Tuesday’s Tidbits

Medicare

Tuesday’s Tidbits

David Ermer–ACA, Medicare, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • STAT News reports
    • “The U.S. Department of Labor claims in a new lawsuit that a UnitedHealth Group unit illegally rejected emergency room care and urine drug screen claims for thousands of people.
    • “UMR, Inc., a Wisconsin-based third-party administrator owned by UnitedHealth, manages benefits for more than 2,100 employee health plans. The federal government says the company denied ER visits and urine drug screens for years using a process that didn’t meet federal standards for health plans that employers fund themselves, known as self-insured plans. The standards are part of a law called the Employee Retirement Income Security Act, or ERISA.
  • The FEHBlog is concerned that the focus of the lawsuit is on services that are well known to be overutilized. Moreover, like the Cigna case, the lawsuit is an attack on auto-adjudication, which the government encouraged.
  • The U.S. Preventive Services Task Force reaffirmed a Grade A recommendation that all persons planning to or who could become pregnant take a daily supplement containing 0.4 to 0.8 mg (400 to 800 mcg) of folic acid at least 1 month prior to anticipated conception and continue through the first 2 to 3 months of pregnancy.

From the Medicare front —

  • Fierce Healthcare tells us,
    • “The Centers for Medicare & Medicaid Services (CMS) has locked in a 3.1% pay bump for inpatient payments to eligible hospitals during fiscal year 2024, which the agency said translates to a $2.2 billion increase in hospital payments.
    • “The baseline inpatient pay rate the agency listed Tuesday afternoon in the FY 2024 Inpatient Prospective Payment Systems (IPPS) and Long-term Care Hospital Prospective Payment System (LTCH PPS) final rule is higher than the 2.8% proposed back in April. However, the listed payout $2.2 billion payout increase is well below the $3.3 billion boost CMS had said in the proposed rule’s fact sheet that hospitals would receive starting this October.
    • “The final rule’s inpatient payment rate reflects a projected FY 2024 IPPS hospital market basket update of 3.3%, reduced by a statutory 0.2 percentage point productivity adjustment intended to reflect longitudinal gains in care delivery efficiency. This applies to general acute hospitals that participate in the IPPS Quality Reporting Program and meaningfully use electronic records.”
  • Health Payer Intelligence points out,
    • “Medicare Part D premiums are projected to decrease from $56.49 in 2023 to $55.50 in 2024, CMS announced.
    • “The projected average Part D premium represents the sum of the average basic premium and the average supplemental premium for plans with enhanced coverage.
    • “The breakdown of the 2024 premium consists of a $34.50 basic Part D premium and a $21.00 supplemental Part D premium.
    • “The agency expects the total Part D premium to fall by 1.8 percent next year, partly due to premium stabilization.
    • Starting in 2024, the Inflation Reduction Act limits the growth in the base beneficiary premium to a 6 percent annual increase. The base beneficiary premium is the basis for calculating a plan-specific Part D premium. This premium will increase by 6 percent in 2024 to $34.70. Without the Inflation Reduction Act provision, the cost would have been $4.65 higher at $39.35.”

In other U.S. healthcare news

  • U.S. News and World Report issued its 2023 U.S. hospital rankings today.
  • Fierce Healthcare relates
    • “Nationwide hospital margins continued their upward recovery in June, though analysts warn that not all hospitals are seeing their fortunes improve.
    • “Per data from consulting firm Kaufman Hall’s latest monthly report, hospitals’ median year-to-date operating margin index rose to 1.4% while the single-month operating margin index hit 3.8%.
    • “Still, “most hospitals underperformed slightly compared to May” due to persistent high expenses and other economic pressures, the firm said. The overall margin improvement could also have benefited from fiscal year-end accounting adjustments, the group wrote in its report, while underlying data suggest that many facilities are finding their finances far from the mean.
    • “As margins continue to stabilize on the surface, the gap between high-performing hospitals and those struggling in this new financial environment is widening,” Kaufman Hall said in an accompanying release.”
  • The Wall Street Journal reports
    • Pfizer reported second-quarter revenue Tuesday that fell short of analysts’ estimates as record sales from its Covid-19 products dry up. 
    • Pfizer says its strategy of relying on internal innovation is bearing fruit, with a series of new drug approvals coming in the second quarter and drugs from recent deals helping drive revenue. 
  • Beckers Payer Issues explains
    • Around 6 in 10 health plans have provider education in place to promote alternative options to costly GLP-1 drugs like Ozempic and Wegovy for obesity and diabetes treatment, according to a survey from diabetes management provider Vitra Health. 
    • In a survey of 80 health plan leaders published Aug. 1, all of the leaders responded they were concerned about the rising costs and utilization of GLP-1 drugs.  * * *
    • See the full survey here. 

Monday Roundup

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

From Washington, DC —

  • The American Hospital Association reports
    • “The Centers for Medicare & Medicaid Services released its fiscal year 2024 final rule for the skilled nursing facility prospective payment system. The rule will increase payments by a net 4.0%, or $1.4 billion, in FY 2024 relative to FY 2023 levels. This includes a 3.0% market basket increase which was reduced by a 0.2% productivity cut, increased by a 3.6% market basket forecast error adjustment for FY 2022, and reduced by a 2.3% behavioral adjustment related to the transition to the patient-driven payment model.”
  • and
    • “The Centers for Medicare & Medicaid Services today announced the Guiding an Improved Dementia Experience (GUIDE) Model, a voluntary national Medicare payment model beginning next July that aims to help dementia patients remain at home and improve the quality of life for them and their caregivers. Participating Medicare Part B providers and suppliers will receive a monthly per-beneficiary amount for providing care management and coordination and caregiver education and support services. Certain safety net providers in the new program track will be eligible for a one-time, lump-sum infrastructure payment to support program development activities. CMS is accepting letters of interest through Sept. 15 and plans to release a request for applications this fall.” 
  • HHS issued “a statement applauding the formation of the Office of Long COVID Research and Practice to lead the Long COVID response and coordination across the federal government and, in addition, the National Institutes of Health (NIH) launch of the Long COVID clinical trials through the RECOVER Initiative.”
  • STAT News reports
    • The U.S. Preventive Services Task Force will discuss recommending Covid-19 screening, the first step in requiring insurers to permanently cover the tests at no cost to patients.
    • The national panel of experts will convene and “determine whether and how Covid-19 screening might be considered within the Task Force’s scope,” chair Michael Barry wrote in a letter to Sen. Elizabeth Warren (D-Mass.) exclusively shared with STAT.
    • Conundrum: “However, he reminded them that “our recommendations only apply to people who do not have any signs or symptoms of disease. We are exploring how testing for Covid-19 might fit within the parameters like these that govern the Task Force’s work.”

