“A small group of Republican senators on Friday called on President Biden to ban travel from China to protect against an outbreak of respiratory illnesses in children there, even as scientists and global and American health officials said there were no signs of a threatening new pathogen.
“Instead, those experts said, the evidence so far pointed to a surge of age-old infectious agents such as influenza, driven by the colder weather and China’s emergence from stringent Covid lockdowns. The World Health Organization said last week that China had shared data about its outbreak, including laboratory results from infected children, that did not show any unusual pathogens.
“Dr. Mandy Cohen, the director of the Centers for Disease Control and Prevention, echoed that assessment on Friday. She said American officials had also been in touch with Chinese authorities, academic experts and health workers.
“What we have all been able to ascertain is that there is no novel pathogen,” she said. “This is all related to upticks of known viruses and bacteria in their pediatric population.”
“There’s just not much that’s very effective for treating the common cold,” said Dr. Lauren Eggert, clinical assistant professor in the Pulmonary Allergy and Critical Care Division at Stanford University. * * *
“She opens a database called UpToDate, which physicians use as a resource when they want to see the summary of evidence for medications targeting specific concerns. The conclusions for cold and flu remedies are disconcerting:
“Antihistamines, vitamins and herbal remedies are deemed ineffective.
“Cough syrups, decongestants, expectorants, and zinc may have minimal or uncertain benefits.
“Nasal sprays and analgesics like Tylenol and ibuprofen may be effective.”
The American Medical Association lets us know what doctors wish their patients knew about Covid oral anti-virals, Paxlovid and molnupiravir.
“Breast cancer has a worse prognosis when diagnosed during pregnancy or postpartum. Methods for early detection are needed, as evidenced every day in the multidisciplinary unit for treating pregnancy-associated breast cancer, which operates within the Breast Unit at the Vall d’Hebron University Hospital in Barcelona, Spain.
“The team working in this field is led by Cristina Saura, PhD, who is also head of the Breast Cancer Group at the Vall d’Hebron Institute of Oncology (VHIO). The results of a study recently published in Cancer Discoveryshow, for the first time, that breast milk from breast cancer patients contains circulating tumor DNA (ctDNA) that can be detected by a liquid biopsy of the milk.”
“The Departments of Health and Human Services, Labor and the Treasury Oct. 27 issued a proposed rule intended to improve how the No Surprises Act independent dispute resolution process functions in response to feedback and challenges shared by stakeholders. The public will have 60 days to submit comments. The rule would require plans to include claim adjustment reason codes and remittance advice remark codes, among other new information, with the initial payment or notice of payment denial for certain items and services subject to the NSA protections. The rule proposes changes to the batching requirements so that Items and services could be batched in the same payment determination if they are: furnished to a single patient on one or more consecutive dates of service and billed on the same claim form (a single patient encounter); billed under the same service code or a comparable code under a different procedural code system; or anesthesiology, radiology, pathology and laboratory items and services billed under service codes belonging to the same Category I CPT code section, as specified in the agencies’ guidance. Batched items would be limited to 25 items or services in a single dispute. Lastly, the proposed rule would amend certain requirements related to the open negotiation period preceding the IDR process, the initiation of the process, the dispute eligibility review, and the payment and collection of administrative fees and certified IDR entity fees.”
The proposed rule will be published in the Federal Register next Friday, November 3, and the proposal creates a sixty-day public comment period.
Here’s a link to the government’s fact sheet on the proposed rule.
The FEHBlog noticed that the proposed rule would run open negotiations through the government’s IDR portal, which will increase the government’s administrative costs. It strikes the FEHBlog that the proposed rule could have established a process for the open negotiation for the parties to follow. The proposed rule will require health plan system changes, which is always expensive.
Also today, the Department of Health and Human Services wrote to stakeholders, including health plans, reminding them the cost of Paxlovid and other Covid drugs is shifting from the government to the private sector beginning on November 1.
“The Food and Drug Administration on Thursday approved an Eli Lilly drug that takes a new approach to treating ulcerative colitis, a chronic inflammatory disease that can cause intense gastrointestinal pain and distress.
“The therapy, dubbed Omvoh, is an antibody that blocks IL-23p19, an immune signaling molecule that plays a key role in sustaining the disease. It’s the first treatment to target this particular pathway in ulcerative colitis. The drug’s approval comes after two late-stage trials found that patients taking Omvoh showed a significant improvement in symptoms after both three months and a year compared with those given a placebo, and that the therapy had minimal side effects.
“Omvoh’s list price will be $9,593 per month for intravenous delivery and $10,360 per dose injected beneath the skin. A company spokesperson told STAT that patients who have the drug covered by commercial insurance may pay as little as $5 per month for up to 30 months.”
“Americans are feeling more optimistic about their well-being than last year, but financial concerns and mental health challenges are still negatively impacting their health, according to a report from The Cigna Group.
“The second annual Vitality in America study reflects responses from 10,000 adults collected in June 2023 by Morning Consult. The study uses the Evernorth Vitality Index, a subjective measure of health and well-being, to assess Americans’ experiences with personal health, finances, and job satisfaction.
“Almost half of respondents said they look forward to each new day, up from 43 percent in 2022. However, fewer adults said they prioritize their physical health (39 percent), feel capable of managing their emotions (45 percent), and can financially support themselves (40 percent).
“The top driver of stress among US adults was finances (40 percent), followed by housing conditions (25 percent), work (25 percent), family or social relationships (25 percent), and health (24 percent).”
“More patients are accessing their medical records online via patient portals or apps and are doing so more often than in years past, according to the Office of the National Coordinator for Health IT (ONC).
“From 2020 to 2022, the portion of U.S. adults who reported being offered access to their medical records by a provider or insurer increased 24% to about 3 in 5, the office wrote in a recent data brief. The percentage who said they were offered access and used it jumped 50% during the same period, from 38% to 57%, according to ONC.
“Together these findings demonstrate increased patient demand for and use of online health information by individuals in recent years,” the office wrote in the brief, citing data from the 6,252-respondent 2022 Health Information National Trends Survey.
“Patients who were offered access to their online medical records also used them more frequently—54% reported accessing their records at least three times during 2022, compared to 38% in 2020 and 26% in 2017.”
“The emergence of telehealth during the COVID-19 pandemic and the resulting surge in the adoption of telemedicine are helping address patients’ needs without major signs of safety concerns, according to a study by Kaiser Permanente.
“The study, published in the Annals of Internal Medicine, analyzed more than 1.5 million adult patients at Kaiser Permanente Northern California in 2021, and compared treatment and follow-up visits among primary care telemedicine (video and telephone) and in-person office visits.
“Of the 2,357,598 primary care visits analyzed, just over half (50.8%) utilized telemedicine, which broke down to just under 20% composed of video visits and 31.3% telephone visits.
“The findings indicate that medication prescriptions were lower for video and telephone visits at 38.4% and 34.6%, respectively, compared to in-person visits at 46.8%. Additionally, follow-up appointments within seven days were less frequent for in-person visits (1.3%) compared to video (6.2%) and telephone (7.6%) visits.”
“Among the 3188 people with type 2 diabetes who were adherent to their tirzepatide (Mounjaro, Lilly) regimen in four pivotal trials of the agent, a quarter achieved at least a 15% cut from their baseline body weight after 40–42 weeks of treatment, and researchers found seven baseline variables that were significantly linked with a higher incidence of this level of weight loss.
“These findings help inform which people with type 2 diabetes are most likely to achieve greater body weight reduction with improved cardiometabolic risk factors with tirzepatide,” say the authors.”
HR Dive offers advice to employers about how to extend a helping hand to employees in their first trimester of pregnancy.
From the U.S. healthcare business front,
Mercer Consulting offers plan design advice to self-fund health plan sponsors. For example,
“Commit to affordable plan designs. One of the biggest reasons people delay care is because they can’t afford to pay for care. Encourage use of preventive care and chronic condition management.
