Plan and Bipartisan Safer Communities Acts to launch the number, designed as an alternative to 911 for those experiencing a mental health crisis. After that infusion runs out, it’s up to states to foot the bill for their call centers.
    • “We don’t know what Congress will allocate in the future,” said Danielle Bennett, a spokesperson for the federal Substance Abuse and Mental Health Services Administration, which oversees 988. “But the hope is that there will be continued strong bipartisan support for funding 988 at the level it needs to be funded at and that states will also create funding mechanisms that make sense for their states.”
    • “Only eight states have enacted legislation to sustain 988 through phone fees, according to the National Alliance on Mental Illness, which is tracking state funding for the system. Others have budgeted short-term funding. But many predominantly rural states, where mental health services are in short supply and suicide rates are often higher than in more urban states, have not made long-term plans to provide support.”
  • MedPage reports,
    • When pseudoephedrine moved “behind-the-counter” nearly 20 years ago, it left oral phenylephrine (with brands including Sudafed PE and Suphedrine PE) as the only nasal decongestant available without pharmacy assistance. But there’s one big problem: phenylephrine doesn’t work, the FDA has finally determined.
    • FDA reviewers released the results of their long-running review of the evidence this week as background for a meeting of the Nonprescription Drugs Advisory Committee to be held on September 11 and 12.
    • The article explains the conundrum this finding creates for the FDA.

From the public health front,

  • MedPage reports that “the global incidence of early-onset cancer has increased by 79% over the past three decades, researchers reported.
    • “In a comment posted on Science Media Centre, Dorothy C. Bennett, MA, PhD, of St. George’s, University of London, cautioned that the increase in new cases of early-onset cancer is based on absolute numbers, rather than age-standardized rates.
    • “The world human population increased by 46% between 1990 and 2019, which explains part of the increase in total case numbers,” she said, adding that the increase in numbers of cancer deaths in this age group (28%) was notably lower than the number of new diagnoses, “which is below the increases in total population and case numbers, indicating a fall in the average cancer death rate in this group.”
  • Per the American Heart Association,
    • Obesity-related cardiovascular disease deaths tripled between 1999 and 2020 in the U.S.
    • Such deaths were higher among Black individuals (highest among Black women) compared with any other racial group, followed by American Indian/Alaska Native people.
    • Black adults who lived in urban communities experienced more obesity-related cardiovascular disease deaths than those living in rural areas, whereas the reverse was true for all other racial groups.
  • McKinsey Health offers a podcast about getting to the bottom of the teen health crisis.

From the U.S. healthcare business front,

  • Fierce Healthcare notes, “Employers’ health benefits costs are set to rise 5.4% next year, but this spike isn’t as high as may have been feared given inflationary pressures in the broader economy, according to a new analysis from Mercer.”
  • STAT News interviews “Amazon’s chief medical officers on where the company’s health care bets are headed next.”
  • Healthcare Dive informs us,
    • “Telehealth sessions comprised 5.4% of claim lines in June, the same amount as the prior month, according to Fair Health’s Monthly Telehealth Regional Tracker.
    • “Mental health conditions continued to top the list of Fair Health’s five most common telehealth diagnoses for June. The median allowed amount billed for a one-hour psychotherapy visit was $103.
    • “But Fair Health’s tracker showed regional variations. Although telehealth use decreased overall by 2.4% in the Midwest, asynchronous telehealth claim lines for mental health conditions more than doubled in the region from 15.9% in May to 36% in June. In asynchronous telehealth, providers collect data or medical images for review, instead of meeting with a patient in real time.” 
  • Per Health Affairs,
    • “Intensive care units (ICUs) are increasingly used for hospital care, yet out-of-pocket spending for ICU hospitalizations remains poorly understood, particularly among the nearly half of the US population with commercial health insurance. Using 2008–19 MarketScan data, we compared 1,441,810 hospitalizations involving ICU services with 13,011,208 hospitalizations that did not involve ICU services.
    • “Average cost sharing, adjusted for patient and admission factors, increased from $1,137 per hospitalization in 2008 to $1,539 in 2019, or a 34 percent increase. This was driven by increasing deductibles, which rose by 163 percent.
    • “Across twenty clinical conditions whose hospitalizations commonly occurred in both ICU and non-ICU settings, ICU admission was associated with $155 higher cost-sharing (13.0 percent higher) relative to cost sharing in non-ICU hospitalizations.
    • “Patients with high-deductible plans faced the highest cost-sharing relative to those with other plan types.
    • “Patients who received out-of-network hospital care encountered higher cost-sharing relative to those admitted to in-network hospitals with in-network clinicians.”