From the research front —

  • Cardiovascular Business informs us
    • “Researchers at Harvard University have found that a new hydrogel ink, infused with gelatin fibers, makes it possible to 3D print a functional heart ventricle that beats like a human heart. The group shared its findings in Nature Materials, noting that the same technique can be used to 3D print heart valves, dual-chambered hearts and more.[1]
    • “People have been trying to replicate organ structures and functions to test drug safety and efficacy as a way of predicting what might happen in the clinical setting,” first author Suji Choi, PhD, a research associate with the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS), said in a prepared statement. 
    • “Creating these complex structures with 3D printing alone has never been possible, Choi et al. explained—until now.”
  • STAT New points out
    • “Unlike today’s crowded market of SSRIs, prescribed once and taken for months, years, or even indefinitely, zuranolone, developed by Sage Therapeutics, promises something different.
    • “It’s a rapid-acting drug, designed to kick in within the first three days of treatment. The patient takes the medication for 14 days, and then stops. Re-dosing occurs on an as-needed basis.
    • “The Food and Drug Administration is expected to decide whether to approve zuranolone for major depressive disorder and for postpartum depression by Aug. 5. And while Meier had a favorable experience with the drug, it has a checkered clinical trial history: a positive outcome, followed by a negative outcome, followed by another positive outcome.
    • “If approved, zuranolone could give psychiatrists something they’ve been looking for: Drugs that provide relief for their patients more quickly. Zuranolone’s mechanism of action, different than that of other antidepressants, also adds a new type of tool — “pliers,” perhaps — to a toolbox that’s full up on “screwdrivers” and “hammers” already, said Olusola Ajilore, a professor of psychiatry at the University of Illinois Center for Depression and Resilience.”
  • The Wall Street Journal reports
    • “Ultrasound, the decades-old technology known for giving early glimpses of unborn babies, could hold a key to a problem that has long challenged drug developers: getting medicines to hard-to-reach places to treat diseases like Alzheimer’s and cancer.
    • “A cutting-edge approach that combines ultrasound waves with tiny bubbles of inert gas injected into the bloodstream can get more chemotherapy to tumor cells and enable drugs to breach one of the most stubborn frontiers in the human body—the blood-brain barrier. It is also being explored as a new way to deliver gene therapy.
    • “There’s an extremely wide variety of where this sort of drug delivery or augmentation with ultrasound and bubbles can take us,” says Flemming Forsberg, professor of radiology and director of ultrasound physics at Thomas Jefferson University in Philadelphia. The effectiveness of drugs in treating diseases like cancer, Alzheimer’s and Parkinson’s is often limited by poor penetration into tissues, he says, whether in the brain or in tumors in other parts of the body.”

From the U.S. healthcare business front —

  • Tenet Healthcare announced its second quarter 2023 financial results today. Per Becker’s ASC Review,
    • “Tenet Healthcare’s second quarter net income hit $123 million, according to its financial report published July 31. 
    • “Here are four more ASC takeaways:
      • “1. Tenet’s $123 million net income in the second quarter of 2023 is an increase of $85 million over the company’s net income in the second quarter of 2022. 
      • “2. Net operating revenues for the company’s ambulatory care segment was $942 million in the second quarter of 2023. 
      • “3. The $942 million number marks a 22.2 percent increase compared to the second quarter 2022 figure — driven by surgical case growth, acquisition and opening of new facilities, service line growth and improved price yielding. 
      • “4. Same-facility systemwide surgical cases were up 6.6 percent in the quarter and 7.2 percent since the start of 2023.” 
  • Fierce Healthcare tells us
    • “Last year, Blues plan giant Anthem unveiled a corporate rebrand as Elevance Health, a move it said better illustrated its ambitions to be more than just a health plan.
    • “Now, the company is updating the branding for its Amerigroup segment to Wellpoint in a bid to better align the government insurance business with its push toward whole health, Elevance Health tells Fierce Healthcare exclusively. The rebrand will roll out in January 2024, pending regulatory approvals, in six states: Arizona, Iowa, New Jersey, Tennessee, Texas and Washington.
    • “Amerigroup plans in Maryland already took on the Wellpoint brand earlier this year. The insurer emphasized that while Amerigroup’s plans may be gaining a new name, the benefits that members enjoy today won’t be changing in tandem.
    • “Felicia Norwood, president of government health benefits for Elevance Health, told Fierce Healthcare that deploying the new name will help “simplify our health plan brands and make it easier for our customers to understand and do business with us over time.”
  • From the patient safety front —
  • STAT News relates
    • “Five elderly people have been blinded in one eye by a severe side effect after receiving injections of a newly approved treatment for eye disease from Apellis Pharmaceuticals. The frequency of this side effect — a severe type of eye inflammation — is low but its cause remains unknown.
    • “The new safety information related to the Apellis drug, called Syfovre, was presented Saturday by a committee of eye disease experts at the annual meeting of the American Society of Retinal Specialists (ASRS).
    • “Apellis cooperated with the ASRS analysis but the company also announced its own internal review Saturday that found fewer cases of retinal occlusive vasculitis, a type of severe eye inflammation that blocks blood flow to the retina and can result in blindness. The rate of retinal occlusive vasculitis reported remains “very rare,” the company said, adding that there is no evidence linking the drug product or its manufacturing to the severe side effect.”
  • The New York Times reports that federal courts have rejected Johnson & Johnson’s bankruptcy defense to the talc class action lawsuits. Johnson & Johnson continues to assert the defense on appeal and elsewhere.

Weekend update

David Ermer–CMS, Federal employment benefits, Medicare, NCQA–

From Washington DC —

  • OPM and its Inspector General remind us that today is National Whistleblower Day.
    • “Whistleblowers play a critical role in promoting accountability and efficiency across the federal government. Federal employees and employees of contractors and grantees can serve as an important resource for identifying fraud, waste, and abuse.”
  • August 15 is OPM’s soft deadline for concluding 2024 benefit and rate negotiations with carriers. OPM has been announcing next year’s FEHB premiums at the end of September.
  • The FEHBlog expects a low government contribution increase for 2024 because OPM authorized Medicare Part D EGWPs in the FEHB for next year. Of course, in future years, the big Part D savings will be baked into FEHB premiums, except for the Inflation Reduction Act changes that are being phased in over the next three to four years.
  • On a related note, the Motley Fool predicts
    • Slowing inflation seems likely to cause Social Security COLAs to be much lower in 2024.
    • Higher Medicare Part B premiums could offset part of the retirees’ Social Security increase.
  • In the FEHBlog’s opinion, the Motley Fool is not going out on a limb because inflation has dropped this year, and CMS gave the green light to Medicare coverage of an expensive Alzheimer’s Disease drug, Leqembi. There’s a chance that Congress may approve Medicare coverage for expensive but effective weight loss drugs, i.e., Wegovy.

More from the Medicare front

  • Fierce Healthcare reports
    • “Most Medicare Advantage (MA) enrollees use one or more supplemental benefits, with most health plan members using multiple benefits, according to a newly released report from the Elevance Health Public Policy Institute.
    • “The report finds that 83% of dual-eligible and 75% of non-dual-eligible individuals used at least one supplemental benefit a year. Those figures only drop to 64% and 48%, respectively, for using at least two different supplemental benefits. It also concluded that dual-eligible enrollees were more likely to live in a food desert, so they are more likely to self-select plans with strong supplemental benefit offerings.”
  • and
    • “Researchers found that once joining Medicare, patients are 50% more likely to get health screenings for breast cancer and colorectal cancer.
    • “Patients with other undiagnosed diseases, such as depression, COPD, type 2 diabetes, lung or prostate cancer, hypertension and hyperlipidemia, are also more likely to discover their condition in their first year of being on Medicare coverage.
    • “The report, by Epic Research, reviewed more than 20 million patients between the ages of 60 and 70 to see whether diagnoses occurred more frequently.
    • “Breast cancer screening rates jump from 15.3% to 30.4%, while colorectal cancer screening rates increase from 4.8% to 11%.”

On a related note, NCQA released its measurement year 2022 Quality Compass for commercial plans, which category includes FEHB plans, on July 28.