“Provide advocacy support to help plan members get to the most appropriate care and setting.
“Review the emerging spectrum of virtual care for options to help rein in costs while making care more accessible and affordable to plan members.
“Now is the time to consider the long list of network options that exist in the market today and could result in cost savings.
“If you haven’t explored reference-based pricing, you might want to do so. The protections offered by the No Surprises Act make this a more attractive and less risky option for plan members.
“Make mental health a priority. People with medical conditions often have mental health needs. People with mental health needs often develop medical conditions. It is an investment you can’t afford to overlook.
“Focus on pharmacy. Prescription drug costs are a top driver of medical plan cost increases mostly associated with new drugs and the cost of specialty drugs.”
Big Pharma is almost finished with the cough and cold medicine business.
French drug giant Sanofi said Friday it plans to spin off its consumer-health business, which includes well-known brands like allergy medicine Allegra and the pain treatments IcyHot and Aspercreme.
Once the split is completed as early as the fourth quarter of next year, there will be just one consumer-health business left under the umbrella of a big drugmaker parent. Germany’s Bayer will be the largest drugmaker with such a business.
Sanofi and its rivals have made the moves in the hunt for higher margins and faster sales growth. “It allows Sanofi to become a pure-play biopharma company. We’ll be more agile and more focused in our areas of key areas of strength,” Chief Executive Paul Hudson said.
Yet the companies lose the crutch of a reliable source of cash flow and now face more pressure to hit on breakthrough medicines with large sales potential.
“GOP Rep. Jim Jordan failed again to win enough votes to be elected House speaker, as divisions hardened for House Republicans, with some lawmakers pursuing new paths to break the impasse that has paralyzed the chamber.
“More than two weeks after former House Speaker Kevin McCarthy (R., Calif.) was ousted, Republicans remained gripped in a fierce internal struggle over his successor. Jordan said he would keep up his campaign, but pushed off any further voting until Thursday at the earliest as mounting GOP defections on his second ballot left Republicans snarled into warring factions over what should happen next.”
The Federal Times informs us that the Senate is considering a bipartisan bill to improve benefits for the families of federal employees who die on the job.
“A bipartisan trio of Senators hope to advance new legislation aimed at improving and “streamlining” federal agencies’ customer service across platforms, in part by adopting practices already employed in the private sector.
“Customer service at agencies that interact with members of the public has been top of mind for lawmakers and administration officials in recent years. During the height of the COVID-19 pandemic, that attention was on electronic means like phone and the Internet, while over the last 18 months, the focus turned toward in-person service as well as backlogs that cropped up over the course of the pandemic.
“The Improving Government Services Act (S. 2866), introduced by Sens. Gary Peters, D-Mich., James Lankford, R-Okla., and John Cornyn, R-Texas, last month but publicized Tuesday, tasks federal agencies that provide services to members of the public to develop annual customer experience action plans and submit them both to the director of the Office of Management and Budget and Congress. The Senate Homeland Security and Governmental Affairs Committee is slated to consider the bill next week.”
MedPage Today discusses today’s confirmation hearing for the President’s nominee to be NIH Director, Dr. Monica Bertagnolli.
“In laying out her vision for the agency, a key theme for Bertagnolli was equity. “NIH can and must support research that is equitable and accessible to all populations,” she said, stressing the need to diversify clinical trials.”
The Internal Revenue Service announced, “The applicable dollar amount that must be used to calculate the [PCORI] fee imposed by sections 4375 and 4376 for policy years and plan years that end on or after October 1, 2023, and before October 1, 2024, is $3.22. This is the per belly button fee that FEHB plans will owe for the current 2023 plan year next July 31, 2024.
HHS Office for Civil Rights issued “Resources for Health Care Providers and Patients to Help Educate Patients about Telehealth and the Privacy and Security of Protected Health Information.”
AHIP posted its helpful comments on the proposed mental health parity rule changes. The public comment deadline was yesterday.
Fedsmith offers its guidance on the upcoming Federal Employee Benefits Open Season.
Treatments like Ozempic, Wegovy, and Mounjaro have been hailed for showing 15% to over 20% weight loss in trials, but those are just averages. In reality, there are big variations in how much weight people lose on the therapies, and it’s unclear what explains those differences.
“One way researchers are trying to figure this out is by focusing on genes.
“The variability is so wide that we want to understand what predicts response,” said Lee Kaplan, chief of obesity medicine at the Geisel School of Medicine at Dartmouth. Since genetics is a significant reason people develop obesity, and since early data also show that genetics may contribute to how people respond to bariatric surgery, “that would argue that there’s probably going to be a genetic contribution” to the amount of weight loss people experience on obesity drugs.”
Beckers Hospital Review discusses what the closure of various Walgreen’s and Rite Aid drug stores means for healthcare.
“The closures also disproportionately affect Black and Latino city neighborhoods, as well as rural areas, according to Serena Guo, MD, PhD, an assistant professor at the Gainesville-based University of Florida College of Pharmacy.
“Closure has the potential to worsen disparities in access to pharmacies,” Dr. Guo told MarketWatch.”
“Starting buprenorphine treatment for opioid use disorder through telehealth was associated with an increased likelihood of staying in treatment longer compared to starting treatment in a non-telehealth setting, according to a new study analyzing Medicaid data from 2019-2020 in Kentucky and Ohio. Published in JAMA Network Open, these findings(link is external) add to a growing body of evidence demonstrating positive outcomes associated with the use of telemedicine for treatment of opioid use disorder.
“In Kentucky, 48% of those who started buprenorphine treatment via telehealth remained in treatment for 90 continuous days, compared to 44% of those who started treatment in non-telehealth settings. In Ohio, 32% of those who started buprenorphine treatment via telehealth remained in treatment for 90 continuous days, compared to 28% of those who started treatment in non-telehealth settings.”
“Pfizer will price a course of its Covid-19 drug Paxlovid at nearly $1,400 when commercial sales begin later this year, more than double what the U.S. government has paid.
“Pfizer told the pharmacies and clinics that will dispense Paxlovid, in a letter dated Wednesday that was viewed by The Wall Street Journal, that a five-day course of the antiviral will list for $1,390. The U.S. government had paid $529.
“Health plans will probably pay much less than the list price for the pills, and most patients will have a small or no out-of-pocket cost because Pfizer is expected to offer price discounts and help patients with their out-of-pocket charges.
“Pfizer has already faced criticism from doctors and patient advocates that raising the price will limit patient access. Disclosure of the list price will probably fuel further criticism.”
“Amid rising inflation, annual family premiums for employer-sponsored health insurance climbed 7% on average this year to reach $23,968, a sharp departure from virtually no growth in premiums last year, the 2023 benchmark KFF Employer Health Benefits Survey finds.
“On average, workers this year contribute $6,575 annually toward the cost of family premium, up nearly $500 from 2022, with employers paying the rest. Future increases may be on the horizon, as nearly a quarter (23%) of employers say they will increase workers’ contributions in the next two years.
“Workers at firms with fewer than 200 workers on average contribute nearly $2,500 more toward family premiums than those at larger firms ($8,334 vs. $5,889). In fact, a quarter of covered workers at small firms pay at least $12,000 annually in premiums for family coverage.
“This year’s 7% increase in average premiums is similar to the year-over-year rise in workers’ wages (5.2%) and inflation (5.8%). Over the past five years, premiums rose 22%, in line with wages (27%) and inflation (21%).”
“Henry Ford Health and Ascension Michigan have signed an agreement to enter into a joint venture, the latest merger between health systems in Michigan.
“According to the health systems, Ascensions Southeast Michigan and Genesys healthcare facilities will join with Henry Ford’s. * * *
According to the companies, the combined organization would employ around 50,000 team members at more than 550 sites of care across the area.”