Midweek Update

David Ermer–CDC, CMS, COVID-19, COVID-19 vaccine, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • The American Hospital Association informs us,
    • “Republicans on the House Energy and Commerce, Ways and Means, and Education & Workforce Committees have released a summary of draft legislation the committees could introduce as soon as this week. The Lower Costs, More Transparency Act includes provisions focused on health care price transparency, site-neutral payment cuts, and extending certain funding set to expire Sept. 30 for Community Health Centers, the National Health Service Corps and the Teaching Health Centers Graduate Medical Education Program. The bill also would delay for two years the start of Medicaid Disproportionate Share Hospital cuts scheduled to take effect on Oct. 1.”
  • CMS changed its No Surprises Act announcement to read
    • Effective September 5, 2023, the Departments have directed certified IDR entities to proceed with eligibility determinations for single and bundled disputes submitted on or before August 3, 2023.  All other aspects of Federal IDR process operations remain suspended. Disputing parties may continue to engage in open negotiation. 
  • The FEHBlog noticed on reginfo.gov that the following two No Surprises Act proposed regulations were submitted for Office of Information and Regulatory Affairs review on August 29:
    • AGENCY: HHS-CMS RIN: 0938-AV15 Status: Pending Review
    • TITLE: Independent Dispute Resolution Operations (CMS-9897)
    • STAGE: Proposed Rule SECTION 3(f)(1) SIGNIFICANT: Yes
    • RECEIVED DATE: 08/29/2023 LEGAL DEADLINE: None
    • and
    • AGENCY: HHS-CMS RIN: 0938-AV39 Status: Pending Review
    • TITLE: Federal Independent Dispute Resolution Process Fees (CMS-9890)
    • STAGE: Proposed Rule SECTION 3(f)(1) SIGNIFICANT: Yes
    • RECEIVED DATE: 08/29/2023 LEGAL DEADLINE: None
  • The first Interested party meetings with OIRA are scheduled for September 8.

From the public health front,

  • The American Hospital Association tells us
    • “The Centers for Disease Control and Prevention Sept. 5 alerted clinicians to a recent increase in respiratory syncytial virus in the Southeastern U.S., which could signal the beginning of the 2023-2024 RSV season nationally. CDC encourages clinicians to prepare to implement prevention options, including the new long-acting monoclonal antibody to protect infants and some young children at higher risk for severe disease and two new vaccines to protect older adults from severe disease.”
  • Per STAT News
    • “More older adults have been hospitalized for COVID-19 over the past several weeks, according to internal data reviewed by health insurance giant Humana.
    • “Humana, which mostly provides health insurance to those 65 and older and who are therefore more vulnerable to the worst effects of Covid, expected more Covid cases and hospitalizations this year. But it didn’t expect the uptick to come during the waning summer months.”
  • BioPharma Dive reports,
    • Moderna said that an updated COVID shot it’s developing can protect against a form of the coronavirus known as BA.2.86, or Pirola, adding to early evidence the emerging variant may not be as troublesome as scientists had feared.
    • The data, delivered in a press release on Wednesday, show that the vaccine helped spur an immune response in humans against Pirola. It follows an announcement by Moderna last month that the same vaccine appears protective against other currently circulating strains known as Eris and Formax.
    • The Food and Drug Administration is currently reviewing the booster shot, with a decision expected shortly.
  • MedPage Today explains how to navigate the fall vaccine season for COVID-19, the flu, and RSV.