Thursday Miscellany

David Ermer–Congress, COVID-19, COVID-19 vaccine, Generative AI, Medicare, Mental health care, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington DC —

  • The Food and Drug Administration announced
    • approve[ing] Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for use in the U.S. without a prescription. Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.
  • The New York Times adds,
    • The pill’s manufacturer, Perrigo Company, based in Dublin, said Opill would most likely become available from stores and online retailers in the United States in early 2024.
  • The OTC contraceptive will be available with no member cost sharing from FEHB plan network pharmacies due to the Affordable Care Act’s contraceptive mandate. Per the New York Times,
    • The company did not say how much the medication would cost — a key question that will help determine how many people will use the pill — but Frédérique Welgryn, Perrigo’s global vice president for women’s health, said in a statement that the company was committed to making the pill “accessible and affordable to women and people of all ages.”
  • The American Hospital Association informs us
    • “The Centers for Medicare & Medicaid Services July 13 issued a proposed rule that would increase Medicare hospital outpatient prospective payment system rates by a net 2.8% in calendar year 2024 compared to 2023. This includes a proposed 3.0% market basket update, offset by a 0.2% cut for productivity.”
  • and
    • “The Centers for Medicare & Medicaid Services July 13 released its calendar year 2024 proposed rule for the physician fee schedule. The rule proposes a decrease to the conversion factor by 3.34%, to $32.75 in calendar year 2024, as compared to $33.89 in CY 2023. This reflects the expiration of the 2.5% statutory payment increase for CY 2023; a 1.25% statutory payment increase for 2024; a 0.00% conversion factor update under the Medicare Access and CHIP Reauthorization Act; and a -2.17% budget-neutrality adjustment.  * * * 
      “CMS also proposes several provisions to advance access to behavioral health services. For example, it would create a new benefit category for marriage and family therapists and mental health counselors under Part B. In addition, CMS would establish new payment codes for mobile psychotherapy for crisis services.”\
  • The public comment deadline for both proposed rules is September 11, 2023.
  • STAT News reports
    • “A key Senate health care panel has developed a plan to tackle reforms to middlemen in the pharmacy drug payment system, according to bill text obtained by STAT.
    • “The draft legislation, authored by Senate Finance Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho), includes several measures to regulate how pharmacy benefit managers are paid by health plans to negotiate with drugmakers.
    • “The most significant measure is a bill from Sens. Bob Menendez (D-N.J.) and Marsha Blackburn (R-Tenn.) that would prohibit PBMs from getting any income outside of service fees, and prohibits those service fees from being related to drugs’ list prices.
    • “Other provisions include a bill from Sens. Catherine Cortez Masto (D-Nev.) and Thom Tillis (R-N.C.) to require PBMs to send annual reports to Medicare insurance plans about their rebate and price negotiations, a policy that would ban PBMs from charging Medicaid more than they pay for drugs (a practice called spread pricing), and a mandate for the Department of Health and Human Services to outline acceptable performance measures for pharmacies.”

From the public health front

  • The Wall Street Journal reports
    • Two different arms of the World Health Organization released separate findings on the widely used sweetener aspartame—one calling it safe and the other identifying it as a possible cancer hazard.
    • Here’s what you need to know:
    • Is it safe to drink Diet Coke?
      • Yes, in moderate amounts. Food regulators around the world agree that aspartame is safe. Aspartame has been studied for decades. The WHO reaffirmed its recommendation that people consume no more than 40 milligrams of aspartame a day for each kilogram they weigh—which would be a lot of soda.
      • With around 200 mg of aspartame per 12-ounce can of Diet Coke, that is roughly 16 cans a day for a 175-pound person. People get aspartame from some other food sources, though, and often the presence or amounts of aspartame in them aren’t disclosed. The WHO and other health experts also caution against consuming large amounts of sweetened products, including soda. They recommend drinking water instead.
      • “This is particularly important for young children” whose tastes are developing, said Dr. Francesco Branca, director of the WHO’s department of nutrition and food safety.
    • Obviously, the article continues on with other FAQs, but this is the one that caught the FEHBlog’s attention.
  • The U.S. Preventive Services Task Force finalized its research plan for chronic kidney disease screening.
  • STAT News tells us
    • “Amid ongoing controversy over the cost of medicines, a key Biden administration official told Covid-19 vaccine manufacturers that their next round of shots should be priced reasonably, a move that comes after two key suppliers were accused of price gouging.”
  • The CMS Administration informed insurers and others
    • “As we look toward efforts to provide updated COVID-19 vaccines this fall, we know you may have questions about the shift away from U.S. Government purchasing of vaccines to a more traditional commercial market. To be clear, that shift has not yet occurred, and the currently authorized and approved COVID-19 vaccines continue to be free and widely available nationwide. We also wanted to send these reminders from the Centers for Medicare & Medicaid Services (CMS) about COVID-19 vaccine coverage and encourage you to start planning now for the fall vaccination campaign.
    • “[M]ost private health insurance, like employer-sponsored plans, Marketplace plans, and other individual market coverage that is subject to the Affordable Care Act (ACA) market reforms are required to cover vaccines for COVID-19 authorized for emergency use or approved by the FDA and recommended by the ACIP and their administration, without patient cost-sharing.”
  • Fierce Healthcare relates
    • The Centers for Medicare & Medicaid Services (CMS) is recommending preexposure prophylaxis (PrEP) with oral or injectable antiretroviral therapy to people at risk of HIV without patient cost sharing. * * *
    • Currently, Medicare beneficiaries are only guaranteed access to daily oral PrEP through Part D, facing out-of-pocket costs, said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. Injectable PrEP has not been covered traditionally.
  • Roll Call points out
    • “One year after the creation of the three-digit crisis hotline known as 988, officials say the next step is expanding awareness and local crisis care.
    • “More than 4 million people have called, texted or chatted the suicide prevention hotline in the year since its creation, according to Laurel Stine, executive vice president and chief policy officer for the American Foundation for Suicide Prevention.
    • “She estimates that number will grow in the next fiscal year to 9 million contacts.
    • “We have to be mindful that Rome was not built in a day,” she said. “We’ve had a fragmented mental health behavioral health crisis system for a number of years.”
  • Forbes reports on the “worsening” cancer drug shortage which it describes as a resolvable public health emergency.

From the generative AI front —

  • Healthcare Dive notes
    • Generative artificial intelligence could capitalize on the healthcare industry’s wealth of unstructured data, alleviating provider documentation burden and improving relationships between patients and their health plans, according to a new report by consulting firm McKinsey.
    • The report argues generative AI could help payers quickly pull benefits material for members or help call center workers aggregate information during conversations about claims denials. Providers could use AI to take conversations with patients and turn them into clinical notes, create discharge summaries or handle administrative questions from workers at health systems.
    • But healthcare leaders should start planning now if they want to use generative AI, as the risks can be high, the report said. Data fidelity and accuracy is key, so executives should begin assessing the quality of their AI tech stacks and considering potential problems like bias and privacy concerns, according to McKinsey.
  • Econtalk host Russ Roberts held an informative interview with Marc Andreessen about generative AI.

Tuesday Tidbits

David Ermer–Congress, Medical / Rx research, Medicare, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The Senate Health Education Labor and Pensions Committee held its Superbugs hearing today.
  • STAT News informs us
    • “The witnesses largely seemed to organize behind the Pasteur Act in terms of how Congress should respond. This bipartisan legislation, which has been introduced in both the House and Senate, would encourage drug development by creating a subscription-style business model. In other words, the U.S. government would offer upfront payments to drugmakers in exchange for responsible stewardship policies and unlimited access to their antibiotics. A similar model has been successfully piloted in England over the past year, with the National Health Service planning a wider rollout to more pharmaceutical companies and to Northern Ireland, Scotland and Wales.
    • “The goal, as STAT has previously reported, is to enable pharmaceutical companies to recover their costs and make a profit — without predicating this on large volumes of antibiotics being prescribed. Helen Boucher, Dean of Tufts University School of Medicine, testified that this law would recognize these drugs “for their value, not for their use. It de-links incentives for overusing antibiotics.”
  • The Government Accountability Office released “a new report on the agency’s key findings and recommendations with an eye toward helping federal agencies be better prepared for future emergencies. GAO has regularly reported on the accountability and effectiveness of the federal government’s $4.7 trillion pandemic response since 2020.”
  • Per the White House,
    • “Today, in the continued efforts to fight the dangerous and deadly combination of xylazine mixed with fentanyl, the White House Office of National Drug Control Policy (ONDCP) released a National Response Plan to coordinate a whole-of-government response against this threat. Earlier this spring, ONDCP Director Dr. Gupta used an executive designation authority to designate fentanyl combined with xylazine as an emerging threat to the United States and proactively address this dangerous threat head-on.”
    • “Read the full National Response Plan to Fentanyl Combined with Xylazine HERE.
    • “Read about the Biden-⁠Harris Administration’s efforts to crack down on illicit fentanyl supply chains HERE.
    • “Read the Biden-Harris Administration’s National Drug Control Strategy HERE.”

