Tuesday Tidbits

Medical / Rx research

Tuesday Tidbits

David Ermer–AHRQ, Congress, Medical / Rx research, Patient safety, SDOH–
Photo by Patrick Fore on Unsplash

From Washington, DC,

Roll Call tells us,

“President Joe Biden and Speaker Kevin McCarthy on Tuesday tapped proxies to negotiate directly over how to increase the debt limit with time running short before the government runs too low on funds.”

and

“Lawmakers are beginning to think about changing their plans and staying in Washington in the coming weeks as a standoff over increasing the debt limit bears down. Members of both parties’ leadership said on Tuesday that plans for the Senate to recess next week and the House to leave town the following week could shift.”

BenefitsLink pointed out that the Internal Revenue Service released a revenue procedure identifying inflation-adjusted high deductible health plan and health savings account amounts for use in 2024 just in time for FEHB high deductible health plan benefit proposals due May 31.

STAT News reports

“In an unexpected move, the Federal Trade Commission on Tuesday filed a lawsuit to block Amgen from acquiring Horizon Therapeutics, claiming the $27.8 billion deal would make it possible for Amgen to develop monopolies through a tactic that manipulates health coverage and drives up consumer costs.

“At issue is a practice known as bundling. Simply put, a drug company combines two or more medicines in a package deal for health plans and pharmacy benefit managers, which determine lists of medicines that are covered by insurance. The practice has previously sparked concerns that a drug company will unfairly offer higher rebates for bundles in order to win favorable placement.”

From the medical and drug research fronts —

  • The National Institute of Health informs us,
    • “A study from the National Institutes of Health shows that new cases of chronic pain occur more often among U.S. adults than new cases of several other common conditions, including diabetes, depression, and high blood pressure. Among people who have chronic pain, almost two-thirds still suffer from it a year later. These findings come from a new analysis of National Health Interview Survey (NHIS) data by investigators from the National Center for Complementary and Integrative Health (NCCIH) at the NIH, Seattle Children’s Research Institute, and University of Washington, Seattle, and are published in JAMA Network Open.”
  • The New York Times reports
    • “The man should have gotten Alzheimer’s disease in his early 40s — he had a gene mutation that guaranteed it, or so it seemed. Scans of his brain even revealed severe atrophying and the hallmarks of the disease: rough, hard, amyloid plaques and spaghetti-like tangles of tau proteins. But the fatal brain disease did not appear until the man was 67.
    • “Now an intense research effort has discovered why. The man was protected because another mutation in a different gene blocked the disease from entering his entorhinal cortex. That tiny area of the brain is a hub for neurons involved in memory, recognition of objects, navigation and time perception. And it is there that scientists believe that Alzheimer’s disease begins.
    • “A paper on the finding was published Monday in the journal Nature Medicine.
    • “More than six million people in the United States have Alzheimer’s, a disease that has been notoriously difficult to treat. Yet here was a man with a mutation that causes the most severe and rapidly progressing form of Alzheimer’s. And his disease was delayed for two decades. If a drug could do what the mutation did, resulting in most people getting Alzheimer’s very late in life, the outcome could be transformative.”

From the SDOH front,

  • the National Institutes of Health shared
    • “New research shows that the economic burden of health disparities in the United States remains unacceptably high. The study, funded by the National Institute on Minority Health and Health Disparities (NIMHD), part of the National Institutes of Health,  revealed that in 2018, racial and ethnic health disparities cost the U.S. economy $451 billion, a 41% increase from the previous estimate of $320 billion in 2014. The study also finds that the total burden of education-related health disparities for persons with less than a college degree in 2018 reached $978 billion, about two times greater than the annual growth rate of the U.S. economy in 2018.”

From the AI department,

  • Beckers Payer Issues informs us
    • Payers are putting artificial intelligence to work. 
    • Google recently launched a new AI-powered cloud program for prior authorization and claims processing. Elevance Health is piloting AI-powered concierge care for members. 
    • Becker’s asked 18 payer executives how AI will transform the insurance industry. [The interview squibs are available in the article.]

From the patient front, here is a link to HHS’s Agency for Healthcare Quality and Research March 2023 Chartbook on Patient Safety.

Thursday Miscellany

David Ermer–Congress, COVID-19, End of the PHE, NE, FDA, Medical / Rx research, Rx coverage–