“Thirty-nine percent of mergers and acquisitions announced in the third quarter included a hospital or health system that cited financial distress as a driver for deal, according to a report by Kaufman Hall.
“Though M&A activity is continuing to trend back to pre-pandemic levels, the number of hospitals in distress shows the financial strain of the past two years, the report said. Eighteen transactions were announced in the third quarter, compared with just seven in the same period in 2021 and 10 during the third quarter in 2022.
“Increased costs, both for labor and other expenses, has been a significant challenge for smaller and medium-sized health systems. Now, more large systems — with annual revenue of $1 billion or more — are pointing to financial concerns as their reason for dealmaking, according to Kaufman.”
“In the third quarter, we completed a strategic review of our operations, assets, and investments to enhance operating efficiency, refine the focus of our investments in innovation and optimize our physical footprint,” the company wrote. “This resulted in a net charge of $697 million, comprised of the write-off of certain information technology assets and contract exit costs, a reduction in staff including the relocation of certain job functions, and the impairment of assets associated with the closure or partial closure of data centers and offices.”
“Elevance Health posted $1.3 billion in net income during the third quarter, a nearly 20% decrease compared to the same period last year, according to the company’s earnings report published Oct. 18.
“Consumers’ overall satisfaction with health insurers is up 4% over 2023, according to a report from the American Customer Satisfaction Index published Oct. 17.
“Customer satisfaction with insurers reached a score of 76 out of 100, the highest in the index’s history, according to the report.”
“Amazon Pharmacy is launching drone delivery for prescription medication orders with the service initially taking flight in College Station, Texas, the company announced Wednesday.
“The pharmacy deliveries will be dropped, quite literally, outside a consumer’s front door within 60 minutes at no additional cost for eligible Amazon Pharmacy customers, the company said.
“Amazon Pharmacy is teaming up with the online retailer’s drone service, Prime Air, which kicked off commercial deliveries in the same Texas city in December.
“Delivery of medications via drone will be offered in College Station initially and will expand to additional cities in the coming years, an Amazon Pharmacy spokesperson said. The announcement was made this week as part of Amazon’s Delivering the Future event in Seattle focused on its latest innovations.”
“Senate Majority Leader Chuck Schumer (D-N.Y.) is ramping up the pressure on Speaker Kevin McCarthy (R-Calif.) to avoid a government shutdown by moving first on a stopgap funding bill that will pass the Senate this week, a few days before the Sept. 30 deadline.
“The Senate’s plan is to send the bill to the House and put pressure on McCarthy to bring it to the floor for a vote it would pass with bipartisan support if given the chance, said senators who are calculating how the endgame will play out.”
The Department of Health and Human Services released a letter from Secretary Xavier Becerra to “the health payer community.” This is the paragraph that grabbed the FEHBlog’s attention:
“I also know that, with the end of the public health emergency, the requirement to cover COVID-19 vaccinations furnished by out-of-network providers generally has ended. However, if a plan or issuer does not have a provider in its network who can provide a qualifying coronavirus preventive service, the plan or issuer must cover the item or service when furnished by an out-of-network provider and may not impose cost-sharing with respect to the item or service. We want to underscore the public health importance of reducing barriers to coverage however possible and urge you to consider any and all ways to reduce these barriers. It is critical to help your members navigate your network, particularly to help people understand the differences between your medical and pharmacy network as appropriate. We know you are already looking for ways to smooth these issues and hope that will continue. In the meantime, we will do our part to urge consumers to seek in-network providers when possible.”
Fierce Healthcare tells us about a D.C. conference at which attendees encouraged the Centers for Medicare and Medicaid Services to offer Medicare coverage for the new generation of anti-obesity drugs.
“Healthcare organizations are continuing to push the Centers for Medicare & Medicaid Services (CMS) to rethink its coverage policy for anti-obesity medications.
“These medicines are not covered by Medicare Part D, because existing statutory exclusion is in place for these drugs that do not cover “agents when used for anorexia, weight loss or weight gain,” according to a press release. In a joint press conference hosted by health experts at Manatt, Phelps & Phillips and the Obesity Action Coalition, advocates laid out a legal basis in support of covering GLP-1s, stating that they can target obesity rather than describing the drugs solely in terms of their effects on weight.
“Obesity is a disease that has multiple causes and consequences not limited to weight,” said Michael Kolber, a healthcare partner at Manatt Health, to reporters. “There are many drugs that cause weight loss or weight gain, even if that’s not why they’re being prescribed.”
“As the Biden administration pushes to make insurers cover mental health care on par with physical care, there’s a similar push from lawmakers and advocates for electronic health records, Ben reports.
“Mental health and substance-use providers weren’t allowed to get billions in federal subsidies for adopting EHRs in the 2009 HITECH Act, which advocates argue has led to significant disparities in uptake between behavioral and physical health providers. While data varies, one recent federal estimate found that 49 percent of psychiatric hospitals have certified electronic health records compared to 96 percent of general and surgical hospitals.
“Without the funding, the behavioral health industry didn’t invest in robust behavioral health-specific electronic health systems, said Alisa Chestler, a Baker Donelson attorney with digital health expertise.
“Legislation from Reps. Doris Matsui (D-Calif.) and Bill Johnson (R-Ohio) and Sens. Markwayne Mullin (R-Okla.) and Catherine Cortez Masto (D-Nev.) would add $20 million in annual grant funding through ONC for behavioral health EHR adoption. Advocates hope it will get into the final SUPPORT Act reauthorization package aimed at addressing the opioid epidemic. The package expires Sept. 30 without Congressional action.
“Al Guida, a lobbyist speaking on behalf of the Behavioral Health IT Coalition, said the lack of EHR adoption in behavioral health prevents such care from being integrated into primary care. David Bucciferro, chair of the HIMSS Electronic Health Record Association, added that it hurts care coordination.”
From the public health front,
In a surprise to the FEHBlog, MedPage Today informs us
“Both nirmatrelvir-ritonavir (Paxlovid) and molnupiravir (Lagevrio) were associated with a reduction in death during the COVID-19 Omicron era, a large retrospective study of electronic health records from the Cleveland Clinic showed.
“Compared with not receiving any treatment, nonhospitalized COVID patients who received nirmatrelvir-ritonavir saw an 84% reduction in mortality (adjusted hazard ratio 0.16, 95% CI 0.11-0.23) and those who took molnupiravir saw a 77% reduction in death (adjusted HR 0.23, 95% CI 0.16-0.34), according to Danyu Lin, PhD, of the University of North Carolina in Chapel Hill, and colleagues. * * *
“We show that these two drugs work very similarly,” Lin told MedPage Today. “The fact that molnupiravir works as well as Paxlovid is an interesting finding, and I would say this finding is not inconsistent with existing literature.”
“Indeed, earlier this week, the American College of Physicians (ACP) issued an updated version of its practice guidelines for outpatient management of COVID in the Omicron era and continued to recommend both antivirals equally.”
That’s very good news.
Precision Vaccinations discusses the four vaccinations now available to pregnant people in their third trimester.
The Institute for Clinical and Economic Research issued “a Draft Evidence Report assessing the comparative clinical effectiveness and value of sotatercept (Merck & Co) for pulmonary arterial hypertension. This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions. * * * On October 5, 2023, as part of ICER’sEarly Insights Webinar Series, ICER’s Chief Medical Officer, David Rind, MD will present the initial findings of this draft report.”
“The declines in body weight that patients experience with injectables like semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro) are no exception to the concept that nothing lasts forever.
“Eventually, everybody reaches a “plateau,” even on newer GLP-1 receptor agonists. It’s a phase at which the body reaches a new “settling point,” specialists said, and weight, along with other metabolic markers like blood pressure and HBA1c stabilize, or fluctuate only slightly. For some, this may mean a gradual increase in appetite or “food noise”; others may be able to maintain their current state.