From the public health front —

  • Federal News Network reports that twelve House of Representatives members are asking the Postal Service about steps being taken to protect letter carriers against the effects of high outdoor heat following the death of a letter carrier who passed away while delivering the mail in Texas.
    • “Eugene Gates Jr., a 66-year-old letter carrier in Texas, died June 20 while delivering mail during a heat wave with temperatures as high as 115 degrees. * * *
    • “The National Association of Letter Carriers, which represented Gates, said he collapsed and died in a customer’s yard while delivering mail. Gates, an Army veteran, served as a letter carrier for 36 years.
    • “Eugene was a dedicated letter carrier with a long and successful Postal Service career,” NALC National President Brian Renfroe said in a statement. “He will be greatly missed.”
  • STAT News tells us,
    • Weight loss medications from Novo Nordisk are being investigated by the European Medicines Agency after several reports of suicidal risks were referred to the watchdog, Bloomberg News reports. The regulator is looking at adverse events noted by the Icelandic Medicines Agency, including two cases of suicidal thoughts linked to the drugs Saxenda and Ozempic. One additional case relating to thoughts of self-injury has been raised in connection with Saxenda. The agency is investigating the possible side effects in relation to patients who have used medicines containing the active ingredients semaglutide or liraglutide for weight loss. Novo’s hit weight loss drug Wegovy also contains semaglutide.
  • The Bloomberg article adds,
    • “Wegovy is currently available in the US with a warning and precaution for suicidal behavior and ideation on the label. While clinical trials of Wegovy did not support an increased risk of suicidal behavior, suicidal ideation, or other psychiatric adverse events, clinical trials of other weight management drugs have reported suicidal behavior and ideation, a spokesperson for the Food and Drug Administration said Monday.
    • “If newly identified safety signals are identified, the FDA will determine what actions are appropriate after a thorough review of the body of evidence,” the spokesperson said.”

From the medical research front,

  • According to the National Science Foundation —
    • “While it’s known that sleep plays a crucial role in strengthening memory, scientists are still decoding how the process plays out in the brain overnight.
    • “U.S. National Science Foundation-supported research led by scientists at UCLA and Tel Aviv University offers new evidence from inside the human brain supporting the dominant theory of how the brain consolidates memory during sleep.
    • “The researchers found that targeted deep brain stimulation during a critical time in the sleep cycle improved memory consolidation. The result came from a novel “closed loop” system that delivered electrical pulses in one brain region that activated the cerebral cortex, synchronized with brain activity recorded in another area, the hippocampus.
    • “The research, published in Nature Neuroscience, could offer new clues to how deep brain stimulation during sleep could help patients with memory disorders, said study co-author and physician-scientist Itzhak Fried of UCLA.”

From the Medicare front, NerdWallet identifies four Medicare policies that “should come with warning labels.” Number 1 is the Part B late enrollment penalty. The article encourages picking up Part B at the first opportunity, even if health expenses at the time are modest. Granted, this article is aimed at people, like the FEHBlog, who have Medicare without supplemental employer coverage. Nevertheless, federal employees should consider the advice too.

From the Rx coverage front

  • Beckers Hospital Review notes
    • “The FDA is allowing 10 more lots of cisplatin from a China-based pharmaceutical company to be imported to the U.S. to ease the ongoing cancer drug shortage, Bloomberg reported July 10. The additional lots are set to arrive next week. 
    • “In June, federal regulators cleared four lots of cisplatin from Qilu Pharmaceutical. While the version of the drug is unapproved in the U.S., it is similar to the approved version distributed across the country. 
    • “We will continue the importation until manufacturers can meet all needs,” Chanapa Tantibanchachai, an FDA spokesperson, told Bloomberg.
    • “Shortages of the essential cancer drug began in February and have caused some cancer centers to ration cisplatin and carboplatin, another cancer drug in shortage, treatments for patients. More recently, there have been signs of supplies stabilizing.” 
  • Fierce Healthcare discusses a recent HHS report on approaches to avoiding drug shortages.
  • Following up on its recent report about the lead-covered cabling problem in our country, the Wall Street Journal points out
    • “Supplies are running out for a key antidote for life-threatening lead poisoning.
    • “The drug, named dimercaprol, has been a go-to treatment for years for the worst cases of lead poisoning. But doctors have had to scrounge for dwindling doses since the medicine’s sole manufacturer for the U.S. declared bankruptcy in February.
    • “Now that some parts of the country don’t have any supplies left, doctors have been forced to turn to other, less preferred treatments.
    • “We’re using whatever we can get, knowing it will help, but not knowing if it’s doing as good of a job,” said Dr. Diane Calello, who directs the New Jersey Poison Control Center at Rutgers New Jersey Medical School.”

In U.S. healthcare business news

  • Beckers Payer Issues tells us
    • “The Cigna Group’s network of behavioral health providers grew by more than 30 percent in 2022, according to the company’s 2022 Environmental, Social, and Governance Report.
    • “The July report said the behavioral health network has grown to include more than 300,000 mental health and substance use providers, doubling its size over the past four years. The company also nearly doubled its virtual care network, which has grown to include more than 163,000 virtual behavioral health providers. In-network providers who support cultural and race-related counseling were increased.
    • “For behavioral health providers that specifically work with children, Cigna added 27,000 providers to its network in 2022, or an increase of 19 percent. It also increased the numbers of facilities treating children by 8 percent to 2,700 total.”
  • The Wall Street Journal delves into high-priced “clinics cater[ing] to a growing number of people obsessed with fighting aging.”
    • “Practitioners at Healthy Longevity Clinic, which has locations in Boca Raton, Fla., and Prague, build patients a personalized “longevity road map.” Those maps can include recommendations for diet, exercise, sleep and supplements. Patients are encouraged to stick with the program for at least a year, over which time their bill can run between $25,000 to more than $100,000, says Petr Sramek, the clinic’s chief executive.
    • “Longevity-clinic treatments aren’t often covered by health insurance. Some providers say they work with insurers to get coverage for medications or laboratory tests. 
    • “Many clinics use membership-based models in an effort to keep client loads low enough that providers can spend time with each patient. Others are fee-for-service or use a combination of the two.”

Monday Roundup

David Ermer–Medicare, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the public health front