From Washington DC —

Photo by Josh Mills on Unsplash
  • The Secretary of Health and Human Services issued a statement on the end of the Covid health emergency which occurred today.
    • Govexec and the Society for Human Resource Management respectively discuss the impact of this event on federal agencies and employers generally.
      • SHRM notes, “President Biden in April ended the pandemic national emergency weeks earlier than expected—but the premature ending won’t shift the deadlines spelled out in the administration’s guidance from March, including the extended deadline for special enrollment in health plans. * * * July 10 will also mark the end of some COBRA-related relief, under which employees were allowed extra time to pay their COBRA premiums or to decide whether they wanted to use the coverage.”
  • The Wall Street Journal reports
    • “A highly anticipated meeting scheduled for Friday between President Biden and congressional leaders to chart a path forward on lifting the debt ceiling was postponed until next week, officials said.
    • “The delay will give White House and congressional staff more time to make progress in their closed-door spending talks, the officials said, adding that one of the lawmakers was unable to attend the meeting Friday because of a scheduling conflict.
  • STAT News informs us
    • “The Senate health committee on Thursday passed a package of bills aimed at speeding generic drug competition and reining in drug middlemen business practices. But they failed to pass an ambitious reform to the pharmacy benefit manager sector, despite strong bipartisan support for it.
    • “Chairman Bernie Sanders (I-Vt.) is pursuing the drug pricing reforms at the behest of Senate Majority Leader Chuck Schumer (D-N.Y.), who wants to hold a floor vote on an even bigger package of health bills later this year. The markup came just a day after the same panel held a major hearing on PBM and drugmakers’ role in high insulin prices.
    • “It’s not clear when the Senate would take up that package, and while the package is bipartisan, it’s not clear whether it has enough support among House Republicans to pass in that chamber. There are a few, tamer PBM bills that the House Energy and Commerce Committee is expected to mark up on May 17, but there is no indication that Senate and House lawmakers are coordinating on PBM legislation.
    • “The committee passed 18 to 3 a bill that would ban PBMs from using so-called spread pricing. It would also require that the middlemen disclose rebates, fees, and other payments they receive and to pass them on to the insurers for whom they negotiate those concessions. * * * The committee included an amendment from Sen. Tina Smith (D-Minn.), that would let patients appeal insurer decisions to make them try cheaper drugs before getting more expensive drugs.”

From the public health front, Healio tells us that “Overweight and obese BMI during adulthood appeared associated with increased risk for colorectal cancer and non colorectal gastrointestinal cancers, according to study results published in JAMA Network Open.” The FEHBlog does not think that the new generation of obesity-reduction drugs needs publicity, but there you go.

From the Rx coverage and more front, the FDA announced

  • “the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication.”
    • Medpage Today adds, “Brexpiprazole’s labelopens in a new tab or window will continue to carry a boxed warning about the risk of increased mortality in elderly patients with dementia-related psychosis treated with antipsychotic drugs. The warning further stipulates that the drug is not approved for patients with dementia-related psychosis who are not experiencing agitation associated with Alzheimer’s dementia.”
  • and “finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV. These questions will be the same for every donor, regardless of sexual orientation, sex or gender. Blood establishments may now implement these recommendations by revising their donor history questionnaires and procedures.”
  • Beckers Hospital Review points out “The Biden administration has been taking action to address the prescription drug supply shortage, which has caused upheaval both for patients and providers, according to a May 10 Bloomberg report.”

From the medical research front —

  • STAT News reports
    • “Home to billions of cells that form trillions of connections, the human brain isn’t just the body’s most important organ; it’s also the hardest to study. But an international team of scientists using cutting-edge stem cell technology has devised a new way to better understand the brain’s cellular cleanup crew — and its connection to neurological disease.
    • “Researchers coaxed stem cells to grow into microglia, immune cells that roam the brain searching for signs of damage and that monitor and maintain neuronal connections. They then added microglia to brain organoids, tiny 3D structures of neurons that mimic some aspects of brain function, and transplanted these microglia-containing “mini-brains” into mice. Doing so caused microglia to look and behave much more like they would in a human brain compared to previous lab experiments conducted in a dish.
    • “The authors also found early hints that they could use these transplanted organoids to study disease, including the role that microglia might play in autism. Microglia in brain organoids derived from people with autism had larger cell bodies than cells from controls and had an overabundance of small cellular extensions associated with an active, inflammatory state researchers believe may contribute to the disorder.”
    • “The findings, published on Thursday in the journal Cell, are the result of a collaboration between scientists from San Diego to Germany to Israel. The study raises the possibility of using transplanted organoids to understand the complex crosstalk between neurons and immune cells across a range of diseases, and to perhaps one day use this system to test potential treatments.”
  • The Washington Post adds
    • “A skin patch being developed by a French pharmaceutical company to treat peanut allergy is showing promise in toddlers, according to a peer-reviewed study published Wednesday.
    • “The “peanut patch” outperformed a placebo in “desensitizing children to peanuts and increasing the peanut dose that triggered allergic symptoms,” said the study, which was funded by the company DBV Technologies and published in the New England Journal of Medicine.”

Midweek Update

David Ermer–Congress, Medical / Rx research, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC, the Wall Street Journal reports

  • “The Biden administration and Capitol Hill leaders are scrambling to avoid a first-ever government default that could arrive as soon as June 1, taking potential alternative strategies more seriously after months of deadlock over raising the country’s borrowing limit.  
  • “Publicly, both Republicans and Democrats are still sticking to their demands as the clock ticks. GOP lawmakers are seeking to force cuts to federal spending in exchange for supporting raising the debt limit, while Democrats continue to call for a debt-limit increase without any other policy conditions.
  • “Privately, though, Biden administration officials and lawmakers have started to weigh potential alternatives to their negotiating position, including a short-term increase in the borrowing limit that would buy them time to find a compromise, according to people familiar with the matter. Biden administration officials are also taking a fresh look at experimental ways the U.S. could potentially keep paying the government’s bills even if Congress doesn’t raise the debt limit, the people said.” 

