Monday Roundup

Rx coverage

Monday Roundup

David Ermer–CMS, Congress, COVID treatment, COVID vaccine mandate, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The Hill reports,
    • “Senate Majority Leader Chuck Schumer (D-N.Y.) is ramping up the pressure on Speaker Kevin McCarthy (R-Calif.) to avoid a government shutdown by moving first on a stopgap funding bill that will pass the Senate this week, a few days before the Sept. 30 deadline.     
    • “The Senate’s plan is to send the bill to the House and put pressure on McCarthy to bring it to the floor for a vote it would pass with bipartisan support if given the chance, said senators who are calculating how the endgame will play out.”   
  • The Department of Health and Human Services released a letter from Secretary Xavier Becerra to “the health payer community.” This is the paragraph that grabbed the FEHBlog’s attention:
    • “I also know that, with the end of the public health emergency, the requirement to cover COVID-19 vaccinations furnished by out-of-network providers generally has ended. However, if a plan or issuer does not have a provider in its network who can provide a qualifying coronavirus preventive service, the plan or issuer must cover the item or service when furnished by an out-of-network provider and may not impose cost-sharing with respect to the item or service. We want to underscore the public health importance of reducing barriers to coverage however possible and urge you to consider any and all ways to reduce these barriers. It is critical to help your members navigate your network, particularly to help people understand the differences between your medical and pharmacy network as appropriate.  We know you are already looking for ways to smooth these issues and hope that will continue. In the meantime, we will do our part to urge consumers to seek in-network providers when possible.”
  • Fierce Healthcare tells us about a D.C. conference at which attendees encouraged the Centers for Medicare and Medicaid Services to offer Medicare coverage for the new generation of anti-obesity drugs.
    • “Healthcare organizations are continuing to push the Centers for Medicare & Medicaid Services (CMS) to rethink its coverage policy for anti-obesity medications.
    • “These medicines are not covered by Medicare Part D, because existing statutory exclusion is in place for these drugs that do not cover “agents when used for anorexia, weight loss or weight gain,” according to a press release. In a joint press conference hosted by health experts at Manatt, Phelps & Phillips and the Obesity Action Coalition, advocates laid out a legal basis in support of covering GLP-1s, stating that they can target obesity rather than describing the drugs solely in terms of their effects on weight.
    • “Obesity is a disease that has multiple causes and consequences not limited to weight,” said Michael Kolber, a healthcare partner at Manatt Health, to reporters. “There are many drugs that cause weight loss or weight gain, even if that’s not why they’re being prescribed.”
  • Politico helpfully points out
    • “As the Biden administration pushes to make insurers cover mental health care on par with physical care, there’s a similar push from lawmakers and advocates for electronic health records, Ben reports.
    • “Mental health and substance-use providers weren’t allowed to get billions in federal subsidies for adopting EHRs in the 2009 HITECH Act, which advocates argue has led to significant disparities in uptake between behavioral and physical health providers. While data varies, one recent federal estimate found that 49 percent of psychiatric hospitals have certified electronic health records compared to 96 percent of general and surgical hospitals.
    • “Without the funding, the behavioral health industry didn’t invest in robust behavioral health-specific electronic health systems, said Alisa Chestler, a Baker Donelson attorney with digital health expertise.
    • “Legislation from Reps. Doris Matsui (D-Calif.) and Bill Johnson (R-Ohio) and Sens. Markwayne Mullin (R-Okla.) and Catherine Cortez Masto (D-Nev.) would add $20 million in annual grant funding through ONC for behavioral health EHR adoption. Advocates hope it will get into the final SUPPORT Act reauthorization package aimed at addressing the opioid epidemic. The package expires Sept. 30 without Congressional action.
    • “Al Guida, a lobbyist speaking on behalf of the Behavioral Health IT Coalition, said the lack of EHR adoption in behavioral health prevents such care from being integrated into primary care. David Bucciferro, chair of the HIMSS Electronic Health Record Association, added that it hurts care coordination.”