  • The New York Times reports,
    • “Drowning is the leading cause of death for children ages 1 to 4, according to the Centers for Disease Control and Prevention. Deaths are likely to surge this month, as they do every July, with children drowning just feet from their parents without a scream, struggle or splash. A 4-year-old at a Texas hotel pool, a 5-year-old in a California river, a 6-year-old at a Missouri lake and a 10-year-old at an Indiana public pool all drowned just this past week. * * *
    • “The National Institutes of Health recently published a call for research proposals to examine drowning prevention, writing that “little is known” about what intervention strategies work. The C.D.C. said it planned to do an in-depth analysis of childhood drownings in several states to better understand the contributing factors.
    • “But epidemiologists point to an array of factors that could make it increasingly difficult to close the gap, including shrinking recreation department budgets, a national lifeguard shortage and an era of distraction on pool decks as parents juggle child supervision with laptops and cellphones when they work from home.”
  • and
    • “When Dr. Benjamin Han, a geriatrician and addiction medicine specialist, meets new patients at the School of Medicine at the University of California, San Diego, he talks with them about the usual health issues that older adults face: chronic conditions, functional ability, medications and how they’re working.
    • “He asks, too, about their use of tobacco, alcohol, cannabis and other nonprescription drugs. “Patients tend to not want to disclose this, but I put it in a health context,” Dr. Han said.
    • “He tells them, “As you get older, there are physiological changes and your brain becomes much more sensitive. Your tolerance goes down as your body changes. It can put you at risk.”
    • “That’s how he learns that someone complaining about insomnia might be using stimulants, possibly methamphetamines, to get going in the morning. Or that a patient who has long taken an opioid for chronic pain has run into trouble with an added prescription for, say, gabapentin. * * *
    • “Aging boomers “still use drugs far more than their parents did, and the field wasn’t ready for that.”
    • “Evidence of a growing problem has been stacking up. A study of opioid use disorder in people over 65 enrolled in traditional Medicare, for instance, showed a threefold increase in just five years — to 15.7 cases per 1,000 in 2018 from 4.6 cases per 1,000 in 2013.”
  • Fierce Healthcare informs us,
    • “Americans are likely to skip important health screenings, and women have a less positive outlook than men regarding their current and future health prospects, according to a survey released by Aflac.
    • “The survey, based on about 2,000 employed adults, examined attitudes, habits and opinions about health and preventive care and found that half of adults have avoided at least one common health screening. These screenings include tests for certain diseases.
    • “But for the 51% of respondents who said they have had cancer, that diagnosis came following a routine checkup or screening. For Hispanic survey respondents, 72% of individuals said a diagnosis was discovered at a routine checkup.
    • “Skipping regular checkups is common among individuals who feel healthy. One in 4 respondents said they miss routine checkups. Reasons cited include a conflict with work hours, the individuals are “not thinking about it,” a general dislike for going to the doctor’s office, insurance issues, fear of hearing bad news and the time commitment required.”
  • In the FEHBlog’s view, the best action for a health plan to take in response to these concerns is to connect members with in-network primary care providers.

From the Medicare front, Beckers Payer Issues points out that “Caps on Medicare prescription drug costs will save Part D enrollees a collective $7.4 billion in 2025, according to a report from HHS’ Office of the Assistant Secretary for Planning and Evaluation.  The report, published July 7, broke down expected savings from price caps by state. An estimated 18.7 million people, around 1 in 3 Medicare Part D enrollees, will save on drug costs in 2025. The average annual saving per person is estimated at $396.08.” That’s good news for FEHB and PSHBP plans with Part D EGWPs.

From the Rx coverage front, Fierce Healthcare notes

  • “On the heels of a similar announcement from Optum Rx, pharmacy benefit management giant Express Scripts said Monday that it will add three biosimilars to its formulary to compete with Humira.
  • “The PBM announced that it will include Boehringer Ingelheim’s Cyltezo and two biosimilars produced by Novartis’ Sandoz in its National Preferred Formulary. Humira, a drug for people with inflammatory conditions, is the top-selling pharmaceutical product in the world and has been viewed as a key target for savings thanks to biosimilar products.
  • “Express Scripts said its trend data show that anti-inflammatory drugs accounted for nearly 25% of total drug spending for its commercial business last year. An analysis from its parent company, Evernorth, found that increased biosimilar competition could save $225 billion to $375 billion over the next decade.”

Those savings will benefit FEHB and PSHBP plans.

From the employment front, the Society for Human Resource Management discusses steps that employers can take to support employees who have children with developmental disabilities.

STAT News and its readers offer 27 healthcare reads and podcasts for the beaches and mountains.

 

Midweek Update

David Ermer–CDC, CMS, Congress, COVID-19, Employee Wellness Programs, FDA, Federal employment benefits, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–

The FEHBlog hopes his readers enjoyed their Fourth of July weekend. The FEHBlog certainly did.

From Washington, DC —

  • FedWeek informs us
    • “The House version of the annual defense authorization bill would require DoD and OPM to conduct a “comprehensive review of the civilian workforce on FEHB to ensure that all family members and dependents who are currently receiving benefits are in fact eligible.”
    • “The language, inserted as an amendment to a bill that could come to floor voting in the upcoming weeks, would be the most concrete response to date regarding an issue that has been the subject of repeated warnings from OPM’s inspector general’s office and most recently from the GAO: ineligible persons being covered in the program as family members.”
  • FEHBlog note — The largest internal control problem with FEHB eligibility stems from the fact that OPM does not take advantage of the HIPAA 820 electronic enrollment roster, which allows health plan carriers to reconcile premium to headcount. For example, if the carrier finds via the HIPAA 820 that it is not receiving premiums on a self and family enrollee, then the outcome may be disenrolling the individual and their covered family members in a fair way. In the FEHBlog’s view, it does not make sense to move forward with a family member eligibility audit until the HIPAA 820 transaction is operational in FEHB. That is the most logical first step.
  • Federal News Network provides us with background on OPM’s new employee assistance program guidance. In the FEHBlog’s opinion, OPM should team up EAPs with FEHB plans in order to better coordinate their respective coverages.
  • Fedweek also explains for the benefit of federal and postal employees how to continue FEGLI coverage into retirement.
  • Healthcare Dive relates
    • “The CMS is proposing to cut Medicare reimbursements to home health agencies by 2.2% next year, or $375 million less than providers received in 2023, according to draft regulation released Friday. 
    • “The agency said the proposed rule includes a 2.7% payment bump that’s offset by a 5.1% cut related to the Patient-Driven Groupings Model, which aimed to better sort patients into different payment categories by clinical need and other factors.
    • “The reimbursement changes also reflect an estimated 0.2% increase due to an updated fixed-dollar loss ratio, according to regulators.”

From the public health front —

  • CBS News reports
    • “Nearly 1 in 4 U.S. adults and older teens had still not caught COVID-19 by the end of last year, according to new estimates from the Centers for Disease Control and Prevention, while 77.5% had antibodies from at least one prior infection. The figures are based on the final batch of results from the agency’s nationwide studies of antibodies in Americans ages 16 and up. * * *
    • “Virtually every American ages 16 and older — 96.7% — had antibodies either from getting vaccinated, surviving the virus or some combination of the two by December, the CDC now estimates. The study found 77.5% had at least some of their immunity from a prior infection. * * *
    • Rates were similar among men and women. Black and White people also have similar prior infection rates, between 75% and 80%. 
    • Among other racial and ethnic groups, Asian Americans had the smallest proportion of people with antibodies from a prior infection, at 66.1%, while Hispanic people had the highest, at 80.6%.