“Studies have shown that, on average, this plateau happens at a little over a year with semaglutide. Even so, physicians say some patients are surprised to learn that there’s a limit to what these medications can do.
“Everyone will plateau, of course. No one on my watch has disappeared. No one has vanished,” Jody Dushay, MD, an endocrinologist at Beth Israel Deaconess Medical Center in Boston, told MedPage Today. “It’s alarming to me that people find that surprising, but everyone will reach a plateau and there’s no way to know when you start the medication what that will be, what percent weight loss that will be, and how quickly they will reach it.”
“Rite Aid proposed closing nearly a fourth of its 2,100 pharmacies and declaring bankruptcy, people familiar with the matter told The Wall Street Journal in a Sept. 22 story.
“The outlet recently reported the pharmacy chain is preparing to file for Chapter 11 bankruptcy as it faces $3.3 billion in debt and numerous lawsuits over its alleged role in the opioid epidemic. Chapter 11 bankruptcies are commonly used to reorganize a company’s structure to continue its business while paying creditors over time.
“The bankruptcy discussions include a plan to close between 400 and 500 of its stores while either having creditors take the remaining pharmacies or selling them. Rite Aid is also considering an auction to sell sections of the business, such as its Elixir pharmacy unit.”
“investing $1 million in national and community-based organizations this fall to address food insecurity among older Americans. Collectively, the funds are expected to provide more than 3 million meals to people in need, increase access to 1.88 million pounds of fresh produce, and save 21 million gallons of water and 2.89 tons of CO2e emissions in responsible food distribution, supporting better health and positively impacting the environment.”
“Fifty-six innovative programs spanning 12 states received critical financial support enabling them to reach thousands of seniors who face food insecurity. The organizations range from local Meals on Wheels chapters and food banks to senior- and veteran-focused coalitions and centers. The sponsorships will also fund food- and nutrition-based programs, such as food pantries, mobile food deliveries, and nutritional meal boxes.”
In a random note, the Washington Post shares opinions on current telephone etiquette which the FEHBlog found illuminating.
“President Biden said negotiators were closing in on a deal to cut spending and raise the $31.4 trillion debt limit, seeking to overcome final hurdles on issues regarding the budget as well as requiring more people to work to receive federal benefits.
“He said talks are “very close” to reaching an agreement and that he was hopeful that there could be a breakthrough as soon as later on Friday. “I hope we’ll have some clear evidence tonight, before the clock strikes 12, that we have a deal,” he said as he departed the White House for Camp David on Friday evening.
“Negotiators are hoping to strike a deal soon in order to set up votes on the legislation next week. The Treasury Department, which is currently using extraordinary measures to avoid exceeding the debt ceiling, estimated Friday that the government could run out of money to pay its bills if Congress doesn’t act by June 5.
“Treasury had previously put the deadline as early June, saying it could come as soon as June 1. Any legislation would likely take at least several days to pass both the House and Senate.
“The federal government’s HR agency on Wednesday unveiled new guidance aimed at standardizing and revitalizing employee assistance programs across the federal government, an effort officials said would prioritize employee wellness and improve productivity.
“Like many private sector employers, federal agencies often offer employees access to employee assistance programs, which provide services related to maintaining one’s mental and physical health, as well as resources related to substance use issues.
“The Office of Personnel Management, spurred by a provision of President Biden’s management agenda tasking agencies with promoting “awareness of employee well-being and [supporting] initiatives that extend beyond the workplace,” underwent a year-long effort to design a “standardized approach” to employee wellness programs, consulting with focus groups, health experts and vendors who provide assistance programs to employers.
“The result is a 19-page guidance document for agencies to reassess their assistance program offerings and, if necessary, expand them.
The FEHBlog wonders why OPM silos its various benefit programs rather than integrate them to get more bang for the buck.
From the healthcare costs front —
Milliman has released its 2023 Medical Index. Milliman estimates the healthcare cost for a hypothetical family of four enrolled in a hypothetical PPO plan is $31,065, a 5.6% increase over 2022.
The Medical Group Management Association issued its 2023 Physician Compensation and Productivity Benchmarks.
“Productivity remained relatively flat or only slightly increased relative to pre-pandemic benchmarks, with the biggest change in work RVUs posted in dermatology, hematology/oncology, and family medicine (without OB).
“The growth in median total compensation for primary care physicians (PCPs) doubled from 2021 (2.13%) to 2022 (4.41%), but was outpaced by inflation at 7% and 6.5%, respectively.
“Surgical and nonsurgical specialists saw their change in median total compensation cool slightly in 2022, dropping from 3.89% for surgical specialists in 2021 to 2.54% in 2022, and from 3.12% for nonsurgical physicians in 2021 to 2.36% in 2022.
“APPs [advanced practice providers]— who saw the biggest change in median total compensation from pre-pandemic levels — saw their 2022 growth ebb slightly to 3.70%, down from 3.98% growth in 2021.”
“There are 293 rural hospitals at immediate risk of closure due to inflation, staffing shortages and other financial stress, according to the Center for Healthcare Quality & Payment Reform.
“Hospitals at immediate risk of closure have lost money on patient services for multiple years, excluding 2020 during the pandemic, and aren’t likely to receive sufficient funds to cover the losses with public assistance ending, according to the report. These hospitals also have low reserves and more debt than assets.”
“The pandemic prompted a great need for technology-enabled care delivery, so the regulations surrounding reimbursement for these services were tossed out the window in 2020. Now that the public health emergency has ended, the healthcare industry has to figure out how it is going to pay for digital health services going forward.
“It’s clear that services like telehealth and remote patient monitoring have potential to provide value, but hospitals and digital health companies need to show payers clearer evidence of the outcomes these care modalities can produce, panelists argued during a Wednesday session at MedCity News’ INVEST conference in Chicago.”
STAT News adds market perspective on the Food and Drug Administration’s full approval of Paxlovid, announced yesterday.
“The full approval for treating adults at high risk of progression to severe disease will help Pfizer expand its marketing campaign. U.S. officials plan to work through much of the government’s Paxlovid inventory, which is available for free at pharmacies around the country, before moving to a normal commercial market for the drug. Pfizer has sold the U.S. government nearly 24 million courses at around $530 a course, but it is not clear yet what price the company will charge.”
“Integrating Immunization Information Systems (IIS) vaccination records into claims data (collected by health insurers) increased the number of people identified as being vaccinated against COVID-19, according to the results of a study published in JAMA Network Open. Having accurate COVID-19 vaccination data is important for future COVID-19 vaccine studies that capture efficacy and safety, according to the study.
“When claims data were supplemented with IIS vaccination records, the proportion of participants with at least one vaccine dose rose from 32.8% to 48.1%. And when IIS vaccine records were included with claims data, the percentage of people who completed a vaccine series increased from 24.4% to 41.9%, varying by state.”
The Food and Drug Administration is looking to develop standardized “supersets of data” and improve data interoperability, analysis and management across the agency, an official said on Wednesday.
The agency is planning to gather information and seek public input on the use of real-world data in its decision-making processes, according to Jose Galvez, deputy director for the office of strategic programs of the FDA’s Center for Drug Evaluation and Research.
Galvez said at the Professional Services Council 2023 FedHealth Summit that the FDA is set to release a Federal Register notice “very shortly” to gain industry input on evaluating new types of data analysis.
“Top White House officials and Republican lawmakers were closing in on Thursday on a deal that would raise the debt limit for two years while capping federal spending on everything but the military and veterans for the same period. Officials were racing to cement an agreement in time to avert a federal default that is projected in just one week.
“The deal taking shape would allow Republicans to say that they were reducing some federal spending — even as spending on the military and veterans’ programs would continue to grow — and allow Democrats to say they had spared most domestic programs from significant cuts.