From the public health front,

  • In a surprise to the FEHBlog, MedPage Today informs us
    • “Both nirmatrelvir-ritonavir (Paxlovid) and molnupiravir (Lagevrio) were associated with a reduction in death during the COVID-19 Omicron era, a large retrospective study of electronic health records from the Cleveland Clinic showed.
    • “Compared with not receiving any treatment, nonhospitalized COVID patients who received nirmatrelvir-ritonavir saw an 84% reduction in mortality (adjusted hazard ratio 0.16, 95% CI 0.11-0.23) and those who took molnupiravir saw a 77% reduction in death (adjusted HR 0.23, 95% CI 0.16-0.34), according to Danyu Lin, PhD, of the University of North Carolina in Chapel Hill, and colleagues. * * *
    • “We show that these two drugs work very similarly,” Lin told MedPage Today. “The fact that molnupiravir works as well as Paxlovid is an interesting finding, and I would say this finding is not inconsistent with existing literature.”
    • “Indeed, earlier this week, the American College of Physicians (ACP) issued an updated version of its practice guidelines for outpatient management of COVID in the Omicron era and continued to recommend both antivirals equally.” 
    • That’s very good news.
  • Precision Vaccinations discusses the four vaccinations now available to pregnant people in their third trimester.
  • The Institute for Clinical and Economic Research issued “a Draft Evidence Report assessing the comparative clinical effectiveness and value of sotatercept (Merck & Co) for pulmonary arterial hypertension. This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions. * * * On October 5, 2023, as part of ICER’s Early Insights Webinar Series, ICER’s Chief Medical Officer, David Rind, MD will present the initial findings of this draft report.”
  • Per MedPage Today,
    • “The declines in body weight that patients experience with injectables like semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro) are no exception to the concept that nothing lasts forever.
    • “Eventually, everybody reaches a “plateau,” even on newer GLP-1 receptor agonists. It’s a phase at which the body reaches a new “settling point,” specialists said, and weight, along with other metabolic markers like blood pressure and HBA1c stabilize, or fluctuate only slightly. For some, this may mean a gradual increase in appetite or “food noise”; others may be able to maintain their current state.
    • “Studies have shown that, on average, this plateau happens at a little over a year with semaglutide. Even so, physicians say some patients are surprised to learn that there’s a limit to what these medications can do.
    • “Everyone will plateau, of course. No one on my watch has disappeared. No one has vanished,” Jody Dushay, MD, an endocrinologist at Beth Israel Deaconess Medical Center in Boston, told MedPage Today. “It’s alarming to me that people find that surprising, but everyone will reach a plateau and there’s no way to know when you start the medication what that will be, what percent weight loss that will be, and how quickly they will reach it.”

From the U.S. healthcare business front,

  • Beckers Hospital Review tells us,
    • “Rite Aid proposed closing nearly a fourth of its 2,100 pharmacies and declaring bankruptcy, people familiar with the matter told The Wall Street Journal in a Sept. 22 story. 
    • “The outlet recently reported the pharmacy chain is preparing to file for Chapter 11 bankruptcy as it faces $3.3 billion in debt and numerous lawsuits over its alleged role in the opioid epidemic. Chapter 11 bankruptcies are commonly used to reorganize a company’s structure to continue its business while paying creditors over time. 
    • “The bankruptcy discussions include a plan to close between 400 and 500 of its stores while either having creditors take the remaining pharmacies or selling them. Rite Aid is also considering an auction to sell sections of the business, such as its Elixir pharmacy unit.”
  • Cigna announced,
    • “investing $1 million in national and community-based organizations this fall to address food insecurity among older Americans. Collectively, the funds are expected to provide more than 3 million meals to people in need, increase access to 1.88 million pounds of fresh produce, and save 21 million gallons of water and 2.89 tons of CO2e emissions in responsible food distribution, supporting better health and positively impacting the environment.”
    • “Fifty-six innovative programs spanning 12 states received critical financial support enabling them to reach thousands of seniors who face food insecurity. The organizations range from local Meals on Wheels chapters and food banks to senior- and veteran-focused coalitions and centers. The sponsorships will also fund food- and nutrition-based programs, such as food pantries, mobile food deliveries, and nutritional meal boxes.”  