From the U.S healthcare business front,

  • Health Payer Intelligence points out four essential components of chronic disease management strategies.
  • Healthcare Dive relates,
    • Salt Lake City-based Intermountain Health last week reported $184 million in operating income for the first half of 2023, a 35% decrease from the prior-year period when the health system posted an operating income of $285 million. 
    • Expenses climbed to a total of $7.4 billion, offsetting a 22% year-over-year increase in revenue. Intermountain logged nearly $8 billion of revenue for the first six months of the year. 
    • The nonprofit operator still inked nearly $1.1 billion in net gain in the first half of the year, driven by investment income of $909 million.
  • Per MedTech Dive,
    • “Abbott reached an agreement to acquire Bigfoot Biomedical, a company that makes smart insulin pen caps that can sync with continuous glucose monitors to provide dose recommendations.
    • “The companies did not disclose the price of the acquisition, but plan to close it in the third quarter, they said in a Tuesday announcement. 
    • “The planned purchase would be Abbott’s first insulin delivery technology, adding to its position as one of the top CGM makers.” 

Tuesday Tidbits

David Ermer–ACA, CMS, Generative AI, OPM, Telehealth–
Photo by Patrick Fore on Unsplash

From Washington DC,

  • Govexec.com offers an interview with OPM’s Deputy Director Rob Shriver.
  • The American Hospital Association informs us
    • “The Centers for Medicare & Medicaid Services will select up to eight states to participate in a new voluntary all-payer model that aims to curb health care cost growth, improve population health, and advance health equity by reducing disparities in health outcomes. CMS plans to detail requirements for the States Advancing All-Payer Health Equity Approaches and Development Model in a funding opportunity notice this fall. Participating states will receive up to $12 million each to implement the model during one of three start dates, with the model concluding in December 2034. CMS expects to begin the pre-implementation period for the first cohort next summer. The model will build on best practices from the Maryland Total Cost of Care model, the Pennsylvania Rural Health Model, and the Vermont All-Payer ACO Model.

From Harrisburg, PA,

  • The Pennsylvania Department of State announced,
    • “Starting Sept. 5, 2023, registered nurses and licensed practical nurses from other states who hold multistate licenses through the Nurse Licensure Compact m(NLC) will be able to provide in-person and telehealth services to PA patients. * * * Pennsylvania nurses will be able to apply for a multistate license once the compact has been fully implemented.”
  • Here is a link to nurse.org’s “Compact Nursing States List 2023,” which now includes forty states, Guam, and the Virgin Islands.
  • This type of licensing flexibility should help with nursing shortages.

From the Affordable Care Act front, Beyond the Basics provides an updated guide to minimum essential coverage.

From the generative AI front, STAT News now provides a tracking service that serves as a guide to health systems and companies driving the adoption of this important new technology.

Speaking of technology,

  • BioPharma Dive reports
    • “Beam Therapeutics has begun human testing in the U.S. of a first-of-its-kind gene editing medicine for cancer, the company said Tuesday.
    • “Beam, a pioneering developer of a precise gene editing technique known as base editing, said in a short statement that it’s dosed its first patient in a study of the treatment, called BEAM-201. The trial involves patients with an aggressive form of blood cancer known as T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma, or T-ALL/T-LL. It will eventually enroll about 100 participants, according to a federal database.
    • “The study’s start makes BEAM-201 the first base editing therapy to enter clinical testing in the U.S., and marks the first time patients have received a cell therapy made by “multiplex editing,” in which several genes are edited. The edits are designed to eliminate expression of four genes known as CD7, TRAC, PDCD1 and CD52.
    • “Beam claims this approach could lead to a more powerful and durable treatment. In its statement, the company noted BEAM-201’s potential to sidestep a variety of issues associated with cell therapies, like propensity for the modified cells to kill one another, or become weaker as time goes on.
    • “Beam also believes the simultaneous edits could yield a more potent donor-derived, or “off the shelf,” cell therapy. Such allogeneic treatments would be more convenient than the personalized CAR-T therapies on the market, but results to date haven’t proven they’re more powerful at killing cancer cells.”
  • Very Buck Rogers.

From the telehealth front,

  • Per Healthcare Dive,
    • “Approximately one-third of behavioral health patients seeking therapy or medication visits said their clinicians did not offer both telehealth and in-person care, according to a study from nonprofit research organization Rand.
    • “The study, published on Tuesday in Health Affairs, revealed that 45% of behavioral health patients did not believe their clinicians considered their preferences for virtual or in-person care. In addition, 32% of respondents said they did not receive their preferred method of treatment.
    • “Despite the lack of choice offered by providers, many patients undergoing behavioral health therapy preferred in-person visits due to the personal nature of the treatment, the ability to build a rapport with providers, and fears around data security and privacy, the report found.”
  • Such reports explain why hub and spoke telemental services are not a solution for mental health parity.