“Negotiators from both sides were talking into the evening and beginning to draft legislative text, though some details remained in flux.”
“The Treasury Department is preparing to change how the U.S. processes federal agencies’ payments if the debt ceiling is breached, dusting off a contingency plan crafted after the 2011 borrowing-limit standoff, people familiar with the matter said.
“Just days away from becoming unable to pay all of the government’s bills on time unless Congress raises the debt limit, Treasury officials have been quietly laying the groundwork for potentially delaying some payments after June 1.
“Under the backup plan created for a debt-limit breach, federal agencies would submit payments to the Treasury Department no sooner than the day before they are due, the people familiar with the talks said. That would represent a change from the current system, in which agencies may submit payment files well before their due dates. The Treasury Department processes them on a rolling basis, often ahead of the deadlines. Some payments are already sent to the department one day early, one person said.
“The plan would enable the Treasury to make daily decisions about whether it can pay all of the government’s bills the next day.”
“The [U.S.] House of Representatives passed legislation on Thursday that would make permanent harsh criminal penalties and strict controls on fentanyl-related drugs, with scores of Democrats joining nearly all Republicans in a vote that reflected the political challenges of tackling what both parties consider America’s most pressing drug crisis.
“The bill, approved by a vote of 289 to 133, would permanently list fentanyl-related drugs as Schedule I controlled substances, a designation that mandates severe prison sentences for highly addictive, nonmedicinal chemicals, and which is now set to expire at the end of 2024.
“The bipartisan vote reflected agreement among Republicans and a solid bloc of Democrats that stiffening penalties for fentanyl-related drugs is a necessary component of the federal response to the crisis. According to the Centers for Disease Control and Prevention, there were roughly 75,000 synthetic opioid overdose deaths in 2022, with fentanyl being a main culprit.”
“With many agencies’ return-to-office plans still uncertain, Republicans on the House Oversight and Accountability Committee want to take matters into their own hands.
“GOP committee leaders changed their strategy for trying to get more federal telework data, now reaching out directly to agency heads. In a series of 25 letters, the lawmakers asked for up-to-date numbers of teleworking federal employees, after saying the Biden administration was “not adequately tracking the specific levels of telework.”
“The Biden administration “has not provided current data about the specific amount of telework occurring within federal agencies or across the entire federal workforce. Furthermore, it has provided no objective evidence concerning the impact of elevated telework on agency performance — including any deleterious impacts,” lawmakers said in the letters, published May 18.”
From the Rx coverage front —
Today the Food and Drug Administration granted full marketing approval to Paxlovid, the Covid treatment pill, which in the FEHBlog’s opinion, brought us to the end of the pandemic. Here’s a link to a MedPage Today report on this FDA action
The Institute for Clinical and Economic Research released “a Final Evidence Report assessing the comparative clinical effectiveness and value of resmetirom (Madrigal Pharmaceuticals, Inc.) and obeticholic acid (Ocaliva®, Intercept Pharmaceuticals, Inc.) for non-alcoholic steatohepatitis (NASH).”
“Independent appraisal committee narrowly voted that currently available evidence for resmetirom is adequate to demonstrate a net health benefit over lifestyle management, whereas current evidence for obeticholic acid was deemed inadequate to demonstrate a net health benefit —
“ICER analyses suggest resmetirom would achieve common thresholds for cost-effectiveness if priced between $39,600 – $50,100 per year assuming that short-term effects on liver fibrosis translate into longer-term reductions in cirrhosis; under the same assumptions, obeticholic acid would achieve common thresholds for cost-effectiveness if priced between $32,600 – $40,400 per year.
“Payers should develop coverage criteria based on non-invasive testing to foster equitable access to early detection and treatment across diverse communities.
“Apellis Pharmaceuticals on Thursday became the latest drugmaker to give up on a potential treatment for amyotrophic lateral sclerosis, a neurodegenerative disorder that has frustrated researchers for decades.
“The decision came after a Phase 2 trial showed no benefit for the drug, known as systemic pegcetacoplan, compared with a placebo. It failed to meet the primary endpoint, measured by a statistical tool called the Combined Assessment of Function and Survival, as well as secondary goals assessing overall function, survival, lung function and muscle strength.
“The final results weren’t a total surprise; an independent board monitoring the study had already advised the company not to start a second, “open-label” part of the trial that would have offered the medicine to all participants after the initial 52-week research period. Apellis executives had also signaled to analysts that the trial had a low chance of success.”
“Initial findings from a study of nearly 10,000 Americans, many of whom had COVID-19, have uncovered new details about long COVID, the post-infection set of conditions that can affect nearly every tissue and organ in the body. Clinical symptoms can vary and include fatigue, brain fog, and dizziness, and last for months or years after a person has COVID-19. The research team, funded by the National Institutes of Health, also found that long COVID was more common and severe in study participants infected before the 2021 Omicron variant.
The study, published in JAMA, is coordinated through the NIH’s Researching COVID to Enhance Recovery initiative, a nationwide effort dedicated to understanding why some people develop long-term symptoms following COVID-19, and most importantly, how to detect, treat, and prevent long COVID. The researchers hope this study is the next step toward potential treatments for long COVID, which affects the health and well-being of millions of Americans.
The New York Times discusses the miraculous case of a paralyzed man who has begun to walk again thanks to brain and spine “implants that provided a “digital bridge” between his brain and his spinal cord, bypassing injured sections” of his body.
“Older Americans are increasingly likely to log into “patient portals” to access their health care information — but confidence levels vary.
“About 78% of people aged 50 to 80 now use at least one patient portal, according to the new University of Michigan (U-M) National Poll on Healthy Aging.
“Five years ago, just 51% in this age range used patient portals, the researchers said.
“The poll also found that 55% of those who used patient portals had done so in the past month. About 49% had accounts on more than one portal.
“This surge is partly due to the increase in use of telehealth visits, said Denise Anthony, the U-M School of Public Health professor who worked on the poll.
“This change makes access to secure portals even more important for older adults who want to see their doctors and other health care providers virtually. It also makes the disparities we found in our poll even more troubling,” Anthony said in a Michigan Medicine news release.
“Older adults with annual household incomes below $60,000, and those who were Black or Hispanic, had lower rates of portal use. These groups were also less likely to say they’re comfortable using a portal.”
“U.S. authorities have seized increasing quantities of illegal ketamine, according to new research, a trend that coincides with the psychedelic drug’s rising popularity as a treatment for mental health ailments.
“The number of ketamine seizures by federal, state and local law enforcement in the United States increased from 55 in 2017 to 247 in 2022, while the total weight increased by more than 1,000 percent over that time, according to a letter published Wednesday in JAMA Psychiatry. Most of the ketamine was in powder form, which could raise the risk of being adulterated with deadly drugs such as fentanyl.”
Fedweek reports on Postal Services Health Benefit Program developments. The headline is that OPM expects “lots of questions” about the new program, which will launch in 2025. The good news for OPM and everyone effect affected is that the law requires the Postal Service to stand up a PSHBP education program this summer, which includes PSHBP navigators similar to the approach taken with the ACA marketplace.
FedWeek also tells us that the U.S. Court of Appeals for the D.C. Circuit rejected on procedural grounds a federal employee challenge to the Biden Administration’s Covid vaccine mandate for federal employees. The mandate has been blocked by a preliminary injunction in another federal judicial circuit. In any event, the vaccine mandates will end on May 12, the day after the Covid public health emergencies end.
A key Senate committee advanced legislation to ban pharmacy benefit manager tactics, such as spread pricing and clawback fees, and heighten transparency of the industry.
The Senate Commerce Committee passed the PBM Transparency Act of 2023 by a vote of 18 to 9 on Wednesday, advancing the reform legislation to the full Senate. Lawmakers said the legislation is meant to address a source of unfair and deceptive practices that increase drug prices.