In a random note, the Washington Post shares opinions on current telephone etiquette which the FEHBlog found illuminating.

Weekend update

David Ermer–Congress, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

From Washington DC,

  • The Wall Street Journal reports
    • “Congress heads into a make-or-break week for avoiding a government shutdown, with leaders of the Republican-controlled House hoping they can persuade GOP holdouts to get on board with four full-year bills and a short-term funding patch. 
    • “With a shutdown set for Oct. 1, unless Congress acts, the plan marks a last-ditch effort by Republicans to find a way forward. If no deal is reached, hundreds of thousands of federal workers are set to be furloughed.
    • “When it gets crunch time, people that have been holding off all this time blaming everybody else will finally hopefully move,” House Speaker Kevin McCarthy (R., Calif.) told reporters Saturday.
    • “McCarthy laid out the path forward in a GOP conference call. The House is expected on Tuesday to vote on a rule establishing the parameters for debate on a defense-spending bill, a bill funding the Homeland Security Department, one funding the State Department and another funding agricultural priorities. 
    • “After that, McCarthy is expected to focus on a short-term spending deal ranging from two weeks to two months to keep the government funded while negotiations continue.”
  • The U.S. Supreme Court has posted its October 2023 Term calendar. The opening conference will be held on Tuesday, September 26. The first oral arguments will be held on October 2, 2023.
  • If history can be a guide, OPM will announce the 2024 FEHB premiums this week, along with the government contribution change.

From the public health front,

  • The Wall Street Journal informs us,
    • “The drug colchicine has been used for more than 2,000 years to treat the fiery joint-pain ailment called gout. It also is a remedy for a genetic disorder called familial Mediterranean fever and for pericarditis, an inflammation of the sac around the heart.
    • “Now, colchicine may be set for a surprising new role. In June, the Food and Drug Administration approved a new low-dose version of the drug as the first-ever medicine to treat cardiovascular inflammation, marking a new approach to heart attack prevention. 
    • “Several things could limit the adoption of colchicine by cardiologists, at least at first, including side-effect concerns and the emergence of several other new options for reducing the risk of heart attacks. But the drug’s approval provides fresh validation for a concept that has been gaining momentum in cardiology over the past 25 years—that inflammation is a key culprit in atherosclerosis, the artery-clogging disease, and that treating it can reduce the risk of a heart attack.
    • T”he bedrock strategy for heart-attack prevention has long been lowering LDL cholesterol with drugs called statins. Adding low-dose colchicine—which in one study reduced cardiovascular risk by 31% in patients already treated with statins and other preventive medicines—would enable doctors to simultaneously hit two biological targets that cause heart attacks. 
    • “This is about combining therapies” that are both effective ways to reduce risk, says Dr. Paul Ridker, director of the Center for Cardiovascular Disease Prevention at Harvard-affiliated Brigham and Women’s Hospital, Boston. “They’re not in conflict; they’re synergistic.”
  • NPR Shots considers whether Ozempic causes mental health side effects.
  • The NY Times discusses the synthetic opioid epidemic plaguing many of the Nation’s large cities, like New York. This article focuses on “collateral damage.”
    • “Opioids have become the leading cause of child poisonings in the United States. More than 1,500 children died in fatal overdoses involving fentanyl in 2021, according to one study; over 100 were children under the age of 4.
    • “Officials have not confirmed whether fentanyl was the cause of death for Nicholas Feliz Dominici, the 1-year-old who died in the Bronx on Sept. 15, but three other children from the same day care were hospitalized that day after they were exposed to fentanyl. Days after the child died, the police discovered a trap door under a play area concealing large, clear storage bags filled with narcotics. The daycare’s operator and a man who lived in the apartment that housed the daycare have been arrested and charged with murder and criminal drug possession.
    • “The rising death toll comes as the city and the state have turned away from the aggressive law enforcement of low-level street drug activity that was common in the late 1990s. The shift has happened gradually over time, as a broader movement has pushed to reframe drug use as a public health crisis rather than as primarily a criminal issue.”