From the human resources front,

  • The Society for Human Resource Management advises,
    • Even though [last week’s] proposed overtime rule is likely to be challenged in court after it is finalized, employers should start examining how it will affect their workplaces, legal experts say.
    • “I don’t think businesses should act now and make concrete changes,” said Jeff Ruzal, an attorney with Epstein Becker Green in New York City. “A preliminary injunction is likely” after the rule is finalized, he said, but employers “should study and audit the workplace” and prepare for the rule to possibly take effect. They should analyze who is exempt and nonexempt and plan for complying “without jeopardizing the business or payroll.” 

Thursday Miscellany

David Ermer–CMS, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington DC,

  • The Washington Post reports
    • “The White House on Thursday urged Congress to adopt a short-term measure to fund the federal government, a move meant to buy time for lawmakers to craft a broader spending deal and avert a shutdown at the end of September.
    • “The Biden administration coupled its call to action with a new request that Congress address funding for a series of cash-starved programs — including, for example, an additional $1.4 billion to prevent a potential disruption in nutritional aid for low-income families.”
  • HHS Secretary Xavier Berrara reflected on the Administration’s efforts to end the opioid public health emergency on this International Overdose Awareness Day.
  • In related news, the New York Times informs us
    • “Narcan, the first opioid overdose reversal medication approved for over-the-counter purchase, is being shipped to drugstore and grocery chains nationwide, its manufacturer said Wednesday. Big-box outlets like Walgreens, CVS, Walmart and Rite Aid said they expected Narcan to be available online and on many store shelves early next week.
    • “Public health experts have long called for greater accessibility to the drug, which they describe as a critical weapon against rising overdose rates. There were more than 100,000 opioid overdose fatalities in each of the last two years in the United States.
    • “Narcan is already a staple for emergency personnel and street outreach teams. Now scientists and health officials are hoping Narcan will eventually become commonplace in public libraries, subways, dorms, corner delis and street vending machines.
    • “They also predict it may become a fixture in medicine cabinets, as more people realize that illicit party drugs like cocaine and counterfeit Xanax pills may be tainted with deadly fentanyl, an opioid.”
  • Govexec relates
    • “President Biden on Thursday formalized his plan to provide civilian federal employees with an average 5.2% pay increase, their largest in four decades, in a letter to congressional leaders.
    • “In March, Biden first announced his pay raise plan as part of his fiscal 2024 budget proposal, recommending the largest pay increase for civilian federal workers since the Carter administration. Thursday’s announcement confirms that, if implemented, federal employees will see an across-the-board increase in basic pay of 4.7% and an average 0.5% boost to locality pay.
    • “In his letter, Biden said the pay raise is critical to his administration’s goal of ensuring that the federal government is a model employer and able to attract qualified candidates to join the workforce.”
  • The U.S. Office of Personnel Management announced issuing
    • the final regulations to implement the Fair Chance to Compete for Jobs Act of 2019 (Fair Chance Act), which prohibits federal agencies and federal contractors from requesting an applicant’s criminal history information before the agency makes a conditional offer of employment to the applicant. The final regulations also provide applicants with a complaint process and hold accountable federal employees who are in violation of the Fair Chance Act. 
    • “If you have the qualifications, skills, and willingness to serve the American public, you deserve a fair chance to compete for employment within the federal government,” said Kiran Ahuja, OPM Director. “America is a nation of second chances, and every person deserves to be treated with dignity and respect.” 

From the Medicare front,

  • MedPage Today reports on CMS efforts to recruit specialty practices in Medicare value-based purchasing programs.
  • Milliman issued a white paper titled “Part D redesign under the Inflation Reduction Act / Potential financial ramifications for Part D plans and pharmaceutical manufacturers.” Check it out.
  • CMS recently announced
    • “a new voluntary nationwide model – the Guiding an Improved Dementia Experience (GUIDE) Model – a model test that aims to support people living with dementia and their unpaid caregivers. CMS is accepting letters of interest for the GUIDE Model through September 15, 2023, and will release a GUIDE Request for Applications (RFA) for the model in Fall 2023. The model will launch on July 1, 2024, and run for eight years. * * *
    • “Participants in the GUIDE Model will establish dementia care programs (DCPs) that provide ongoing, longitudinal care and support to people living with dementia through an interdisciplinary team. GUIDE participants will be Medicare Part B enrolled providers/suppliers, excluding durable medical equipment (DME) and laboratory suppliers, who are eligible to bill for Medicare Physician Fee Schedule services and agree to meet the care delivery requirements of the model.”