From the Rx coverage front —

MedPage Today informs us,

  • “The FDA has approved the first-ever vaccine for respiratory syncytial virus (RSV), the agency announced on Wednesday.
  • “Marketed under the trade name of Arexvy, the adjuvanted RSV prefusion F protein-based vaccine is specifically indicated for preventing lower respiratory tract infections in adults 60 and over.
  • “Until now, no vaccine has existed to protect against RSV infection, a common scourge both for young children and older adults.  * * *
  • “GSK said the vaccine would be available ahead of the 2023/2024 RSV season, and that the CDC’s Advisory Committee on Immunization Practices will weigh in on the RSV vaccine’s appropriate use in June.”

Beckers Pay Issues points out,

  • “Payers are anticipating the cost of expensive new gene therapy drugs to be a significant issue in the coming years, according to a survey from the Pharmaceutical Strategy Group. 
  • “The survey, published May 1, asked 182 benefits leaders at employers and health plans about their organization’s specialty drug benefit design. 
  • “Read the full report here. “

From the drug research front, the Wall Street Journal reports

  • “An experimental Eli Lilly drug slowed cognitive and functional decline for people with early-stage Alzheimer’s disease in a new study that signals drugmakers are turning a corner in long-running efforts to find meaningful treatments for the memory-robbing disease.
  • “Based on the new data, Lilly said Wednesday it plans to apply this quarter to the U.S. Food and Drug Administration for approval to market the drug, setting up a potential agency decision later in 2023 or in 2024. * * *
  • “Researchers designed Lilly’s drug donanemab and Leqembi, from Eisai and Biogen, to work by targeting and reducing amyloid, a substance that forms plaque in the brain and is a prime suspect in fueling the worsening of Alzheimer’s. * * *
  • “In the study of more than 1,730 patients, the [intravenously administered] drug slowed patients’ decline by 35% compared with people who received a placebo over 18 months of treatment, Lilly said. Researchers gave the drug to elderly people who testing indicated were in the early stages of Alzheimer’s. * * *
  • “The findings could bolster donanemab’s appeal to some doctors and patients when compared with Eisai and Biogen’s Leqembi, according to analysts.
  • “Leqembi slowed Alzheimer’s patients’ decline by 27% versus a placebo over 18 months in a separate study, though there were differences in the studies that make direct comparisons difficult.
  • “Yet Leqembi’s safety profile might give it an advantage over donanemab with other doctors and patients, analysts said.”

From the U.S. healthcare business front, Healthcare Dive informs us that “CVS [Health] lowers 2023 earnings outlook on Oak Street, Signify deal costs.”

  • “Despite lowering 2023 earnings guidance by 20 cents to a range of $8.50 to $8.70 per share, “we remain committed to achieving the $9 and $10 targets for 2024 and 2025,” CFO Shawn Guertin said on a Wednesday earnings call.”

From the patient safety front, the Leapfrog Group released

  • “the spring 2023 Leapfrog Hospital Safety Grade. An analysis found the average risk of three healthcare-associated infections (HAIs)— including Methicillin-resistant Staphylococcus aureus (MRSA), central line-associated bloodstream infections (CLABSI) and catheter-associated urinary tract infections (CAUTI)—spiked to a 5-year high in hospitals during the COVID-19 pandemic.” 
  • “Additional highlights from the spring 2023 Safety Grades include:
  • “Twenty-nine percent of hospitals received an “A,” 26% received a “B,” 39% received a “C,” 6% received a “D,” and less than 1% received an “F.”
  • “The top ten states with the highest percentages of “A” hospitals are: New Jersey, Idaho, Utah, Pennsylvania, Connecticut, North Carolina, South Carolina, Colorado, Virginia and Massachusetts.
  • “There were no “A” hospitals in Delaware, the District of Columbia or North Dakota.

Monday Roundup

David Ermer–CMS, Congress, End of the PHE, NE, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC, The Wall Street Journal reports

  • “Treasury Secretary Janet Yellen said the U.S. government could become unable to pay all of its bills on time as soon as June 1 if Congress doesn’t first raise the debt limit.
  • “President Biden on Monday invited the top Republicans and Democrats on Capitol Hill to meet next week to discuss raising the country’s roughly $31.4 trillion borrowing limit, the White House said soon after Ms. Yellen’s warning. 
  • “The new estimate released Monday sets a shorter timeline than forecasters had previously expected, putting the U.S. potentially just weeks away from the first default on the U.S. debt. Republicans and Democrats have been debating how to raise the debt ceiling for months, but they have so far made little progress toward reaching an agreement.  * * *
  • “Ms. Yellen said the Treasury’s latest projection was still uncertain. The Treasury could ultimately be able to pay the nation’s bills for several weeks beyond early June, she said. The Treasury tends to be conservative when communicating projected deadlines for possible default.
  • “It is impossible to predict with certainty the exact date when Treasury will be unable to pay the government’s bills,” Ms. Yellen wrote in a letter to House Speaker Kevin McCarthy (R., Calif.).” 