 In Medicare news, Fortune Well tells us about 2024 Medicare changes and other relevant matters as we approach the Medicare open enrollment period, which begins on October 15, 2023.

In business news,

  • HR Dive points out, “Employers have 44 days on average to “make or break” a new hire, and first impressions make a lasting impression, according to a Sept. 20 report from BambooHR, a cloud-based human resources platform.”
    • “Creating a “buddy system” to pair new hires with experienced employees can make the onboarding experience stronger, according to a McLean & Co. report. The tenured employee can personalize the onboarding experience, serve as a contact person and provide advice about team processes or organizational culture.”

Midweek update

David Ermer–CDC, Congress, COVID-19 testing, FDA, Generative AI, Medical / Rx research, NIH, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • Roll Call informs us
    • House Republicans appeared to be moving closer to an agreement Wednesday on an opening bid for stopgap funding legislation that would keep the lights on at federal agencies beyond Sept. 30 and pave the way for their chamber to take up its full-year appropriations bills.
    • At least a handful of conservative holdouts still maintained their opposition as of Wednesday night, which would be enough to sink a revised bill unless GOP leaders are able to change some minds in the next few days. Speaker Kevin McCarthy, R-Calif., is expected to keep the chamber in session on Saturday if necessary.
    • Even if GOP leaders’ new effort is successful, however, it was starting to look more like a bid to reopen the government after a brief shutdown, given the deadline is 10 days away and the Senate is likely to ping-pong a much different bill back to the House.
  • The FEHBlog notes that it would not be unusual for Congress to pass a brief continuing resolution next week to allow for the passage of a longer continuing resolution, thereby side stepping the partial government shutdown.
  • Fierce Healthcare offers details on the House Ways and Means Committee’s No Surprises Act hearing, while Healthcare Dive shares details on the House Oversight and Accountability’s PBM reform hearing. Both hearings were held yesterday.
  • Speaking of the No Surprises Act, the ACA regulators released a proposed rule increasing the government’s NSA arbitration fee from $50 per party to $150 per party next year. The FEHBlog has no idea why the government doesn’t ladder the fee based on the amount in dispute. The government also increased the maximum fee independent dispute resolution entities can charge the parties.
  • MedCity News informs us
    • “FDA Approves GSK Myelofibrosis Med That Has Edge Over Others in Drug Class 
    • “FDA approval of GSK’s Ojjaara in myelofibrosis introduces a new competitor to blockbuster Incyte drug Jakafi. Ojjaara was part of GSK’s $1.9 billion acquisition of Sierra Oncology last year.”
  • and
    • “FDA Rejects ARS Pharma’s Nasal Spray Alternative to Injectable Epinephrine 
    • “ARS Pharmaceuticals frames its intranasal epinephrine spray as a needle-free alternative to products such as EpiPen. Though this spray won the backing of an FDA advisory committee, the agency is now requiring that ARS Pharma run another study to support a regulatory submission.”

