The Washington Post reports “A congressional deal for billions of dollars in additional coronavirus funding appeared all but dead Thursday [June 16] after Senate Republicans accused the White House of being dishonest about the nation’s pandemic funding needs.” The FEHBlog expects we have not heard the end of this issue.
The Centers for Disease Control and Prevention recommended that children as young as 6 months receive newly authorized Covid-19 shots, the final step to making the vaccines available.
On a related note, Precision Vaccinations tells us
The U.S. Centers for Disease Control and Prevention (CDC) reported today the number of pneumonia-related fatalities continues to outpace both COVID-19 and Influenza. * * *
In the USA, common causes of viral pneumonia are influenza, respiratory syncytial virus, and SARS-CoV-2 viruses. A common cause of bacterial pneumonia is Streptococcus pneumoniae.
The good news is pneumonia is a vaccine-preventable disease, and the U.S. FDA has approved two types of pneumococcal vaccines, PCV13, and PPSV23. * * *
Unfortunately, the CDC’s data shows that in 2020, the percentage of adults who received a pneumococcal vaccination was just 25.5%.
FEHB plans may want to focus on this issue given the Program’s demographics.
From the U.S. healthcare front, the American Medical Association provides background on its freshly inaugurated President, Dr. Jack Resneck, Jr., and gives an account of Dr. Resneck’s inaugural address. Good luck, Dr. Resneck.
The Senate on Thursday took a major step toward broadening America’s commitment to take care of sick veterans, passing a bill to offer new health care and tax-free disability benefits to as many as 3.5 million veterans on an 84-14 vote.
Under the legislation written by Veterans’ Affairs Chairman Jon Tester, D-Mont., and ranking member Jerry Moran, R-Kan., the Department of Veterans Affairs would consider a veteran with any of 23 conditions, ranging from brain cancer to hypertension, who was deployed to a combat zone during the wars in Iraq or in Afghanistan automatically eligible for care at government cost, based on the presumption that exposure to toxic chemicals in the war zone caused the ailments.
The House must now pass the revised bill before President Joe Biden can sign it, which seems likely. The legislation largely mirrors, and slightly expands on, a House bill by Veterans’ Affairs Chairman Mark Takano, D-Calif., that passed 256-174 in March. Biden issued a statement at the time saying he supported the measure.
Under current law, veterans who believe toxic exposure during their service caused them to develop a disease can have trouble proving it, even when the linkage is known. So it’s likely that many veterans are denied care and disability benefits they deserve, advocates say. The new law, at a projected cost of $278.5 billion over 10 years, shifts the calculus, meaning the government will now pay for the care of veterans whose sickness is tied to their service, as well as others whose ailments might not be.
Because the federal government employs many veterans, this bill will reduce benefits costs for the FEHB Program once it becomes law.
From the Omicron and siblings front, the Wall Street Journal informs us
Many people are embarking on a summer of vacations, concerts and weddings put off during the height of the pandemic. Covid-19 is still finding ways to disrupt some of those plans.
Covid-19 isn’t causing acute illness and death on the scale it once did, thanks in part to protection built up by vaccines and prior infections. * * *
The U.S. is logging some 100,000 known cases a day, and many more are being detected via at-home tests health departments don’t track. This is a stark difference from a year ago, when U.S. cases sank below 12,000 a day, the lowest level since the first surge, as vaccinations rose and many hoped the virus was in retreat.
The era of 12,000 cases a day was over when Delta and then Omicron arrived and will remain around until Omicron departs.
In a notable move, the Federal Trade Commission put drugmakers and pharmacy benefit managers on notice that the agency will “ramp up enforcement” of any “illegal bribes and rebate schemes” that make it harder for patients to access lower-cost medicines.
The new policy statement noted the FTC plans to scrutinize rebates and assorted fees for signs that these payments are violating antitrust and consumer protection laws. As part of that effort, the agency expects to monitor lawsuits and file its own legal briefs in cases where it can provide assistance in analyzing illegal practices that may raise prescription drug prices.
“Today’s action should put the entire prescription drug industry on notice: when we see illegal rebate practices that foreclose competition and raise prescription drug costs for families, we won’t hesitate to bring our full authorities to bear,” said FTC Chair Lina Khan in a statement. “Protecting Americans from unlawful business practices that are raising drug prices is a top priority for the Commission.”
While the end of Omicron is not in the offing, the end of prescription drug rebates appears to be getting closer. However, the federal government should not put the kibosh on rebates unless the drug manufacturers agree to maintain the economic equities by offering price reductions equivalent to the rebates.
Drugmaker acquisitions of all sizes could receive closer scrutiny in the future if the Federal Trade Commission follows the advice of experts who spoke at a two-day agency meeting on market concentration and anticompetitive conduct.
The experts, mostly economists and other antitrust regulators, warned that some drugmakers have gained unfair market power due to the breadth of their product portfolios, allowing them to negotiate for preferred or even exclusive status on insurers’ coverage lists and thereby squeeze out competitors.
Taken together with the FTC’s plans to investigate the practices of pharmacy benefit managers, the meeting signals the Biden administration may take a tougher line on monopolistic practices in an effort to spark competition and target drug pricing.