In public health emergency (PHE) news,

  • Govexec informs us “The White House announced on Monday it’s officially ending the COVID-19 vaccine mandates for federal employees and contractors when the public health emergency ends on May 11.”
  • The Centers for Disease Control issued public fact sheets on post-PHE coverage for over-the-counter Covid tests. OPM’s end of PHE guidance requires carriers to continue coverage of these items but allows cost sharing.

From the public health front —

  • The National Institutes of Health announced
    • “Researchers have found the “Eat, Sleep, Console” (ESC) care approach to be more effective than using the Finnegan Neonatal Abstinence Scoring Tool (FNAST) to assess and manage opioid-exposed newborns, according to a national, randomized controlled clinical trial funded by the National Institutes of Health. Newborns cared for with ESC were medically ready for discharge approximately 6.7 days earlier and 63% less likely to receive medication as part of their treatment, compared to newborns cared for with FNAST. ESC prioritizes non-pharmacologic approaches to care, such as a low-stimulation environment, swaddling, skin-to-skin contact and breastfeeding. ESC also encourages parental involvement in the care and assessment of their infants. These findings are based on the hospital outcomes of a large and geographically diverse group of opioid-exposed infants. A two-year follow-up study of a subset of infants is ongoing. The current findings are published in the New England Journal of Medicine.
    • “Medical care for newborns who were exposed to opioids during pregnancy varies widely across hospitals,” said Diana W. Bianchi, M.D., director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which co-led the study with the NIH Environmental Influences on Child Health Outcomes (ECHO) Program. “These findings are an important step toward standard, evidence-based guidance for the care of these infants.”
  • The McKinsey Health Institute evaluates the impact of tech and social media on Gen Z mental health.
    • “Much like many relationships a person might have between ages 18 and 24, the relationship a young person has with social media can be complicated. No matter where they live, respondents in a new global survey said social media usage can lead to a fear of missing out (FOMO) or poor body image, but it also can help with social connections and self-expression.”

From the Rx coverage front, STAT News tells us,

  • “It’s hard to imagine now, but there was a time when obesity was a desert for drug development. Now that drugs originally conceived to control diabetes appear to be such sweeping successes in weight loss, competitors may soon crowd the field. Some candidates may move beyond the current class of GLP-1-based drugs, which mimic the hormone that helps regulate insulin and hunger. 
  • “STAT’s Elaine Chen and Allison DeAngelis explore novel approaches still in development, including some that don’t induce muscle loss, unlike the GLP-1 drugs, and some that mirror the effect of bariatric surgery. Still, among roughly 80 obesity treatments in development, more than half are GLP-1-based, according to tallies by STAT and analysts at TD Cowen. And combination treatments may be the future. Read more.“

From the U.S. healthcare business front,

  • Beckers Hospital Review points out that “Nursing shortages are easing for some hospitals after falling pay from temp agencies and new hospital perks drive more nurses back into permanent positions, The Wall Street Journal reported May 1.”
  • Beckers Payer Issues relates “Molina Healthcare reported double-digit growth in net income since the same period last year and raised its year-end earnings guidance, according to the company’s first-quarter earnings posted April 26.”
  • According to BioPharma Dive
    • “Japanese drugmaker Astellas Pharma on Sunday agreed to acquire Iveric Bio for about $5.9 billion, betting that a medicine the biotechnology company has developed for a common type of vision loss can help it build an eye drug business. * * *
    • “The deal hands Astellas a drug called Zimura that Iveric is studying as a treatment for a form of vision loss known as geographic atrophy. Iveric’s drug already succeeded in a pair of Phase 3 trials and is currently being reviewed by U.S. regulators. A decision is expected by Aug. 19.
    • “Pharmaceutical companies have increasingly turned to dealmaking to help offset patent losses that are soon expected for many of the industry’s top-selling drugs. Over the last two months, drugmakers have spent roughly $65 billion in total on buyouts, led by Pfizer’s $43 billion acquisition of cancer biotech Seagen, according to BioPharma Dive data.”

Midweek Update

David Ermer–CMS, Congress, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From Capitol Hill, Roll Call reports, “House Republicans narrowly passed legislation Wednesday pairing nearly $4.8 trillion in deficit reduction measures with a debt limit increase into next year — a move they argue should force Democrats to finally negotiate conditions for raising the nation’s borrowing limit.” Time will tell.

Politico explains why and how prescription benefit managers are playing defense on Capitol Hill.

From the U.S. healthcare business front, Healthcare Dive informs us

  • “Kaiser Permanente is acquiring Geisinger Health and forming a new nonprofit to buy and operate other value-oriented nonprofit systems, the organizations announced Wednesday.
  • “The new nonprofit, Risant Health, will operate separately from Kaiser Permanente. Geisinger will become part of Risant but maintain its own name and mission, according to a press release.
  • “Geisinger president and CEO Jaewon Ryu will be CEO of Risant as the transaction closes, subject to regulatory review. Risant will have its headquarters in Washington, D.C.