From the public health and medical research fronts

  • We have four articles from STAT News
    • Miscarriage treatment news. “A [Woodbury,] Minnesota clinic tries to rewrite medicine’s approach to miscarriage.” Bravo.
    • CAR-T Therapy News — “Saar Gill and Carl June, cell therapy researchers at the University of Pennsylvania, wanted to make a single treatment that could tackle virtually all blood cancers. It was an audacious goal. * * *
    • “On Thursday, though, Gill, June and a graduate student, Nils Wellhausen, published a solution in Science Translational Medicine. It’s a complicated dance involving a new form of genome editing and multiple cellular infusions, and still years away from clinical trials. But outside experts say that if academics or companies can figure out manufacturing and logistics, it could open new avenues to tackling cancers that have so far remained out of reach.
    • “It’s very clever and really a tour de force,” said Marcela Maus, director of the cellular immunotherapy program at Mass General Hospital.”
    • Depression treatment news — “A single dose of psilocybin may have enduring benefits for people with major depressive disorder, according to a randomized clinical trial published Thursday in the Journal of the American Medical Association.”
    • AD Treatment News — Drug firms are studying whether drugs like Leqembi can halt Alzheimer’s Disease before symptoms appears.
  • From the U.S. healthcare business front,
    • Per Fierce Healthcare,
      • “GoodRx has launched a new feature to allow healthcare professionals to see the cost of a patient’s prescription with their insurance.
      • “The real-time benefit check (RTBC) feature was developed in collaboration with AssistRx, a specialty therapy initiation and patient solutions provider. The RTBC surfaces a patient’s coverage and benefits at the point of care with the goal of increasing price transparency and access to drugs. It also includes whether a prior authorization is required.
      • “AssistRx built its advanced access and patient support solutions to be interoperable, Edward Hensley, the company’s co-founder and chief commercial officer, said in a press release.”

Quick Takes

David Ermer–ACA, CDC, CMS, FDA, Medicare, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Mercer Consulting informs us,
    • “The Affordable Care Act (ACA) benchmark for determining the affordability of employer-sponsored health coverage will drop significantly to 8.39% of an employee’s household income for the 2024 plan year — down from the 2023 plan-year level of 9.12%, according to IRS Rev. Proc. 2023-29. This affordability percentage can affect individuals’ eligibility for federally subsidized coverage from a public exchange, as well as employers’ potential liability for shared responsibility (or “play or pay”) assessments. Importantly, employers that use the exact safe harbor dollar amount to set employee contributions will need to reduce the current employee contribution for the lowest-cost, self-only option for the 2024 plan year.”
  • The Food and Drug Administration has “approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko, like Tysabri, is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α (tumor necrosis factor, a substance in your body that causes inflammation).”
  • Per the American Hospital Association
    • The Centers for Disease Control and Prevention Aug. 24 announced the launch of its Hospital Sepsis Program Core Elements initiative, a new program to provide hospitals with a blueprint for managing medical emergencies stemming from sepsis. The program, which is modeled after a similar effort for antibiotic stewardship, is intended as a “manager’s guide” to organizing staff and making the resources available to improve sepsis care and bring survival rates up.”
  • CMS tells us that
    • “The Medicare Shared Savings Program saved money for Medicare while continuing to support high-quality care. Specifically, the program saved Medicare $1.8 billion in 2022 compared to spending targets for the year. This marks the sixth consecutive year the program has generated overall savings and high-quality performance results. This represents the second-highest annual savings accrued for Medicare since the program’s inception more than ten years ago.” 

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • Cigna is the latest health insurer to roll back prior authorization requirements, announcing Thursday that it will no longer require the approvals for nearly 25% of medical services.
    • Cigna plans to remove more than 600 prior authorization codes in its commercial plans, bringing Cigna’s total prior authorization removals to more than 1,100 since 2020, the payer said.
    • Cigna plans to nix another 500 or so codes for its Medicare Advantage plans before the end of this year.