From the Food and Drug Administration front, BioPharma Dive notes that
An experimental and closely followed drug for Alzheimer’s disease has failed a key clinical study, dealing yet another blow to the prevailing theory on how to treat a neurodegenerative illness that affects millions of people.
The drug’s developer, Roche, along with Banner Alzheimer’s Institute, the Phoenix-based organization helping lead the study, announced the negative results Thursday. After years following a family believed to be genetically predisposed to the disease, researchers found no significant difference in cognition or the ability to store and retrieve new memories between participants who received the drug and those who got placebo.
The failure is an upset not only to Roche, which hopes to follow its rival Biogen in getting an Alzheimer’s therapy approved for market, but also to the wider Alzheimer’s research field. For years, a protein called beta amyloid has been at the center of efforts to treat the disease. But every drug designed to block this protein, including Biogen’s, has faced setbacks. Roche’s announcement may therefore add to concerns that this protein isn’t the best research target.
In other drug research news, Walgreens announced “the launch of its clinical trial business to redefine the patient experience and increase access and retention in sponsor-led drug development research. Walgreen’s flexible clinical trial model combines the company’s vast foundation of patient insights, partner-enabled health and technology capabilities and in-person and virtual care options to break through barriers to engaging broader and more diverse communities.”
In U.S healthcare news, the American Medical Association completed its annual meeting. The AMA offers highlights from the session here.
Also, the Commonwealth Fund released its 2022 Scorecard on State Health System Performance.
Hawaii and Massachusetts top the 2022 State Scorecard rankings, based on overall performance across 56 measures of health care access and quality, service use and cost, health disparities, and health outcomes during the COVID-19 pandemic in 2020. The lowest-performing states were Mississippi, Oklahoma, and West Virginia.
From 2000-2019 overall life expectancy in the United States increased by 2.3 years, but the increase was not consistent among racial and ethnic groups and by geographic area. In addition, most of these gains were prior to 2010. This is according to a new study funded by the National Institutes of Health that examined trends in life expectancy at the county level. The study was led by researchers at the Institute for Health Metrics and Evaluation at the University of Washington’s School of Medicine, Seattle, in collaboration with researchers from NIH and published on June 16th in The Lancet.
MedCity News reports “Online healthcare marketplace Sesame closed a $27 million Series B funding round on Tuesday, bringing its total funding to $75 million. David Goldhill, CEO of the New York City-based startup, said the company is ‘an Expedia for medical care’ because patients can buy the care they want directly online, without the middleman of an insurance company.”
From the federal employee benefits front, Govexec delves into the impact of cost of living adjustments on federal employee retirement benefits.
The Senate Committee on Health, Education, Labor and Pensions voted Tuesday to send a bill to the Senate that would reauthorize the Food and Drug Administration to collect user fees from device- and drug-makers for the next five years.
A provision would require the FDA to finalize guidance that would create a category of over-the-counter hearing aids within a month of the bill’s passage. The FDA last issued a proposed guidance in October.
Committee Ranking Member Sen. Richard Burr, R-N.C.,questioned on Tuesday whether the FDA should have that expanded authority, despite co-sponsoring legislation that would change how diagnostic tests are regulated, including laboratory-developed tests.
The American Hospital Association (AHA) penned a last-ditch letter to congressional leaders pleading for Medicare sequester cuts slated to take effect July 1 to be halted in light of the financial strain many of the nation’s hospitals are expected to face throughout 2022.
Congress had initially paused the 2% payment cut as part of the CARES Act when the COVID-19 pandemic began to threaten providers’ bottom lines. Sequestration cuts were continually punted downfield until last December, when a bill was signed to resume a 1% cut in April and the full 2% in July.
With half a month to go, AHA Executive Vice President Stacey Hughes warned majority and minority leaders Tuesday that financial relief from the pending cut is necessary for hospitals “to maintain access to care for the patients and communities they serve.”
From the Supreme Court, the American Hospital Association gleefully informs us
The U.S. Supreme Court today ruled unanimously in favor of the AHA and others, reversing a 2020 [U.S.] court of appeals decision upholding the authority of the Department of Health and Human Services to significantly cut payments to certain hospitals that participate in the 340B Drug Pricing Program, and thereby threatening access to care for patients.
The Supreme Court held that “HHS’s 2018 and 2019 reimbursement rates for 340B hospitals were contrary to the statute and unlawful.” Noting that “340B hospitals perform valuable services for low-income and rural communities but have to rely on limited federal funding for support,” the Supreme Court observed that “this case has immense economic consequences, about $1.6 billion annually.”
Despite those serious practical impacts, the Supreme Court concluded that “[u]nder the text and structure of the statute,” the case is “straightforward” as a matter of law: “Because HHS did not conduct a survey of hospitals’ acquisition costs, HHS acted unlawfully by reducing the reimbursement rates for 340B hospitals.”
The panel voted 21 to 0 in a pair of votes on Wednesday in support of expanding access to the vaccines.
The positive recommendations will likely lead soon to expanding the U.S. Covid-19 vaccination campaign to the 19.6 million children from 6 months to under 5 years of age, one of the last groups of people in the U.S. waiting for shots.
The Food and Drug Administration, which doesn’t have to follow the panel’s recommendations but usually does, is expected to authorize the shots within days. Vaccinations could begin as early as June 21, according to the Biden administration.