Both Kaiser and Geisinger are FEHB plan carriers. Kaiser is the third largest carrier in the FEHB Program. Healthcare Dive adds

  • “Kaiser, which reported $95 billion in revenue in 2022, plans to spend $5 billion on Risant over the next five years and add five or six health systems to Risant over that period, according to reports.
  • “Kaufman Hall said recently it expects a “new wave of transaction activity” and a growing number of cross-regional partnerships.
  • “Pennsylvania-based Geisinger has ten hospital campuses and a health plan that covers more than 500,000 members. It has more than 25,000 employees. Both Geisinger and Kaiser reported operating losses last year, as supply and labor expenses rose.

Beckers Payer Issues tells us,

  • “Humana posted a 33 percent increase in profits year over year and added more than 500,000 Medicare Advantage members in the past year, according to its first-quarter earnings posted April 26. 
  • “We’ve had a strong start to the year, with our outperformance underpinned by strong membership growth and favorable inpatient utilization trends in our individual Medicare Advantage business,” CEO Bruce Broussard said. 
  • “The company posted $1.3 billion in net income in the first quarter of 2023, up from $930 million in the first quarter of 2022.”

From the public health front,

  • The National Cancer Institute released a bevy of research articles.
  • The FEHBlog ran across this helpful Johns Hopkins article about U.S infertility statistics,
    • “For the new study, Snow and Trent analyzed data on 53,764 women who participated in the federally supported National Survey of Family Growth (NSFG). While the survey did not ask explicitly about infertility, it contained questions about sexual activity, contraception and pregnancy that were not used in previous studies to estimate infertility rates. It also collected information about sociodemographic and healthcare factors.
    • “Based on the responses, the researchers concluded that the rate of infertility varied slightly from year to year, with a low from 2006 to 2010 of 5.8% and a high between 2017 to 2019 of 8.1%. However, these fluctuations are not considered statistically significant, and the team concluded that overall fertility rates did not significantly change during the study period.
    • “In particular populations, however, infertility rates were significantly higher than average compared with the general population. Women aged 40 to 44 were about 11 times more likely to be infertile than younger women, women who did not complete high school were twice as likely to be infertile as those with higher levels of education, non-Hispanic Black women were 44% more likely to be infertile than women of other races and women who had not recently received sexual health care were 61% more likely to be infertile. Unlike previous studies, the new data did not show a higher rate of infertility for Hispanic women.
  • MedPage Today offers an interview with Dr. Atul Gawande about the importance of palliative care.
  • Medscape identifies emerging cardiovascular disease risk factors.

From the Rx coverage front

Biopharma Dive reports

  • “The Food and Drug Administration has conditionally approved a new ALS medicine in a decision likely to influence how other experimental treatments for the nerve-destroying disease are tested and reviewed.
  • “The medicine, known until now as tofersen, is only for ALS patients who have a specific genetic mutation. Estimates cited by the FDA hold that this group accounts for less than 500 of the roughly 30,000 people in the U.S. with the disease.
  • “Until Tuesday, the few therapies that had secured FDA approval did so because they were shown to help patients live a bit better or a bit longer. Tofersen, which will be sold as Qalsody, is different. It failed the key clinical trial meant to demonstrate it can slow the functional decline associated with ALS, or amyotrophic lateral sclerosis.
  • “Rather, tofersen’s approval hinged on its ability to lower levels of “neurofilament light chain,” a protein that’s drawn increasing interest from ALS researchers. It’s the first ALS drug approved based on so-called “biomarker” data, setting a precedent that could provide another, perhaps faster path to market for some developers.

Biopharma Dive adds

  • “Roche’s new eye drug Vabysmo brought in nearly $500 million during the first quarter, the company said Wednesday. The more than 500% year-over-year sales increase outpaced all other of Roche’s medicines, surpassing top-sellers like the multiple sclerosis treatment Ocrevus and hemophilia therapy Hemlibra.
  • “Vabysmo’s market launch for age-related vision loss comes as one of the first treatments for the condition, Roche’s own Lucentis, faces copycat rivals, and another, Regeneron’s Eylea, could soon.
  • “The strong growth from Vabysmo helped propel a 9% increase in pharmaceutical division sales, which contrasted with a 3% decline in first quarter revenue for the overall business due to lower COVID-19 test sales.”

From the miscellany front —

  • Per the American Hospital Association, “The Centers for Medicare & Medicaid Services today announced changes to its enforcement process for the hospital price transparency rule. CMS said it will now automatically impose a civil monetary penalty if hospitals fail to submit a corrective action plan on time or fail to complete the CAP within 45 days. In addition, the agency will no longer issue a warning notice to hospitals that have not posted any machine-readable file or shoppable services list/price estimator tool, but will immediately ask the hospital to submit a CAP.”
  • The Office of Personnel Management announced
    • its OPM Data Strategy Fiscal Years 2023-2026, which lays out a vision to fully leverage OPM and agency human capital data, and to provide federal agencies, federal employees, and public users seamless access to OPM data products and services. In addition to the overarching strategy, OPM released a set of initial data dashboards to the updated OPM Data Portal at www.opm.gov/data, including FedScope datasets which can now be accessed at www.opm.gov/data/datasets. The OPM Data Portal is a redesigned OPM webpage providing increased access to OPM data products and services.
  • HIMSS posted a wrap-up page from last week’s conference.