Senators Chuck Grassley (R Iowa) and Maggie Hanson (D NH) have “introduced the Healthy Moms and Babies Act to improve maternal and child health care. The United States has a maternal health crisis that particularly affects women of color and those living in rural America. The Healthy Moms and Babies Act would achieve its goal by
Coordinating and providing “whole-person” care, supporting outcome-focused and community-based prevention, and supporting stillbirth prevention activities and expanding the maternal health workforce.
Modernizing maternal health care through telehealth to support women of color and women living in rural America.
Reducing maternal mortality and high-risk pregnancies including C-section births, and improving our understanding of social determinants of health in pregnant and postpartum women.
The future of Alzheimer’s treatments and coverage hung heavily over lawmakers’ Wednesday [March 22 Senate Finance Committee] hearing with Health and Human Services Secretary Xavier Becerra.
Dotted throughout the hearing room for Becerra’s testimony on the president’s proposed health care budget for 2024 were purple-clad advocates for Alzheimer’s disease treatments, who Democrats and Republicans alike acknowledged repeatedly throughout the hearing. But while senators from both parties pushed for speedy approvals and Medicare coverage of new drugs for the disease, they unsurprisingly diverged on how to manage the costs.
At the center of discussions was a controversial Medicare decision, last year, not to cover Biogen’s Aduhelm except through clinical trials, a decision later extended to Eisai’s Leqembi. The Food and Drug Administration approved both via the accelerated pathway, with limited data on either drug’s effectiveness. The drugmakers are required to follow up with more extensive data proving each medicine’s benefit.
CMS expects to revisit this Medicare decision publicly this summer.
For about an hour and a half on March 22, four pharmaceutical supply experts outlined ideas to lawmakers to reform the nation’s slippery access to critical drugs.
The FDA reports 130 drugs are currently in shortage; the American Society of Health-System Pharmacists says there are 302. Recently, the availability of vital drugs for cancer patients and emergencies has shrunk, and the closure of a U.S. drugmaker could put more out of stock.
The hearing waded through causes of shortages — including manufacturing delays and opaque supply data. Some members on the Senate Committee on Homeland Security and Governmental Affairs pushed back on some pitched solutions, such as changing FDA practices and working to control drug prices.
In 2022, the number of new drug shortages increased by 30 percent, according to a report released by the Senate Committee on Homeland Security and Governmental Affairs hours before the hearing began.
“Colleagues and other hospitals have asked me to respond to the never-ending game of drug shortage Whac-A-Mole,” Andrew Shuman, MD, chief of the clinical ethics service center for bioethics and social sciences in medicine for the University of Michigan Medical School in Ann Arbor, said during the hearing.
The House Ways and Means Committee’s Health subcommittee held a hearing yesterday on healthcare costs. The American Hospital Association submitted a letter to the subcommittee that “shared how rising labor and other costs for hospitals and health systems are exacerbating workforce shortages and delaying patient access to care.”
Looking forward, Mercer Consulting identifies innovation in cancer treatment and prevention as the next frontier and McKinsey and Co. explores the pharmacy of the future.
“Use of nirmatrelvir-ritonavir (Paxlovid) in older adults with risk factors for severe disease was associated with a roughly 25% lower risk of a post-COVID condition (PCC), a retrospective study of Veterans Affairs data showed.
“In the cohort of over 280,000 patients with a confirmed COVID case, 13% of those prescribed nirmatrelvir-ritonavir went on to develop a PCC over the following 6 months compared with 18% of those who were not prescribed the antiviral (relative risk [RR] 0.74, 95% CI 0.72-0.77), Ziyad Al-Aly, MD, of the VA St. Louis Health Care System in St. Louis, and colleagues reported.” Fehblog observation: Go Paxlovid!
42% of adults in the U.S. are living with obesity, meaning they have a body mass index of 30 or higher, according to an analysis from NORC at the University of Chicago.
Researchers used 2013 to 2021 data from the CDC’s Behavioral Risk Factor Surveillance System to estimate obesity rates at the national and state level. To account for any reporting biases in the BMI measure, NORC adjusted BMI distribution to that of the National Health and Nutrition Examination Survey for corresponding time periods. NORC also created an interactive map to present its findings.
The article lists estimated state obesity rates for 2019 to 2021, ranked from highest (Mississippi – 51%) to lowest (Colorado 34%). FEHBlog observation At least one-third of every state’s population is morbidly obese, and yet we wonder why the life expectancy of Americans is dropping.
For women who are overdue for cervical cancer screening, mailing self-sampling kits for high-risk human papillomavirus (HPV) is a cost-effective means of increasing screening uptake, reveals an analysis of a large US trial.
The finding comes from a randomized trial in almost 20,000 women, which compared women who received a mailed HPV testing kit with those who did not. The results show that mailing was most cost-effective in women aged 50-64 years and in those who were only recently overdue for cervical screening.
The study was published by JAMA Network Open on March 22.
“These results support mailing HPV kits as an efficient outreach strategy for increasing screening rates in US health care systems,” say the authors, led by Rachel L. Winer, PhD, MPH, Department of Epidemiology, University of Washington School of Public Health, Seattle, Washington. (FEHBlog observation: Good idea.)
The Wall Street Journal reported this morning that maternal mortality cases in the U.S. spiked in 2021, rising from around 850 to 1200 nationwide. From examining Journal reader comments, the FEHBlog ran across a helpful breakdown of maternal deaths per U.S. state. The lowest maternal death rate is in California, and the highest maternal death rate is in Louisiana. The breakdown points out what the States with the lowest rates are doing right and what the States with the highest rates are doing to remedy the problem. Healthcare is local.
The FEHBlog also was directed to this article from the T.H. Chan public health school at Harvard:
October 21, 2022 – Women in the U.S. who are pregnant or who have recently given birth are more likely to be murdered than to die from obstetric causes—and these homicides are linked to a deadly mix of intimate partner violence and firearms, according to researchers from Harvard T.H. Chan School of Public Health.
Homicide deaths among pregnant women are more prevalent than deaths from hypertensive disorders, hemorrhage, or sepsis, wrote Rebecca Lawn, postdoctoral research fellow, and Karestan Koenen, professor of psychiatric epidemiology, in an October 19 editorial in the journal BMJ.
The U.S. has a higher prevalence of intimate partner violence than comparable countries, such violence is often fatal, and it frequently involves guns, Lawn and Koenen noted. They cited one study that found that, from 2009–2019, 68% of pregnancy-related homicides involved firearms. That study also found that Black women face substantially higher risk of being killed than white or Hispanic women.
I also located the CDC’s website on keeping new mothers alive.
This evening the Journal discussed why our country’s maternal mortality rate is so high.
Finally, STAT News reports that this afternoon the Centers for Disease Control announced preliminary 2022 maternal mortality figures.
Deaths of pregnant women in the U.S. fell in 2022, dropping significantly from a six-decade high during the pandemic, new data suggests.
More than 1,200 U.S. women died in 2021 during pregnancy or shortly after childbirth, according to a final tally released Thursday by the Centers for Disease Control and Prevention. In 2022, there were 733 maternal deaths, according to preliminary agency data, though the final number is likely to be higher.
Officials say the 2022 maternal death rate is on track to get close to pre-pandemic levels. But that’s not great: The rate before Covid-19 was the highest it had been in decades.
The CDC counts women who die while pregnant, during childbirth, and up to 42 days after birth. Excessive bleeding, blood vessel blockages, and infections are leading causes.
Covid-19 can be particularly dangerous to pregnant women, and experts believe it was the main reason for the 2021 spike. Burned out physicians may have added to the risk by ignoring pregnant women’s worries, some advocates said.
In 2021, there were about 33 maternal deaths for every 100,000 live births. The last time the government recorded a rate that high was 1964.