Moderna Inc. is planning to test its Covid-19 vaccine in babies 3 months to 6 months old, the youngest age group studied to date.
The Cambridge, Mass., company said Wednesday it is in the final stages of planning the study, to be called BabyCove and expected to begin enrolling as many as 700 babies in September.
Pfizer said Tuesday that a much-watched study of its antiviral Paxlovid in patients who have Covid but don’t have risk factors for severe disease failed to show a benefit in speeding alleviation of Covid symptoms, but did seem to prevent doctor’s visits and hospitalizations.
Additionally, because of the small number of hospitalizations overall in the study, it failed to produce a statistically significant finding on whether patients who had previously been vaccinated against Covid were hospitalized less often if they received Paxlovid.
The data in no way invalidate earlier results that show that Paxlovid prevents hospitalizations and saves lives in patients at high risk of severe Covid. But the results, published in a press release, are likely to take time for experts to digest and understand.
From the unusual viruses front, the American Hospital Association explains
The Centers for Disease Control and Prevention yesterday [June 14] updated its guidance to help clinicians evaluate and test patients with relevant history, signs and symptoms for monkeypox. Over 1,800 monkeypox or orthopoxvirus cases have been reported globally this year, including 72 in the United States. According to CDC, the virus does not spread easily between people without close contact, so the risk to the general population remains low.
The World Health Organization plans to change monkeypox’s name next week.
Anthem will officially become Elevance Health on June 28, and, as part of its corporate rebrand, it’s also launching new brands for two of its subsidiaries.
The insurer will consolidate its healthcare services businesses under one umbrella, called Carelon. Carelon is a combination of the word “care” with the suffix “lon,” which means full or complete, representing the company’s ambition to offer an end-to-end care experience.
Carelon will include Anthem’s in-house pharmacy benefit manager Ingenio Rx as well as recent acquisitions such as Beacon Health Options, a behavioral health provider, and myNEXUS, a home healthcare company. Carelon will serve 1 in 3 people in the U.S., according to the announcement.
Humana is moving its pharmacy brands under the CenterWell umbrella.
Humana Pharmacy and Humana Specialty Pharmacy will now operate as CenterWell Pharmacy and CenterWell Specialty Pharmacy, respectively, the insurer announced. Enclara Pharmacia and Humana Pharmacy Solutions, the company’s pharmacy benefit management arm, will maintain their original branding.
“The CenterWell brand symbolizes our ongoing and strong commitment to keeping members, customers and patients at the center of everything we do,” said Scott Greenwell, Humana Pharmacy Solutions president, in a statement.
Morning Consult discusses how CVS Health and Walgreens retained “high customer trust” in 2021.
From the benefit design front, Employee Benefits News offers the case for health savings accounts. The FEHBlog is already sold.
A bipartisan group of senators announced an agreement Sunday on significant updates to the nation’s gun laws, and the Senate majority leader said it would be put on the floor once legislative text is ready.
The agreement, announced by 10 Republicans and 10 Democratic caucus members, certainly will not go as far as many Democrats would have hoped, but the scale of the GOP support suggests it could get the all-important 60 votes to overcome the filibuster rule that kept derailing the last bipartisan attempt to change gun laws, in 2013.
The agreement, which is not yet in legislative language, is the product of discussions led by Sens. Christopher S. Murphy, D-Conn., and John Cornyn, R-Texas, in the wake of recent mass shootings, including at an elementary school in Uvalde, Texas.
“Our plan increases needed mental health resources, improves school safety and support for students, and helps ensure dangerous criminals and those who are adjudicated as mentally ill can’t purchase weapons,” the 20 senators said in a statement. “Most importantly, our plan saves lives while also protecting the constitutional rights of law-abiding Americans.”
From the Omicron and siblings front —
MedPage Today discusses the latest Omicron siblings — BA.4 and BA.5. “Generally, BA.4 and BA.5 variants cause mild disease but spread in large numbers potentially because, unlike the Wuhan strain, which settles in the lungs, these newer strains seem to attach to the more benign upper nasal passages.”
Bloomberg Prognosis answers a reader’s question about whether to get a fourth Covid booster now.
Moderna said just this week that a new version of its Covid vaccine led to a better antibody response against omicron compared with its current mRNA shot. It plans to submit data to the US Food and Drug Administration in the coming weeks and hopes the shot will be available as soon as late summer. That shot is what’s called a bivalent vaccine, meaning it contains mRNA coding for the spike protein of both the original strain of the virus and omicron.
Pfizer should also have updated mRNA vaccines available as soon as the fall, says Monica Gandhi, an infectious disease expert at the University of California, San Francisco. The FDA will hold an advisory committee meeting later this month to address whether fall shots should be modified, and if so what strains they should include.
But while currently available boosters are less effective against omicron, Gandhi points out, they still do offer some protection. So, she says, that answer to whether to get boosted now depends on a few factors.
”I would advise — depending on case rates in your area and your age— getting the fourth dose now,” she says. “And then deciding what to get in the fall.”
MedPage Today also explains why “the [Novovax Covid] technology is quite innovative and has potential to enhance protection against” the disease.