Thursday Miscellany

David Ermer–Congress, Medical / Rx research, OPM, Rx coverage, Telehealth, U.S. Healthcare–

Today was the belated second day of the OPM AHIP FEHB carrier conference. We learned this afternoon:

  • OPM has requested contractor proposals for its Postal Service Health Benefits Program (PSHBP) enrollment system.
  • OPM has created a new Carrier Connect system to receive PSHBP applications and benefit and rate proposals from carriers.
  • The new system will be available to receive PSHBP applications beginning June 26, 2023, and ending August 31, 2023, for the inaugural PSHBP year 2025.
  • OPM will release decisions on those applications in November 2023.
  • All cross-over enrollments to the PSHBP will become effective on January 1, 2025.

OPM also discussed its well-received initiative to allow FEHB carriers to offer integrated Medicare Part D prescription drug plans for 2024. These Part D EGWPs will be features of all PSHB plans beginning in 2025.

From Capitol Hill, Politico reports

  • “President Joe Biden immediately rejected Kevin McCarthy‘s opening debt-limit proposal, but it prompted movement elsewhere: A growing number of House Democrats want party leaders to restart negotiations.
  • “The party is still firmly behind Biden and Senate Majority Leader Chuck Schumer, who declared the speaker’s pitch dead on arrival in the upper chamber, in the position that Congress should raise the debt ceiling without any conditions. But a growing contingent of Democrats are acknowledging that Biden’s blanket refusal to engage with McCarthy may need to change — especially if House Republicans manage to pass their bill as planned next week.”

A Senate Finance Committee press release informs us, “Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) and Chair Ron Wyden (D-Oregon) released a bipartisan framework that the Committee will use to pursue legislative solutions to modernize and enhance federal prescription drug programs, with the goal of reducing drug costs for patients and taxpayers.”

STAT News adds, “A legislative package of mostly drug pricing policies is coming together in the Senate, and these policies were not expected to be part of it, four drug lobbyists said. It seems to be an effort by Finance Chair Ron Wyden (D-Ore.) to play catch-up, in an effort to be included in the package that Senate Majority Leader Chuck Schumer is pulling together.”

Also from Washington DC —

  • STAT News tells us
    • “President Biden will nominate oncologist Monica Bertagnolli, director of the National Cancer Institute, to lead the National Institutes of Health, three people familiar with the White House’s plans told STAT.
    • “Bertagnolli last fall became the first woman to direct NCI, the largest of the NIH’s 27 departments, amid the president’s efforts to relaunch the Cancer Moonshot with the goal of halving cancer deaths and vastly curbing new cases.”
  • The U.S. Preventive Services Task Force is making progress in reevaluating the incomplete grade given to screening for partner violence or abuse of older and vulnerable adults.
  • Health Leaders Media points out
    • “CMS recently released the fiscal year 2024 inpatient prospective payment system proposed rule, and with it came the annual proposed ICD-10-CM diagnosis code changes which include new codes to enhance the tracking and progression of Parkinson’s disease and more reimbursement for certain social determinates of health (SDOH).
    • “The proposed rule includes 395 additions, 12 revisions, and 25 deletions to the ICD-10-CM diagnosis code set. If finalized, these changes will take effect October 1.
    • “Of the 395 new ICD-10-CM codes, 123 of them are external cause codes to capture accidents and injuries. CMS also proposes 36 new codes for osteoporosis with current pathological pelvic fracture.”

In studies news

  • Health Affairs informs us
    • “Hospitals must disclose their cash prices, commercial negotiated rates, and chargemaster prices for seventy common, shoppable services under the hospital price transparency rule. Examining prices reported by 2,379 hospitals as of September 9, 2022, we found that a given hospital’s cash prices and commercial negotiated rates both tended to reflect a predetermined and consistent percentage discount from its chargemaster prices. On average, cash prices and commercial negotiated rates were 64 percent and 58 percent of the corresponding chargemaster prices for the same procedures at the same hospital and in the same service setting, respectively. Cash prices were lower than the median commercial negotiated rates in 47 percent of instances, and most likely so at hospitals with government or nonprofit ownership, located outside of metropolitan areas, or located in counties with relatively high uninsurance rates or low median household incomes. Hospitals with stronger market power were most likely to offer cash prices below their median negotiated rates, whereas hospitals in areas where insurers had stronger market power were less likely to do so.”
  • The All of Us Program offers its research roundup.

From the U.S. healthcare business front, Fierce Healthcare reports

  • “Express Scripts is rolling out new programs that aim to better support independent pharmacies in rural areas.
  • “The pharmacy benefit management giant said Thursday that the IndependentRx Initiative is designed to build on a slew of recently announced updates to its model that put a focus on greater transparency. The PBM said it will boost reimbursement to independent pharmacies that are the only location within 10 or more miles of an Express Scripts customer.
  • “This includes growing incentive-based programs that pay for performance, such as when a pharmacy dispenses 90-day prescriptions to improve medication adherence.
  • “The PBM added that these pharmacies will have greater opportunities to participate in its retail pharmacy network.”