What happened “isn’t that hard to explain,” said Eugene Declercq, a long-time maternal mortality researcher at Boston University. “The surge was Covid-related.”
The FEHBlog’s goal is to provide perspective on this vital issue.
From the Omicron and siblings front, MedPage Today informs us
An FDA panel recommended the agency grant full approval to nirmatrelvir-ritonavir (Paxlovid) for treating high-risk COVID-19.
By a vote of 16-1 on Thursday, the Antimicrobial Drugs Advisory Committee said the totality of evidence supports the traditional approval of the oral antiviral, which has been widely used since late 2021 under an emergency use authorization to reduce the risk of hospitalization or death in outpatients at risk for severe outcomes.
“Besides oxygen, Paxlovid has probably been the single most important treatment tool in this epidemic, and it continues to be,” said Richard Murphy, MD, MPH, of the White River Junction VA Medical Center in Hartford, Vermont.
The Mercer consulting firm considers employer approaches to coverage of Covid tests following the end of the public health emergency.
Employers have some important decisions to make over the next two months before the COVID Public Health Emergency (PHE) comes to an end on May 11. One is how to handle cost-sharing for PCR and other COVID tests and related services provided by a licensed healthcare or otherwise authorized provider. Under the PHE, group health plans had to cover testing received either in- or out-of-network at no cost to participants.
We recently polled recipients of our New Shape of Work newsletter to ask whether they planned to impose cost-sharing requirements once allowed. Of the more than 1,000 readers who responded, about half indicated that their organization will not make any change when the PHE ends: 22% will continue to cover PCR testing at 100% both in- and out-of-network, and 29% say that they require COVID testing at their worksites and provide it at no cost. Only about a fourth (26%) will now require cost-sharing from participants even when they use an in-network facility for testing; about another fourth (23%) will add a cost-sharing requirement only for out-of-network services.
Personally, the FEHBlog would opt for restoring a cost-sharing requirement only for out-of-network services.
From the Rx coverage front
STAT News tells us, “Following the lead of its rivals, Sanofi will cut the price of its most widely prescribed insulin in the U.S. by 78% and also place a $35 cap on out-of-pocket costs for commercially insured patients who take the treatment, which is called Lantus. The moves will go into effect on Jan. 1, 2024.”
The Mercer consulting firm offers its perspective on coverage of the new era of weight loss drugs, e.g., Ozempic.
For plans covering weight-loss medications, adding prior authorization criteria can help manage cost growth. These include requirements such as a certain body mass index (BMI), co-morbid conditions, enrollment in a behavior modification program, and/or reduced calorie diet. Upon initiation of therapy, patients and clinicians should partner to create a comprehensive plan to achieve goals and use the medication purposefully alongside a targeted and managed lifestyle program. The plan should include a discussion regarding medication discontinuation when/if goals are met to prevent relapse and weight regain/ weight cycling. Medical nutrition therapy (MNT) with a registered dietitian should be covered; ideally 14 in-person or telenutrition sessions.
Cognitive-behavioral therapy, self-monitoring, motivational interviewing, structured meal plans, portion control and goal setting are recommended interventions. Ideally, patients would progress from dietary intervention (covered MNT or weight management solution), to weight loss medications, and then, potentially, to bariatric surgery.
In recognition of Patient Safety Awareness Week, the Partnership to Fight Infectious Disease announced, making March 18 a day of action to raise awareness of the need to #squashsuperbugs so that we can all do our part to prepare and perhaps even prevent a future pandemic due to antibiotic resistance.
From the No Surprises Act front, Fierce Healthcare reports
An “astronomical” number of surprise billing arbitration dispute cases is impacting the Centers for Medicare & Medicaid Services (CMS), a top agency official said.
Education and communication are integral to an “orderly transition” in the handling of independent dispute resolutions for out-of-pocket charges, the official said. The agency has grappled with legal issues and implementation hiccups surrounding a controversial process for settling feuds between payers and providers on out-of-network charges.
“We are seeing more than expected number of disputes getting to that last stopgap part, which is the independent dispute resolution part,” said Ellen Montz, director of CMS’ Center for Consumer Information and Insurance Oversight. Montz spoke during a session Wednesday at the AHIP Medicare, Medicaid, Duals & Commercial Markets Forum in Washington, D.C.
The agency is also seeing a lot of ineligible cases that don’t qualify for the dispute resolution process, which requires a third party to choose between out-of-network charges submitted by the payer and provider.
These ineligible cases require “a lot of casework, phone calls and back and forth to determine eligibility,” Montz said.
The group that advises Congress on Medicare policy is recommending updating base physician payment rates by 1.45% for 2024, according to its annual March report out Wednesday.
The Medicare Advisory Payment Commission, or MedPAC, did not make recommendations for ambulatory surgery center payment updates or for Medicare Advantage plans.
The commission did note concern with MA plan coding intensity, and said Medicare now spends more on MA enrollees than it would have spent had those enrollees remained in fee-for-service plans.
The FEHBlog doubts that this MedPAC report made anyone happy.
From the federal employee benefits front, FedWeek reminds folks that while the dependent care flexible spending accounts available to federal employees typically are used for child care, they also can be used for senior care in certain circumstances.
From the Affordable Care Act front, the WTW consulting firm informs us
Group health plans and health insurance issuers will not be required to submit certain information on air ambulance services by March 31, 2023 (the deadline included in an example in the proposed regulations). The Centers for Medicare & Medicaid Services has informally confirmed that since final regulations have not yet been issued, no reporting is required in 2023.
Also following up on recent posts, Healthcare Dive tells us that
Amazon completed its $3.9 billion acquisition of primary care chain One Medical on Wednesday, significantly increasing its healthcare offerings with the addition of physical medical clinics.
UnitedHealth has closed its $5.4 billion acquisition of home health business LHC Group, continuing a trend of payers elbowing into direct care delivery.
In other U.S. healthcare business news, Forbes points out that
Aledade, a startup that helps primary care doctors enter into value-based contracts with insurers, has acquired artificial intelligence software company Curia. The acquisition follows a pilot program, where Aledade used Curia’s predictive algorithms to identify 8,000 patients to get them enrolled in a special end-of-life care program.
In a bit of good regulatory news for the FEHB Program, the CMS has delayed for up to one year final rulemaking on a civil monetary penalty rule for Medicare secondary payer violations. The proposed rule issued in Feburary 2020 treated FEHB plans and other group health plans inequitably as compared to non-group health plans, including trial lawyers. The FEHBlog is glad that CMS is trying to create a fair rule.
In other regulatory news, the Food and Drug Administration announced filing civil monetary penalty complaints against four e-cigarette manufacturers.
From the medical research front, MedPage Today reports
Patients with mild to moderate COVID-19 treated with the oral antiviral ensitrelvir within 5 days of symptom onset saw their symptoms resolve a day earlier, according to data from a phase II/III randomized trial.
Median time to symptom resolution was 24.3 hours earlier for patients treated with 125-mg ensitrelvir compared with those receiving placebo (P=0.04), reported Takeki Uehara, PhD, senior vice president of drug development and regulatory science at Shionogi and Co. in Osaka, Japan, during the Conference on Retroviruses and Opportunistic Infections. * * *
Ensitrelvir is a novel 3C-like protease inhibitor that targets the SARS-CoV-2 virus. “Because of its mode of action, ensitrelvir maintains antiviral activities across various different types of variants, including recently circulating Omicron variants,” Uehara said.
Of note, follow-up of patients continued out to 3 months and 6 months to evaluate the drug’s effectiveness on long COVID.
An important new study came out last week in the New England Journal of Medicine (NEJM), which found that a candidate vaccine against RSV was highly effective in preventing lower respiratory tract (read: lung) disease [in adults]. The study also found the vaccine prevented severe disease.