From the healthcare business front, the Wall Street Journal reports on a
A philanthropic organization founded by the ex-energy trader [John Arnold] and his wife Laura is providing financial backing to three lawsuits against giant hospital systems in Wisconsin, Connecticut and North Carolina, alleging the systems used their market power to squash competition and illegally inflate prices. The systems say the lawsuits from employers and consumers are baseless. * * *
The financing from Arnold Ventures is supporting the work of Fairmark Partners LLP, the law firm behind the lawsuits. Fairmark secured its funding from the philanthropy after filing its first lawsuit, one of the founders said. The firm’s founders say the backing is key to a targeted effort to reshape hospital markets through the courts, and that it received money from other philanthropies it declined to identify.
While the FEHBlog is not a fan of litigation, this strikes him as a worthy effort.
From the medical research front —
Kaiser Health News summarizes recent drug research developments.
NPR Shots reports on efforts to connect human nerve systems to prosthetic devices.
Researchers at CVS studied the relationship between total cost of care and the use of National Comprehensive Cancer Network (NCCN) guidelines to direct care and found savings among both breast cancer and colon cancer patients. The studies, released at the American Society of Clinical Oncology’s meeting earlier this month, build on a similar analysis among lung cancer patients.
In both studies, the researchers found that using NCCN guidelines drove significant declines in total cost of care.
“Evidence-based medicine does result in improvement in quality of life,” Shirisha Reddy, M.D., senior medical director at CVS Health and an author on both studies, told Fierce Healthcare. “There’s a lot of external data that supports that.”
The first study included 937 patients with colon cancer. Among Medicare beneficiaries, concordance with NCCN guidelines was linked to a 33% reduction in total cost per care per member per month. The results were less significant among commercially insured patients.
In the second study, the researchers retrospectively looked at 315 patients with breast cancer. They found total cost of care reductions for patients treated in ways consistent with NCCN across multiple insurance types, including 25% among fully insured commercial patients, 28% among self-insured commercial patients and 43% in Medicare.
This included notable decreases in administered chemotherapy spend as well as outpatient care between Jan. 1, 2019, and Dec. 31, 2020.
From our Nation’s capital, the New York Times reports,
White House officials said on Wednesday that they would have to repurpose federal Covid-19 funds meant for coronavirus tests and protective equipment in order to supply more antiviral pills and vaccines, after so far failing to persuade Congress to pass a new pandemic relief package.
Roughly $10 billion from Department of Health and Human Services funds will be rerouted, around half of it to purchase vaccines for Americans ahead of a possible fall or winter wave of virus cases, when an updated shot may be needed, according to one White House official. The other half will go mostly to purchasing 10 million courses of Paxlovid, the antiviral treatment made by Pfizer that has been shown to substantially reduce the severity of Covid-19 in high-risk people, the official said. Around $300 million will be spent on another kind of treatment, monoclonal antibodies.
Also from the Omnicron and siblings front, a friend of the FEHBlog, journalist Theresa Defino, points out
Today and tomorrow NIH’s Advisory Committee to the Director is holding its first of two annual meetings. Today Dr. Fauci gave a presentation on Covid and Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, spoke on recovery from Covid.
The most interesting comments Dr. Fauci made begin on page 45. Dr. Koroshetz’s talk was about NIH’s efforts to understand long COVID. Lots of trials are going on. He also mentioned this website on Covid recovery which is worth a look.
From the unusual viruses report, Becker’s Hospital Review brings us up to date on roughly 700 cases of acute hepatitis of unknown etiology infecting young children in 34 countries, including our own. “The U.S. has reported 274 probable hepatitis cases in 39 states and jurisdictions as of June 8, according to the CDC.”
From the maternal health front, the American Hospital Association informs us
The Health Resources and Services Administration has released a report evaluating the Rural Maternity and Obstetrics Management Strategies Program, which completed its first year last August. The program uses a network approach to coordinate and improve maternal health care from preconception to postpartum; telehealth services to increase access to care in rural areas; potential aggregation of low-volume rural obstetric services; and payment structures that promote financial sustainability for access to high-quality maternal care. The cohort includes networks in Missouri, New Mexico and Texas that provided prenatal, delivery and postpartum care to 3,101 rural mothers. Participants said hiring patient navigators emerged as an early success strategy. The networks also laid the groundwork for expanding telehealth.
From the Rx coverage front, STAT News offers an interesting article about the drug pricing reform debate ongoing in Congress using an AMA Journal report showing skyrocketing launch prices for newly approved drugs.
Health Payer Intelligence tells us that “AHIP has subscribed to the Institute for Clinical and Economic Review’s (ICER) cloud-based analytics platform, providing [its] health plan members with access to benchmark reports, cost-effectiveness data, and policy recommendations.” Good idea, AHIP.
From the federal employee benefits front, a financial planner discusses how divorce may affect FEHB and FEGLI benefits at the My Federal Retirement website.
From the HIPAA standard transactions front, the CMS National Standards Group has released an updated Compliance Review Program Findings report identifying the most common violations of those standard and operating rules from compliance reviews.
From Capitol Hill, Roll Call reports that FY 2023 appropriations work is gearing up.
From the Omicron and siblings front
The Wall Street Journal reports the following good news
Moderna Inc. said a modified [mRNA based] Covid-19 booster shot provided a stronger immune response than the company’s original vaccine against the Omicron variant in a new study.
The Cambridge, Mass., company said Wednesday it will submit preliminary data from the study to U.S. health regulators in the coming weeks with the hope of making the modified booster shot available in late summer.