From the telehealth front, mhealth Intelligence observes

  • “Published in the American Journal of Drug and Alcohol Abuse, new data shows that patient retention rates following the implementation of telehealth for opioid use disorder (OUD) treatment were higher than those for in-person care.
  • “According to the Centers for Disease Control and Prevention (CDC), about 2.7 million people in the US have OUD, and overdoses appeared to have increased during the COVID-19 pandemic.
  • “However, the pandemic allowed physicians to explore new methods of providing care, including telehealth. To assess the efficacy of treating OUD through telehealth, a digital provider of medication-assisted treatment (MAT), Ophelia Health, conducted a study that assessed patient 180-day and 365-day retention rates.”

From the miscellany front

  • The Wall Street Journal offers its occasional Future of Healthcare series.
  • Kaiser Family Foundation provides a resource to answer “Key Questions About Implementation of the Medicare Drug Price Negotiation Program.”
  • Here’s a final HIMSS report from the last day of the conference.

Monday Roundup

David Ermer–ACA, CDC, CMS, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

The HIMSS conference is being held this week in Chicago. The HIMSS organization is providing the publich with morning and afternoon session updates.

From the regulatory front, the Department of Health and Human Services released the final 2024 Notice of Benefit and Payment Parameters which is applicable to qualified health plans in the marketplaces.

From the US healthcare business front

  • Healthcare Dive reports
    • Hospital and health system merger and acquisition activity remained consistent in the first quarter of 2023 with 15 healthcare industry transactions, a slight drop from 17 in the fourth quarter of 2022, according to a new report from hospital consultancy Kaufman Hall. The 15 transactions comprised $12.4 billion in total transacted revenue, down from the high of $12.7 billion in 2018.
    • Mergers and acquisitions are trending toward cross-regional partnerships, and the size of the smaller party in mergers is increasing to between $250 million and $750 million in annual revenue, according to the report.
    • Realignment of for-profit health system portfolios continued in the first quarter of 2023, particularly for high financial and operational performing health systems.
  • AHIP issued a report finding that hospital markups on specialty drugs cost patients thousands of dollars.
  • Beckers Hospital CFO Reports identifies 22 US hospitals that are cutting care.
  • Beckers Payer Issues informs us that
    • UnitedHealthcare’s plans to implement a gold-card program in 2024 might cut another 10 percent of its prior authorization volumes on top of a 20 percent reduction that will roll out this summer, UnitedHealthcare CEO Brian Thompson said during UnitedHealth Group’s April 14 earnings call, which was transcribed by Seeking Alpha.
    • The payer plans to implement the national gold-card program in early 2024 for care provider groups that meet eligibility requirements, according to a March 29 company news release. The gold-card status applies for most UnitedHealthcare members across commercial, Medicare Advantage and Medicaid. 
    • Qualifying care provider groups “will follow a simple notification process for most procedure codes rather than the prior authorization process,” according to the release. 

From the public health front, Medpage Today reports

  • Chronic pain continued to affect more than one in five U.S. adults, new CDC survey data showed.
  • During 2021, an estimated 51.6 million adults (20.9%) had chronic pain lasting 3 months or longer, and 17.1 million (6.9%) had high-impact chronic pain — pain severe enough to restrict daily activities — reported S. Michaela Rikard, PhD, of the CDC’s National Center for Injury Prevention and Control, and co-authors.
  • Pain prevalence was higher in adults who were American Indian or Alaska Native, who identified as bisexual, or who were divorced or separated, the researchers said in Morbidity and Mortality Weekly Report.

From the Rx coverage front, the Institute for Clincical and Economic Research released a Final Evidence Report on Lecanemab for Alzheimer’s Disease.

  • — Independent appraisal committee voted that currently available evidence is not adequate to demonstrate a net health benefit for lecanemab when compared to supportive care —
  • — Using best estimates from current data, ICER analyses suggest lecanemab would achieve common thresholds for cost-effectiveness if priced between $8,900 – $21,500 per year —
  • — Manufacturers should release all patient-level data to help patients, clinicians, researchers, and regulators understand more about the link between amyloid reduction and cognitive outcomes

Lecanemab is an FDA approved drug that the CDC is considering for Medicare coverage beyond clinical testing. The VA has agreed to cover FDA marketing label uses for the drug in its patient population which overlaps with FEHBP.

From the medical research front, a National Institutes of Health study outlines “opportunities to achieve President Biden’s Cancer Moonshot goal of reducing cancer death rates in the United States. Accelerated progress is needed to achieve Cancer Moonshot goal of cutting the age-adjusted cancer death rate by at least 50% over 25 years, NIH study says.”