From the public health and medical research fronts,

  • STAT News reports,
    • “The federal government is again offering free Covid-19 tests to Americans, providing a fifth round of free tests in part to meet current needs and in part to stimulate a domestic testing industry that has struggled with cratering demand for rapid diagnostics.
    • “The measure, announced Wednesday, will see rapid tests released from the Strategic National Stockpile. In addition, 12 domestic test manufacturers will receive investments totaling $600 million to help “warm-base” the U.S. capacity for rapid test production, both for Covid and future disease threats. * * *
    • “Households will be entitled to receive four free rapid tests apiece, with ordering at COVIDtests.gov opening on Sept. 25. O’Connell said test shipments are expected to start on Oct. 2.”
  • The FEHBlog thinks that the government is fighting the last pandemic. Why not incent the production of the FDA-approved (last February) at-home tests for Covid or the flu, not just Covid?
  • In any event, the Wall Street Journal points out
    • “Don’t throw out that seemingly outdated at-home rapid Covid-19 test just yet. It may still be good. 
    • “The Food and Drug Administration has been extending expiration dates for some authorized at-home, over-the-counter Covid test kits, meaning some unused tests may still be viable. The agency’s updated list of expiration dates may be useful to those reaching for their stash of Covid-19 tests amid new variants and a recent bump in cases and hospitalizations.”
  • The National Institutes of Health announced,
    • “A trial of a preventive HIV vaccine candidate has begun enrollment in the United States and South Africa. The Phase 1 trial will evaluate a novel vaccine known as VIR-1388 for its safety and ability to induce an HIV-specific immune response in people. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has provided scientific and financial support throughout the lifecycle of this HIV vaccine concept and is contributing funding for this study.”
  • Per NBC News,
    • “Is morning the best time of day to exercise? Research published Tuesday in the journal Obesity finds that early morning activity — between 7 a.m. and 9 a.m. — could help with weight loss. 
    • “My cautious suggestion from this study is that if we choose to exercise in the early morning before we eat, we can potentially lose more weight compared to exercise at other times of the day,” said lead researcher Tongyu Ma, a research assistant professor at The Hong Kong Polytechnic University.”

From the U.S. healthcare business front,

  • Healthcare Dive tells us
    • “Ochsner Health is launching a pilot program this month that will use generative artificial intelligence to draft “simple” messages to patients.
    • “About a hundred clinicians across the New Orleans-based health system will participate in the first phase of the program, where AI will prepare responses to patient questions unrelated to diagnoses or clinical judgments. The messages will be reviewed and edited by providers before being sent to patients, according to a news release. 
    • “Ochsner is part of an early adopter group of Microsoft’s Azure OpenAI Service, which integrates with the Epic electronic health record. The health system will test the messaging feature over three phases this fall, and Ochsner will collect patient feedback to improve the system.” 
  • Per Fierce Healthcare,
    • “Making sense of mountains of data continues to be an often elusive goal for most of the healthcare system, but Cambia Health Solutions said it hopes its latest effort will allow it to better corral useable information.
    • “Cambia and Abacus Insights, a data management company that tacklesthe challenge of making healthcare networks interoperable, launched a new data aggregating system that processes information for about 3.4 million members across four Blues plans. 
    • “According to an Abacus case study (PDF), “Cambia recognized that to deliver care orchestrated around the unique needs of each individual, data must be actionable. To be actionable, case study data must be understandable, usable, timely, and have clinical utility.”

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Wall Street Journal reports
    • “House Republican leaders worked to salvage a short-term spending bill that sparked angry disagreements among the party’s rank-and-file, but they remained short of the support needed to pass the measure and show the party could unite to avert a government shutdown. * * *
    • “The effort to pass a short-term deal comes as Congress is working to pass the 12 annual appropriation bills that fund the government. Leaders of both parties in the House and Senate have thrown their support behind reaching a short-term deal that would give both chambers more time to negotiate a full-year spending agreement.
    • “Both McCarthy and Senate Minority Leader Mitch McConnell (R., Ky.) have warned of the political fallout for the GOP from a shutdown.
    • “I’ve seen a few of them over the years, they never have produced a policy change, and they’ve always been a loser for Republicans politically,” said McConnell to reporters.”
  • Govexec offers federal employees a “guide to pay and benefits during a shutdown.”
  • The House Ways and Means Committee held a No Surprises Act hearing today. Here are a link to the Chairman’s opening statement and a link to the AHIP witness statements.
  • Federal News Network tells us,
    • “Enrollees in the Federal Long-Term Care Insurance Program (FLTCIP) are bracing for another big premium increase starting in 2024.
    • “The Office of Personnel Management, which runs the federal insurance program, announced plans to hike up premium rates for current enrollees. The changes will take effect on Jan. 1.
    • “Unlike the averages offered in past years, OPM declined to share an average percentage increase for FLTCIP premiums. An agency spokesperson said the percentage increases for enrollees were too variable for an average to accurately depict how much the rates are rising.
    • “But anecdotal experiences from program participants who spoke with Federal News Network and who shared their premium notification letters with the National Active and Retired Federal Employees Association (NARFE) show the increases are as large as 86%, if the enrollees choose to stick with their same coverage options. In a few other instances, enrollees received notice from OPM that their premiums will go up 77% and 49%, according to NARFE.”
  • The U.S. Preventive Services Task Force issued a revised Grade B recommendation today. “The USPSTF recommends screening for hypertensive disorders in [asymptomatic] pregnant persons with blood pressure measurements throughout pregnancy.”
  • The Wall Street Journal adds,
    • “The recommendation made Tuesday by the U.S. Preventive Services Task Force broadens 2017 guidance to screen regularly only for preeclampsia, a dangerous and increasingly common condition that can arise in pregnancy. It involves high blood pressure along with kidney or liver trouble and other problems and is believed to occur when the placenta develops abnormally because of a problem with the blood vessels that supply it.  
    • “The recommendation applies to other disorders marked by high blood pressure that, like preeclampsia, normally develop in the second half of pregnancy. They include gestational hypertension—high blood pressure without the other signs of preeclampsia—and eclampsia, which involves seizures and is life-threatening.” 
  • Per Healthcare Dive
    • “Eighty-one percent of nursing home facilities nationwide and 90% of for-profit facilities would need to hire additional registered nurses or nurse aides to meet the minimum nursing staff hours standards proposed by the CMS earlier this month, according to a KFF estimate published Monday.”