The study has many of the features you want to see from a well-conducted study: the vaccine was compared to placebo and the study was blinded, meaning that participants and the scientists carrying out the analysis were not aware of who got what. The study had nearly 25,000 participants and was carried out across 17 nations.
The vaccine was found to be over 80% effective against lower respiratory tract disease (the main outcome the study was designed to measure) and 94% effective against severe disease. This is great news.
.From the Rx coverage front —
Bloomberg relates “Eli Lilly & Co said on Tuesday that all doses of its new diabetes drug Mounjaro are now available after social-media enthusiasm about the drug’s weight-loss benefits sparked a two-month-long shortage.”
Drugs like Ozempic have become so popular among people seeking to lose weight that they are now in short supply for patients with diabetes who depend on the medicines.
Diabetes patients said they are spending hourstrying to find nearby pharmacies that have their prescriptions in stock. If they don’t, some patients have had to reduce dosing of Ozempic and similar drugs to stretch out their supplies, or switch to alternative drugs.
The shortfalls are making it harder for people with diabetes to keep their blood-sugar levels low and limit their risk of complications like kidney disease and damage to blood vessels, doctors said. * * *
Novo Nordisk A/S, which sells Ozempic, has been moving to expand production capacity. People may still experience periodic shortages, however, Chief Executive Lars Fruergaard Jorgensen said, because the work hasn’t been finished while demand may remain high.
By and large, doctors appear to be comfortable prescribing biosimilar drugs, the copycat version of biologic medicines like inflammatory disease drug Humira or eye treatment Lucentis. But they aren’t yet sure the discounts offered are enough to justify switching patients who are stable on the brand-name products, according to an annual report from healthcare distributor Cardinal Health released Wednesday. * * *
[A] majority of physicians from the three Humira-prescribing specialties [rheumatology, gastroenterology and dermatology] said they were “very” or “somewhat” comfortable prescribing biosimilars, including 100% of gastroenterologists. Among the ophthalmologists, 48% said they were “uncomfortable from a clinical standpoint” among their primary concerns prescribing biosimilars.
When asked which patients they are most likely to prescribe a biosimilar, the most common response among the Humira-prescribing specialists was “existing patients for whom payers have mandated a biosimilar,” suggesting that insurers’ policies will drive uptake. However, 40% of rheumatologists said “new patients” would be the most likely people to get a biosimilar prescription.
Drug Channels offers its annual update on copay assistance accumulator and maximizer programs.
From the miscellany department –
The Milbank Memorial Fund issued a Baseline Scorecard Tracking Support for High Quality Primary Care. The baseline leaves a lot of room for improvement.
Fierce Healthcare informs us that CMS recently has issued price transparency warnings to hospitals, 300 of which have been satisfactorily resolved.
While Medicare Advantage enrollment has increased by 1.5 million beneficiaries in 2023, this marks a slower growth compared to the last three years, according to data from Chartis.
The analysis reflects Medicare Advantage enrollment, plan, and pricing data from January 2019 to January 2023.
The House of Representatives and the Senate are on District/State work breaks this week.
Govexec alerts us, “Labor Secretary Marty Walsh will be leaving the Biden administration in mid-March to become executive director of the National Hockey League Players’ Association.”
Federal News Network offers an update on implementing the Postal Service Health Benefits Program that takes effect on January 1, 2025. The article expresses concern about a tight timeline for implementation. The article does not consider OPM’s January 2023 decision to allow FEHB plans to offer Medicare Part D EGWPs in 2024. That welcome decision puts the new PSHBP and the existing FEHB on a similar footing.
While the new PSHBP will be more tightly integrated with Medicare Part B., the benefits of that phased in change will develop over time. For example, although the Postal Services will offer a one-time, penalty-free Part B Special Open Enrollment Period next year for annuitants over 65 who did not elect Part B, early retirees under 65 and active employees over age 64 on January 1, 2025, will be exempt from the PSHBP’s mandatory Part B election requirement.
In other FEHB news, AHIP has made available a topic overview for the March 29 – 30 OPM AHIP FEHB Carrier Conference.
In OPM news, Meritalk breaks down last week’s inaugural DEIA Annual Report from OPM’s Office of Diversity, Equity, Inclusion, and Accessibility (ODEIA).
From the Omicron and siblings front, the Wall Street Journal and Fierce Healthcare report on the Covid death rate. The Journal points out, “Deaths caused by Covid are heavily concentrated among the elderly, an analysis of CDC data shows. In recent weeks people 75 years and older have represented about seven of every 10 Covid-19 deaths.” Fierce Healthcare provides this perspective:
The JAMA Network Open study concluded that “COVID-19 due to the Omicron variant was associated with a higher risk of in-hospital mortality compared with patients with influenza. This indicates that the SARS-CoV-2 Omicron variant should still be taken seriously, and improved prevention and treatment strategies are still highly relevant, although overburdening of the health care system has become less likely over time.”
Fortune Well tells us about the importance of cardiac care following even a mild case of Covid.
In a bid to determine why and how COVID can affect the heart, Dr. Andrew Marks, a cardiologist and biophysics professor at Columbia University, and Steven Reiken, a research scientist in his lab, studied heart tissue from people who died of COVID, in addition to the hearts of mice that had been infected with COVID.
Heart tissue from humans shows increased levels of oxidative stress and inflammation, and changes in calcium levels due to damage to the system that regulates them in the heart. Such alterations can lead to arrhythmia or heart failure, according to the researchers.
Chest pain and tachycardia, or an unusually fast heartbeat, are common long-term among COVID survivors.
Heart tissue from mice shows an increased percentage of fibrosis and dilation of fibers—a common signal of early cardiomyopathy, which makes it more difficult for the heart to pump blood and can result in heart failure.
The death of heart cells and blood clots in the hearts of mice who had been infected with COVID-19 were also observed.
“Doctors should be aware of heart changes related to COVID-19 infections and should be looking for them,” Marks says. He hopes his research leads to increased awareness among medical providers of the virus’s potentially stealthy cardiac fallout—and, eventually, treatments for those whose hearts have been damaged by the pathogen.
People who took the antiviral Paxlovid to treat COVID-19 infections were not more likely to get back-to-back bouts of the virus, a new study shows.
The findings offer clarity amid concerns that the use of Paxlovid, which works by stopping the spread of the virus in the body, increased the risk of COVID-19 rebound.
“Rebound is a re-emergence of symptoms and an uptick in viral load after a period of recovery,” the Center for Infectious Disease Research and Policy explained in a summary of the study.
Researchers found that patients who received Paxlovid, another antiviral called Lagevrio, or no antiviral medication had rebounds at similar rates, ranging from 4.5% to 6.6%.
From the medical research front, the Wall Street Journal reports
A fist that opened and shut. A once-limp arm that moved from her side. Two women whose strokes left them with partial paralysis for years saw life trickle back to their limbs when electric pulses were delivered to the back of their spinal cord as part of a pilot study.
Neurologists said the approach, reported Monday in the journal Nature Medicine, could be transformative for stroke survivors, many of whom have some arm impairment after the event.
“I think it is amazing,” said Helmi Lutsep, a neurologist at Oregon Health & Science University, who wasn’t involved with the study. “I think patients will be thrilled if this comes to fruition.”
The pilot study was convincing but it would take much larger studies and a decade or more to know if stroke patients generally could benefit, according to Nick Ward, a neurologist at the University College London who wasn’t involved with the study.
From the U.S. healthcare business front, the Wall Street Journal informs us why “Walgreens CEO Bets on Doctors Over Drugstores in Search for Growth; Rosalind Brewer is shifting the chain’s focus to medical clinics,” like Village MD.
The strategy is guided by Ms. Brewer’s belief that the nation’s second-largest drugstore chain is in a business that she says no longer works. Industry growth is chronically slow, she said. Meanwhile, a shortage of workers is further cutting into revenue because the chain has had to reduce pharmacy hours.
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