  • The study was conducted by researchers in NCI’s Division of Cancer Epidemiology and Genetics, the Center for Cancer Research, and their collaborators, using data from NCI’s Surveillance, Epidemiology, and End Results (SEER) Program and the Centers for Disease Control and Prevention’s National Center for Health Statistics. The researchers examined trends in age-standardized cancer incidence, survival, and mortality rates from 2000 to 2019 for all cancers combined, as well as for the six cancers that together account for 57% of cancer deaths: lung, colorectal, pancreatic, breast, prostate, and liver. They then projected the overall cancer death rate in 2047 based on the assumption that current trends would continue.
  • According to their analysis, because of decreasing cancer incidence and improvements in survival, age-adjusted death rates from all cancers combined declined by 1.4% per year from 2000 to 2015 and by 2.3% per year from 2016 to 2019. These declines reflect substantial reductions in deaths from lung cancer (-4.7% per year during 2014–2019), as well as colorectal cancer (-2.0% per year during 2010–2019) and breast cancer (-1.2% per year during 2013–2019).
  • Trends in prostate, pancreatic, and liver cancer death rates have been less promising. Death rates from prostate cancer had declined strongly (-3.4% per year during 2000–2013), but the decline has slowed (to -0.6% per year during 2013–2019). Death rates from pancreatic cancer have been increasing (0.2% per year during 2006–2019). Death rates from liver cancer, which had been increasing for decades, recently began to decline (-0.5% per year during 2016–2019). Death rates from all other cancer types combined have declined (-1.7% per year during 2016–2019).

Weekend Update

David Ermer–Congress, End of the PHE, NE, Medical / Rx research, OPM, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

The Senate and the House of Representatives return to Washington, DC for Committee business and floor voting tomorrow.

On Thursday, April 20, OPM will hold the postponed second day of the OPM AHIP FEHB Carrier Conference. Of course, the FEHBlog will be in attendance.

Federal News Network tells us

  • “Just 19 of the 74 agencies in the 2022 Best Places to Work in the Federal Government rankings either held steady or improved their employee engagement score.
  • “But among many declining trends in the Partnership for Public Service’s results, some agencies still managed to shine.
  • “When we look at these averages, I think it’s so much more powerful when we pull apart and look at the variation across government and within agencies,” said Max Stier, the Partnership’s president and CEO, at a Best Places to Work ceremony Wednesday.”

From the regulatory front, the Department of Health and Human Services announced its plan to continue PREP Act liability protections related to Covid testing, preventive services and treatments well beyond May 11.

From the U.S. healthcare business front

  • Beckers Payer Issues lists 100 things to know about the Blue Cross Blue Shield system.
  • The Wall Street Journal reports “Merck & Co. said it agreed to acquire Prometheus Biosciences Inc. for $10.8 billion, a push into the lucrative market for immune-disease treatments.”
  • Healthcare Dive discusses the financial condition of non-profit hospitals.

From the medical research front, The Wall Street Journal informs us

  • “Moderna Inc. and Merck & Co.’s cancer vaccine helped prevent relapse for melanoma patients, results from a midstage trial showed, demonstrating progress in the pursuit of shots to ward off cancer by jump-starting the immune system. 
  • “About 79% of high-risk melanoma patients who got the personalized vaccine and Merck’s immunotherapy Keytruda were alive and cancer-free at 18 months, compared with about 62% of patients who received immunotherapy alone, researchers said Sunday. The 157-person trial offers some of the strongest evidence yet that such vaccines could benefit cancer patients. 
  • “I am fairly encouraged that this will open up a whole new set of trials,” said Jeffrey Weber, the senior investigator on the trial and deputy director of the Perlmutter Cancer Center at NYU Langone Health.”

From the artificial intelligence front, NPR discusses efforts to use AI to improve a volunteer driven app for the visually impaired called Be My Eyes.

  • “Hans Jørgen Wiberg, a Danish furniture craftsman, created the app after he got tired of calling his friends and family to ask for help identifying things. (Wiberg is visually impaired.) He spent a couple years developing it, and the app launched in 2015. 
  • “But eight years later, there’s a twist. As artificial intelligence, or AI, becomes more accessible, app creators are experimenting with an AI version using tech as well as human volunteers. Be My Eyes CEO Mike Buckley says the argument for AI is that it can do things people cannot. 
  • “What if the AI ingested every service manual of every consumer product ever?,” says Buckley. “And so you could tap into the AI and say, ‘How do I hook up my Sony stereo?'” Furthermore, Buckley says, “we took a picture of our refrigerator and it not only told us what all the ingredients were but it told us what we could make for dinner.”

Nifty.

Fortune Well identifies “The five best supplements for healthy aging, according to a longevity expert.” The article notes “If you’ve ever walked down the supplement aisle in a pharmacy, you’ve seen the overwhelming abundance of options available for your medicine cabinet. According to the 2022 Council on Responsible Nutrition Consumer Survey on Dietary Supplements, 75% of Americans use dietary supplements, most on a regular basis.” By the way, the five best are

  • Calcium for bone strength
  • Vitamin D for immunity and bone strength
  • Probiotics for gut health
  • Magnesium for mood, and
  • Multivitamins to cover the bases.

Midweek update

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

From our Nation’s capital —

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

From the public health front —

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

From the mental healthcare front —

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

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

From the Rx coverage front —

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

From the medical research developments front

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