From the public health front,

  • NBC News reports,
    • “Doctors say they’re finding it increasingly difficult to distinguish Covid from allergies or the common cold, even as hospitalizations tick up.
    • “The illness’ past hallmarks, such as a dry cough or the loss of sense of taste or smell, have become less common. Instead, doctors are observing milder disease, mostly concentrated in the upper respiratory tract. 
    • “It isn’t the same typical symptoms that we were seeing before. It’s a lot of congestion, sometimes sneezing, usually a mild sore throat,” said Dr. Erick Eiting, vice chair of operations for emergency medicine at Mount Sinai Downtown in New York City.”
  • The Wall Street Journal offers “A Game Plan for Timing Your Flu, Covid, and RSV Shots This Fall.”
  • The Washington Post informs us,
    • “Doing puzzles, playing memory-boosting games, taking classes, and reading are activities that we often turn to for help keeping our brains sharp. However, research is showing that what you eat, how often you exercise, and the type of exercise you do can help lower your risk of dementia to a greater extent than previously thought.
    • “Although more studies are needed, “there’s a lot of data that suggests exercise and diet are good for the brain and can prevent or help slow down” cognitive changes, says Jeffrey Burns, co-director of the University of Kansas Alzheimer’s Disease Research Center in Fairway.
    • “And living a healthy lifestyle can produce brain benefits regardless of age.”

From the healthcare business front,

  • Fierce Health identifies the most influential minority executives in healthcare for 2023. Maazal tov to those execs.
  • Beckers Payer Issues points out,
    • “Elevance Health’s pharmacy benefit manager, CarelonRx, is launching a new integrated cost savings program to automatically offer members the lowest price for generic prescription drugs at their preferred pharmacy.
    • “We will automatically compare prices to emulate a comparative shopping experience, similar to when a member would use a discount card,” Michele Paige, vice president of product at CarelonRx, told Becker’s. “But now they don’t have to because it’s integrated within their benefits.” 
    • “The new program, EnsureRx, is set to launch in February and will automatically compare prices for more than 50 generic medications against a variety of cash discount cards, with savings automatically applied. Ms. Paige shared that the list of generic medications covered will be constantly evaluated for potential additions.” 
  • and
    • “Cigna Healthcare offers employers a supplemental benefit designed to help employees diagnosed with musculoskeletal conditions. 
    • “The payer is adding musculoskeletal conditions to its Supplemental Health Critical Illness plans, according to a Sept. 18 news release. The program provides an annual payment of $3,000 to employees to help them cover out-of-pocket hospital costs or other expenses such as rent, childcare and groceries. 
    • “Cigna offers similar benefits for cancer, heart attack and stroke.” 

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–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.”