From the Rx and medical devices coverage front —

  • BioPharma Dive points out
    • “Moderna on Wednesday said it’s submitted applications to regulatory agencies around the world in a bid to win approval of a new vaccine to fight respiratory syncytial virus, or RSV, in older adults.
    • “The company filed with regulatory agencies in Europe, Switzerland and Australia and began a rolling submission to the U.S. Food and Drug Administration for the vaccine, which is currently known as mRNA-1345. Future applications are planned for other nations as well.
    • “Moderna’s submissions come two months after the FDA approved the first RSV vaccine, developed by GSK. The agency cleared a second RSV shot from Pfizer weeks later. Both products are approved for use in patients who are at least 60 years old, the same group Moderna aims to treat.”
  • Forbes reports
    • “On Wednesday, medtech giant Abbott announced that its new leadless pacemaker system, Aveir DR, has been approved by the FDA. This is the first time the FDA has given a thumbs up to a device of this type for two different chambers of the heart, which opens up this technology to nearly any patient who needs a pacemaker.
    • “From a clinical perspective, we know that leadless pacing offers a number of important advantages to patients in terms of getting away from the complications related to traditional pacemakers,” says Leonard Ganz, a cardiologist and Abbot’s chief medical officer for cardiac rhythm management. “This will expand the number of patients who can benefit from leadless pacing many, manyfold,” he tells Forbes.” * * *
    • “Although pacemakers have been life-changing for millions of people, they do carry downsides, explains Ganz, in particular, risk of infection both from the surgical procedure needed to implant them as well as the leads themselves should their insulation become compromised. Leadless pacemakers, by contrast, are much smaller, don’t require surgical implantation and have no wires connected to the heart. Instead, they are injected using a catheter in a vein and placed directly in the heart in a way that allows for removal if need be. All of these factors significantly reduce the risk of complications.
    • “The first leadless pacemaker, manufactured by Medtronic, was cleared by the FDA in 2016. Abbott’s first leadless pacemaker, the Aveir VR, was approved by the FDA in March 2022. [In contrast to the new Abbott device, b]oth of these products only work in a single chamber of the heart. About 80% of the patients that require a pacemaker need shocks in two cardiac chambers in order to keep the desired heart rhythm.”
  • The New York Times discusses “food noise,” which the new weight loss drugs dissipate.
    • “The active ingredient in Ozempic and Wegovy is semaglutide, a compound that affects the areas in the brain that regulate appetite, Dr. Gabbay said; it also prompts the stomach to empty more slowly, making people taking the medication feel fuller faster and for longer. That satiation itself could blunt food noise, he said.
    • “There’s another theoretical framework for why Ozempic might quash food noise: Semaglutide activates receptors for a hormone called GLP-1. Studies in animals have shown those receptors are found in cells in regions of the brain that are particularly important for motivation and reward, pointing to one potential way semaglutide could influence cravings and desires. It’s possible, although not proven, that the same happens in humans, Dr. Hwang said, which could explain why people taking the medication sometimes report that the food (and, in some cases, alcohol) they used to crave no longer gives them joy.”

From the U.S. healthcare business front

  • Segal Consulting delves into health plan prior authorization practices.
  • The Wall Street Journal reports that “Some hospitals that spent big on nurses during the pandemic are now short on cash; Distressed institutions are closing unprofitable services, selling assets to avoid default on debts.” Ruh-roh!
  • Forbes reports
    • “Rite Aid reported a quarterly loss of more than $306 million as the drugstore chain grapples with the loss of customers from its Elixir pharmacy benefits business as executives work to turn around the struggling drugstore chain.
    • “Rite Aid, which has closed more than 140 unprofitable stores in the last two years, reported a fiscal first-quarter loss of $306.7 million, or $5.56 per share, for the period ended June 3, 2023. That compares with a loss of $110.2 million, or $2.03 per share, in last year’s first quarter.”

From the fraud, waste, and abuse front, HealthTech explains how the Justice Department is using advanced analytics to combat healthcare fraud.

From the medical research front, the National Institutes of Health announced that “The first clinical trial of a three-month TB treatment regimen is closing enrollment because of a high rate of unfavorable outcomes with the investigational course of treatment.” The FEHBlog appreciates NIH’s transparency.

Friday Factoids

David Ermer–CDC, CMS, Medical / Rx research, Medicare, Rx coverage–

On the day I return to Texas, the DC air quality improved from unhealthy to unhealthy for sensitive groups, all due to wildfire smoke. The air quality in Dripping Springs, TX, where the FEHBlog lives, is good.

Also from Washington, DC, the Supreme Court closed its October 2022 term today.

Politico tells us

  • “It’s CDC Director Rochelle Walensky’s last day at the agency, but she’s still thinking a lot about the agency’s work ahead.
  • “She’s been working to smooth potential bumps in a transition, in contact with her successor, Mandy Cohen — an Obama administration alum and formerly North Carolina’s top public health official.
  • “And she looks to stay in the game, telling Pulse she’s “eagerly wanting to champion health and public health from a new perch,” though she’s been vague about what that might be.”

The Department of Health and Human Services announced

  • “actions to lower health care costs and implement President Biden’s lower cost prescription drug law – the Inflation Reduction Act (IRA) – which is already saving covered seniors and people with disabilities hundreds of dollars annually.
  • “HHS released revised drug price negotiation guidance from the Centers for Medicare & Medicaid Services (CMS). The guidance is a critical step in implementing the IRA, which finally took on Big Pharma and will allow Medicare to negotiate lower drug prices on behalf of people with Medicare. * * * “
  • “HHS today also announced that President Biden’s cap on insulin costs at $35 per month will go into effect for people who get their insulin through Medicare Part B and Medicare Advantage with use of a traditional pump starting tomorrow, July 1, 2023. Millions of people with Medicare Part D are already benefiting from the Inflation Reduction Act’s $35 monthly cap on insulin costs, and if these rules for Part B and Part D had been in effect in 2020, 1.5 million beneficiaries would have saved an average of $500 per year.
  • “More information on the Medicare Drug Price Negotiation Program is available at https://www.cms.gov/inflation-reduction-act-and-medicare/medicare-drug-price-negotiation
  • “To read more on how the $35 insulin cap is already benefiting seniors and other Medicare enrollees across the country, visit: https://aspe.hhs.gov/reports/insulin-affordability-ira-data-point.”

From the public health front, MedPage Today informs us

  • “Drug overdose deaths with xylazine involvement have multiplied, with age-adjusted death rates 35 times higher in 2021 than in 2018, the CDC reported.
  • “The age-adjusted rate of drug overdose deaths involving the animal sedative, also known as “tranq,” rose from 0.03 per 100,000 people to 1.06 per 100,000, Merianne Rose Spencer, PhD, MPH, a researcher at the CDC’s National Center for Health Statistics in Hyattsville, Maryland, and co-authors reported in Vital Statistics Rapid Release. * * *
  • “While never approved for human use, xylazine has increasingly been found adulterating other drugs, particularly fentanyl. It slows breathing and heart rate, lowers blood pressure to unsafe levels, complicates efforts to reverse opioid overdoses with naloxone (Narcan), and can lead to serious flesh wounds.”

From the medical research front, the National Institutes of Health announced

  • “Insights into healing and aging were discovered by National Institutes of Health researchers and their collaborators, who studied how a tiny sea creature regenerates an entire new body from only its mouth. The researchers sequenced RNA from Hydractinia symbiolongicarpus, a small, tube-shaped animal that lives on the shells of hermit crabs. Just as the Hydractinia were beginning to regenerate new bodies, the researchers detected a molecular signature associated with the biological process of aging, also known as senescence. According to the study published in Cell Reports, Hydractinia demonstrates that the fundamental biological processes of healing and aging are intertwined, providing new perspective on how aging evolved.
  • “Studies like this that explore the biology of unusual organisms reveal both how universal many biological processes are and how much we have yet to understand about their functions, relationships and evolution,” said Charles Rotimi, Ph.D., director of the Intramural Research Program at the National Human Genome Research Institute (NHGRI), part of NIH. “Such findings have great potential for providing novel insights into human biology.”

From the healthcare spending front, Mercer Consulting explains what’s happening with the boatload of claims data that health plans began posting to their websites last year.

  • “It’s been almost a year since group health plan sponsors and issuers, in order to comply with the Transparency in Coverage final rule, posted machine-readable files (MRFs) that contain in-network negotiated charges for every medical service with every provider in their networks. This data had previously been considered by insurers as proprietary and confidential, but the government saw the need to put more data about the cost of healthcare into the hands of consumers. There have been eye-opening reports in the past revealing wide discrepancies in the price of medical services from one healthcare facility to the next; the hope was that making price data freely available would make these kinds of studies much easier to do. Given that the data has been available to the public since July 2022, why haven’t we seen more stories on the cost of healthcare in the United States? What happened to all that medical price data?
  • “Well, it’s certainly out there. By some estimates, over 700 terabytes of MRF data have been published since last summer. * * *
  • “While we’re excited about the possibilities for this price data, we’ll need to be patient as the market moves to put more of it to use. Importantly, this data also underpins the final leg of the transparency regulations, which requires real-time benefit cost estimators be made available to the public for 500 shoppable services this year and for everything else by 2024. So if you haven’t already, make sure your data partners are ready for this next step of compliance.
  • “While we are still a long way from achieving price transparency in health care, this data is a crucial starting point.”