Researchers found that the levels of neutralizing antibodies against Omicron among people getting the modified shot were 1.75 times higher than in people who received a booster shot of the original vaccine, Moderna said.
AstraZeneca PLC said a study found its Covid-19 antibody treatment cut the risk of severe disease when given soon after symptoms develop, paving the way for its broader use.
The development comes at a time when the use of antibody treatments—once a mainstay for patients at high risk of developing severe Covid-19—has been complicated by the rise of the Omicron family of variants, which are less susceptible to some of the treatments. The treatments also face fierce competition from the more-convenient antiviral pills.
AstraZeneca’s antibody drug, called Evusheld, was found in its latest clinical trial to ward off severe disease in people who had already developed symptoms, according to results published late Tuesday in the Lancet Respiratory Medicine. The trial was conducted prior to the rise of the Omicron variant, but AstraZeneca has said that laboratory testing shows the antibody continues to work against the highly infectious strain.
The Food and Drug Administration released a revised checklist for prescribing the Pfizer Covid pill Paxlovid. While the checklist is intended for healthcare provider reference, it could be helpful to patients and health plans as well.
From the unusual virus front, STAT News offers an interesting article on how the hard lessons of the AIDS virus is shaping the U.S. response to monkeypox. The article notes
“[T]he monkeypox strain now in circulation is infinitesimally milder than HIV — zero fatalities have been reported out of the more than 1,000 cases so far.”
“Monkeypox isn’t transmitted sexually but by close contact with the disease’s hallmark pustules.”
From the Rx coverage front, Medpage Today informs us
The combination GIP and GLP-1 receptor agonist tirzepatide (Mounjaro [manufactured by Eli Lilly]) could soon be the next new treatment option for people with overweight or obesity, researchers reported.
In the 72-week, phase III SURMOUNT-1 clinical trial, people with obesity, but without diabetes, on 15 mg of the once-weekly injectable had a mean percentage change in weight of -20.9% (95% CI -21.8 to -19.9%) versus -3.1% (95% CI -4.3 to -1.9) with placebo, according to Ania M. Jastreboff, MD, PhD, of the Yale University School of Medicine in New Haven, and colleagues.
An open-source automated insulin delivery (AID) system — also known as a do-it-yourself system — was both safe and effective for patients with type 1 diabetes, according to the CREATE trial.
Over 24 weeks, users of the AID system spent more time in target glucose range (70 to 180 mg/dL) — an average of 14% longer — than those who were using sensor augmented pump therapy without automation, reported Martin de Bock, PhD, of the University of Otago in Christchurch, New Zealand, during a presentation at the American Diabetes Association (ADA) annual meeting.
The open-source AID system consists of the OpenAPS algorithm from a version of AndroidAPS implemented in a smartphone, paired with the DANA-i insulin pump and Dexcom G6 continuous glucose monitor. The researchers previously published additional information on the ins and outs of the algorithm in the Journal of Diabetes & Metabolic Disorders.
“Open-source AID, despite not being [FDA] regulated … is safe and efficacious in children and adults with type 1 diabetes compared to sensor augmented pump therapy,” de Bock noted.
The American Diabetes Association offers more details on this significant development here.
From the transparency front, the Wall Street Journal tells us
Two Georgia hospitals on Wednesday were hit with federal financial penalties for failing to disclose their prices, marking the first such enforcement action taken under federal rules that have met with uneven compliance since taking effect in January 2021.
The Centers for Medicare and Medicaid Services (CMS), which is responsible for enforcing the rules, levied fines on Northside Hospital Atlanta and Northside Hospital Cherokee. The two hospitals, which are owned by Northside Hospital, together face penalties totaling roughly $1.1 million.
Perfect timing; right before the enforcement period for the transparency in coverage rule applicable to health plans begins on July 1.
From Capitol Hill, Medpage Today suggests that prior authorization practices are under Congress’s spotlight.
From the Omicron and siblings front–
The Wall Street Journal offers an interesting report on the ups and downs of Omicron and its siblings.
Govexec tells us about recent Safer Federal Workforce changes to “its COVID-19 protocols to draw more distinctions between the policies for vaccinated and unvaccinated workers, including those related to travel and paid leave.”
From the federal employment front, the Society for Human Resource Management explains how the federal government is “struggling mightily to recruit, retain and develop the talent it needs to succeed and earn the reputation of being a “model employer.” Agencies and their HR leaders are working to upgrade antiquated systems and processes. The new-hire process currently takes an average of 100 days to complete, double that of the private sector.” Good luck.
From the Rx coverage front, Prime Therapeutics announced last week
Leading pharmacy benefit manager (PBM) Prime Therapeutics LLC (Prime) analyzed its real-world data to assess clinical outcomes and drug waste differences between medically integrated dispensing (MID) and central specialty pharmacy dispensing of oral cancer therapies. This study of a Prime pilot program showed a potential average savings opportunity of $1,800 per medication dose change at a MID pharmacy compared to a central fill specialty pharmacy. Results reinforced Prime’s position of the advantages of the MID model, on which its IntegratedRx™ program is based.
With the MID model, care providers – including doctors and pharmacists – have access to prescribing history, test results and other important patient information in the EMR. This coordination informs the care team earlier than the traditional model. This early look has potential to help lower the number of 30-day prescriptions going to waste.