From the Rx coverage front, BioPharma Dive discusses Biomarin Phamaceutical’s plans to market its FDA-approved hemophilia gene therapy in the U.S.

  • “BioMarin’s chief commercial officer, Jeff Ajer, told investors during a conference call Thursday afternoon that the first priority of the launch will be getting the country’s largest hemophilia treatment centers to use Roctavian. The FDA approved the therapy for certain people living with severe hemophilia A, a group that totals around 2,500 in the U.S. by BioMarin’s estimates.
  • “Like other approved gene therapies, Roctavian is expensive. BioMarin set its list price at $2.9 million, which Ajer said translates to net revenue of approximately $1.9 million. The company expects to record between $50 million and $150 million in Roctavian revenue this year. BioMarin is also tying the drug’s price to patient outcomes, promising a warranty that will reimburse insurers up to 100% if patients don’t respond, and a pro-rated rebate for the first four years if the response wanes.  
  • “But unlike most available gene therapies, Roctavian treats a disease with a variety of available options. BioMarin argues that its therapy would likely save the healthcare system money over time. Many hemophilia A patients are currently treated multiple times a week with “replacement Factor,” medicines that supply them with the key blood-clotting protein they’re missing. These treatments are costly too, at about $800,000 per year for the typical patient, according to BioMarin.”

Thursday Miscellany

David Ermer–Congress, Federal employment benefits, Medicare, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC —

  • The Senate Finance Committee informs us
    • “U.S. Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) and Finance Committee member Michael Bennet (D-Colorado), along with Finance Committee members Tim Scott (R-South Carolina) and Ben Cardin (D-Maryland), are reintroducing legislation that would provide Medicare coverage for screening tests to save lives and costs to the health care system. 
    • “The Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act would ensure Medicare patients have coverage for innovative tests that can detect multiple types of cancer before symptoms develop.  Bipartisan companion legislation (H.R. 2407) was also introduced in the U.S. House of Representatives.”  
  • Here’s a link to the National Cancer Institute’s FAQs on multi-cancer detection tests.
  • The American Hospital Association reports
    • “A bipartisan group of 233 representatives and 61 senators yesterday called on the Centers for Medicare & Medicaid Service to enhance its proposal to streamline prior authorization processes in Medicare Advantage, Medicaid and the federally-facilitated Marketplace to require real-time electronic decision-making for routinely approved services, responses for emergency procedures within 24 hours and additional transparency. They said adding these provisions would better align the rule with the Improving Seniors’ Timely Access to Care Act, House-passed legislation supported by the AHA to streamline prior authorization in the MA program, and urged CMS to quickly finalize the rule with these updates.
    • “AHA also has urged CMS to quickly finalize the proposed rule, adequately enforce and monitor the requirements and test and vet any electronic standards before mandating their adoption.”
  • Govexec.com tells us
    • “President Biden’s plan to provide civilian federal employees with an average 5.2% pay raise in 2024 appears safe for now, as a key House panel advanced spending legislation that does not address federal employee compensation.
    • “But Democrats and federal employee groups blasted the GOP-led appropriations package, which cuts spending on financial agencies and government administration by 58% compared with fiscal 2023 levels and includes policy riders restricting telework at federal agencies and targeting transgender federal workers and their family members.
    • “The House Appropriations Committee’s Financial Services and General Government Subcommittee on Thursday advanced its annual appropriations bill—one of 12 such pieces of legislation covering different areas of government—to the full committee.”
  • The EEOC reminds us
    • “The Pregnant Workers Fairness Act (PWFA) is a new law that requires covered employers to provide “reasonable accommodations” to a worker’s known limitations related to pregnancy, childbirth, or related medical conditions unless the accommodation will cause the employer an “undue hardship.”
    • “The PWFA applies only to accommodations. Existing laws that the EEOC enforces make it illegal to fire or otherwise discriminate against workers on the basis of pregnancy, childbirth, or related medical conditions.
    • “The PWFA does not replace federal, state, or local laws that are more protective of workers affected by pregnancy, childbirth, or related medical conditions. More than 30 states and cities have laws that provide accommodations for pregnant workers.”
  • The new law takes effect on Tuesday, June 27, 2023.
  • STAT News explains why five cases have been filed in federal district courts challenging the constitutionality of the Inflation Reduction Act’s authorization for CMS to negotiate Medicare drug prices.
    • “The pharmaceutical industry has been filing a lawsuit here, there, and pretty much everywhere.
    • “Drugmakers lost a two-decade long lobbying fight in Congress last summer when Democrats gave Medicare more power to choose what it pays for prescription drugs. Now, they’re taking their battle to the courts.
    • “Merck filed suit in the District of Columbia. Bristol Myers Squibb filed in New Jersey. The Chamber of Commerce filed in Ohio. PhRMA filed in Texas. And there’s no reason to believe the barrage of lawsuits will stop anytime soon.
    • “They’re dividing and conquering to advance different legal arguments. The Merck and Bristol Myers Squibb lawsuits were strikingly similar. They relied on the same legal reasoning, and were filed by the same firm and a few of the same attorneys, even. The PhRMA and Chamber of Commerce suits advanced different arguments that were also similar to each other.
    • “The scattershot approach, according to legal experts, increases the industry’s chance of producing conflicting decisions that the Supreme Court would have to resolve.”

From the public health front —

  • Healthcare Dive points out
    • “From 2019 to 2021, preventable deaths in Louisiana, Mississippi, Texas and New Mexico climbed by more than 35%, and the rates in Arizona increased by 45%, according to nonprofit Commonwealth Fund’s 2023 Scorecard on State Health System Performance released Thursday. The report attributes the increase in deaths mostly to the COVID-19 pandemic.
    • “The mortality rate for women in their reproductive years (age 15 to 44) rose nearly 40% due to maternal deaths, COVID-19, and substance misuse.
    • “Massachusetts, Hawaii, New Hampshire, Rhode Island and Vermont had the best overall health system performances while states in the Southeast and South Central regions ranked the lowest. Those included Arkansas, Texas, Oklahoma, West Virginia and Mississippi.”
  • Here’s a link to the scorecard.
  • The Department of Health and Human Services announced
    • “A large nationally representative study shows in-hospital delivery-related maternal mortality rates improved 57% between 2008 and 2021, despite identified increases in severe maternal morbidity (SMM). This observational study of over 11 million hospital discharges, conducted by the HHS Office on Women’s Health (OWH) and published in JAMA Open Network, intends to more clearly define trends and risk factors leading to maternal mortality and morbidity in the United States and to improve overall national prevention and treatment efforts.
    • “This decline in deaths during delivery hospitalization likely demonstrates the impact of national and local strategies to improve the quality of care by hospitals during delivery-related hospitalizations. This includes HHS quality improvement activities such as state Perinatal Quality Collaboratives and the Alliance for Innovation on Maternal Health, and ties into the Administration’s commitment to addressing the maternal health crisis, with the United States facing some of the highest maternal death rates among developed nations.”
  • The Wall Street Journal reports
    • “Severe fungal disease used to be a freak occurrence. Now it is a threat to millions of vulnerable Americans, and treatments have been losing efficacy as fungal pathogens develop resistance to standard drugs. 
    • “Medical experts say one reason for the surge is that more people have compromised immune systems, including cancer patients and those taking medicines after organ transplants. Compounding the problem, research shows, is that rising temperatures appear to have expanded the geographical range of some deadly fungal pathogens and possibly made them better adapted to human hosts.
    • “It’s going to get worse,” said Dr. Tom Chiller, head of the fungal-disease branch of the Centers for Disease Control and Prevention.
    • “The failure of some doctors to recognize quickly enough what is happening to stricken patients is causing deaths and complications they could have prevented.
    • “Fungi aren’t being given enough thought,” said Dr. Peter Pappas, an infectious-disease specialist at the University of Alabama at Birmingham. “When symptoms can’t be explained, fungi should be one of the first things you think about.”

From the Rx coverage front —

  • STAT News reports
    • The Food and Drug Administration granted conditional approval Thursday to the first gene therapy for Duchenne muscular dystrophy. Regulators restricted the treatment to younger patients, with additional data required to broaden its use.
    • The gene therapy, called Elevydis, is made by Sarepta Therapeutics. The company will charge $3.2 million for the treatment, making it the U.S.’s second most expensive drug, behind a recently approved gene therapy for hemophilia. CEO Doug Ingram said on a conference call the price was below what a recently published company-funded analysis found would be cost-effective.
  • Here’s a link to the FDA announcement, which includes more details.

Tuesday Tidbits

David Ermer–Congress, COVID-19, COVID-19 vaccine, Medical / Rx research, Medicare, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The House of Representatives Committee on Education and the Workforce held a hearing today to examine the policies and priorities of the Department of Health and Human Services.
  • STAT News adds
    • “A key House Republican ramped up his criticism of pharmacy benefit managers Tuesday, calling for the government to dismantle companies that have consolidated drug supply chain operations.
    • “We should break these PBMs up,” House Oversight Committee Chair James Comer (R-Ky.) said during an Education and Workforce Committee hearing. Health Secretary Xavier Becerra testified at the hearing on his department’s priorities. * * *
    • “Comer asked Becerra what the administration thinks should be done to reform PBMs.
    • “Transparency,” Becerra responded. “As they say, sunshine is the best disinfectant.”
  • STAT News reports from the Senate
    • “In another bid to lower prescription drug prices, U.S. Sen. Bernie Sanders (I-Vt.) issued a report showing that medicines developed with help from the National Institutes of Health have often cost Americans more than what is paid in other countries. And he called on the agency to reinstate a provision in federal law that would require companies to set reasonable prices when they license NIH inventions. * * *
    • “The report was issued as the Biden administration seeks confirmation of Monica Bertagnolli, who currently heads the National Cancer Institute and was nominated to run the NIH. But the confirmation cannot proceed without support from Sanders because, as chair of the Senate health committee, he controls when nominees are reviewed for positions in the Department of Health and Human Services.
    • “However, Sanders threatened that he will not proceed until the Biden administration provides a “comprehensive” plan to lower prescription drug prices. The White House reportedly responded by acknowledging that prescription drug costs remain high for many Americans and pointed to the Inflation Reduction Act, a recently enacted law that allows Medicare to negotiate prices for certain medicines.”
  • Fierce Healthcare reports
    • “The Biden administration is rolling out new flexibilities that aim to prevent procedural coverage losses as states work through a backlog of Medicaid eligibility determinations.
    • “The Department of Health and Human Services announced that managed care plans can take on a more direct role in assisting members in completing renewal forms. This extends to filling out certain parts of the paperwork on behalf of the member.
    • “In addition, states are able to delay administrative disenrollments by a month for further outreach, which will allow for greater time to fill out necessary forms and paperwork. The agency will also allow pharmacies and community-based organizations to assist in getting coverage reinstated for people who are still eligible but lost coverage for procedural reasons.
    • “Procedural disenrollment is a key concern during the Medicaid redetermination period, as many people who are at risk of losing coverage are not aware that the process is even going on. A recent analysis from KFF looking at early redetermination data found that in a number of states, large numbers of disenrollments are linked to administrative issues.”
  • and
    • “Industry hospital groups are pushing the Centers for Medicare & Medicaid Services (CMS) to consider a higher annual pay bump and to shed some light on why it believes the number of uninsured patients won’t be increasing during fiscal year 2024.
    • “In April, CMS released its proposed fiscal year 2024 Inpatient Prospective Payment Systems (IPPS) rule with a 2.8% increase in payments for the 12-month period beginning in October.
    • “The tentative pay raise for eligible participating hospitals translates to a collective $3.3 billion increase, CMS said at the time, and is based on a 3% projected hospital market basket update minus a 0.2 percentage point productivity adjustment.
    • “Comment letters submitted by the American Hospital Association (AHA) and other major hospital industry groups on Friday homed in on the 2.8% net update as “woefully inadequate” in light of cost pressures, such as inflation and labor spend, that have not subsided since the height of the COVID-19 pandemic.”

From the public health front —

  • The Wall Street Journal tells us
    • “Longevity researchers have spent decades hunting for a magic pill to slow the aging process. But the best solution—at least for now—may be the simplest one: Move more.
    • “No single thing—whether it’s regular cold plunges or off-label drugs and supplements like metformin, rapamycin or taurine—has a track record that can match exercise’s in terms of protecting against age-related diseases and helping people get more from their later years, a vast body of research shows.
    • “The muscle and bone growth stimulated by exercise can help older adults maintain their independence, lessen fatigue and protect against bad injuries from falls, the leading cause of injury-related death among those over 65. 
    • “Regular exercise can reduce the risk of developing certain age-related diseases, including Alzheimer’s, cancer, diabetes and cardiovascular disease. * * *
    • “Any amount of physical activity can help extend a person’s life, research suggests, especially for people who currently are doing very little. Federal guidelines recommend that adults get at least 150 minutes of moderate-intensity exercise a week. 
    • “A team of researchers who analyzed data on more than 650,000 adults over about a decade found that, compared with those who were inactive, those who got about half the government’s recommended physical activity added an average of 1.8 years to their lives. Those who exercised for roughly five to eight hours weekly gained an average of 4.2 years.
    • “When you think about that, in terms of how many years you’re gaining per how many minutes of activity, it’s a very sizable yield,” says Steven C. Moore, the study’s lead author and senior investigator at the National Cancer Institute.”
  • Healthcare Dive informs us
    • “Uber will soon be able to deliver groceries and other over-the-counter items to patients of its payer and provider clients, in the latest benefits expansion of its Uber Health platform.
    • “Uber Health, which already provides non-emergency medical transportation and prescription delivery, has been expanding beyond medical transportation to care coordination across multiple benefits, Catilin Donovan, the head of the division, said in an interview. Soon, provider users will have access to patient benefit data and eligibility files from their health insurers, so they can prescribe services they know are covered.
    • Uber is not yet giving specifics of Uber Health’s financial performance, but Uber Health grew bookings by 75% year over year in the first quarter. Donovan declined to say whether Uber Health was profitable.”
  • The Government Accountability Office released a watchdog report on law enforcement-oriented approaches to reducing deaths from drunk driving.
  • The All of Us campaign issued its June report.

From the medical research front,

  • The National Institutes of Health announced
    • “Repeat treatment with corticosteroid injections improved vision in people with persistent or recurrent uveitis-related macular edema better than two other therapies, according to results from a clinical trial funded by the National Eye Institute (NEI). Compared with methotrexate or ranibizumab intravitreal (in-the-eye) injections, the corticosteroid treatment achieved greater reductions in retinal swelling and was the only therapy in the study that improved vision. The report was published today in the journal Ophthalmology. NEI is part of the National Institutes of Health.”
  • The Cigna Newsroom relates,
    • “A new study by Cigna Healthcare found that site-of-care redirection is associated with favorable clinical outcomes and increased access and affordability for peg­filgrastim, an injection used to prevent infection in cancer patients. The results showed that patients experienced better outcomes when the injection was administered in a home setting rather than a nonhome setting. The study was recently published in the Journal of Clinical Pathways.
    • “This study shows that we can help improve health outcomes by providing cancer patients with treatment such as infusions in a setting where many are most comfortable – home,” said Dr. Scott Josephs, chief medical officer, Cigna Healthcare. “These findings confirm that home infusion of complex and expensive specialty medications presents new opportunities to maximize access, improve effectiveness, increase affordability, and enhance convenience for patients.”