Prime’s MID pilot program was implemented in early 2021 within three oncology practices and across three Blue Plans’ commercially insured lives to prove the potential care and cost advantages with this distinct model compared to a centralized specialty pharmacy model. Study participants were prescribed oral drugs that did not require dispensing and shipment from a payer-directed specialty pharmacy to the oncologist (aka white bagging).
From the studies department —
Health Payer Intelligence informs us “More consumers reported that their health plans are offering transparency tools and overall consumer awareness about the availability of transparency tools has grown, according to a study conducted on behalf of HealthSparq.”
MedPage Today discusses a study finding that weight loss, even when achieved by bariatric surgery, will reduce the risk of obesity-related cancer. The FEHBlog wonders if weight loss produced by the current, effective weight loss drugs would have a similar health impact.
mHealth Intelligence notes that “To reduce the amount of time spent in a virtual waiting room, researchers from the University of California San Diego conducted a pilot that used text messaging to provide patients with a meeting link when their provider was ready to see them, finding it to be a successful alternative.”
The New York Times reports on a GlaxoSmithKline “checkpoint inhibitor” drug trial conducted on eighteen rectal cancer patients. The drug wiped out the cancer in all of those patients. Quite amazing. According to the Times experts indicate that the trial needs to be replicated.
BioPharma Dive reports “Twenty-four years ago, a drug called Herceptin changed how doctors treat breast cancer. Its approval in 1998 made it possible to target the aggressive breast tumors tied to a gene called HER2. Other drugs quickly followed Herceptin and, over the years since, have substantially improved survival for people with the disease. A quarter of a century later, another shift in treatment could be on the horizon. At the American Society of Clinical Oncology meeting, AstraZeneca and Daiichi Sankyo are presenting results proving that, for the first time, a targeted medicine can help metastatic breast cancer patients whose tumors express only low levels of HER2. Clinical trial data revealed at ASCO and published in The New England Journal of Medicine Sunday show the drug, Enhertu, halved the risk of cancer progression compared to chemotherapy and reduced the risk of death by 36%.”
The Guardian tells us “Taller people have an increased risk of peripheral neuropathy, as well as skin and bone infections, but a lower risk of heart disease, high blood pressure and high cholesterol, according to the world’s largest study of height and disease. A person’s height raises and reduces their risk of a variety of diseases, according to the research led by Sridharan Raghavan of the Rocky Mountain Regional VA Medical Center in the US. The findings are published in the journal PLOS Genetics.”
From the potpourri department, check out this NIH Newsletter for June 2022.
Congress is back on Capitol Hill this week for floor voting and Committee business. Roll Call notes
Lawmakers return next week for a busy June, with Senate Republicans tested by politically wrought gun talks and President Joe Biden dealing with a spate of crises and headaches.
The Hill identifies the five “looming disputes” out of 33 pending disputes that the Supreme Court is expected to decide this month which typically is the last month of its October 2021 Term. Although not found among the Hill’s cases, here’s a Medicare secondary payer act case that has not been decided yet and could impact FEHBP.
Issue(s): (1) Whether a group health plan that provides uniform reimbursement of all dialysis treatments observe the prohibition provided by the Medicare Secondary Payer Act that group health plans may not “take into account” the fact that a plan participant with end stage renal disease is eligible for Medicare benefits; (2) whether a plan that provides the same dialysis benefits to all plan participants, and reimburses dialysis providers uniformly regardless of whether the patient has end stage renal disease, observe the prohibition under the Medicare Secondary Payer Act that a group health plan also may not “differentiate” between individuals with end stage renal disease and others “in the benefits it provides”; and (3) whether the Medicare Secondary Payer Act is a coordination-of-benefits measure designed to protect Medicare, not an antidiscrimination law designed to protect certain providers from alleged disparate impact of uniform treatment.
The Western U.S. region, which includes mountain and coastal states, has recently eclipsed the Northeast to have the nation’s highest rate of known cases per 100,000 people, a Wall Street Journal analysis of CDC data shows. Recent increases in parts of the West come amid declines in the Northeast.
NPR Shots provides more background on the Novovax Covid vaccine that the FDA advisory committee will consider for emergency use authorization this Tuesday. NPR Shots adds
The federal government is trying to decide what kind of booster people should get in the fall to try to blunt the severity of a possible new wave of infections next winter. The panel of FDA advisers will meet late this month to consider which strains of the coronavirus should be targeted by updated vaccines.
From the mental health coverage front, the American Hospital Association released a TrendWatch about the pandemic’s adverse impact on mental health. Also, Healthcare Dive informs us that while telehealth use dropped in February and March 2022, according to a Fair Health study,
Teletherapy continued to remain robust, snagging the top procedure spot for telehealth visits in March and representing 26% of virtual claim lines, the report noted. Mental health conditions claimed 65% of diagnoses across all regions. Likewise, social workers remained the most popular specialty in telehealth claims for the second month in a row.
From the value-based care front, Health Payer Intelligence discusses how payers can move providers away from fee-for-service contracts to value-based contracts. It’s worth a read.
From Capitol Hill, A bipartisan PBM transparency bill was introduced by Senators Maria Cantwell (D Wash) and Charles Grassley (R Iowa) last week.
Sens. Chuck Grassley (R-Iowa), ranking member of the Judiciary Committee, and Maria Cantwell (D-Wash.), chair of the Committee on Commerce, Science and Transportation, have introduced legislation that would empower the Federal Trade Commission (FTC) to increase drug pricing transparency and hold pharmacy benefit managers (PBMs) accountable for unfair and deceptive practices that drive up the costs of prescription drugs at the expense of consumers.
The Pharmacy Benefit Manager Transparency Act of 2022 would ban deceptive unfair pricing schemes; prohibit arbitrary claw backs of payments made to pharmacies; and require PBMs to report to the FTC how much money they make through spread pricing and pharmacy fees.
Healthcare Dive reports on a recent study supporting the goals of this bill.
From the Omicron and siblings front
Bloomberg Prognosis informs us
Turns out a third dose of messenger RNA vaccine provides a key boost to immunity against Covid regardless of the original shot.
That’s what scientists from the Chinese University of Hong Kong found after scouring 53 studies that contained at least 24 different vaccine regimens.
Three mRNA doses offered the best protection against infection, the researchers found, though just one of those shots as a booster after other types of Covid-19 vaccines worked almost as well.
The request Wednesday to the Food and Drug Administration comes after the companies said last month that three doses of the shot were 80% effective at preventing symptomatic Covid-19 and generated a robust immune response in children ages 6 months to 5 years old.
The Pfizer-BioNTech vaccine was also found to be safe and well-tolerated among the children in studies, according to the companies.
FDA clearance could come before the end of the month. If the Centers for Disease Control and Prevention signs off, the last remaining group of people in the U.S.—roughly 19 million young children—would get access to shots at doctors’ offices, pharmacies and other locations.
The FDA is scheduled to consider the Pfizer and Moderna emergency authorization requests for mRNA Covid vaccinations for children aged six months to five years.
A National Institutes of Health-funded study has found that people with food allergies are less likely to become infected with SARS-CoV-2, the virus that causes COVID-19, than people without them. In addition, while previous research identified obesity as a risk factor for severe COVID-19, the new study has identified obesity and high body mass index (BMI) as associated with increased risk for SARS-CoV-2 infection. In contrast, the study determined that asthma does not increase risk for SARS-CoV-2 infection.
The Human Epidemiology and Response to SARS-CoV-2 (HEROS) study also found that children ages 12 years or younger are just as likely to become infected with the virus as teenagers and adults, but 75% of infections in children are asymptomatic. In addition, the study confirmed that SARS-CoV-2 transmission within households with children is high. These findings were published today in the Journal of Allergy and Clinical Immunology.
Optum is still on an acquisition hot streak, scooping up Healthcare Associates of Texas, Axios reported Wednesday.
Sources told the news outlet that the purchase from Webster Equity Partners would earn HCAT a $300 million enterprise value and earnings before interest, taxes, depreciation and amortization in the high teens. UnitedHealth Group, Optum’s parent company, has made overtures to purchase HCAT in the past, according to the report.
HCAT has a large footprint in the Dallas-Fort Worth metropolitan area and has also invested heavily in value-based care, both of which make it an attractive buy for Optum.
Webster bought HCAT in 2016. Neither UnitedHealth nor HCAT has verified the veracity of the deal.
GSK is betting big to reenergize its fight for a share of the pneumococcal vaccine market, agreeing to pay $2.1 billion upfront to acquire Affinivax for a challenger to Pfizer’s blockbuster Prevnar franchise.
The British Big Pharma already has an approved pneumococcal vaccine, Synflorix, but has failed to turn it into a true rival to Pfizer’s incumbent. Sales of Synflorix fell (PDF) to 357 million pounds sterling ($450 million) last year, while the Prevnar range of vaccines still topped (PDF) $5 billion in the face of COVID-related headwinds and the timing of government purchases. Last year’s approval of Merck & Co.’s Vaxneuvance further intensified competition.
From the studies department
Forbes informs us “The U.S. spends twice as much on cancer care than average for high-income countries but mortality rates are only slightly better than average for these countries, according to a new study.”
Fierce Healthcare reports on a Kaiser Family News projection of 2022 insurer rebates required by the Affordable Care Act.
Kaiser’s analysis—which is based on data reported by insurers to state regulators—predicts that individual market insurers will have to pay out $603 million in rebates for 2022, with small group markets sending out $275.5 million and $168.1 million for large group plans. The final rates will be released later this year.
The $603 million for individual market plans, which includes the ACA’s exchanges, is far below the $1.3 billion in rebates for 2021 and $1.7 billion for 2020.
The sweeping FDA funding bill unveiled by senators Friday would direct the FDA to stand up an “intra-agency coordinating council” to oversee its use of the controversial accelerated approval pathway, my colleague Lev Facher writes. The policy seems a clear response to the controversy over the FDA’s approval of Aduhelm — and it’s the latest sign that lawmakers are within striking distance of reforming the controversial pathway, which allows the FDA to greenlight drugs without clear evidence they extend patients’ lives.
Accelerated approval not your bailiwick? There’s plenty more in the 433-page bill too, including a proposal from Sen. Elizabeth Warren that would force the FDA to finally release regulations meant to lower the cost of hearing aids. Conspicuously missing from the legislation? Any of the House’s proposals on clinical trial diversity.
The coronavirus mutant [BA 2.12.1] that is now dominant in the United States is a member of the omicron family but scientists say it spreads faster than its omicron predecessors, is adept at escaping immunity and might possibly cause more serious disease.
Why? Because it combines properties of both omicron and delta, the nation’s dominant variant in the middle of last year.
A genetic trait that harkens back to the pandemic’s past, known as a “delta mutation,” appears to allow the virus “to escape pre-existing immunity from vaccination and prior infection, especially if you were infected in the omicron wave,” said Dr. Wesley Long, a pathologist at Houston Methodist in Texas. That’s because the original omicron strain that swept the world didn’t have the mutation.
Most people with Covid-19 will still test positive on a rapid test at five days, and a “fairly large percentage” test positive after 10 days, CDC spokeswoman Jasmine Reed said. Infectiousness drops significantly at eight days, with few people remaining contagious at 10 days, she said.
The CDC guidance also takes symptoms into account as a factor to gauge contagiousness, she said, noting that people should only leave isolation after five days if their symptoms are improving. The CDC recommends that everyone wear a well-fitted mask and avoid travel and being around high-risk people for 10 days, no matter when the person leaves isolation. * * *
At the beginning of an infection, when a person’s viral load is rising, it might take a few days before tests turn positive. That is why health authorities recommend that people with symptoms and negative rapid-test results wait and retest or get a more sensitive lab-based PCR test.
As a person’s viral load drops, rapid tests are a better indicator of who is no longer infectious, public-health experts said. * * *
Immunocompromised people and those who get severely ill can be contagious even longer than 10 days, studies suggest, and patients who experience rebounding symptoms or who test positive again after taking Pfizer Inc.’s Paxlovid pill should also assume that they are contagious, infectious-disease experts said.
David Leonhardt writes about the benefits of one-way masking in his New York Times column today. “Because masks work and mandates often don’t, people can make their own decisions. Anybody who wants to wear a snug, high-quality mask can do so and will be less likely to contract Covid.” That makes sense to the FEHBlog.
In healthcare business new, the American Hospital Association informs us
According to a report by Kaufman Hall, hospitals faced decreases in both patient volume and revenue in April. Year-to-date hospitals have struggled to rebound from winter surges and new spikes in COVID-19. Median operating margins declined for the fourth straight month with patient volume down 6.5%, revenue down 7%, and expenses continued to climb well above pre-pandemic levels and 9.6% year-to-date higher than 2021.
* In its latest earnings report, Change Healthcare highlighted its momentum heading into the next fiscal year, outlining what 2023 could look like for the data analytics company as a standalone business in the event its controversial $13 billion merger with UnitedHealth falls through.
* In previous quarters, Change has not provided formal forward-looking guidance given the pending transaction. But in fourth-quarter results released last week, Change said it expects between 2% to 4% growth in its core Solutions business in 2023, moderately below analysts’ consensus, and roughly flat earnings before interest, taxes, depreciation and amortization margins.
* Change noted the flat margins are due to some wage pressure, lower volume-driven revenues as COVID-19 cases drop and client attrition due to its proposed merger with UnitedHealth’s health services arm, Optum.
The trial over the Justice Department’s challenge to this merger begins in August.
In public health news Medscape explains
Each day between 2017 and 2019, nearly 2,300 adolescents and young adults became new daily tobacco users — a figure that mirrors statistics from 1989 to 1993.
According to a longitudinal study, the total number of daily vape (or e-cigarette) users under 21 years of age rose to more than 1 million by 2019. Of those, 56.3% used Juul products in particular, reported cancer prevention researcher John Pierce, PhD, of the University of California San Diego in La Jolla, and colleagues in Pediatrics.
“The large increase in daily use among U.S. adolescents could presage future health consequences and needs urgent additional action from the [FDA],” the authors wrote.
From the mental health coverage front, the Society for Human Resources Management discusses how employers are grappling with a surge in employee mental health issues.
Also the Biden Administration marks the end of mental health awareness month by listing its accomplishments and plans, including
In addition to facilitating access to comprehensive telebehavioral health benefits through the Federal Employees Health Benefits Program, the Office of Personnel Management (OPM) is working to reinvigorate Employee Assistance Programs provided by all federal agencies to better meet employees’ behavioral health needs, while disseminating best practices and new ideas for improving federal workplace mental health.
From the medical research front, STAT News reports
Bay Area biotech Ultima Genomics on Tuesday claimed that its technology can sequence a whole human genome for $100, making it a surprise player in the race to read DNA quickly, accurately, and cheaply.
The company didn’t provide specifics or immediately reply to an inquiry from STAT as to how it calculated that cost. But a $100 genome would represent a major drop in price, one that could help researchers unlock sequencing’s potential to unravel the mysteries of undiagnosed diseases, spot early signs of cancer, and better understand human health. That’s because while the cost of reading a full human genome has plummeted from around $95 million in 2001 to about $560 in 2021, according to the National Human Genome Research Institute, sequencing is still too pricey to be routinely used in health care and research.
That’s an intriguing development.
We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.
This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the ...
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
Cookie
Duration
Description
cookielawinfo-checbox-analytics
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checbox-functional
11 months
The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checbox-others
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-necessary
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-performance
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy
11 months
The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
